European Parliament 2019-2024

Committee on the Environment, Public Health and Food Safety

2021/2013(INI)

10.6.2021

AMENDMENTS 1 - 723

Draft report Dolors Montserrat (PE681.109v02-00)

A Pharmaceutical Strategy for Europe (2021/2013(INI))

AM\1233943EN.docx PE693.845v01-00

EN United in diversityEN AM_Com_NonLegReport

PE693.845v01-00 2/362 AM\1233943EN.docx EN Amendment 1 Alessandra Moretti

Motion for a resolution Citation 2 a (new)

Motion for a resolution Amendment

— having regard to Article 6 TEU and Article 35 of the Charter of Fundamental Rights of the European Union on the right to preventive healthcare for all European citizens;

Or. en

Amendment 2 Ondřej Knotek, Linea Søgaard-Lidell, Susana Solís Pérez, Claudia Gamon, Billy Kelleher

Motion for a resolution Citation 3 a (new)

Motion for a resolution Amendment

— having regard to the Commission communication of 5 May 2021 on Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe's recovery (COM(2021)350),

Or. en

Amendment 3 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Citation 5 a (new)

Motion for a resolution Amendment

— having regard to the Commission’s Strategic Agenda for Medical Ionising Applications(SAMIRA) Action Plan of 5 February 2021 in support of the

AM\1233943EN.docx 3/362 PE693.845v01-00 EN European Beating Cancer Plan;

Or. en

Amendment 4 Margarita de la Pisa Carrión

Motion for a resolution Citation 5 a (new)

Motion for a resolution Amendment

— having regard to the Commission communication of 10 March 2020 entitled ‘A New Industrial Strategy for Europe’ COM (2020) 102 final

Or. es

Amendment 5 Alessandra Moretti

Motion for a resolution Citation 6 a (new)

Motion for a resolution Amendment

— having regard to the ongoing Commission revision of the Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products;

Or. en

Amendment 6 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Citation 6 a (new)

Motion for a resolution Amendment

PE693.845v01-00 4/362 AM\1233943EN.docx EN — having regard to the Council conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the EU and its Member States,

Or. en

Amendment 7 Alessandra Moretti

Motion for a resolution Citation 6 b (new)

Motion for a resolution Amendment

— having regard to the ongoing Commission revision of the Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use;

Or. en

Amendment 8 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Citation 6 b (new)

Motion for a resolution Amendment

— having regard to the Council’s conclusions on innovation for the benefit of patients of 1 December 2014;

Or. en

Amendment 9 Tiemo Wölken

Motion for a resolution Citation 7 a (new)

AM\1233943EN.docx 5/362 PE693.845v01-00 EN Motion for a resolution Amendment

— having regards to its resolution of 13 September 2018 on a European One Health Action Plan against Antimicrobial Resistance

Or. en

Amendment 10 Frédérique Ries

Motion for a resolution Citation 8 a (new)

Motion for a resolution Amendment

— having regard to its resolution of 10 July 2020 on the EU’s public health strategy post-COVID- 19(2020/2691(RSP)), calling for an EU action plan on rare and neglected diseases,

Or. en

Amendment 11 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Citation 8 a (new)

Motion for a resolution Amendment

— having regard to its resolution of 14 February 2017 on EU options for improving access to medicines;

Or. en

Amendment 12 César Luena, Javi López, Nicolás González Casares

PE693.845v01-00 6/362 AM\1233943EN.docx EN Motion for a resolution Citation 8 b (new)

Motion for a resolution Amendment

— having regard to its resolution of 13 September2018 entitled “A European One Health Action Plan against Antimicrobial Resistance”;

Or. en

Amendment 13 Tilly Metz

Motion for a resolution Citation 12 a (new)

Motion for a resolution Amendment

— having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency,

Or. en

Amendment 14 Véronique Trillet-Lenoir

Motion for a resolution Citation 12 a (new)

Motion for a resolution Amendment

— having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

AM\1233943EN.docx 7/362 PE693.845v01-00 EN Or. en

Amendment 15 Tilly Metz

Motion for a resolution Citation 12 b (new)

Motion for a resolution Amendment

— having regard to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products,

Or. en

Amendment 16 Véronique Trillet-Lenoir

Motion for a resolution Citation 12 b (new)

Motion for a resolution Amendment

— having regard to the Commission communication of 11 December 2019 on ‘The European Green Deal’

Or. en

Amendment 17 Tilly Metz

Motion for a resolution Citation 12 c (new)

Motion for a resolution Amendment

— having regard to Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use,

PE693.845v01-00 8/362 AM\1233943EN.docx EN Or. en

Amendment 18 Véronique Trillet-Lenoir

Motion for a resolution Citation 12 c (new)

Motion for a resolution Amendment

— having regard to its resolution of 15 January 2020 on the European Green Deal

Or. en

Amendment 19 Tilly Metz

Motion for a resolution Citation 12 d (new)

Motion for a resolution Amendment

— having regard to the Joint evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December2006 on medicinal products for paediatric use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products,

Or. en

Amendment 20 Tilly Metz

Motion for a resolution Citation 12 e (new)

Motion for a resolution Amendment

AM\1233943EN.docx 9/362 PE693.845v01-00 EN — having regard to the proposal for a Regulation of the European Parliament and of the Council on health technology assessment and the work of EUNetHTA Joint Actions,

Or. en

Amendment 21 Tilly Metz

Motion for a resolution Citation 12 f (new)

Motion for a resolution Amendment

— having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use,

Or. en

Amendment 22 Tilly Metz

Motion for a resolution Citation 12 g (new)

Motion for a resolution Amendment

— having regard to Directive 2010/63/EU of the European Parliament and of the Council of22 September 2010 on the protection of animals used in scientific procedures,

Or. en

Amendment 23 Tilly Metz

Motion for a resolution

PE693.845v01-00 10/362 AM\1233943EN.docx EN Citation 12 h (new)

Motion for a resolution Amendment

— having regard to its resolution of 2 March 2017 on EU options for improving access to medicines (2016/2057(INI)),

Or. en

Amendment 24 Tilly Metz

Motion for a resolution Citation 12 i (new)

Motion for a resolution Amendment

— having regard to the Council conclusions of 17 June2016 on strengthening the balance in the pharmaceutical systems in the EU and its Member States,

Or. en

Amendment 25 Tilly Metz

Motion for a resolution Citation 12 j (new)

Motion for a resolution Amendment

— having regard to Articles 101 and 102 TFEU laying down rules on competition,

Or. en

Amendment 26 Tilly Metz

Motion for a resolution

AM\1233943EN.docx 11/362 PE693.845v01-00 EN Citation 12 k (new)

Motion for a resolution Amendment

— having regard to the Doha Declaration on the Agreement on Trade- Related Aspects of Intellectual Property Rights and Public Health (WTO/MIN(01/DEC/2) and to the implementation of Paragraph 6 of the Doha Declaration of 1 September 2003(WTO/L/540),

Or. en

Amendment 27 Tilly Metz

Motion for a resolution Citation 12 l (new)

Motion for a resolution Amendment

— having regard to the 72nd World Health Assembly Resolution of May 2019 on Improving the transparency of markets for medicines, vaccines, and other health products,

Or. en

Amendment 28 Tilly Metz

Motion for a resolution Citation 12 m (new)

Motion for a resolution Amendment

— having regard to its resolution of 17 September 2020 on a strategic approach to pharmaceuticals in the environment,

Or. en

PE693.845v01-00 12/362 AM\1233943EN.docx EN Amendment 29 Tilly Metz

Motion for a resolution Citation 12 n (new)

Motion for a resolution Amendment

— having regard to Article 35 of the Charter of Fundamental Rights in the EU and Article 6(1) TEU on right to health protection for European citizens,

Or. en

Amendment 30 Tilly Metz

Motion for a resolution Recital A

Motion for a resolution Amendment

A. whereas health is fundamental to A. whereas the Charter of the well-being of Europeans and equitable Fundamental Rights of the European access to healthcare is a pillar of the EU; Union recognises the fundamental right whereas safe, affordable medicines are of citizens to health, quality of life and needed to combat all diseases; whereas medical treatment and public health patients should be at the centre of all health systems are crucial to guaranteeing policies, alongside investment and equitable access to health care and safe, research; effective and affordable medicines; whereas patients should be at the centre of all health policies and involved throughout the medicines regulatory pathway; whereas access inequalities exist between and within Member States and special regard should be paid to people in vulnerable situation with specific health risks, including women, children, the elderly, pregnant women, persons with disabilities, patients with chronic conditions and comorbidities, patients in intensive care units (ICU) and persons on long-term medication;

Or. en

AM\1233943EN.docx 13/362 PE693.845v01-00 EN Amendment 31 Véronique Trillet-Lenoir

Motion for a resolution Recital A

Motion for a resolution Amendment

A. whereas health is fundamental to A. whereas ensuring patient access to the well-being of Europeans and equitable medicines is one of the core objectives of access to healthcare is a pillar of the EU; the EU and the WHO, and of Sustainable whereas safe, affordable medicines are Development Goal 3; whereas universal needed to combat all diseases; whereas access to medicines depends on their patients should be at the centre of all health timely availability and their affordability policies, alongside investment and for everyone, without any geographical research; discrimination; whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research;

Or. en

Amendment 32 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Recital A

Motion for a resolution Amendment

A. whereas health is fundamental to A. whereas health is fundamental to the well-being of Europeans and equitable the well-being of Europeans and equitable access to healthcare is a pillar of the EU; access to healthcare is a pillar of the EU; whereas safe, affordable medicines are whereas the pandemic has demonstrated needed to combat all diseases; whereas the weakness of European health care patients should be at the centre of all health systems; whereas safe, innovative, policies, alongside investment and affordable medicines are needed to combat research; all diseases; whereas patients should be at the centre of all health policies, alongside investment and research;

PE693.845v01-00 14/362 AM\1233943EN.docx EN Or. en

Amendment 33 Andrey Slabakov, Joanna Kopcińska, Pietro Fiocchi, Ryszard Antoni Legutko, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Recital A

Motion for a resolution Amendment

A. whereas health is fundamental to A. whereas health is fundamental to the well-being of Europeans and equitable the well-being of Europeans and equitable access to healthcare is a pillar of the EU; access to healthcare is a pillar of the EU whereas safe, affordable medicines are Member States’ national health policies; needed to combat all diseases; whereas whereas safe, effective and affordable patients should be at the centre of all medicines are needed to combat all health policies, alongside investment and diseases; whereas public interest and research; patient safety and well-being should be at the centre of all health policies, alongside investment and research;

Or. en

Amendment 34 Kateřina Konečná

Motion for a resolution Recital A

Motion for a resolution Amendment

A. whereas health is fundamental to A. whereas health is fundamental to the well-being of Europeans and equitable the well-being of Europeans and equitable access to healthcare is a pillar of the EU; access to healthcare is a pillar of the EU; whereas safe, affordable medicines are whereas safe, affordable medicines are needed to combat all diseases; whereas needed to combat all diseases; whereas patients should be at the centre of all health patients should be at the centre of all health policies, alongside investment and policies, alongside investment and research; research; whereas patients should be involved in every aspect of the medicine regulatory lifecycle;

Or. en

AM\1233943EN.docx 15/362 PE693.845v01-00 EN Amendment 35 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Stelios Kympouropoulos, Cindy Franssen, Roberta Metsola

Motion for a resolution Recital A

Motion for a resolution Amendment

A. whereas health is fundamental to A. whereas health is fundamental to the well-being of Europeans and equitable the well-being of Europeans and equitable access to healthcare is a pillar of the EU; access to healthcare is a pillar of the EU; whereas safe, affordable medicines are whereas safe, affordable medicines are needed to combat all diseases; whereas needed to combat all diseases; whereas patients should be at the centre of all health patients should be at the centre of all health policies, alongside investment and policies, alongside investment and research; research, and in every aspect of the medicine regulatory lifecycle;

Or. en

Amendment 36 Pernille Weiss

Motion for a resolution Recital A

Motion for a resolution Amendment

A. whereas health is fundamental to A. whereas health is fundamental to the well-being of Europeans and equitable the well-being of Europeans and equitable access to healthcare is a pillar of the EU; access to healthcare is a pillar of the EU; whereas safe, affordable medicines are whereas safe, affordable and needed to combat all diseases; whereas innovative medicines are needed to combat patients should be at the centre of all health all diseases; whereas patients should be at policies, alongside investment and the centre of all health policies, alongside research; investment and research;

Or. en

Amendment 37 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Recital A

PE693.845v01-00 16/362 AM\1233943EN.docx EN Motion for a resolution Amendment

A. whereas health is fundamental to A. whereas health is fundamental to the well-being of Europeans and equitable the well-being of all and equitable access access to healthcare is a pillar of the EU; to healthcare is a pillar of the EU; whereas whereas safe, affordable medicines are safe, affordable medicines are needed to needed to combat all diseases; whereas combat all diseases; whereas patients patients should be at the centre of all health should be at the centre of all health policies, alongside investment and policies, and investment and research research; should be patient-centred;

Or. en

Amendment 38 Sara Cerdas

Motion for a resolution Recital A

Motion for a resolution Amendment

A. whereas health is fundamental to A. whereas health is fundamental to the well-being of Europeans and equitable the well-being of Europeans and equitable access to healthcare is a pillar of the EU; access to healthcare is a pillar of the EU; whereas safe, affordable medicines are whereas safe, affordable medicines are needed to combat all diseases; whereas needed to combat and prevent diseases; patients should be at the centre of all health whereas patients should be at the centre of policies, alongside investment and all health policies, alongside investment research; and research;

Or. en

Amendment 39 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Emma Wiesner

Motion for a resolution Recital A

Motion for a resolution Amendment

A. whereas health is fundamental to A. whereas health and equitable the well-being of Europeans and equitable access to healthcare are fundamental to access to healthcare is a pillar of the EU; the well-being of Europeans; whereas safe, whereas safe, affordable medicines are affordable medicines are needed to combat needed to combat all diseases; whereas all diseases; whereas patients should be at

AM\1233943EN.docx 17/362 PE693.845v01-00 EN patients should be at the centre of all health the centre of all health policies, alongside policies, alongside investment and investment and research; research;

Or. en

Amendment 40 Alessandra Moretti

Motion for a resolution Recital A a (new)

Motion for a resolution Amendment

A a. whereas the Treaties and the Charter of Fundamental Rights of the European Union state that everyone shall have access to preventive healthcare and the right to benefit from medical treatment under the conditions established by national laws and practices; whereas this right should be enforced for all citizens, including those living in the economically disadvantaged or smaller Member States and in the most peripheral areas of the Union; whereas shortage of medicines is a growing public health threat with a serious impact on healthcare systems and the right of every patient in the EU to access appropriate medical treatment;

Or. en

Amendment 41 Tilly Metz

Motion for a resolution Recital A a (new)

Motion for a resolution Amendment

A a. whereas the increasing burden of chronic diseases and health needs of aging populations combined with high and rising prices of medicinal products

PE693.845v01-00 18/362 AM\1233943EN.docx EN and an increase in the societal cost of providing care cause budgetary and affordability constraints and serious threats to the sustainability of European health systems; whereas the adoption of integrated models of care for chronic and other long term conditions, underpinned by a person-centred and multi- disciplinary approach to health care is essential to deliver high quality health services;

Or. en

Amendment 42 Kateřina Konečná

Motion for a resolution Recital A a (new)

Motion for a resolution Amendment

A a. A. whereas over time, trust in the pharmaceutical sector and its ability to promote the development of medical innovations while ensuring sustainable access has been eroded, and confidence in how this system works needs to be restored;

Or. en

Amendment 43 Jessica Polfjärd

Motion for a resolution Recital A a (new)

Motion for a resolution Amendment

A a. whereas a competitive and innovative pharmaceutical industry is of vital importance for the Union's public health, economic growth, science base and ability to create jobs and drive technological progress;

AM\1233943EN.docx 19/362 PE693.845v01-00 EN Or. en

Amendment 44 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Recital A a (new)

Motion for a resolution Amendment

A a. whereas the right to health is a fundamental right enshrined in article 35 of the Charter of Fundamental Rights of the European Union;

Or. en

Amendment 45 Pernille Weiss

Motion for a resolution Recital B

Motion for a resolution Amendment

B. whereas COVID-19 has had an B. whereas COVID-19 has had an impact on people’s health and on the impact on people’s health and on the economy; whereas it has highlighted both economy; whereas it has highlighted both the EU’s strengths and weaknesses; the EU’s strengths and weaknesses; whereas in order to strengthen the whereas development, production and resilience of our national health systems delivery of accessible, affordable, and to cross-border threats, more European available medicines can be supported by integration is necessary; whereas a applying a predictable EU policy European Health Union, which framework that fosters public and private contributes to an increasingly social investments benefitting both patients and Union, is key in this process; society as a whole;

Or. en

Amendment 46 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Susana Solís Pérez, Emma Wiesner

Motion for a resolution

PE693.845v01-00 20/362 AM\1233943EN.docx EN Recital B

Motion for a resolution Amendment

B. whereas COVID-19 has had an B. whereas COVID-19 has had an impact on people’s health and on the impact on people’s health and on the economy; whereas it has highlighted both economy; whereas it has highlighted both the EU’s strengths and weaknesses; the EU’s strengths and weaknesses; whereas in order to strengthen the whereas in order to strengthen the resilience of our national health systems to resilience of our national health systems to cross-border threats, more European cross-border threats, more European integration is necessary; whereas a integration is necessary; whereas a European Health Union, which contributes European Health Union should contribute to an increasingly social Union, is key in to and foster closer cooperation, this process; coordination and knowledge sharing on health between Member States and relevant stakeholders;

Or. en

Amendment 47 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Recital B

Motion for a resolution Amendment

B. whereas COVID-19 has had an B. whereas COVID-19 has had an impact on people’s health and on the impact on people’s health and on the economy; whereas it has highlighted both economy; whereas it has highlighted both the EU’s strengths and weaknesses; the EU’s strengths and weaknesses; whereas in order to strengthen the whereas in order to strengthen the resilience of our national health systems to resilience of our national health systems to cross-border threats, more European cross-border threats, more European integration is necessary; whereas a cooperation is necessary as well as a European Health Union, which contributes greater sharing of epidemiological and to an increasingly social Union, is key in health data at European level; whereas a this process; European Health Union, which contributes to an increasingly social Union, is key in this process;

Or. en

Amendment 48

AM\1233943EN.docx 21/362 PE693.845v01-00 EN Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Recital B

Motion for a resolution Amendment

B. whereas COVID-19 has had an B. whereas COVID-19 has had a huge impact on people’s health and on the impact on people’s health, physical and economy; whereas it has highlighted both mental, and on the economy; whereas it the EU’s strengths and weaknesses; has highlighted both the EU’s strengths whereas in order to strengthen the and weaknesses; whereas in order to resilience of our national health systems to strengthen the resilience of our national cross-border threats, more European health systems to cross-border threats, a integration is necessary; whereas a certain level of European integration is European Health Union, which necessary; contributes to an increasingly social Union, is key in this process;

Or. en

Amendment 49 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Recital B

Motion for a resolution Amendment

B. whereas COVID-19 has had an B. whereas COVID-19 has had an impact on people’s health and on the impact on people’s health and on the economy; whereas it has highlighted both economy; whereas it has highlighted both the EU’s strengths and weaknesses; the EU’s strengths and weaknesses; whereas in order to strengthen the whereas in order to strengthen the resilience of our national health systems to resilience and integrity of our national cross-border threats, more European health systems to cross-border health integration is necessary; whereas a threats, more European cooperation is European Health Union, which contributes necessary; whereas a European Health to an increasingly social Union, is key in Union plays an important role in this this process; process;

Or. en

Amendment 50 Jessica Polfjärd

PE693.845v01-00 22/362 AM\1233943EN.docx EN Motion for a resolution Recital B

Motion for a resolution Amendment

B. whereas COVID-19 has had an B. whereas COVID-19 has had an impact on people’s health and on the impact on people’s health and on the economy; whereas it has highlighted both economy; whereas it has highlighted both the EU’s strengths and weaknesses; the EU’s strengths and weaknesses; whereas in order to strengthen the whereas in order to strengthen the resilience of our national health systems to resilience of our national health systems to cross-border threats, more European cross-border threats, more integration is necessary; whereas a European cooperation and coordination is European Health Union, which contributes necessary; whereas a European Health to an increasingly social Union, is key in Union, which contributes to these this process; objectives, is key in this process;

Or. en

Amendment 51 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Stelios Kympouropoulos, Cindy Franssen, Roberta Metsola

Motion for a resolution Recital B a (new)

Motion for a resolution Amendment

B a. whereas the disruption of the global supply chain ensuing from the COVID-19 pandemic has highlighted the EU’s dependency on third countries in the health sector; whereas the EU's open strategic autonomy and security of supply should be ensured by diversification of supply chains for essential medicines and medicinal products, including European manufacturing sites, as well as by applying public procurement rules that should not consider price as the sole criterion;

Or. en

Amendment 52 Tilly Metz

AM\1233943EN.docx 23/362 PE693.845v01-00 EN Motion for a resolution Recital B a (new)

Motion for a resolution Amendment

B a. whereas the increasing levels of medicine shortages across Europe pose severe threats to patient safety and adversely impact patient outcomes and the patient care continuum; whereas the COVID-19 pandemic further highlighted the fragility of supply chains of medicinal products; whereas the understanding of root causes of medicine shortages are crucial for constructing an appropriate European response to this long-standing challenge;

Or. en

Amendment 53 Aldo Patriciello

Motion for a resolution Recital B a (new)

Motion for a resolution Amendment

B a. Whereas the combination of cost containment measures, lack of market predictability, combined with an onerous and rigid regulatory framework are challenging sustainable and equitable access to medicines, especially for very old inexpensive essential drugs, as well as the competitiveness of the European pharmaceutical industry;

Or. en

Amendment 54 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Recital B a (new)

PE693.845v01-00 24/362 AM\1233943EN.docx EN Motion for a resolution Amendment

B a. whereas during the COVID-19 pandemic, uncoordinated actions at national level, such as hoarding and extreme stockpiling, undermined the delivery of equitable supply in all markets; whereas this represents a lesson learnt to avoid in any future crisis situation

Or. en

Amendment 55 Jessica Polfjärd

Motion for a resolution Recital B a (new)

Motion for a resolution Amendment

B a. whereas healthcare is a national competence and thus an area over which Member States have ultimate responsibility;

Or. en

Amendment 56 Aldo Patriciello

Motion for a resolution Recital B b (new)

Motion for a resolution Amendment

B b. Whereas the COVID-19 experience also demonstrated how the European pharmaceutical industry and manufacturers have been resilient and had contingency plans in place avoiding any major disruption for critical products, notably on ICU medicines; whereas this was also possible thanks to the bilateral dialogue and two-way communication

AM\1233943EN.docx 25/362 PE693.845v01-00 EN established, demand visibility and close cooperation between governments/regulators and actors, a practice which should be maintained and continued on a regular basis;

Or. en

Amendment 57 Tilly Metz

Motion for a resolution Recital B b (new)

Motion for a resolution Amendment

B b. whereas there exists a large duplication in medical research which predominantly focuses on limited therapeutic areas; whereas public investment should be driven by public health and unmet medical needs; whereas a high degree of transparency should apply in publicly funded medical research from decision-making, investment to open science;

Or. en

Amendment 58 Tilly Metz

Motion for a resolution Recital B c (new)

Motion for a resolution Amendment

B c. whereas pharmaceutical companies receive public financial support at both national and EU level for the development and production of medicines; whereas these grants and subsidies are currently not conditioned by obligations to supply the market with subsidised products for affordable prices;

PE693.845v01-00 26/362 AM\1233943EN.docx EN Or. en

Amendment 59 Aldo Patriciello

Motion for a resolution Recital B c (new)

Motion for a resolution Amendment

B c. Whereas during the COVID-19 pandemic, uncoordinated actions at national level, such as hoarding and extreme stockpiling undermined the industry’s ability to deliver equitable supply in all markets; whereas this represents a lesson learnt to avoid in any future crisis situation;

Or. en

Amendment 60 Tilly Metz

Motion for a resolution Recital B d (new)

Motion for a resolution Amendment

B d. whereas gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring benefits in relation to the prevention, diagnosis, treatment and care of all diseases, provided they are effective, safe, affordable and accessible to all patients who need them;

Or. en

Amendment 61 Tilly Metz

AM\1233943EN.docx 27/362 PE693.845v01-00 EN Motion for a resolution Recital B e (new)

Motion for a resolution Amendment

B e. whereas accelerated approvals of medicinal products granted by the European Medicines Agency (EMA) should not compromise safety and efficacy of new treatments coming the EU market, not even in the times of public health crises; whereas all new treatments should demonstrate added clinical benefit and cost-effectiveness compared to existing products;

Or. en

Amendment 62 Tilly Metz

Motion for a resolution Recital B f (new)

Motion for a resolution Amendment

B f. whereas access to generics and biosimilars can generate substantial savings that can be reinvested in improved healthcare provision, as the EU annually spends 274billion USD (224 billion EUR) on pharmaceuticals, of which 76% (or 170 billion EUR)on patented medicinal products, compared to an annual expenditure of 24% (54billion EUR) on generic products; whereas robust competition rules and scrutiny is needed to enable entry of generics onto the market, reducing prices and ensuring the sustainability of healthcare systems and improving timely access for patients to affordable medicines;

Or. en

Amendment 63

PE693.845v01-00 28/362 AM\1233943EN.docx EN Tilly Metz

Motion for a resolution Recital B g (new)

Motion for a resolution Amendment

B g. whereas supplementary protection certificate (SPC) extends patent protection up to 5additional years, after the 20 years of patent expiry, with no proven direct link to innovation, by which it delays access to more affordable generic and biosimilar products, placing an unnecessary financial burden on national healthcare systems and hampering patients access to needed medicines;

Or. en

Amendment 64 Tilly Metz

Motion for a resolution Recital B h (new)

Motion for a resolution Amendment

B h. whereas the aim of intellectual property and regulatory incentives to benefit society and promote innovation in areas of public health and unmet medical needs should not be misused/abused nor pose threats to affordability and patient access to pharmaceuticals; whereas awarding such incentives and public funds should be conditioned by transparency of public funding, research data, R&D and other associated costs, and product prices, to ensure affordability and fair return on public investment;

Or. en

Amendment 65 Tilly Metz

AM\1233943EN.docx 29/362 PE693.845v01-00 EN Motion for a resolution Recital B i (new)

Motion for a resolution Amendment

B i. whereas, during a health emergency, the EU should support the introduction of waivers of patents, data and market exclusivity to enable global access to crucial health products to swiftly overcome the crisis;

Or. en

Amendment 66 Tilly Metz

Motion for a resolution Recital B j (new)

Motion for a resolution Amendment

B j. whereas rising prices of medicines and growing uncertainty on their real-life effectiveness pose challenges to health decision-making; whereas collaboration on horizon scanning, health technology assessment (HTA), joint price negotiations and joint procurement is crucial to achieve high quality evaluation, affordability and equal access to medicines throughout the EU;

Or. en

Amendment 67 Tilly Metz

Motion for a resolution Recital B k (new)

Motion for a resolution Amendment

B k. whereas the ‘One Health’ approach in restricting and optimising the

PE693.845v01-00 30/362 AM\1233943EN.docx EN use of antibiotics is needed to address antimicrobial resistance;

Or. en

Amendment 68 Tilly Metz

Motion for a resolution Recital B l (new)

Motion for a resolution Amendment

B l. whereas action is required throughout the lifecycle of medicines to reduce resource use, emissions and levels of pharmaceutical waste and residues in the environment;

Or. en

Amendment 69 Kateřina Konečná

Motion for a resolution Recital C

Motion for a resolution Amendment

C. whereas the pharmaceutical C. whereas the pharmaceutical strategy covers the full cycle of medicines, strategy covers the full cycle of medicines, including research, testing, authorisation, including research, testing, authorisation, consumption and disposal, and contributes consumption and disposal, and contributes to meeting the objectives of the European to meeting the objectives of the European Green Deal, the digital transformation and Green Deal, the digital transformation and climate neutrality; climate neutrality; whereas the strategy offers the opportunity to restore balance in the pharmaceutical sector between public and private interests in order to fulfil the Union’s primary mission in the pharmaceutical sector, which is to ensure patients’ access to affordable medicines that bring additional therapeutic benefits;

Or. en

AM\1233943EN.docx 31/362 PE693.845v01-00 EN Amendment 70 Tilly Metz

Motion for a resolution Recital C

Motion for a resolution Amendment

C. whereas the pharmaceutical C. whereas, in the spirit of the ‘One strategy covers the full cycle of medicines, Health’ approach, the pharmaceutical including research, testing, authorisation, strategy covers the full cycle of medicines, consumption and disposal, and contributes including research, testing, authorisation, to meeting the objectives of the European consumption and disposal, and contributes Green Deal, the digital transformation and to meeting the objectives of the European climate neutrality; Green Deal, the digital transformation and climate neutrality; whereas animal welfare should be ensured by meeting the goal of Directive 2010/63/EU for full replacement of all animals that are used for scientific purposes;

Or. en

Amendment 71 Alessandra Moretti

Motion for a resolution Recital C

Motion for a resolution Amendment

C. whereas the pharmaceutical C. whereas the pharmaceutical strategy covers the full cycle of medicines, strategy covers the full life cycle of including research, testing, authorisation, medicines, including collection and consumption and disposal, and contributes production of starting material, research, to meeting the objectives of the European testing, manufacturing, authorisation, Green Deal, the digital transformation and consumption and disposal, and contributes climate neutrality; to meeting the objectives of the European Green Deal, the Europe’s Beating Cancer Plan, the digital transformation and climate neutrality;

Or. en

PE693.845v01-00 32/362 AM\1233943EN.docx EN Amendment 72 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Recital C

Motion for a resolution Amendment

C. whereas the pharmaceutical C. whereas the pharmaceutical strategy covers the full cycle of medicines, strategy covers the full cycle of medicines, including research, testing, authorisation, including research, testing, authorisation, consumption and disposal, and contributes pre-and post-marketing to meeting the objectives of the European pharmacovigilance, consumption and Green Deal, the digital transformation and disposal, and contributes to meeting the climate neutrality; objectives of the European Green Deal, the digital transformation and climate neutrality;

Or. en

Amendment 73 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Recital C

Motion for a resolution Amendment

C. whereas the pharmaceutical C. whereas the pharmaceutical strategy covers the full cycle of medicines, strategy covers the full cycle of medicines, including research, testing, authorisation, including research, testing, authorisation, consumption and disposal, and contributes consumption and disposal, the digital to meeting the objectives of the European transformation and climate neutrality; Green Deal, the digital transformation and climate neutrality;

Or. en

Amendment 74 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez, Emma Wiesner

Motion for a resolution Recital C

AM\1233943EN.docx 33/362 PE693.845v01-00 EN Motion for a resolution Amendment

C. whereas the pharmaceutical C. whereas the pharmaceutical strategy covers the full cycle of medicines, strategy covers the full cycle of medicines, including research, testing, authorisation, including research, testing, authorisation, consumption and disposal, and contributes consumption and disposal, and contributes to meeting the objectives of the European to meeting the objectives of the European Green Deal, the digital transformation and Green Deal, the digital transformation, the climate neutrality; circular economy and climate neutrality;

Or. en

Amendment 75 Véronique Trillet-Lenoir

Motion for a resolution Recital C

Motion for a resolution Amendment

C. whereas the pharmaceutical C. whereas the pharmaceutical strategy covers the full cycle of medicines, strategy covers the full cycle of medicines, including research, testing, authorisation, including research, assessment, testing, consumption and disposal, and contributes authorisation, production, access, to meeting the objectives of the European consumption and disposal, and contributes Green Deal, the digital transformation and to meeting the objectives of the European climate neutrality; Green Deal, the digital transformation and climate neutrality;

Or. en

Amendment 76 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Recital C

Motion for a resolution Amendment

C. whereas the pharmaceutical C. whereas the pharmaceutical strategy covers the full cycle of medicines, strategy covers the full cycle of medicines including research, testing, authorisation, and medical devices, including research, consumption and disposal, and contributes testing, authorisation, consumption and to meeting the objectives of the European disposal, and contributes to meeting the Green Deal, the digital transformation and objectives of the European Green Deal, the climate neutrality; digital transformation and climate

PE693.845v01-00 34/362 AM\1233943EN.docx EN neutrality;

Or. en

Amendment 77 Sirpa Pietikäinen

Motion for a resolution Recital C

Motion for a resolution Amendment

C. whereas the pharmaceutical C. whereas the pharmaceutical strategy covers the full cycle of medicines, strategy covers the full cycle of medicines, including research, testing, authorisation, including research, manufacturing, consumption and disposal, and contributes testing, authorisation, consumption and to meeting the objectives of the European disposal, and contributes to meeting the Green Deal, the digital transformation and objectives of the European Green Deal, the climate neutrality; digital transformation and climate neutrality;

Or. en

Amendment 78 Peter Liese, Christine Schneider, Cindy Franssen

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. Whereas many innovations of the pharmaceutical industry are not really offering breakthrough improvements for the patients but are either so-called ‘me- too’ pharmaceuticals, which are just another substance for the same indication without major benefits or offer only minor improvements with significantly higher costs; whereas it would be beneficial for patients if the framework for the pharmaceutical industry in Europe would better incentivize real breakthrough innovations;

Or. en

AM\1233943EN.docx 35/362 PE693.845v01-00 EN Amendment 79 Christine Schneider

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

Ca. whereas the strategy must focus more on the innovative potential of European pharmaceutical research, in particular that conducted by SMEs and MidCaps, in order to strengthen Europe for the future; whereas close links must therefore be established with current and future EU strategies, whilst steps are taken to ensure that no additional administrative burdens are imposed on the undertakings in question;

Or. de

Amendment 80 Frédérique Ries

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas 40% of medicinal end products marketed in the EU originate in non-EU countries, while 60 - 80% of active pharmaceutical ingredients are produced in China and India; whereas this delocalisation of part of the production of essential components of medicines, vaccines and medical devices has direct consequences on the follow-up of treatments for patients;

Or. en

Amendment 81

PE693.845v01-00 36/362 AM\1233943EN.docx EN Stanislav Polčák

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas the overall consumption of pharmaceuticals continues to grow both globally and in the EU; whereas an important part of pharmaceuticals is prescribed, dispensed, sold or used inappropriately; whereas such misuse of pharmaceuticals means a waste of precious resources and can lead to health and environmental hazards;

Or. en

Amendment 82 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez, Emma Wiesner

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas, to secure the Union's lead position in the pharmaceutical development, the strategy must focus on strengthening the innovative potential of European pharmaceutical research as well as acknowledging and reinforcing the link with the EU industrial strategy, the SME strategy and the European Health Data Space;

Or. en

Amendment 83 Kateřina Konečná

Motion for a resolution Recital C a (new)

AM\1233943EN.docx 37/362 PE693.845v01-00 EN Motion for a resolution Amendment

C a. Whereas the pandemic has revealed the Union’s neglect of the EU pharmaceutical sector’s capacity to combat cross-border health threats by underfunding biomedical innovation and entrusting R&D necessary to meet public health needs to private companies operating for the purpose of making profit;

Or. en

Amendment 84 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas the strategy recognises the key role that generic and biosimilar medicines play in hugely increasing equitable access for patients and for the sustainability of healthcare systems and that their entry into the market after exclusivity expiry should not be delayed;

Or. en

Amendment 85 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. Whereas, to make Europe fit for the future, the strategy must focus on strengthening the innovative potential of European pharmaceutical research; whereas this requires a close link with the EU industrial strategy and the European

PE693.845v01-00 38/362 AM\1233943EN.docx EN Health Data Space;

Or. en

Amendment 86 Sirpa Pietikäinen

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas to make Europe fit for the future, the strategy must focus on strengthening the innovative potential of European pharmaceutical research; whereas this requires a close link with the EU industrial strategy and the European Health Data Space

Or. en

Amendment 87 Stanislav Polčák

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas the shortage of medicines in the European Union has worsened, in particular as a result of increased global demand; whereas the European Union has lost pharmaceutical independence and self-sufficiency as a result of the relocation of production to third countries;

Or. cs

Amendment 88 Sara Cerdas

AM\1233943EN.docx 39/362 PE693.845v01-00 EN Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas a competitiveand resilient European research-based pharmaceutical industry is more responsive to patients’ needs and to strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;

Or. en

Amendment 89 Marian-Jean Marinescu

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas one of the 20 principles of the European Pillar of Social Rights, reinforced by the Porto declaration, establishes that everyone has the right to timely access to affordable, preventive and curative health care of good quality;

Or. en

Amendment 90 Margarita de la Pisa Carrión

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

Ca. whereas the new pharmaceutical strategy must be implemented taking into account the lessons learned from the COVID-19 crisis, especially the need to reduce the EU's dependence in sectors of a strategic nature.

PE693.845v01-00 40/362 AM\1233943EN.docx EN Or. es

Amendment 91 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Stelios Kympouropoulos, Cindy Franssen, Roberta Metsola

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas a competitive and resilient European research-based pharmaceutical industry is more responsive to patients’ needs and to strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;

Or. en

Amendment 92 Aldo Patriciello

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas a competitive and resilient European research-based pharmaceutical industry is more responsive to patients’ needs and to strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;

Or. en

Amendment 93 Petros Kokkalis

Motion for a resolution Recital Γ a (new)

Motion for a resolution Amendment

AM\1233943EN.docx 41/362 PE693.845v01-00 EN Ca. whereas ensuring that patients have access to affordable essential medicines is one of the core objectives of the EU, the WHO and UN Sustainable Development Goal 3;

Or. el

Amendment 94 Alessandra Moretti

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas the entry of generics and biosimilars into the market is an important tool for increasing competition, reducing prices and ensuring the sustainability of healthcare systems; whereas their market entry should not be delayed;

Or. en

Amendment 95 Anja Hazekamp

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

Ca. whereas intensive animal husbandry, with large numbers of animals crowded together, leads to excessive use of veterinary pharmaceuticals, including antibiotics, as well as outbreaks of zoonotic diseases;

Or. nl

Amendment 96

PE693.845v01-00 42/362 AM\1233943EN.docx EN Pietro Fiocchi

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas a molecule can be repurposed, reformulated and combined with new digital technologies (complex combination) to address unmet patient needs and contribute to healthcare system sustainability;

Or. en

Amendment 97 Tiemo Wölken

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. whereas there is a need for coordination and interlinkage between the Pharmaceutical Strategy, the Beating Cancer plan, the Industrial Strategy for Europe and the Health Data Space;

Or. en

Amendment 98 Maria Spyraki

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. Whereas the strategy highlights the importance of removing barriers to access for generic and biosimilar medicines and the encouragement of their rapid uptake;

AM\1233943EN.docx 43/362 PE693.845v01-00 EN Or. en

Amendment 99 Pernille Weiss

Motion for a resolution Recital C a (new)

Motion for a resolution Amendment

C a. Whereas a growing portion of Europeans are living with co-morbidities; whereas these must be addressed in European health policies;

Or. en

Amendment 100 Alessandra Moretti

Motion for a resolution Recital C b (new)

Motion for a resolution Amendment

C b. whereas the longstanding problem of shortages of medicines within the EU has worsened in recent years; whereas the increase in global demand, as well as the COVID-19 pandemic, have further aggravated shortages of medicines, undermining health services in the Member States and entailing considerable risks for the health and care of patients, including disease progression and/or worsening of symptoms, increased delays or interruption in care or therapy, longer hospitalisations, increased exposure to falsified medicines, medication errors or adverse events occurring when the missing medicine is substituted by another, avoidable transmission of infectious diseases, significant psychological distress, and increased expenditure for the healthcare system; whereas the Member States have a duty to

PE693.845v01-00 44/362 AM\1233943EN.docx EN find swift and effective solutions, including through common European coordination and action; whereas medicine shortages have multifactorial and complex root causes; whereas some decision-making by the pharmaceutical industry, such as discontinuations of products and withdrawals from less profitable Member States’ markets, is also often a reason for medicine shortages;

Or. en

Amendment 101 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Susana Solís Pérez

Motion for a resolution Recital C b (new)

Motion for a resolution Amendment

C b. whereas there are variances and differences in health care systems, national regulation, implementation of EU-regulation, pricing and authorisation processes in the different Member States; whereas these differences are a result of Member States' legitimate competences on health; whereas the differences can lead to fragmentation and unpredictable circumstances for actors in the pharmaceutical sector that operate outside their own country;

Or. en

Amendment 102 Maria Spyraki

Motion for a resolution Recital C b (new)

Motion for a resolution Amendment

C b. Whereas for the Pharmaceutical

AM\1233943EN.docx 45/362 PE693.845v01-00 EN Strategy to be fully effective it is necessary that it incorporates lessons learnt from the COVID-19 crisis and takes into consideration the resilience demonstrated by the off-patent medicines industry during the COVID-19 outbreak, so as to build on in the existing European manufacturing capacity;

Or. en

Amendment 103 Aldo Patriciello

Motion for a resolution Recital C b (new)

Motion for a resolution Amendment

C b. whereas medicine producers made the biggest contribution to research investment in 2019, with over €37 billion; whereas the sector provides 800 000 direct jobs and a €109.4billion trade surplus; whereas the sector generates about three times more employment indirectly – upstream and downstream – than it does directly;

Or. en

Amendment 104 Pietro Fiocchi

Motion for a resolution Recital C b (new)

Motion for a resolution Amendment

C b. whereas the strategy recognises the key role that generic and biosimilar medicines play in hugely increasing equitable access for patients and for the sustainability of healthcare systems and that their entry into the market after exclusivity expiry should not be delayed;

PE693.845v01-00 46/362 AM\1233943EN.docx EN Or. en

Amendment 105 Margarita de la Pisa Carrión

Motion for a resolution Recital C b (new)

Motion for a resolution Amendment

Cb. whereas the pandemic has brought to the fore a number of pre-existing problems, such as limited capacity to produce vaccines, lack of essential medicines and an unevenly functioning supply chain.

Or. es

Amendment 106 Stanislav Polčák

Motion for a resolution Recital C b (new)

Motion for a resolution Amendment

C b. whereas the transfer of production to third countries tends to be motivated by an attempt to reduce production costs; whereas these savings are mainly due to more lax environmental, safety and labour law standards;

Or. cs

Amendment 107 Petros Kokkalis

Motion for a resolution Recital Γ b (new)

Motion for a resolution Amendment

AM\1233943EN.docx 47/362 PE693.845v01-00 EN Cb. whereas universal access to medicines, which is a basic right for all without discrimination, depends on their availability when needed and their affordability;

Or. el

Amendment 108 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Recital C b (new)

Motion for a resolution Amendment

C b. whereas generic medicines are the majority of prescription medicines dispensed to European patients and have doubled the access to medicines without impacting the healthcare budgets;

Or. en

Amendment 109 Tiemo Wölken

Motion for a resolution Recital C b (new)

Motion for a resolution Amendment

C b. whereas the entry of generic and biosimilar medicines play a key role in increasing equitable access for patients and hence market entry should not be unduly delayed;

Or. en

Amendment 110 Alessandra Moretti

Motion for a resolution

PE693.845v01-00 48/362 AM\1233943EN.docx EN Recital C c (new)

Motion for a resolution Amendment

C c. whereas the loss of European independence in the health sector is linked to the relocation of production, with 40 % of medicinal end products marketed in the EU now originating in third countries; whereas while Europe has a strong manufacturing footprint, the supply chain still relies heavily on subcontractors to produce pharmaceutical raw materials outside the EU, where labour costs and environmental standards are often lower, with the result that 60 % to 80 % of chemical active ingredients are manufactured outside the EU, mainly in China and India; whereas, to date, no label or labelling visible to patients and customers is required for medicinal products and active pharmaceutical ingredients (APIs) concerning their origin and country of manufacturing; whereas limited access to APIs required for the production of generic medicines poses a particular challenge; whereas the disruption of the global supply chain ensuing from the COVID-19 pandemic has highlighted even more the EU’s dependency on third countries in the health sector; whereas the novel coronavirus pandemic has also revealed shortages of medical devices, medical products and protective equipment;

Or. en

Amendment 111 Stanislav Polčák

Motion for a resolution Recital C c (new)

Motion for a resolution Amendment

C c. whereas there is convincing evidence that pharmaceuticals leach into

AM\1233943EN.docx 49/362 PE693.845v01-00 EN the environment, in particular into soil and water; whereas their presence can have adverse effects on wild animals such as fish, birds and insects and, as a result, broader impacts on the stability of individual ecosystems; whereas these medicines also appear in drinking water at lower concentrations;

Or. cs

Amendment 112 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez

Motion for a resolution Recital C c (new)

Motion for a resolution Amendment

C c. whereas it is both in the interest of the individual patient and the society as such to have a competitive and resilient pharmaceutical industry with strong roots in research; whereas a thriving industry to a higher degree can identify and address patients' medical needs and contribute to advances in public health, economic growth, employment, trade relations and in science and technology;

Or. en

Amendment 113 Pietro Fiocchi

Motion for a resolution Recital C c (new)

Motion for a resolution Amendment

C c. whereas the Bolar exemption allows the development of generic and biosimilar medicinal products for regulatory approvals during the IP protection of the reference product in

PE693.845v01-00 50/362 AM\1233943EN.docx EN order to ensure market entry as soon as possible after the IP expiry, based on the basic rationale that free competition should be allowed as soon as protection expires;

Or. en

Amendment 114 Maria Spyraki

Motion for a resolution Recital C c (new)

Motion for a resolution Amendment

C c. whereas it is important to recognise that cooperation is required between the Commission and Member States so as to set out ambitious implementation agendas with clear timelines and the necessary long-term financing to implement concrete actions that follow from the Pharmaceutical Strategy for Europe;

Or. en

Amendment 115 Petros Kokkalis

Motion for a resolution Recital Γ c (new)

Motion for a resolution Amendment

Cc. whereas, in many cases, the price of new innovative medicines is extremely high, to the point of being unaffordable for many European citizens and also threatening the sustainability of national health care systems;

Or. el

AM\1233943EN.docx 51/362 PE693.845v01-00 EN Amendment 116 Margarita de la Pisa Carrión

Motion for a resolution Recital C c (new)

Motion for a resolution Amendment

Cc. whereas there is a need to seek new synergies between the updated European industrial strategy, the pharmaceutical strategy, the EU4 health programme and the European recovery plan.

Or. es

Amendment 117 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Recital C c (new)

Motion for a resolution Amendment

C c. whereas biosimilar medicines create opportunities beyond access to medicines, such as benefit sharing across healthcare and thus providing better health and services to patients;

Or. en

Amendment 118 Pietro Fiocchi

Motion for a resolution Recital C d (new)

Motion for a resolution Amendment

C d. whereas a patent linkage system is declared incompatible with the EU pharmaceutical legislation in the Commission’s Pharmaceutical Sector Inquiry Report of 2009; whereas in the

PE693.845v01-00 52/362 AM\1233943EN.docx EN fragmented system of national pharmaceutical policies patent linkages exist, causing disruptions in the functioning of the single market with undue delays to competition at IP expiry;

Or. en

Amendment 119 Margarita de la Pisa Carrión

Motion for a resolution Recital C d (new)

Motion for a resolution Amendment

Cd. whereas the European Green Deal must encourage rather than hinder the development of a vibrant and dynamic pharmaceutical industry within the EU.

Or. es

Amendment 120 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Recital C d (new)

Motion for a resolution Amendment

C d. whereas the root causes of medicines shortage should be assessed and tackled in the context of a strategy on medicines shortage;

Or. en

Amendment 121 Pietro Fiocchi

Motion for a resolution Recital C e (new)

AM\1233943EN.docx 53/362 PE693.845v01-00 EN Motion for a resolution Amendment

C e. whereas biosimilar medicines create opportunities beyond access to medicines, such as benefit sharing across healthcare and thus providing better health and services to patients;

Or. en

Amendment 122 Pietro Fiocchi

Motion for a resolution Recital C f (new)

Motion for a resolution Amendment

C f. whereas generic medicines are the majority of prescription medicines dispensed to European patients and have doubled the access to medicines without impacting the healthcare budgets;

Or. en

Amendment 123 Pietro Fiocchi

Motion for a resolution Recital C g (new)

Motion for a resolution Amendment

C g. whereas patents have a significant impact on access to medicines and on sustainability of healthcare budgets; whereas the European Patent Office (EPO) plays a key role in the registration of European patents and it is fundamental to ensure the highest quality and efficiency of the patent granting process in the interest of patent applicants, consumers and the public;

Or. en

PE693.845v01-00 54/362 AM\1233943EN.docx EN Amendment 124 Tilly Metz

Motion for a resolution Subheading 1

Motion for a resolution Amendment

Putting patients at the centre of all health Putting patients and public health at the policies centre of pharmaceutical research and decision-making

Or. en

Amendment 125 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Paragraph -1 (new)

Motion for a resolution Amendment

-1. Underlines that COVID-19 has brought challenges for health systems, their sustainability, but also had a dramatic impact on non-covid patients, including those suffering from chronic conditions, and their ability to access treatments and care; calls on the Commission and Member States to take seriously the impact for non-covid patients and to work collaboratively to ensure no patient is left behind and continuity of care is ensured even during emergency situations;

Or. en

Amendment 126 Nathalie Colin-Oesterlé

Motion for a resolution Paragraph -1 (new)

AM\1233943EN.docx 55/362 PE693.845v01-00 EN Motion for a resolution Amendment

-1. Stresses the geostrategic imperative for the Union to regain its independence with regard to healthcare, to secure rapidly and efficiently its supply of affordable medicines, medical equipment, medical devices, active substances, diagnostic tools and vaccines, and to prevent shortages thereof, prioritising the interest and safety of patients;

Or. fr

Amendment 127 Tilly Metz

Motion for a resolution Paragraph -1 (new)

Motion for a resolution Amendment

-1. Calls for national and European measures to guarantee the rights of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies; calls on Member States to guarantee the sustainability of public healthcare systems; stresses that patient access to medicines is a shared responsibility of all actors in the healthcare system;

Or. en

Amendment 128 Alessandra Moretti

Motion for a resolution Paragraph -1 (new)

Motion for a resolution Amendment

-1 Stresses that the EU pharmaceutical strategy should be

PE693.845v01-00 56/362 AM\1233943EN.docx EN focusing on the interest of patients and that any support or public funding should be conditioned to the protection of public health and equitable access to healthcare services and treatments in the EU;

Or. en

Amendment 129 Alessandra Moretti

Motion for a resolution Paragraph -1 a (new)

Motion for a resolution Amendment

-1 a Stresses the geostrategic imperative for the Union to regain its independence with regard to healthcare, to secure rapidly and efficiently its supply of affordable medicines, medical equipment, medical devices, active substances, diagnostic tools and vaccines, and stresses the importance to decrease the EU’s reliance on third countries’ imports of key starting material of plasma for the manufacturing of plasma-derived medicinal products, and to prevent shortages thereof, prioritising the interest and safety of patients; stresses the importance of ensuring that all Member States have fair access to the supply chain; highlights, to that end, the need for the Union’s pharmaceutical industry to have a diversified supply chain and a medicine shortage risk mitigation plan to cope with any vulnerabilities and risks to their supply chain;

Or. en

Amendment 130 Nathalie Colin-Oesterlé

Motion for a resolution Paragraph -1 a (new)

AM\1233943EN.docx 57/362 PE693.845v01-00 EN Motion for a resolution Amendment

-1a. Points out that while the Member States are responsible for the definition and organisation of their health policies, the Union is responsible for pharmaceutical legislation as well as various public health policies, and it is incumbent on the EU to coordinate and complement national measures to guarantee access to affordable and high- quality health services for all EU citizens and residents;

Or. fr

Amendment 131 Alessandra Moretti

Motion for a resolution Paragraph 1

Motion for a resolution Amendment

1. Stresses that investment in research 1. Stresses that fair and equitable into and the development of innovative access to safe, effective, high-quality and medicines and treatments, as well as access affordable healthcare services and to safe, effective and high-quality treatments for all, as well as investment in medicines, are essential for making research into and the development of progress in the prevention and treatment of innovative medicines and treatments, are diseases; essential for making progress in the prevention, diagnosis, treatment of diseases and quality of life of patients; regrets the disparities into the access to high quality healthcare services among member states and also between different regions within member states and asks the Commission to address those disparities with the appropriate legislative measures in order to ensure equal rights in the EU;

Or. en

Amendment 132 Tilly Metz

PE693.845v01-00 58/362 AM\1233943EN.docx EN Motion for a resolution Paragraph 1

Motion for a resolution Amendment

1. Stresses that investment in research 1. Stresses that public and private into and the development of innovative investment in research, including the medicines and treatments, as well as development of innovative treatments, access to safe, effective and high-quality shall be driven by public health and medicines, are essential for making unmet medical needs, defined with the progress in the prevention and treatment involvement of regulators, academia, of diseases; healthcare professionals, patients and payers at early stages of R&D, to ensure research priorities respond to societal needs and enable access to safe, effective, high-quality and affordable medicines, while ensuring collaboration and minimum duplication in ongoing studies;

Or. en

Amendment 133 Tiemo Wölken

Motion for a resolution Paragraph 1

Motion for a resolution Amendment

1. Stresses that investment in research 1. Stresses that investment in research into and the development of innovative into and the development of innovative medicines and treatments, as well as access diagnostics and medicines and treatments, to safe, effective and high-quality as well as access to safe, effective and medicines, are essential for making high-quality medicines, are essential for progress in the prevention and treatment of making progress in the prevention and diseases; treatment of diseases; points out that embedding meaningful patient involvement throughout the entire life cycle of medicines and other therapies will be an indispensable requirement to achieve high-value innovation, patient benefit and patient safety; further underlines that EU Funding Programmes such as the future Framework Programme (Horizon Europe) must prioritize research on public health needs, especially those in the area neglected by

AM\1233943EN.docx 59/362 PE693.845v01-00 EN the for-profit private sector, hence contributing to the development of medicines that bring actual added therapeutic value;

Or. en

Amendment 134 Simona Baldassarre, Silvia Sardone, Gianantonio Da Re, Lucia Vuolo, Susanna Ceccardi

Motion for a resolution Paragraph 1

Motion for a resolution Amendment

1. Stresses that investment in research 1. Stresses that investment in research into and the development of innovative into and the development of innovative medicines and treatments, as well as access medicines and treatments, as well as access to safe, effective and high-quality to safe, effective and high-quality medicines, are essential for making medicines, are essential for making progress in the prevention and treatment of progress in the prevention and treatment of diseases; diseases; underlines that women are under-represented in clinical trials, resulting in late-stage studies with no sound data on the efficacy or side-effects of a drug in the female population, and that it is therefore necessary to differentiate safety data and analyses by sex;

Or. en

Amendment 135 Kateřina Konečná

Motion for a resolution Paragraph 1

Motion for a resolution Amendment

1. Stresses that investment in research 1. Stresses that investment in research into and the development of innovative into and the development of innovative medicines and treatments, as well as access medicines and treatments, as well as access to safe, effective and high-quality to safe, effective and high-quality medicines, are essential for making and affordable medicines, are essential for

PE693.845v01-00 60/362 AM\1233943EN.docx EN progress in the prevention and treatment of making progress in the prevention and diseases; treatment of diseases and for improving the quality of healthcare given to patients;

Or. en

Amendment 136 Sara Cerdas

Motion for a resolution Paragraph 1

Motion for a resolution Amendment

1. Stresses that investment in research 1. Stresses that investment in research into and the development of innovative into and the development of innovative medicines and treatments, as well as access medicines and treatments, as well as access to safe, effective and high-quality to safe, effective and high-quality medicines, are essential for making medicines, are essential for making progress in the prevention and treatment of progress in the prevention and treatment of diseases; diseases and for improving the quality of healthcare given to patients;

Or. en

Amendment 137 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 1

Motion for a resolution Amendment

1. Stresses that investment in research 1. Stresses that public investment in into and the development of innovative research into and the development of medicines and treatments, as well as access innovative medicines and treatments, as to safe, effective and high-quality well as ensuring access to safe, effective medicines, are essential for making and high-quality medicines, are essential progress in the prevention and treatment of for making progress in the prevention and diseases; treatment of diseases;

Or. en

Amendment 138

AM\1233943EN.docx 61/362 PE693.845v01-00 EN Nicolae Ştefănuță

Motion for a resolution Paragraph 1

Motion for a resolution Amendment

1. Stresses that investment in research 1. Stresses that investment in research into and the development of innovative and the development of innovative medicines and treatments, as well as access medicines and treatments, as well as equal to safe, effective and high-quality access to safe, effective, affordable and medicines, are essential for making high-quality medicines, are essential for progress in the prevention and treatment of making progress in the prevention and diseases; treatment of diseases;

Or. en

Amendment 139 Nicolás González Casares

Motion for a resolution Paragraph 1

Motion for a resolution Amendment

1. Stresses that investment in research 1. Stresses that investment in research into and the development of innovative into and the development of innovative medicines and treatments, as well as access medicines and treatments, as well as access to safe, effective and high-quality to safe, effective and high-quality medicines, are essential for making medicines, are essential for making progress in the prevention and treatment of progress in the prevention, diagnostics and diseases; treatment of diseases;

Or. en

Amendment 140 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez, Emma Wiesner

Motion for a resolution Paragraph 1

Motion for a resolution Amendment

1. Stresses that investment in research 1. Stresses that investment in research into and the development of innovative into and the development of innovative

PE693.845v01-00 62/362 AM\1233943EN.docx EN medicines and treatments, as well as access medicines, diagnostics and treatments, as to safe, effective and high-quality well as access to safe, effective and high- medicines, are essential for making quality medicines, are essential for making progress in the prevention and treatment of progress in the prevention and treatment of diseases; diseases;

Or. en

Amendment 141 Marian-Jean Marinescu

Motion for a resolution Paragraph 1 – point 1 (new)

Motion for a resolution Amendment

(1) Considers that equal access to medicines for all EU patients, in terms of affordability and accessibility should be one of the pillars of the revised Pharmaceutical Strategy, as the principles of putting patients at the centre of all health policies demands;

Or. en

Amendment 142 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez

Motion for a resolution Paragraph 1 a (new)

Motion for a resolution Amendment

1 a. Notes with concern that most new medicines are launched earlier in the US than in the EU; notes that this delay is partly due to longer timelines for authorisation procedures in the EU; requests the Commission to assess how the EU’s procedures for authorisation can be made more efficient and timely, in order to allow EU patients to benefit from medicines that can improve their conditions sooner; invites the Commission

AM\1233943EN.docx 63/362 PE693.845v01-00 EN to propose adequate resources for the EMA to achieve this objective;

Or. en

Amendment 143 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Paragraph 1 a (new)

Motion for a resolution Amendment

1 a. Calls on the Commission and Member States to take the necessary measures so that non-covid patients do not suffer in terms of access to care and treatments during health crisis, as it has been the case during the COVID-19 emergency; underlines the importance of acting in terms of monitoring, access to diagnosis, screening and treatments, digital solutions and appropriate resources;

Or. en

Amendment 144 Pietro Fiocchi

Motion for a resolution Paragraph 1 a (new)

Motion for a resolution Amendment

1 a. Stresses the importance of optimisation and efficient use of existing therapeutic options, including off-patent generic and biosimilar medicines use wherever they are available, in all policies in support of sustainable and equitable access and care, equity and affordability;

Or. en

PE693.845v01-00 64/362 AM\1233943EN.docx EN Amendment 145 Petros Kokkalis

Motion for a resolution Paragraph 1 a (new)

Motion for a resolution Amendment

1a. Points out that healthcare is a human right enshrined in the Universal Declaration of Human Rights; points out that equal access to medicines must be ensured in order to uphold this right;

Or. el

Amendment 146 Frédérique Ries

Motion for a resolution Paragraph 1 a (new)

Motion for a resolution Amendment

1 a. Stresses that in order to develop effective treatments, the patient’s perspective must be taken into account in the research, development but also in regulatory, assessment and appraisal processes for rare diseases therapies;

Or. en

Amendment 147 Petar Vitanov

Motion for a resolution Paragraph 1 a (new)

Motion for a resolution Amendment

1 a. Recognizes the role of off-patent generic and biosimilar medicines, wherever they are available, in contributing to the sustainable and equitable access, care and affordability

AM\1233943EN.docx 65/362 PE693.845v01-00 EN for patients;

Or. en

Amendment 148 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 1 a (new)

Motion for a resolution Amendment

1 a. Calls for the strengthening of the European Medicines Market to speed up patient access to medicines, improve public health, make care more affordable and maximize savings in national health budgets;

Or. en

Amendment 149 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Stelios Kympouropoulos, Cindy Franssen

Motion for a resolution Paragraph 1 a (new)

Motion for a resolution Amendment

1 a. Stresses the importance of improving patients and healthcare professionals’ education on medicines by setting up a dedicated Europe-wide online resource centre;

Or. en

Amendment 150 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Stelios Kympouropoulos, Cindy Franssen, Roberta Metsola

Motion for a resolution Paragraph 1 b (new)

PE693.845v01-00 66/362 AM\1233943EN.docx EN Motion for a resolution Amendment

1 b. Welcomes the upcoming creation of the European Health Emergency Preparedness and Response Authority (HERA) and calls for the allocation of sufficient resources and power autonomy to broadly address all the cross-borders threats to health that EU could face in the middle term and beyond the sole COVID- 19 pandemic, including resources for the development of new therapeutics against viral and bacterial pathogens;

Or. en

Amendment 151 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 1 b (new)

Motion for a resolution Amendment

1 b. Considers that Member States should converge on the evaluation of medical technologies; looks forward to a timely adoption of the Regulation on Health Technology Assessment (HTA) by the European Parliament and the Council to ensure rapid access to innovative treatments;

Or. en

Amendment 152 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that research and research has not been sufficient to meet scientific progress have so far not resulted

AM\1233943EN.docx 67/362 PE693.845v01-00 EN the therapeutic needs of patients with rare in developing successful therapies for diseases, paediatric cancers and patients with rare diseases, chronic neurodegenerative diseases or to deal with diseases including cancer and paediatric antimicrobial resistance (AMR); cancers, and neurodegenerative diseases, or in means to deal with the growing threat of antimicrobial resistance (AMR), concerning all AMR pathogens, or to prevent infectious diseases outbreaks; calls for the introduction of new targeted measures to effectively address these areas;

Or. en

Amendment 153 Aldo Patriciello

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that research and research has not been sufficient to meet scientific progress have not yet been the therapeutic needs of patients with rare sufficient for the underserved areas of rare diseases, paediatric cancers and diseases, paediatric cancers and neurodegenerative diseases or to deal with neurodegenerative diseases, or to deal with antimicrobial resistance (AMR); antimicrobial resistance (AMR) concerning all AMR concerning all AMR pathogens, or to prevent infectious diseases outbreaks; calls for the introduction of new targeted incentives to effectively address these areas;

Or. en

Amendment 154 Alessandra Moretti

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Underlines that investment in research has not been sufficient to meet research should be further conditioned to

PE693.845v01-00 68/362 AM\1233943EN.docx EN the therapeutic needs of patients with rare public interest, recalls that public and diseases, paediatric cancers and private investments should be oriented neurodegenerative diseases or to deal with with the necessary regulatory and antimicrobial resistance (AMR); legislative measures to meet the therapeutic needs of patients, including rare diseases, rare adult cancers and paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);

Or. en

Amendment 155 Pietro Fiocchi

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that research and research has not been sufficient to meet scientific progress have not yet been the therapeutic needs of patients with rare sufficient for the underserved areas of rare diseases, paediatric cancers and diseases, paediatric cancers and neurodegenerative diseases or to deal with neurodegenerative diseases, to deal with antimicrobial resistance (AMR); antimicrobial resistance (AMR) concerning all AMR pathogens, or to prevent infectious diseases outbreaks; calls for the introduction of new targeted incentives to effectively address these areas;

Or. en

Amendment 156 Petar Vitanov

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that research and research has not been sufficient to meet scientific progress has not yet produced the therapeutic needs of patients with rare sufficiently successful therapies diseases, paediatric cancers and for patients with rare diseases, chronic

AM\1233943EN.docx 69/362 PE693.845v01-00 EN neurodegenerative diseases or to deal with diseases, cancers, in particular paediatric antimicrobial resistance (AMR); cancers, and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);

Or. en

Amendment 157 Marian-Jean Marinescu

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Stresses that investments in research has not been sufficient to meet research should prioritise the needs of the therapeutic needs of patients with rare patients and health systems and focus on diseases, paediatric cancers and the greatest unmet needs of patients with neurodegenerative diseases or to deal with rare diseases, paediatric cancers and antimicrobial resistance (AMR); neurodegenerative diseases or to deal with antimicrobial resistance (AMR);

Or. en

Amendment 158 Nicolae Ştefănuță

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that investment in research has not been sufficient to meet the research has not been sufficient to meet the therapeutic needs of patients with rare therapeutic needs of patients with rare diseases, paediatric cancers and diseases, paediatric cancers and neurodegenerative diseases or to deal with neurodegenerative diseases or to deal with antimicrobial resistance (AMR); antimicrobial resistance (AMR); acknowledges the need to find innovative financing models for incentivizing research and development of novel medicine for diseases that are otherwise perceived as being unattractive to industry due to potentially low market value and revenue;

PE693.845v01-00 70/362 AM\1233943EN.docx EN Or. en

Amendment 159 Tilly Metz

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that investment in research has not been sufficient to meet the research has not been sufficient in relation therapeutic needs of patients with rare to quality of life and late effects of diseases, paediatric cancers and treatments, to meet the specific therapeutic neurodegenerative diseases or to deal with needs of patients with rare diseases, antimicrobial resistance (AMR); paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance(AMR); calls for gender equality and additional research inpatient populations regularly excluded from clinical studies, such as children, pregnant women and the elderly;

Or. en

Amendment 160 Carlo Calenda

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that investment in research has not been sufficient to meet the research has not been sufficient to meet the therapeutic needs of patients with rare therapeutic needs of patients with rare diseases, paediatric cancers and diseases, paediatric cancers and neurodegenerative diseases or to deal with neurodegenerative diseases or to deal with antimicrobial resistance (AMR); antimicrobial resistance (AMR); calls on the Commission to strengthen industrial policy in the pharmaceutical sector and stimulate investment in non-patented paediatric medicines;

Or. it

AM\1233943EN.docx 71/362 PE693.845v01-00 EN Amendment 161 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that investment in research has not been sufficient to meet the research has not been sufficient to meet the therapeutic needs of patients with rare therapeutic needs of patients with rare diseases, paediatric cancers and diseases, paediatric cancers and neurodegenerative diseases or to deal with neurodegenerative diseases or to deal with antimicrobial resistance (AMR); antimicrobial resistance (AMR); calls for unmet needs and the concept of additional therapeutic value too be more closely defined.

Or. es

Amendment 162 Tiemo Wölken

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that investment in research has not been sufficient to meet the research has not been sufficient to meet the therapeutic needs of patients with rare therapeutic needs of patients with rare diseases, paediatric cancers and diseases, paediatric cancers and neurodegenerative diseases or to deal with neurodegenerative diseases, deal with antimicrobial resistance (AMR); antimicrobial resistance (AMR) concerning all AMR pathogens, or prevent infectious diseases outbreaks;

Or. en

Amendment 163 Sara Cerdas

Motion for a resolution Paragraph 2

PE693.845v01-00 72/362 AM\1233943EN.docx EN Motion for a resolution Amendment

2. Considers that investment in 2. Considers that investment in research has not been sufficient to meet the research has not been sufficient to meet the therapeutic needs of patients with rare therapeutic needs of patients with rare diseases, paediatric cancers and diseases, paediatric cancers, neurodegenerative diseases or to deal with neurodegenerative diseases or chronic antimicrobial resistance (AMR); diseases, to deal with antimicrobial resistance (AMR) or to deal with prevent infectious diseases;

Or. en

Amendment 164 Kateřina Konečná

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that investment in research has not been sufficient to meet the research has not been sufficient to meet the therapeutic needs of patients with rare therapeutic needs of many patients with diseases, paediatric cancers and chronic diseases – including those with neurodegenerative diseases or to deal with rare diseases, paediatric cancers and antimicrobial resistance (AMR); neurodegenerative diseases, or to deal with antimicrobial resistance (AMR);

Or. en

Amendment 165 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez, Emma Wiesner

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that investment in research has not been sufficient to meet the research has not been sufficient to meet the therapeutic needs of patients with rare diagnostic and therapeutic needs of diseases, paediatric cancers and patients with rare or chronic diseases such neurodegenerative diseases or to deal with as paediatric cancers and

AM\1233943EN.docx 73/362 PE693.845v01-00 EN antimicrobial resistance (AMR); neurodegenerative diseases or to deal with antimicrobial resistance (AMR);

Or. en

Amendment 166 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that public investment in research has not been sufficient to meet the research has not been sufficient to meet the therapeutic needs of patients with rare therapeutic needs of patients, particularly diseases, paediatric cancers and patients with rare diseases, paediatric neurodegenerative diseases or to deal with cancers and neurodegenerative diseases, or antimicrobial resistance (AMR); to deal with antimicrobial resistance (AMR);

Or. en

Amendment 167 Alexander Bernhuber

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that investment in research has not been sufficient to meet the research and scientific progress have therapeutic needs of patients with rare not been sufficient to meet the therapeutic diseases, paediatric cancers and needs of patients with rare diseases, neurodegenerative diseases or to deal with paediatric cancers and neurodegenerative antimicrobial resistance (AMR); diseases or to deal with antimicrobial resistance (AMR);

Or. en

Amendment 168 Tiemo Wölken

PE693.845v01-00 74/362 AM\1233943EN.docx EN Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that investment in research has not been sufficient to meet the research has not been sufficient to meet the therapeutic needs of patients with rare diagnostic and therapeutic needs of diseases, paediatric cancers and patients with rare diseases, paediatric neurodegenerative diseases or to deal with cancers and neurodegenerative diseases or antimicrobial resistance (AMR); to deal with antimicrobial resistance (AMR);

Or. en

Amendment 169 Pernille Weiss

Motion for a resolution Paragraph 2

Motion for a resolution Amendment

2. Considers that investment in 2. Considers that investment in research has not been sufficient to meet the research has not been sufficient to meet the therapeutic needs of patients with rare therapeutic needs of patients with rare diseases, paediatric cancers and diseases, paediatric cancers, obesity and neurodegenerative diseases or to deal with neurodegenerative diseases or to deal with antimicrobial resistance (AMR); antimicrobial resistance (AMR);

Or. en

Amendment 170 Tilly Metz

Motion for a resolution Paragraph 2 a (new)

Motion for a resolution Amendment

2 a. Calls for research results and data sets from all clinical trials submitted to the EMA for marketing authorisation to be publicly available, in order to build trust in the EU’s regulatory framework and foster further research concerning a

AM\1233943EN.docx 75/362 PE693.845v01-00 EN products’ efficacy and safety; stresses that timely public disclosure of results from clinical trials increases value and efficiency in the use of funds and reduces reporting bias, which ultimately leads to better decision-making in health;

Or. en

Amendment 171 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Paragraph 2 a (new)

Motion for a resolution Amendment

2 a. Recalls its invitation to the Member States, in cooperation with the Commission, to consider the possibility of the establishment of a pooled public platform for R&D financed by all Member States via a minimum contribution of 0.01 % of their GDP; considers that this platform should also be able to directly produce life-saving medicines in the EU in the event of a market failure being identified1a; ______1a P8_TA(2017)0061

Or. en

Amendment 172 Pietro Fiocchi

Motion for a resolution Paragraph 2 a (new)

Motion for a resolution Amendment

2 a. Welcomes the intention of the European Commission to assess and review the existing incentives framework; calls on the Commission to stimulate

PE693.845v01-00 76/362 AM\1233943EN.docx EN competition by adapting a regulatory framework and stimulating investments in off-patent orphan and paediatric medicines, including for oncology, paediatric cancers, and neurological diseases;

Or. en

Amendment 173 Maria Spyraki

Motion for a resolution Paragraph 2 a (new)

Motion for a resolution Amendment

2 a. Welcomes the intention of the European Commission to assess and review the existing incentives framework; calls on the Commission to stimulate competition by adapting a regulatory framework and stimulating investments in off-patent orphan and paediatric medicines, including for oncology, paediatric cancers, and neurological diseases;

Or. en

Amendment 174 Sara Cerdas

Motion for a resolution Paragraph 2 a (new)

Motion for a resolution Amendment

2 a. Considers the serious and constantly increasing risks of AMR to public health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;

AM\1233943EN.docx 77/362 PE693.845v01-00 EN Or. en

Amendment 175 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Cindy Franssen

Motion for a resolution Paragraph 2 a (new)

Motion for a resolution Amendment

2 a. Considers the serious and constantly increasing risks of AMR to public health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;

Or. en

Amendment 176 Aldo Patriciello

Motion for a resolution Paragraph 2 a (new)

Motion for a resolution Amendment

2 a. Considers the serious and constantly increasing risks of AMR topublic health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;

Or. en

Amendment 177 Pernille Weiss

Motion for a resolution Paragraph 2 a (new)

PE693.845v01-00 78/362 AM\1233943EN.docx EN Motion for a resolution Amendment

2 a. Calls on the Commission to support research into the treatment of major noncommunicable diseases, including obesity as a primary morbidity as well as where it exists as a gateway chronic disease to other noncommunicable diseases;

Or. en

Amendment 178 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 2 a (new)

Motion for a resolution Amendment

2a. Considers it essential to establish a new dialogue with patients and to place their needs at the heart of R&D strategy and policy;

Or. es

Amendment 179 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 2 b (new)

Motion for a resolution Amendment

2b. Highlights the valuable role of community pharmacies and recognises also their valuable contribution during the pandemic by continuously providing an essential and quality service; Stresses that pharmacists are an independent, reliable and trustworthy source of information; Suggests that pharmacists play a more active role in pharmacovigilance activities to assess and monitor the effectiveness of medicines

AM\1233943EN.docx 79/362 PE693.845v01-00 EN and invites Member States to include them in their health, care and research programmes; Calls for greater recognition of pharmacies in rural areas, which enable such areas to retain their populations and ensure the well-being of citizens.

Or. es

Amendment 180 Pietro Fiocchi

Motion for a resolution Paragraph 2 b (new)

Motion for a resolution Amendment

2 b. Considers the serious and constantly increasing risks of AMR to public health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;

Or. en

Amendment 181 Tilly Metz

Motion for a resolution Paragraph 3

Motion for a resolution Amendment

3. Considers it imperative that a 3. Considers it imperative that the common EU therapeutic guide for ‘One Health’ approach guides reduction antimicrobials be introduced and that and use optimisation for antimicrobials, as communication campaigns on AMR be well as the development of new medicines, coordinated through a single calendar at including antimicrobial agents; stresses EU level; the importance of investment into the development of new non-animal methodologies, such as in silico and organoids, to shorten pre-clinical observation periods, increase efficiency in

PE693.845v01-00 80/362 AM\1233943EN.docx EN research and reduce unnecessary and often less reliable experiments on animals;

Or. en

Amendment 182 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Susana Solís Pérez, Emma Wiesner

Motion for a resolution Paragraph 3

Motion for a resolution Amendment

3. Considers it imperative that a 3. Considers it imperative that a common EU therapeutic guide for common EU therapeutic guide for antimicrobials be introduced and that antimicrobials be introduced and that communication campaigns on AMR be communication campaigns on AMR be coordinated through a single calendar at coordinated to create more awareness on EU level; antimicrobial resistance, its variants and its consequences at EU level; supports the Commission’s intentions of making the EU a ’best practice region’ and the introduction of interdisciplinary tools, as the future CAP, to tackle AMR;

Or. en

Amendment 183 Alessandra Moretti

Motion for a resolution Paragraph 3

Motion for a resolution Amendment

3. Considers it imperative that a 3. Considers it imperative that a common EU therapeutic guide for common EU therapeutic guide for antimicrobials be introduced and that antimicrobials be introduced and that communication campaigns on AMR be communication campaigns on AMR be coordinated through a single calendar at coordinated through a single calendar at EU level; EU level; calls on the Commission and member states to address AMR with concrete and prompt measures, also with regulatory and legislative ones if needed;

AM\1233943EN.docx 81/362 PE693.845v01-00 EN Or. en

Amendment 184 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 3

Motion for a resolution Amendment

3. Considers it imperative that a 3. Considers it imperative that a common EU therapeutic guide for common EU therapeutic guide for antimicrobials be introduced and that antimicrobials be drafted in close communication campaigns on AMR be cooperation with all relevant authorities; coordinated through a single calendar at recommends that this guidance document EU level; be introduced and that communication campaigns on AMR be coordinated more closely at EU level;

Or. en

Amendment 185 Nicolae Ştefănuță

Motion for a resolution Paragraph 3

Motion for a resolution Amendment

3. Considers it imperative that a 3. Considers it imperative that a common EU therapeutic guide for common EU therapeutic guide for antimicrobials be introduced and that antimicrobials be introduced, setting up communication campaigns on AMR be traceable antimicrobial use reduction coordinated through a single calendar at targets at EU level and that EU level; communication campaigns on AMR be coordinated through a single calendar at EU level;

Or. en

Amendment 186 Margarita de la Pisa Carrión

Motion for a resolution

PE693.845v01-00 82/362 AM\1233943EN.docx EN Paragraph 3 a (new)

Motion for a resolution Amendment

3a. Takes note of the increase in antimicrobial resistance and the threat it poses to public health and food safety; Notes that despite the lack of development of new antibiotics in Europe, it is essential to boost their production within the EU and reduce disparities in access across the Member States.

Or. es

Amendment 187 Tiemo Wölken

Motion for a resolution Paragraph 3 a (new)

Motion for a resolution Amendment

3 a. Calls on the Commission to further look into new delinked pull incentives models such as market exclusivity transfer and the subscription model for the development of new antibiotics; stresses that financial incentives are needed to re-creatre an investment friendly environment for research and innovation in this field and thus enable long-term investments into the AMR field;

Or. en

Amendment 188 Pernille Weiss

Motion for a resolution Paragraph 3 a (new)

Motion for a resolution Amendment

3 a. Points out that antibiotic

AM\1233943EN.docx 83/362 PE693.845v01-00 EN resistance is an urgent health challenge; Calls on the Commission to propose as soon as possible an effective legal framework to encourage innovation for new antibiotics with incentives either comparable to the area of orphan drugs or paediatrics or new innovative incentives to stimulate innovation to brings new antibiotics to the market;

Or. en

Amendment 189 Kateřina Konečná

Motion for a resolution Paragraph 3 a (new)

Motion for a resolution Amendment

3 a. Considers that while the public co- creates and is a major investor in health technologies, their exploitation is largely left to the discretion of industry driven by commercial interests alone, resulting in many of their promises not been fully translated into available and affordable clinical advances;

Or. en

Amendment 190 Peter Liese, Dolors Montserrat, Radan Kanev, Cindy Franssen, Christine Schneider

Motion for a resolution Paragraph 3 a (new)

Motion for a resolution Amendment

3 a. Calls on the Commission to propose as soon as possible a legal framework to encourage innovation for new antibiotics with incentives either comparable to the area of orphan drugs or paediatrics or new innovative incentives to stimulate innovation to bring

PE693.845v01-00 84/362 AM\1233943EN.docx EN new antibiotics the market;

Or. en

Amendment 191 Pietro Fiocchi

Motion for a resolution Paragraph 3 a (new)

Motion for a resolution Amendment

3 a. Highlights the importance of existing antibiotics in the fight against AMR and the need to continue to make these available for patients by developing targeted measures aimed at ensuring that economic conditions do not lead to market withdrawals;

Or. en

Amendment 192 Kateřina Konečná

Motion for a resolution Paragraph 3 b (new)

Motion for a resolution Amendment

3 b. Considers that the current R&D system is biased towards high revenue generating diseases, leading to an increasing gap between real unmet medical needs and investment;

Or. en

Amendment 193 Tiemo Wölken

Motion for a resolution Paragraph 3 b (new)

AM\1233943EN.docx 85/362 PE693.845v01-00 EN Motion for a resolution Amendment

3 b. Points out that it is essential to promote and/or maintain incentives in areas of low profitability such as rare diseases, paediatrics and AMR;

Or. en

Amendment 194 Tiemo Wölken

Motion for a resolution Paragraph 3 c (new)

Motion for a resolution Amendment

3 c. Points out that science and research play a crucial role in the development of standards in the fight against AMR; asks the Commission to also look into alternative antibiotic therapies such as bacteriophage therapy, building up on the EU-funded Project Phagoburn; notes that so far no bacteriophage therapies have been authorized at EU Level and thus reiterates its call on the Commission to propose a Framework for bacteriophage therapy based on the latest scientific research;

Or. en

Amendment 195 Kateřina Konečná

Motion for a resolution Paragraph 3 c (new)

Motion for a resolution Amendment

3 c. Calls on the Commission to play an active role in defining directions for health innovation to create a system that is aligned with medical and social needs, rather than leaving it to be driven by

PE693.845v01-00 86/362 AM\1233943EN.docx EN commercial interests alone;

Or. en

Amendment 196 Kateřina Konečná

Motion for a resolution Paragraph 3 d (new)

Motion for a resolution Amendment

3 d. Calls on the Commission to reshape the system of incentives to foster the development of relevant health innovations and more actively explore alternative models for encouraging innovation which, instead of relying on the IPR system, decouple investment in innovation from medicine sales volumes and high prices; calls on the Commission to review thoroughly the Supplementary Protection Certificate(SPC) to assess its necessity to cover industry R&D costs and its impact on the medicines’ accessibility;

Or. en

Amendment 197 Pietro Fiocchi

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to build incorporate new criteria into the system of on the existing incentives regime, and incentives for research into and the improve it with additional incentives, such development of new medicines for unmet as transferable exclusivity extensions, for therapeutic needs, prioritising projects medicines for underserved therapeutic promoted by the pharmaceutical industry and prophylactic areas, where the combating rare diseases, paediatric development of products would otherwise cancers, neurodegenerative diseases and not be sustainable for companies, AMR, with the aim of finding more prioritising projects combating rare therapeutic options and meeting the needs diseases, paediatric cancers, and AMR,

AM\1233943EN.docx 87/362 PE693.845v01-00 EN of patients and health systems; calls on the with the aim of finding more therapeutic Commission to promote the creation of an and prophylactic options and meeting the EU framework to guide and regularly needs of patients and health systems; calls evaluate the implementation of national on the Commission to target its plans to fight these diseases; framework programme funding into projects where there is insufficient basic science to develop treatments, such as neurodegenerative disease; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Or. en

Amendment 198 Aldo Patriciello

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to build incorporate new criteria into the system of on the existing incentives regime, and incentives for research into and the improve it with additional incentives, such development of new medicines for unmet as transferable exclusivity extensions, for therapeutic needs, prioritising projects underserved therapeutic and prophylactic promoted by the pharmaceutical industry areas where the development of products combating rare diseases, paediatric would otherwise not be sustainable for cancers, neurodegenerative diseases and companies, prioritising projects and AMR, AMR, with the aim of finding more with the aim of finding more therapeutic therapeutic options and meeting the needs and prophylactic options and meeting the of patients and health systems; calls on the needs of patients and health systems; calls Commission to promote the creation of an on the Commission to target its EU framework to guide and regularly framework programme funding into evaluate the implementation of national projects where there is insufficient basic plans to fight these diseases; science to develop treatments, such as neurodegenerative disease; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Or. en

PE693.845v01-00 88/362 AM\1233943EN.docx EN Amendment 199 Tilly Metz

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Welcomes the intention to revise incorporate new criteria into the system of pharmaceutical legislation for orphan and incentives for research into and the paediatric medicines and addressing development of new medicines for unmet AMR, with the aim of finding more therapeutic needs, prioritising projects affordable therapeutic options and meeting promoted by the pharmaceutical industry the needs of patients and health systems; combating rare diseases, paediatric calls on the Commission to provide public cancers, neurodegenerative diseases and research funding to investigate the use of AMR, with the aim of finding more repurposed, off-label and off-patent therapeutic options and meeting the needs products that can be used safely and of patients and health systems; calls on the effectively in patients; stresses that Commission to promote the creation of an medicines resulting from publicly funded EU framework to guide and regularly research must be equally available across evaluate the implementation of national the Union for a fair and affordable price; plans to fight these diseases; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Or. en

Amendment 200 Alessandra Moretti

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to revise incorporate new criteria into the system of the system of incentives and incorporate incentives for research into and the new criteria to promote public health development of new medicines for unmet driven research into and the development therapeutic needs, prioritising projects of new medicines for unmet therapeutic promoted by the pharmaceutical industry needs, as for example rare diseases, rare combating rare diseases, paediatric adult cancers and paediatric cancers, cancers, neurodegenerative diseases and neurodegenerative diseases and AMR, with AMR, with the aim of finding more the objective of protecting public health, therapeutic options and meeting the needs guaranteeing equitable rights and access of patients and health systems; calls on the to treatment for all, finding more

AM\1233943EN.docx 89/362 PE693.845v01-00 EN Commission to promote the creation of an therapeutic options at affordable prices EU framework to guide and regularly and meeting the needs of patients and evaluate the implementation of national health systems; calls on the Commission to plans to fight these diseases; promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Or. en

Amendment 201 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission, together incorporate new criteria into the system of with the Member States, to incorporate incentives for research into and the new criteria into the system of incentives development of new medicines for unmet for research into and the development of therapeutic needs, prioritising projects new medicines for unmet therapeutic promoted by the pharmaceutical industry needs, prioritising public interests and combating rare diseases, paediatric patient safety when assessing projects cancers, neurodegenerative diseases and promoted by the pharmaceutical industry to AMR, with the aim of finding more combat rare diseases, cancer, including therapeutic options and meeting the needs paediatric cancers, neurodegenerative of patients and health systems; calls on the diseases and AMR, with the aim of finding Commission to promote the creation of an more therapeutic options and meeting the EU framework to guide and regularly needs of patients and health systems; calls evaluate the implementation of national on the Commission to actively promote plans to fight these diseases; awareness and provide for guidance and support with the implementation of national plans to fight these diseases;

Or. en

Amendment 202 Jessica Polfjärd

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

PE693.845v01-00 90/362 AM\1233943EN.docx EN 4. Calls on the Commission to 4. Calls on the Commission to incorporate new criteria into the system of strengthen the criteria in the system of incentives for research into and the incentives for research into and the development of new medicines for unmet development of new medicines for unmet therapeutic needs, prioritising projects therapeutic needs, prioritising projects promoted by the pharmaceutical industry promoted by the pharmaceutical industry combating rare diseases, paediatric combating rare diseases, paediatric cancers, neurodegenerative diseases and cancers, neurodegenerative diseases and AMR, with the aim of finding more AMR, with the aim of finding more therapeutic options and meeting the needs therapeutic options and meeting the needs of patients and health systems; calls on the of patients and health systems; emphasizes Commission to promote the creation of an that EU funding should be steered EU framework to guide and regularly towards projects where research is needed evaluate the implementation of national the most; invites the Commission plans to fight these diseases; to evaluate the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Or. en

Amendment 203 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to incorporate new criteria into the system of incorporate new criteria into the system of incentives for research into and the incentives for research into and the development of new medicines for unmet development of new medicines for unmet therapeutic needs, prioritising projects therapeutic needs, prioritising projects promoted by the pharmaceutical industry promoted by the pharmaceutical industry combating rare diseases, paediatric combating rare diseases, paediatric cancers, neurodegenerative diseases and cancers, neurodegenerative and mental AMR, with the aim of finding more diseases and AMR, with the aim of finding therapeutic options and meeting the needs more therapeutic options and meeting the of patients and health systems; calls on the needs of patients and health systems; calls Commission to promote the creation of an on the Commission to promote the creation EU framework to guide and regularly of an EU framework to guide and regularly evaluate the implementation of national evaluate the implementation of national plans to fight these diseases; plans to fight these diseases and on the Member States to support research and development that focuses on the unmet medical needs of all citizens, and to guarantee non-exclusive licensing where

AM\1233943EN.docx 91/362 PE693.845v01-00 EN R&;D is publicly funded and that access to medical advances in the European Union is non-discriminatory;

Or. en

Amendment 204 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez, Emma Wiesner

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to further incorporate new criteria into the system of strengthen the current system of incentives for research into and the incentives for research and the development of new medicines for unmet development of new medicines for unmet therapeutic needs, prioritising projects therapeutic needs and to incorporate new promoted by the pharmaceutical industry criteria into the system of incentives for combating rare diseases, paediatric research into and the development of new cancers, neurodegenerative diseases and medicines for unmet diagnostic and AMR, with the aim of finding more therapeutic needs, while maintaining the therapeutic options and meeting the needs overall stability and predictability of the of patients and health systems; calls on the system, and prioritising projects promoted Commission to promote the creation of an by the pharmaceutical industry combating EU framework to guide and regularly rare or chronic diseases such as paediatric evaluate the implementation of national cancers, neurodegenerative diseases and plans to fight these diseases; AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Or. en

Amendment 205 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Paragraph 4

PE693.845v01-00 92/362 AM\1233943EN.docx EN Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to further incorporate new criteria into the system of strengthen the system of incentives for incentives for research into and the research and the development of new development of new medicines for unmet medicines for unmet therapeutic needs therapeutic needs, prioritising projects and incorporate new criteria into the promoted by the pharmaceutical industry system of incentives for research and the combating rare diseases, paediatric development of advanced diagnostics and cancers, neurodegenerative diseases and medicines for unmet therapeutic needs, AMR, with the aim of finding more while maintaining the overall stability and therapeutic options and meeting the needs predictability of the system, prioritising of patients and health systems; calls on the projects promoted by the pharmaceutical Commission to promote the creation of an industry combating rare diseases paediatric EU framework to guide and regularly cancers, neurodegenerative diseases and evaluate the implementation of national AMR, with the aim of finding more plans to fight these diseases; therapeutic options and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Or. en

Amendment 206 Radka Maxová

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to incorporate new criteria into the system of incorporate new criteria into the system of incentives for research into and the incentives for research into and the development of new medicines for unmet development of new medicines for unmet therapeutic needs, prioritising projects therapeutic needs, prioritising projects promoted by the pharmaceutical industry promoted by the pharmaceutical industry combating rare diseases, paediatric combating rare diseases, paediatric cancers, neurodegenerative diseases and cancers, neurodegenerative diseases and AMR, with the aim of finding more AMR, with the aim of finding more therapeutic options and meeting the needs therapeutic options and meeting the needs of patients and health systems; calls on the of patients and health systems; calls on the Commission to promote the creation of an Commission to promote the creation of an EU framework to guide and regularly EU framework to guide and regularly evaluate the implementation of national evaluate the implementation of national plans to fight these diseases; plans to fight these diseases; recalls the

AM\1233943EN.docx 93/362 PE693.845v01-00 EN need to facilitate access to treatment across borders for patients with rare diseases when not available in their country of origin;

Or. en

Amendment 207 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Cindy Franssen

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to incorporate new criteria into the system of incorporate new criteria into the system of incentives for research into and the incentives for research into and the development of new medicines for unmet development of new medicines for unmet therapeutic needs, prioritising projects therapeutic needs, prioritising projects promoted by the pharmaceutical industry promoted by the pharmaceutical industry combating rare diseases, paediatric combating rare diseases, paediatric cancers cancers, neurodegenerative diseases and (especially to incentivise First-in-Child AMR, with the aim of finding more development of paediatric anticancer therapeutic options and meeting the needs medicines), neurodegenerative diseases of patients and health systems; calls on the and AMR, with the aim of finding more Commission to promote the creation of an therapeutic options and meeting the needs EU framework to guide and regularly of patients and health systems; calls on the evaluate the implementation of national Commission to promote the creation of an plans to fight these diseases; EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Or. en

Amendment 208 Petar Vitanov

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to incorporate new criteria into the system of incorporate new criteria into the system of

PE693.845v01-00 94/362 AM\1233943EN.docx EN incentives for research into and the incentives for research into and the development of new medicines for unmet development of new medicines for unmet therapeutic needs, prioritising projects therapeutic needs, prioritising public promoted by the pharmaceutical industry interests and patient safety when combating rare diseases, paediatric assessing projects promoted by the cancers, neurodegenerative diseases and pharmaceutical industry in order to combat AMR, with the aim of finding more rare diseases, cancers, including paediatric therapeutic options and meeting the needs cancers, neurodegenerative diseases and of patients and health systems; calls on the AMR, with the aim of finding more Commission to promote the creation of an therapeutic options and meeting the needs EU framework to guide and regularly of patients and health systems; calls on the evaluate the implementation of national Commission to promote the creation of an plans to fight these diseases; EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Or. en

Amendment 209 Pernille Weiss

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to incorporate new criteria into the system of incorporate new criteria into the system of incentives for research into and the incentives for research into and the development of new medicines for unmet development of new medicines for unmet therapeutic needs, prioritising projects therapeutic needs, prioritising projects promoted by the pharmaceutical industry promoted by the pharmaceutical industry combating rare diseases, paediatric combating rare diseases, paediatric cancers, neurodegenerative diseases and cancers, neurodegenerative diseases, AMR, with the aim of finding more obesity and the interlinkages with other therapeutic options and meeting the needs noncommunicable diseases and AMR, of patients and health systems; calls on the with the aim of finding more therapeutic Commission to promote the creation of an options and meeting the needs of patients EU framework to guide and regularly and health systems; calls on the evaluate the implementation of national Commission to promote the creation of an plans to fight these diseases; EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;

Or. en

AM\1233943EN.docx 95/362 PE693.845v01-00 EN Amendment 210 Kateřina Konečná

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to incorporate new criteria into the system of promote public health driven research and incentives for research into and the the development of new medicines for development of new medicines for unmet unmet therapeutic needs, such as in the therapeutic needs, prioritising projects field of rare diseases, paediatric cancers, promoted by the pharmaceutical industry neurodegenerative diseases and AMR, with combating rare diseases, paediatric the aim of finding more therapeutic options cancers, neurodegenerative diseases and at affordable prices and meeting the needs AMR, with the aim of finding more of patients and health systems; calls on the therapeutic options and meeting the needs Commission to promote the creation of an of patients and health systems; calls on the EU framework to guide and regularly Commission to promote the creation of an evaluate the implementation of national EU framework to guide and regularly plans to fight these diseases; evaluate the implementation of national plans to fight these diseases;

Or. en

Amendment 211 Nicolae Ştefănuță

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to incorporate new criteria into the system of incorporate new criteria into the system of incentives for research into and the incentives for research into and the development of new medicines for unmet development of new medicines for unmet therapeutic needs, prioritising projects therapeutic needs, prioritising combating promoted by the pharmaceutical industry rare diseases, paediatric cancers, combating rare diseases, paediatric neurodegenerative diseases and AMR, with cancers, neurodegenerative diseases and the aim of finding more therapeutic options AMR, with the aim of finding more and meeting the needs of patients and therapeutic options and meeting the needs health systems; calls on the Commission to of patients and health systems; calls on the promote the creation of an EU framework Commission to promote the creation of an to guide and regularly evaluate the EU framework to guide and regularly implementation of national plans to fight evaluate the implementation of national these diseases;

PE693.845v01-00 96/362 AM\1233943EN.docx EN plans to fight these diseases;

Or. en

Amendment 212 Sara Cerdas

Motion for a resolution Paragraph 4

Motion for a resolution Amendment

4. Calls on the Commission to 4. Calls on the Commission to incorporate new criteria into the system of incorporate new criteria into the system of incentives for research into and the incentives for research into and the development of new medicines for unmet development of new medicines for unmet therapeutic needs, prioritising projects therapeutic needs, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric combating rare diseases, paediatric cancers, neurodegenerative diseases, cancers, neurodegenerative diseases and chronic diseases, AMR, prevent infectious AMR, with the aim of finding more diseases, with the aim of finding more therapeutic options and meeting the needs therapeutic options and meeting the needs of patients and health systems; calls on the of patients and health systems; calls on the Commission to promote the creation of an Commission to promote the creation of an EU framework to guide and regularly EU framework to guide and regularly evaluate the implementation of national evaluate the implementation of national plans to fight these diseases; plans to fight these diseases;

Or. en

Amendment 213 Aldo Patriciello

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Welcomes the very positive impact that the Regulation on orphan medicinal products EC/141/2000) and the Regulation on medicinal products for paediatric use (EC/1901/2006) have had on developing medicines; invites the Commission to maintain the philosophy of these Regulations, namely incentives and

AM\1233943EN.docx 97/362 PE693.845v01-00 EN rewards, and appropriate disease thresholds to allow for investment in rare disease; recognises that more work is needed to enhance the lives of more patients and calls on the Commission to allow for measures targeting important underserved areas, such as transferable exclusivities, and streamlining and simplifying regulatory procedures.

Or. en

Amendment 214 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4a. Notes that there is a lack of instruments to combat antibiotic resistance and that there are no short- term solutions. Calls on the Commission to encourage R&D in the field of antimicrobial resistance; supports new legislative initiatives to ensure more effective R&D, with better planning as regards European research funding, making it possible to tackle the rise of antimicrobial resistance.

Or. es

Amendment 215 Tilly Metz

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Calls on the Member States and the Commission to support research, development and innovation in the field of pharmaceuticals that are equally effective

PE693.845v01-00 98/362 AM\1233943EN.docx EN for patients and intrinsically less harmful for the environment, given that ‘greener pharmaceuticals’ are not toxic for the environment, do not bioaccumulate, and degrade more readily, into harmless substances, in wastewater treatment plants and the environment;

Or. en

Amendment 216 Pietro Fiocchi

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Stresses the importance of continuous innovation, including in the off-patent segment, to address patients’ unmet needs; calls on the Commission to design a fit-for purpose regulatory framework that will enable the development of the so-called value added medicines as well as recognise this category of affordable innovation with appropriate incentives and its value for healthcare systems;

Or. en

Amendment 217 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Stresses the importance of continuous innovation, including in the off-patent segment, to address patients’ unmet needs; calls on the Commission to design a fit-for purpose regulatory framework that will enable the

AM\1233943EN.docx 99/362 PE693.845v01-00 EN development of the so-called value added medicines as well as recognise this category of affordable innovation with appropriate incentives and its value for healthcare systems;

Or. en

Amendment 218 Peter Liese, Christine Schneider, Cindy Franssen

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Calls on the Commission, where appropriate in dialogue with the Member States, to work on a framework for pharmaceutical legislation and a reimbursement system that favours real breakthrough innovations for patients and incentivizes less so-called ‘me too’ pharmaceuticals which do not have an added value or highly expensive pharmaceuticals that offer only minor improvements for patients;

Or. en

Amendment 219 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Stresses the importance of continuous innovation, including in the off-patent segment, to address patients’ unmet needs; calls on the Commission to design a fit-for purpose regulatory framework that will enable the development of the so-called value added medicines as well as recognise this

PE693.845v01-00 100/362 AM\1233943EN.docx EN category of affordable innovation and its value for healthcare systems;

Or. en

Amendment 220 Frédérique Ries

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Calls on the European Commission and Member States to establish streamlined regulatory, pricing and reimbursement policies for therapies addressing rare diseases; stresses that these policies should encourage a continuum of evidence generation along the full life cycle of a product or technology as well as the patient journey from diagnosis to treatment access;

Or. en

Amendment 221 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Calls on the Commission to strengthen the mechanism enforced by Regulation on orphan medicinal products (EC/141/2000)1a and Regulation on medicinal products for paediatric use (EC/1901/2006)1b through funding and public-private partnership projects, especially the relationship between local health authorities, universities and industry;

AM\1233943EN.docx 101/362 PE693.845v01-00 EN ______1a OJ L 18, 22.1.2000, p. 1–5 1b OJ L 378, 27.12.2006, p. 1–19

Or. en

Amendment 222 Ondřej Knotek

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Highlights the fact that therapies such as homeopathy, physiotherapy and acupuncture can bring benefits to the patients in relation to the parallel effects of several diseases and their treatments such as cancer; stresses the importance to develop a holistic, integrative and patient- centric approach and to encourage the complementary use of these therapies;

Or. en

Amendment 223 Marian-Jean Marinescu

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Calls on the Commission to start the process of defining unmet medical needs, under the coordination of EMA, in order to reach a commonly accepted definition that would help a better orientation of research needs and would avoid the use of various definitions of unmet medical needs for exorbitant pricing and marketing medicines at an early stage;

PE693.845v01-00 102/362 AM\1233943EN.docx EN Or. en

Amendment 224 Petar Vitanov

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Underlines that continuous innovation, including in the off-patent segment, should strive to address patients’ unmet needs; in this regard, considers that a fit-for purpose regulatory framework could enable the development of value added medicines as well as recognise the category of affordable innovation;

Or. en

Amendment 225 Carlo Calenda

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4a. Emphasises the need to support continuing innovation in the area of non- patented medicines as well, with a view to offering patients appropriate treatment; calls on the Commission to ensure that such medicines remain affordable for both health systems and patients;

Or. it

Amendment 226 Nicolae Ştefănuță

Motion for a resolution

AM\1233943EN.docx 103/362 PE693.845v01-00 EN Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Calls on the Commission to consider setting research targets and milestone prizes as a complement to other research and development incentives, especially for developing medicines and therapies that are of low interest for industry due to market value;

Or. en

Amendment 227 Tiemo Wölken

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Stresses that a common European understanding of key concepts such as "unmet needs" and "added therapeutic value" such as a definition or a set of common criteria is needed at Union level;

Or. en

Amendment 228 Kateřina Konečná

Motion for a resolution Paragraph 4 a (new)

Motion for a resolution Amendment

4 a. Stresses that a common understanding of concepts such as innovation, value and added therapeutic value should be agreed in dialogue with patient organisations;

Or. en

PE693.845v01-00 104/362 AM\1233943EN.docx EN Amendment 229 Pietro Fiocchi

Motion for a resolution Paragraph 4 b (new)

Motion for a resolution Amendment

4 b. Welcomes the very positive impact that the Regulation on orphan medicinal products (EC/141/2000) and the Regulation on medicinal products for paediatric use (EC/1901/2006) have had on developing medicines; invites the Commission to maintain the philosophy of these Regulations, namely incentives and rewards, and appropriate disease thresholds to allow for investment in rare disease; recognises that more work is needed to enhance the lives of more patients and calls on the Commission to allow for measures targeting important underserved areas, such as transferable exclusivities, and streamlining and simplifying regulatory procedures;

Or. en

Amendment 230 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 4 b (new)

Motion for a resolution Amendment

4 b. Considers that antimicrobial resistance constitutes a serious threat to public health, whose cause should be found above all in the incorrect and superficial use of antibiotic drugs; calls on the Commission and Member States to fund projects aimed at improving diagnostics as well as suggesting a protocol for administrating antibiotics

AM\1233943EN.docx 105/362 PE693.845v01-00 EN and an awareness campaign for health professionals to encourage more targeted treatment based on patients’ real needs;

Or. en

Amendment 231 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 4 b (new)

Motion for a resolution Amendment

4b. Calls on the Commission to faciliate the Member States' ability to set their own priorities for innovation in the manufacturing process of new antibiotics; Notes the need to facilitate access to new antibiotics while maintaining access to old ones;

Or. es

Amendment 232 Marian-Jean Marinescu

Motion for a resolution Paragraph 4 b (new)

Motion for a resolution Amendment

4 b. Calls on the Commission to take the first steps to enhance transparency of research and development costs of medicines and to introduce new conditions for research funds so as to increase access for patients;

Or. en

Amendment 233 Margarita de la Pisa Carrión

PE693.845v01-00 106/362 AM\1233943EN.docx EN Motion for a resolution Paragraph 4 c (new)

Motion for a resolution Amendment

4c. Supports the continuation of the Innovative Medicines Initiative and invites the European Investment Bank to play a more active role in financing innovative initiatives in the field of antimicrobial resistance; Stresses the importance of implementing the joint action plan on antimicrobial resistance and health infections.

Or. es

Amendment 234 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 4 d (new)

Motion for a resolution Amendment

4d. Points out that the concept of unmet medical needs cannot exclude those areas where treatment is available but patients need better results; Stresses that in order to encourage this type of research, solutions are needed to encourage the achievement of these objectives; stresses that a system based solely on research incentives will not achieve the objectives in the fight against rare diseases; Proposes extending the EMA's PRIME scheme to orphan drugs.

Or. es

Amendment 235 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 4 e (new)

AM\1233943EN.docx 107/362 PE693.845v01-00 EN Motion for a resolution Amendment

4e. Stresses the relevance of developing a new funding model for antimicrobial medicines that provides a return on R&D investment without relying on the sale of medicines.

Or. es

Amendment 236 Kateřina Konečná

Motion for a resolution Paragraph 5

Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to promote dialogue with the Member States promote dialogue with the Member States and stakeholders to assess new criteria for and stakeholders to assess new criteria for national pricing, such as whether a product national pricing, such as whether a product is ‘Made in Europe’, whether the EU is ‘Made in Europe’, whether any type of invested in the product to support research, public funding was used in the product to or whether prices should be adapted to the support research, or whether prices should value of the therapeutic benefit of the be adapted to the value of the therapeutic medicine, and the primary and broader benefit of the medicine, and the primary needs of the population; and broader needs of the population and the wider patient community; stresses the need to promote discussion as well on what constitutes a socially acceptable profit margin for pharmaceutical products; calls for the timely development by the Commission and Member States of guidelines on principles and costing methods for establishing the research and development costs of medicines and their use at the national level;

Or. en

Amendment 237 Tilly Metz

Motion for a resolution Paragraph 5

PE693.845v01-00 108/362 AM\1233943EN.docx EN Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to promote dialogue with the Member States facilitate and enable dialogue among the and stakeholders to assess new criteria for Member States to steer cooperation in national pricing, such as whether a horizon scanning, pricing and product is ‘Made in Europe’, whether the reimbursement, including best practice EU invested in the product to support and information exchange related to research, or whether prices should be national pricing strategies, taking into adapted to the value of the therapeutic account levels of public investment, cost benefit of the medicine, and the primary of R&D, added therapeutic benefit and and broader needs of the population; cost-effectiveness; such dialogue should further encourage cooperation in pricing negotiations and joint procurement and guidance on principles and costing methods for establishing R&D costs of medicines and their use at the national level; calls on the Commission to promote information sharing among Member States on medicine net prices through the EURIPID collaboration;

Or. en

Amendment 238 Pietro Fiocchi

Motion for a resolution Paragraph 5

Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to promote dialogue with the Member States promote a high-level dialogue with the and stakeholders to assess new criteria for Member States and stakeholders, including national pricing, such as whether a product patient and industry representatives, to is ‘Made in Europe’, whether the EU assess how national pricing can incentivise invested in the product to support R&D investment in the EU, including research, or whether prices should be considerations such as high adapted to the value of the therapeutic environmental manufacturing standards, benefit of the medicine, and the primary capacity of supply and investment in and broader needs of the population; innovation, and to promote novel pricing and payment models to foster sustainability in European health systems, strong patient outcomes, and rewards for innovation, and drive a harmonised transformation to an outcomes-focused

AM\1233943EN.docx 109/362 PE693.845v01-00 EN approach considering the value of the therapeutic and prophylactic benefit of the medicine, and the primary and broader needs of the population;

Or. en

Amendment 239 Alessandra Moretti

Motion for a resolution Paragraph 5

Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to promote dialogue with the Member States promote a dialogue to assess new criteria and stakeholders to assess new criteria for for negotiating national pricing, such as national pricing, such as whether a product whether a product is ‘Made in Europe’, is ‘Made in Europe’, whether the EU whether the EU invested in the research invested in the product to support research, and development of the product, while or whether prices should be adapted to the promoting an analysis as well on what value of the therapeutic benefit of the constitutes a socially acceptable profit medicine, and the primary and broader margin for pharmaceutical products; needs of the population; recalls that national pricing should be based on transparency of factors such as public and private research, development costs and added therapeutic value; calls for the timely development by the Commission and Member States of guidelines on principles and costing methods for establishing the research and development costs of medicines and their use at the national level;

Or. en

Amendment 240 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 5

Motion for a resolution Amendment

PE693.845v01-00 110/362 AM\1233943EN.docx EN 5. Calls on the Commission to 5. Calls on the Commission to promote dialogue with the Member States promote a well-structured and and stakeholders to assess new criteria for institutionalised dialogue with the Member national pricing, such as whether a States and stakeholders to assess how product is ‘Made in Europe’, whether the national pricing may encourage EU invested in the product to support investment in R&D in the EU, and guide a research, or whether prices should be harmonised transformation towards an adapted to the value of the therapeutic approach based on results and on the benefit of the medicine, and the primary basic and most extensive needs of the and broader needs of the population; population, considering the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;

Or. en

Amendment 241 Jessica Polfjärd

Motion for a resolution Paragraph 5

Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to promote dialogue with the Member States promote dialogue with the Member States and stakeholders to assess new criteria for and stakeholders to assess how to ensure a national pricing, such as whether a resilient, diversified and sustainable value product is ‘Made in Europe’, whether the chain that meets that delivers on the EU invested in the product to support Member States' healthcare objectives and research, or whether prices should be meets the primary and broader needs of the adapted to the value of the therapeutic population; benefit of the medicine, and the primary and broader needs of the population;

Or. en

Amendment 242 Pietro Fiocchi

Motion for a resolution Paragraph 5

Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to

AM\1233943EN.docx 111/362 PE693.845v01-00 EN promote dialogue with the Member States promote the dialogue with Member States and stakeholders to assess new criteria for and stakeholders to include procurement national pricing, such as whether a criteria in national tenders, such as product is ‘Made in Europe’, whether the 'Resilient and robust supply chain EU invested in the product to support management,’ investments in research, or whether prices should be manufacturing, investments made by the adapted to the value of the therapeutic EU to support research, or also adaptation benefit of the medicine, and the primary to the value of the therapeutic benefit of and broader needs of the population; the medicine, and the primary and broad needs of the population;

Or. en

Amendment 243 Petar Vitanov

Motion for a resolution Paragraph 5

Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to promote dialogue with the Member States promote dialogue with the Member States and stakeholders to assess new criteria for and stakeholders to assess additional national pricing, such as whether a product criteria for national pricing, such as is ‘Made in Europe’, whether the EU whether the supply chain management is invested in the product to support research, sufficiently resilient and robust; whether or whether prices should be adapted to the there have been investments in innovation value of the therapeutic benefit of the and/or high environmental medicine, and the primary and broader manufacturing standards; whether a needs of the population; product is ‘Made in Europe’; whether the EU invested in the product to support research, or whether prices should be adapted to the costs as well as to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;

Or. en

Amendment 244 Tiemo Wölken

Motion for a resolution Paragraph 5

PE693.845v01-00 112/362 AM\1233943EN.docx EN Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to promote dialogue with the Member States promote dialogue with the Member States and stakeholders to assess new criteria for and stakeholders to assess new criteria for national pricing, such as whether a product national pricing and to include is ‘Made in Europe’, whether the EU procurement criteria in national tenders invested in the product to support research, such as "resilient and robust supply or whether prices should be adapted to the chains management", investment in value of the therapeutic benefit of the research, development and medicine, and the primary and broader manufacturing within the Union (Made in needs of the population; Europe), whether the EU invested in the product to support research, or whether prices should be adapted to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;

Or. en

Amendment 245 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 5

Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to actively promote dialogue with the Member States promote dialogue with the Member States and stakeholders to assess new criteria for and stakeholders to provide for more national pricing, such as whether a product guidance with existing and potentially is ‘Made in Europe’, whether the EU new criteria for national prices, such as invested in the product to support research, whether a product ‘Made in Europe’ or whether prices should be adapted to the represents a more effective and affordable value of the therapeutic benefit of the treatment alternative, whether the EU has medicine, and the primary and broader invested in the product to support research, needs of the population; or whether prices should be adapted to the costs as well as to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;

Or. en

Amendment 246

AM\1233943EN.docx 113/362 PE693.845v01-00 EN Alexander Bernhuber

Motion for a resolution Paragraph 5

Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to promote dialogue with the Member States promote a high level dialogue with the and stakeholders to assess new criteria for Member States and stakeholders, including national pricing, such as whether a product patients and representatives from the is ‘Made in Europe’, whether the EU health sector to assess new criteria for invested in the product to support research, national pricing, such as whether a product or whether prices should be adapted to the is ‘Made in Europe’, whether the EU value of the therapeutic benefit of the invested in the product to support research, medicine, and the primary and broader or whether prices should be adapted to the needs of the population; value of the therapeutic benefit of the medicine, and the primary and broader needs of the population such as quality and capacity of supply;

Or. en

Amendment 247 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Stelios Kympouropoulos, Cindy Franssen

Motion for a resolution Paragraph 5

Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to promote dialogue with the Member States promote dialogue with the Member States and stakeholders to assess new criteria for and stakeholders to assess new criteria for national pricing, such as whether a product national pricing, such as whether a product is ‘Made in Europe’, whether the EU is ‘Made in Europe’, whether the EU invested in the product to support research, invested in the product to support research, or whether prices should be adapted to the or whether prices should be adapted to the value of the therapeutic benefit of the value of the therapeutic benefit of the medicine, and the primary and broader medicine, or whether it is a generic or needs of the population; biosimilar medicine, and the primary and broader needs of the population;

Or. en

PE693.845v01-00 114/362 AM\1233943EN.docx EN Amendment 248 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Emma Wiesner

Motion for a resolution Paragraph 5

Motion for a resolution Amendment

5. Calls on the Commission to 5. Calls on the Commission to promote dialogue with the Member States promote dialogue with the Member States and stakeholders to assess new criteria for and stakeholders to assess additional national pricing, such as whether a product criteria for national pricing, such as is ‘Made in Europe’, whether the EU whether a product is ‘Developed in invested in the product to support research, Europe’, whether the EU invested in the or whether prices should be adapted to the product to support research, or whether value of the therapeutic benefit of the prices should be adapted to the value of the medicine, and the primary and broader therapeutic benefit of the medicine, and the needs of the population; primary and broader needs of the population;

Or. en

Amendment 249 Pietro Fiocchi

Motion for a resolution Paragraph 5 a (new)

Motion for a resolution Amendment

5 a. Calls on the Commission to build on the work of the Europe’s Beating Cancer Plan and ensure that Europe becomes the worldwide centre of excellence for R&D in emerging, innovative fields of medicine; underlines that State-of-the art technologies and treatment classes, such as nanomedicines, stand to provide solutions to current treatment challenges in areas such as cancer and cardiovascular diseases; Highlights that these innovative fields of medicine should be supported by fit-for- purpose regulatory frameworks, such as a centralised approval procedure for nanomedicines;

AM\1233943EN.docx 115/362 PE693.845v01-00 EN Or. en

Amendment 250 Tilly Metz

Motion for a resolution Paragraph 5 a (new)

Motion for a resolution Amendment

5 a. Calls on the Commission to implement the World Health Assembly Resolution of May 2019on Improving the transparency of markets for medicines, vaccines, and other health products, by requiring companies to publicly disclose the costs of R&D and manufacturing, public funding contributions, regulatory dossiers containing clinical trial data, active pharmaceutical ingredient (API) sources and supply chains, number and status of patents and patent applications; calls for the revision of Directive 89/105/EEC to enhance the transparency of medicine pricing and reimbursement decisions;

Or. en

Amendment 251 Sirpa Pietikäinen

Motion for a resolution Paragraph 5 a (new)

Motion for a resolution Amendment

5 a. Calls on the Commission to explore the possibility to establish a European fund, co-financed by the Member States, for negotiating and purchasing the orphan medicines and other new, personalised and experimental medication, as to guarantee equal access for patients from different Member States to effective therapeutics, treatments and

PE693.845v01-00 116/362 AM\1233943EN.docx EN prevent individual health care units from excessive and unreasonable costs when treating rare diseases;

Or. en

Amendment 252 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 5 a (new)

Motion for a resolution Amendment

5a. Calls for greater price transparency and invites Member States to continue to share their best-pricing practices on a voluntary basis; Stresses that pricing should remain a national competence, taking account of diversity across the EU.

Or. es

Amendment 253 Marian-Jean Marinescu

Motion for a resolution Paragraph 5 a (new)

Motion for a resolution Amendment

5 a. Calls on the Commission to develop fair pricing model for essential medicines that would reflect the real cost of research and production, limit the expenditure on sales and medical information and would reward medicines with an added therapeutic value, assuring fairness towards patients, industry and health systems;

Or. en

AM\1233943EN.docx 117/362 PE693.845v01-00 EN Amendment 254 Kateřina Konečná

Motion for a resolution Paragraph 5 a (new)

Motion for a resolution Amendment

5 a. Calls on the Commission to make all forms of public investment in the R&D process, incentives and rewards subject to concrete commitments (e.g. on pricing, transparency, or availability) to guarantee fair return on public investments;

Or. en

Amendment 255 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 5 a (new)

Motion for a resolution Amendment

5 a. Stresses that affordable medicines can be best guaranteed through public R&D coupled with public production of medicines, and urges Member States to invest accordingly;

Or. en

Amendment 256 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Stelios Kympouropoulos, Cindy Franssen, Roberta Metsola

Motion for a resolution Paragraph 5 a (new)

Motion for a resolution Amendment

5 a. Calls on the Commission to apply public procurement rules that should not consider price as the sole and main selection criterion;

PE693.845v01-00 118/362 AM\1233943EN.docx EN Or. en

Amendment 257 Pietro Fiocchi

Motion for a resolution Paragraph 5 b (new)

Motion for a resolution Amendment

5 b. Calls on the Commission and Member States to develop new pricing models for generic medicines aimed at ensuring healthy competition from day one whilst encouraging the continued marketing of mature products still therapeutically valuable;

Or. en

Amendment 258 Cyrus Engerer

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to work the incentive system, increase price with Member States and medicine transparency, highlight the causes limiting marketing authorization holders to affordability and patient access to identify and address the root-causes of medicinal products, and propose unavailability of medicines, and find sustainable solutions that also promote adequate solutions to address the competition; outstanding barriers to timely and effective patient access; calls on the Commission to enhance affordability based on the fundamental pricing principle of solidarity across Member States and to increase price transparency via a revision of the Transparency Directive in order to include voluntary/secret agreements, public procurement and generic medicines;

Or. en

AM\1233943EN.docx 119/362 PE693.845v01-00 EN Amendment 259 Pietro Fiocchi

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to work the incentive system, increase price with Member States and medicine transparency, highlight the causes marketing authorization holders to limiting affordability and patient access to identify and address the root-causes of medicinal products, and propose unavailability of medicines, and find sustainable solutions that also promote adequate solutions to address the competition; outstanding barriers to timely and effective patient access; calls on the Commission to enhance affordability, based on the fundamental pricing principle of solidarity across Member States, adequately rewarding the value of medicines across EU Member States and supporting the research-based industry as EU strategic, competitive and globally leading sector;

Or. en

Amendment 260 Jessica Polfjärd

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to work the incentive system, increase price with Member States and relevant Union transparency, highlight the causes and Member State agencies to assess the limiting affordability and patient access to root causes of shortages of medicinal products, and propose pharmaceuticals and medicinal products sustainable solutions that also promote within the Union; and propose sustainable competition; solutions that promote competition and preserves and strengthens the Union's strong basis for innovation;

Or. en

PE693.845v01-00 120/362 AM\1233943EN.docx EN Amendment 261 Alessandra Moretti

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to review the incentive system, increase price the incentive system, increase price transparency, highlight the causes limiting transparency, also via a revision of the affordability and patient access to Transparency Directive in order to medicinal products, and propose include voluntary/secret agreements, sustainable solutions that also promote public procurement and generic competition; medicines, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition; recalls that all public funding must be made conditional on the full transparency and traceability of investments, on supply obligations on the EU market, to ensure accessibility and affordability of manufactured medicines in the EU and to guarantee fair return of public investments;

Or. en

Amendment 262 Tilly Metz

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to the incentive system, increase price periodically evaluate and review the transparency, highlight the causes limiting incentive system and its criteria, increase affordability and patient access to price transparency,highlight the causes medicinal products, and propose limiting affordability and patient access to sustainable solutions that also promote medicinal products, and propose competition; sustainable solutions that also promote on and off-patent competition and the timely entry to market of generics and

AM\1233943EN.docx 121/362 PE693.845v01-00 EN biosimilars; stresses the right balance between awarding incentives in medicines development, particularly where there exist no treatment alternatives, and preventing competition distortion and unintended effects on affordability and availability of medicinal products;

Or. en

Amendment 263 Tiemo Wölken

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to review the incentive system, increase price the incentive system, increase price transparency, highlight the causes limiting transparency, highlight the causes limiting affordability and patient access to affordability and patient access to medicinal products, and propose medicinal products, and propose sustainable solutions that also promote sustainable solutions that also promote competition; competition; in the same vein asks the Commission to work together with Member States and industry to identify and address the root-causes of unavailability of medicines in order to find solutions to address the outstanding barriers to timely and effective patient access;

Or. en

Amendment 264 Jan Huitema

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to review the incentive system, increase price the incentive system, increase price transparency, highlight the causes limiting transparency, highlight the causes limiting

PE693.845v01-00 122/362 AM\1233943EN.docx EN affordability and patient access to affordability and patient access to medicinal products, and propose medicinal products, and to cooperate with sustainable solutions that also promote relevant stakeholders and Member States competition; to identify the root-causes of the unavailability of medicines and to find systematic, safe and sustainable solutions to address this long-standing issue of medicine shortages for patients while promoting a competitive industrial market in the European Union;

Or. en

Amendment 265 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to review the incentive system, increase price the incentive system, increase price transparency, highlight the causes limiting transparency, highlight the causes limiting affordability and patient access to affordability and patient access to medicinal products, and propose medicinal products, and propose sustainable solutions that also promote sustainable solutions that also promote competition; competition; Calls for maximum transparency in the use of public research and development funding and for easy public access to information regarding patenting/licensing conditions, the findings of clinical trials and public/private contributions.

Or. es

Amendment 266 Alexander Bernhuber

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to review

AM\1233943EN.docx 123/362 PE693.845v01-00 EN the incentive system, increase price the incentive system, increase price transparency, highlight the causes limiting transparency, highlight the causes limiting affordability and patient access to affordability and patient access to medicinal products, and propose medicinal products, and propose sustainable solutions that also promote sustainable solutions that also promote competition; competition; Calls on the Commission to collaborate with Member States and EMA to identify and address the causes of shortages of medicines, find solutions and guarantee effective patient access to medicine;

Or. en

Amendment 267 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to review the incentive system, increase price the incentive system, increase price transparency, highlight the causes limiting transparency, highlight the causes limiting affordability and patient access to affordability and patient access to medicinal products, and propose medicinal products, and propose sustainable solutions that also promote sustainable solutions that also promote competition; competition; in this regard, calls on the Commission to submit a legislative proposal on transparency of decisions regulating the prices and the reimbursement of medicinal products in EU countries;

Or. en

Amendment 268 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nicolae Ştefănuță, Emma Wiesner

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

PE693.845v01-00 124/362 AM\1233943EN.docx EN 6. Calls on the Commission to review 6. Calls on the Commission to review the incentive system, increase price the incentive system, ensuring price transparency, highlight the causes limiting transparency, highlight the causes limiting affordability and patient access to affordability and patient access to medicinal products, and propose medicinal products, and propose sustainable solutions that also promote sustainable solutions that also promote competition; competition; further calls on the Commission, especially DG Competition, to be alert of anti-competitive conduct and investigate anti-competitive practices in the pharmaceutical industry;

Or. en

Amendment 269 Petros Kokkalis

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to review the incentive system, increase price the incentive system, increase price transparency, highlight the causes limiting transparency, highlight the causes limiting affordability and patient access to affordability and patient access to medicinal products, and propose medicinal products, and propose sustainable solutions that also promote sustainable solutions that also promote competition; competition; calls on the Commission and the national competition authorities to monitor unfair practices in order to protect consumers from artificially inflated drug prices;

Or. el

Amendment 270 Kateřina Konečná

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to review the incentive system, increase price the incentive system so it contributes to

AM\1233943EN.docx 125/362 PE693.845v01-00 EN transparency, highlight the causes limiting innovation and medicine affordability, affordability and patient access to increase price transparency, highlight the medicinal products, and propose causes limiting affordability and patient sustainable solutions that also promote access to medicinal products, and propose competition; sustainable solutions that also promote competition and the timely entry to market of generics and biosimilars;

Or. en

Amendment 271 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to review the incentive system, increase price the incentive system, increase price transparency, highlight the causes limiting transparency, while taking into account affordability and patient access to the overall R&D efforts of the medicinal products, and propose pharmaceutical industry and its implicit sustainable solutions that also promote failure rate, highlight the causes limiting competition; affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition;

Or. en

Amendment 272 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to work the incentive system, increase price with Member States to review the transparency, highlight the causes limiting incentive system, increase price affordability and patient access to transparency when it comes to the costs medicinal products, and propose calculated in the prices, highlight the sustainable solutions that also promote causes for limiting affordability and patient

PE693.845v01-00 126/362 AM\1233943EN.docx EN competition; access to medicinal products, and propose sustainable solutions that also promote competition;

Or. en

Amendment 273 Radka Maxová

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to review the incentive system, increase price the incentive system, increase price transparency, highlight the causes limiting transparency, conduct an assessment of affordability and patient access to the causes limiting affordability and patient medicinal products, and propose access to medicinal products, and propose sustainable solutions that also promote sustainable solutions that also promote competition; competition;

Or. en

Amendment 274 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 6

Motion for a resolution Amendment

6. Calls on the Commission to review 6. Calls on the Commission to review the incentive system, increase price the incentive system, increase price transparency, highlight the causes limiting transparency, highlight the causes limiting affordability and patient access to affordability and patient access to medicinal products, and propose medicinal products, and propose sustainable solutions that also promote sustainable solutions; competition;

Or. en

Amendment 275 Pietro Fiocchi

AM\1233943EN.docx 127/362 PE693.845v01-00 EN Motion for a resolution Paragraph 6 a (new)

Motion for a resolution Amendment

6 a. Stresses the importance of generic, biosimilar and value added medicines for consistently increasing equitable access for patients and making the healthcare systems sustainable in a European Union where access is still uneven; calls urgently on the Commission to ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition, such as patent linkage and banning IP evergreening practices that unduly delay access to medicines and allowing single global development;

Or. en

Amendment 276 Tiemo Wölken

Motion for a resolution Paragraph 6 a (new)

Motion for a resolution Amendment

6 a. Underlines the importance of generic and biosimilar and value added medicines for increasing equitable access for patients and making the Unions healthcare systems sustainable where access is still uneven; Calls on the Commission to ensure healthy competition upon the expiry of intellectual property (IP) exclusivities by removing all barriers to access competitions such as patent linkage, IP evergreening and other misuse and abusive of IP related incentives and practices that unduly delay access to medicines;

Or. en

PE693.845v01-00 128/362 AM\1233943EN.docx EN Amendment 277 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Susana Solís Pérez

Motion for a resolution Paragraph 6 a (new)

Motion for a resolution Amendment

6 a. Underlines that shortages and unavailability of medicines are multi- factorial issues; believes it is necessary to find solutions to address barriers to timely and effective patient access; calls on the Commission to work with Member States, medicine marketing authorisation holders and other relevant actors to identify and address the root-causes of unavailability of medicines while respecting Member States competences;

Or. en

Amendment 278 Marlene Mortler

Motion for a resolution Paragraph 6 a (new)

Motion for a resolution Amendment

6 a. Considers it imperative to ensure broad and fact-based education and information about communicable and non-communicable diseases for adults as well as for children and adolescents, the treating and underlying causes thereof and healthy lifestyles in order to counteract misinformation and promote preventative actions; calls on the Commission to further support prevention measures and invest in research and promotion;

Or. en

AM\1233943EN.docx 129/362 PE693.845v01-00 EN Amendment 279 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 6 a (new)

Motion for a resolution Amendment

6 a. Considers that the European Union should encourage pharmaceutical companies to settle or return to European territory through state aids or via the Instrument for Important Projects of Common Interest (PIIEC); points out that incentives should be conditioned on companies' full compliance with the EU environmental and societal standards;

Or. en

Amendment 280 Alessandra Moretti

Motion for a resolution Paragraph 6 a (new)

Motion for a resolution Amendment

6 a. Calls on the Commission to introduce measures to increase transparency into the research and development cost of medicinal products and to contribute to the development of a pricing mechanism in consultation with Member States which takes into account the actual cost of development and production;

Or. en

Amendment 281 Petar Vitanov

Motion for a resolution

PE693.845v01-00 130/362 AM\1233943EN.docx EN Paragraph 6 a (new)

Motion for a resolution Amendment

6 a. Calls on the Commission to ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition, such as patent linkage, as well as to limit IP evergreening practices that delay access to medicines;

Or. en

Amendment 282 Tilly Metz

Motion for a resolution Paragraph 6 a (new)

Motion for a resolution Amendment

6 a. Calls on the Commission to evaluate the added value and if appropriate remove the supplementary protection certificate (SPC) mechanism in order to prevent delays in access to generic medicines and improve financial sustainability of healthcare systems;

Or. en

Amendment 283 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 6 a (new)

Motion for a resolution Amendment

6a. Recalls that the administration must be proactive in reaching agreements to improve access to medicines for which public funds have been granted in their conception and development phase.

AM\1233943EN.docx 131/362 PE693.845v01-00 EN Or. es

Amendment 284 Alessandra Moretti

Motion for a resolution Paragraph 6 b (new)

Motion for a resolution Amendment

6 b. Recalls that transparency on pricing should be enhanced, urges the Commission to take action in this sense particularly with regard to clearer information about list and net prices to be made publicly available, in order to mitigate asymmetry of information and disparities between Member States notably for products under market exclusivity; recalls its position on Directive 89/105/EC and calls on the Commission to revise the directive to ensure price transparency facilitating overall pricing and reimbursement;

Or. en

Amendment 285 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 6 b (new)

Motion for a resolution Amendment

6 b. Insists on the need to ensure equal access to affordable drugs within the EU; promotes collective negotiation of the price of medicines with pharmaceutical industries such as the Beneluxa initiative and the Valetta Declaration; considers that pharmaceutical industries should respect a conditionality on the affordable price of medicines in the framework of publicly funded research;

PE693.845v01-00 132/362 AM\1233943EN.docx EN Or. en

Amendment 286 Pietro Fiocchi

Motion for a resolution Paragraph 6 b (new)

Motion for a resolution Amendment

6 b. Recommends that political accountability of the European Patent Office (EPO) to the European Parliament be established in the interest of patent applicants, consumers and the public; calls on the Commission to address any abuses of EPO patent granting processes considered anticompetitive in its Pharmaceutical Sector Inquiry Report of 2009;

Or. en

Amendment 287 Alessandra Moretti

Motion for a resolution Paragraph 6 c (new)

Motion for a resolution Amendment

6 c. Stresses that commercial withdrawals often have serious consequences in terms of availability of medicines and thus hamper the right of patients to timely and equitable access to high quality treatment; stresses that commercial withdrawals should be further regulated and only take place in exceptional cases, in a situation where substitute and equivalent treatment is already available for patients, duly taking into account health outcomes for patients and calls, before any actual commercial withdrawal begins, for extended early notification obligations to be required to

AM\1233943EN.docx 133/362 PE693.845v01-00 EN MAHs and distributors to ensure that Member State authorities are able to make adequate plans and address the consequences in the interest of patients;

Or. en

Amendment 288 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 6 c (new)

Motion for a resolution Amendment

6 c. Calls on the Commission to present a revision of Directive 89/105 /EEC on transparency in order to ensure effective controls and full transparency of the procedures used to determine the prices and reimbursement of medicines in the Member States;

Or. en

Amendment 289 Alessandra Moretti

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines are accessible and affordable treatments and contribute greatly to the treatments, allowing a broader budgetary sustainability of healthcare competition and contributing greatly to systems; calls on the Commission to the budgetary sustainability of healthcare introduce measures to support a greater systems, thus helping to improve access to market presence of these medicines and to treatment for patients; calls on the harmonise at EU level the interpretation Commission to introduce legislative and of the so-called Bolar provision non-legislative measures to support a concerning possible exemptions from the greater market presence of these medicines legal framework for the Unitary Patent and their timely access to markets across system for generic drug manufacturers; the EU; regrets that generic and further calls on the Commission to design biosimilar alternatives are often not

PE693.845v01-00 134/362 AM\1233943EN.docx EN rules for the industry that promote available in low and middle income research, development and the production member states where they might be of generic and biosimilar medicines in the needed most; deplores the litigation cases EU and to propose EU protocols for the aimed at delaying generic entry and calls interchangeability of biosimilar on the Commission to address any misuse medicines; of the IPR system to delay entry of generic and biosimilar medicines into the market; calls on the Commission to ensure that the end of the innovator’s period of commercial exclusivity is respected in order to make treatments available to patients as swiftly as possible;

Or. en

Amendment 290 Jessica Polfjärd

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and 7. Emphasizes that competition leads biosimilar medicines are accessible and to lower prices and greater affordability; affordable treatments and contribute calls on the Commission to harmonise at greatly to the budgetary sustainability of EU level the interpretation of the so-called healthcare systems; calls on the Bolar provision concerning possible Commission to introduce measures to exemptions from the legal framework for support a greater market presence of the Unitary Patent system for generic drug these medicines and to harmonise at EU manufacturers; further calls on the level the interpretation of the so-called Commission to take action that promotes Bolar provision concerning possible research, development and the production exemptions from the legal framework for of generic and biosimilar medicines in the the Unitary Patent system for generic drug EU and to propose EU protocols for the manufacturers; further calls on the interchangeability of biosimilar medicines, Commission to design rules for the emphasizes that such proposals must industry that promote research, respect the individual needs and development and the production of generic preferences of patients and their and biosimilar medicines in the EU and to clinicians; propose EU protocols for the interchangeability of biosimilar medicines;

Or. en

Amendment 291

AM\1233943EN.docx 135/362 PE693.845v01-00 EN Pietro Fiocchi

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and 7. Stresses that competition after loss biosimilar medicines are accessible and of patent and exclusivity leads to price affordable treatments and contribute decreases, greater affordability and greatly to the budgetary sustainability of contributes greatly to the budgetary healthcare systems; calls on the sustainability of healthcare systems; calls Commission to introduce measures to on the Commission to harmonise at EU support a greater market presence of level the interpretation of the so-called these medicines and to harmonise at EU Bolar provision with the broader scope of level the interpretation of the so-called the Bolar exemption in force in the patent Bolar provision concerning possible laws of most member states; further calls exemptions from the legal framework for on the Commission to promote research, the Unitary Patent system for generic drug development and the production of generic manufacturers; further calls on the and biosimilar medicines in the EU and to Commission to design rules for the propose EU protocols for the industry that promote research, interchangeability of biosimilar medicines, development and the production of generic in respect of individual patient needs and and biosimilar medicines in the EU and to clinicians’ freedom to prescribe the best propose EU protocols for the treatment choice for each patient; interchangeability of biosimilar medicines;

Or. en

Amendment 292 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines are accessible and affordable treatments and contribute greatly to the treatments and contribute greatly to budgetary sustainability of healthcare broadly increasing patient access to systems; calls on the Commission to treatments as well as to the budgetary introduce measures to support a greater sustainability of healthcare systems by market presence of these medicines and to generating cost savings while maintaining harmonise at EU level the interpretation of equal quality of care, as well as freeing up the so-called Bolar provision concerning resources for the development of new possible exemptions from the legal treatments; calls on the Commission to framework for the Unitary Patent system introduce the necessary and appropriate

PE693.845v01-00 136/362 AM\1233943EN.docx EN for generic drug manufacturers; further measures to support a greater market calls on the Commission to design rules for presence of these medicines and to the industry that promote research, harmonise and enlarge at EU level the development and the production of generic interpretation of the so-called Bolar and biosimilar medicines in the EU and to provision concerning possible exemptions propose EU protocols for the from the legal framework for the Unitary interchangeability of biosimilar medicines; Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose common European guidelines for the implementation of physician-led switching of biologic medicine, including biosimilar medicines as defined by EMA; underlines that for the purposes of these guidelines, “physician” must signify exclusively medical doctors authorised to prescribe medical products;

Or. en

Amendment 293 Aldo Patriciello

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines offer accessible and affordable treatments and contribute greatly to the treatments and contribute greatly to the budgetary sustainability of healthcare budgetary sustainability of healthcare systems; calls on the Commission to systems; calls on the Commission to introduce measures to support a greater provide measures to support a greater market presence of these medicines and to market presence of these medicines, to harmonise at EU level the interpretation of harmonise and enlarge at European level the so-called Bolar provision concerning the interpretation of the so-called “Bolar possible exemptions from the legal provision,” concerning possible framework for the Unitary Patent system exemptions on patents regulatory for generic drug manufacturers; further framework for generic drug manufacturers; calls on the Commission to design rules for further calls on the Commission to design the industry that promote research, rules for the industry that promote development and the production of generic research, development and production of and biosimilar medicines in the EU and to generic and biosimilar medicines in propose EU protocols for the Europe and to

AM\1233943EN.docx 137/362 PE693.845v01-00 EN interchangeability of biosimilar medicines; promote harmonized European and Member States guidelines for the implementation of physician-led switching of biologic medicines, including biosimilar medicines as defined by the European Medicines Agency;

Or. en

Amendment 294 Pietro Fiocchi

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines offer accessible and affordable treatments and contribute greatly to the treatments and contribute greatly to the budgetary sustainability of healthcare budgetary sustainability of healthcare systems; calls on the Commission to systems; calls on the Commission to introduce measures to support a greater provide measures to support a greater market presence of these medicines and to market presence of these medicines, to harmonise at EU level the interpretation of harmonise and enlarge at European level the so-called Bolar provision concerning the interpretation of the so-called "Bolar possible exemptions from the legal provision," concerning possible framework for the Unitary Patent system exemptions on patent regulatory for generic drug manufacturers; further framework for generic drug manufacturers; calls on the Commission to design rules for further calls on the Commission to design the industry that promote research, rules for the industry that promote development and the production of generic research, development and production of and biosimilar medicines in the EU and to generic and biosimilar medicines in propose EU protocols for the Europe and to promote harmonised interchangeability of biosimilar medicines; European Member State guidelines for the implementation of physician-led switching of biological medicines, including biosimilar medicines as defined by the European Medicines Agency;

Or. en

Amendment 295 Kateřina Konečná

Motion for a resolution

PE693.845v01-00 138/362 AM\1233943EN.docx EN Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines are accessible and affordable treatments and contribute greatly to the treatments and contribute greatly to budgetary sustainability of healthcare broadly increasing patient access to systems; calls on the Commission to treatments as well as to the budgetary introduce measures to support a greater sustainability of healthcare systems by market presence of these medicines and to providing more treatment options and harmonise at EU level the interpretation of potentially by helping reduce medicine the so-called Bolar provision concerning shortages and by generating cost savings possible exemptions from the legal while maintaining equal quality of care, framework for the Unitary Patent system freeing up resources also for the for generic drug manufacturers; further development of new treatments; calls on calls on the Commission to design rules for the Commission to introduce measures to the industry that promote research, support a greater market presence of these development and the production of generic medicines and to harmonise at EU level the and biosimilar medicines in the EU and to interpretation of the so-called Bolar propose EU protocols for the provision concerning possible exemptions interchangeability of biosimilar medicines; from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines; keeping the patient always informed and at the centre of all decision-making;

Or. en

Amendment 296 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines are accessible and affordable treatments and contribute greatly to the treatments and contribute greatly to the budgetary sustainability of healthcare budgetary sustainability of healthcare systems; calls on the Commission to systems; calls on the Commission to

AM\1233943EN.docx 139/362 PE693.845v01-00 EN introduce measures to support a greater introduce measures to support a greater market presence of these medicines and to market presence of these medicines and to harmonise at EU level the interpretation of harmonise at EU level the interpretation of the so-called Bolar provision concerning the so-called Bolar provision concerning possible exemptions from the legal possible exemptions from the legal framework for the Unitary Patent system framework for the Unitary Patent system for generic drug manufacturers; further for generic drug manufacturers; further calls on the Commission to design rules for calls on the Commission to design rules for the industry that promote research, the industry that promote research, development and the production of generic development and the production of generic and biosimilar medicines in the EU and to and biosimilar medicines in the EU, to propose EU protocols for the propose EU protocols for the interchangeability of biosimilar medicines; interchangeability of biosimilar medicines, and to ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition, such as patent linkage and banning IP evergreening practices that unduly delay access to medicines and allowing single global development;

Or. en

Amendment 297 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines are accessible and affordable treatments and contribute greatly to the treatments and contribute greatly to the budgetary sustainability of healthcare budgetary sustainability of healthcare systems; calls on the Commission to systems; calls on the Commission to introduce measures to support a greater introduce changes to the legislation and a market presence of these medicines and to simplified approval procedure to support a harmonise at EU level the interpretation of greater market presence of these medicines the so-called Bolar provision concerning in specific cases; calls to harmonise at EU possible exemptions from the legal level the interpretation of the so-called framework for the Unitary Patent system Bolar provision concerning possible for generic drug manufacturers; further exemptions from the legal framework for calls on the Commission to design rules for the Unitary Patent system for generic drug the industry that promote research, manufacturers; calls for the revision of the development and the production of generic Bolar provision to bring legal certainty to and biosimilar medicines in the EU and to the sector and encourage investment in propose EU protocols for the key areas; calls, furthermore, on the

PE693.845v01-00 140/362 AM\1233943EN.docx EN interchangeability of biosimilar medicines; Commission and the Member States to design rules that are conducive to the promotion of research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;

Or. es

Amendment 298 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Points out that generic and medicines are accessible and affordable biosimilar medicines enable treatment treatments and contribute greatly to the efficacy and safety,increased competition, budgetary sustainability of healthcare reduced prices and savings for healthcare systems; calls on the Commission to systems, thus helping to improve access to introduce measures to support a greater medicines for patients ; Stresses that market presence of these medicines and to generic and biosimilar medicines are harmonise at EU level the interpretation of accessible and affordable treatments and the so-called Bolar provision concerning contribute greatly to the budgetary possible exemptions from the legal sustainability of healthcare systems; calls framework for the Unitary Patent system on the Commission to introduce measures for generic drug manufacturers; further to support a greater market presence of calls on the Commission to design rules for these medicines and to harmonise at EU the industry that promote research, level the interpretation of the so-called development and the production of generic Bolar provision concerning possible and biosimilar medicines in the EU and to exemptions from the legal framework for propose EU protocols for the the Unitary Patent system for generic drug interchangeability of biosimilar medicines; manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;

Or. en

Amendment 299

AM\1233943EN.docx 141/362 PE693.845v01-00 EN Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines are accessible and affordable treatments and contribute greatly to the treatments and contribute greatly to the budgetary sustainability of healthcare budgetary sustainability of healthcare systems; calls on the Commission to systems; calls on the Commission to introduce measures to support a greater introduce measures to support a greater market presence of these medicines and to market presence of these medicines and to harmonise at EU level the interpretation of harmonise at EU level the interpretation of the so-called Bolar provision concerning the so-called Bolar provision concerning possible exemptions from the legal possible exemptions from the legal framework for the Unitary Patent system framework for the Unitary Patent system for generic drug manufacturers; further for generic drug manufacturers; further calls on the Commission to design rules for calls on the Commission to design rules for the industry that promote research, the industry that promote research, development and the production of generic development and the production of generic and biosimilar medicines in the EU and to and biosimilar medicines in the EU and to propose EU protocols for the propose EU protocols for the interchangeability of biosimilar medicines; interchangeability of biosimilar medicines; calls for the removal of barriers to the production and distribution of generic medicines; calls on Member States to increase public production of generic and biosimilar medicines;

Or. en

Amendment 300 Nicolae Ştefănuță

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines are accessible and affordable treatments and contribute greatly to the treatments and contribute greatly to the budgetary sustainability of healthcare budgetary sustainability of healthcare systems; calls on the Commission to systems; calls on the Commission to introduce measures to support a greater introduce measures to support a greater market presence of these medicines and to market presence of these medicines and to

PE693.845v01-00 142/362 AM\1233943EN.docx EN harmonise at EU level the interpretation of harmonise at EU level the interpretation of the so-called Bolar provision concerning the so-called Bolar provision concerning possible exemptions from the legal possible exemptions from the legal framework for the Unitary Patent system framework for the Unitary Patent system for generic drug manufacturers; further for generic drug manufacturers; calls on calls on the Commission to design rules for the Commission to address the misuse of the industry that promote research, the IPR (intellectual property rights) development and the production of generic system to delay market entry of generic and biosimilar medicines in the EU and to and biosimilar medicines; further calls on propose EU protocols for the the Commission to design rules for the interchangeability of biosimilar medicines; industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;

Or. en

Amendment 301 Sara Cerdas

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines are accessible and affordable treatments and contribute greatly to the treatments and contribute greatly to the budgetary sustainability of healthcare budgetary sustainability of healthcare systems; calls on the Commission to systems by providing more treatment introduce measures to support a greater options and potentially by helping reduce market presence of these medicines and to medicine shortages; calls on the harmonise at EU level the interpretation of Commission to introduce measures to the so-called Bolar provision concerning support a greater market presence of these possible exemptions from the legal medicines and to harmonise at EU level the framework for the Unitary Patent system interpretation of the so-called Bolar for generic drug manufacturers; further provision concerning possible exemptions calls on the Commission to design rules for from the legal framework for the Unitary the industry that promote research, Patent system for generic drug development and the production of generic manufacturers; further calls on the and biosimilar medicines in the EU and to Commission to design rules for the propose EU protocols for the industry that promote research, interchangeability of biosimilar medicines; development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;

AM\1233943EN.docx 143/362 PE693.845v01-00 EN Or. en

Amendment 302 Petar Vitanov

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines are accessible and affordable treatments and contribute greatly to the treatments and contribute greatly to the budgetary sustainability of healthcare budgetary sustainability of healthcare systems; calls on the Commission to systems; calls on the Commission to introduce measures to support a greater introduce measures to support a greater market presence of these medicines and to market presence of these medicines and to harmonise at EU level the interpretation of harmonise and widen at EU level the the so-called Bolar provision concerning interpretation of the so-called Bolar possible exemptions from the legal provision concerning possible exemptions framework for the Unitary Patent system from the legal framework for the Unitary for generic drug manufacturers; further Patent system for generic drug calls on the Commission to design rules for manufacturers; further calls on the the industry that promote research, Commission to design rules for the development and the production of generic industry that promote research, and biosimilar medicines in the EU and to development and the production of generic propose EU protocols for the and biosimilar medicines in the EU and to interchangeability of biosimilar medicines; propose EU protocols for the interchangeability of biosimilar medicines, as defined by the European Medicines Agency;

Or. en

Amendment 303 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that generic and biosimilar medicines are accessible and affordable medicines are accessible and affordable treatments and contribute greatly to the treatments and contribute greatly to the

PE693.845v01-00 144/362 AM\1233943EN.docx EN budgetary sustainability of healthcare budgetary sustainability of healthcare systems; calls on the Commission to systems; calls on the Commission to introduce measures to support a greater introduce measures to support a greater market presence of these medicines and to market presence of these medicines and to harmonise at EU level the interpretation of harmonise at EU level the interpretation of the so-called Bolar provision concerning the so-called Bolar provision concerning possible exemptions from the legal possible exemptions from the legal framework for the Unitary Patent system framework for the Unitary Patent system for generic drug manufacturers; further for generic drug manufacturers; further calls on the Commission to design rules for calls on the Commission to design rules for the industry that promote research, the industry that promote research, development and the production of generic development and the production of generic and biosimilar medicines in the EU and to and biosimilar medicines in the EU; propose EU protocols for the interchangeability of biosimilar medicines;

Or. en

Amendment 304 Tilly Metz

Motion for a resolution Paragraph 7

Motion for a resolution Amendment

7. Stresses that generic and biosimilar 7. Stresses that timely access to medicines are accessible and affordable generic and biosimilar medicines is key to treatments and contribute greatly to the ensure accessible and affordable budgetary sustainability of healthcare treatments and contribute greatly to the systems; calls on the Commission to budgetary sustainability of healthcare introduce measures to support a greater systems; calls on the Commission to market presence of these medicines and to introduce measures to support a greater harmonise at EU level the interpretation of market presence of these medicines and to the so-called Bolar provision concerning harmonise at EU level the interpretation of possible exemptions from the legal the so-called Bolar provision concerning framework for the Unitary Patent system possible exemptions from the legal for generic drug manufacturers; further framework for the Unitary Patent system calls on the Commission to design rules for for generic drug manufacturers; further the industry that promote research, calls on the Commission to design rules for development and the production of generic the industry that promote research, and biosimilar medicines in the EU and to development and the production of generic propose EU protocols for the and biosimilar medicines in the EU and to interchangeability of biosimilar medicines; propose EU protocols for the interchangeability of biosimilar medicines;

Or. en

AM\1233943EN.docx 145/362 PE693.845v01-00 EN Amendment 305 Maria Spyraki

Motion for a resolution Paragraph 7 a (new)

Motion for a resolution Amendment

7 a. Welcomes the Commission's recognition of the importance of full clarification of the provision for the conduct of trials on patented products to support generic and biosimilar medicines marketing authorization applications (so called Bolar provision); calls for an urgent European harmonization and enlargement of the Bolar exemption, including all the processes needed to launch off-patent medicine at the expiry of patents including administrative actions to enable generic and biosimilar medicines to be on the market on day-1; urges a clear ban on all forms of patent linkage in the EU legislation, which are anti-competitive and delay generic and biosimilar market entry, frustrating the objectives of the Bolar exemption;

Or. en

Amendment 306 Pietro Fiocchi

Motion for a resolution Paragraph 7 a (new)

Motion for a resolution Amendment

7 a. Welcomes the Commission’s recognition of the importance of full clarification of the provision for the conduct of trials on patented products to support generic and biosimilar medicines marketing authorisation applications (so called Bolar provision); calls for urgent European harmonisation and

PE693.845v01-00 146/362 AM\1233943EN.docx EN enlargement of the Bolar exemption, including all the processes needed to launch off-patent medicine at the expiry of patents including administrative actions to enable generic and biosimilar medicines to be on the market on day-1. Urges a clear ban on all forms of patent linkage in the EU legislation, which are anti-competitive and delay generic and biosimilar market entry, frustrating the objectives of the Bolar exemption;

Or. en

Amendment 307 Sirpa Pietikäinen

Motion for a resolution Paragraph 7 a (new)

Motion for a resolution Amendment

7 a. Stresses the need to take gender into account in the research, diagnosis, treatment and impact of medicines and therapeutics as women across the lifespan remain under-represented in biomedical and health research and data; underlines that consequently, the evidence base is weaker for women as well as for older people, leading to many conditions being underdiagnosed with women, such as cardiovascular disease; underlines that to reduce inequalities and health disparities, sex and gender must be balanced and incorporated in research throughout the process from stem cell testing to design of clinical trial protocols, data analysis, health technology assessment and access to care;

Or. en

Amendment 308 Kateřina Konečná

AM\1233943EN.docx 147/362 PE693.845v01-00 EN Motion for a resolution Paragraph 7 a (new)

Motion for a resolution Amendment

7 a. Stresses that cost savings generated from the use of biosimilars should be reinvested in a transparent and tangible way; calls on the Commission to encourage Member States to support the transparent practices of biosimilar-related cost savings; calls on the Commission to facilitate arrangements such as gainsharing programmes that allow savings from biosimilar competition to stream back to hospitals and be used to improve patient care in a given healthcare setting; calls on the Commission to launch a ‘Best Practice Network’ where Member States as well as hospitals can share best practices on reinvestment of the freed-up budget;

Or. en

Amendment 309 Andrey Slabakov, Pietro Fiocchi

Motion for a resolution Paragraph 7 a (new)

Motion for a resolution Amendment

7 a. Stresses that cost savings generated from the use of generics and biosimilars should be reinvested in a transparent and tangible way; calls on the European Commission to facilitate arrangements such as gainsharing programmes that allow savings from generic and biosimilar competition to stream back to hospitals and be used to improve patient care in a given healthcare setting; calls on the European Commission to launch and actively promote the awareness of a ‘Best Practice Network’ where Member States as well as hospitals can share best practices on

PE693.845v01-00 148/362 AM\1233943EN.docx EN reinvestment of the freed-up budget;

Or. en

Amendment 310 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Stelios Kympouropoulos, Cindy Franssen

Motion for a resolution Paragraph 7 a (new)

Motion for a resolution Amendment

7 a. Stresses that cost savings generated from the use of biosimilars should be reinvested in a transparent and tangible way; calls on the European Commission to encourage Member States to support the transparent practices of biosimilar-related cost savings; calls on the European Commission to facilitate arrangements such as gainsharing programmes;

Or. en

Amendment 311 Simona Baldassarre, Silvia Sardone, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 7 a (new)

Motion for a resolution Amendment

7 a. Underlines that biosimilars and generics can be an important component within the pharmaceutical strategy for Europe, however it underlines that there is no identity with the originator, therefore their interchangeability should not be automatic but subject to the evaluation of the physician; pharmacovigilance should be a key tool in the evaluation of biological drugs in terms of efficacy and safety, for which

AM\1233943EN.docx 149/362 PE693.845v01-00 EN continuous monitoring can provide all the useful elements for decision-making in both clinical and regulatory contexts; highlights the need for an EMA- authorized reference platform for generics and biosimilars;

Or. en

Amendment 312 Alessandra Moretti

Motion for a resolution Paragraph 7 a (new)

Motion for a resolution Amendment

7 a. Calls on the Commission to harmonise at EU level the interpretation of the so called Bolar provision and extend its application for exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers in order to facilitate and speed up their entry to market; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;

Or. en

Amendment 313 Aldo Patriciello

Motion for a resolution Paragraph 7 a (new)

Motion for a resolution Amendment

7 a. Calls on the Commission to leverage the Pharmaceutical, Industrial, Digital Strategies and the renewed EU

PE693.845v01-00 150/362 AM\1233943EN.docx EN trade policy to promote European competitiveness by ensuring sound intellectual property frameworks that protect investment in medical research and allow industry to remain an innovator and world leader, making the EU capable to compete with challenger regions such as the US and China;

Or. en

Amendment 314 Marian-Jean Marinescu

Motion for a resolution Paragraph 7 a (new)

Motion for a resolution Amendment

7 a. Considers it important that the Commission addresses the issue of legal parallel trade in order to prevent shortages due to exports caused by high differences in terms of prices of a medicine between Member States and calls on starting to consider the possibility of declaring medicines public goods;

Or. en

Amendment 315 Tiemo Wölken

Motion for a resolution Paragraph 7 a (new)

Motion for a resolution Amendment

7 a. Stresses the need for the Commission to continue preventing anti- competitive practices and agreements by the pharmaceutical industry including pay-for-delay or abuse of dominant position to ensure a competitive market of generic and biosimilar;

AM\1233943EN.docx 151/362 PE693.845v01-00 EN Or. en

Amendment 316 Andrey Slabakov, Joanna Kopcińska, Pietro Fiocchi, Ryszard Antoni Legutko

Motion for a resolution Paragraph 7 b (new)

Motion for a resolution Amendment

7 b. Highlights that the take-up of new and innovative treatments, as well as their successful delivery to patients, depends on the knowledge, preparedness of and technical base at the disposal of medical personnel; calls on the Commission and on Member States to further cooperate through sharing knowledge and best practices regarding emerging innovative medicines and treatments, to better prepare their medical professionals;

Or. en

Amendment 317 Pietro Fiocchi

Motion for a resolution Paragraph 7 b (new)

Motion for a resolution Amendment

7 b. Calls on the Commission to leverage the Pharmaceutical, Industrial, Digital Strategies and the renewed EU trade policy to promote European competitiveness by ensuring sound intellectual property frameworks that protect investment in medical research and allow industry to remain an innovator and world leader, making the EU capable to compete with challenger regions such as the US and China;

Or. en

PE693.845v01-00 152/362 AM\1233943EN.docx EN Amendment 318 Kateřina Konečná

Motion for a resolution Paragraph 7 b (new)

Motion for a resolution Amendment

7 b. Stresses the importance of improving education on biosimilars; calls on the European Commission to promote relevant educational and communication activities amongst healthcare professionals by setting up a dedicated Europe-wide online resource centre;

Or. en

Amendment 319 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Stelios Kympouropoulos, Cindy Franssen, Inese Vaidere, Roberta Metsola

Motion for a resolution Paragraph 7 b (new)

Motion for a resolution Amendment

7 b. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of final products;

Or. en

Amendment 320 Pietro Fiocchi

Motion for a resolution Paragraph 8

Motion for a resolution Amendment

8. Welcomes the fact that the 8. Notes the fact that the Commission Commission will launch a pilot project to will launch a pilot project to better

AM\1233943EN.docx 153/362 PE693.845v01-00 EN better understand the root causes of the understand the root causes of the delayed delayed arrival of medicines on the market; arrival of medicines on the market; stresses further welcomes the fact that the the need for Member States to work Commission will continue to monitor towards making centrally authorised mergers between pharmaceutical medicines available to patients at the time companies to avoid distortions of of European Medicines Agency (EMA)’s competition; stresses the need to reduce approval, in order to ensure rapid and medicine approval times at national level equal access to medicines for everyone in and align them with European Medicines the EU; Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;

Or. en

Amendment 321 Kateřina Konečná

Motion for a resolution Paragraph 8

Motion for a resolution Amendment

8. Welcomes the fact that the 8. Welcomes the fact that the Commission will launch a pilot project to Commission will launch a pilot project to better understand the root causes of the better understand the root causes of the delayed arrival of medicines on the market; delayed arrival of medicines on the market; further welcomes the fact that the calls on the Commission to tackle the Commission will continue to monitor problem of diverging market launches of mergers between pharmaceutical medicines by linking the centralised companies to avoid distortions of marketing authorisation to a commitment competition; stresses the need to reduce on the part of pharmaceutical companies, medicine approval times at national level i.e., once authorised, medicinal products and align them with European Medicines have to be launched in all EU countries in Agency (EMA) times, in order to ensure a timely manner and pharmaceutical rapid and equal access to medicines for companies should not be allowed to everyone in the EU; subsequently withdraw these products from particular markets for commercial reasons;

Or. en

Amendment 322 Tilly Metz

Motion for a resolution

PE693.845v01-00 154/362 AM\1233943EN.docx EN Paragraph 8

Motion for a resolution Amendment

8. Welcomes the fact that the 8. Welcomes the fact that the Commission will launch a pilot project to Commission will launch a pilot project to better understand the root causes of the better understand the root causes of the delayed arrival of medicines on the market; delayed arrival of medicines on the market; further welcomes the fact that the further welcomes the fact that the Commission will continue to monitor Commission will continue to monitor mergers between pharmaceutical mergers between pharmaceutical companies to avoid distortions of companies to avoid distortions of competition; stresses the need to reduce competition; welcomes and supports medicine approval times at national level Commission action against abuses of and align them with European Medicines dominant positions in the pharmaceutical Agency (EMA) times, in order to ensure sector; rapid and equal access to medicines for everyone in the EU;

Or. en

Amendment 323 Alessandra Moretti

Motion for a resolution Paragraph 8

Motion for a resolution Amendment

8. Welcomes the fact that the 8. Welcomes the fact that the Commission will launch a pilot project to Commission will launch a pilot project to better understand the root causes of the better understand the root causes of the delayed arrival of medicines on the market; delayed arrival of medicines on the market further welcomes the fact that the and also recalls the importance of Commission will continue to monitor addressing the issue of disparities in the mergers between pharmaceutical availability of certain medicines due to companies to avoid distortions of discontinuation of products or competition; stresses the need to reduce withdrawals from less profitable markets medicine approval times at national level of some Member States, where patients do and align them with European Medicines not have access to treatments due to Agency (EMA) times, in order to ensure commercial decisions made by rapid and equal access to medicines for pharmaceutical companies and MAHs; everyone in the EU; calls on the Commission and Member States to implement the necessary measures in order to make centrally authorised medicines timely available to patients without any further delay and calls on the Commission to tackle the

AM\1233943EN.docx 155/362 PE693.845v01-00 EN problem of diverging market launches by linking the centralised marketing authorization to commitments on the part of pharmaceutical companies to not delay the availability of the product in any Member State; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition and calls on the Commission to further develop capabilities to investigate potential anti-competitive practices; stresses the need address the reasons why the medicine approval time is so heterogeneous across the EU and to reduce medicine approval times at national level and align them with European Medicines Agency (EMA) times, when considered safe and beneficial for patients, in order to remove any obstacle to a rapid and equitable access to medicines for all in the EU; emphasises that any revision of the regulatory procedures and approaches to the assessment of scientific evidence must be cautiously undertaken in order to adequately take patient benefit and safety aspects into consideration;

Or. en

Amendment 324 Marian-Jean Marinescu

Motion for a resolution Paragraph 8

Motion for a resolution Amendment

8. Welcomes the fact that the 8. Welcomes the fact that the Commission will launch a pilot project to Commission will launch a pilot project to better understand the root causes of the better understand the root causes of the delayed arrival of medicines on the market; delayed arrival of medicines on the market; further welcomes the fact that the calls on the Commission to look at the Commission will continue to monitor huge differences across EU of the average mergers between pharmaceutical number of days between approval of a companies to avoid distortions of medicine and the moment it is available to competition; stresses the need to reduce the patients and to propose new ways to

PE693.845v01-00 156/362 AM\1233943EN.docx EN medicine approval times at national level speed up the regulatory process;further and align them with European Medicines welcomes the fact that the Commission Agency (EMA) times, in order to ensure will continue to monitor mergers between rapid and equal access to medicines for pharmaceutical companies to avoid everyone in the EU; distortions of competition; stresses the need to reduce medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;

Or. en

Amendment 325 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 8

Motion for a resolution Amendment

8. Welcomes the fact that the 8. Welcomes the fact that the Commission will launch a pilot project to Commission will launch a pilot project to better understand the root causes of the better understand the root causes of the delayed arrival of medicines on the market; delayed arrival of medicines on the market; further welcomes the fact that the further welcomes the fact that the Commission will continue to monitor Commission will continue to monitor mergers between pharmaceutical mergers between pharmaceutical companies to avoid distortions of companies to avoid distortions of competition; stresses the need to reduce competition; stresses the need to devote medicine approval times at national level more resources at European level to and align them with European Medicines combat unfair and abusive market Agency (EMA) times, in order to ensure practices with regard to medicines; rapid and equal access to medicines for stresses the need to reduce and speed up everyone in the EU; medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;

Or. es

Amendment 326 Tiemo Wölken

Motion for a resolution

AM\1233943EN.docx 157/362 PE693.845v01-00 EN Paragraph 8

Motion for a resolution Amendment

8. Welcomes the fact that the 8. Welcomes the fact that the Commission will launch a pilot project to Commission will launch a pilot project to better understand the root causes of the better understand the root causes of the delayed arrival of medicines on the market; delayed arrival of medicines on the market; further welcomes the fact that the stresses the need of a complementary Commission will continue to monitor study looking into multi-factorial causes mergers between pharmaceutical of access delays and inequality; further companies to avoid distortions of welcomes the fact that the Commission competition; stresses the need to reduce will continue to monitor mergers between medicine approval times at national level pharmaceutical companies to avoid and align them with European Medicines distortions of competition; stresses the Agency (EMA) times, in order to ensure need to reduce medicine approval times at rapid and equal access to medicines for national level and align them with everyone in the EU; European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;

Or. en

Amendment 327 Petar Vitanov

Motion for a resolution Paragraph 8

Motion for a resolution Amendment

8. Welcomes the fact that the 8. Welcomes the fact that the Commission will launch a pilot project to Commission will launch a pilot project to better understand the root causes of the better understand the root causes of the delayed arrival of medicines on the market; delayed arrival of medicines on the market; further welcomes the fact that the further welcomes the fact that the Commission will continue to monitor Commission will continue to monitor mergers between pharmaceutical mergers between pharmaceutical companies to avoid distortions of companies to avoid distortions of competition; stresses the need to reduce competition; stresses the need for Member medicine approval times at national level States to work towards making centrally and align them with European Medicines authorised medicines available to patients Agency (EMA) times, in order to ensure as close to the European Medicines rapid and equal access to medicines for Agency (EMA) approval times as possible, everyone in the EU; in order to ensure rapid and equal access to medicines for everyone in the EU and avoid discrimination between EU citizens;

PE693.845v01-00 158/362 AM\1233943EN.docx EN Or. en

Amendment 328 Alexander Bernhuber

Motion for a resolution Paragraph 8

Motion for a resolution Amendment

8. Welcomes the fact that the 8. Strongly welcomes the fact that the Commission will launch a pilot project to Commission will launch a pilot project to better understand the root causes of the better understand the root causes of the delayed arrival of medicines on the market; delayed arrival of medicines on the market; further welcomes the fact that the Calls on the Commission to implement Commission will continue to monitor innovative solutions to reduce medicine mergers between pharmaceutical shortage; further welcomes the fact that companies to avoid distortions of the Commission will continue to monitor competition; stresses the need to reduce mergers between pharmaceutical medicine approval times at national level companies to avoid distortions of and align them with European Medicines competition; stresses the need to reduce Agency (EMA) times, in order to ensure medicine approval times at national level rapid and equal access to medicines for and align them with European Medicines everyone in the EU; Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;

Or. en

Amendment 329 Marlene Mortler

Motion for a resolution Paragraph 8

Motion for a resolution Amendment

8. Welcomes the fact that the 8. Welcomes the fact that the Commission will launch a pilot project to Commission will launch a pilot project to better understand the root causes of the better understand the root causes of the delayed arrival of medicines on the market; delayed arrival of medicines on the market; further welcomes the fact that the further welcomes the fact that the Commission will continue to monitor Commission will continue to monitor mergers between pharmaceutical mergers between pharmaceutical companies to avoid distortions of companies to avoid distortions of competition; stresses the need to reduce competition; stresses the need to reduce

AM\1233943EN.docx 159/362 PE693.845v01-00 EN medicine approval times at national level medicine approval times at national level and align them with European Medicines and align them with European Medicines Agency (EMA) times, in order to ensure Agency (EMA) times, in order to ensure rapid and equal access to medicines for rapid and equal access to medicines, everyone in the EU; diagnostic services and prevention measures for everyone in the EU;

Or. en

Amendment 330 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Stelios Kympouropoulos, Cindy Franssen

Motion for a resolution Paragraph 8

Motion for a resolution Amendment

8. Welcomes the fact that the 8. Welcomes the fact that the Commission will launch a pilot project to Commission will launch a pilot project to better understand the root causes of the better understand the root causes of the delayed arrival of medicines on the market; delayed arrival of medicines on the market; further welcomes the fact that the further welcomes the fact that the Commission will continue to monitor Commission will continue to monitor mergers between pharmaceutical mergers between pharmaceutical companies to avoid distortions of companies to avoid distortions of competition; stresses the need to reduce competition; stresses the need to reduce medicine approval times at national level medicine approval times, setting a time and align them with European Medicines limit for approval at national level, and Agency (EMA) times, in order to ensure align them with European Medicines rapid and equal access to medicines for Agency (EMA) times, in order to ensure everyone in the EU; rapid and equal access to medicines for everyone in the EU;

Or. en

Amendment 331 Cyrus Engerer

Motion for a resolution Paragraph 8 a (new)

Motion for a resolution Amendment

8 a. Notes that only around 5% of shortages and non-availabilities are EU-

PE693.845v01-00 160/362 AM\1233943EN.docx EN wide, and that therefore issues such as non-launch and commercial withdrawals could be addressed via better use of the Internal Market and cross-border tools; Calls on the Commission to include this aspect in an upcoming revision of Directive 2001/83;

Or. en

Amendment 332 Nicolae Ştefănuță

Motion for a resolution Paragraph 8 a (new)

Motion for a resolution Amendment

8 a. Calls on the Commission to start an inquiry into the effects of parallel trade on medicine scarcity and market penetration of novel treatments into Member States with less developed economies;

Or. en

Amendment 333 Anja Hazekamp

Motion for a resolution Paragraph 9

Motion for a resolution Amendment

9. Highlights the benefits of public- deleted private partnership tenders for national health systems in funding research into and the production of innovative medicines;

Or. nl

Amendment 334

AM\1233943EN.docx 161/362 PE693.845v01-00 EN Tilly Metz

Motion for a resolution Paragraph 9

Motion for a resolution Amendment

9. Highlights the benefits of public- 9. Highlights the role of public- private partnership tenders for national private partnerships in funding research health systems in funding research into and into and the production of innovative the production of innovative medicines; medicines; stresses that such collaboration must guarantee that research priorities are driven by patient and public health needs and public funds are invested in a transparent manner, ensuring availability and affordability of products resulting from these partnerships and other public funds; calls on the Commission to ensure that the European Partnership for Health Innovation is driven by public interest considerations and to maximise public return on public investment; calls on the Commission to adopt and implement a general policy on such conditionalities under Horizon Europe;

Or. en

Amendment 335 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez

Motion for a resolution Paragraph 9

Motion for a resolution Amendment

9. Highlights the benefits of public- 9. Highlights the benefits of public- private partnership tenders for national private partnership tenders for national health systems in funding research into and health systems in funding research into and the production of innovative medicines; the production of innovative medicines; stresses that public-private partnership dialogues and academia-pharma cooperation are essential for the exchange of knowledge and information for the benefit of all patients across the Union;

PE693.845v01-00 162/362 AM\1233943EN.docx EN Or. en

Amendment 336 Alessandra Moretti

Motion for a resolution Paragraph 9

Motion for a resolution Amendment

9. Highlights the benefits of public- 9. Highlights the role of public- private partnership tenders for national private partnership tenders for national health systems in funding research into and health systems in funding research into and the production of innovative medicines; the production of innovative medicines; recalls that any PPPs must produce results in the interest of patients, maximise public return on public investment and respect the principles of transparency, traceability and affordability;

Or. en

Amendment 337 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 9

Motion for a resolution Amendment

9. Highlights the benefits of public- 9. Highlights the problems related to private partnership tenders for national public-private partnerships for national health systems in funding research into and health systems in funding research into and the production of innovative medicines; the production of innovative medicines, such as concentration of research and development in profitable medicinal areas; underscores how this model has contributed to the neglect of rare diseases in particular;

Or. en

Amendment 338

AM\1233943EN.docx 163/362 PE693.845v01-00 EN Kateřina Konečná

Motion for a resolution Paragraph 9

Motion for a resolution Amendment

9. Highlights the benefits of public- 9. Highlights the role of public- private partnership tenders for national private partnerships in funding research health systems in funding research into and into and the production of innovative the production of innovative medicines; medicines; calls on the Commission to ensure that the European Partnership for Health Innovation is driven by public interest considerations and to maximise public return on public investment;

Or. en

Amendment 339 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Cindy Franssen, Inese Vaidere

Motion for a resolution Paragraph 9

Motion for a resolution Amendment

9. Highlights the benefits of public- 9. Highlights the benefits of public- private partnership tenders for national private partnership tenders for national health systems in funding research into and health systems in funding research into and the production of innovative medicines; the production of innovative medicines, only if driven by public interest considerations;

Or. en

Amendment 340 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Paragraph 9

Motion for a resolution Amendment

9. Highlights the benefits of public- 9. Highlights the benefits of public- private partnership tenders for national private partnership tenders for national

PE693.845v01-00 164/362 AM\1233943EN.docx EN health systems in funding research into and health systems in funding research into and the production of innovative medicines; the production of innovative medicines and medicines repurposing;

Or. en

Amendment 341 Pietro Fiocchi

Motion for a resolution Paragraph 9

Motion for a resolution Amendment

9. Highlights the benefits of public- 9. Highlights the benefits of public- private partnership tenders for national private partnership tenders for national health systems in funding research into health systems in order to fund research and the production of innovative and production of innovative medicines medicines; and medicine repurposing;

Or. en

Amendment 342 Tilly Metz

Motion for a resolution Paragraph 9 a (new)

Motion for a resolution Amendment

9 a. Calls on the Commission to ensure that beneficiaries of funding disbursed through the HERA incubator initiative commit to sharing of intellectual property and know-how to scale-up the production and availability of COVID-19 products; supports the Commission’s plan to set up a Health Emergency Preparedness and Response Authority (HERA); calls for ensuring that HERA is public-interest driven and contributes effectively to the development, availability and affordability of safe and effective medical countermeasures;

Or. en

AM\1233943EN.docx 165/362 PE693.845v01-00 EN Amendment 343 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 9 a (new)

Motion for a resolution Amendment

9 a. Welcomes the Commission’s intention to adopt a legislative proposal to establish a Health Emergency Preparedness and Response Authority (HERA); considers that the Authority should identify health threats, initiate and support the development of innovation, establish at European level a list of medicinal products of major therapeutic interest, facilitate their production within the EU, promote the joint purchase and build up strategic stocks of those medicines;

Or. en

Amendment 344 Nicolae Ştefănuță

Motion for a resolution Paragraph 9 a (new)

Motion for a resolution Amendment

9 a. Calls on the Commission to draw conclusions from the experience of joint negotiations gained during the pandemic and to promote joint procurement of medicine; points out that a stronger position of different Member States speaking with one voice should be used in joint negotiation with industry to attain high transparency standards, equal and sustainable medicine procurement;

Or. en

PE693.845v01-00 166/362 AM\1233943EN.docx EN Amendment 345 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 9 a (new)

Motion for a resolution Amendment

9a. Underlines the need for new funding lines to support the work of new start-ups and SMEs in the field of medical biotechnology, while respecting criteria relating to safety and ethics.

Or. es

Amendment 346 Alessandra Moretti

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Stresses the importance of new joint EU public procurement contracts by joint EU public procurement contracts by the Commission and the Member States, the Commission and the Member States, especially for emergency medicines and especially for emergency medicines and unmet therapeutic needs; unmet therapeutic needs; emphasises the importance of diversified supplies and procurement practices for pharmaceuticals; urges the Commission, in the context of Directive 2014/24/EU, to swiftly propose guidelines for the Member States, notably on how to best implement the most economically advantageous tender (MEAT) criteria, looking beyond the lowest price criteria only; proposes that investments in the manufacture of active ingredients and medicinal end products in the EU should also be retained as a criterion, as well as the number and location of production sites, the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards; notes that procurement procedures with only one successful

AM\1233943EN.docx 167/362 PE693.845v01-00 EN tenderer and/or only one production site of the basic substance may exacerbate vulnerability should supplies be disrupted; calls on the Commission and the Member States to consider introducing procurement procedures under which contracts may be awarded to a number of successful tenderers, including joint tenderers;

Or. en

Amendment 347 Pietro Fiocchi, Andrey Slabakov

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Stresses the importance of new joint EU public procurement contracts by joint EU public procurement contracts by the Commission and the Member States, the Commission and the Member States; especially for emergency medicines and stresses that EU joint procurement should unmet therapeutic needs; be used only in exceptional circumstances and for extraordinary public cross-border health threats, such as the COVID-19 pandemic, if purchase of products cannot be ensured as efficiently by other means, to ensure patient access to emergency medicines; highlights that joint public procurement should have a clearly defined scope and be limited in time, and should not hinder patient access, medical innovation and fair competition; highlights that joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU or third countries, and should not jeopardise product choice, or create market distortion or any concentration of demand;

Or. en

Amendment 348

PE693.845v01-00 168/362 AM\1233943EN.docx EN Tilly Metz

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Stresses the importance of new joint EU public procurement contracts by joint EU public procurement contracts by the Commission and the Member States, the Commission and the Member States, especially for emergency medicines and especially for,but not limited to, unmet therapeutic needs; emergency medicines and unmet therapeutic needs; calls for exploration of such practices in areas of high priced medicines, including for rare diseases and cancer with a clear outline of milestones, objectives and commitments undertaken by all parties involved; highlights the need to ensure high levels of transparency in these initiatives and apply lessons learned from the joint procurement of COVID-19 products;

Or. en

Amendment 349 Andrey Slabakov, Joanna Kopcińska, Pietro Fiocchi, Ryszard Antoni Legutko, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Stresses the importance of new joint EU public procurement contracts by joint EU public procurement contracts by the Commission and the Member States, the Commission and the Member States, especially for emergency medicines and especially for medicines during health unmet therapeutic needs; crises, as well as unmet therapeutic needs, while taking into account the need for a better balance between public and private interests, including clear rules on liability for manufacturers, as well as the need for sufficient flexibility for Member States, as well as respect for the principle of subsidiarity, due to national specificities or divergent financial capacities across the EU;

AM\1233943EN.docx 169/362 PE693.845v01-00 EN Or. en

Amendment 350 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Highlights the potential of joint joint EU public procurement contracts by EU public procurement contracts by the the Commission and the Member States, Commission and the Member States; especially for emergency medicines and considers that the EU joint procurement unmet therapeutic needs; has potential as a tool for extraordinary cross-border health threats; suggests that joint public procurement be clearly defined in scope, time, continues to be used on the mandate of Member States on a case-by-case basis and it should not create barriers for patient access, medical innovation or fair competition

Or. en

Amendment 351 Simona Baldassarre, Silvia Sardone, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Stresses the importance of new joint EU public procurement contracts by joint EU public procurement contracts by the Commission and the Member States, the Commission and the Member States; especially for emergency medicines and stresses that joint EU procurement should unmet therapeutic needs; be implemented only in exceptional circumstances and for extraordinary cross-border public health threats, such as the COVID-19 pandemic, if the purchase of products cannot be secured as efficiently by other means, to ensure patient’s access to emergency medicines and unmet therapeutic needs;

PE693.845v01-00 170/362 AM\1233943EN.docx EN Or. en

Amendment 352 Jessica Polfjärd

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Notes the value of new joint EU joint EU public procurement contracts by public procurement contracts by the the Commission and the Member States, Commission and the Member States for especially for emergency medicines and emergency medicines and unmet unmet therapeutic needs; therapeutic needs; stresses that such joint procurement initiatives should be undertaken only under exceptional circumstances and in situations where such action has a clear and demonstrable added value, such as serious cross-border health threats;

Or. en

Amendment 353 Kateřina Konečná

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Stresses the importance of new joint EU public procurement contracts by joint EU public procurement contracts by the Commission and the Member States, the Commission and the Member States, especially for emergency medicines and especially, but not limited to, emergency unmet therapeutic needs; medicines and unmet therapeutic needs; highlights the need to ensure high levels of transparency in these initiatives and apply lessons learned from the joint procurement of COVID-19 vaccines;

Or. en

AM\1233943EN.docx 171/362 PE693.845v01-00 EN Amendment 354 Alexander Bernhuber

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Stresses the importance of new joint EU public procurement contracts by joint EU public procurement contracts by the Commission and the Member States, the Commission and the Member States, especially for emergency medicines and especially for emergency medicines such unmet therapeutic needs; as extraordinary health threats like the COVID-19 pandemic; stresses that joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU;

Or. en

Amendment 355 Alessandra Moretti

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Stresses the need for joint EU joint EU public procurement contracts by public procurement contracts by the the Commission and the Member States, Commission and the Member States, especially for emergency medicines and especially for, but not limited to, unmet therapeutic needs; emergency medicines and unmet therapeutic needs; underlines the need to ensure high levels of transparency in these initiatives and apply lessons learned from joint procurement of COVID-19 vaccines;

Or. en

Amendment 356 Pernille Weiss

Motion for a resolution Paragraph 10

PE693.845v01-00 172/362 AM\1233943EN.docx EN Motion for a resolution Amendment

10. Stresses the importance of new 10. Calls on the Commission to assess joint EU public procurement contracts by the impact of new joint EU public the Commission and the Member States, procurement contracts by the Commission especially for emergency medicines and and the Member States, especially for unmet therapeutic needs; emergency medicines and unmet therapeutic needs; stresses that joint public procurement should not hinder patient access, medical innovation or competition;

Or. en

Amendment 357 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Strongly supports the use of joint joint EU public procurement contracts by EU public procurement procedures by the the Commission and the Member States, Commission and the Member States, especially for emergency medicines and especially for medicinal products of major unmet therapeutic needs; therapeutic interest, emergency medicines and unmet therapeutic needs to improve their affordability and their access at EU level;

Or. en

Amendment 358 Marian-Jean Marinescu

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Stresses the importance of new joint EU public procurement contracts by joint EU public procurement contracts by the Commission and the Member States, the Commission and the Member States, especially for emergency medicines and especially for emergency medicines and

AM\1233943EN.docx 173/362 PE693.845v01-00 EN unmet therapeutic needs; unmet therapeutic needs; research funding should focus on the objective of increasing patients innovative medicines;

Or. en

Amendment 359 Sara Cerdas

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Stresses the importance of new joint EU public procurement contracts by joint EU public procurement contracts by the Commission and the Member States, the Commission and the Member States, especially for emergency medicines and especially for, but not limited to, unmet therapeutic needs; emergency medicines and unmet therapeutic needs;

Or. en

Amendment 360 Nicolae Ştefănuță

Motion for a resolution Paragraph 10

Motion for a resolution Amendment

10. Stresses the importance of new 10. Stresses the importance of new joint EU public procurement contracts by joint EU public procurement contracts by the Commission and the Member States, the Commission and the Member States, especially for emergency medicines and especially for emergency medicines, unmet therapeutic needs; orphan medicines and unmet therapeutic needs;

Or. en

Amendment 361 Pietro Fiocchi

Motion for a resolution

PE693.845v01-00 174/362 AM\1233943EN.docx EN Paragraph 10 a (new)

Motion for a resolution Amendment

10 a. Calls on the Commission to make an assessment of the ICU joint procurement initiative and take the lesson learned to improve this tool by limiting it to serious cross-border threats to health; considers that it should not impact pre- existing contractual agreements with suppliers of medical countermeasures and should be carried out in accordance with the Directive 2014/24/EU in a transparent manner, while respecting the following conditions: the procurement process, criteria, timelines, specifications, and formalities must be transparent and workable; a preliminary consultation phase involving potential participating manufacturers must take place; clear volume commitments irrespective of the selected supply modality must be ensured;

Or. en

Amendment 362 Nathalie Colin-Oesterlé

Motion for a resolution Paragraph 10 a (new)

Motion for a resolution Amendment

10a. Emphasises that joint European procurement procedures can make it possible to counter shortages, especially in times of health crises, as was the case with the procedure launched following the onset of the COVID-19 epidemic, with simplified and transparent procedures in the interests of improved response times; calls, in particular, for the establishment of EU joint procurement for medicines to treat rare diseases in order to ensure that these medicines are available in all Member States;

AM\1233943EN.docx 175/362 PE693.845v01-00 EN Or. fr

Amendment 363 Frédérique Ries

Motion for a resolution Paragraph 10 a (new)

Motion for a resolution Amendment

10 a. Calls on the European Commission and Member States to strengthen European cooperation in pricing and negotiations, by exploring the feasibility of establishing a European Table of Negotiations, supported by joint procurement initiatives, specifically for rare and complex diseases, together with a functioning cooperation on Health Technology Assessment (HTA);

Or. en

Amendment 364 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez

Motion for a resolution Paragraph 10 a (new)

Motion for a resolution Amendment

10 a. Believes it will be beneficial to have a common definition of unmet medical needs as the concept is a key criterion for medical prioritisation as well as a qualifier for adaptive and accelerated authorisation processes; therefore calls on the Commission to initiate talks to establish transparent criteria on how to define unmet needs;

Or. en

PE693.845v01-00 176/362 AM\1233943EN.docx EN Amendment 365 Kateřina Konečná

Motion for a resolution Paragraph 10 a (new)

Motion for a resolution Amendment

10 a. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of end-products; calls on the Commission to adopt and implement a general policy on such conditionalities under Horizon Europe;

Or. en

Amendment 366 Alessandra Moretti

Motion for a resolution Paragraph 10 a (new)

Motion for a resolution Amendment

10 a. Calls on the Commission and Member States to promote the creation of one or more European non-profit pharmaceutical undertakings which operate in the public interest to manufacture medicinal products of health and strategic importance for healthcare;

Or. en

Amendment 367 Aldo Patriciello

Motion for a resolution Paragraph 10 a (new)

Motion for a resolution Amendment

10 a. Recognises the low healthcare

AM\1233943EN.docx 177/362 PE693.845v01-00 EN budget allocations to immunisation programmes, including immunisation implementation and monitoring, across Member States, compared to the far- reaching health and economic benefits that vaccinations provide;

Or. en

Amendment 368 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 10 a (new)

Motion for a resolution Amendment

10 a. Considers that, in times of crisis, part of the Union joint procurement should, in the spirit of solidarity, be pre- allocated to low- and middle-income countries, in particular African countries.

Or. en

Amendment 369 Sirpa Pietikäinen

Motion for a resolution Paragraph 10 a (new)

Motion for a resolution Amendment

10 a. Highlights the need to set a minimum level of public procurement produced within Europe for medical devices , personal protective equipment, medicines and such to be set at least 30%;

Or. en

Amendment 370 Nicolae Ştefănuță

PE693.845v01-00 178/362 AM\1233943EN.docx EN Motion for a resolution Paragraph 10 a (new)

Motion for a resolution Amendment

10 a. Stresses the importance of securing joint medicine stocks to prevent the recurrence of essential medicine scarcity across Member States;

Or. en

Amendment 371 Kateřina Konečná

Motion for a resolution Paragraph 10 b (new)

Motion for a resolution Amendment

10 b. Calls on the Commission to ensure that beneficiaries of funding disbursed through the HERA incubator initiative commit to sharing intellectual property and know-how to scale-up the production and availability of vaccines against new COVID-19 variants; calls for ensuring that HERA is public-interest driven and contributes effectively to the development, availability and affordability of safe and effective medical countermeasures;

Or. en

Amendment 372 Aldo Patriciello

Motion for a resolution Paragraph 10 b (new)

Motion for a resolution Amendment

10 b. Recognises that an increased pressure on vaccine pricing could discourage investment in the development of innovative technologies and production

AM\1233943EN.docx 179/362 PE693.845v01-00 EN capacity in EU; stresses that vaccine prices should be reflective of the comprehensive value of vaccination to the European citizens;

Or. en

Amendment 373 Pietro Fiocchi, Andrey Slabakov

Motion for a resolution Paragraph 10 b (new)

Motion for a resolution Amendment

10 b. Recognises the low healthcare budget allocations to immunisation programmes, including immunisation implementation and monitoring, across Member States, compared to the far- reaching health and economic benefits that vaccinations provide;

Or. en

Amendment 374 Aldo Patriciello

Motion for a resolution Paragraph 10 c (new)

Motion for a resolution Amendment

10 c. Recalls that the primary purpose of joint procurement should be to guarantee stability in an unpredictable environment in the context of a cross- border health crisis only, ensuring equitable access for patients and increased visibility and predictability for the actors involved; believes that for multi-source markets, joint procurement is not the right solution to achieve its objective; however, if it is used, it shall be in the context of cross border threats to health only and shall be carried in a

PE693.845v01-00 180/362 AM\1233943EN.docx EN transparent, timely and effective way to prevent market disruption and to ensure that all parties involved, both relevant authorities and manufacturers, can fulfil their contractual responsibilities,

Or. en

Amendment 375 Kateřina Konečná

Motion for a resolution Paragraph 10 c (new)

Motion for a resolution Amendment

10 c. Stresses the importance of the World Health Assembly Resolution of May 2019 on Improving the transparency of markets for medicines, vaccines, and other health products; calls on the Commission to promote information sharing among Member States on medicine net prices through the EURIPID collaboration; calls for the revision of Directive 89/105/EEC to enhance the transparency of medicine pricing and reimbursement decisions.

Or. en

Amendment 376 Kateřina Konečná

Motion for a resolution Paragraph 10 d (new)

Motion for a resolution Amendment

10 d. Highlights the need to ensure that the revision of the general pharmaceutical legislation contributes to the strengthening of evidentiary requirements on medicine safety and efficacy; calls on the EMA and national medicine agencies to prioritise the submission of data from

AM\1233943EN.docx 181/362 PE693.845v01-00 EN randomised controlled clinical trials that compare an investigational medicine against the standard treatment; stresses the importance of this type of evidence in health technology assessments and for clinical decisions on treatment;

Or. en

Amendment 377 Kateřina Konečná

Motion for a resolution Paragraph 10 e (new)

Motion for a resolution Amendment

10 e. Calls on the Commission to ensure adequate consultation with consumer and patient representatives throughout the implementation of the Pharmaceutical Strategy;

Or. en

Amendment 378 Alessandra Moretti

Motion for a resolution Paragraph 11

Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that accessibility and of medicines remains a challenge for affordability of medicines remain a national health systems, and that challenge for national health systems, and innovative medicines are expensive; that innovative medicines are expensive or welcomes the Commission’s intention to not even launched in certain Member review pharmaceutical legislation to States for commercial reasons; welcomes promote robust competition and to stabilise the Commission’s intention to review and balance national drug pricing systems; pharmaceutical legislation to promote robust and fair competition and to promote fair national drug pricing systems; stresses the need to link any form of incentive to affordability clauses in order to ensure equal and fair pricing of pharmaceuticals,

PE693.845v01-00 182/362 AM\1233943EN.docx EN particularly innovative ones; calls for an increased transparency on research costs incurred for pharmaceutical development to better adjust the pricing mechanism to the actual costs; calls on the Commission and Member States in this regard to establish a framework for reporting research cost as regards pharmaceutical development;

Or. en

Amendment 379 Kateřina Konečná

Motion for a resolution Paragraph 11

Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a challenge for national health systems, and that national health systems, and that innovative medicines are expensive; innovative medicines are expensive; welcomes the Commission’s intention to welcomes the Commission’s intention to review pharmaceutical legislation to review pharmaceutical legislation to promote robust competition and to stabilise promote robust competition and to stabilise and balance national drug pricing systems; and balance national drug pricing systems; draws attention to the fact that national pricing policies in some Member States use different price levels to reduce expenditure on national health budgets by encouraging the links in the supply chain to buy medicines intended for patients in other Member States, thereby causing the secondary unavailability of those medicines for the patients for whom they were originally intended;

Or. cs

Amendment 380 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Paragraph 11

AM\1233943EN.docx 183/362 PE693.845v01-00 EN Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a challenge for national health systems, and that national health systems and that the ability innovative medicines are expensive; to pay remains very different across EU welcomes the Commission’s intention to Member States ; believes that the solution review pharmaceutical legislation to to this challenge lies in a transition promote robust competition and to stabilise towards an outcomes-based approach and balance national drug pricing which recognizes the value of medicines systems; to patients and the economic benefits brought to healthcare systems and society; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and improve access for patients across Member States;

Or. en

Amendment 381 Tilly Metz

Motion for a resolution Paragraph 11

Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a systemic challenge national health systems, and that for national health systems, a key access innovative medicines are expensive; barrier for patients and that innovative welcomes the Commission’s intention to medicines are expensive with often review pharmaceutical legislation to uncertain added clinical benefit; stresses promote robust competition and to the need for solid evidence, based on well- stabilise and balance national drug designed comparative randomised clinical pricing systems; trials to meet health needs with meaningful endpoints and to evaluate medicine; stresses that the regulatory framework must facilitate the best possible outcomes for patients and public interest;

Or. en

Amendment 382

PE693.845v01-00 184/362 AM\1233943EN.docx EN Petar Vitanov

Motion for a resolution Paragraph 11

Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a challenge for national health systems, and that national health systems, that innovative innovative medicines are expensive; medicines are expensive, and that the welcomes the Commission’s intention to ability to pay remains very divergent review pharmaceutical legislation to across EU Member States, leading to promote robust competition and to stabilise unequal access to medicines for EU and balance national drug pricing systems; citizens; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition, to stabilise and balance national drug pricing systems, and to ensure more equitable access for patients across Member States;

Or. en

Amendment 383 Pernille Weiss

Motion for a resolution Paragraph 11

Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a challenge for national health systems, and that national health systems, and that equitable innovative medicines are expensive; access to innovative medicines is a welcomes the Commission’s intention to challenge across Member States; review pharmaceutical legislation to welcomes the Commission’s intention to promote robust competition and to review pharmaceutical legislation to stabilise and balance national drug promote robust competition; highlights pricing systems; that decisions on the pricing and reimbursement of medicines are the purview of Member States;

Or. en

AM\1233943EN.docx 185/362 PE693.845v01-00 EN Amendment 384 Alexander Bernhuber

Motion for a resolution Paragraph 11

Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a challenge for national health systems, and that national health systems, and that innovative medicines are expensive; innovative medicines are expensive; welcomes the Commission’s intention to welcomes the Commission’s intention to review pharmaceutical legislation to review pharmaceutical legislation to promote robust competition and to stabilise promote robust competition and ensure and balance national drug pricing systems; equal access to medicines and medical products across the Member States and stabilise and balance national drug pricing systems;

Or. en

Amendment 385 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 11

Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a challenge for national health systems, and that national health systems, and that innovative medicines are expensive; innovative medicines are expensive; welcomes the Commission’s intention to welcomes the Commission’s intention to review pharmaceutical legislation to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing stabilise and balance national drug pricing systems; strongly believes that the pricing systems; of medicines should not be left to fluctuations in the market;

Or. en

Amendment 386 Pietro Fiocchi

PE693.845v01-00 186/362 AM\1233943EN.docx EN Motion for a resolution Paragraph 11

Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a challenge for national health systems, and that national health systems, and that innovative medicines are expensive; innovative medicines are expensive; welcomes the Commission’s intention to welcomes the Commission's intention to review pharmaceutical legislation to review pharmaceutical legislation to promote robust competition and to promote robust and timely competition as stabilise and balance national drug pricing a key enabler for resilience and efficiency, systems; as well as to stabilize and balance the national drugs pricing systems;

Or. en

Amendment 387 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 11

Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a challenge for national health systems, and that national health systems, and that innovative medicines are expensive; innovative medicines are expensive; welcomes the Commission’s intention to welcomes the Commission’s intention to review pharmaceutical legislation to review pharmaceutical legislation to promote robust competition and to promote robust competition in order to stabilise and balance national drug pricing support Member States in stabilising and systems; balancing national drug pricing systems;

Or. en

Amendment 388 Jessica Polfjärd

Motion for a resolution Paragraph 11

Motion for a resolution Amendment

AM\1233943EN.docx 187/362 PE693.845v01-00 EN 11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a challenge for national health systems, and that national health systems, and that innovative medicines are expensive; innovative medicines are expensive; takes welcomes the Commission’s intention to note of the Commission’s intention to review pharmaceutical legislation to review pharmaceutical legislation to promote robust competition and to stabilise promote robust competition and to stabilise and balance national drug pricing systems; and balance national drug pricing systems;

Or. en

Amendment 389 Tiemo Wölken

Motion for a resolution Paragraph 11

Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a challenge for national health systems, and that national health systems, and that innovative medicines are expensive; innovative medicines are expensive; welcomes the Commission’s intention to welcomes the Commission’s intention to review pharmaceutical legislation to review pharmaceutical legislation to promote robust competition and to stabilise promote robust and timely competition and and balance national drug pricing systems; to stabilise and balance national drug pricing systems in order to ensure more equitable access for patients within the Union;

Or. en

Amendment 390 Kateřina Konečná

Motion for a resolution Paragraph 11

Motion for a resolution Amendment

11. Is concerned that the affordability 11. Is concerned that the affordability of medicines remains a challenge for of medicines remains a challenge for national health systems, and that patients and national health systems, and innovative medicines are expensive; that innovative medicines are expensive; welcomes the Commission’s intention to welcomes the Commission’s intention to

PE693.845v01-00 188/362 AM\1233943EN.docx EN review pharmaceutical legislation to review pharmaceutical legislation to promote robust competition and to stabilise promote robust competition and to stabilise and balance national drug pricing systems; and balance national drug pricing systems;

Or. en

Amendment 391 Alessandra Moretti

Motion for a resolution Paragraph 11 a (new)

Motion for a resolution Amendment

11 a. Calls the Commission to consider new processes for promoting the repurposing of medicinal products given that, as new research into certain medicinal products has proved, for example for anti-inflammatory and immunosuppressant Rheumatic and Musculoskeletal Disease (RMD), they can be adopted quickly to provide more effective and lower cost treatments for many burdensome inflammation-linked diseases including COVID-19, cancer, cardiovascular disease and diabetes; calls on the Commission to analyse the existing situation concerning off-label use of medicines, including less expensive medicines and medicines used for rare cancers among others, and underlines the need to address this issue in order to facilitate the use of those medicines when beneficial for the patient;

Or. en

Amendment 392 Nathalie Colin-Oesterlé

Motion for a resolution Paragraph 11 a (new)

Motion for a resolution Amendment

AM\1233943EN.docx 189/362 PE693.845v01-00 EN 11a. Calls on the Commission to develop European health strategies on the basis of a common basket of medicines for the treatment of cancer, infections, rare diseases and other areas particularly affected by shortages; calls on the Commission to consider the option of harmonised pricing criteria to make such medicines affordable;

Or. fr

Amendment 393 Tiemo Wölken

Motion for a resolution Paragraph 11 a (new)

Motion for a resolution Amendment

11 a. Points out that medicines are often pulled form markets due to company low commercial interest in them; Calls on the Commission to look into policy options that help secure that centrally authorized medicines are marketed in all EU Member States and not just in those that are commercially interesting;

Or. en

Amendment 394 Pietro Fiocchi, Andrey Slabakov

Motion for a resolution Paragraph 11 a (new)

Motion for a resolution Amendment

11 a. Calls on the Commission to support and promote wide implementation of novel pricing and payment models to improve patient access to innovative medicines, by facilitating best-practice sharing between Member States, ensuring an appropriate data infrastructure, and

PE693.845v01-00 190/362 AM\1233943EN.docx EN addressing legal barriers;

Or. en

Amendment 395 Aldo Patriciello

Motion for a resolution Paragraph 11 a (new)

Motion for a resolution Amendment

11 a. Calls on the Commission to support and promote wide implementation of novel pricing and payment models to improve patient access to innovative medicines, by facilitating best-practice sharing between Member States, ensuring an appropriate data infrastructure, and addressing legal barriers;

Or. en

Amendment 396 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez

Motion for a resolution Paragraph 11 a (new)

Motion for a resolution Amendment

11 a. Believes that facilitating faster access would be especially beneficial for patients with severe chronical diseases; suggests accordingly to allow patients to take part in the decisions on risk-benefit from early access to new and innovative medicines and treatment;

Or. en

Amendment 397 Cyrus Engerer

AM\1233943EN.docx 191/362 PE693.845v01-00 EN Motion for a resolution Paragraph 11 a (new)

Motion for a resolution Amendment

11 a. Considers that unjustified import and export restrictions and/or bans exacerbate shortages and reduce competition in the Internal Market decreasing affordability; calls on the Commission to tackle such unjustified restrictions and/or bans;

Or. en

Amendment 398 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Stelios Kympouropoulos, Cindy Franssen

Motion for a resolution Paragraph 11 a (new)

Motion for a resolution Amendment

11 a. Calls on the Commission to create a High-Level Forum on Better Access to Medicines to identify multi-stakeholder solutions to introducing new health technologies that can broaden access, reduce delays and mitigate the impact of shortages;

Or. en

Amendment 399 Alexander Bernhuber

Motion for a resolution Paragraph 11 a (new)

Motion for a resolution Amendment

11 a. Calls on the Commission to start a dialogue to exchange on better access to health innovation and technologies and to

PE693.845v01-00 192/362 AM\1233943EN.docx EN reduce delays and mitigate the impact of shortage of medicines within the Union;

Or. en

Amendment 400 Tiemo Wölken

Motion for a resolution Paragraph 11 b (new)

Motion for a resolution Amendment

11 b. Welcomes the creation of the new EU agency HERA and underlines its key role to address the needs of patients when health emergencies occur, thus filling gaps in foresight, stockpiling essential medicines and medical devices, and coordinating the EU's Response to cross- border health threats;

Or. en

Amendment 401 Alessandra Moretti

Motion for a resolution Paragraph 11 b (new)

Motion for a resolution Amendment

11 b. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of end-products; calls on the Commission to adopt and implement a general policy on such conditionalities under Horizon Europe;

Or. en

Amendment 402

AM\1233943EN.docx 193/362 PE693.845v01-00 EN Nathalie Colin-Oesterlé

Motion for a resolution Paragraph 11 b (new)

Motion for a resolution Amendment

11b. Calls on the Commission consider creating a European contingency reserve for medicinal products of health and strategic importance (MISSs) that are at high risk of shortage, along the lines of the ‘RescEU’ mechanism, in order to alleviate recurrent shortages;

Or. fr

Amendment 403 Pietro Fiocchi, Andrey Slabakov

Motion for a resolution Paragraph 11 b (new)

Motion for a resolution Amendment

11 b. Calls on the Commission to create a High-Level Forum on Better Access to Health Innovation to identify multi- stakeholder solutions to introducing new health technologies that can broaden access, reduce delays and mitigate the impact of shortages;

Or. en

Amendment 404 Aldo Patriciello

Motion for a resolution Paragraph 11 b (new)

Motion for a resolution Amendment

11 b. Calls on the Commission to create a High-Level Forum on Better Access to Health Innovation to identify multi-

PE693.845v01-00 194/362 AM\1233943EN.docx EN stakeholder solutions to introducing new health technologies that can broaden access, reduce delays and mitigate the impact of shortages;

Or. en

Amendment 405 Tiemo Wölken

Motion for a resolution Paragraph 11 c (new)

Motion for a resolution Amendment

11 c. Points out that new health technologies should demonstrate their clinical added-value and cost- effectiveness compared to what is already available on the market; emphasizes that health technology assessment is a tool to support this analysis and inform national pricing and reimbursement decisions and that currently such assessment is highly fragmented within the Union, although it can enable cooperation on clinical evidence requirements and clinical trial design and therefore support Member States’ timely and evidence-based decision making on patient access to new medicines; once again stresses the need for more cooperation on HTA on Union level;

Or. en

Amendment 406 Alessandra Moretti

Motion for a resolution Paragraph 11 c (new)

Motion for a resolution Amendment

11 c. Calls on the Commission to ensure that beneficiaries of funding disbursed

AM\1233943EN.docx 195/362 PE693.845v01-00 EN through the HERA incubator initiative commit to sharing intellectual property and know-how to scale-up the production and availability of vaccines against new COVID-19 variants; supports the Commission’s plan to set up a Health Emergency Preparedness and Response Authority (HERA); calls for ensuring that HERA is public-interest driven and contributes effectively to the development, availability and affordability of safe and effective medical countermeasures;

Or. en

Amendment 407 Alessandra Moretti

Motion for a resolution Paragraph 11 d (new)

Motion for a resolution Amendment

11 d. Encourages the inclusion of disease-based communities in the European Medicines Agency’s Scientific Advice processes, for rare cancers and diseases, to provide regulators with their expertise of the disease and factor in its rarity and unmet needs;

Or. en

Amendment 408 Tilly Metz

Motion for a resolution Subheading 2

Motion for a resolution Amendment

Supporting a competitive and innovative Supporting a transparent competitive and EU pharmaceutical industry innovative EU pharmaceutical industry to respond to public health needs

Or. en

PE693.845v01-00 196/362 AM\1233943EN.docx EN Amendment 409 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Subheading 2

Motion for a resolution Amendment

Supporting a competitive and innovative Supporting an EU pharmaceutical industry EU pharmaceutical industry that meets peoples' needs

Or. en

Amendment 410 Nathalie Colin-Oesterlé

Motion for a resolution Paragraph 11 c (new)

Motion for a resolution Amendment

11c. Urges the Commission and the Member States to introduce financial incentives, in line with State aid rules, to preserve and expand the EU’s pharmaceutical industrial base, from the production of active pharmaceutical ingredients to medicine manufacturing, packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies in order to diversify resources and encourage the development of innovative production technologies capable of enhancing the responsiveness of entire production lines; recalls that all public funding must be made conditional on the transparency and traceability of investments, on supply obligations on the European market, and on facilitating the best outcome for patients, including in terms of accessibility of manufactured medicines;

Or. fr

AM\1233943EN.docx 197/362 PE693.845v01-00 EN Amendment 411 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Susana Solís Pérez

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Welcomes the Commission's pharmaceutical industry is strategic and objective of improving the innovation more responsive to patients’ needs; points capacity and competitiveness in the out that the industry needs a stable, flexible pharmaceutical industry; insists that a and agile regulatory environment; believes competitive EU pharmaceutical industry is that it can thrive globally with a clear, strategic and more responsive to patients’ robust and efficient intellectual property needs and that it is in the interest of system; welcomes the initiative to build patients that the industry is in the interoperable digital infrastructure for the strongest possible position to meet their European Health Data Space; diagnostic and therapeutic needs; points out that the industry needs a stable, flexible and agile regulatory environment; underlines that the marketing authorisation system should build on the existing legislative framework and prevent duplication and additional administrative burdens, believes that it can thrive globally with a clear, robust and efficient intellectual property system;

Or. en

Amendment 412 Alessandra Moretti

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that public responsibilities pharmaceutical industry is strategic and fall upon the EU pharmaceutical industry more responsive to patients’ needs; points and that its competitiveness is strategic for out that the industry needs a stable, functioning and effective healthcare flexible and agile regulatory environment; systems in the EU and for public believes that it can thrive globally with a authorities to be more responsive to clear, robust and efficient intellectual patients’ needs and protect public health;

PE693.845v01-00 198/362 AM\1233943EN.docx EN property system; welcomes the initiative to points out a predictable and agile build interoperable digital infrastructure for regulatory environment is beneficial to the European Health Data Space; address the needs of patients and to create a better environment for innovation and drugs development; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space; underlines that a harmonised interpretation of the General Data Protection Regulation (GDPR) in all EU Member States is the foundation for such initiatives;

Or. en

Amendment 413 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a focus on pharmaceutical industry is strategic and competitiveness for the EU pharmaceutical more responsive to patients’ needs; points industry is contrary to meeting patients’ out that the industry needs a stable, needs; points out that the industry needs to flexible and agile regulatory environment; be regulated to ensure patients' needs are believes that it can thrive globally with a met; believes that the industry can provide clear, robust and efficient intellectual an essential public good by providing property system; welcomes the initiative to medicines to people in need rather than build interoperable digital infrastructure profits to patent-holders; recalls the for the European Health Data Space; contribution to global public health from the act of avoiding the intellectual properly system, such as with the development of the highly-successful polio vaccine;

Or. en

Amendment 414 Tilly Metz

Motion for a resolution Paragraph 12

AM\1233943EN.docx 199/362 PE693.845v01-00 EN Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive EU pharmaceutical industry is strategic and pharmaceutical industry is strategic and more responsive to patients’ needs; points more responsive to patients’ needs; points out that the industry needs a stable, flexible out that the industry needs a stable and and agile regulatory environment; believes predictable regulatory environment; that it can thrive globally with a clear, welcomes the initiative to support real robust and efficient intellectual property world evidence generation and to build system; welcomes the initiative to build interoperable digital infrastructure within interoperable digital infrastructure for the the European Health Data Space, while European Health Data Space; ensuring privacy and security of health data;

Or. en

Amendment 415 Nicolás González Casares

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive EU pharmaceutical industry is strategic and pharmaceutical industry is strategic and more responsive to patients’ needs; points more responsive to patients’ needs; points out that the industry needs a stable, flexible out that the industry needs a stable, flexible and agile regulatory environment; believes and agile regulatory environment; believes that it can thrive globally with a clear, that the current intellectual property robust and efficient intellectual property system should be reviewed in order to system; welcomes the initiative to build ensure that it incentives innovation, while interoperable digital infrastructure for the ensuring a universal and equitable access European Health Data Space; to medicinal products, especially in emergency situations; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;

Or. en

Amendment 416 Andrey Slabakov, Pietro Fiocchi

Motion for a resolution Paragraph 12

PE693.845v01-00 200/362 AM\1233943EN.docx EN Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive EU pharmaceutical industry is strategic and pharmaceutical industry is strategic and more responsive to patients’ needs; points more responsive to patients’ needs; points out that the industry needs a stable, flexible out that the industry needs a stable, flexible and agile regulatory environment; believes and agile regulatory environment, which at that it can thrive globally with a clear, the same time sustains a robust and robust and efficient intellectual property responsible framework of requirements, system; welcomes the initiative to build safeguarding the principle of prevention interoperable digital infrastructure for the and the availably of safe, effective and European Health Data Space; quality medicines on the EU market; believes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;

Or. en

Amendment 417 Tiemo Wölken

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive EU pharmaceutical industry is strategic and pharmaceutical industry is strategic and more responsive to patients’ needs; points more responsive to patients’ needs; points out that the industry needs a stable, flexible out that the industry needs a stable, flexible and agile regulatory environment; believes and agile regulatory environment and that that it can thrive globally with a clear, should build on the existing framework robust and efficient intellectual property and prevent duplication and additional system; welcomes the initiative to build bureaucratic burdens; believes that it can interoperable digital infrastructure for the thrive globally with a clear, robust and European Health Data Space; efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space to leverage the full potential of real-world-date and access to rare therapies;

Or. en

AM\1233943EN.docx 201/362 PE693.845v01-00 EN Amendment 418 Ondřej Knotek, Billy Kelleher, Susana Solís Pérez, Claudia Gamon

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive EU pharmaceutical industry is strategic and pharmaceutical industry is strategic and more responsive to patients’ needs; points more responsive to patients’ needs; points out that the industry needs a stable, flexible out that the industry needs a stable, flexible and agile regulatory environment; believes and agile regulatory environment; believes that it can thrive globally with a clear, that it can thrive globally with a clear, robust and efficient intellectual property robust and efficient intellectual property system; welcomes the initiative to build system; welcomes the initiative to build interoperable digital infrastructure for the interoperable digital infrastructure for the European Health Data Space; European Health Data Space; calls on the Commission to develop guidance to promote the secondary use of data for research and to ensure fair, transparent and non-discriminatory access to data throughout Europe;

Or. en

Amendment 419 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive EU pharmaceutical industry is strategic and pharmaceutical industry is strategic and more responsive to patients’ needs; points more responsive to patients’ needs; points out that the industry needs a stable, flexible out that the industry needs a stable, flexible and agile regulatory environment; believes and agile regulatory environment; believes that it can thrive globally with a clear, that it can thrive globally with a clear, robust and efficient intellectual property robust and efficient intellectual property system; welcomes the initiative to build system; calls on the Commission to interoperable digital infrastructure for the establish a unified supplementary European Health Data Space; protection certificate (SPCs) for the internal market, following the excellent results achieved on national basis; welcomes the initiative to build

PE693.845v01-00 202/362 AM\1233943EN.docx EN interoperable digital infrastructure for the European Health Data Space;

Or. en

Amendment 420 Jessica Polfjärd

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive EU pharmaceutical industry is strategic and pharmaceutical industry is strategic and more responsive to patients’ needs; points more responsive to patients’ needs; points out that the industry needs a stable, flexible out that the industry needs a stable, flexible and agile regulatory environment; believes and agile regulatory environment; believes that it can thrive globally with a clear, that it can only thrive globally with a clear, robust and efficient intellectual property robust and efficient intellectual property system; welcomes the initiative to build system and that the framework for interoperable digital infrastructure for the intellectual property must therefore be European Health Data Space; protected and preserved; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;

Or. en

Amendment 421 Pietro Fiocchi

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive EU pharmaceutical industry is strategic and research-based pharmaceutical industry is more responsive to patients’ needs; points strategic and more responsive to patients’ out that the industry needs a stable, flexible needs; points out that the industry needs a and agile regulatory environment; believes stable, flexible and agile regulatory that it can thrive globally with a clear, environment; believes that it the European robust and efficient intellectual property research-based pharmaceutical industry system; welcomes the initiative to build can only thrive globally with a clear, interoperable digital infrastructure for the robust and efficient intellectual property

AM\1233943EN.docx 203/362 PE693.845v01-00 EN European Health Data Space; system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;

Or. en

Amendment 422 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Stelios Kympouropoulos

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive EU pharmaceutical industry is strategic and pharmaceutical industry is strategic and more responsive to patients’ needs; points more responsive to patients’ needs; points out that the industry needs a stable, flexible out that the industry needs a stable, flexible and agile regulatory environment; believes and agile regulatory environment; believes that it can thrive globally with a clear, that it can thrive globally with a clear, robust and efficient intellectual property robust and efficient intellectual property system; welcomes the initiative to build system; welcomes the initiative to build interoperable digital infrastructure for the interoperable digital infrastructure for the European Health Data Space; European Health Data Space, which will integrate data from real-world evidence;

Or. en

Amendment 423 Stanislav Polčák

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive, self- pharmaceutical industry is strategic and sufficient and sustainable EU more responsive to patients’ needs; points pharmaceutical industry is strategic and out that the industry needs a stable, flexible more responsive to patients’ needs; points and agile regulatory environment; believes out that the industry needs a stable, flexible that it can thrive globally with a clear, and agile regulatory environment; believes robust and efficient intellectual property that it can thrive globally with a clear, system; welcomes the initiative to build robust and efficient intellectual property interoperable digital infrastructure for the system; welcomes the initiative to build the

PE693.845v01-00 204/362 AM\1233943EN.docx EN European Health Data Space; European Health Data Space and interoperable digital infrastructure;

Or. cs

Amendment 424 Sirpa Pietikäinen

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive EU pharmaceutical industry is strategic and pharmaceutical industry is strategic, fosters more responsive to patients’ needs; points innovation and is more responsive to out that the industry needs a stable, flexible patients’ needs; points out that the industry and agile regulatory environment; believes needs a stable, flexible and agile regulatory that it can thrive globally with a clear, environment; believes that it can thrive robust and efficient intellectual property globally with a clear, robust and efficient system; welcomes the initiative to build intellectual property system; welcomes the interoperable digital infrastructure for the initiative to build interoperable digital European Health Data Space; infrastructure for the European Health Data Space;

Or. en

Amendment 425 Alexander Bernhuber

Motion for a resolution Paragraph 12

Motion for a resolution Amendment

12. Insists that a competitive EU 12. Insists that a competitive EU pharmaceutical industry is strategic and pharmaceutical industry based on more responsive to patients’ needs; points research is strategic and more responsive out that the industry needs a stable, flexible to patients’ needs; points out that the and agile regulatory environment; believes industry needs a stable, flexible and agile that it can thrive globally with a clear, regulatory environment; believes that it can robust and efficient intellectual property thrive globally with a clear, robust and system; welcomes the initiative to build efficient intellectual property system; interoperable digital infrastructure for the welcomes the initiative to build European Health Data Space; interoperable digital infrastructure for the European Health Data Space;

AM\1233943EN.docx 205/362 PE693.845v01-00 EN Or. en

Amendment 426 Alessandra Moretti

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Notes that patent protection is a key incentive for companies to invest in innovation and produce new medicines; notes, at the same time, that the exclusionary effect of patents may lead to limited market supply and reduced access to medicines as well as pharmaceutical products; stresses that a balance should be struck between encouraging innovation through the exclusionary effect of patents and ensuring access to medicines and protecting public health; recalls that a company that markets a medicine can enjoy data exclusivity for a period of eight years as of the first marketing authorisation pursuant to Article 14(11) of Regulation (EC) No 726/2004; calls on the Commission to propose a revision of that regulation to provide for the possibility to temporarily authorise the granting of compulsory licenses in the event of a health crisis in order to allow the production of generic versions of life-saving medicines; recalls that this is one of the public health flexibilities in the field of patent protection already included in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as further reaffirmed by the 2001 Doha Declaration; calls on the Commission to ensure that the implementation of the EU free trade agreements (FTAs) does not interfere with the possibilities of invoking flexibilities provided by the TRIPS Agreement and to provide guidance to Member States in order to encourage voluntary licencing over immediate

PE693.845v01-00 206/362 AM\1233943EN.docx EN compulsory licencing;

Or. en

Amendment 427 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Welcomes the strong focus and several initiatives included in the pharmaceuticals strategy on the need to optimize and modernize the existing regulatory framework, such as the revision of the variations legislation, more digitalised and efficient regulatory processes, the implementation of the Electronic product information (ePI), streamlining API assessment, and better GMP/ Manufacturing management and resources; urges the Commission to advance fast on this agenda making the best use of existing digital tools at EU level (telematics) and enhancing regulatory cost efficiency and fit-for- purpose regulatory measures and processes, supporting this way both security of supply, tackling medicines shortage, as well as manufacturing resilience in Europe;

Or. en

Amendment 428 Pietro Fiocchi

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Recalls that priority should be given to the continuous optimisation of

AM\1233943EN.docx 207/362 PE693.845v01-00 EN regulatory processes while maintaining high scientific standards, in order to keep up with scientific and technological progress, ensure fit-for-purpose requirements, enable simplified administrative tasks associated with maintaining medicinal products on the market by amending the existing Variations Regulation, ensure continuous access to information for patients and healthcare professionals, and simplified flow of medicines from one Member State to another in case of a shortage. Encourages the Commission to make the best use of information technology for regulatory processes, including digital and telematics tools, in order to improve regulatory efficiency;

Or. en

Amendment 429 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nicolae Ştefănuță, Susana Solís Pérez

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space; highlights the need to promote both primary and secondary use of aggregated health data and the need in this regard for a clearer definition of secondary data use vs. primary data collection; believes that awareness on fragmentation regarding the implementation of GDPR should be raised; further believes that it is of outmost importance to enable and promote trust and data innovation in digital health, which will be possible through education and capability building for regulators, industry and patients;

Or. en

PE693.845v01-00 208/362 AM\1233943EN.docx EN Amendment 430 Petros Kokkalis

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12a. Expresses concern that certain groups at particular risk of social exclusion and particularly affected by the COVID-19 pandemic have difficulty in accessing treatment and other services aimed at eradicating infectious diseases such as HIV/AIDS, hepatitis C and B and tuberculosis; calls on the Commission and the ECDC, working to a single timetable with an agreed set of guidelines/ good practices, to invite Member States to draw up integrated action plans to improve access, focusing on cooperation between state and non-state actors in reaching out to those concerned;

Or. el

Amendment 431 Anja Hazekamp

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Notes that there is significant public demand for the adoption and implementation of a new legislative framework to eliminate animal testing; calls on the Commission to stimulate research for the development of alternative non-animal testing methods applicable to pharmaceuticals; notes that the EU should intensify its international cooperation on alternative testing methods under EPAA, ICRR and ICATM; stresses that the objective of

AM\1233943EN.docx 209/362 PE693.845v01-00 EN these efforts must be a complete phase-out of animal testing in the EU;

Or. en

Amendment 432 Aldo Patriciello

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Calls on expanding the role of EMA in the assessment of drug- device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting amore expertise- driven scientific assessment on marketing authorisations within the European Medicines Agency (EMA); believes that the final decision-making should occur within maximum 7 days of the final scientific opinion;

Or. en

Amendment 433 Tiemo Wölken

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Asks the Commission to assess the need for a supportive legislative framework which goes beyond the scope of the GDPR when it comes to the uses of real-world data or artificial intelligence in medicines development; underlines in this regards that all information systems where health data is generated, used or stored must be designed to meet the

PE693.845v01-00 210/362 AM\1233943EN.docx EN highest quality and safety standards;

Or. en

Amendment 434 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Cindy Franssen, Roberta Metsola

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Calls on the Commission to expand the role of EMA in the assessment of drug-device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting a more expertise-driven scientific assessment on marketing authorisations within the European Medicines Agency(EMA);

Or. en

Amendment 435 Cyrus Engerer

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Calls on expanding the role of EMA in the assessment of drug- device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting a more expertise- driven scientific assessment on marketing authorisations within the European Medicines Agency (EMA);

Or. en

AM\1233943EN.docx 211/362 PE693.845v01-00 EN Amendment 436 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12a. Stresses that EU legislation frequently acts as a bottleneck, stifling many of the innovations that SMEs are seeking to market; calls on the EU to review its pharmaceutical policies and become a hub for global medical innovation;

Or. es

Amendment 437 Marlene Mortler

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Stresses that Intellectual Property Rights incentivise research, development and innovation and ensure that European patients receive the latest and best scientific advances to address unmet medical needs; acknowledges, that market exclusivity for orphan drugs is a specific incentive for the development of new drugs for rare diseases;

Or. en

Amendment 438 Frédérique Ries

Motion for a resolution Paragraph 12 a (new)

PE693.845v01-00 212/362 AM\1233943EN.docx EN Motion for a resolution Amendment

12 a. Calls for relocation back to the European Union of some of the plants producing active ingredients and medicinal end products of strategic importance for health care, given that breaks in supply put at immediate risk patients with serious conditions who are more often unable to obtain recommended alternative treatments;

Or. en

Amendment 439 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Recalls the importance of close collaboration between the Commission and Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;

Or. en

Amendment 440 Sara Cerdas

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed,

AM\1233943EN.docx 213/362 PE693.845v01-00 EN adopted and implemented in healthcare systems through inclusivity, capacity and trust;

Or. en

Amendment 441 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Underlines the key role of medical gases, such as oxygen, in treating patients; calls on the Commission to simplify the procedures for production and distribution of medical gases as part of the revision of Directive 2001/83/EC1c; ______1c OJ L 311, 28.11.2001, p. 67–128

Or. en

Amendment 442 Marian-Jean Marinescu

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Calls on the Commission to include in the EU Statistics on Income and Living Conditions (EU-SILC) data on self-reported lack of access to medicines, as so far access to medicines in not measured in the EU-SILC;

Or. en

PE693.845v01-00 214/362 AM\1233943EN.docx EN Amendment 443 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Encourages European federated data networks to improve research, development and healthcare delivery; highlights the importance of defining more clearly Secondary data use vs. Primary data collection;

Or. en

Amendment 444 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Supports the conclusion of industrial agreements between actors of the EU pharmaceutical industry to ensure a stronger EU production of medicines and improve the constant access to affordable medicines;

Or. en

Amendment 445 Pernille Weiss

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Stresses that the intellectual property framework acts as an essential driver of investments in research and development, which is key to innovation to

AM\1233943EN.docx 215/362 PE693.845v01-00 EN the benefit of patients and society as a whole;

Or. en

Amendment 446 Petar Vitanov

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Calls on the Commission and the Member States to ensure full and harmonised application of the General Data Protection Regulation in regards to conducting clinical research across the EU;

Or. en

Amendment 447 Ondřej Knotek, Billy Kelleher, Susana Solís Pérez, Claudia Gamon

Motion for a resolution Paragraph 12 a (new)

Motion for a resolution Amendment

12 a. Calls for the Commission and Member States to use real-world data for regulatory decisions on medicines to complement evidence from randomised- controlled clinical trials;

Or. en

Amendment 448 Alessandra Moretti

Motion for a resolution Paragraph 12 b (new)

PE693.845v01-00 216/362 AM\1233943EN.docx EN Motion for a resolution Amendment

12 b. Recalls that Regulation (EC) No 816/2006 harmonises the procedure for granting compulsory licences in relation to patents and supplementary protection certificates concerning the manufacture and sale of pharmaceutical products; Calls on the Commission to update and harmonise the rules on granting compulsory licensing of medicinal products and to introduce waivers for data and market exclusivity to allow effective compulsory licensing as an important public health safeguard for EU Member States allowing them to respond faster and more effectively to future European public health crises;

Or. en

Amendment 449 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Paragraph 12 b (new)

Motion for a resolution Amendment

12 b. Welcomes the fact that the strategy recognises that the better use of the electronic product information (ePI) will support the better delivery of the information for patients and support a wider availability of medicines, especially in critical situations; calls on the Commission to urgently implement the ePI with a targeted dialogue - between regulators, the industry and all relevant stakeholders – to design a EU roadmap that will define timelines and harmonised EU standards as well as educational campaigns for patients and healthcare stakeholders;

Or. en

AM\1233943EN.docx 217/362 PE693.845v01-00 EN Amendment 450 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 12 b (new)

Motion for a resolution Amendment

12 b. Underlines that in times of crisis, other mechanisms should be used to enable a global response and crises mitigation, including a Union export control mechanism, enhanced cooperation agreements on the production of medical countermeasures, pre- allocating part of the Union joint procurement, and both voluntary and compulsory technology know-how pools and licensing agreements between companies, which should guarantee access to counter-measures to low- and middle-income countries, in particular the African countries;

Or. en

Amendment 451 Petar Vitanov

Motion for a resolution Paragraph 12 b (new)

Motion for a resolution Amendment

12 b. Calls for the continuous optimisation and digitalisation of regulatory processes in order to keep up with scientific and technological progress, while maintaining high scientific standards; calls to ensure fit-for-purpose requirements and continuous access to information for patients and healthcare professionals; stresses that the Commission and the Member States should make the best use of information technology for regulatory processes, including digital and telematics tools;

PE693.845v01-00 218/362 AM\1233943EN.docx EN Or. en

Amendment 452 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 12 b (new)

Motion for a resolution Amendment

12 b. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust, while adhering to the high EU standards for personal data protection; reiterates that with all AI-based technologies, human oversight must at all times be guaranteed;

Or. en

Amendment 453 Pietro Fiocchi

Motion for a resolution Paragraph 12 b (new)

Motion for a resolution Amendment

12 b. Calls on the Commission and relevant authorities to provide regulatory flexibility to mitigate medicines shortages when they occur, by allowing targeted measures such as more flexibility for multi-language packs, different pack size and e-leaflet, to ensure that patients are able to access high-quality and safe medicines faster;

Or. en

AM\1233943EN.docx 219/362 PE693.845v01-00 EN Amendment 454 Frédérique Ries

Motion for a resolution Paragraph 12 b (new)

Motion for a resolution Amendment

12 b. Invites the Commission to initiate the creation of a “European Fund” to support the generation of additional real- world evidence data in the years following marketing authorisation for selected, innovative and transformative medicines for complex and low prevalence diseases, with true cross-border value;

Or. en

Amendment 455 Pernille Weiss

Motion for a resolution Paragraph 12 b (new)

Motion for a resolution Amendment

12 b. Calls for the prudent implementation of the General Data Protection Regulation (GDPR) with regard to data minimisation, purpose limitation, the secondary use of data as well as on data transfer to third countries to avoid unnecessary restriction for health research and cross-border data sharing;

Or. en

Amendment 456 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 12 b (new)

Motion for a resolution Amendment

PE693.845v01-00 220/362 AM\1233943EN.docx EN 12b. Stresses that innovation is far outstripping legislation; calls on the Commission to introduce a degree of regulatory flexibility in order to be able to respond more rapidly and effectively to new requirements and products, while respecting safety and ethical criteria.

Or. es

Amendment 457 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Paragraph 12 b (new)

Motion for a resolution Amendment

12 b. Supports adapting existing frameworks to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;

Or. en

Amendment 458 Aldo Patriciello

Motion for a resolution Paragraph 12 b (new)

Motion for a resolution Amendment

12 b. Calls on the Commission to legitimise EMA’s PRIME scheme and include a PRIME designation in the legislative framework;

Or. en

Amendment 459 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Cindy Franssen

AM\1233943EN.docx 221/362 PE693.845v01-00 EN Motion for a resolution Paragraph 12 b (new)

Motion for a resolution Amendment

12 b. Calls on the Commission to legitimise EMA’s PRIME scheme and include a PRIME designation in the legislative framework;

Or. en

Amendment 460 Alessandra Moretti

Motion for a resolution Paragraph 12 c (new)

Motion for a resolution Amendment

12 c. Emphasises that patent protection and enforcement should have due regard for the interests of society, namely the safeguarding of human rights and public health priorities; recalls, in the same vein, that patent protection should not interfere with the right to health and should not serve to widen the gap between wealthier and poorer citizens when it comes to access to medicines; considers that the Union’s approach to this question should ensure harmonisation and coherence among the different measures at the disposal of the Member States;

Or. en

Amendment 461 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 12 c (new)

Motion for a resolution Amendment

PE693.845v01-00 222/362 AM\1233943EN.docx EN 12c. Stresses that innovation must focus on those areas of greatest need in order to create a true health and innovation strategy that does not currently exist; calls on the Commission to create an innovation ecosystem that facilitates the exchange of experience and access for SMEs; suggests giving greater weight to scientific research so that it can identify medical priorities independently of commercial interests.

Or. es

Amendment 462 Pietro Fiocchi

Motion for a resolution Paragraph 12 c (new)

Motion for a resolution Amendment

12 c. Calls on expanding the role of EMA in the assessment of drug- device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting amore expertise- driven scientific assessment on marketing authorisations with in the European Medicines Agency (EMA); believes that the final decision making should occur within maximum 7 days of the final scientific opinion;

Or. en

Amendment 463 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Cindy Franssen, Roberta Metsola

Motion for a resolution Paragraph 12 c (new)

AM\1233943EN.docx 223/362 PE693.845v01-00 EN Motion for a resolution Amendment

12 c. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated; calls on the EMA and national medicine agencies to prioritise the submission of data from randomised controlled clinical trials that compare an investigational medicine against the standard treatment;

Or. en

Amendment 464 Petar Vitanov

Motion for a resolution Paragraph 12 c (new)

Motion for a resolution Amendment

12 c. Calls on the Commission and Member States to intensify work towards the implementation of the electronic product information (ePI), as it could support the better delivery of information to patients and a wider availability of medicines, especially in critical situations;

Or. en

Amendment 465 Cyrus Engerer

Motion for a resolution Paragraph 12 c (new)

Motion for a resolution Amendment

12 c. Urges the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which would facilitate the conducting of clinical research in Europe;

PE693.845v01-00 224/362 AM\1233943EN.docx EN Or. en

Amendment 466 Aldo Patriciello

Motion for a resolution Paragraph 12 c (new)

Motion for a resolution Amendment

12 c. Calls on the Commission to ensure that the regulatory system is adequately resourced to share advice given across the system, and to rapidly embrace new technologies via regulatory alignment;

Or. en

Amendment 467 Cyrus Engerer

Motion for a resolution Paragraph 12 c (new)

Motion for a resolution Amendment

12 c. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated;

Or. en

Amendment 468 Alessandra Moretti

Motion for a resolution Paragraph 12 d (new)

Motion for a resolution Amendment

12 d. Stresses the need for a harmonised implementation of the General Data Protection Regulation (GDPR), especially by Data Protection Authorities and its

AM\1233943EN.docx 225/362 PE693.845v01-00 EN interaction with the Clinical Trials Regulation (CTR) once applicable; requests the European Data Protection Board to ensure its guidelines concerning health research are updated with the aim of fostering research;

Or. en

Amendment 469 Cyrus Engerer

Motion for a resolution Paragraph 12 d (new)

Motion for a resolution Amendment

12 d. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;

Or. en

Amendment 470 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 12 d (new)

Motion for a resolution Amendment

12d. Points out that the Pharmaceutical Strategy should contribute to improved interaction with regulators, the development of non-legislative initiatives, flexibility in labelling and the adaptation of clinical trials to new needs.

Or. es

PE693.845v01-00 226/362 AM\1233943EN.docx EN Amendment 471 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Cindy Franssen, Roberta Metsola

Motion for a resolution Paragraph 12 d (new)

Motion for a resolution Amendment

12 d. Requests the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;

Or. en

Amendment 472 Aldo Patriciello

Motion for a resolution Paragraph 12 d (new)

Motion for a resolution Amendment

12 d. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated;

Or. en

Amendment 473 Pietro Fiocchi

Motion for a resolution Paragraph 12 d (new)

Motion for a resolution Amendment

12 d. Calls on the Commission to legitimise EMA’s PRIME scheme and include a PRIME designation in the legislative framework;

AM\1233943EN.docx 227/362 PE693.845v01-00 EN Or. en

Amendment 474 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 12 e (new)

Motion for a resolution Amendment

12e. Invites the Commission and Member States to provide information, communication and advice to enable SMEs to participate more effectively and in a coordinated manner in innovation projects; Notes that the Commission should seek new advisory strategies to facilitate access to innovation funds for smaller companies; Points out that bureaucratic hurdles and complexity make it difficult for SMEs or public research centres to take full advantage of European innovation programmes.

Or. es

Amendment 475 Aldo Patriciello

Motion for a resolution Paragraph 12 e (new)

Motion for a resolution Amendment

12 e. Notes that decisions taken regarding the EU's pharmaceutical regulatory environment will have implications beyond Europe's borders, given that several third countries recognise and rely on EU requirements, particularly when it comes to the facilitation of exports and the waiving of requirements to test these in third countries when they come from the EU; therefore emphasises the importance of maintaining such mutual recognition

PE693.845v01-00 228/362 AM\1233943EN.docx EN agreements with third countries and ensuring that these remain up to date;

Or. en

Amendment 476 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Cindy Franssen, Roberta Metsola

Motion for a resolution Paragraph 12 e (new)

Motion for a resolution Amendment

12 e. Notes that decisions taken regarding the EU's pharmaceutical regulatory environment will have implications beyond Europe's borders, given that several third countries recognize and rely on EU requirements, particularly when it comes to the facilitation of exports and the waiving of requirements to test these in third countries when they come from the EU; therefore emphasizes the importance of maintaining such mutual recognition agreements with third countries and ensuring that these remain up to date;

Or. en

Amendment 477 Pietro Fiocchi

Motion for a resolution Paragraph 12 e (new)

Motion for a resolution Amendment

12 e. Calls on the Commission to ensure that the regulatory system is adequately resourced to share advice given across the system, and to rapidly embrace new technologies via regulatory alignment;

Or. en

AM\1233943EN.docx 229/362 PE693.845v01-00 EN Amendment 478 Aldo Patriciello

Motion for a resolution Paragraph 12 f (new)

Motion for a resolution Amendment

12 f. Encourages European federated data networks that contribute to optimal research, development and healthcare delivery; highlights the need for a clearer definition of Secondary data use vs. Primary data collection;

Or. en

Amendment 479 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 12 f (new)

Motion for a resolution Amendment

12f. Underlines that the current intellectual property model has proven its effectiveness but needs to develop further to respond to new challenges in the pharmaceutical sector;

Or. es

Amendment 480 Pietro Fiocchi

Motion for a resolution Paragraph 12 f (new)

Motion for a resolution Amendment

12 f. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data

PE693.845v01-00 230/362 AM\1233943EN.docx EN and evidence as they are generated;

Or. en

Amendment 481 Aldo Patriciello

Motion for a resolution Paragraph 12 g (new)

Motion for a resolution Amendment

12 g. Supports the adaptation of existing frame works for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;

Or. en

Amendment 482 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 12 g (new)

Motion for a resolution Amendment

12g. Invites the Commission and the Member States to consider the possibility of introducing exceptional and temporary mechanisms to be able to react rapidly to crises and shortages.

Or. es

Amendment 483 Pietro Fiocchi

Motion for a resolution Paragraph 12 g (new)

AM\1233943EN.docx 231/362 PE693.845v01-00 EN Motion for a resolution Amendment

12 g. Urges the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;

Or. en

Amendment 484 Pietro Fiocchi

Motion for a resolution Paragraph 12 h (new)

Motion for a resolution Amendment

12 h. Notes that decisions taken regarding the EU's pharmaceutical regulatory environment will have implications beyond Europe's borders, given that several third countries recognise and rely on EU requirements, particularly when it comes to the facilitation of exports and the waiving of requirements to test these in third countries when they come from the EU; therefore emphasises the importance of maintaining such mutual recognition agreements with third countries and ensuring that these remain up to date;

Or. en

Amendment 485 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 12 h (new)

Motion for a resolution Amendment

PE693.845v01-00 232/362 AM\1233943EN.docx EN 12h. Points out that the EU should focus on developing adequate capacity for the sustainable production of active substances, raw materials and medicines which reduce dependence on external sources; Advocates providing greater legal certainty for drug developers.

Or. es

Amendment 486 Aldo Patriciello

Motion for a resolution Paragraph 12 h (new)

Motion for a resolution Amendment

12 h. Urges the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;

Or. en

Amendment 487 Pietro Fiocchi

Motion for a resolution Paragraph 12 i (new)

Motion for a resolution Amendment

12 i. Encourages European federated data networks that contribute to optimal research, development and healthcare delivery; highlights the need for a clearer definition of Secondary data use vs. Primary data collection;

Or. en

AM\1233943EN.docx 233/362 PE693.845v01-00 EN Amendment 488 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 12 i (new)

Motion for a resolution Amendment

12i. Suggests promoting clinical data registries to improve the ability to assess the outcome of a given medicine.

Or. es

Amendment 489 Pietro Fiocchi

Motion for a resolution Paragraph 12 j (new)

Motion for a resolution Amendment

12 j. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;

Or. en

Amendment 490 Tilly Metz

Motion for a resolution Paragraph 13

Motion for a resolution Amendment

13. Calls on the Commission to revise deleted the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less

PE693.845v01-00 234/362 AM\1233943EN.docx EN competitive inside and outside the EU;

Or. en

Amendment 491 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 13

Motion for a resolution Amendment

13. Calls on the Commission to revise deleted the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU;

Or. en

Amendment 492 Pietro Fiocchi

Motion for a resolution Paragraph 13

Motion for a resolution Amendment

13. Calls on the Commission to revise 13. Calls on the Commission to address the use of supplementary protection the fragmented implementation of certificates based on technological and supplementary protection certificates scientific advances to prevent generic and (SPCs) across Member States by biosimilar medicines from becoming less introducing a unified SPC grant competitive inside and outside the EU; mechanism and/or create a unitary SPC title;

Or. en

Amendment 493 Alessandra Moretti

Motion for a resolution Paragraph 13

AM\1233943EN.docx 235/362 PE693.845v01-00 EN Motion for a resolution Amendment

13. Calls on the Commission to revise 13. Calls on the Commission to revise the use of supplementary protection the use of supplementary protection certificates based on technological and certificates based on technological and scientific advances to prevent generic and scientific advances to allow generic and biosimilar medicines from becoming less biosimilar medicines to become more competitive inside and outside the EU; competitive inside and outside the EU; Recalls that supplementary protection certificates (SPCs), by extending the patent term up to 5 years, delay access to more affordable generic and biosimilar products thereby placing a major financial burden on national healthcare systems and hampering patients access to treatment; underlines therefore that the use of SPCs should be allowed only for exceptional and justified cases;

Or. en

Amendment 494 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 13

Motion for a resolution Amendment

13. Calls on the Commission to revise 13. Calls on the Commission to revise the use of supplementary protection the use of supplementary protection certificates based on technological and certificates based on technological and scientific advances to prevent generic and scientific advances to prevent generic and biosimilar medicines from becoming less biosimilar medicines from becoming less competitive inside and outside the EU; competitive inside and outside the EU; Stresses that this revision should be accompanied by an impact assessment and take account of horizontal regulation in the area of intellectual property.

Or. es

Amendment 495 Nicolae Ştefănuță

PE693.845v01-00 236/362 AM\1233943EN.docx EN Motion for a resolution Paragraph 13

Motion for a resolution Amendment

13. Calls on the Commission to revise 13. Calls on the Commission to revise the use of supplementary protection the use of supplementary protection certificates based on technological and certificates to prevent generic and scientific advances to prevent generic and biosimilar medicines from becoming biosimilar medicines from becoming less competitive inside and outside the EU; competitive inside and outside the EU;

Or. en

Amendment 496 Tiemo Wölken

Motion for a resolution Paragraph 13 a (new)

Motion for a resolution Amendment

13 a. Calls on the Commission to thoroughly evaluate the actual impact that a proposal for a unitary SPC would have on the generic and biosimilar medicines market entry, and on equitable patient access to treatments; at the same time calls on the Commission to take full account of and assess the effective implementation of the SPC Manufacturing Waiver in light of the conditions and limitations to it, especially in regards to stockpiling;

Or. en

Amendment 497 Christian Doleschal, Marlene Mortler, Markus Ferber

Motion for a resolution Paragraph 13 a (new)

Motion for a resolution Amendment

13a. Emphasises that reliable and

AM\1233943EN.docx 237/362 PE693.845v01-00 EN robust protection of intellectual property is vital for the development of new medicines and, in particular, for the promotion of research and development in Europe; takes the view that any restrictions on the protection of intellectual property will hamper the development of new medicines and undermine Europe's economic standing;

Or. de

Amendment 498 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez

Motion for a resolution Paragraph 13 a (new)

Motion for a resolution Amendment

13 a. Encourages Member States to establish regional business hubs to promote biosolutions and green technology in the production of biosimilar medicines as well as other sustainable and innovative pharmaceutical products; underlines the importance of improving education on biosimilars for health care professionals on Member State level;

Or. en

Amendment 499 Pietro Fiocchi

Motion for a resolution Paragraph 13 a (new)

Motion for a resolution Amendment

13 a. Urges the Commission to take full account of, and assess the effective implementation of, the SPC manufacturing waiver in light of the several conditions and limitations posed to

PE693.845v01-00 238/362 AM\1233943EN.docx EN it;

Or. en

Amendment 500 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez

Motion for a resolution Paragraph 13 b (new)

Motion for a resolution Amendment

13 b. Calls on the Commission to develop a separate European Life Science strategy drawing on the lessons from the Industrial Strategy, Pharmaceutical strategy and a European Health Union; suggests that the new strategy should be horizontal and include a strategic approach including areas such as industry, research, health union, crisis preparedness and trade;

Or. en

Amendment 501 Pietro Fiocchi

Motion for a resolution Paragraph 13 b (new)

Motion for a resolution Amendment

13 b. Stresses the importance of timely and healthy competition to deliver equitable access to medicines; calls on the Commission to carefully evaluate the actual impact that any proposal for a unitary or unified SPC would have on generic and biosimilar medicines, and on equitable patients’ access to treatments;

Or. en

AM\1233943EN.docx 239/362 PE693.845v01-00 EN Amendment 502 Alessandra Moretti

Motion for a resolution Paragraph 14

Motion for a resolution Amendment

14. Stresses the importance of creating 14. Stresses the importance of creating quality jobs in the EU along the entire quality jobs in the EU along the entire pharmaceutical value chain, with the pharmaceutical value chain, with the support of the NextGenerationEU support of the NextGenerationEU instrument; calls on the Commission to instrument; calls on the Commission to propose measures to promote employment propose measures to promote employment in the pharmaceutical sector, facilitating in the pharmaceutical sector, facilitating talent retention and mobility at EU level; talent retention and mobility at EU level; recalls that any form of fund or support must be conditioned to clauses on traceability, transparency, accessibility and affordability of manufactured medicines and supply obligations;

Or. en

Amendment 503 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 14

Motion for a resolution Amendment

14. Stresses the importance of creating 14. Underlines that the quality jobs in the EU along the entire pharmaceutical sector remains an pharmaceutical value chain, with the important industrial pillar as well as a support of the NextGenerationEU driving force in terms of job creation; instrument; calls on the Commission to Stresses the importance of creating quality propose measures to promote employment jobs in the EU along the entire in the pharmaceutical sector, facilitating pharmaceutical value chain, with the talent retention and mobility at EU level; support of the Next Generation EU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutical sector, facilitating talent retention and mobility at EU level;

Or. en

PE693.845v01-00 240/362 AM\1233943EN.docx EN Amendment 504 Andrey Slabakov, Joanna Kopcińska, Pietro Fiocchi, Ryszard Antoni Legutko, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 14

Motion for a resolution Amendment

14. Stresses the importance of creating 14. Stresses the importance of creating quality jobs in the EU along the entire quality jobs in the EU along the entire pharmaceutical value chain, with the pharmaceutical value chain, with the support of the NextGenerationEU support of the NextGenerationEU instrument; calls on the Commission to instrument; calls on the Commission to propose measures to promote employment propose measures to promote employment in the pharmaceutical sector, facilitating in the pharmaceutical sector in all EU talent retention and mobility at EU level; Member States, facilitating geographical balance, talent retention and employment opportunities across the whole EU;

Or. en

Amendment 505 Tilly Metz

Motion for a resolution Paragraph 14

Motion for a resolution Amendment

14. Stresses the importance of creating 14. Stresses the importance of quality jobs in the EU along the entire recognition and creating quality jobs in the pharmaceutical value chain, with the EU along the entire pharmaceutical value support of the NextGenerationEU chain and the medical field, including the instrument; calls on the Commission to health workforce, with the support of the propose measures to promote employment NextGenerationEU instrument; calls on the in the pharmaceutical sector, facilitating Commission to propose measures to talent retention and mobility at EU level; promote employment in the medical sector, facilitating talent retention and mobility at EU level;

Or. en

Amendment 506

AM\1233943EN.docx 241/362 PE693.845v01-00 EN Petar Vitanov

Motion for a resolution Paragraph 14

Motion for a resolution Amendment

14. Stresses the importance of creating 14. Stresses the importance of creating quality jobs in the EU along the entire quality jobs in the EU along the entire pharmaceutical value chain, with the pharmaceutical value chain, with the support of the NextGenerationEU support of the NextGenerationEU instrument; calls on the Commission to instrument; calls on the Commission to propose measures to promote employment propose measures to promote employment in the pharmaceutical sector, facilitating in the pharmaceutical sector in all Member talent retention and mobility at EU level; States, ensuring geographical balance and facilitating talent retention and mobility at EU level;

Or. en

Amendment 507 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez

Motion for a resolution Paragraph 14

Motion for a resolution Amendment

14. Stresses the importance of creating 14. Stresses the importance of creating quality jobs in the EU along the entire quality jobs in the EU along the entire pharmaceutical value chain, with the pharmaceutical value chain, with the support of the NextGenerationEU support of the NextGenerationEU instrument; calls on the Commission to instrument; calls on the Commission to propose measures to promote employment propose measures to promote employment in the pharmaceutical sector, facilitating and skill-building in the pharmaceutical talent retention and mobility at EU level; sector, facilitating talent retention and mobility at EU level;

Or. en

Amendment 508 Tilly Metz

Motion for a resolution Paragraph 15

PE693.845v01-00 242/362 AM\1233943EN.docx EN Motion for a resolution Amendment

15. Highlights the fact that gene and deleted cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post-treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations;

Or. en

Amendment 509 Alessandra Moretti

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanomedicines, nanotechnology, next- e-health and the ‘Million plus genomes’ generation vaccines, e-health and the initiative can bring enormous benefits in ‘Million plus genomes’ initiative can bring relation to the prevention, diagnosis, substantial benefits in relation to the treatment and post-treatment of all prevention, diagnosis, treatment and post- diseases; urges the Commission to develop treatment of all diseases if they prove their appropriate regulatory frameworks, to added value compared to existing health guide new business models, and to run technologies before and after the information campaigns to raise awareness marketing authorisation phase; highlights and encourage the use of these innovations; as well that the increasing number of advanced medicinal products entering the market with high prices and so far limited information on their added therapeutic value and safety issues poses a great challenge for the sustainability of health budgets and may hamper doctors’ and patients’ ability to choose the adequate treatment; underlines the transformative potential of these novel therapies and

AM\1233943EN.docx 243/362 PE693.845v01-00 EN technologies for patients as well as societies at large, for example by enabling a shift from chronic management and care to one-time treatment, thereby contributing to reduce costs for health systems, and strengthening their efficacy, sustainability and resilience; urges the Commission to develop appropriate regulatory frameworks and to run information campaigns to raise awareness and encourage the use of these innovations when beneficial for patients and once their risk-benefit balance is proved to be positive assessment and improve overall the quality of life of patients; reminds that any decision on the authorization of these innovative products and treatments should be conditioned to the maximum level of patient safety and that fast track approval should be limited to exceptional cases and if needed for urgent public health needs;

Or. en

Amendment 510 Cyrus Engerer

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in initiative can bring enormous benefits in relation to the prevention, diagnosis, relation to the prevention, diagnosis, treatment and post-treatment of all treatment and post-treatment of all diseases; urges the Commission to develop diseases; stresses the transformative appropriate regulatory frameworks, to potential of these novel therapies and guide new business models, and to run technologies for patients as well as information campaigns to raise awareness societies at large, for example by enabling and encourage the use of these innovations; a shift from expensive chronic management and care to one-time treatment, thereby reducing costs for health systems, and strengthening their

PE693.845v01-00 244/362 AM\1233943EN.docx EN efficacy, sustainability and resilience; urges the Commission to ensure sufficient regulatory expertise to support intensive dialogue with developers, and to develop appropriate regulatory frameworks, including for new vaccines and therapeutics for use in emergencies and those addressing unmet medical needs, to guide new business models without compromising/lower standards for safe and efficacious products of consistently high-quality, and to run information campaigns to raise awareness and encourage the use of these innovations;

Or. en

Amendment 511 Pietro Fiocchi

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in initiative can bring enormous benefits in relation to the prevention, diagnosis, relation to the prevention, diagnosis, treatment and post-treatment of all treatment and post-treatment of all diseases; urges the Commission to develop diseases; stresses the transformative appropriate regulatory frameworks, to potential of these novel therapies and guide new business models, and to run technologies for patients as well as information campaigns to raise awareness societies at large, for example by enabling and encourage the use of these innovations; a shift from expensive chronic management and care to one-time treatment, thereby reducing costs for health systems, and strengthening their efficacy, sustainability and resilience; urges the Commission to ensure sufficient regulatory expertise to support intensive dialogue with developers, and to develop appropriate regulatory frameworks, including for new vaccines and therapeutics for use in emergencies and those addressing other unmet medical

AM\1233943EN.docx 245/362 PE693.845v01-00 EN needs, to guide new business models without compromising/lower standards for safe and efficacious products of consistently high-quality, and to run information campaigns to raise awareness and encourage the use of these innovations;

Or. en

Amendment 512 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, radionuclide therapy, nanotechnology, e-health and the ‘Million plus genomes’ next-generation vaccines, e-health and the initiative can bring enormous benefits in ‘Million plus genomes’ initiative can bring relation to the prevention, diagnosis, significant benefits in relation to the treatment and post-treatment of all prevention, diagnosis, treatment and post- diseases; urges the Commission to develop treatment of all diseases; stresses the appropriate regulatory frameworks, to transformative potential of these novel guide new business models, and to run therapies and technologies for patients as information campaigns to raise awareness well as societies at large, for example by and encourage the use of these innovations; enabling a shift from expensive chronic management and care to one-time treatment, thereby reducing costs for health systems, and strengthening their efficacy, sustainability and resilience; urges the Commission, in close cooperation with Member States, to develop appropriate regulatory frameworks, to guide new business models without compromising the high level of safety, quality and effectiveness of medicines, and to run information campaigns to raise awareness and encourage the use of these innovations;

Or. en

Amendment 513

PE693.845v01-00 246/362 AM\1233943EN.docx EN Ondřej Knotek, Billy Kelleher, Susana Solís Pérez, Claudia Gamon

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in initiative have a transformative potential relation to the prevention, diagnosis, and can bring enormous benefits to treatment and post-treatment of all patients and societies in relation to the diseases; urges the Commission to develop prevention, diagnosis, treatment and post- appropriate regulatory frameworks, to treatment of all diseases; urges the guide new business models, and to run Commission to ensure sufficient information campaigns to raise awareness regulatory expertise to support dialogue and encourage the use of these innovations; with developers, to develop appropriate regulatory frameworks, to guide new business models without compromising safety standards and product efficacy, and to run information campaigns to raise awareness and encourage the use of these innovations; calls on Member States to authorize the use of these innovative treatments abroad in an effective and timely manner and to accelerate the reimbursement process for cross-border treatment of patients;

Or. en

Amendment 514 Nicolae Ştefănuță

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ e-health and gene sequencing can bring initiative can bring enormous benefits in enormous benefits in relation to the relation to the prevention, diagnosis, prevention, diagnosis, treatment and post- treatment and post-treatment of all treatment of all diseases; urges the

AM\1233943EN.docx 247/362 PE693.845v01-00 EN diseases; urges the Commission to develop Commission to develop appropriate appropriate regulatory frameworks, to regulatory frameworks, to guide new guide new business models, and to run business models, and to run information information campaigns to raise awareness campaigns to raise awareness and and encourage the use of these innovations; encourage the use of these innovations; calls on the Commission to encourage enhanced data generation on these new products through improved cooperation among regulatory agencies, HTA bodies and patients organizations, healthcare professionals and pharmaceutical companies;

Or. en

Amendment 515 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in initiative can bring enormous benefits in relation to the prevention, diagnosis, relation to the prevention, diagnosis, treatment and post-treatment of all treatment and post-treatment of all diseases; urges the Commission to develop diseases; highlights that eHealth, home appropriate regulatory frameworks, to care, and technological innovation in guide new business models, and to run addition to education campaigns are key information campaigns to raise awareness weapons in infection control, treatment of and encourage the use of these innovations; COVID-19 and other infectious diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations;

Or. en

Amendment 516 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae

PE693.845v01-00 248/362 AM\1233943EN.docx EN Ştefănuță, Frédérique Ries, Susana Solís Pérez

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in initiative can bring enormous benefits in relation to the prevention, diagnosis, relation to the prevention, diagnosis, treatment and post-treatment of all treatment and post-treatment of all diseases; urges the Commission to develop diseases; urges the Commission to develop appropriate regulatory frameworks, to appropriate regulatory frameworks, to guide new business models, and to run guide new business models, and to run information campaigns to raise awareness information campaigns to raise awareness and encourage the use of these innovations; and encourage the use of these innovations; urges the Commission to propose adequate resources for the EMA to meet these objectives effectively;

Or. en

Amendment 517 Anja Hazekamp

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in initiative for the prevention, diagnosis, relation to the prevention, diagnosis, treatment and post-treatment of all diseases treatment and post-treatment of all are potentially hazardous and should diseases; urges the Commission to develop therefore be used only with great care and appropriate regulatory frameworks, to in accordance with the precautionary guide new business models, and to run principle; urges the Commission to information campaigns to raise awareness develop appropriate regulatory and encourage the use of these frameworks, to guide new business models, innovations; and to run information campaigns to raise awareness of these innovations;

AM\1233943EN.docx 249/362 PE693.845v01-00 EN Or. nl

Amendment 518 Alexander Bernhuber

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in initiative can bring enormous benefits in relation to the prevention, diagnosis, relation to the prevention, diagnosis, treatment and post-treatment of all treatment and post-treatment of all diseases; urges the Commission to develop diseases; urges the Commission to promote appropriate regulatory frameworks, to sufficient expertise and to develop guide new business models, and to run appropriate regulatory frameworks, to information campaigns to raise awareness guide new business models and and encourage the use of these innovations; consistently ensure high standards for safe products, and to run information campaigns to raise awareness and encourage the use of these innovations;

Or. en

Amendment 519 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Cindy Franssen, Roberta Metsola

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanomedicines and nanotechnology, next- e-health and the ‘Million plus genomes’ generation vaccines, including the m-RNA initiative can bring enormous benefits in derivatives, e-health and the ‘Million plus relation to the prevention, diagnosis, genomes’ initiative can bring enormous treatment and post-treatment of all benefits in relation to the prevention, diseases; urges the Commission to develop diagnosis, treatment and post-treatment of appropriate regulatory frameworks, to all diseases; urges the Commission to

PE693.845v01-00 250/362 AM\1233943EN.docx EN guide new business models, and to run develop appropriate regulatory information campaigns to raise awareness frameworks, to guide new business models, and encourage the use of these innovations; and to run information campaigns to raise awareness and encourage the use of these innovations;

Or. en

Amendment 520 Petar Vitanov

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, medicine repurposing, nanotechnology, next-generation vaccines, personalised medicine, nanotechnology, e-health and the ‘Million plus genomes’ next-generation vaccines, e-health and the initiative can bring enormous benefits in ‘Million plus genomes’ initiative can bring relation to the prevention, diagnosis, enormous benefits in relation to the treatment and post-treatment of all prevention, diagnosis, treatment and post- diseases; urges the Commission to develop treatment of all diseases; urges the appropriate regulatory frameworks, to Commission to develop appropriate guide new business models, and to run regulatory frameworks, to guide new information campaigns to raise awareness business models, and to run information and encourage the use of these innovations; campaigns to raise awareness and encourage the use of these innovations;

Or. en

Amendment 521 Jessica Polfjärd

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanotechnology, nanomedicines, next- e-health and the ‘Million plus genomes’ generation vaccines, e-health and the initiative can bring enormous benefits in ‘Million plus genomes’ initiative can bring relation to the prevention, diagnosis, enormous benefits in relation to the

AM\1233943EN.docx 251/362 PE693.845v01-00 EN treatment and post-treatment of all prevention, diagnosis, treatment and post- diseases; urges the Commission to develop treatment of all diseases; urges the appropriate regulatory frameworks, to Commission to develop appropriate guide new business models, and to run regulatory frameworks, to guide new information campaigns to raise awareness business models, and to run information and encourage the use of these innovations; campaigns to raise awareness and encourage the use of these innovations;

Or. en

Amendment 522 Pietro Fiocchi

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights that gene and cell cell therapies, personalised medicine, therapies, personalised medicine, nanotechnology, next-generation vaccines, nanotechnology, next generation vaccines, e-health and the ‘Million plus genomes’ e-health, medicines repurposing and the initiative can bring enormous benefits in 'Million plus genomes' initiative can bring relation to the prevention, diagnosis, enormous benefits in the prevention, treatment and post-treatment of all diagnosis, treatment and post-treatment of diseases; urges the Commission to develop all diseases; urges the Commission to appropriate regulatory frameworks, to develop appropriate regulatory guide new business models, and to run frameworks, to guide new business models, information campaigns to raise awareness and to promote information campaigns to and encourage the use of these raise awareness and encourage the innovations; application of these innovations;

Or. en

Amendment 523 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 15

Motion for a resolution Amendment

15. Highlights the fact that gene and 15. Highlights the fact that gene and cell therapies, personalised medicine, cell therapies, personalised medicine, nanotechnology, next-generation vaccines, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ e-health and the ‘Million plus genomes’

PE693.845v01-00 252/362 AM\1233943EN.docx EN initiative can bring enormous benefits in initiative can bring enormous benefits in relation to the prevention, diagnosis, relation to the prevention, diagnosis, treatment and post-treatment of all treatment and post-treatment of all diseases; urges the Commission to develop diseases; urges the Commission to develop appropriate regulatory frameworks, to the appropriate regulatory frameworks, to guide new business models, and to run regulate new business models, and to run information campaigns to raise awareness information campaigns to raise awareness and encourage the use of these and ensure the uptake of these innovations; innovations;

Or. en

Amendment 524 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Cindy Franssen

Motion for a resolution Paragraph 15 a (new)

Motion for a resolution Amendment

15 a. Recognises that ATMPs are fundamentally different from traditional pharmaceuticals as they address the root causes of disease and that their fundamental durability and potential curative nature can allow them to be the future of medicine; acknowledges that regulatory bodies such as the EMA are set to review and approve dozens of ATMPs over the coming years, underlining the need for the Commission to establish in addition to its ATMP Action Plan a robust regulatory landscape that facilitates access for all the eligible European patients, and to continue to build on Europe’s position as a major player in ATMPs in order for Europe to remain globally competitive in ATMP development;

Or. en

Amendment 525 Danilo Oscar Lancini, Simona Baldassarre

AM\1233943EN.docx 253/362 PE693.845v01-00 EN Motion for a resolution Paragraph 15 a (new)

Motion for a resolution Amendment

15 a. Urges the European Commission and EMA to consider the full life-cycle of all innovative medicines and therapies including gene and cell therapies, personalised medicine, nanotechnology, next generation vaccines, and ensure a fit-for-purpose framework for off-patent competition at the time of loss of exclusivity;

Or. en

Amendment 526 Pietro Fiocchi

Motion for a resolution Paragraph 15 a (new)

Motion for a resolution Amendment

15 a. Urges the European Commission and EMA to consider the full life-cycle of all innovative medicines and therapies including gene and cell therapies, personalised medicine, nanotechnology, next generation vaccines, and ensure a fit-for-purpose framework for off-patent competition at the time of loss of exclusivity;

Or. en

Amendment 527 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Cindy Franssen, Inese Vaidere

Motion for a resolution Paragraph 15 b (new)

Motion for a resolution Amendment

PE693.845v01-00 254/362 AM\1233943EN.docx EN 15 b. Calls on the Commission to establish a coordinating body to facilitate cross-border treatments and to ensure that patients across Europe enjoy equitable access to innovative therapies; urges the Commission to work with the EMA to create a one-stop-shop for ATMP developers to seek guidance and communication on their applications;

Or. en

Amendment 528 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Stelios Kympouropoulos, Cindy Franssen, Roberta Metsola

Motion for a resolution Paragraph 15 c (new)

Motion for a resolution Amendment

15 c. Calls on the Commission to establish a regulatory framework for nanomedicines and nanosimilars, and calls for these products to be approved through a compulsory centralised procedure;

Or. en

Amendment 529 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 16

Motion for a resolution Amendment

16. Calls on the Commission to fully 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; implement the Clinical Trials welcomes the revision of pharmaceutical Regulation9to facilitate the launch of large legislation to adapt it to cutting-edge clinical trials carried out in a harmonized products, scientific advances and and coordinated manner at European technological transformation; supports a level; stresses that patient associations new framework for the design of should be more involved in defining innovative trials and the pilot project to research strategies for public and private

AM\1233943EN.docx 255/362 PE693.845v01-00 EN adopt a framework for the reuse of off- clinical trials, in order to ensure that they patent medicines; welcomes the launch of a meet the unmet needs of European vaccine platform to monitor vaccine patients; welcomes the revision of efficacy and safety, supported by an EU- pharmaceutical legislation to adapt it to wide clinical trials network; cutting-edge products, scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; ______9 Regulation (EU) No 536/2014 of the 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of European Parliament and of the Council of 16 April 2014 on clinical trials on 16 April 2014 on clinical trials on medicinal products for human use, and medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1. 27.5.2014, p. 1.

Or. en

Amendment 530 Tilly Metz

Motion for a resolution Paragraph 16

Motion for a resolution Amendment

16. Calls on the Commission to fully 16. 16. Calls on the Commission to implement the Clinical Trials Regulation9 ; fully implement the Clinical Trials welcomes the revision of pharmaceutical Regulation9; welcomes the revision of legislation to adapt it to cutting-edge pharmaceutical legislation, including for products, scientific advances and blood, tissues and cells products; supports technological transformation; supports a a new framework for the design of new framework for the design of innovative trials and the pilot project to innovative trials and the pilot project to adopt a framework for the re-purposing of adopt a framework for the reuse of off- off-patent medicines; welcomes the launch patent medicines; welcomes the launch of a of a vaccine platform to monitor vaccine vaccine platform to monitor vaccine efficacy and safety, supported by an EU- efficacy and safety, supported by an EU- wide clinical trials network; stresses the wide clinical trials network; need for more comparative and collaborative, multi-centre platform trials; stresses that comparative randomised double-blind well-designed clinical trials

PE693.845v01-00 256/362 AM\1233943EN.docx EN with relevant endpoints are necessary to meet the health needs and respond to questions or regulators, health technology assessment and health payers; ______9 Regulation (EU) No 536/2014 of the 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of European Parliament and of the Council of 16 April 2014 on clinical trials on 16 April 2014 on clinical trials on medicinal products for human use, and medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1. 27.5.2014, p. 1.

Or. en

Amendment 531 Sara Cerdas

Motion for a resolution Paragraph 16

Motion for a resolution Amendment

16. Calls on the Commission to fully 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge legislation to adapt it to cutting-edge products, scientific advances and products, scientific advances and technological transformation; supports a technological transformation; supports a new framework for the design of new framework for the design of innovative trials and the pilot project to innovative trials and the pilot project to adopt a framework for the reuse of off- adopt a framework for the reuse of off- patent medicines; welcomes the launch of a patent medicines; welcomes the launch of a vaccine platform to monitor vaccine vaccine platform to monitor vaccine efficacy and safety, supported by an EU- efficacy and safety, supported by an EU- wide clinical trials network; wide clinical trials network; calls on the Commission to establish mechanisms for continuous dialogue between the ECDC, EMA and vaccines developers on the establishment and functioning of the vaccine platform to monitor vaccine efficacy and safety; ______9 Regulation (EU) No 536/2014 of the 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of European Parliament and of the Council of 16 April 2014 on clinical trials on 16 April 2014 on clinical trials on medicinal products for human use, and medicinal products for human use, and

AM\1233943EN.docx 257/362 PE693.845v01-00 EN repealing Directive 2001/20/EC, OJ L 158, repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1. 27.5.2014, p. 1.

Or. en

Amendment 532 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 16

Motion for a resolution Amendment

16. Calls on the Commission to fully 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge legislation to adapt it to cutting-edge products, scientific advances and products, scientific advances and technological transformation; supports a technological transformation; supports a new framework for the design of new framework for the design of innovative trials and the pilot project to innovative trials and the pilot project to adopt a framework for the reuse of off- adopt a framework for the reuse of off- patent medicines; welcomes the launch of a patent medicines; welcomes the creation of vaccine platform to monitor vaccine a data monitoring committee exclusively efficacy and safety, supported by an EU- for emergency clinical trials to ensure the wide clinical trials network; human dignity of patients involved in research and to avoid duplication of emergency trials; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; ______9 Regulation (EU) No 536/2014 of the 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of European Parliament and of the Council of 16 April 2014 on clinical trials on 16 April 2014 on clinical trials on medicinal products for human use, and medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1. 27.5.2014, p. 1.

Or. en

Amendment 533 Pietro Fiocchi

PE693.845v01-00 258/362 AM\1233943EN.docx EN Motion for a resolution Paragraph 16

Motion for a resolution Amendment

16. Calls on the Commission to fully 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; implement the Clinical Trials Regulation; welcomes the revision of pharmaceutical welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge legislation to adapt it to cutting-edge products, scientific advances and products, scientific advances and technological transformation; supports a technological transformation; supports a new framework for the design of new framework for the design of innovative trials and the pilot project to innovative trials and the pilot project to adopt a framework for the reuse of off- adopt a framework for the reuse of off- patent medicines; welcomes the launch of a patent medicines; welcomes the launch of a vaccine platform to monitor vaccine vaccine platform to monitor vaccine efficacy and safety, supported by an EU- efficacy and safety, supported by an EU- wide clinical trials network; wide clinical trials network; calls on the Commission to establish mechanisms for continuous dialogue between the ECDC, EMA and vaccines developers on the establishment and functioning of the vaccine platform to monitor vaccine efficacy and safety; ______9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.

Or. en

Amendment 534 Andrey Slabakov, Pietro Fiocchi

Motion for a resolution Paragraph 16

Motion for a resolution Amendment

16. Calls on the Commission to fully 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; implement the Clinical Trials Regulation; welcomes the revision of pharmaceutical welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge legislation to adapt it to cutting-edge products, scientific advances and products, scientific advances and

AM\1233943EN.docx 259/362 PE693.845v01-00 EN technological transformation; supports a technological transformation and re- new framework for the design of examine the need for exemptions in light innovative trials and the pilot project to of these advances, while safeguarding the adopt a framework for the reuse of off- interest of public health and of patients patent medicines; welcomes the launch of a for safe, effective and quality medicines vaccine platform to monitor vaccine on the EU market; supports a new efficacy and safety, supported by an EU- framework for the design of innovative wide clinical trials network; trials and the pilot project to adopt a framework for the reuse of off-patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; ______9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.

Or. en

Amendment 535 Tiemo Wölken

Motion for a resolution Paragraph 16

Motion for a resolution Amendment

16. Calls on the Commission to fully 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; implement the Clinical Trials Regulation9 , welcomes the revision of pharmaceutical actively monitor its implementation on legislation to adapt it to cutting-edge Member States Level and enforce trial products, scientific advances and sponsors' compliance with transparency technological transformation; supports a provisions; welcomes the revision of new framework for the design of pharmaceutical legislation to adapt it to innovative trials and the pilot project to cutting-edge products, scientific advances adopt a framework for the reuse of off- and technological transformation; supports patent medicines; welcomes the launch of a a new framework for the design of vaccine platform to monitor vaccine innovative trials and the pilot project to efficacy and safety, supported by an EU- adopt a framework for the reuse of off- wide clinical trials network; patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network;

PE693.845v01-00 260/362 AM\1233943EN.docx EN ______9 Regulation (EU) No 536/2014 of the 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of European Parliament and of the Council of 16 April 2014 on clinical trials on 16 April 2014 on clinical trials on medicinal products for human use, and medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1. 27.5.2014, p. 1.

Or. en

Amendment 536 Alexander Bernhuber

Motion for a resolution Paragraph 16

Motion for a resolution Amendment

16. Calls on the Commission to fully 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge legislation to adapt it to cutting-edge products, scientific advances and products, scientific advances and technological transformation; supports a technological transformation; supports a new framework for the design of new framework for the design of innovative trials and the pilot project to innovative trials and the pilot project to adopt a framework for the reuse of off- adopt a framework for the reuse of off- patent medicines; welcomes the launch of a patent medicines; welcomes the launch of a vaccine platform to monitor vaccine vaccine platform to monitor vaccine efficacy and safety, supported by an EU- efficacy and safety, supported by an EU- wide clinical trials network; wide clinical trials network; Calls on the Commission to establish continuous dialogue between ECDC, EMA, and vaccines developers; ______9 Regulation (EU) No 536/2014 of the 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of European Parliament and of the Council of 16 April 2014 on clinical trials on 16 April 2014 on clinical trials on medicinal products for human use, and medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1. 27.5.2014, p. 1.

Or. en

Amendment 537

AM\1233943EN.docx 261/362 PE693.845v01-00 EN Ondřej Knotek, Billy Kelleher, Susana Solís Pérez, Claudia Gamon

Motion for a resolution Paragraph 16

Motion for a resolution Amendment

16. Calls on the Commission to fully 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge legislation to adapt it to cutting-edge products, scientific advances and products, scientific advances and technological transformation; supports a technological transformation; supports new framework for the design of clinical trials that are more patient- innovative trials and the pilot project to centred as well as a new framework for the adopt a framework for the reuse of off- design of innovative trials and the pilot patent medicines; welcomes the launch of a project to adopt a framework for the reuse vaccine platform to monitor vaccine of off-patent medicines; welcomes the efficacy and safety, supported by an EU- launch of a vaccine platform to monitor wide clinical trials network; vaccine efficacy and safety, supported by an EU-wide clinical trials network; ______9 Regulation (EU) No 536/2014 of the 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of European Parliament and of the Council of 16 April 2014 on clinical trials on 16 April 2014 on clinical trials on medicinal products for human use, and medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1. 27.5.2014, p. 1.

Or. en

Amendment 538 Radka Maxová

Motion for a resolution Paragraph 16

Motion for a resolution Amendment

16. Calls on the Commission to fully 16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge legislation to reduce the red tape and products, scientific advances and adapt it to cutting-edge products, scientific technological transformation; supports a advances and technological transformation; new framework for the design of supports a new framework for the design of innovative trials and the pilot project to innovative trials and the pilot project to

PE693.845v01-00 262/362 AM\1233943EN.docx EN adopt a framework for the reuse of off- adopt a framework for the reuse of off- patent medicines; welcomes the launch of a patent medicines; welcomes the launch of a vaccine platform to monitor vaccine vaccine platform to monitor vaccine efficacy and safety, supported by an EU- efficacy and safety, supported by an EU- wide clinical trials network; wide clinical trials network; ______9 Regulation (EU) No 536/2014 of the 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of European Parliament and of the Council of 16 April 2014 on clinical trials on 16 April 2014 on clinical trials on medicinal products for human use, and medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1. 27.5.2014, p. 1.

Or. en

Amendment 539 Alessandra Moretti

Motion for a resolution Paragraph 16 a (new)

Motion for a resolution Amendment

16 a. Urges the Commission, having regard to the European Strategy for Data and the digital transformation of healthcare and considering the vast potential that health data has for improving healthcare quality and patient outcomes, to encourage implementation of interoperable technologies in the Member States’ health sectors which will facilitate delivery of innovative health solutions to patients; welcomes the planned creation of a fully cooperative and operational European Health Data Space with a governance framework which fosters the creation of an innovative data-driven ecosystem, based on a secured and controlled exchange of information and critical data, among Member States; asks the Commission to promote next-generation standards, tools and infrastructure in order to store and process data suitable for research and the development of innovative products and services; underlines that personal health

AM\1233943EN.docx 263/362 PE693.845v01-00 EN data may only be collected and processed on the legal grounds provided for in Article 6(1) of the GDPR, coupled with the conditions provided for in Article 9 of the GDPR; considers that in this context further processing of personal health data should be prohibited; urges the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe; recalls the need of finding a balance between data protection and the condition for a productive research collaboration at EU and international level and to ensure access to large, high quality health data sets to researchers and clinicians, which could be fundamental for developing innovative treatments;

Or. en

Amendment 540 Nicolás González Casares

Motion for a resolution Paragraph 16 a (new)

Motion for a resolution Amendment

16 a. Urges the Commission to ensure more transparency in clinical trial results, with pharmaceutical companies sharing participant-level data, both positive and negative results (avoiding bias derived from lack of public access to negative trials that weakens the conclusions of systematic reviews and provides a false sense of reassurance on the efficacy or safety of medicinal products), protocols and other trial documents, in a timely manner (urgently in case of emergency);

Or. en

PE693.845v01-00 264/362 AM\1233943EN.docx EN Amendment 541 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 16 a (new)

Motion for a resolution Amendment

16a. Calls for an in-depth review of the rules governing clinical trials in order to consolidate a clear and proportionate set of rules to ensure legal certainty for operators; Notes that many European companies conduct their clinical trials outside the EU because of the many bureaucratic hurdles imposed by EU law in areas such as data protection.

Or. es

Amendment 542 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 16 b (new)

Motion for a resolution Amendment

16b. Calls on the Commission to improve the participation of public researchers in clinical trials, to provide new guidelines on clinical trials, to encourage European networking for better use of public funds, to facilitate cooperation with the UK, to relax regulations to allow clinical trials in several countries simultaneously, and to develop specific provisions in relation to cancer or personalised medicines where long-term research is essential.

Or. es

Amendment 543 Alessandra Moretti

AM\1233943EN.docx 265/362 PE693.845v01-00 EN Motion for a resolution Paragraph 16 b (new)

Motion for a resolution Amendment

16 b. Recalls the importance of adapting existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems in the interest of patients;

Or. en

Amendment 544 Alessandra Moretti

Motion for a resolution Paragraph 16 c (new)

Motion for a resolution Amendment

16 c. Calls on the Commission to require pharmaceutical companies to publicly disclose the costs of R&D and manufacturing, public funding contributions, regulatory dossiers containing clinical trial data and active pharmaceutical ingredient sources, number and status of patents and patent applications, and supply chains as a condition for market approval;

Or. en

Amendment 545 Anja Hazekamp

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Calls on the Commission to work the experience with the authorisation of with the EMA to develop the use of

PE693.845v01-00 266/362 AM\1233943EN.docx EN COVID-19 vaccines, to work with the electronic product information for all EMA to consider extending the medicines in the EU; application of rolling reviews to other emergency medicines; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU;

Or. nl

Amendment 546 Pietro Fiocchi

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Further calls on the Commission to the experience with the authorisation of work with EMA and the EU regulatory COVID-19 vaccines, to work with the network to develop the use of electronic EMA to consider extending the product information for all medicines in application of rolling reviews to other the EU; emergency medicines; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU;

Or. en

Amendment 547 Alessandra Moretti

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews to other emergency medicines; further calls on the medicines; further calls for the paper Commission to work with the EMA to information notice to be supplemented by develop the use of electronic product an electronic product information leaflet

AM\1233943EN.docx 267/362 PE693.845v01-00 EN information for all medicines in the EU; notice, to be drawn up in all languages for all the countries where the medicine is marketed in order to facilitate the moving and sales of medicines within the single market and thus mitigate shortages; stresses that electronic product information could complement, but never replace, the package information leaflet;

Or. en

Amendment 548 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews to other emergency medicines; further calls on the Commission medicines; further calls on the Commission to work with the EMA to develop the use to work with the EMA to develop the use of electronic product information for all of electronic product information for all medicines in the EU; medicines in the EU; Points to the urgent need to move forward with the creation of a European health data space to improve the scope and added value of clinical studies and research, thereby facilitating the digital transformation of our health systems.

Or. es

Amendment 549 Jessica Polfjärd

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on

PE693.845v01-00 268/362 AM\1233943EN.docx EN the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews to other emergency medicines; further calls on the Commission medicines and evaluate how further to work with the EMA to develop the use regulatory flexibilities, including for of electronic product information for all GMO medicinal products, could medicines in the EU; contribute to a more efficient authorisation system; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU, including a shift towards electronic labelling and package leaflets;

Or. en

Amendment 550 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews and to incorporate medicines; further calls on the Commission lessons learned from the extraordinary to work with the EMA to develop the use and accelerated authorisation process of electronic product information for all where it is relevant, safe and beneficial medicines in the EU; for patients and for innovative medicinal products for underserved areas; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU;

Or. en

Amendment 551 Maria Spyraki

Motion for a resolution

AM\1233943EN.docx 269/362 PE693.845v01-00 EN Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews to other emergency medicines; further calls on the Commission medicines; further calls on the Commission to work with the EMA to develop the use to work with the EMA, the industry and of electronic product information for all all relevant stakeholders accelerate the medicines in the EU; development and adoption of electronic product information for all medicines in the EU by defining timelines and harmonised standards within a common European interoperable information exchange network;

Or. en

Amendment 552 Tilly Metz

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews to other emergency medicines; further calls on the Commission medicines; further calls on the Commission to work with the EMA to develop the use to work with the EMA to develop the use of electronic product information for all of electronic product information for all medicines in the EU; medicines in the EU; stresses that electronic product information should complement, but not replace, the package information leaflet as a primary source of information for patients;

Or. en

Amendment 553

PE693.845v01-00 270/362 AM\1233943EN.docx EN Pietro Fiocchi

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews and further regulatory medicines; further calls on the Commission flexibilities to other emergency medicines to work with the EMA to develop the use and innovative medicinal products for of electronic product information for all underserved areas; further calls on the medicines in the EU; Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU and allow electronic patients information instead of paper insert;

Or. en

Amendment 554 Kateřina Konečná

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews to other emergency medicines; further calls on the Commission medicines; further calls on the Commission to work with the EMA to develop the use to work with the EMA to develop the use of electronic product information for all of electronic product information for all medicines in the EU; medicines in the EU; stresses that electronic product information should complement, but not replace, the package information leaflet;

Or. en

AM\1233943EN.docx 271/362 PE693.845v01-00 EN Amendment 555 Andrey Slabakov, Joanna Kopcińska, Pietro Fiocchi, Ryszard Antoni Legutko, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work in close EMA to consider extending the application cooperation with the EMA to consider of rolling reviews to other emergency extending the application of rolling reviews medicines; further calls on the Commission to other emergency medicines, while to work with the EMA to develop the use safeguarding high level of safety, quality of electronic product information for all and effectiveness; further calls on the medicines in the EU; Commission to work with the EMA to further accelerate the use of electronic product information for all medicines in the EU;

Or. en

Amendment 556 Sara Cerdas

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews to other emergency medicines; further calls on the Commission medicines; further calls on the Commission to work with the EMA to develop the use to work with the EMA to develop the use of electronic product information for all of electronic product information for all medicines in the EU; medicines in the EU in all EU's official languages;

Or. en

Amendment 557

PE693.845v01-00 272/362 AM\1233943EN.docx EN Carlo Calenda

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews to other emergency medicines; further calls on the Commission medicines; further calls on the Commission to work with the EMA to develop the use to work with the EMA and the European of electronic product information for all regulatory network to develop the use of medicines in the EU; electronic product information for all medicines in the EU;

Or. it

Amendment 558 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Paragraph 17

Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews to other emergency medicines; further calls on the Commission medicines; further calls on the Commission to work with the EMA to develop the use to work with the EMA and the EU of electronic product information for all regulatory network to develop the use of medicines in the EU; electronic product information for all medicines in the EU;

Or. en

Amendment 559 Nicolae Ştefănuță

Motion for a resolution Paragraph 17

AM\1233943EN.docx 273/362 PE693.845v01-00 EN Motion for a resolution Amendment

17. Urges the Commission, based on 17. Urges the Commission, based on the experience with the authorisation of the experience with the authorisation of COVID-19 vaccines, to work with the COVID-19 vaccines, to work with the EMA to consider extending the application EMA to consider extending the application of rolling reviews to other emergency of rolling reviews to other essential medicines; further calls on the Commission medicines; further calls on the Commission to work with the EMA to develop the use to work with the EMA to develop the use of electronic product information for all of electronic product information for all medicines in the EU; medicines in the EU;

Or. en

Amendment 560 Andrey Slabakov, Joanna Kopcińska, Pietro Fiocchi, Ryszard Antoni Legutko

Motion for a resolution Paragraph 17 a (new)

Motion for a resolution Amendment

17 a. Welcomes the Commission’s acknowledgement of the difficulties faced by SMEs during the regulatory approval, licensing and product launch processes; highlights that the heavy administrative burden may hinder SMEs’ ability to develop and bring to patients innovative medical products, including for unmet medical needs and rare diseases; reiterates that the administrative burden often forces SMEs into buyouts by larger pharmaceutical companies or into leaving the EU altogether; calls on the Commission and Member States to take SMEs under special consideration when ensuring a level playing field in the process for simplifying and streamlining procedures, due to the fact that, unlike large pharmaceutical companies, SMEs cannot easily absorb administrative costs; calls on the Commission to bring up to date the capabilities of EMA for providing information and assistance to SMEs during the authorisation process; calls on the Member States to establish One-Stop-

PE693.845v01-00 274/362 AM\1233943EN.docx EN Shop contact points for SMEs, providing all necessary information, as well as expert help and assistance, to facilitate compliance with national standards and procedures;

Or. en

Amendment 561 Pietro Fiocchi

Motion for a resolution Paragraph 17 a (new)

Motion for a resolution Amendment

17 a. Welcomes the fact that the strategy recognises that the better use of electronic product information (ePI) will support the better delivery of information to patients and support a wider availability of medicines, especially in critical situations; calls on the Commission to urgently implement the ePI with a targeted dialogue - between regulators, the industry and all relevant stakeholders – to design a EU Roadmap that will define timelines and harmonised EU standards as well as educational campaigns for patients and healthcare stakeholders;

Or. en

Amendment 562 Alessandra Moretti

Motion for a resolution Paragraph 17 a (new)

Motion for a resolution Amendment

17 a. Calls for a review of the incentives put in place to encourage research in orphan medicines to evaluate their effects and consider appropriate actions to this end; calls for Regulation (EC) No

AM\1233943EN.docx 275/362 PE693.845v01-00 EN 141/2000 on orphan medicinal products to be revised in order to reverse the burden of proof for the 10-year market exclusivity clause so that the holder of the market authorisation has to prove that the product is not sufficiently profitable to cover R&D costs;

Or. en

Amendment 563 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 17 a (new)

Motion for a resolution Amendment

17a. Emphasises that research into and the production and use of medicines should follow ethical principles that guarantee the right to life, dignity and the integrity of the person.

Or. es

Amendment 564 Alessandra Moretti

Motion for a resolution Paragraph 17 b (new)

Motion for a resolution Amendment

17 b. Calls on the Commission to address the negative impacts of parallel trade with regards to shortage of medicines in the Member States and to tackle problems adequately by taking the necessary action to ensure that medicines reach all patients in the EU in a timely manner;

Or. en

PE693.845v01-00 276/362 AM\1233943EN.docx EN Amendment 565 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez

Motion for a resolution Paragraph 18

Motion for a resolution Amendment

18. Calls on the Commission to 18. Calls on the Commission to reassess the system which leads from reassess the system which leads from conditional marketing authorisation to conditional marketing authorisation to standard marketing authorisation or to the standard marketing authorisation or to the exceptional renewal of the authorisation; exceptional renewal of the authorisation; calls on the EMA to thoroughly carry out calls on the EMA to thoroughly carry out the final evaluation and ensure the strict the final evaluation and ensure the strict compliance by producers with all of the compliance by producers with all of the requirements for each medicine under requirements for each medicine under conditional marketing authorisation in conditional marketing authorisation in order to ensure the efficacy and safety of order to ensure the efficacy and safety of such medicine; asks for the time before the such medicine; asks for the time before the final evaluation to be reduced from five to final evaluation to be reduced from five to three years; three years; encourages the Commission in cooperation with the EMA to consider how already established tools like accelerated authorisation, early dialogue, expanded guidance and the PRIME scheme can be used to make medicine available to patients at a faster pace, especially medicine that has potential to address an urgent public health threat or an unmet medical need;

Or. en

Amendment 566 Pietro Fiocchi

Motion for a resolution Paragraph 18

Motion for a resolution Amendment

18. Calls on the Commission to 18. Calls on the Commission to assess reassess the system which leads from how the conditional marketing conditional marketing authorisation to authorisation approach has been used by standard marketing authorisation or to the regulators and industry to speed up the exceptional renewal of the authorisation; availability of innovative medicines to

AM\1233943EN.docx 277/362 PE693.845v01-00 EN calls on the EMA to thoroughly carry out patients, with a view to making better use the final evaluation and ensure the strict of conditional marketing authorisation in compliance by producers with all of the the future; reassess the system which leads requirements for each medicine under from conditional marketing authorisation conditional marketing authorisation in to standard marketing authorisation or to order to ensure the efficacy and safety of the exceptional renewal of the such medicine; asks for the time before the authorisation; calls on the EMA to final evaluation to be reduced from five to thoroughly carry out the final evaluation three years; and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine;

Or. en

Amendment 567 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 18

Motion for a resolution Amendment

18. Calls on the Commission to 18. Calls on the Commission to reassess the system which leads from reassess the system which leads from conditional marketing authorisation to conditional marketing authorisation to standard marketing authorisation or to the standard marketing authorisation or to the exceptional renewal of the authorisation; exceptional renewal of the authorisation, calls on the EMA to thoroughly carry out based on robust clinical data; calls on the the final evaluation and ensure the strict EMA to thoroughly carry out the final compliance by producers with all of the evaluation and ensure the strict compliance requirements for each medicine under by producers with all of the requirements conditional marketing authorisation in for each medicine under conditional order to ensure the efficacy and safety of marketing authorisation in order to ensure such medicine; asks for the time before the the efficacy and safety of such medicine; final evaluation to be reduced from five to asks for the time before the final evaluation three years; to be reduced from five to three years, where sufficient data are available;

Or. en

Amendment 568 Peter Liese, Christine Schneider, Cindy Franssen

Motion for a resolution

PE693.845v01-00 278/362 AM\1233943EN.docx EN Paragraph 18 a (new)

Motion for a resolution Amendment

18 a. Underlines – especially in view of the experiences of the COVID-19 crisis – the importance of drug repurposing as a faster way to new treatment options and therefore demands five years of data protection for valuable innovation on known substance; in addition, underlines that a framework which supports the marketing and use of the drug with the approved new label claim - instead of off- label use - should be urgently considered to make drug repurposing attractive in the EU;

Or. en

Amendment 569 Simona Baldassarre, Susanna Ceccardi, Marco Campomenosi, Luisa Regimenti, Danilo Oscar Lancini

Motion for a resolution Paragraph 18 a (new)

Motion for a resolution Amendment

18a. Emphasises that the term medical device means any instrument, device, item of equipment, software package, implant, reagent, material or other article intended by the manufacturer for use on human beings. If the medical device is to be used alone or in combination with other substances, the Commission is asked to refer to rule 21 in Annex VIII to Regulation 745/2017 on the classification of medical devices;

Or. it

Amendment 570 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

AM\1233943EN.docx 279/362 PE693.845v01-00 EN Motion for a resolution Paragraph 18 a (new)

Motion for a resolution Amendment

18 a. Welcomes the Commission’s SAMIRA Action Plan and calls on the Commission to evaluate whether the current pharmaceutical legislation remains appropriately aligned with scientific progress in the development of therapeutic applications of nuclear medicine, recognising that the current legislative framework is largely tailored to diagnostic applications of radiopharmaceuticals;

Or. en

Amendment 571 Nathalie Colin-Oesterlé

Motion for a resolution Paragraph 18 a (new)

Motion for a resolution Amendment

18a. Calls on the Commission, the EMA and the competent authorities to capitalise on all the pragmatic efforts made during the COVID-19 crisis, in particular as regards regulatory flexibility with a view to tackling medicine shortages more effectively;

Or. fr

Amendment 572 Kateřina Konečná

Motion for a resolution Paragraph 18 a (new)

Motion for a resolution Amendment

18 a. Calls on the Commission to extend

PE693.845v01-00 280/362 AM\1233943EN.docx EN the mandate of the EMA further, to allow it to monitor medicines shortages even outside health crises and to ensure it has the necessary resources;

Or. en

Amendment 573 Sara Cerdas

Motion for a resolution Paragraph 18 a (new)

Motion for a resolution Amendment

18 a. Calls on the Commission to extend the mandate of the EMA further, to allow it to monitor medicines shortages even outside health crises and to ensure it has the necessary resources;

Or. en

Amendment 574 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 18 b (new)

Motion for a resolution Amendment

18 b. Calls on the Commission to reinforce the role and capacities of EMA with regards to novel medicines; recalls that new treatment modalities, such as radionuclide therapies and nanotechnologies, may require the development of specific clinical development guidelines to support manufacturers with the development of new medicines in innovative fields; reiterates that ensuring sufficient experience and capacity in relation to new treatment modalities is fundamental for the EMA to efficiently guide companies and assess new medicines;

AM\1233943EN.docx 281/362 PE693.845v01-00 EN Or. en

Amendment 575 Tilly Metz

Motion for a resolution Subheading 3

Motion for a resolution Amendment

Increasing resilience: secure supply chains, Increasing resilience: prevention of sustainable medicines, crisis preparedness medicine shortages, secure supply chains, and response mechanisms sustainable medicines, crisis preparedness and response mechanisms

Or. en

Amendment 576 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; recalls that medicines develop an early warning system for drug shortages have a direct impact on shortages, based on a European patients' health, safety and the information network on supply problems, continuation of their treatment; stresses to increase public-private collaboration and that for patients, the consequences of to monitor the obligation on the part of drug shortages include: progression of the industry to provide early and transparent disease and / or worsening of symptoms information on the availability of due to delay in treatment, avoidable medicines; calls on the Commission to transmission of infectious diseases, develop a mechanism to safeguard increased risk of exposure to falsified transparency in production and supply medicines and significant psychological chains in the event of emergencies; distress for patients and their families; notes that the risks are particularly high amongst vulnerable populations such as children, the elderly, pregnant women, people affected by a disability, patients with chronic diseases or cancer or people in intensive care unit (ICU); calls on the

PE693.845v01-00 282/362 AM\1233943EN.docx EN Commission to present a specific strategy for managing shortages of medicines and medical products in Europe; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Or. en

Amendment 577 Tilly Metz

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Calls on the Commission to heed autonomy is linked to the constant and the recommendations of the European sufficient availability of medicines in all Parliament stated in resolution of 17 Member States; calls on the Commission to September 2020 on the shortage of develop an early warning system for drug medicines; Recalls that the EU’s open shortages, based on a European strategic autonomy, particularly focused information network on supply problems, on production of critical products, to increase public-private collaboration and contributes to the availability of medicines to monitor the obligation on the part of in all Member States; calls on the industry to provide early and transparent Commission to develop an early warning information on the availability of system for drug shortages, based on medicines; calls on the Commission to transparency of medicines' stocks and on develop a mechanism to safeguard a centralised European information transparency in production and supply network on medicine shortages, to chains in the event of emergencies; increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability and stocks of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains and impose dissuasive sanctions in

AM\1233943EN.docx 283/362 PE693.845v01-00 EN the event of non-compliance;

Or. en

Amendment 578 Pietro Fiocchi

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; recognises the multiple develop an early warning system for drug drivers of shortages and therefore the shortages, based on a European importance of ensuring the involvement information network on supply problems, of manufacturers and other supply chain to increase public-private collaboration and stakeholders to prevent and manage to monitor the obligation on the part of medicines’ shortages; calls on the industry to provide early and transparent Commission to build on existing systems information on the availability of such as the European Medicines medicines; calls on the Commission to Verification System (EMVS), to develop a develop a mechanism to safeguard warning system for drug shortages, based transparency in production and supply on a European information network on chains in the event of emergencies; supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry and all supply chain stakeholders to provide early and transparent information on the demand of medicines, parallel trade activities, export bans and unexpected manufacturing or quality problems, while ensuring that reporting burdens do not increase, become ineffective or unjustified; stresses that confidentiality should be safeguarded; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; calls for systematic regulatory measures of flexibility to mitigate shortages when they occur;

Or. en

PE693.845v01-00 284/362 AM\1233943EN.docx EN Amendment 579 Radka Maxová

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. 19. Recalls that the EU’s open autonomy is linked to the constant and strategic autonomy is linked to the constant sufficient availability of medicines in all and sufficient availability of medicines in Member States; calls on the Commission to all Member States; considers it imperative develop an early warning system for drug to increase the EU’s manufacturing shortages, based on a European production and ensure sustainable, information network on supply problems, diversified and robust supply chains; calls to increase public-private collaboration and on the Commission to define a robust to monitor the obligation on the part of supply chain, conduct an assessment of industry to provide early and transparent causes and drivers of vulnerabilities and information on the availability of dependencies of the supply chain and of medicines; calls on the Commission to cost implications of increasing the develop a mechanism to safeguard robustness of the supply chains, conduct a transparency in production and supply mapping of the EU manufacturing chains in the event of emergencies; capacity, and identify the products critical from the public health view; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; stresses in this regard the importance of monitoring and fighting against counterfeit pharmaceuticals;

Or. en

Amendment 580 Ondřej Knotek, Billy Kelleher, Susana Solís Pérez, Claudia Gamon

Motion for a resolution Paragraph 19

AM\1233943EN.docx 285/362 PE693.845v01-00 EN Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; recognises the multiple develop an early warning system for drug drivers of shortages; stresses the shortages, based on a European importance to involve all stakeholders information network on supply problems, including manufacturers, wholesalers and to increase public-private collaboration and pharmacists to prevent and manage to monitor the obligation on the part of medicines’ shortages; recommends, when industry to provide early and transparent shortages of medicine occur, to inform information on the availability of healthcare professionals and patients medicines; calls on the Commission to about available alternatives; calls on the develop a mechanism to safeguard Commission to develop an early warning transparency in production and supply system for drug shortages, based on a chains in the event of emergencies; European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines, parallel trade activities, export bans and unexpected manufacturing or quality problems, while limiting the administrative burdens on stakeholders and safeguarding confidentiality; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Or. en

Amendment 581 Alessandra Moretti

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission, develop an early warning system for drug Member States and the European shortages, based on a European Medicines Agency to develop an early information network on supply problems, warning system for medicine shortages,

PE693.845v01-00 286/362 AM\1233943EN.docx EN to increase public-private collaboration and based on an electronic platform capable of to monitor the obligation on the part of determining the volume of stock existing industry to provide early and transparent at any given moment, as well as the actual information on the availability of level of demand, providing data capable of medicines; calls on the Commission to detecting, predicting and preventing develop a mechanism to safeguard shortages of medicinal products; calls transparency in production and supply also to increase public-private chains in the event of emergencies; collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies and beyond;

Or. en

Amendment 582 Jessica Polfjärd

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission to develop an early warning system for drug explore an early warning system for drug shortages, based on a European shortages based on existing structures, information network on supply problems, based on a European information network to increase public-private collaboration and on supply problems, to increase public- to monitor the obligation on the part of private collaboration and to monitor the industry to provide early and transparent obligation on the part of all relevant supply information on the availability of chain stakeholders to provide early and medicines; calls on the Commission to transparent information on relevant develop a mechanism to safeguard factors, including but not limited to the transparency in production and supply availability of medicines, demand for chains in the event of emergencies; medicines, parallell trade activities and market distortions without undue regulatory burden; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Or. en

AM\1233943EN.docx 287/362 PE693.845v01-00 EN Amendment 583 Nicolás González Casares

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission, develop an early warning system for drug the Member States and the European shortages, based on a European Medicines Agency to develop an electronic information network on supply problems, platform capable of determining the to increase public-private collaboration and volume of stock existing at any given to monitor the obligation on the part of moment, as well as the actual level of industry to provide early and transparent demand, providing data capable of information on the availability of detecting, predicting and preventing medicines; calls on the Commission to shortages of medicinal products; calls also develop a mechanism to safeguard to increase public-private collaboration and transparency in production and supply to monitor the obligation on the part of chains in the event of emergencies; industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Or. en

Amendment 584 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission to develop an early warning system for drug develop an early warning system for drug shortages, based on a European shortages, based on the improved information network on supply problems, collection of digital information linked to

PE693.845v01-00 288/362 AM\1233943EN.docx EN to increase public-private collaboration and telematics and digital shortages reporting, to monitor the obligation on the part of to increase public-private collaboration and industry to provide early and transparent to monitor the obligation on the part of information on the availability of industry to provide early and transparent medicines; calls on the Commission to information on the availability of develop a mechanism to safeguard medicines; calls on the Commission to transparency in production and supply develop a mechanism to safeguard chains in the event of emergencies; transparency in production and supply chains in the event of emergencies;

Or. en

Amendment 585 Pietro Fiocchi

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU's open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission to develop an early warning system for drug develop an early warning system for drug shortages, based on a European shortages, based on the improved information network on supply problems, collection of digital information linked to to increase public-private collaboration telematics and digital shortages reporting, and to monitor the obligation on the part of and greater public-private collaboration, to industry to provide early and transparent monitor the obligation on the part of information on the availability of industry to provide early and transparent medicines; calls on the Commission to information on the availability of develop a mechanism to safeguard medicines; calls on the Commission to transparency in production and supply develop a mechanism to safeguard chains in the event of emergencies; transparency in production and supply chains in the event of emergencies;

Or. en

Amendment 586 Jan Huitema

Motion for a resolution Paragraph 19

AM\1233943EN.docx 289/362 PE693.845v01-00 EN Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission to develop an early warning system for drug develop an early warning system for drug shortages, based on a European shortages, based on improved collection of information network on supply problems, digital information and digital shortages to increase public-private collaboration reporting, and an increased public-private and to monitor the obligation on the part collaboration while monitoring the of industry to provide early and transparent obligation on the part of industry to information on the availability of provide early and transparent information medicines; calls on the Commission to on the availability of medicines; calls on develop a mechanism to safeguard the Commission to develop a mechanism transparency in production and supply to safeguard transparency in production chains in the event of emergencies; and supply chains in the event of emergencies;

Or. en

Amendment 587 Sirpa Pietikäinen

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission to develop an early warning system for drug develop an early warning system for drug shortages, based on a European shortages, based on a European information network on supply problems, information network on supply problems, to increase public-private collaboration and to increase public-private collaboration and to monitor the obligation on the part of to monitor the obligation on the part of industry to provide early and transparent industry to provide early and transparent information on the availability of information on the availability of medicines; calls on the Commission to medicines; calls on the Commission to develop a mechanism to safeguard develop a mechanism to safeguard transparency in production and supply transparency in production and supply chains in the event of emergencies; chains in the event of emergencies and create an emergency preparedness plan to fast track an increase in the production capacity so that it is sufficient to fulfil Union needs for the medicinal products in

PE693.845v01-00 290/362 AM\1233943EN.docx EN times of crisis and unexpected demand;

Or. en

Amendment 588 Tiemo Wölken

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission to develop an early warning system for drug develop an early warning system for drug shortages, based on a European shortages, based on a European information network on supply problems, information network on supply problems, to increase public-private collaboration and to increase public-private collaboration and to monitor the obligation on the part of to monitor the obligation on the part of industry to provide early and transparent industry to provide early and transparent information on the availability of information on the availability of medicines; calls on the Commission to medicines; underlines that shortages are a develop a mechanism to safeguard critical public health problem that can transparency in production and supply seriously harm patients' health and safety, chains in the event of emergencies; quality of care, professionals' ability to deliver care and health system functioning; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Or. en

Amendment 589 Alexander Bernhuber

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all

AM\1233943EN.docx 291/362 PE693.845v01-00 EN Member States; calls on the Commission to Member States; calls on the Commission to develop an early warning system for drug develop an early warning system for drug shortages, based on a European shortages, based on a European information network on supply problems, information network on supply problems, to increase public-private collaboration and to increase public-private collaboration and to monitor the obligation on the part of to monitor the obligation on the part of industry to provide early and transparent industry to provide early and transparent information on the availability of information on the availability of medicines; calls on the Commission to medicines; calls on the Commission to develop a mechanism to safeguard develop a mechanism to safeguard transparency in production and supply transparency in production and supply chains in the event of emergencies; chains in the event of emergencies; calls on the Commission for measures of flexibility to mitigate shortages when they occur;

Or. en

Amendment 590 Stanislav Polčák

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission to develop an early warning system for drug take steps in this direction leading to the shortages, based on a European strengthening of cooperation between information network on supply problems, Member States, in order to develop an to increase public-private collaboration and early warning system for drug shortages, to monitor the obligation on the part of based on a European information network industry to provide early and transparent on supply problems, to increase public- information on the availability of private collaboration and to monitor the medicines; calls on the Commission to obligation on the part of industry to develop a mechanism to safeguard provide early and transparent information transparency in production and supply on the availability of medicines; calls on chains in the event of emergencies; the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;

Or. cs

PE693.845v01-00 292/362 AM\1233943EN.docx EN Amendment 591 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s dependence autonomy is linked to the constant and on the constant and sufficient availability sufficient availability of medicines in all of medicines in all Member States; calls on Member States; calls on the Commission to the Commission to develop an early develop an early warning system for drug warning system for drug shortages, based shortages, based on a European on a European information network on information network on supply problems, supply problems, and to monitor the to increase public-private collaboration obligation on the part of industry to and to monitor the obligation on the part of provide early and transparent information industry to provide early and transparent on the availability of medicines; calls on information on the availability of the Commission to develop a mechanism medicines; calls on the Commission to to safeguard transparency in production develop a mechanism to safeguard and supply chains in the event of transparency in production and supply emergencies; chains in the event of emergencies;

Or. en

Amendment 592 Petar Vitanov

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission to develop an early warning system for drug develop an early warning system for drug shortages, based on a European shortages, based on a European information network on supply problems, information network on supply problems, to increase public-private collaboration and to increase public-private collaboration and to monitor the obligation on the part of to monitor the obligation on the part of industry to provide early and transparent industry to provide early and transparent information on the availability of information on the availability of medicines; calls on the Commission to medicines in all Member States; calls on develop a mechanism to safeguard the Commission to develop a mechanism transparency in production and supply to safeguard transparency in production

AM\1233943EN.docx 293/362 PE693.845v01-00 EN chains in the event of emergencies; and supply chains in the event of emergencies;

Or. en

Amendment 593 Kateřina Konečná

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission to develop an early warning system for drug develop an early warning system for drug shortages, based on a European shortages, based on a European information network on supply problems, information network on supply problems, to increase public-private collaboration and to increase public-private collaboration and to monitor the obligation on the part of to monitor the obligation on the part of industry to provide early and transparent industry to provide early and transparent information on the availability of information on the availability of medicines; calls on the Commission to medicines; calls on the Commission to develop a mechanism to safeguard develop a mechanism to safeguard transparency in production and supply transparency in production and supply chains in the event of emergencies; chains in the event of emergencies and beyond;

Or. en

Amendment 594 Maria Spyraki

Motion for a resolution Paragraph 19

Motion for a resolution Amendment

19. Recalls that the EU’s open strategic 19. Recalls that the EU’s open strategic autonomy is linked to the constant and autonomy is linked to the constant and sufficient availability of medicines in all sufficient availability of medicines in all Member States; calls on the Commission to Member States; calls on the Commission to develop an early warning system for drug develop an early warning system for drug shortages, based on a European shortages, based on a European

PE693.845v01-00 294/362 AM\1233943EN.docx EN information network on supply problems, information exchange network on supply to increase public-private collaboration and problems, to increase public-private to monitor the obligation on the part of collaboration and to monitor the obligation industry to provide early and transparent on the part of industry to provide early and information on the availability of transparent information on the availability medicines; calls on the Commission to of medicines; calls on the Commission to develop a mechanism to safeguard develop a mechanism to safeguard transparency in production and supply transparency in production and supply chains in the event of emergencies; chains in the event of emergencies;

Or. en

Amendment 595 Alessandra Moretti

Motion for a resolution Paragraph 19 a (new)

Motion for a resolution Amendment

19 a. Underlines that the EP in its recent resolution on shortage of medicines has recalled the obligations for the supply of medicinal products by marketing authorisation holders (MAHs) and distributors, as well as a notification obligation in the event of a temporary or permanent supply interruption, as provided by Directive 2001/83/EC; regrets once more the disparities observed in the transposition of these obligations into national legislations for which the Commission and member states must react promptly and with binding measures; calls on the Commission and the Member States to ensure that MAHs and wholesale distributors comply with the requirements of Directive 2001/83/EC in order to ensure appropriate and continued supplies of medicines; calls on the Commission to further clarify the obligations for MAHs under Directive 2001/83/EC and highlights the need to ensure that they report medicine shortages within the established timeframes; stresses the need to apply dissuasive and proportionate sanctions in the event of non-compliance with these

AM\1233943EN.docx 295/362 PE693.845v01-00 EN legal obligations in line with the existing legislative framework;

Or. en

Amendment 596 Christine Schneider

Motion for a resolution Paragraph 19 a (new)

Motion for a resolution Amendment

19a. Points out that the EU’s open strategic autonomy is linked to the availability of sufficient medicines in all Member States at all times; calls on the Commission, therefore, to diversify and thereby strengthen medicine supply chains and to further develop and expand European production sites for essential medicines, in particular those operated by SMEs and MidCaps; calls on the Commission to develop an early-warning system for medicine shortages which draws on a European information network focusing on supply problems; calls on the Commission to enhance cooperation between the public and private sectors and to monitor industry compliance with the requirement to provide timely and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in emergencies;

Or. de

Amendment 597 Nathalie Colin-Oesterlé

Motion for a resolution Paragraph 19 a (new)

PE693.845v01-00 296/362 AM\1233943EN.docx EN Motion for a resolution Amendment

19a. Emphasises that security of supply is an essential factor and must be used as a qualitative criterion in connection with the award of public pharmacy contracts and calls for tender for the supply of medicines; emphasises the importance of diversified supplies and procurement practices for pharmaceuticals; urges the Commission, in the context of Directive 2014/24/EU, to act swiftly in proposing guidelines for the Member States, to look beyond the lowest price criterion, and to ensure that investments in the manufacture of active ingredients and medicinal end products in the EU are also retained as an essential criterion;

Or. fr

Amendment 598 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 19 a (new)

Motion for a resolution Amendment

19a. Calls on the Commission to draw up a new definition of 'supply shortages' and to implement an early warning system; invites the Commission to take into consideration the information exchange systems in place in some Member States, based on communication between distribution and pharmacies, which have so far been effective in detecting supply shortages and which may inspire future initiatives without creating new structures, building rather on the experience gained in the Member States and the capacity of national medicines agencies.

Or. es

AM\1233943EN.docx 297/362 PE693.845v01-00 EN Amendment 599 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Paragraph 19 a (new)

Motion for a resolution Amendment

19 a. Recalls the importance to look at the root causes of medicines shortage and to implement systemic sustainable policies, before applying any disproportionate regulatory requirements, obligation to supply, penalties or ill- conceived stockpiling fragmenting the single market or threatening products’ economic sustainability, which may lead to further shortages; underlines that root causes include economic causes, increasing regulatory burdens, unforeseen surges in demand, supply chain interdependencies and manufacturing challenges;

Or. en

Amendment 600 Aldo Patriciello

Motion for a resolution Paragraph 19 a (new)

Motion for a resolution Amendment

19 a. Recalls that the root causes of medicines shortage should be assessed and tackled and systemic sustainable reforms put in place, before imposing any disproportionate, quick-fix and punitive measures, such as penalties and uncoordinated and extreme stockpiling requirements; underlines that root causes include economic causes, increasing regulatory burdens, unforeseen surges in demand, supply chain interdependencies and manufacturing challenges;

Or. en

PE693.845v01-00 298/362 AM\1233943EN.docx EN Amendment 601 Cyrus Engerer

Motion for a resolution Paragraph 19 a (new)

Motion for a resolution Amendment

19 a. Insists that the Public Service Obligation (PSO) as established in Article 81 of Directive 2001/83 is not sufficient to ensure that the EU as a whole is sufficiently supplied; calls on the Commission to put in place an obligation for MAH’s to report to EMA the total quantities supplied to the Internal Market and to ensure the right to be supplied for wholesalers in order to meet patient demand and to ensure a competitive internal market;

Or. en

Amendment 602 Carlo Calenda

Motion for a resolution Paragraph 19 a (new)

Motion for a resolution Amendment

19a. Points out that the underlying causes of medicine shortages should be tackled and assessed in the light of the lack of a European industrial policy and that the links between the supply chain and production challenges should be addressed as a matter of urgency with a view to guaranteeing the independence of European pharmaceutical production;

Or. it

Amendment 603

AM\1233943EN.docx 299/362 PE693.845v01-00 EN Kateřina Konečná

Motion for a resolution Paragraph 19 a (new)

Motion for a resolution Amendment

19 a. Urges the Commission to address transparency in the entire pharmaceutical system, including transparency of the costs of developing new therapies, transparency of clinical trials, and transparency of the decision-making process and criteria to patients and citizens;

Or. en

Amendment 604 Jessica Polfjärd

Motion for a resolution Paragraph 19 a (new)

Motion for a resolution Amendment

19 a. Invites the Commission to evaluate which medicinal products have to go through a mandatory centralized approval at EMA in order to ensure a safe and efficient approval procedure for the most innovative and complex medicinal products, including nanomedicines;

Or. en

Amendment 605 Alexander Bernhuber

Motion for a resolution Paragraph 19 a (new)

Motion for a resolution Amendment

19 a. Calls on the Commission to ensure a reliable and independent supply of

PE693.845v01-00 300/362 AM\1233943EN.docx EN medicines for European citizens and urges to strengthen the production of medicines and medical products within the EU;

Or. en

Amendment 606 Tilly Metz

Motion for a resolution Paragraph 19 a (new)

Motion for a resolution Amendment

19 a. Calls on the Commission to ensure that the revision of the general pharmaceutical legislation builds on a good understanding of the root causes of medicine shortages;

Or. en

Amendment 607 Tilly Metz

Motion for a resolution Paragraph 19 b (new)

Motion for a resolution Amendment

19 b. Stresses the need for the publication of concrete and legally binding shortage management and prevention plans as part of the medicine supply obligations of marketing authorisation holders based on an analysis of the manufacturing and distribution risks, including minimum stock levels, measures allowing for the diversification of raw materials supply sources, and the development of other manufacturing sites when necessary;

Or. en

AM\1233943EN.docx 301/362 PE693.845v01-00 EN Amendment 608 Nathalie Colin-Oesterlé

Motion for a resolution Paragraph 19 b (new)

Motion for a resolution Amendment

19b. Calls on the Commission and the Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management; takes the view that the EMA is the body best suited to be designated as the regulatory authority tasked with preventing shortages of medicines at EU level during emergencies and beyond;

Or. fr

Amendment 609 Tilly Metz

Motion for a resolution Paragraph 19 c (new)

Motion for a resolution Amendment

19 c. Urges the Commission to address medicine shortages specifically aimed at women such as female hormonal medicines used for contraception and hormone replacement therapy (HRT); stresses the importance to take into account the threats posed by such shortages to women’s and girls’ sexual and reproductive health and rights, particularly among those most vulnerable such as older women or transgender women; highlights the importance of enhancing the control and management of the manufacturing, stockpiling and marketing of those medicines to ensure continuity in supply chains, fair pricing and availability;

PE693.845v01-00 302/362 AM\1233943EN.docx EN Or. en

Amendment 610 Nathalie Colin-Oesterlé

Motion for a resolution Paragraph 19 c (new)

Motion for a resolution Amendment

19c. Calls on the Commission to set up an innovative, user-friendly, transparent and centralised digital platform for reporting and notifying information provided by national agencies and all stakeholders regarding available stocks and shortages of medicines and medical equipment; calls for existing information systems to be evaluated and improved so as to provide a clear overview of difficulties, shortages and requirements in each Member State to prevent overstocking;

Or. fr

Amendment 611 Kateřina Konečná

Motion for a resolution Paragraph 20

Motion for a resolution Amendment

20. Supports the Commission in its 20. Supports the Commission in its efforts to conduct a structured dialogue efforts to conduct a structured dialogue with players in the pharmaceutical value with players in the pharmaceutical value chain, public authorities, non-governmental chain, public authorities, non-governmental patient and health organisations and the patient and health organisations and the research community to address weaknesses research community to address weaknesses in the global medicines manufacturing and in the global medicines manufacturing and supply chain; supply chain; stresses the need to discuss key health policies directly with representatives of patient organisations, health service providers, industry, regulators and other key stakeholders, on

AM\1233943EN.docx 303/362 PE693.845v01-00 EN the basis of the High-Level Forum format, which has proven successful in coordinating joint action against COVID- 19;

Or. cs

Amendment 612 César Luena, Javi López, Nicolás González Casares

Motion for a resolution Paragraph 20

Motion for a resolution Amendment

20. Supports the Commission in its 20. Supports the Commission in its efforts to conduct a structured dialogue efforts to conduct a structured dialogue with players in the pharmaceutical value with players in the pharmaceutical value chain, public authorities, non-governmental chain, public authorities, non-governmental patient and health organisations and the patient and health organisations and the research community to address weaknesses research community to address weaknesses in the global medicines manufacturing and in the global medicines manufacturing and supply chain; supply chain; believes that in addition to the structured dialogue on manufacturing and supply chain, a wider political high level pharmaceutical forum is also needed, including the involvement of policymakers, regulators, payers, industry representatives and patients organizations, among others;

Or. en

Amendment 613 Tilly Metz

Motion for a resolution Paragraph 20

Motion for a resolution Amendment

20. Supports the Commission in its 20. Considers it essential to improve efforts to conduct a structured dialogue early communication with healthcare with players in the pharmaceutical value professionals and patients on the chain, public authorities, non-governmental availability of medicines; supports the patient and health organisations and the Commission in its efforts to conduct a

PE693.845v01-00 304/362 AM\1233943EN.docx EN research community to address weaknesses transparent and inclusive structured in the global medicines manufacturing and dialogue with players in the pharmaceutical supply chain; value chain, public authorities, healthcare professionals, non-governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain; calls on the Commission to ensure a balanced representation of stakeholders;

Or. en

Amendment 614 Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 20

Motion for a resolution Amendment

20. Supports the Commission in its 20. Supports the Commission in its efforts to conduct a structured dialogue efforts to achieve a public disclosure, in with players in the pharmaceutical value accordance to Good Clinical Practices, chain, public authorities, non-governmental through a structured dialogue with players patient and health organisations and the in the pharmaceutical value chain, public research community to address weaknesses authorities, non-governmental patient and in the global medicines manufacturing and health organisations and the research supply chain; community, with the aim of protecting the dignity of human beings involved in clinical trials and to address weaknesses in the global medicines manufacturing and supply chain;

Or. en

Amendment 615 Marlene Mortler

Motion for a resolution Paragraph 20

Motion for a resolution Amendment

20. Supports the Commission in its 20. Supports the Commission in its

AM\1233943EN.docx 305/362 PE693.845v01-00 EN efforts to conduct a structured dialogue efforts to conduct a structured dialogue with players in the pharmaceutical value with players in the pharmaceutical value chain, public authorities, non-governmental chain, public authorities, non-governmental patient and health organisations and the patient and health organisations and the research community to address weaknesses research community to address weaknesses in the global medicines manufacturing and in the global medicines manufacturing and supply chain; supply chain; emphasises that actions such as dual sourcing and safety stocks mitigate upcoming risks, increase resilience and the security of supply;

Or. en

Amendment 616 Alessandra Moretti

Motion for a resolution Paragraph 20

Motion for a resolution Amendment

20. Supports the Commission in its 20. Notes the efforts of the efforts to conduct a structured dialogue Commission to conduct a structured with players in the pharmaceutical value dialogue with players in the pharmaceutical chain, public authorities, non-governmental value chain, public authorities, non- patient and health organisations and the governmental patient and health research community to address weaknesses organisations and the research community in the global medicines manufacturing and as one of the tool to explore weaknesses supply chain; and deficiencies in the global medicines manufacturing and supply chain; calls on the Commission to ensure a balanced representation of stakeholders;

Or. en

Amendment 617 Kateřina Konečná

Motion for a resolution Paragraph 20

Motion for a resolution Amendment

20. Supports the Commission in its 20. Supports the Commission in its efforts to conduct a structured dialogue efforts to conduct a structured dialogue with players in the pharmaceutical value with players in the pharmaceutical value

PE693.845v01-00 306/362 AM\1233943EN.docx EN chain, public authorities, non-governmental chain, public authorities, non-governmental patient and health organisations and the patient and health organisations and the research community to address weaknesses research community to address weaknesses in the global medicines manufacturing and in the global medicines manufacturing and supply chain; supply chain; calls on the Commission to ensure a balanced representation of stakeholders;

Or. en

Amendment 618 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Stelios Kympouropoulos, Cindy Franssen, Inese Vaidere, Roberta Metsola

Motion for a resolution Paragraph 20

Motion for a resolution Amendment

20. Supports the Commission in its 20. Supports the Commission in its efforts to conduct a structured dialogue efforts to conduct a structured dialogue with players in the pharmaceutical value with players in the pharmaceutical value chain, public authorities, non-governmental chain, public authorities, non-governmental patient and health organisations and the patient and health organisations and the research community to address weaknesses research community to address the root in the global medicines manufacturing and causes of shortages of medicines and the supply chain; weaknesses in the global medicines manufacturing and supply chain;

Or. en

Amendment 619 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez, Emma Wiesner

Motion for a resolution Paragraph 20

Motion for a resolution Amendment

20. Supports the Commission in its 20. Supports the Commission in its efforts to conduct a structured dialogue efforts to conduct a structured dialogue with players in the pharmaceutical value with players in the pharmaceutical value chain, public authorities, non-governmental chain, public authorities, non-governmental patient and health organisations and the patient and health organisations and the research community to address weaknesses research community to address weaknesses

AM\1233943EN.docx 307/362 PE693.845v01-00 EN in the global medicines manufacturing and and identify opportunities for innovation supply chain; in the global medicines manufacturing and supply chain;

Or. en

Amendment 620 Tiemo Wölken

Motion for a resolution Paragraph 20

Motion for a resolution Amendment

20. Supports the Commission in its 20. Supports the Commission in its efforts to conduct a structured dialogue efforts to conduct a structured dialogue with players in the pharmaceutical value with players in the pharmaceutical value chain, public authorities, non-governmental chain, public authorities, non-governmental patient and health organisations and the patient and health organisations, research community to address weaknesses pharmacists and the research community in the global medicines manufacturing and to address weaknesses in the global supply chain; medicines manufacturing and supply chain;

Or. en

Amendment 621 Andrey Slabakov, Joanna Kopcińska, Pietro Fiocchi, Ryszard Antoni Legutko, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 20

Motion for a resolution Amendment

20. Supports the Commission in its 20. Supports the Commission in its efforts to conduct a structured dialogue efforts to conduct a structured dialogue with players in the pharmaceutical value with relevant actors in the pharmaceutical chain, public authorities, non-governmental value chain, public authorities, non- patient and health organisations and the governmental patient and health research community to address weaknesses organisations and the research community in the global medicines manufacturing and to address weaknesses in the global supply chain; medicines manufacturing and supply chain;

Or. en

PE693.845v01-00 308/362 AM\1233943EN.docx EN Amendment 622 Pietro Fiocchi

Motion for a resolution Paragraph 20 a (new)

Motion for a resolution Amendment

20 a. Call on the Commission, in the context of the medicines manufacturing structured dialogue, to propose reforms and incentives to stimulate investments in medicines manufacturing and resilience of the pharmaceutical supply chain by introducing market reforms that make markets sustainable via smart procurement to reduce industrial consolidation pressure and create a level playing field, including digital transformation of the regulatory system that would maintain high EU scientific standards while dramatically reducing administrative burdens and vastly improving the EU crisis response to shortages as well as to stimulate investments in manufacturing technology (greening, digital, process technology, automation) that are needed to enable EU manufacturers to upgrade their technology to compete and to meet societal expectations for security, value added innovation and the environment;

Or. en

Amendment 623 Maria Spyraki

Motion for a resolution Paragraph 20 a (new)

Motion for a resolution Amendment

20 a. Call on the Commission, in the context of the medicines manufacturing structured dialogue, to propose reforms and incentives to stimulate investments in medicines manufacturing and resilience

AM\1233943EN.docx 309/362 PE693.845v01-00 EN of the pharmaceutical supply chain by introducing market reforms that make markets sustainable via smart procurement to reduce industrial consolidation pressure and create a level playing field, including digital transformation of the regulatory system that would maintain high EU scientific standards while dramatically reducing administrative burdens and vastly improve the EU crisis response to shortages as well as to stimulate investments in manufacturing technology (greening, digital, process technology, automation) that are needed to enable EU manufacturers to upgrade their technology to compete and to meet societal expectations for security, value added innovation and the environment;

Or. en

Amendment 624 Aldo Patriciello

Motion for a resolution Paragraph 20 a (new)

Motion for a resolution Amendment

20 a. Welcomes the reference in the strategy to the fact that actions in the area of public procurement can foster competition and improve access. In this context, urges the Commission to consider the importance of diversified supplies and sustainable procurement practices for pharmaceuticals, notably with multi- winners tender, and, in the context of the EU public procurement Directive 2014/24/EU, to promptly propose ad-hoc guidance for Member States to support sustainable tenders practices for pharmaceuticals, where tender practices are used, notably on how to best implement the MEAT (Most Economic Advantageous Criteria) criteria, looking beyond the lowest price criteria only and

PE693.845v01-00 310/362 AM\1233943EN.docx EN rewarding quality and security of supply, as well as environmental and social investments in manufacturing;

Or. en

Amendment 625 Carlo Calenda

Motion for a resolution Paragraph 20 a (new)

Motion for a resolution Amendment

20a. Welcomes the establishment of structured dialogue on production and the supply chain with the actors in the pharmaceutical value chain and the public authorities with a view to identifying the weak points in the global supply chain for critical medicines, raw materials and active ingredients; in that connection, urges the Commission, the Member States and stakeholders to draw up a clear and ambitious political roadmap of economic, legislative and industrial measures designed to safeguard and modernise medicine production capacity and stimulate investment in security of supply and improved production;

Or. it

Amendment 626 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 20 a (new)

Motion for a resolution Amendment

20 a. Encourages the development of shortage prevention and management plans across all Member States; believes that these plans could result from an

AM\1233943EN.docx 311/362 PE693.845v01-00 EN analysis of manufacturing and distribution risks and include measures on building up stocks of medicinal products of major therapeutic interest , diversifying sources of supply for raw materials and creating other manufacturing sites to ensure resilience from production; underlines that several Member States have already established alert systems which facilitate the anticipation and prevention of shortages; calls for the establishment of alert systems to anticipate shortage of medicines at national and European levels;

Or. en

Amendment 627 Jan Huitema

Motion for a resolution Paragraph 20 a (new)

Motion for a resolution Amendment

20 a. Welcomes the strong focus and several initiatives included in the pharmaceuticals strategy on the need to optimise and modernise the existing regulatory framework; urges the Commission to make the best use of existing digital tools at EU level; stresses the need to prioritise a structured dialogue on the manufacturing, the supply chain and the security of supply of Active Pharmaceutical Ingredients (APIs), raw pharmaceutical materials and intermediates; underlines the need to bring all relevant stakeholders together to define a policy roadmap to tackle medicine shortages by enhancing the manufacturing resilience within the European Union;

Or. en

PE693.845v01-00 312/362 AM\1233943EN.docx EN Amendment 628 Nathalie Colin-Oesterlé

Motion for a resolution Paragraph 20 a (new)

Motion for a resolution Amendment

20a. Welcomes the introduction of a structured dialogue with all stakeholders to identify weak links in the global supply chain for critical medicines, pharmaceutical raw materials, intermediate products and active pharmaceutical ingredients; with that in mind, urges the Commission, the Member States and stakeholders to draw up, as soon as possible, a clear and ambitious policy roadmap to secure and modernise Europe’s existing manufacturing capacity for medicines, technology and active pharmaceutical ingredients;

Or. fr

Amendment 629 Kateřina Konečná

Motion for a resolution Paragraph 20 a (new)

Motion for a resolution Amendment

20 a. Calls on the Commission to recognise patients as the end-users of medicines and thus an essential stakeholder group in the assessment of the value of new medicines; calls for investment in frameworks, structures and methodologies for meaningfully incorporating patients in setting research priorities, regulatory and Health Technology Assessment, and pricing and reimbursement decision-making;

Or. en

AM\1233943EN.docx 313/362 PE693.845v01-00 EN Amendment 630 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Susana Solís Pérez, Emma Wiesner

Motion for a resolution Paragraph 20 a (new)

Motion for a resolution Amendment

20 a. Considers it important that the Internal Market for medicines is safeguarded and that unjustified import and export restrictions, that can cause harm to the internal market and decrease affordability, should be avoided and addressed by the Commission if they occur;

Or. en

Amendment 631 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 20 a (new)

Motion for a resolution Amendment

20a. Stresses that flexibility in pharmaceutical regulations to meet the challenges of COVID-19 should be extended to unmet needs through more streamlined and less bureaucratic procedures, while maintaining all guarantees of safety and quality.

Or. es

Amendment 632 Marlene Mortler

Motion for a resolution Paragraph 20 a (new)

Motion for a resolution Amendment

PE693.845v01-00 314/362 AM\1233943EN.docx EN 20 a. Recalls that localization policies may have adverse effects on the access to medicines; stresses that global networks and supply chains lower the dependency on one specific country or continent, which acts as an additional resilience factor;

Or. en

Amendment 633 Kateřina Konečná

Motion for a resolution Paragraph 20 b (new)

Motion for a resolution Amendment

20 b. The EU should aim to create a framework for fair and equitable access that can maximise societal benefit and patient access whilst avoiding unacceptable impact on healthcare budgets, encompassing at least the following elements: - closer collaboration by Member States on price negotiations and scaling-up of pilots on early dialogues; - closer collaboration by Member States on price negotiations and scaling-up of pilots on early dialogues; - adoption of common principles and mechanisms for encouraging and rewarding innovation in order to encourage continued investment in R&D, based on the evaluation of the current EU IP and incentives legal framework; - exploration of innovative models for incentivising research & development especially in areas of high unmet need; - exploration of the potential of optimal use of mechanisms such as adaptive pathways, managed entry agreements and others for optimising access and determination of value;

AM\1233943EN.docx 315/362 PE693.845v01-00 EN - exploration of differential pricing mechanisms, barriers and potential solutions to dealing with practical issues such as parallel trade; - common EU principles for calculating a fair price, taking into account the specifics of each Member State;

Or. en

Amendment 634 Pietro Fiocchi

Motion for a resolution Paragraph 20 b (new)

Motion for a resolution Amendment

20 b. Recalls the role of sustainable procurement practices in preventing medicines shortages and that, as recognised in the EU industrial strategy, public procurement can lead to market consolidation and increases the risk of shortages; calls on the Commission to support Member States in the prevention of shortages by developing EU rules on procurement of medicines, under the current public procurement directive, aimed at ensuring long-term sustainability, competition, security of supply and stimulating investments in manufacturing; considers that these targeted guidelines should cover clarifications and recommendations to Member States on how to implement multi-winner framework agreements, apply Most Economically Advantageous Tender (MEAT) criteria, recognise investments in security of supply for Europe, ensure timely procurement processes to ensure the plurality of manufacturers and competition of multi- source medicines as soon as they are available;

Or. en

PE693.845v01-00 316/362 AM\1233943EN.docx EN Amendment 635 Jan Huitema

Motion for a resolution Paragraph 20 b (new)

Motion for a resolution Amendment

20 b. W Welcomes the reference in the pharmaceutical strategy that actions in the area of public procurement can foster competition and improve access; emphasises the importance of diversified supplies and sustainable procurement practices for pharmaceuticals; urges the Commission, in the context of Directive2014/24/EU, to swiftly propose guidelines for the Member States on the implementation of the most economically advantageous tender (MEAT) criteria, looking beyond the lowest price criteria only; proposes that investments in the manufacturing of Active Pharmaceutical Ingredients (APIs) and medicinal end products in the EU should be considered, as well as the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards;

Or. en

Amendment 636 Carlo Calenda

Motion for a resolution Paragraph 20 b (new)

Motion for a resolution Amendment

20b. Urges the Commission, in the context of Directive 2014/24/EU on public procurement, to put forward guidelines for the Member States which are designed in particular to steer contracting authorities towards applying the award

AM\1233943EN.docx 317/362 PE693.845v01-00 EN criterion of the most economically advantageous tender rather than that of the lowest price; takes the view that investment in the production of active ingredients and medicinal products in the European Union, security of supply, the reinvestment of profits in research and development and the application of social, environmental, ethical and quality standards should be taken into account in assessing bids;

Or. it

Amendment 637 Marlene Mortler

Motion for a resolution Paragraph 20 b (new)

Motion for a resolution Amendment

20 b. Calls on the Commission to draft a harmonized definition of “shortages” and to standardize reporting requirements across Member States in order to enable closer cooperation and enhanced data exchange across Europe;

Or. en

Amendment 638 Marlene Mortler

Motion for a resolution Paragraph 20 c (new)

Motion for a resolution Amendment

20 c. Calls on the Commission to audit the level of prevention, preparedness and response planning within the Member States; considers it imperative to consult with relevant stakeholders from the pharmaceutical and health sectors;

PE693.845v01-00 318/362 AM\1233943EN.docx EN Or. en

Amendment 639 Marlene Mortler

Motion for a resolution Paragraph 20 d (new)

Motion for a resolution Amendment

20 d. Considers it imperative to ensure a joint approach and procurement for safety stocks in each Member State; stresses that national stockpiles and capacities of critical medical products as well as of diagnostic services and tools and safety equipment contribute to the security of supply on Union level;

Or. en

Amendment 640 Kateřina Konečná

Motion for a resolution Paragraph 21

Motion for a resolution Amendment

21. Calls on the Commission to 21. Calls on the Commission to facilitate agreements between the EMA facilitate agreements between the EMA and non-EU regulatory agencies on and non-EU regulatory agencies on preventing emergencies and coordinating preventing emergencies and coordinating responses to them; encourages the responses to them; encourages the Commission to work with World Trade Commission to work with World Trade Organization members to facilitate trade in Organization members to facilitate trade in health products, increase resilience in health products, increase resilience in global supply chains through stable access global supply chains through stable access to raw materials, and contribute to an to raw materials, and contribute to an effective response in the event of a health effective response in the event of a health emergency; emergency; calls on the Commission to promote the use of TRIPS flexibilities to improve access to medicines and to support that Member States can import medicines produced under a compulsory license by reversing their opt-out of

AM\1233943EN.docx 319/362 PE693.845v01-00 EN Article 31bis of the TRIPs agreement;

Or. en

Amendment 641 Alessandra Moretti

Motion for a resolution Paragraph 21

Motion for a resolution Amendment

21. Calls on the Commission to 21. Calls on the Commission to facilitate agreements between the EMA facilitate agreements between the EMA and non-EU regulatory agencies on and non-EU regulatory agencies on preventing emergencies and coordinating preventing emergencies and coordinating responses to them; encourages the responses to them; encourages the Commission to work with World Trade Commission to work with World Trade Organization members to facilitate trade in Organization members to facilitate trade in health products, increase resilience in health products, increase resilience in global supply chains through stable access global supply chains through stable access to raw materials, and contribute to an to raw materials, and contribute to an effective response in the event of a health effective response in the event of a health emergency; emergency; calls on the Commission to promote the use of TRIPS flexibilities to improve access to medicines and to support that Member States can import medicines produced under a compulsory license by reversing their opt-out of Article 31bis of the TRIPs agreement;

Or. en

Amendment 642 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 21

Motion for a resolution Amendment

21. Calls on the Commission to 21. Calls on the Commission to facilitate agreements between the EMA facilitate agreements between the EMA and non-EU regulatory agencies on and non-EU regulatory agencies on preventing emergencies and coordinating preventing emergencies and coordinating responses to them; encourages the responses to them, while adhering to the

PE693.845v01-00 320/362 AM\1233943EN.docx EN Commission to work with World Trade high EU standards for personal data Organization members to facilitate trade in protection; encourages the Commission to health products, increase resilience in work with World Trade Organization global supply chains through stable access members to facilitate trade in health to raw materials, and contribute to an products, increase resilience in global effective response in the event of a health supply chains through stable access to raw emergency; materials, and to ensure the creation of minimum necessary stocks for both raw materials and medical equipment, and contribute to an effective response in the event of a health emergency;

Or. en

Amendment 643 Nicolás González Casares

Motion for a resolution Paragraph 21

Motion for a resolution Amendment

21. Calls on the Commission to 21. Calls on the Commission to facilitate agreements between the EMA facilitate agreements between the EMA and non-EU regulatory agencies on and non-EU regulatory agencies on preventing emergencies and coordinating preventing emergencies and coordinating responses to them; encourages the responses to them; encourages the Commission to work with World Trade Commission to work with World Trade Organization members to facilitate trade in Organization members to facilitate trade in health products, increase resilience in health products, increase resilience in global supply chains through stable access global supply chains through stable access to raw materials, and contribute to an to raw materials, while developing a effective response in the event of a health strategic autonomy in Europe for certain emergency; essential raw materials, and contribute to an effective response in the event of a health emergency;

Or. en

Amendment 644 Petar Vitanov

Motion for a resolution Paragraph 21

AM\1233943EN.docx 321/362 PE693.845v01-00 EN Motion for a resolution Amendment

21. Calls on the Commission to 21. Calls on the Commission to facilitate agreements between the EMA facilitate agreements between the EMA and non-EU regulatory agencies on and non-EU regulatory agencies on preventing emergencies and coordinating preventing emergencies and coordinating responses to them; encourages the responses to them, in full respect of the Commission to work with World Trade highest EU standards for personal data Organization members to facilitate trade in protection; encourages the Commission to health products, increase resilience in work with World Trade Organization global supply chains through stable access members to facilitate trade in health to raw materials, and contribute to an products, increase resilience in global effective response in the event of a health supply chains through stable access to raw emergency; materials, and contribute to an effective response in the event of a health emergency;

Or. en

Amendment 645 Maria Spyraki

Motion for a resolution Paragraph 21 a (new)

Motion for a resolution Amendment

21 a. Recalls the role of sustainable procurement practices in preventing medicines shortage and that, as recognised in the EU industrial strategy public procurement can lead to market consolidation and increases the risk of shortages; calls on the Commission to support Member States in the prevention of shortages by developing EU rules on procurement of medicines, under the current public procurement directive, aimed at ensuring long-term sustainability, competition, security of supply and stimulating investments in manufacturing; considers that these targeted guidelines should cover clarifications and recommendations to Member States on how to implement multi-winner framework agreements, apply Most Economically Advantageous Tender (MEAT) criteria, recognise

PE693.845v01-00 322/362 AM\1233943EN.docx EN investments in security of supply for Europe, ensure timely procurement processes to ensure the plurality of manufacturers and competition of multi- source medicines as soon as they are available;

Or. en

Amendment 646 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Frédérique Ries, Susana Solís Pérez

Motion for a resolution Paragraph 21 a (new)

Motion for a resolution Amendment

21 a. Welcomes HERA as a permanent structure that should help facilitate agile and quick decision-making, response and action for future European health crises; stresses that public-private partnerships are a key element in this regard; calls on HERA to facilitate a structured dialogue with industry with the aim of identifying vulnerabilities in the global supply chain of critical medicines and raw materials;

Or. en

Amendment 647 Kateřina Konečná

Motion for a resolution Paragraph 21 a (new)

Motion for a resolution Amendment

21 a. Calls on the Commission to ensure that the revision of the general pharmaceutical legislation builds on a good understanding of the root causes of medicine shortages; stresses the need to put the focus on preventative measures such as the diversification of supply

AM\1233943EN.docx 323/362 PE693.845v01-00 EN chains; calls for obliging medicine manufacturers to submit shortage prevention and management plans to the EMA and national authorities;

Or. en

Amendment 648 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 21 a (new)

Motion for a resolution Amendment

21 a. Supports the broadened mandate of the EMA and its new responsibilities; calls for the centralisation of scientific advice procedures, thereby strengthening the EMA's capacity in the field of medical technologies; reiterates that the approval process must respond in an appropriate and timely manner to the needs of patients and the pharmaceutical industry.

Or. es

Amendment 649 Andrey Slabakov, Joanna Kopcińska, Pietro Fiocchi, Ryszard Antoni Legutko, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 21 a (new)

Motion for a resolution Amendment

21 a. Insists that the quality of raw material imports for the pharmaceutical industry from outside the EU must be ensured at all times; calls on the Commission and on Member States to improve quality control and introduce penalties for repeat offenders;

Or. en

PE693.845v01-00 324/362 AM\1233943EN.docx EN Amendment 650 Alessandra Moretti

Motion for a resolution Paragraph 21 a (new)

Motion for a resolution Amendment

21 a. Calls on the Commission to evaluate the TRIPS+ commitments in EU trade agreements in light of the lessons learned from the covid-19 pandemic, and to increase the effective use of intellectual property rights flexibilities;

Or. en

Amendment 651 Alessandra Moretti

Motion for a resolution Paragraph 21 b (new)

Motion for a resolution Amendment

21 b. Calls on the Commission to ensure that the revision of the general pharmaceutical legislation builds on a good understanding of the root causes of medicine shortages; stresses the need to put the focus on preventative measures such as the diversification of supply chains; calls for the implementation of binding shortage prevention and management risk plans address to EMA and national authorities to be made mandatory for MAHs and wholesale distributors;

Or. en

Amendment 652 Alessandra Moretti

AM\1233943EN.docx 325/362 PE693.845v01-00 EN Motion for a resolution Paragraph 21 c (new)

Motion for a resolution Amendment

21 c. Calls on the Commission to take stock of the lessons learnt with the negotiations around COVID-19 vaccines and facilitate clear contracts between the EMA and industry on preventing and managing pharmaceutical supply chain disruptions; stresses that contracts should come with conditionalities and sanctions should a stakeholder not fulfil its commitments;

Or. en

Amendment 653 Aldo Patriciello

Motion for a resolution Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for an pharmaceutical industry to be environmentally-friendly and climate- environmentally friendly and climate- neutral pharmaceutical industry neutral throughout the life cycles of throughout the life cycle of the medicinal medicinal products; calls on the product and ensure that no action taken Commission to strengthen inspection and jeopardises access to safe and effective auditing throughout the production pharmaceutical treatments for human chain; urges the Commission to ensure patients; calls on the Commission to quality environmental sustainability develop with industry global standards for active pharmaceutical manufacturing frameworks for ingredients imported from non-EU environmental protection in medicines countries; calls on the Commission to manufacturing; urges the Commission to address the problem of domestic ensure quality and environmental pharmaceutical waste, with measures to sustainability framework for active reduce packaging and the size of pharmaceutical ingredients imported from containers to ensure they are no larger third countries; calls on the Commission to than necessary, and to bring medical address the problem of domestic prescriptions into line with real pharmaceutical waste, with incentives to therapeutic needs; optimise packaging, as well as to facilitate medicines movement to mitigate shortages if they occur; Call on the Commission to take into account existing and self-

PE693.845v01-00 326/362 AM\1233943EN.docx EN regulated initiatives as models in future EU initiatives on pharmaceuticals in the environment, which shall be proportionate and based on scientific evidence;

Or. en

Amendment 654 Pietro Fiocchi

Motion for a resolution Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for an pharmaceutical industry to be environmentally-friendly and climate- environmentally friendly and climate- neutral pharmaceutical industry neutral throughout the life cycles of throughout the life cycle of the medicinal medicinal products; calls on the product and to ensure that no action Commission to strengthen inspection and taken jeopardises access to safe and auditing throughout the production effective pharmaceutical treatments for chain; urges the Commission to ensure human patients; calls on the Commission quality environmental sustainability to develop, with industry, global standards for active pharmaceutical manufacturing frameworks for ingredients imported from non-EU environmental protection in medicines countries; calls on the Commission to manufacturing; urges the Commission to address the problem of domestic ensure a quality and environmental pharmaceutical waste, with measures to sustainable framework for active reduce packaging and the size of pharmaceutical ingredients imported from containers to ensure they are no larger third countries; calls on the Commission to than necessary, and to bring medical address the problem of domestic prescriptions into line with real pharmaceutical waste, with incentives to therapeutic needs; optimise packaging, also to facilitate medicines movement to mitigate shortages if they occur; calls on the Commission to take into account existing and self- regulated initiatives as models in future EU initiatives on pharmaceuticals in the environment, as well as to be based on scientific evidence;

Or. en

Amendment 655

AM\1233943EN.docx 327/362 PE693.845v01-00 EN Simona Baldassarre, Silvia Sardone, Joëlle Mélin, Aurélia Beigneux, Gianantonio Da Re, Lucia Vuolo, Danilo Oscar Lancini, Susanna Ceccardi

Motion for a resolution Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for the pharmaceutical industry to be pharmaceutical industry to be environmentally friendly and climate- environmentally friendly and climate- neutral throughout the life cycles of neutral throughout the life cycles of medicinal products; calls on the medicinal products; calls on the Commission to strengthen inspection and Commission to identify a system of auditing throughout the production incentives and funding for companies to chain; urges the Commission to ensure ensure the achievements of such quality environmental sustainability objectives; urges the Commission to ensure standards for active pharmaceutical quality environmental sustainability ingredients imported from non-EU standards for active pharmaceutical countries; calls on the Commission to ingredients imported from non-EU address the problem of domestic countries; calls on the Commission to pharmaceutical waste, with measures to address the problem of domestic reduce packaging and the size of containers pharmaceutical waste, with measures to to ensure they are no larger than necessary, reduce packaging and the size of containers and to bring medical prescriptions into line to ensure they are no larger than necessary, with real therapeutic needs; highlighting the correlation between packaging and the prescribed treatment, and to bring medical prescriptions into line with real therapeutic needs;

Or. en

Amendment 656 Jan Huitema

Motion for a resolution Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for the pharmaceutical industry to be pharmaceutical industry to be environmentally friendly and climate- environmentally friendly and climate- neutral throughout the life cycles of neutral throughout the life cycles of medicinal products; calls on the medicinal products and the insurance of Commission to strengthen inspection and access to safe and effective auditing throughout the production pharmaceutical treatments for patients; chain; urges the Commission to ensure calls on the Commission to develop a

PE693.845v01-00 328/362 AM\1233943EN.docx EN quality environmental sustainability framework for environmental protection standards for active pharmaceutical while manufacturing medicines; urges the ingredients imported from non-EU Commission to ensure high-quality, safe countries; calls on the Commission to and environmental sustainable standards address the problem of domestic for active pharmaceutical ingredients pharmaceutical waste, with measures to imported from non-EU countries; calls on reduce packaging and the size of containers the Commission to address the problem of to ensure they are no larger than necessary, domestic pharmaceutical waste, with and to bring medical prescriptions into line measures to reduce packaging and the size with real therapeutic needs; of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs;

Or. en

Amendment 657 Anja Hazekamp

Motion for a resolution Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for the pharmaceutical industry to be pharmaceutical industry to be environmentally friendly and climate- environmentally friendly and climate- neutral throughout the life cycles of neutral throughout the life cycles of medicinal products; calls on the medicinal products; calls on the Commission to strengthen inspection and Commission to strengthen inspection and auditing throughout the production chain; auditing throughout the production chain; urges the Commission to ensure quality urges the Commission to ensure quality environmental sustainability standards for environmental sustainability standards for active pharmaceutical ingredients imported active pharmaceutical ingredients imported from non-EU countries; calls on the from non-EU countries; welcomes the Commission to address the problem of intention to revise the pharmaceuticals domestic pharmaceutical waste, with legislation; calls on the Commission to measures to reduce packaging and the size address the problem of domestic of containers to ensure they are no larger pharmaceutical waste, with measures to than necessary, and to bring medical reduce packaging and the size of containers prescriptions into line with real therapeutic to ensure they are no larger than necessary, needs; and to bring medical prescriptions into line with real therapeutic needs; commends the Commission's intention to consider advertising, marketing and prescription of pharmaceuticals having negative environmental impact; calls on the Commission to include an ERA that

AM\1233943EN.docx 329/362 PE693.845v01-00 EN assesses the impact of pharmaceutical substances, their degradation products and metabolites on the quality of surface and ground water bodies, including drinking water resources, in the risk- benefit analysis; urges the Commission to speed up the catch-up procedure for ERA of pharmaceuticals authorised before 2006;

Or. en

Amendment 658 Tilly Metz

Motion for a resolution Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for the pharmaceutical industry to be pharmaceutical industry to be environmentally friendly and climate- environmentally friendly and climate- neutral throughout the life cycles of neutral throughout the life cycles of medicinal products; calls on the medicinal products; calls on the Commission to strengthen inspection and Commission to heed the calls of the auditing throughout the production chain; European Parliament in its resolution of urges the Commission to ensure quality 17September 2020 on a strategic environmental sustainability standards for approach to pharmaceuticals in the active pharmaceutical ingredients imported environment, in particular to revise the from non-EU countries; calls on the pharmaceutical legislation to strengthen Commission to address the problem of the environmental risk assessment domestic pharmaceutical waste, with requirements and conditions of approval measures to reduce packaging and the size and use for medicines by including the of containers to ensure they are no larger environmental impacts of than necessary, and to bring medical pharmaceuticals in the benefit-risk prescriptions into line with real therapeutic assessment of human medicines; calls on needs; the Commission to strengthen inspection and auditing throughout the production chain; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary,

PE693.845v01-00 330/362 AM\1233943EN.docx EN and to bring medical prescriptions into line with real therapeutic needs;

Or. en

Amendment 659 Dolors Montserrat, Lídia Pereira, Radan Kanev, Bartosz Arłukowicz, Pernille Weiss, Cindy Franssen

Motion for a resolution Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for the pharmaceutical industry to be pharmaceutical industry to be environmentally friendly and climate- environmentally friendly and climate- neutral throughout the life cycles of neutral throughout the life cycles of medicinal products; calls on the medicinal products; calls on the Commission to strengthen inspection and Commission to strengthen inspection and auditing throughout the production chain; auditing throughout the production chain, urges the Commission to ensure quality particularly outside the EU; urges the environmental sustainability standards for Commission to ensure quality active pharmaceutical ingredients imported environmental sustainability standards for from non-EU countries; calls on the active pharmaceutical ingredients imported Commission to address the problem of from non-EU countries; calls on the domestic pharmaceutical waste, with Commission to address the problem of measures to reduce packaging and the size domestic pharmaceutical waste, with of containers to ensure they are no larger measures to reduce packaging and the size than necessary, and to bring medical of containers to ensure they are no larger prescriptions into line with real therapeutic than necessary, and to bring medical needs; prescriptions into line with real therapeutic needs; notes that the creation of electronic systems of information and identification of packaging would be an effective way to reduce it; acknowledges steps taken already by the pharmaceutical industry like, for example, the Eco-Pharmaco- Stewardship initiative;

Or. en

Amendment 660 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Susana Solís Pérez

Motion for a resolution

AM\1233943EN.docx 331/362 PE693.845v01-00 EN Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for the pharmaceutical industry to be pharmaceutical industry to be environmentally friendly and climate- environmentally friendly and climate- neutral throughout the life cycles of neutral throughout the life cycles and medicinal products; calls on the value chain of medicinal products; calls on Commission to strengthen inspection and the Commission to strengthen inspection auditing throughout the production chain; and auditing throughout the production urges the Commission to ensure quality chain; encourages the Commission to environmental sustainability standards for consider the potential of e-leaflets to active pharmaceutical ingredients imported reduce use of paper in packaging while from non-EU countries; calls on the also maintaining equal access to Commission to address the problem of important information; urges the domestic pharmaceutical waste, with Commission to ensure quality measures to reduce packaging and the size environmental sustainability standards for of containers to ensure they are no larger active pharmaceutical ingredients imported than necessary, and to bring medical from non-EU countries; calls on the prescriptions into line with real therapeutic Commission to address the problem of needs; domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, while ensuring convenient and safe handling for patients or consumers with limited mobility, and to bring medical prescriptions into line with real therapeutic needs;

Or. en

Amendment 661 Pietro Fiocchi

Motion for a resolution Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for the pharmaceutical industry to be pharmaceutical industry to be environmentally friendly and climate- environmentally friendly and climate- neutral throughout the life cycles of neutral throughout the life cycles of medicinal products; calls on the medicinal products; calls on the Commission to strengthen inspection and Commission to strengthen inspection and auditing throughout the production chain; auditing throughout the production chain, urges the Commission to ensure quality particularly outside the EU; urges the

PE693.845v01-00 332/362 AM\1233943EN.docx EN environmental sustainability standards for Commission to ensure quality active pharmaceutical ingredients imported environmental sustainability standards for from non-EU countries; calls on the active pharmaceutical ingredients imported Commission to address the problem of from non-EU countries; calls on the domestic pharmaceutical waste, with Commission to address the problem of measures to reduce packaging and the size domestic pharmaceutical waste, with of containers to ensure they are no larger measures to reduce packaging and the size than necessary, and to bring medical of containers to ensure they are no larger prescriptions into line with real therapeutic than necessary, and to bring medical needs; prescriptions into line with real therapeutic needs; notes that the creation of e-leaflets would be an effective way to reduce packaging; acknowledges steps taken already by the pharmaceutical industry to adopt and strengthen green practices, including for example the Eco-Pharmaco- Stewardship initiative;

Or. en

Amendment 662 Véronique Trillet-Lenoir

Motion for a resolution Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Considers that the European pharmaceutical industry to be Green Deal constitutes a major environmentally friendly and climate- opportunity to encourage pharmaceutical neutral throughout the life cycles of manufacturers to participate to the green medicinal products; calls on the recovery plan by producing in compliance Commission to strengthen inspection and with environmental and ecological auditing throughout the production chain; standards; Stresses the need for the urges the Commission to ensure quality pharmaceutical industry to be environmental sustainability standards for environmentally friendly and climate- active pharmaceutical ingredients imported neutral throughout the life cycles of from non-EU countries; calls on the medicinal products; calls on the Commission to address the problem of Commission to strengthen inspection and domestic pharmaceutical waste, with auditing throughout the production chain; measures to reduce packaging and the size urges the Commission to ensure quality of containers to ensure they are no larger environmental sustainability standards for than necessary, and to bring medical active pharmaceutical ingredients imported prescriptions into line with real therapeutic from non-EU countries; calls on the needs; Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size

AM\1233943EN.docx 333/362 PE693.845v01-00 EN of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs;

Or. en

Amendment 663 Tiemo Wölken

Motion for a resolution Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for the pharmaceutical industry to be pharmaceutical industry to be environmentally friendly and climate- environmentally friendly and climate- neutral throughout the life cycles of neutral throughout the life cycles of medicinal products; calls on the medicinal products; calls on the Commission to strengthen inspection and Commission to strengthen inspection and auditing throughout the production chain; auditing throughout the production chain, urges the Commission to ensure quality particularly outside the Union; urges the environmental sustainability standards for Commission to ensure quality active pharmaceutical ingredients imported environmental sustainability standards for from non-EU countries; calls on the active pharmaceutical ingredients imported Commission to address the problem of from non-EU countries; calls on the domestic pharmaceutical waste, with Commission to address the problem of measures to reduce packaging and the size domestic pharmaceutical waste, with of containers to ensure they are no larger measures to reduce packaging and the size than necessary, and to bring medical of containers to ensure they are no larger prescriptions into line with real therapeutic than necessary, and to bring medical needs; prescriptions into line with real therapeutic needs; notes that that eProduct information should be available as a complementary tool to the paper version;

Or. en

Amendment 664 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 22

PE693.845v01-00 334/362 AM\1233943EN.docx EN Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for the pharmaceutical industry to be pharmaceutical industry to be environmentally friendly and climate- environmentally friendly and climate- neutral throughout the life cycles of neutral throughout the life cycles of medicinal products; calls on the medicinal products; calls on the Commission to strengthen inspection and Commission to strengthen inspection and auditing throughout the production chain; auditing throughout the production chain, urges the Commission to ensure quality including outside the EU; urges the environmental sustainability standards for Commission to ensure quality active pharmaceutical ingredients imported environmental sustainability standards for from non-EU countries; calls on the active pharmaceutical ingredients imported Commission to address the problem of from non-EU countries; calls on the domestic pharmaceutical waste, with Commission to address the problem of measures to reduce packaging and the size domestic pharmaceutical waste, with of containers to ensure they are no larger measures specifically aimed at reducing than necessary, and to bring medical packaging and the size of containers to prescriptions into line with real therapeutic ensure they are not larger or more needs; intricately layered than necessary, thus helping to reduce price and waste, and to bring medical prescriptions into line with real therapeutic needs;

Or. en

Amendment 665 Pernille Weiss

Motion for a resolution Paragraph 22

Motion for a resolution Amendment

22. Stresses the need for the 22. Stresses the need for the pharmaceutical industry to be pharmaceutical industry to be environmentally friendly and climate- environmentally friendly and climate- neutral throughout the life cycles of neutral throughout the life cycles of medicinal products; calls on the medicinal products; calls on the Commission to strengthen inspection and Commission to strengthen inspection and auditing throughout the production chain; auditing throughout especially the part of urges the Commission to ensure quality the production chain located outside the environmental sustainability standards for EU; urges the Commission to ensure active pharmaceutical ingredients imported quality environmental sustainability from non-EU countries; calls on the standards for active pharmaceutical Commission to address the problem of ingredients imported from non-EU domestic pharmaceutical waste, with countries; calls on the Commission to measures to reduce packaging and the size address the problem of domestic

AM\1233943EN.docx 335/362 PE693.845v01-00 EN of containers to ensure they are no larger pharmaceutical waste, with measures to than necessary, and to bring medical reduce packaging and the size of containers prescriptions into line with real therapeutic to ensure they are no larger than necessary, needs; and to bring medical prescriptions into line with real therapeutic needs;

Or. en

Amendment 666 Anja Hazekamp

Motion for a resolution Paragraph 22 – point c (new)

Motion for a resolution Amendment

(c) Highlights the importance of faster, more ambitious and targeted action to eliminate the environmental risks posed by pharmaceuticals, including and based on research providing a better understanding of the impact of pharmaceuticals on human health, animal health and the environment;

Or. en

Amendment 667 Anja Hazekamp

Motion for a resolution Paragraph 22 – point a (new)

Motion for a resolution Amendment

(a) Recalls that information such as the impact of pharmaceuticals on water, environmental behaviour, degradability and potential cocktail effects, plays a key role in risk management and that this type of information should be transparant and made available to all relevant stakeholders; calls on the Commission and the relevant authorities to set up a secure, centralised database enabling all stakeholders concerned to have access to

PE693.845v01-00 336/362 AM\1233943EN.docx EN the results of environmental risk assessment;

Or. en

Amendment 668 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22 a. Welcomes the fact that the strategy recognises that better use of the electronic product information (ePI) will support the better delivery of the information for patients and support a wider availability of medicines; calls on the Commission to release an EU Implementation Roadmap for ePI with a defined timeline and suggested measures at EU and Member State level; urges the Commission to review the requirement of the pharmaceutical legislation(Article 58 of Directive 2001/83/EC1) to include a package leaflet (PL) in the packaging of all medicines or directly convey all information required (by Articles 59 and 62 of the Directive) on the outer or immediate packaging with a goal to completely replace PL with ePI;

Or. en

Amendment 669 Danilo Oscar Lancini, Simona Baldassarre

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22 a. Calls on the Commission, on top of the structured dialogue on manufacturing and supply chain, to set up a focused,

AM\1233943EN.docx 337/362 PE693.845v01-00 EN action oriented High Level Pharmaceutical Forum involving Ministers of Health and policy makers, regulators, payers, industry and other concerned stakeholders of the Healthcare supply chain; underlines that the key objective would be to share the learnings from the COVID19 situation and draw the conclusions to establish a pan European and effective policy framework to prevent shortages in the long term and ensuring a well-functioning, sustainable industry that continues to act as a catalyst to enable sustainable access to medicines for patients and innovation;

Or. en

Amendment 670 Stanislav Polčák

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22 a. Welcomes the Commission’s efforts to address the problem of pharmaceuticals in the environment; draws attention, in this connection, to the need to continue and to step up these efforts, in particular as regards investments in technologies providing more effective solutions for the removal of pharmaceuticals from waste water, the assessment of the environmental impact of veterinary medicines, the development of continuous monitoring and data sharing on potential significant sources of this type of pollution, and the improvement of the management of animal by-products containing pharmaceutical residues, such as antibiotics;

Or. cs

PE693.845v01-00 338/362 AM\1233943EN.docx EN Amendment 671 Aldo Patriciello

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22 a. Believes that in addition to the structured dialogue on manufacturing and supply chain, a wider political high level pharmaceutical forum is also needed, bringing together policymakers, regulators, payers, patient organizations, industry representatives and other relevant stakeholders in the healthcare supply chain in order to tackle other policy areas, such as prevent shortages, address pharmaceutical sustainability issues and ensure the competitiveness of the European pharmaceutical industry overall;

Or. en

Amendment 672 Linea Søgaard-Lidell, Jan Huitema, Asger Christensen, Nils Torvalds, Nicolae Ştefănuță, Susana Solís Pérez

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22 a. Stresses that for pharmaceutical waste should be handled in a safe and hygienic matter with regard to the objections and targets of the circular economy and to protect the environment; believes that the pharmaceutical industry should have the same requirements and standards on packaging and waste management as other sectors; calls on the Commission to create a uniform framework for packaging that takes into account user-friendliness and the circumstances for industry;

AM\1233943EN.docx 339/362 PE693.845v01-00 EN Or. en

Amendment 673 Stanislav Polčák

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22 a. Is of the opinion that environmental sustainability of medicinal products cannot be achieved without proper assessment of environmental effects associated with their production and use; asks the Commission to ensure that negative environmental effects of medicinal products, both existing and new, are duly assessed and taken into account during the authorisation procedure or post-authorisation monitoring;

Or. en

Amendment 674 Pernille Weiss

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22 a. Points out that residue of production, use and disposal of medicines can negatively affect ecosystems and water quality; calls on the Commission to assess the sufficiency of current requirements for environmental risk assessment and conditions of uses of medicines; urges the Commission to explore innovative digital solutions for monitoring and improving the efficiency of medicines consumption and quality;

Or. en

PE693.845v01-00 340/362 AM\1233943EN.docx EN Amendment 675 Tiemo Wölken

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22 a. Calls on the Commission to include the environmental impact of pharmaceuticals in the benefit-risk assessment of human medicines, as it is already the case for veterinary medicines, provided that marketing authorisation are not delayed nor refused solely on the grounds of adverse environmental impact;

Or. en

Amendment 676 Sara Cerdas

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22 a. Calls on the Commission to include the environmental impacts of pharmaceuticals in the benefit-risk assessment of human medicines, as is already the case for veterinary medicines, provided that marketing authorisations are not delayed nor refused solely on the grounds of adverse environmental impacts;

Or. en

Amendment 677 Jan Huitema

Motion for a resolution Paragraph 22 a (new)

AM\1233943EN.docx 341/362 PE693.845v01-00 EN Motion for a resolution Amendment

22 a. Urges the Commission, without further delays, to implement the electronic product information leaflet notice (ePi), made available in all languages for all the member states where the medicine is marketed in order to mitigate shortages and to attain a swifter implementation of the e-leaflet;

Or. en

Amendment 678 Nicolae Ştefănuță

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22 a. Calls on the Commission to speed up the catch-up procedure for environmental risk assessments of human medicines authorized before 2006 where they are not available;

Or. en

Amendment 679 Cyrus Engerer

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22 a. Calls on the Commission to develop clear guidance on the role of procurement policy in promoting greener pharmaceuticals;

Or. en

PE693.845v01-00 342/362 AM\1233943EN.docx EN Amendment 680 Stanislav Polčák

Motion for a resolution Paragraph 22 b (new)

Motion for a resolution Amendment

22 b. stresses that rational use of medicines and prevention of wastage are crucial in minimization of their negative environmental effects and can help to ensure that medicines are affordable and available for people who need them, especially from disadvantaged and vulnerable groups; asks the Commission to pay attention to the promotion of rational use of medicines, including by responsible prescribing, consumer awareness and technical measures such as reduction of pack sizes and their alignment to real use;

Or. en

Amendment 681 Jan Huitema

Motion for a resolution Paragraph 22 b (new)

Motion for a resolution Amendment

22 b. Calls on the Commission to set up a focused and action-oriented High Level Pharmaceutical Forum on Better Access to Health Innovation by bringing together multi-stakeholder solutions; Asks the Commission to share via this Forum lessons learned from the COVID-19 emergency situation and to establish an effective policy framework to prevent shortages in the long-term and enable access to medicines for patients and innovation;

Or. en

AM\1233943EN.docx 343/362 PE693.845v01-00 EN Amendment 682 Anja Hazekamp

Motion for a resolution Paragraph 22 – point b (new)

Motion for a resolution Amendment

(b) Calls on the Member States and the Commission to support research, development and innovation in the field of pharmaceuticals that are equally effective for patients as well as harmless to animal health and the environment, given that green pharmaceuticals are not toxic for the environment, do not bioaccumulate and degrade into harmless substances, particularly in wastewater treatment plants and the environment;

Or. en

Amendment 683 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 22 b (new)

Motion for a resolution Amendment

22 b. Highlights the fact that currently 40% of medicines marketed in the EU originate in non-EU countries, while 60 - 80% of active pharmaceutical ingredients are produced in China and India; stresses the urgent need to bring the pharmaceutical industry back to Europe and to stimulate new job growth inside the EU by establishing a minimal required percentage of the value chain to remain within the EU;

Or. en

PE693.845v01-00 344/362 AM\1233943EN.docx EN Amendment 684 Nicolae Ştefănuță

Motion for a resolution Paragraph 22 b (new)

Motion for a resolution Amendment

22 b. Calls on the Commission to update environmental risk assessment requirements of human medicine waste to ensure a proper assessment of persistent, bio-accumulative and toxic substances and of mixture effects, and to take into account the risk of antimicrobial resistance developing in the environment.

Or. en

Amendment 685 Pernille Weiss

Motion for a resolution Paragraph 22 b (new)

Motion for a resolution Amendment

22 b. Insists that the pharmaceutical strategy for Europe should consider the objectives of the Zero Pollution Action Plan for water, air and soil;

Or. en

Amendment 686 Cyrus Engerer

Motion for a resolution Paragraph 22 b (new)

Motion for a resolution Amendment

22 b. Supports the implementation of the ‘polluter pays principle’ to improve the responsibility of the pharmaceutical industry;

AM\1233943EN.docx 345/362 PE693.845v01-00 EN Or. en

Amendment 687 Tiemo Wölken

Motion for a resolution Paragraph 22 b (new)

Motion for a resolution Amendment

22 b. Calls on the Commission to develop clear guidance on the role of procurement policy in promoting greener pharmaceuticals;

Or. en

Amendment 688 Sara Cerdas

Motion for a resolution Paragraph 22 b (new)

Motion for a resolution Amendment

22 b. Calls on the Commission to develop clear guidance on the role of procurement policy in promoting greener pharmaceuticals;

Or. en

Amendment 689 Tiemo Wölken

Motion for a resolution Paragraph 22 c (new)

Motion for a resolution Amendment

22 c. Calls on the Commission to speed up the catch-up procedure for environmental risk assessment of human medicines that were authorized before

PE693.845v01-00 346/362 AM\1233943EN.docx EN 2006 where they are not available;

Or. en

Amendment 690 Sara Cerdas

Motion for a resolution Paragraph 22 c (new)

Motion for a resolution Amendment

22 c. Calls on the Commission to speed up the catch-up procedure for environmental risk assessments of human medicines authorised before 2006 where they are not available;

Or. en

Amendment 691 Nicolae Ştefănuță

Motion for a resolution Paragraph 22 c (new)

Motion for a resolution Amendment

22 c. Calls on the Commission to include environmental criteria in the Good Manufacturing Practice (GMP) framework;

Or. en

Amendment 692 Anja Hazekamp

Motion for a resolution Paragraph 22 – point a (new)

Motion for a resolution Amendment

(a) Calls on the Commission to

AM\1233943EN.docx 347/362 PE693.845v01-00 EN propose a targeted approach in a bid to drastically reduce the concentration of antibiotics and other plant treatment products in the soil; calls on the Commission to submit a programme for the monitoring of both pharmaceuticals and antibiotics in the soil;

Or. nl

Amendment 693 Sara Cerdas

Motion for a resolution Paragraph 22 d (new)

Motion for a resolution Amendment

22 d. Supports the implementation of the ‘polluter pays principle’ to improve the responsibility of the pharmaceutical industry;

Or. en

Amendment 694 Tiemo Wölken

Motion for a resolution Paragraph 22 d (new)

Motion for a resolution Amendment

22 d. Calls on the Commission to include compulsory environmental criteria in the Good Manufacturing practice (GMP) Framework;

Or. en

Amendment 695 Tiemo Wölken

Motion for a resolution

PE693.845v01-00 348/362 AM\1233943EN.docx EN Paragraph 22 e (new)

Motion for a resolution Amendment

22 e. Supports the "polluter pays principle" to improve the responsibility of the Pharmaceutical industry;

Or. en

Amendment 696 Tilly Metz

Motion for a resolution Subheading 4

Motion for a resolution Amendment

The EU is leading the world in healthcare Needs-driven and sustainable healthcare in the EU and the world

Or. en

Amendment 697 Anja Hazekamp

Motion for a resolution Paragraph 22 – point d (new)

Motion for a resolution Amendment

(d) Calls on the Commission to include pharmaceuticals that pose a risk to the environment in the list of priority substances under the Water Framework Directive and to set strict environmental quality standards and concentration limits under the Environmental Quality Standards (EOS) Directive;

Or. en

Amendment 698 Christine Schneider

AM\1233943EN.docx 349/362 PE693.845v01-00 EN Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22a. Calls on the Commission to secure supply chains and Europe's open strategic autonomy by diversifying supply chains for essential medicines and critical product components, focusing also on European production sites for the European pharmaceutical industry, which consists mostly of SMEs and MidCaps, by ensuring that public procurement rules take greater account of this objective and are more conducive to efforts to achieve it;

Or. de

Amendment 699 Anja Hazekamp

Motion for a resolution Paragraph 22 a (new)

Motion for a resolution Amendment

22a. Calls on the Commission to examine the contribution of the pharmaceutical sector to climate change through greenhouse gas emissions; calls for special attention to be paid to emission hot spots, such as hospitals, pharmaceutical plants and intensive stockbreeding areas;

Or. nl

Amendment 700 Pietro Fiocchi

Motion for a resolution Paragraph 23

PE693.845v01-00 350/362 AM\1233943EN.docx EN Motion for a resolution Amendment

23. Calls on the Commission to further 23. Calls on the Commission to seek a facilitate access to global markets for the better enabling environment for EU pharmaceutical industry, including innovation through stronger protection of small and medium-sized enterprises, intellectual property in the EU and in through a level playing field and a foreign markets; encourages the regulatory framework facilitating trade Commission to further facilitate access to agreements that prize innovation-based global markets for the EU pharmaceutical competitiveness, in order to make the industry, including small and medium- pharmaceutical sector a strategic pillar of sized enterprises, through a level playing the EU; field and a regulatory framework promoting the highest standards on quality and safety at international level, facilitating trade agreements that value innovation-based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU; highlights the importance of removing trade barriers and red tape in third countries, and ensuring fair access to international markets for companies operating in the EU;

Or. en

Amendment 701 Pietro Fiocchi

Motion for a resolution Paragraph 23

Motion for a resolution Amendment

23. Calls on the Commission to further 23. Calls on the Commission to further facilitate access to global markets for the facilitate access to global markets for the EU pharmaceutical industry, including European pharmaceutical industry, small and medium-sized enterprises, including SMEs, with a level playing field through a level playing field and a and a regulatory framework, facilitating regulatory framework facilitating trade trade agreements that prize manufacturing agreements that prize innovation-based and technological know-how competitiveness, in order to make the competitiveness, to make the pharmaceutical sector a strategic pillar of pharmaceutical sector a strategic pillar of the EU; the EU;

Or. en

AM\1233943EN.docx 351/362 PE693.845v01-00 EN Amendment 702 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 23

Motion for a resolution Amendment

23. Calls on the Commission to further 23. Calls on the Commission to further facilitate access to global markets for the facilitate access to global markets for the EU pharmaceutical industry, including EU pharmaceutical industry, including small and medium-sized enterprises, small and medium-sized enterprises, through a level playing field and a through a level playing field and a regulatory framework facilitating trade regulatory framework facilitating trade agreements that prize innovation-based agreements that are based on peoples' competitiveness, in order to make the needs, in order to make the pharmaceutical pharmaceutical sector a strategic pillar of sector a strategic and public sector of the the EU; EU;

Or. en

Amendment 703 Alessandra Moretti

Motion for a resolution Paragraph 23

Motion for a resolution Amendment

23. Calls on the Commission to further 23. Calls on the Commission to further facilitate access to global markets for the facilitate access to global markets for the EU pharmaceutical industry, including EU pharmaceutical industry, including small and medium-sized enterprises, small and medium-sized enterprises, through a level playing field and a through a level playing field and a regulatory framework facilitating trade regulatory framework facilitating trade agreements that prize innovation-based agreements that prize innovation-based competitiveness, in order to make the competitiveness, in order to make the pharmaceutical sector a strategic pillar of pharmaceutical sector a strategic pillar of the EU; the EU; calls on the Commission to ensure that trade agreements contribute to improved access to safe, affective and affordable medicines in the EU and in third countries.

Or. en

PE693.845v01-00 352/362 AM\1233943EN.docx EN Amendment 704 Tilly Metz

Motion for a resolution Paragraph 23

Motion for a resolution Amendment

23. Calls on the Commission to further 23. Calls on the Commission to further facilitate access to global markets for the facilitate access to global markets for the EU pharmaceutical industry, including EU pharmaceutical industry, including small and medium-sized enterprises, small and medium-sized enterprises, through a level playing field and a through a level playing field and a regulatory framework facilitating trade regulatory framework facilitating trade agreements that prize innovation-based agreements that prize innovation-based competitiveness, in order to make the competitiveness, in order to make the pharmaceutical sector a strategic pillar of pharmaceutical sector a strategic pillar of the EU; the EU; calls on the Commission to ensure that trade agreements contribute to improved access to safe, affective and affordable medicines in the EU and in third countries;

Or. en

Amendment 705 Kateřina Konečná

Motion for a resolution Paragraph 23

Motion for a resolution Amendment

23. Calls on the Commission to further 23. Calls on the Commission to further facilitate access to global markets for the facilitate access to global markets for the EU pharmaceutical industry, including EU pharmaceutical industry, including small and medium-sized enterprises, small and medium-sized enterprises, through a level playing field and a through a level playing field and a regulatory framework facilitating trade regulatory framework facilitating trade agreements that prize innovation-based agreements that prize innovation-based competitiveness, in order to make the competitiveness, in order to make the pharmaceutical sector a strategic pillar of pharmaceutical sector a strategic pillar of the EU; the EU; calls on the Commission to ensure that trade agreements contribute to improved access to safe, affective and affordable medicines in the EU and in third countries.

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Amendment 706 Alexander Bernhuber

Motion for a resolution Paragraph 23

Motion for a resolution Amendment

23. Calls on the Commission to further 23. Calls on the Commission to further facilitate access to global markets for the facilitate access to global markets for the EU pharmaceutical industry, including EU pharmaceutical industry, including small and medium-sized enterprises, small and medium-sized enterprises, through a level playing field and a through a level playing field and a regulatory framework facilitating trade regulatory framework promoting the agreements that prize innovation-based highest standards on quality and safety at competitiveness, in order to make the international level, facilitating trade pharmaceutical sector a strategic pillar of agreements that prize innovation-based the EU; competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU;

Or. en

Amendment 707 Andrey Slabakov, Joanna Kopcińska, Pietro Fiocchi, Ryszard Antoni Legutko, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 23

Motion for a resolution Amendment

23. Calls on the Commission to further 23. Calls on the Commission to further facilitate access to global markets for the facilitate access to global markets for the EU pharmaceutical industry, including EU pharmaceutical industry, including small and medium-sized enterprises, small and medium-sized enterprises, through a level playing field and a through a level playing field and a robust regulatory framework facilitating trade and clear regulatory framework facilitating agreements that prize innovation-based trade agreements that prize innovation- competitiveness, in order to make the based competitiveness, in order to make pharmaceutical sector a strategic pillar of the pharmaceutical sector a strategic pillar the EU; of the EU;

Or. en

PE693.845v01-00 354/362 AM\1233943EN.docx EN Amendment 708 Jessica Polfjärd

Motion for a resolution Paragraph 23

Motion for a resolution Amendment

23. Calls on the Commission to further 23. Calls on the Commission to further facilitate access to global markets for the facilitate access to global markets for the EU pharmaceutical industry, including EU pharmaceutical industry, including small and medium-sized enterprises, small and medium-sized enterprises, through a level playing field and a through a level playing field and a regulatory framework facilitating trade regulatory framework facilitating trade agreements that prize innovation-based agreements that prize innovation-based competitiveness, in order to make the competitiveness, in order to preserve the pharmaceutical sector a strategic pillar of pharmaceutical sector as a strategic pillar the EU; of the EU;

Or. en

Amendment 709 Pietro Fiocchi

Motion for a resolution Paragraph 23 a (new)

Motion for a resolution Amendment

23 a. Emphasises that the implementation of an open, free, fair, transparent and enforceable rules-based multilateral trading system is fundamental to ensure global availability of medical products and limiting vulnerabilities in the future; calls on the Commission to develop a medicines trade agenda that ensures that EU Free Trade Agreements should not focus exclusively on enforcing Intellectual Property standards in third countries, but they should take into account the impact on generic and biosimilar medicines in the EU and in third countries, as well as include coordination on regulatory standards; calls on the Commission to

AM\1233943EN.docx 355/362 PE693.845v01-00 EN implement the single development programmes with third parties on generic medicines, complex generic medicines and biosimilar medicines to avoid unnecessary and unethical studies;

Or. en

Amendment 710 Petros Kokkalis

Motion for a resolution Paragraph 23 a (new)

Motion for a resolution Amendment

23a. Stresses that the WTO TRIPS Agreement offers flexibility with regard to patent rights, for example through compulsory licensing, thereby bringing down prices substantially; points out that this flexibility can be effectively turned to account to address public health concerns in exceptional circumstances, enabling the necessary medicines to be supplied at affordable prices as part of domestic policy aimed at promoting public health;

Or. el

Amendment 711 Tilly Metz

Motion for a resolution Paragraph 23 a (new)

Motion for a resolution Amendment

23 a. Urges the Commission to issue a proposal in the framework of paragraph 9 of Article218 TFEU to update the EU position regarding ongoing WTO TRIPS flexibilities so as in times of health emergency, to allow for use of TRIPS waiver, as well as lifting data and market exclusivity, to enable use of compulsory

PE693.845v01-00 356/362 AM\1233943EN.docx EN licensing by the Member States and third countries as an important public health safeguard, and to evaluate the TRIPS+ commitments in EU trade agreements;

Or. en

Amendment 712 Pernille Weiss

Motion for a resolution Paragraph 23 a (new)

Motion for a resolution Amendment

23 a. Points out that small and medium sized enterprises (SMEs) and mid-caps play a crucial role in the pharmaceutical value chain, often as first-movers and drivers of innovation; urges the Commission to maintain a comprehensive and predictable regulatory framework that fosters the investment and innovation of especially European pharmaceutical SMEs and mid-caps;

Or. en

Amendment 713 Mick Wallace, Clare Daly, Kateřina Konečná

Motion for a resolution Paragraph 23 a (new)

Motion for a resolution Amendment

23 a. Believes the EU Member States have a responsibility to ensure equitable access to medicines and therapeutics worldwide; calls on the EU to advocate access to medicines globally, and to commit to ensuring that none of its actions block access to medicines and therapeutic care, including in the WTO;

Or. en

AM\1233943EN.docx 357/362 PE693.845v01-00 EN Amendment 714 Tilly Metz

Motion for a resolution Paragraph 23 b (new)

Motion for a resolution Amendment

23 b. Calls on the Commission to ensure due diligence, transparency, ethical and responsible behaviour throughout the pharmaceutical sector to promote trust in health decision-making and protect the environment and societal welfare;

Or. en

Amendment 715 Petros Kokkalis

Motion for a resolution Paragraph 23 b (new)

Motion for a resolution Amendment

23b. Calls for EU initiatives to provide patients with equal access to medicines at global level;

Or. el

Amendment 716 Tilly Metz

Motion for a resolution Paragraph 23 c (new)

Motion for a resolution Amendment

23 c. Calls on the Commission to ensure adequate consultation with stakeholders, in particular consumer, patient and healthcare professionals and non-profit research organisations throughout the implementation of the Pharmaceutical

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Or. en

Amendment 717 Tilly Metz

Motion for a resolution Paragraph 24

Motion for a resolution Amendment

24. Reiterates its commitment to 24. Reiterates its commitment to continue working with the Commission continue working with the Commission and the World Health Organization to and the World Health Organization to standardise effective, safe and sustainable improve access to safe, effective and regulatory frameworks for medicinal affordable medicines; products;

Or. en

Amendment 718 Alessandra Moretti

Motion for a resolution Paragraph 24

Motion for a resolution Amendment

24. Reiterates its commitment to 24. Reiterates its commitment to continue working with the Commission continue working with the Commission and the World Health Organization to and the World Health Organization to standardise effective, safe and sustainable improve access to safe, effective and regulatory frameworks for medicinal affordable medicines; products;

Or. en

Amendment 719 Pietro Fiocchi

Motion for a resolution Paragraph 24

AM\1233943EN.docx 359/362 PE693.845v01-00 EN Motion for a resolution Amendment

24. Reiterates its commitment to 24. Reiterates its commitment to continue working with the Commission continue working with the Commission and the World Health Organization to and the World Health Organization and the standardise effective, safe and sustainable International Council for Harmonisation regulatory frameworks for medicinal to standardise effective, safe and products; sustainable regulatory frameworks for medicinal products;

Or. en

Amendment 720 Andrey Slabakov, Pietro Fiocchi, Margarita de la Pisa Carrión, Hermann Tertsch

Motion for a resolution Paragraph 24 a (new)

Motion for a resolution Amendment

24 a. Highlights that according to the WHO, an increasing number of counterfeit drugs are also being sold in developing countries in connection with COVID-19, and continue to be distributed in Europe as well; calls on the Commission and on Member States to improve control of medical products and equipment entering the EU; calls further for the introduction of more stringent penalties for producers and distributors of counterfeit medicines;

Or. en

Amendment 721 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 24 a (new)

Motion for a resolution Amendment

24 a. Stresses the need to ensure that Brexit does not adversely affect our capacity for innovation in the medical

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Or. es

Amendment 722 Margarita de la Pisa Carrión

Motion for a resolution Paragraph 24 b (new)

Motion for a resolution Amendment

24 b. Recalls that, in situations of crisis or health emergencies, changes to intellectual property rules are not useful to meet short-term needs; invites the Commission to seek solutions, for example in the area of licensing, to address new needs for the production of vaccines or medicines.

Or. es

Amendment 723 Kateřina Konečná

Motion for a resolution Paragraph 25 a (new)

Motion for a resolution Amendment

25 a. Calls on the Commission to address the systemic problems embedded in the global pharmaceutical sector to ensure that the development and allocation of essential pharmaceuticals is driven by medical and social needs, not profit, and governed by public mechanisms instead of being left to the discretion of private interests, particularly during health emergencies;

Or. en

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