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.