European Parliament 2019-2024

Committee on Industry, Research and Energy

2020/0321(COD)

26.3.2021

AMENDMENTS 65 - 322

Draft opinion Joëlle Mélin (PE689.565v01-00)

A reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices

Proposal for a regulation (COM(2020)0725 – C9-0365/2020 – 2020/0321(COD))

AM\1227699EN.docx PE691.131v01-00

EN United in diversityEN AM_Com_LegOpinion

PE691.131v01-00 2/137 AM\1227699EN.docx EN Amendment 65 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Recital 1 a (new)

Text proposed by the Commission Amendment

(1 a) According to Article 4(2) of the TFEU, common safety concerns in public health matters is amongst the shared competences of the EU;

Or. en

Amendment 66 Aldo Patriciello, Massimiliano Salini, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Recital 2

Text proposed by the Commission Amendment

(2) The unprecedented experience of (2) The unprecedend experience of the the COVID-19 pandemic has demonstrated COVID-19 pandemic has demonstrated that the Union should be more effective in that the Union should be more effective in managing the availability of medicinal managing the availability of medicinal products and medical devices and in products and medical devices and in developing medical countermeasures to developing medical countermeasures to address the threats posed to public health. address the threats posed to public health The Union’s ability to do so has been in a harmonised way between authorities, severely impeded by the absence of a industry and other stakeholders of the clearly defined legal framework for pharmaceuticals supply chain. Europe managing its response to the pandemic, and needs to give a higher priority to health also by the limited degree of Union not with standing the competences of the preparedness in case of a public health Member States in the area of healthcare, emergency impacting a majority of to have health systems ready to provide Member States. state of the art care, and to be prepared to cope with epidemics and other unforeseeable health threats in line with the International Health Regulations. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the

AM\1227699EN.docx 3/137 PE691.131v01-00 EN limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.

Or. en

Amendment 67 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Josianne Cutajar, Alicia Homs Ginel

Proposal for a regulation Recital 2

Text proposed by the Commission Amendment

(2) The unprecedented experience of (2) The unprecedented experience of the COVID-19 pandemic has demonstrated the COVID-19 pandemic has demonstrated that the Union should be more effective in that the Union should be more effective in managing the availability of medicinal managing the availability of medicinal products and medical devices and in products and medical devices and in developing medical countermeasures to developing medical countermeasures to address the threats posed to public health. address the threats posed to public health. The Union’s ability to do so has been The Union’s ability to do so has been severely impeded by the absence of a severely impeded by the absence of a clearly defined legal framework for clearly defined legal framework for managing its response to the pandemic, and managing its response to the pandemic, and also by the limited degree of Union also by the limited degree of Union preparedness in case of a public health preparedness in case of a public health emergency impacting a majority of emergency impacting a majority of Member States. Member States. The pandemic has also shown the necessity of having an innovative and research based pharmaceutical industry that works closely with EMA in order to be better prepared for future health crisis and disruptions in the supply chain. COVID- 19 also underlined the need for more transparency on medicines pricing and EU marketing authorisation.

Or. en

Amendment 68 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

PE691.131v01-00 4/137 AM\1227699EN.docx EN Proposal for a regulation Recital 2

Text proposed by the Commission Amendment

(2) The unprecedented experience of (2) The unprecedented experience of the COVID-19 pandemic has demonstrated the COVID-19 pandemic has demonstrated that the Union should be more effective in that the Union should be more effective managing the availability of medicinal and transparent in managing the products and medical devices and in availability of medicinal products and developing medical countermeasures to medical devices and in developing medical address the threats posed to public health. countermeasures to address the threats The Union’s ability to do so has been posed to public health. The Union’s ability severely impeded by the absence of a to do so has been severely impeded by clearly defined legal framework for austerity measures affecting public health managing its response to the pandemic, and services, insufficient public control on also by the limited degree of Union production, and by the absence of a clearly preparedness in case of a public health defined legal framework for managing its emergency impacting a majority of response to the pandemic, and also by the Member States. limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.

Or. en

Amendment 69 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 2

Text proposed by the Commission Amendment

(2) The unprecedented experience of (2) The unprecedented experience of the COVID-19 pandemic has demonstrated the COVID-19 pandemic has demonstrated that the Union should be more effective in that the Union must be more effective in managing the availability of medicinal managing the availability of medicinal products and medical devices and in products and medical devices and in developing medical countermeasures to developing medical countermeasures to address the threats posed to public health. address the threats posed to public health. The Union’s ability to do so has been The Union’s ability to do so has been severely impeded by the absence of a severely impeded by the absence of a clearly defined legal framework for clearly defined legal framework for managing its response to the pandemic, and managing its response to the pandemic, also by the limited degree of Union insufficient mandates of its health preparedness in case of a public health agencies and also by the limited degree of emergency impacting a majority of Union and Member States preparedness in

AM\1227699EN.docx 5/137 PE691.131v01-00 EN Member States. case of a public health emergency impacting a majority of Member States.

Or. en

Amendment 70 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Recital 3

Text proposed by the Commission Amendment

(3) The often complex supply chains (3) The COVID-19 pandemic has of medicinal products and medical exacerbated the already existing difficulty devices, national export restrictions and of shortages for certain medicinal bans, border closures impeding the free products considered as critical in movement of those goods, and uncertainty addressing the pandemic, and has related to their supply and demand in the highlighted the structural limitations in context of the COVID-19 pandemic have the Union’s ability to rapidly and led to significant impediments to the effectively react to such challenges during smooth functioning of the single market public health crises, also due to the lack of and to addressing the serious threats to implementation of sustainable economic, public health across the Union. regulatory and industrial policy reforms needed.

Or. en

Amendment 71 Joëlle Mélin

Proposal for a regulation Recital 3 a (new)

Text proposed by the Commission Amendment

(3a) The COVID-19 crisis has revealed the complexity of the supply of raw materials and highlighted a highly fragmented production chain and complex distribution networks, which are factors that the manufacturers and their management controllers are struggling to deal with and which require real collaboration between states, as well as a

PE691.131v01-00 6/137 AM\1227699EN.docx EN clear stance to be taken by the EMA;

Or. fr

Amendment 72 Joëlle Mélin

Proposal for a regulation Recital 3 b (new)

Text proposed by the Commission Amendment

(3b) the essential free movement of goods must be possible with a revised border management;

Or. fr

Amendment 73 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 4

Text proposed by the Commission Amendment

(4) Dealing with the issue of shortages (4) Dealing with the issue of shortages of medicinal products has been a long- of medicinal products has been a long- standing priority for the Member States standing but unresolved problem for the and European Parliament as illustrated by Member States and European Parliament as several reports from the European illustrated by several reports from the Parliament11 as well as discussions under European Parliament11 as well as recent Presidencies of the Council of the discussions under recent Presidencies of European Union. the Council of the European Union. ______11 European Parliament resolution of 17 11 European Parliament resolution of 17 September 2020 on the shortage of September 2020 on the shortage of medicines – how to address an emerging medicines – how to address an emerging problem (2020/2071(INI)) problem (2020/2071(INI))

Or. en

AM\1227699EN.docx 7/137 PE691.131v01-00 EN Amendment 74 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel

Proposal for a regulation Recital 4 a (new)

Text proposed by the Commission Amendment

(4 a) The COVID-19 pandemic is a clear example of the need to reinforce the application of the One Health approach in the EU to achieve better public health outcomes, since, as stated in the EU4Health Programme, human health is connected to animal health and the environment and actions to tackle threats to health should take into account those three dimensions.

Or. en

Amendment 75 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 5

Text proposed by the Commission Amendment

(5) The COVID-19 pandemic has (5) The COVID-19 pandemic has exacerbated the problem of shortages for exacerbated the problem of shortages for certain medicinal products considered as certain medicinal products considered as critical in addressing the pandemic, and has critical in addressing the pandemic, and has highlighted the structural limitations in the highlighted the structural limitations in the Union’s ability to rapidly and effectively Union’s and the Member States’ ability to react to such challenges during public rapidly and effectively react to such health crises. challenges during public health crises.

Or. en

Amendment 76 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

PE691.131v01-00 8/137 AM\1227699EN.docx EN Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) The rapid evolution of COVID-19 (6) The rapid evolution of COVID-19 and the spread of the virus led to a sharp and the spread of the virus led to a sharp increase in demand for medical devices increase in demand for personal protective such as ventilators, surgical masks, and equipments and medical devices such as COVID-19 test kits while disruption of ventilators, surgical masks, and COVID-19 production or limited capacity to rapidly test kits while disruption of production or increase production and the complexity and limited capacity to rapidly increase global nature of the supply chain for production and the complexity and global medical devices, led to a negative impact nature of the supply chain for medical on supply. Those issues resulted in new devices, led to a negative impact on supply. entities being involved in the production of Those issues resulted in new entities being those products, which subsequently involved in the production of those resulted in bottlenecks in conformity products, which subsequently resulted in assessment, as well as the prevalence of bottlenecks in conformity assessment, as non-compliant, unsafe, and in some cases well as the prevalence of non-compliant, counterfeit products. It is therefore unsafe, and in some cases counterfeit appropriate to establish long-term products. It is therefore appropriate to structures within an appropriate Union establish long-term structures within an body to ensure monitoring of shortages of appropriate Union body to ensure medical devices resulting from a public monitoring of shortages of medical devices health emergency. resulting from a public health emergency.

Or. en

Amendment 77 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) The rapid evolution of COVID-19 (6) The rapid evolution of COVID-19 and the spread of the virus led to a sharp and the spread of the virus led to a sharp increase in demand for medical devices increase in demand for medical devices such as ventilators, surgical masks, and such as ventilators, surgical masks, and COVID-19 test kits while disruption of COVID-19 test kits while disruption of production or limited capacity to rapidly production or limited capacity to rapidly increase production and the complexity and increase production and the complexity and global nature of the supply chain for global nature of the supply chain for medical devices, led to a negative impact medical devices, led to a negative impact

AM\1227699EN.docx 9/137 PE691.131v01-00 EN on supply. Those issues resulted in new on supply. Those issues resulted in new entities being involved in the production of entities being involved in the production of those products, which subsequently those products, which subsequently resulted in bottlenecks in conformity resulted in bottlenecks in conformity assessment, as well as the prevalence of assessment, as well as the prevalence of non-compliant, unsafe, and in some cases overpriced, non-compliant, unsafe, and in counterfeit products. It is therefore some cases counterfeit products. It is appropriate to establish long-term therefore appropriate to establish long-term structures within an appropriate Union structures within an appropriate Union body to ensure monitoring of shortages of body to ensure monitoring of shortages of medical devices resulting from a public medical devices resulting from a public health emergency. health emergency.

Or. en

Amendment 78 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Recital 6 a (new)

Text proposed by the Commission Amendment

(6 a) The COVID-19 pandemic has shown the need for increased cooperation of the European Medicines Agency with Member States and the pharmaceutical industry in order to improve the capacity of the EU and Member States to combat future health emergencies or serious events;

Or. en

Amendment 79 Ivars Ijabs, Izaskun Bilbao Barandica, Mauri Pekkarinen, Christophe Grudler

Proposal for a regulation Recital 7

Text proposed by the Commission Amendment

(7) Uncertainty of supply and demand (7) Uncertainty of supply and demand and the risk of shortages of essential and the risk of shortages of essential medicinal products and medical devices medicinal products and medical devices

PE691.131v01-00 10/137 AM\1227699EN.docx EN during a public health emergency like the during a public health emergency like the COVID-19 pandemic can trigger export COVID-19 pandemic can trigger export restrictions amongst Member States and restrictions amongst Member States and other national protective measures, which other national protective measures, which can seriously impact the functioning of the can seriously impact the functioning of the internal market. Furthermore, shortages of internal market as well as lead to the need medicinal products can result in serious for temporary export transparency and risks to the health of patients in the Union export authorisation mechanisms. due to their lack of availability, which can Furthermore, shortages of medicinal cause, medication errors, increased products can result in serious risks to the duration of hospital stays, and adverse health of patients in the Union due to their reactions caused by the administration of lack of availability, which can cause, unsuitable products used as a substitute for medication errors, increased duration of unavailable ones. With respect to medical hospital stays, and adverse reactions devices, shortages can lead to a lack of caused by the administration of unsuitable diagnostic resources with negative products used as a substitute for consequences for public health measures, a unavailable ones. With respect to medical lack of treatment or deterioration of the devices, shortages can lead to a lack of disease and may also prevent health diagnostic resources with negative professionals from adequately carrying out consequences for public health measures, a their tasks. Those shortages can also have a lack of treatment or deterioration of the significant impact on controlling the spread disease and may also prevent health of a given pathogen caused by, for professionals from adequately carrying out example, an insufficient supply of COVID- their tasks. Those shortages can also have a 19 test kits. It is therefore important to significant impact on controlling the spread address the question of shortages and to of a given pathogen caused by, for reinforce and formalise monitoring of example, an insufficient supply of COVID- critical medicinal products and medical 19 test kits. It is therefore important to devices. address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices.

Or. en

Amendment 80 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 7

Text proposed by the Commission Amendment

(7) Uncertainty of supply and demand (7) Uncertainty of supply and demand and the risk of shortages of essential and the risk of shortages of essential medicinal products and medical devices medicinal products and medical devices during a public health emergency like the during a public health emergency like the

AM\1227699EN.docx 11/137 PE691.131v01-00 EN COVID-19 pandemic can trigger export COVID-19 pandemic can trigger export restrictions amongst Member States and restrictions amongst Member States and other national protective measures, which other national protective measures, which can seriously impact the functioning of the can seriously impact the functioning of the internal market. Furthermore, shortages of internal market. Furthermore, shortages of medicinal products can result in serious medicinal products can result in serious risks to the health of patients in the Union risks to the health of patients in the Union due to their lack of availability, which can due to their lack of availability, which can cause, medication errors, increased cause fatalities, medication errors, duration of hospital stays, and adverse increased duration of hospital stays, and reactions caused by the administration of adverse reactions caused by the unsuitable products used as a substitute for administration of unsuitable products used unavailable ones. With respect to medical as a substitute for unavailable ones. With devices, shortages can lead to a lack of respect to medical devices, shortages can diagnostic resources with negative lead to a lack of diagnostic resources with consequences for public health measures, a negative consequences for public health lack of treatment or deterioration of the measures, a lack of treatment or disease and may also prevent health deterioration of the disease and may also professionals from adequately carrying out prevent health professionals from their tasks. Those shortages can also have a adequately carrying out their tasks or being significant impact on controlling the spread protected doing so. Those shortages can of a given pathogen caused by, for also have a significant impact on example, an insufficient supply of COVID- controlling the spread of a given pathogen 19 test kits. It is therefore important to caused by, for example, an insufficient address the question of shortages and to supply of COVID-19 test kits. It is reinforce and formalise monitoring of therefore important to address the question critical medicinal products and medical of shortages and to reinforce and formalise devices. monitoring of critical medicinal products and medical devices.

Or. en

Amendment 81 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 8

Text proposed by the Commission Amendment

(8) Safe and efficacious medicinal (8) Safe and efficacious medicinal products that treat, prevent or diagnose products that treat, prevent or diagnose diseases which cause public health diseases which cause public health emergencies, should be developed and emergencies, should be developed, if made available within the Union as soon as necessary, and made available within the possible during such emergencies. The Union as soon as possible during such COVID-19 pandemic has also highlighted emergencies. The COVID-19 pandemic

PE691.131v01-00 12/137 AM\1227699EN.docx EN sub-optimal coordination and decision- has also highlighted lacking coordination making as regards multinational clinical and decision-making as regards trials, and Union-level advice on the use of multinational clinical trials, and missing medicinal products in national Union-level advice on the use of medicinal compassionate use programmes or outside products in national compassionate use of their authorised indications in the Union, programmes or outside of their authorised causing delays in the adoption of research indications in the Union, causing delays in outcomes and in the development and the adoption of research outcomes and in availability of new or repurposed the development and availability of new or medicines. repurposed medicines.

Or. en

Amendment 82 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Recital 9

Text proposed by the Commission Amendment

(9) During the COVID-19 pandemic ad (9) During the COVID-19 pandemic ad hoc solutions, including contingent hoc solutions, including contingent arrangements between the Commission, the arrangements between the Commission, the European Medicines Agency (‘the European Medicines Agency (‘the Agency’), marketing authorisation holders, Agency’), marketing authorisation holders, manufacturers and Member States, had to manufacturers, other stakeholders of the be found to achieve the objective of pharmaceutical supply chain and Member making available safe and efficacious States, had to be found to achieve the medicinal products to treat COVID-19 or objective of making available safe and prevent its spread, and to facilitate and efficacious medicinal products to treat speed up the development and marketing COVID-19 or prevent its spread, and to authorisation of treatments and vaccines. facilitate and speed up the development and marketing authorisation of treatments and vaccines.

Or. en

Amendment 83 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Josianne Cutajar, Alicia Homs Ginel

Proposal for a regulation Recital 9 a (new)

AM\1227699EN.docx 13/137 PE691.131v01-00 EN Text proposed by the Commission Amendment

(9 a) The outbreak of COVID-19 and the subsequent health crisis revealed the need for a more coordinated European approach in crisis management. Although the emergency of the situation explains the lack of an impact assessment, sufficient allocation of resources in terms of staff and funding needs to be secured, taking into account the specificities of the health sector in the different Member States.

Or. en

Amendment 84 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Josianne Cutajar, Alicia Homs Ginel

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) In order to ensure a better (10) In order to ensure a better functioning of the internal market of those functioning of the internal market of those products and contribute to a high level of products and contribute to a high level of human health protection, it is therefore human health protection, it is therefore appropriate to approximate the rules on appropriate to approximate the rules on monitoring of shortages of medicinal monitoring of shortages of medicinal products and medical devices, and to products and medical devices, and to facilitate the research and development of facilitate the research and development of medicinal products, which may have the medicinal products, which may have the potential to treat, prevent, or diagnose potential to treat, prevent, or diagnose diseases that cause public health crises. diseases that cause public health crises. Highlights in this respect the necessity of developing analytics to predict emerging risks, including the use of alternative data sources.

Or. en

Amendment 85

PE691.131v01-00 14/137 AM\1227699EN.docx EN Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 11

Text proposed by the Commission Amendment

(11) This Regulation aims to ensure the (11) This Regulation aims to ensure the smooth functioning of the internal market smooth functioning of the internal market as regards medicinal products and medical as regards medicinal products and medical devices, with a high level of human health devices, with a high level of human health protection being fundamental in those protection being fundamental in those aims. Moreover, this Regulation aims to aims. Moreover, this Regulation aims to ensure the quality, safety and efficacy of ensure the quality, safety and efficacy of medicinal products with the potential to medicinal products with the potential to address public health emergencies. Both address public health emergencies. Both objectives are being pursued objectives are being pursued simultaneously and are inseparably linked simultaneously, but quality, safety and whilst one not being secondary to the efficacy of medical products should be a other. As regards Article 114 TFEU, this paramount priority. As regards Article 114 Regulation establishes a framework for the TFEU, this Regulation establishes a monitoring and reporting on shortages of framework for the monitoring and medicinal products and medical devices reporting on shortages of medicinal during public health crises. As regards products and medical devices during public Article 168(4)(c) TFEU, this Regulation health crises. As regards Article 168(4)(c) provides for a strengthened Union TFEU, this Regulation provides for a framework ensuring the quality and safety strengthened Union framework ensuring of medicinal products and medical devices. the quality and safety of medicinal products and medical devices.

Or. en

Amendment 86 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 11 a (new)

Text proposed by the Commission Amendment

(11 a) This Regulation establishes a framework to address the problem of shortages during public health emergencies and major events. However, shortages of medicinal products and medical devices is a persistent problem

AM\1227699EN.docx 15/137 PE691.131v01-00 EN that affects health and lives of EU citizens between emergencies as well. Therefore, the Commission should subsequently propose the expansion of this framework to ensure that the problem of shortages is tackled on a permanent basis.

Or. en

Amendment 87 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 12

Text proposed by the Commission Amendment

(12) In order to improve crisis (12) In order to improve crisis preparedness and management for preparedness and management for medicinal products and medical devices medicinal products and medical devices and increase resilience and solidarity and increase resilience and solidarity across the Union, the procedures and the across the Union, the procedures and the respective roles and obligations of different respective roles and obligations of different concerned entities involved should be concerned entities involved should be clarified. The framework should build on clarified. The framework should build on the ad hoc solutions identified so far in the the ad hoc solutions identified so far in the response to the COVID-19 pandemic. response to the COVID-19 pandemic and on experiences and examples in other countries.

Or. en

Amendment 88 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Recital 13

Text proposed by the Commission Amendment

(13) A harmonised system of monitoring (13) A harmonised system, based on of shortages of medicinal products and common data fields, of monitoring of medical devices should be established, shortages of medicinal products, personal which will facilitate appropriate access to protective equipments and medical devices

PE691.131v01-00 16/137 AM\1227699EN.docx EN critical medicinal products and medical should be established, which will facilitate devices during public health emergencies appropriate access for relevant national and major events, which may have a and EU authorities on markets situations serious impact on public health. That for critical medicinal products and medical system should be complemented with devices during public health emergencies improved structures to ensure appropriate and major events, which may have a management of public health crises and serious impact on public health. That coordinate and provide advice on the system should be complemented with research and development of medicinal improved telematic structures to ensure products which may have the potential to appropriate management of public health address public health emergencies. In order crises and coordinate and provide advice to facilitate the monitoring and reporting on the research and development of on potential or actual shortages of medicinal products which may have the medicinal products and medical devices, potential to address public health the Agency should be able to ask and emergencies. In order to facilitate the obtain information and data from the monitoring and reporting on potential or concerned marketing authorisation holders, actual shortages of medicinal products and manufacturers and Member States through medical devices, as well as to avoid designated points of contact. duplications of the information submitted, the Agency should be able to ask and obtain additional information and data, not already in the system, from the concerned marketing authorisation holders, manufacturers and Member States who all have the obligation to provide complete information and data through designated points of contact.

Or. en

Amendment 89 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 13

Text proposed by the Commission Amendment

(13) A harmonised system of monitoring (13) A harmonised system of monitoring of shortages of medicinal products and of shortages of medicinal products and medical devices should be established, medical devices should be established, which will facilitate appropriate access to which will facilitate appropriate access to critical medicinal products and medical critical medicinal products and medical devices during public health emergencies devices during public health emergencies and major events, which may have a and major events, which may have a serious impact on public health. That serious impact on public health. That system should be complemented with system should be complemented with

AM\1227699EN.docx 17/137 PE691.131v01-00 EN improved structures to ensure appropriate improved structures to ensure appropriate management of public health crises and management of public health crises and coordinate and provide advice on the coordinate and provide advice on the research and development of medicinal research and development of medicinal products which may have the potential to products which may have the potential address public health emergencies. In to mitigate public health emergencies. In order to facilitate the monitoring and order to facilitate the monitoring and reporting on potential or actual shortages reporting on potential or actual shortages of medicinal products and medical devices, of medicinal products and medical devices, the Agency should be able to ask and the Agency should be able to ask and obtain information and data from the obtain information and data from the concerned marketing authorisation holders, concerned marketing authorisation holders, manufacturers and Member States through manufacturers, wholesalers and Member designated points of contact. States through designated points of contact.

Or. en

Amendment 90 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 15

Text proposed by the Commission Amendment

(15) With respect to medicinal products, (15) With respect to medicinal products, an executive steering group should be an executive steering group should be established within the Agency to ensure a established within the Agency to ensure a robust response to major events and to robust response to major events and to coordinate urgent actions within the Union coordinate urgent actions within the Union in relation to the management of issues in relation to the management of issues relating to the supply of medicinal relating to the supply of medicinal products. The Steering Group should products. The Steering Group should establish lists of critical medicinal products establish a general list of critical to ensure monitoring of those products and medicinal products applicable to any it should be able to provide advice on the major event or public health emergency, necessary action to take to safeguard the such as those related to emergency care, quality, safety, and efficacy of medicinal surgical operations and intensive medical products and ensure a high level of human care. This list would serve as the basis for health protection. more specific lists of critical medicinal products, applicable in specific health crises to ensure monitoring of those products. The Steering Group should be able to provide advice on the necessary action to take to safeguard the quality, safety, and efficacy of medicinal products and ensure a high level of human health

PE691.131v01-00 18/137 AM\1227699EN.docx EN protection.

Or. en

Amendment 91 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Recital 15

Text proposed by the Commission Amendment

(15) With respect to medicinal products, (15) With respect to medicinal products, an executive steering group should be an executive steering group should be established within the Agency to ensure a established within the Agency to ensure a robust response to major events and to robust response to major events and to coordinate urgent actions within the Union coordinate urgent actions within the Union in relation to the management of issues in relation to the management of issues relating to the supply of medicinal relating to the supply of medicinal products. The Steering Group should products. The Steering Group shall establish lists of critical medicinal products establish list of critical medicinal products, to ensure monitoring of those products and in close cooperation with industry, to it should be able to provide advice on the ensure monitoring of those products and it necessary action to take to safeguard the should be able to provide advice on the quality, safety, and efficacy of medicinal necessary action to take to safeguard the products and ensure a high level of human quality, safety, and efficacy of medicinal health protection. products and ensure a high level of human health protection during public health emergencies and major events.

Or. en

Amendment 92 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Recital 17

Text proposed by the Commission Amendment

(17) In order to ensure that safe, high (17) In order to ensure that safe, high quality, and efficacious medicinal quality, and efficacious medicinal products, which have the potential to products, which have the potential to address public health emergencies, can be address public health emergencies, can be developed and made available within the developed and made available within the

AM\1227699EN.docx 19/137 PE691.131v01-00 EN Union as soon as possible during public Union as soon as possible during public health emergencies, an emergency task health emergencies, an emergency task force should be established within the force driven by public-health needs only Agency to provide advice on such should be established within the Agency to medicinal products. The Emergency Task provide advice on such medicinal products. Force should provide advice free of charge The Emergency Task Force should provide on scientific questions related to the independent advice free of charge on development of treatments and vaccines scientific questions related to the and on clinical trial protocols, to those development of treatments and vaccines organisations involved in their and on clinical trial protocols, to those development, such as marketing organisations involved in their authorisation holders, clinical trial development, such as marketing sponsors, public health bodies, and authorisation holders, clinical trial academia, irrespective of their exact role in sponsors, public health bodies, and the development of such medicinal academia, irrespective of their exact role in products. the development of such medicinal products.

Or. en

Amendment 93 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 17

Text proposed by the Commission Amendment

(17) In order to ensure that safe, high (17) In order to ensure that safe, high quality, and efficacious medicinal quality, and efficacious medicinal products, which have the potential to products, which have the potential to address public health emergencies, can be address public health emergencies, can be developed and made available within the developed, if necessary, and made Union as soon as possible during public available within the Union as soon as health emergencies, an emergency task possible during public health emergencies, force should be established within the an emergency task force should be Agency to provide advice on such established within the Agency to provide medicinal products. The Emergency Task advice on such medicinal products. The Force should provide advice free of charge Emergency Task Force should provide on scientific questions related to the advice free of charge on scientific development of treatments and vaccines questions related to the development of and on clinical trial protocols, to those treatments and vaccines and on clinical organisations involved in their trial protocols, to those organisations development, such as marketing involved in their development, such as authorisation holders, clinical trial marketing authorisation holders, clinical sponsors, public health bodies, and trial sponsors, public health bodies, and academia, irrespective of their exact role in academia, irrespective of their exact role in

PE691.131v01-00 20/137 AM\1227699EN.docx EN the development of such medicinal the development of such medicinal products. products.

Or. en

Amendment 94 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The work of the Emergency Task (18) While guaranteeing the Force should be separate from the work of independence of any subsequent the scientific committees of the Agency evaluations, the work of the Emergency and should be carried out without prejudice Task Force should be separate from the to the scientific assessments of those work of the scientific committees of the committees. The Emergency Task Force Agency and should be carried out without should provide recommendations with prejudice to the scientific assessments of regard to the use of medicinal products in those committees. The Emergency Task the fight against the disease that is Force should provide recommendations responsible for the public health crisis. The driven only by science and public-health Committee for Medicinal Products for needs and not by other interests, with Human Use should be able to use those regard to the use of medicinal products in recommendations when preparing the fight against the disease that is scientific opinions on compassionate or responsible for the public health crisis. The other early use of a medicinal product prior Committee for Medicinal Products for to marketing authorisation. Human Use should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation.

Or. en

Amendment 95 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The work of the Emergency Task (18) The work of the Emergency Task

AM\1227699EN.docx 21/137 PE691.131v01-00 EN Force should be separate from the work of Force should be separate from the work of the scientific committees of the Agency the scientific committees of the Agency and should be carried out without prejudice and should be carried out without prejudice to the scientific assessments of those to the scientific assessments of those committees. The Emergency Task Force committees. The Emergency Task Force should provide recommendations with should provide recommendations with regard to the use of medicinal products in regard to the use of medicinal products in the fight against the disease that is the fight to overcome the public health responsible for the public health crisis. The crisis. The Committee for Medicinal Committee for Medicinal Products for Products for Human Use should be able to Human Use should be able to use those use those recommendations when recommendations when preparing preparing scientific opinions on scientific opinions on compassionate or compassionate or other early use of a other early use of a medicinal product prior medicinal product prior to marketing to marketing authorisation. authorisation.

Or. en

Justification

Not every health crisis is resulted from a disease. For example, extreme heat waves can also lead to health crises.

Amendment 96 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Maria da Graça Carvalho

Proposal for a regulation Recital 19

Text proposed by the Commission Amendment

(19) The establishment of the (19) The establishment of the Emergency Task Force should build on the emergency task force is committed to support provided by the Agency during the overcome the divergencies among the COVID-19 pandemic, notably as regards individual regulatory frameworks, placing scientific advice on clinical trials design itself as guarantee and protection for EU and product development as well as the citizens. The task force should build on the ‘rolling’ review i.e. on an on-going basis, support provided by the Agency during the of emerging evidence to allow a more COVID-19 pandemic, notably as regards efficient assessment of medicinal products scientific advice on clinical trials design including vaccines during public health and product development as well as the emergencies. rolling review i.e. on an ongoing basis, of emerging evidence to allow a more efficient assessment of medical products including vaccines during public health emergencies.

PE691.131v01-00 22/137 AM\1227699EN.docx EN Or. en

Amendment 97 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Recital 19

Text proposed by the Commission Amendment

(19) The establishment of the (19) The establishment of the Emergency Task Force should build on the Emergency Task Force should build on the support provided by the Agency during the support provided by the Agency during the COVID-19 pandemic, notably as regards COVID-19 pandemic, notably as regards scientific advice on clinical trials design scientific advice on clinical trials design and product development as well as the and product development, the ‘rolling’ review i.e. on an on-going basis, transparency of related activities, of emerging evidence to allow a more including the rapid publishing clinical efficient assessment of medicinal products data for the products in question, as well including vaccines during public health as the ‘rolling’ review i.e. on an on-going emergencies. basis, of emerging evidence to allow a more efficient assessment of medicinal products including vaccines during public health emergencies.

Or. en

Amendment 98 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 19 a (new)

Text proposed by the Commission Amendment

(19 a) Experience with clinical trials during the COVID-19 pandemic revealed a tremendous amount of duplication, plethora of small trials, underrepresentation of important population groups and the lack of collaboration that increased the risk of research waste. To improve the clinical research agenda, there is a need for robust evidence on quality, efficacy and

AM\1227699EN.docx 23/137 PE691.131v01-00 EN safety of medicinal products through well- designed, well-supported, large, randomised and controlled trials. Clinical results and data of trials need to be made public.

Or. en

Amendment 99 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Josianne Cutajar, Alicia Homs Ginel

Proposal for a regulation Recital 20

Text proposed by the Commission Amendment

(20) Individual research entities may (20) Individual research entities may agree together, or with another party, to act agree together, or with another party, to act as a sponsor in order to prepare one as a sponsor in order to prepare one harmonised Union-wide clinical trial harmonised Union-wide clinical trial protocol, yet experience during the protocol, yet experience during the COVID-19 pandemic has shown that COVID-19 pandemic has shown that initiatives to set up large multinational initiatives to set up large multinational trials struggle to materialise due to the lack trials struggle to materialise due to the lack of a single entity that can undertake all the of a single entity that can undertake all the responsibilities and activities of a sponsor responsibilities and activities of a sponsor within the Union, while interacting with within the Union, while interacting with multiple Member States. It is therefore multiple Member States. It is therefore appropriate for the Agency to identify and appropriate for the Agency to identify and facilitate such initiatives by giving advice facilitate such initiatives by giving advice on the possibilities to act as a sponsor or, on the possibilities to act as a sponsor or, where applicable, to define respective where applicable, to define respective responsibilities as co-sponsors in responsibilities as co-sponsors in accordance with Article 72 of Regulation accordance with Article 72 of Regulation (EU) 536/2014. Such an approach would (EU) 536/2014. Such an approach would strengthen the research environment in the strengthen the research environment in the Union, and promote harmonisation and Union, while encouraging the avoid subsequent delays in integrating the collaboration with external experts results of research to a marketing including academia, and target authorisation. A Union sponsor could recruitment of data scientists, omics benefit from Union research funding specialists, biostatisticians, available at the time of the public health epidemiologists, and experts in advanced emergency as well as existing clinical trial analytics and AI, as well as to promote networks to facilitate the development, harmonisation and avoid subsequent delays application, submission, and running of the in integrating the results of research to a trial. This may be particularly valuable for marketing authorisation. A Union sponsor

PE691.131v01-00 24/137 AM\1227699EN.docx EN trials established by Union or international could benefit from Union research funding public health or research organisations. available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development, application, submission, and running of the trial. This may be particularly valuable for trials established by Union or international public health or research organisations.

Or. en

Amendment 100 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 20

Text proposed by the Commission Amendment

(20) Individual research entities may (20) Individual research entities may agree together, or with another party, to act agree together, or with another party, to act as a sponsor in order to prepare one as a sponsor in order to prepare one harmonised Union-wide clinical trial harmonised Union-wide clinical trial protocol, yet experience during the protocol, yet experience during the COVID-19 pandemic has shown that COVID-19 pandemic has shown that initiatives to set up large multinational initiatives to set up large multinational trials struggle to materialise due to the lack trials struggle to materialise due to the lack of a single entity that can undertake all the of a single entity that can undertake all the responsibilities and activities of a sponsor responsibilities and activities of a sponsor within the Union, while interacting with within the Union, while interacting with multiple Member States. It is therefore multiple Member States. It is therefore appropriate for the Agency to identify and appropriate for the Agency to identify and facilitate such initiatives by giving advice facilitate such initiatives by giving advice on the possibilities to act as a sponsor or, on the possibilities to act as a sponsor or, where applicable, to define respective where applicable, to define respective responsibilities as co-sponsors in responsibilities as co-sponsors in accordance with Article 72 of Regulation accordance with Article 72 of Regulation (EU) 536/2014. Such an approach would (EU) 536/2014 and coordinate the strengthen the research environment in the development of clinical trial protocols. Union, and promote harmonisation and Such an approach would strengthen the avoid subsequent delays in integrating the research environment in the Union, and results of research to a marketing promote harmonisation and avoid authorisation. A Union sponsor could subsequent delays in integrating the results benefit from Union research funding of research to a marketing authorisation. A available at the time of the public health Union sponsor could benefit from Union emergency as well as existing clinical trial research funding available at the time of networks to facilitate the development, the public health emergency as well as

AM\1227699EN.docx 25/137 PE691.131v01-00 EN application, submission, and running of the existing clinical trial networks to facilitate trial. This may be particularly valuable for the development, application, submission, trials established by Union or international and running of the trial. This may be public health or research organisations. particularly valuable for trials established by Union or international public health or research organisations or other non- commercial entities.

Or. en

Amendment 101 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 20 a (new)

Text proposed by the Commission Amendment

(20 a) The Emergency Task Force should review clinical trial protocols and advice developers on clinical trials that are conducted in the Union. The Emergency Task Force should define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials, so that they can meet the criteria for effective public health interventions.

Or. en

Amendment 102 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 21

Text proposed by the Commission Amendment

(21) With respect to medical devices, an (21) With respect to medical devices, an executive steering group on medical executive steering group on medical devices should be established to coordinate devices should be established to coordinate urgent actions within the Union in relation urgent actions within the Union in relation to the management of supply and demand to the management of supply and demand

PE691.131v01-00 26/137 AM\1227699EN.docx EN issues of medical devices, and to establish issues of medical devices, and to establish a list of critical devices in the case of a a list of critical devices for the most public health emergency. probable cases of public health emergencies.

Or. en

Amendment 103 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) This Regulation also provides the (22) This Regulation also provides the Agency with a role to support the expert Agency with a role to support the expert panels on medical devices designated panels on medical devices designated under Commission Implementing Decision under Commission Implementing Decision (EU) 2019/139612 to provide independent (EU) 2019/139612 to provide independent scientific and technical assistance to the scientific and technical assistance to the Member States, the Commission, the Member States, the Commission, the Medical Device Coordination Group Medical Device Coordination Group (MDCG), notified bodies and (MDCG), notified bodies and manufacturers. manufacturers, while upholding maximum transparency as a condition for fostering trust and confidence in the EU regulatory system. ______12 Commission Implementing Decision 12 Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of laying down the rules for the application of Regulation (EU) 2017/745 of the European Regulation (EU) 2017/745 of the European Parliament and of the Council as regards Parliament and of the Council as regards the designation of expert panels in the field the designation of expert panels in the field of medical devices OJ L 234, 11.9.2019, p. of medical devices OJ L 234, 11.9.2019, p. 23 23

Or. en

Amendment 104 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation

AM\1227699EN.docx 27/137 PE691.131v01-00 EN Recital 23 a (new)

Text proposed by the Commission Amendment

(23 a) Temporary exemption from the conformity assessment procedure for medical devices should only be considered in exceptional circumstances. Before allowing for such a derogation, the considerations should take into account both the safety of citizens using the device and the safety of the product. Only if both can be ensured even without a conformity assessment procedure, and the benefits for safeguarding supply outweigh the risks, a temporary exemption could be offered.

Or. en

Amendment 105 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 24

Text proposed by the Commission Amendment

(24) Given the Agency’s long-standing (24) Given the Agency’s long-standing and proven record of expertise in the field and proven record of expertise in the field of medicinal products and considering the of medicinal products and considering the Agency’s experience from working with a Agency’s experience from working with a multitude of groups of experts, it is multitude of groups of experts, it is appropriate to establish the appropriate appropriate to establish the appropriate structures within the Agency to monitor structures within the Agency to monitor potential shortages of medical devices in potential shortages of medical devices in the context of a public health emergency the context of a public health emergency and to provide the Agency with a mandate and to provide the Agency with a mandate to host the expert panels on medical to host the expert panels on medical devices. This would allow for long-term devices. In this regard, all national and, sustainability for the functioning of the eventually, Union entities that are panels and provide clear synergies with engaged in stockpiling of medical devices, related crisis preparedness work for should report their stocks to the Agency. medicinal products. Those structures would This would allow for long-term in no way change the regulatory system or sustainability for the functioning of the the decision-making procedures in the area panels and provide clear synergies with of medical devices already in place in the related crisis preparedness work for

PE691.131v01-00 28/137 AM\1227699EN.docx EN Union, which should remain clearly medicinal products. Those structures would distinct from the one for medicinal in no way change the regulatory system or products. the decision-making procedures in the area of medical devices already in place in the Union, which should remain clearly distinct from the one for medicinal products.

Or. en

Justification

As the Commission plans to issue a legislative proposal for a new EU agency HERA which should engage, inter alia, in stockpiling, it is appropriate to address future developments in a recital of this regulation.

Amendment 106 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel

Proposal for a regulation Recital 25

Text proposed by the Commission Amendment

(25) In order to facilitate the work and (25) In order to facilitate the work and the exchange of information under this the exchange of information under this Regulation, provision should be made for Regulation, provision should be made the establishment and management of IT through further implementing acts with a infrastructures and synergies with other view to outlining the roles of the actors existing IT systems or systems under involved in the processing of personal development, including the EUDAMED IT data for the establishment and management platform for medical devices. That work of IT infrastructures and synergies with should also be facilitated by, where other existing IT systems or systems under appropriate, emerging digital technologies development, including the EUDAMED IT such as computational models and platform for medical devices and Data simulations for clinical trials, as well as Analysis and Real World Interrogation data from the EU Space Programme such Network - DARWIN. That work should as the Galileo geolocation services, and also be facilitated by, where appropriate, Copernicus earth observation data. emerging digital technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation services, and Copernicus earth observation data, while enabling data discoverability.

AM\1227699EN.docx 29/137 PE691.131v01-00 EN Or. en

Amendment 107 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Maria da Graça Carvalho

Proposal for a regulation Recital 25

Text proposed by the Commission Amendment

(25) In order to facilitate the work and (25) In order to facilitate the work and the exchange of information under this the exchange of information under this Regulation, provision should be made for Regulation, provision should be made for the establishment and management of IT the establishment and management of IT infrastructures and synergies with other infrastructures and synergies with other existing IT systems or systems under existing IT systems or systems under development, including the EUDAMED IT development, including the use of the platform for medical devices. That work European Medicines Verification System should also be facilitated by, where (set up in the context of the Falsified appropriate, emerging digital technologies Medicines FMD) data for preventing such as computational models and medicines shortages in an epidemiological simulations for clinical trials, as well as crisis by enabling national regulators to data from the EU Space Programme such assess the availability of products versus as the Galileo geolocation services, and what has been consumed or parallel Copernicus earth observation data. exported in their market, as well as the Substance, product, organisation and referential (SPOR) master management1a for human medicines and the EUDAMED IT platform for medical devices. ______1a https://www.ema.europa.eu/en/human- regulatory/research-development/data- medicines-iso-idmp-standards/substance- product-organisation-referential-spor- master-data

Or. en

Amendment 108 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Recital 25

PE691.131v01-00 30/137 AM\1227699EN.docx EN Text proposed by the Commission Amendment

(25) In order to facilitate the work and (25) In order to facilitate the work and the exchange of information under this the exchange of information under this Regulation, provision should be made for Regulation, provision should be made for the establishment and management of IT the establishment and management of IT infrastructures and synergies with other infrastructures and synergies with other existing IT systems or systems under existing IT systems or systems under development, including the EUDAMED IT development, including use of including platform for medical devices. That work use of the European Medicines should also be facilitated by, where Verification System (set up in the context appropriate, emerging digital technologies of the Falsified Medicines FMD) data for such as computational models and mapping consumption for human simulations for clinical trials, as well as medicines and preventing medicines data from the EU Space Programme such shortages, and of the Substance, product, as the Galileo geolocation services, and organisation and referential (SPOR) Copernicus earth observation data. master management1 for human medicines and the EUDAMED IT platform for medical devices.

Or. en

Amendment 109 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Josianne Cutajar, Alicia Homs Ginel

Proposal for a regulation Recital 25 a (new)

Text proposed by the Commission Amendment

(25 a) Underlines the potential of Big Data to complement the evidence from clinical trials and fill knowledge gaps on medicines, as well as to help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems. The global pandemic has also shown how High Performance Computing, in combination with Big Data and AI, can be of critical importance in the global fight against COVID-19.

Or. en

AM\1227699EN.docx 31/137 PE691.131v01-00 EN Amendment 110 Patrizia Toia

Proposal for a regulation Recital 25 a (new)

Text proposed by the Commission Amendment

(25 a) Calling upon the NCAs to establish a reliable and harmonized pan- European interoperable and digital reporting system consisting of harmonized and common data fields and able to operate with other systems like SPOR, EMA systems and iSPOC and operate in a digital environment and having and effective alert system to discriminate between national and/or pan-European shortages and preventing duplication of shortages reporting.

Or. en

Amendment 111 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel

Proposal for a regulation Recital 26

Text proposed by the Commission Amendment

(26) Rapid access and exchange of (26) Rapid access and exchange of health data, including real world data i.e. health data, including real world data i.e. health data generated outside of clinical health data generated outside of clinical studies, is essential to ensure effective studies, such as electronic health records, management of public health emergencies insurance claims data and data from and other major events. This Regulation patient registries, is essential to ensure should allow the Agency to use and effective management of public health facilitate such exchange and be part of the emergencies and other major events. This establishment and operation of the Regulation should allow the Agency to use European Health Data Space infrastructure. and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure, while ensuring the applicability of the GDPR and EUDPR, and the respect of the principles relating to the processing of

PE691.131v01-00 32/137 AM\1227699EN.docx EN personal data (as per Article 5 GDPR and 4 EUDPR).

Or. en

Amendment 112 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Maria da Graça Carvalho

Proposal for a regulation Recital 26

Text proposed by the Commission Amendment

(26) Rapid access and exchange of (26) Rapid access and exchange of health data, including real world data i.e. health data, including real world data i.e. health data generated outside of clinical health data generated outside of clinical studies, is essential to ensure effective studies, is essential to ensure effective management of public health emergencies management of public health emergencies and other major events. This Regulation and other major events. This Regulation should allow the Agency to use and should allow the Agency to use and facilitate such exchange and be part of the facilitate such exchange and be part of the establishment and operation of the establishment and operation of the European Health Data Space infrastructure. European Health Data Space infrastructure. It shall allow as well the definition of programs and data collection systems relating to outcomes, results, adverse and undesiderable events usable for all developers.

Or. en

Amendment 113 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 26

Text proposed by the Commission Amendment

(26) Rapid access and exchange of (26) Rapid access and exchange of health data, including real world data i.e. health data, including real world data i.e. health data generated outside of clinical health data generated outside of clinical studies, is essential to ensure effective studies, is essential to ensure effective management of public health emergencies management of public health emergencies

AM\1227699EN.docx 33/137 PE691.131v01-00 EN and other major events. This Regulation and other major events. This Regulation should allow the Agency to use and should allow the Agency to use and facilitate such exchange and be part of the facilitate such exchange and be part of the establishment and operation of the establishment and operation of the European Health Data Space infrastructure. European Health Data Space infrastructure. It is of utmost importance to ensure that health data is used in full respect to the provisions of the GDPR on personal data protection.

Or. en

Amendment 114 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Recital 26

Text proposed by the Commission Amendment

(26) Rapid access and exchange of (26) Rapid access and exchange of health data, including real world data i.e. health data, including when generated with health data generated outside of clinical appropriate quality criteria, real world studies, is essential to ensure effective data i.e. health data generated outside of management of public health emergencies clinical studies, can be essential as and other major events. This Regulation supportive evidence or signal-eliciting should allow the Agency to use and evidence to ensure effective management facilitate such exchange and be part of the of public health emergencies and other establishment and operation of the major events. This Regulation should allow European Health Data Space infrastructure. the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure.

Or. en

Amendment 115 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Recital 26 a (new)

Text proposed by the Commission Amendment

(26 a) It is imperative to have in place

PE691.131v01-00 34/137 AM\1227699EN.docx EN robust transparency measures and standards regarding the Agency’s regulatory activities on treatments, vaccines and medical devices falling under the scope of this Regulation. These measures should include timely publication of all relevant information on approved products and clinical data, having taken due regard to protection of personal data protection and commercially confidential information. The Agency should make public the recommendations, opinions and decisions from the steering groups. The membership of the steering groups and working parties should be made public. Members of the steering groups and experts should not have financial or other interests in the pharmaceutical industry which could affect their impartiality;

Or. en

Amendment 116 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel

Proposal for a regulation Recital 26 a (new)

Text proposed by the Commission Amendment

(26 a) The handling of sensitive health data requires a high level of protection against cyber-attacks. The Agency was the target of a cyber-attack that resulted in some of the unlawfully accessed documents related to COVID-19 medicines and vaccines belonging to third parties. Highlights in this respect the need for a high level of security against cyber- attacks, and particularly cyber-espionage, at all times and especially during public health emergencies;

Or. en

AM\1227699EN.docx 35/137 PE691.131v01-00 EN Amendment 117 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel

Proposal for a regulation Recital 26 a (new)

Text proposed by the Commission Amendment

(26 a) Calls for the swift implementation of binding rules on security information and cybersecurity in line with the Security Union Strategy. Urges the Member States to accelerate the work towards completing the implementation of the main 5G Toolbox measures by the second quarter of 2021;

Or. en

Amendment 118 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Recital 27

Text proposed by the Commission Amendment

(27) During a public health emergency (27) During a public health emergency or in relation to a major event, the Agency or in relation to a major event, the Agency should ensure cooperation with the should ensure cooperation with the European Centre for Disease Prevention European Centre for Disease Prevention – and Control and other Union Agencies as which should provide forecasts in a timely appropriate. Such cooperation should manner to relevant actor of the include data sharing, including data on pharmaceutical supply chain - and epidemiological forecasting, regular Control and other Union Agencies as communication at an executive level, and appropriate. Such cooperation should invitations to representatives of the include data sharing, including data on European Centre for Disease Prevention epidemiological forecasting, regular and Control and other Union Agencies to communication at an executive level, and attend meetings of the Emergency Task invitations to representatives of the Force, the Medicines Steering Group, and European Centre for Disease Prevention the Medical Devices Steering Group, as and Control and other Union Agencies to appropriate. attend meetings of the Emergency Task

PE691.131v01-00 36/137 AM\1227699EN.docx EN Force, the Medicines Steering Group, and the Medical Devices Steering Group, as appropriate. Regular two-way communication and exchange of information between regulators, industry and pertinent stakeholders of the pharmaceutical supply chain shall also be guaranteed to kick off prompt debates about estimated potential drug shortages in the market by way of sharing expected supply constraints which authorities become aware of via the notification process, allowing better coordination, interactions and proper response when required;

Or. en

Amendment 119 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Recital 28

Text proposed by the Commission Amendment

(28) Since the objectives of this (28) As stressed out as well by Regulation cannot be sufficiently achieved EU4Health Programme recently adopted by the Member States alone due to the by the EU, since the objectives of this cross-border dimension of public health Regulation cannot be sufficiently achieved emergencies and major events and can, by the Member States alone due to the therefore, be better achieved at Union cross-border dimension of public health level, the Union may adopt measures, in emergencies and major events and can, accordance with the principle of therefore, be better achieved at Union subsidiarity as set out in Article 5 of the level, the Union may adopt measures, in Treaty on European Union. In accordance accordance with the principle of with the principle of proportionality, as set subsidiarity as set out in Article 5 of the out in that Article, this Regulation does not Treaty on European Union. In accordance go beyond what is necessary in order to with the principle of proportionality, as set achieve those objectives. out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

Or. en

AM\1227699EN.docx 37/137 PE691.131v01-00 EN Amendment 120 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Recital 29 a (new)

Text proposed by the Commission Amendment

(29 a) In order to ensure that the democratic oversight on EMA is maintained, especially in times of crisis, the Commission commits to answer questions asked by Members of the European Parliament before the deadline expires;

Or. en

Amendment 121 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Recital 31 a (new)

Text proposed by the Commission Amendment

(31 a) To enable the Agency to be better prepared for the consequences of major events for human or veterinary medicinal products and public health emergencies, it is necessary to establish an European High Level Forum composed by health and pharmaceutical experts, Agency members and other interested parties with the purpose of sharing useful information, exchanging different points of view and finding appropriate solutions.

Or. en

Amendment 122 Patrizia Toia

Proposal for a regulation

PE691.131v01-00 38/137 AM\1227699EN.docx EN Recital 31 a (new)

Text proposed by the Commission Amendment

(31 a) Shortages consist of different and complex root causes which still need to be further mapped, understood and analysed together with all different stakeholders to be capable of addressing all the different root causes . A better understanding of the should include identification of bottlenecks in the supply chain;

Or. en

Amendment 123 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Recital 31 a (new)

Text proposed by the Commission Amendment

(31 a) Recalls the applicability of the GDPR and EUDPR and the respect of the principles relating to the processing of personal data (as per Article 5 GDPR and 4EUDPR);

Or. en

Amendment 124 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Recital 31 b (new)

Text proposed by the Commission Amendment

(31 b) Calling upon the National Competent Authorities (NCAs) to establish a reliable and harmonised pan- European interoperable and digital

AM\1227699EN.docx 39/137 PE691.131v01-00 EN reporting system for shortages and preventing duplication of shortages reporting. The standardized reporting requirements for information on clearly defined shortages should be agreed, giving priority to critical products with high potential impact. For this the NCAs need to establish a uniform harmonized pan-European interoperable and digital NCAs reporting system consisting of harmonised and common data fields and interoperable with other systems like Substance, product, organisation and referential (SPOR) master management, EMA systems and Industry Single Point of Contact (iSPOC) and operating in a digital environment and having and effective alert system to discriminate between national and/or pan-European shortages;

Or. en

Amendment 125 Patrizia Toia

Proposal for a regulation Recital 31 b (new)

Text proposed by the Commission Amendment

(31 b) During COVID-19’s emergency, the regulatory flexibility allowed by the Commission has proven to be a tool for industry to prevent shortages. Such regulatory flexibilities should also be feasible outside of a crisis to help manufacturers to prevent shortages;

Or. en

Amendment 126 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

PE691.131v01-00 40/137 AM\1227699EN.docx EN Proposal for a regulation Recital 31 c (new)

Text proposed by the Commission Amendment

(31 c) In order to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, identification of human medicinal products will be based on the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP);

Or. en

Amendment 127 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Recital 31 d (new)

Text proposed by the Commission Amendment

(31 d) acknowledges the role of the pharmaceutical industry during the COVID-19 crisis and the fact that industry demonstrated resilience, through continued manufacturing, avoiding any major supply disruption for patients during the whole COVID-19 crisis;

Or. en

Amendment 128 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Recital 31 e (new)

AM\1227699EN.docx 41/137 PE691.131v01-00 EN Text proposed by the Commission Amendment

(31 e) Shortages consist of different and complex root causes which still need to be further mapped, understood and analysed together with all different stakeholders to be capable of addressing all the different root causes. A better understanding of the root causes and drivers of shortages should include identification of bottlenecks in the supply chain via the European Medicines Verification System (set up in the context of the Falsified Medicines Directive) could readily be used for this purpose;

Or. en

Amendment 129 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Recital 31 f (new)

Text proposed by the Commission Amendment

(31 f) During COVID-19 the regulatory flexibility allowed by the Commission has proven to be a tool for industry to prevent shortages. Such regulatory flexibilities, such as electronic product information (e- leaflet), should also be feasible outside of a crisis to help manufacturers to prevent shortages.

Or. en

Amendment 130 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 1 – paragraph 1 – point b

PE691.131v01-00 42/137 AM\1227699EN.docx EN Text proposed by the Commission Amendment

(b) monitor and report on shortages of (b) monitor and report to prevent on medicinal products for human use and shortages of medicinal products for human medical devices; use and medical devices;

Or. en

Amendment 131 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 1 – paragraph 1 a (new)

Text proposed by the Commission Amendment

This Regulation shall not prejudice the potential expansion of this framework by subsequent legislation in order to be applicable on a permanent basis beyond public health emergencies and major events.

Or. en

Amendment 132 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 2 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) ‘public health emergency’ means a (a) ‘public health emergency’ means a public health emergency at Union level public health emergency at Union level recognised by the European Commission in recognised by the European Commission in accordance with Article 23(1) of accordance with Article 23(1) of Regulation (EU) 2020/[…]17 ; Regulation (EU) 2020/[…]17 ;arising from a threat of human, animal, plant, food or environmental origin having a health dimension which requires urgent action by Authorities. ______

AM\1227699EN.docx 43/137 PE691.131v01-00 EN 17 [insert reference to the Regulation of the 17 [insert reference to the Regulation of the European Parliament and of the Council on European Parliament and of the Council on serious cross-border threats to health and serious cross-border threats to health and repealing Decision No 1082/2013/EU] OJ repealing Decision No 1082/2013/EU] OJ C […], […], p. […]. C […], […], p. […].

Or. en

Amendment 133 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 2 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) ‘public health emergency’ means a (a) ‘public health emergency’ means a public health emergency at Union level public health emergency at Union level recognised by the European Commission in recognised by the European Commission in accordance with Article 23(1) of accordance with Article 23(1) of Regulation (EU) 2020/[…]17 ; Regulation (EU) 2020/[…]17 and the Agency will define upfront the actual criteria to capture the drivers of such an emergency in Article 3. ______17 [insert reference to the Regulation of the 17 [insert reference to the Regulation of the European Parliament and of the Council on European Parliament and of the Council on serious cross-border threats to health and serious cross-border threats to health and repealing Decision No 1082/2013/EU] OJ repealing Decision No 1082/2013/EU] OJ C […], […], p. […]. C […], […], p. […].

Or. en

Amendment 134 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 2 – paragraph 1 – point d

Text proposed by the Commission Amendment

(d) ‘shortage’ means that supply of a (d) ‘shortage’ means that supply of a

PE691.131v01-00 44/137 AM\1227699EN.docx EN medicinal product for human use or a medicinal product for human use or a medical device does not meet demand for medical device does not meet that medicinal product or medical device; patients' demand plus appropriate buffer stock for that medicinal product or medical device at national level;

Or. en

Amendment 135 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 2 – paragraph 1 – point d

Text proposed by the Commission Amendment

(d) ‘shortage’ means that supply of a (d) ‘shortage’ means that supply of a medicinal product for human use or a medicinal product for human or veterinary medical device does not meet demand for use or a medical device does not meet that medicinal product or medical device; patient need for that medicinal product or medical device at national level no matter the cause;

Or. en

Amendment 136 Patrizia Toia

Proposal for a regulation Article 2 – paragraph 1 – point d

Text proposed by the Commission Amendment

(d) ‘shortage’ means that supply of a (d) ‘shortage’ means that supply of a medicinal product for human use or a medicinal product for human use or a medical device does not meet demand for medical device does not meet demand that medicinal product or medical device; patient and healthcare actors’ needs for that medicinal product or medical device at national level;

Or. en

Amendment 137

AM\1227699EN.docx 45/137 PE691.131v01-00 EN Pietro Fiocchi

Proposal for a regulation Article 2 – paragraph 1 – point d

Text proposed by the Commission Amendment

(d) ‘shortage’ means that supply of a (d) ‘shortage’ means that supply of a medicinal product for human use or a medicinal product for human or veterinary medical device does not meet demand for use or a medical device does not meet that medicinal product or medical device; demand for that medicinal product or medical device for patient need, no matter the cause;

Or. en

Amendment 138 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 2 – paragraph 1 – point d

Text proposed by the Commission Amendment

(d) ‘shortage’ means that supply of a (d) ‘shortage’ means that supply of a medicinal product for human use or a medicinal product for human use or a medical device does not meet demand for medical device does not meet patient and that medicinal product or medical device; healthcare actor’s needs at national level for a period of more than two weeks.

Or. en

Amendment 139 Carlo Calenda

Proposal for a regulation Article 2 – paragraph 1 – point d

Text proposed by the Commission Amendment

(d) ‘shortage’ means that supply of a (d) ‘shortage’ means that supply of a medicinal product for human use or a medicinal product for human use or a medical device does not meet demand for medical device does not meet patients' that medicinal product or medical device; needs for that medicinal product or medical device at national level;

PE691.131v01-00 46/137 AM\1227699EN.docx EN Or. it

Amendment 140 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 2 – paragraph 1 – point e

Text proposed by the Commission Amendment

(e) ‘developer’ means any legal or (e) ‘developer’ means any legal or natural person seeking to generate natural person holding intellectual scientific data with regard to the quality, property rights for a medicinal product safety and efficacy of a medicinal product and who, as part of that product’s as part of that product’s development; development, is seeking to generate scientific data with regard to the product's quality, safety and efficacy;

Or. en

Amendment 141 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 2 – paragraph 1 – point f

Text proposed by the Commission Amendment

(f) ‘major event’ means an event (f) ‘major event’ means an event which is likely to pose a serious risk to which is likely to pose a serious risk to public health in relation to medicinal public health in relation to medicinal products in more than one Member State. products in more than one Member State. Such an event concerns a deadly threat or Such an event concerns a deadly threat or otherwise serious threat to health of otherwise serious threat to health of biological, chemical, environmental or biological, chemical, environmental or other origin or incident that can affect the other origin or incident that can affect the supply or quality, safety, and efficacy of demand and/or supply, or quality, safety, medicinal products. Such an event may and efficacy of medicinal products. Such lead to shortages of medicinal products in an event may lead to shortages of critical more than one Member State and medicinal products in more than one necessitates urgent coordination at Union Member State and necessitates urgent level in order to ensure a high level of coordination at Union level in order to human health protection. ensure a high level of human health protection.

AM\1227699EN.docx 47/137 PE691.131v01-00 EN Or. en

Amendment 142 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 2 – paragraph 1 – point f

Text proposed by the Commission Amendment

(f) ‘major event’ means an event (f) ‘major event’ means an event which is likely to pose a serious risk to which is likely to pose a serious risk to public health in relation to medicinal public health in relation to medicinal products in more than one Member State. products in more than one Member State. Such an event concerns a deadly threat or Such an event concerns a deadly threat or otherwise serious threat to health of otherwise serious threat to health of biological, chemical, environmental or biological, chemical, environmental or other origin or incident that can affect the other origin or incident that can affect the supply or quality, safety, and efficacy of demand and/or supply or quality, safety, medicinal products. Such an event may and efficacy of medicinal products. Such lead to shortages of medicinal products in an event may lead to shortages of critical more than one Member State and medicinal products in more than one necessitates urgent coordination at Union Member State and necessitates urgent level in order to ensure a high level of coordination at Union level in order to human health protection. ensure a high level of human health protection.

Or. en

Amendment 143 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 2 – paragraph 1 – point f

Text proposed by the Commission Amendment

(f) ‘major event’ means an event (f) ‘major event’ means an event which is likely to pose a serious risk to which is likely to pose a serious risk to public health in relation to medicinal public health in relation to medicinal products in more than one Member State. products in one or more Member States. Such an event concerns a deadly threat or Such an event concerns a deadly threat or otherwise serious threat to health of otherwise serious threat to health of biological, chemical, environmental or biological, chemical, environmental or

PE691.131v01-00 48/137 AM\1227699EN.docx EN other origin or incident that can affect the other origin or incident that can affect the supply or quality, safety, and efficacy of supply and availability or quality, safety, medicinal products. Such an event may and efficacy of medicinal products. Such lead to shortages of medicinal products in an event may lead to shortages of more than one Member State and medicinal products and/or medical necessitates urgent coordination at Union devices in one or more Member State and level in order to ensure a high level of necessitates urgent coordination at Union human health protection. level in order to ensure a high level of human health protection.

Or. en

Amendment 144 Patrizia Toia

Proposal for a regulation Article 2 – paragraph 1 – point f

Text proposed by the Commission Amendment

(f) ‘major event’ means an event (f) ‘major event’ means an event which is likely to pose a serious risk to which is likely to pose a serious risk to public health in relation to medicinal public health in relation to medicinal products in more than one Member State. products in more than one Member State. Such an event concerns a deadly threat or Such an event concerns a deadly threat or otherwise serious threat to health of otherwise serious threat to health of biological, chemical, environmental or biological, chemical, environmental or other origin or incident that can affect the other origin or incident that can affect the supply or quality, safety, and efficacy of demand and/or supply, or quality, safety, medicinal products. Such an event may and efficacy of medicinal products. Such lead to shortages of medicinal products in an event may lead to shortages of critical more than one Member State and medicinal products in more than one necessitates urgent coordination at Union Member State and necessitates urgent level in order to ensure a high level of coordination at Union level in order to human health protection. ensure a high level of human health protection.

Or. en

Amendment 145 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Josianne Cutajar, Alicia Homs Ginel

Proposal for a regulation Article 2 – paragraph 1 – point f

AM\1227699EN.docx 49/137 PE691.131v01-00 EN Text proposed by the Commission Amendment

(f) ‘major event’ means an event (f) ‘major event’ means an event which is likely to pose a serious risk to which is likely to pose a serious risk to public health in relation to medicinal public health in relation to medicinal products in more than one Member State. products in more than one Member State. Such an event concerns a deadly threat or Such an event concerns a deadly threat or otherwise serious threat to health of otherwise serious threat to health of biological, chemical, environmental or biological, chemical, environmental or other origin or incident that can affect the other origin or incident that can affect the supply or quality, safety, and efficacy of manufacturing, supply or quality, safety, medicinal products. Such an event may and efficacy of medicinal products. Such lead to shortages of medicinal products in an event may lead to shortages of more than one Member State and medicinal products in more than one necessitates urgent coordination at Union Member State and necessitates urgent level in order to ensure a high level of coordination at Union level in order to human health protection. ensure a high level of human health protection.

Or. en

Amendment 146 Carlo Calenda

Proposal for a regulation Article 2 – paragraph 1 – point f

Text proposed by the Commission Amendment

(f) ‘major event’ means an event (f) ‘major event’ means an event which is likely to pose a serious risk to which is likely to pose a serious risk to public health in relation to medicinal public health in relation to medicinal products in more than one Member State. products in more than one Member State. Such an event concerns a deadly threat or Such an event concerns a deadly threat or otherwise serious threat to health of otherwise serious threat to health of biological, chemical, environmental or biological, chemical, environmental or other origin or incident that can affect the other origin or incident that can affect the supply or quality, safety, and efficacy of demand for, and/or supply or quality, medicinal products. Such an event may safety, and efficacy of, medicinal products. lead to shortages of medicinal products in Such an event may lead to shortages of more than one Member State and medicinal products in more than one necessitates urgent coordination at Union Member State and necessitates urgent level in order to ensure a high level of coordination at Union level in order to human health protection. ensure a high level of human health protection.

Or. it

PE691.131v01-00 50/137 AM\1227699EN.docx EN Amendment 147 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 3 – paragraph 1

Text proposed by the Commission Amendment

1. The Executive Steering Group on 1. The Executive Steering Group on Shortages and Safety of Medicinal Shortages and Safety of Medicinal Products (‘the Medicines Steering Group’) Products (‘the Medicines Steering Group’) is hereby established as part of the Agency. is hereby established as part of the Agency. It shall meet either in person or remotely, It shall meet either in person or remotely. in preparation for or during a public health Meetings may be scheduled in preparation emergency or following a request for for or during a public health emergency or assistance referred to in Article 4(3). The following a request for assistance referred Agency shall provide its secretariat. to in Article 4(3) or to deal with a shortage that has been declared by at least one Member State. The Agency shall provide its secretariat.

Or. en

Amendment 148 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 3 – paragraph 1 a (new)

Text proposed by the Commission Amendment

1 a. The Medicines Steering Group will be established for a fixed term and will cease its activities when the health emergency or the imminent major event has been declared to end.

Or. en

Amendment 149 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

AM\1227699EN.docx 51/137 PE691.131v01-00 EN Proposal for a regulation Article 3 – paragraph 2

Text proposed by the Commission Amendment

2. The Medicines Steering Group 2. The Medicines Steering Group shall be composed of a representative of shall be composed of a representative of the Agency, a representative of the the Agency, a representative of the Commission and one senior representative Commission and one senior representative per Member State. Each Member State per Member State. Each Member State shall appoint their representative. Members shall appoint their representative. Members may be accompanied by experts in specific may be accompanied by experts in specific scientific or technical fields. scientific or technical fields. The declarations of interests of all experts shall be made public and all necessary restrictions shall apply where conflicts of interest occur.

Or. en

Amendment 150 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 3 – paragraph 2 a (new)

Text proposed by the Commission Amendment

2 a. The membership of the Medicines Steering Group shall be made public. Members of the Medicines Steering Group and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to the industry shall be entered in a register held by the Agency and shall be accessible to the public, on request.

Or. en

PE691.131v01-00 52/137 AM\1227699EN.docx EN Amendment 151 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 3 – paragraph 3

Text proposed by the Commission Amendment

3. The Medicines Steering Group 3. The Medicines Steering Group shall be chaired by the Agency. The Chair shall be chaired by the Agency. The Chair may invite third parties, including should invite third parties, including representatives of medicinal product representatives of medicinal product interest groups and marketing authorisation interest groups and marketing authorisation holders to attend its meetings. holders to attend its meetings. The chair shall ensure that a broad spectrum of opinions is taken into account. The chair shall ensure that the stakeholders in the medicines supply chain can give an informed opinion about the situation in the various Member States concerned;

Or. en

Amendment 152 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 3 – paragraph 3

Text proposed by the Commission Amendment

3. The Medicines Steering Group 3. The Medicines Steering Group shall be chaired by the Agency. The Chair shall be chaired by the Agency. The Chair may invite third parties, including may invite third parties, including representatives of medicinal product representatives of medicinal product interest groups and marketing authorisation interest groups and marketing authorisation holders to attend its meetings. holders, representatives of patients, consumers and healthcare professionals to attend its meetings. To avoid market distortions, the Medicines Steering Group shall ensure that data is evenly shared within or withheld from all marketing authorisation holders.

Or. en

AM\1227699EN.docx 53/137 PE691.131v01-00 EN Amendment 153 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 3 – paragraph 3

Text proposed by the Commission Amendment

3. The Medicines Steering Group 3. The Medicines Steering Group shall be chaired by the Agency. The Chair shall be chaired by the Agency. The Chair may invite third parties, including may invite third parties, including representatives of medicinal product representatives of medicinal product interest groups and marketing authorisation interest groups and marketing authorisation holders to attend its meetings. holders, via the industry single point of contact (iSPOC), and other stakeholders in the medicines supply chain as well as interest groups representing patients and healthcare professionals, to attend its meetings.

Or. en

Amendment 154 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 3 – paragraph 3

Text proposed by the Commission Amendment

3. The Medicines Steering Group 3. The Medicines Steering Group shall be chaired by the Agency. The Chair shall be chaired by the Agency. The Chair may invite third parties, including may decide to hear third parties, including representatives of medicinal product marketing authorisation holders, interest groups and marketing developers of medicinal products, clinical authorisation holders to attend its trial experts, public-health advocacy meetings. groups, sectoral trade unions, consumer and patient organisations, as well as healthcare professionals.

Or. en

Amendment 155

PE691.131v01-00 54/137 AM\1227699EN.docx EN Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 3 – paragraph 4

Text proposed by the Commission Amendment

4. The Medicines Steering Group 4. The Medicines Steering Group shall establish its rules of procedure shall establish its rules of procedure including procedures relating to the including procedures relating to the working party referred to the paragraph 5 working party referred to the paragraph 5 and on the adoption of lists, sets of and on the adoption of lists, sets of information, and recommendations. The information, and recommendations. The rules of procedure shall enter into force rules of procedure shall enter into force after receiving a favourable opinion from after receiving a favourable opinion from the Commission and the Management the Commission and the Management Board of the Agency. Board of the Agency. After being established, these rules shall be made publicly available.

Or. en

Amendment 156 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 3 – paragraph 4

Text proposed by the Commission Amendment

4. The Medicines Steering Group 4. The Medicines Steering Group shall establish its rules of procedure shall establish its rules of procedure including procedures relating to the including the clarified mention of its working party referred to the paragraph 5 competences, procedures relating to the and on the adoption of lists, sets of working party referred to the paragraph 5 information, and recommendations. The and on the adoption of lists, sets of rules of procedure shall enter into force information, and recommendations. The after receiving a favourable opinion from rules of procedure shall enter into force the Commission and the Management after receiving a favourable opinion from Board of the Agency. the Commission and the Management Board of the Agency.

Or. en

Amendment 157

AM\1227699EN.docx 55/137 PE691.131v01-00 EN Patrizia Toia

Proposal for a regulation Article 3 – paragraph 5

Text proposed by the Commission Amendment

5. The Medicines Steering Group 5. The Medicines Steering Group shall be supported in its work by a working shall be supported in its work by a working party comprised of single points of contact party comprised of single points of contact related to shortages from national related to shortages from industry (iSPOC) competent authorities for medicinal and a two way communication line need products established in accordance with to be established between the Medicines Article 9(1). Steering Group and the iSPOC.

Or. en

Amendment 158 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 3 – paragraph 5 a (new)

Text proposed by the Commission Amendment

5 a. The Medicines Steering Group shall be supported in its work by a working party comprised of industry single points of contact related to shortages (iSPOC) and a two way communication line need to be established between the Medicines Steering Group and the iSPOC.

Or. en

Amendment 159 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 3 – paragraph 6 a (new)

PE691.131v01-00 56/137 AM\1227699EN.docx EN Text proposed by the Commission Amendment

6 a. The Medicines Steering Group shall exercise its competencies in full compliance with the principles of proportionality and subsidiarity.

Or. en

Amendment 160 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 4 – paragraph 1

Text proposed by the Commission Amendment

1. The Agency shall continuously 1. The Agency shall continuously monitor any event that is likely to lead to a monitor any event that has the potential to major event or a public health emergency. lead to a major event or a public health emergency. In this regard, the Agency shall cooperate closely with the European Centre for Disease Prevention and Control or other Union agencies, where relevant.

Or. en

Amendment 161 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 4 – paragraph 1

Text proposed by the Commission Amendment

1. The Agency shall continuously 1. The Agency shall continuously monitor any event that is likely to lead to a monitor any event that is likely to lead to a major event or a public health emergency. major event or a public health emergency and it should be capable of establishing the necessary preventive mechanisms that are necessary-.

Or. en

AM\1227699EN.docx 57/137 PE691.131v01-00 EN Amendment 162 Joëlle Mélin

Proposal for a regulation Article 4 – paragraph 1

Text proposed by the Commission Amendment

1. The Agency shall continuously 1. The Agency, in coordination with monitor any event that is likely to lead to a the ECDC, shall continuously monitor any major event or a public health emergency. event that is likely to lead to a major event or a public health emergency.

Or. fr

Amendment 163 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 4 – paragraph 2

Text proposed by the Commission Amendment

2. To facilitate the monitoring task 2. To facilitate the monitoring task referred to in paragraph 1, the national referred to in paragraph 1, the national competent authorities, through the single competent authorities, through the single points of contact referred to in Article 3(5), points of contact referred to in Article 3(5), shall, based on the reporting criteria shall, based on the reporting criteria specified by the Agency pursuant to Article specified by the Agency pursuant to Article 9(1)(b), report to the Agency on any event, 9(1)(b) pro-actively and with the shortest including a shortage of a medicinal product delay, report to the Agency on any event, in a given Member State, that is likely to including a shortage of a medicinal product lead to a major event or a public health in a given Member State, that is likely to emergency. Where a national competent lead to a major event or a public health authority informs the Agency of a shortage emergency. Where a national competent of a medicinal product in a given Member authority informs the Agency of a shortage State, it shall provide the Agency with any of a medicinal product in a given Member information received from the marketing State, it shall provide the Agency with any authorisation holder pursuant to Article 23a information received from the marketing of Directive 2001/83/EC. Based on a report authorisation holder pursuant to Article 23a of an event from a national competent of Directive 2001/83/EC. Based on a report authority and in order to understand the of an event from a national competent impact of the event in other Member authority and in order to understand the States, the Agency may request impact of the event in other Member information from the national competent States, the Agency may request

PE691.131v01-00 58/137 AM\1227699EN.docx EN authorities, through the working party information from the national competent referred to in Article 3(5). authorities, through the working party referred to in Article 3(5).

Or. en

Amendment 164 Carlo Calenda

Proposal for a regulation Article 4 – paragraph 2

Text proposed by the Commission Amendment

2. To facilitate the monitoring task 2. To facilitate the monitoring task referred to in paragraph 1, the national referred to in paragraph 1, the national competent authorities, through the single competent authorities, through the single points of contact referred to in Article 3(5), points of contact referred to in Article 3(5), shall, based on the reporting criteria shall, based on the reporting criteria specified by the Agency pursuant to Article specified by the Agency pursuant to Article 9(1)(b), report to the Agency on any event, 9(1)(b), report to the Agency on any including a shortage of a medicinal potential shortage of a medicinal product product in a given Member State, that is in a given Member State, that is likely to likely to lead to a major event or a public jeopardise a timely and appropriate health emergency. Where a national response to a major event or a public competent authority informs the Agency of health emergency. Where a national a shortage of a medicinal product in a competent authority informs the Agency of given Member State, it shall provide the a shortage of a medicinal product in a Agency with any information received given Member State, it shall provide the from the marketing authorisation holder Agency with any information received pursuant to Article 23a of Directive from the marketing authorisation holder 2001/83/EC. Based on a report of an event pursuant to Article 23a of Directive from a national competent authority and in 2001/83/EC. Based on a report of an event order to understand the impact of the event from a national competent authority and in in other Member States, the Agency may order to understand the impact of the event request information from the national in other Member States, the Agency may competent authorities, through the working request information from the national party referred to in Article 3(5). competent authorities, through the working party referred to in Article 3(5).

Or. it

Amendment 165 Jutta Paulus on behalf of the Verts/ALE Group

AM\1227699EN.docx 59/137 PE691.131v01-00 EN Proposal for a regulation Article 4 – paragraph 2

Text proposed by the Commission Amendment

2. To facilitate the monitoring task 2. To facilitate the monitoring task referred to in paragraph 1, the national referred to in paragraph 1, the national competent authorities, through the single competent authorities, through the single points of contact referred to in Article 3(5), points of contact referred to in Article 3(5), shall, based on the reporting criteria shall, based on the reporting criteria specified by the Agency pursuant to Article specified by the Agency pursuant to Article 9(1)(b), report to the Agency on any event, 9(1)(b), report to the Agency on any event, including a shortage of a medicinal product including a shortage of a medicinal product in a given Member State, that is likely to in a given Member State, that has the lead to a major event or a public health potential to lead to a major event or a emergency. Where a national competent public health emergency. Where a national authority informs the Agency of a shortage competent authority informs the Agency of of a medicinal product in a given Member a shortage of a medicinal product in a State, it shall provide the Agency with any given Member State, it shall provide the information received from the marketing Agency with any information received authorisation holder pursuant to Article 23a from the marketing authorisation holder of Directive 2001/83/EC. Based on a report pursuant to Article 23a of Directive of an event from a national competent 2001/83/EC. Based on a report of an event authority and in order to understand the from a national competent authority and in impact of the event in other Member order to understand the impact of the event States, the Agency may request in other Member States, the Agency may information from the national competent request information from the national authorities, through the working party competent authorities, through the working referred to in Article 3(5). party referred to in Article 3(5).

Or. en

Amendment 166 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 4 – paragraph 2

Text proposed by the Commission Amendment

2. To facilitate the monitoring task 2. To facilitate the monitoring task referred to in paragraph 1, the national referred to in paragraph 1, the national competent authorities, through the single competent authorities, through the single points of contact referred to in Article 3(5), points of contact referred to in Article 3(5), shall, based on the reporting criteria shall, based on the reporting criteria specified by the Agency pursuant to Article specified by the Agency pursuant to Article 9(1)(b), report to the Agency on any event, 9(1)(b), report to the Agency on any

PE691.131v01-00 60/137 AM\1227699EN.docx EN including a shortage of a medicinal potential a shortage of a critical medicinal product in a given Member State, that is product in a given Member State, as in the likely to lead to a major event or a public case of a major event or a public health health emergency. Where a national emergency. Where a national competent competent authority informs the Agency of authority informs the Agency of a shortage a shortage of a medicinal product in a of a medicinal product in a given Member given Member State, it shall provide the State, it shall provide the Agency with any Agency with any information received information received from the marketing from the marketing authorisation holder authorisation holder pursuant to Article 23a pursuant to Article 23a of Directive of Directive 2001/83/EC. Based on a report 2001/83/EC. Based on a report of an event of an event from a national competent from a national competent authority and in authority and in order to understand the order to understand the impact of the event impact of the event in other Member in other Member States, the Agency may States, the Agency may request request information from the national information from the national competent competent authorities, through the working authorities, through the working party party referred to in Article 3(5). referred to in Article 3(5).

Or. en

Amendment 167 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Josianne Cutajar, Alicia Homs Ginel

Proposal for a regulation Article 4 – paragraph 5 – point a

Text proposed by the Commission Amendment

(a) where the major event or public (a) where the major event or public health emergency may affect the safety, health emergency may affect the quality, and efficacy of medicinal products, manufacturing, safety, quality, and Article 5 shall apply; efficacy of medicinal products, Article 5 shall apply;

Or. en

Amendment 168 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 5 – paragraph 1

AM\1227699EN.docx 61/137 PE691.131v01-00 EN Text proposed by the Commission Amendment

Following the recognition of a public Following the express recognition of a health emergency or a request for public health emergency or a request for assistance referred to in Article 4(3), the assistance referred to in Article 4(3), the Medicines Steering Group shall evaluate Medicines Steering Group shall evaluate the information related to the major event the information related to the major event or the public health emergency and or the public health emergency and consider the need for urgent and consider the need for urgent and coordinated action with regard to the coordinated action with regard to the safety, quality, and efficacy of the safety, quality, and efficacy of the medicinal products concerned. medicinal products concerned. The information evaluated shall become public in due time.

Or. en

Amendment 169 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel

Proposal for a regulation Article 5 – paragraph 1

Text proposed by the Commission Amendment

Following the recognition of a public Following the recognition of a public health emergency or a request for health emergency or a request for assistance referred to in Article 4(3), the assistance referred to in Article 4(3), the Medicines Steering Group shall evaluate Medicines Steering Group shall evaluate the information related to the major event the information related to the major event or the public health emergency and or the public health emergency and consider the need for urgent and consider the need for urgent and coordinated action with regard to the coordinated action with regard to the safety, quality, and efficacy of the manufacturing safety, quality, and medicinal products concerned. efficacy of the medicinal products concerned.

Or. en

Amendment 170 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation

PE691.131v01-00 62/137 AM\1227699EN.docx EN Article 5 – paragraph 2

Text proposed by the Commission Amendment

The Medicines Steering Group shall The Medicines Steering Group shall provide advice to the Commission and provide advice to the Commission and Member States on any appropriate action it Member States on any appropriate action it believes should be taken at Union level on believes should be taken at Union level on the medicinal products concerned in the medicinal products concerned in accordance with the provisions of Directive accordance with the provisions of Directive 2001/83/EC or Regulation (EC) No 2001/83/EC or Regulation (EC) No 726/2004.18 726/2004.18This advice shall be made public, together with all the relevant information based on which the advice was compiled. If certain information can't be made available to the public, in order to respect confidentiality, the public health, commercial interests, grounds derived from Article 30 of this regulation, or the public order, it is mentioned. The Medicines Steering Group shall strive for the greatest transparency possible. ______18 Regulation (EC) No 726/2004 18 Regulation (EC) No 726/2004

Or. en

Amendment 171 Joëlle Mélin

Proposal for a regulation Article 6 – paragraph 1

Text proposed by the Commission Amendment

1. Following a request for assistance 1. Following a request for assistance referred to in Article 4(3) and after referred to in Article 4(3) and after consultation of its working party, the consultation of its working party, the Medicines Steering Group shall adopt a list Medicines Steering Group, after of medicinal products authorised in consulting the marketing authorisation accordance with Directive 2001/83/EC or holders and representatives of Regulation (EC) No 726/2004 which it stakeholders in the sector, shall adopt a considers as critical during the major event list of medicinal products authorised in (‘the major event critical medicines list ’). accordance with Directive 2001/83/EC or The list shall be updated whenever Regulation (EC) No 726/2004 which it necessary until the major event has been considers as critical during the major event sufficiently addressed. (‘the major event critical medicines list ’).

AM\1227699EN.docx 63/137 PE691.131v01-00 EN The list shall be updated whenever necessary until the major event has been sufficiently addressed.

Or. fr

Amendment 172 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 6 – paragraph 1

Text proposed by the Commission Amendment

1. Following a request for assistance 1. Following a request for assistance referred to in Article 4(3) and after referred to in Article 4(3) and after consultation of its working party, the consultation of its working party, the Medicines Steering Group shall adopt a list Medicines Steering Group, in consultation of medicinal products authorised in with marketing authorisation holders, accordance with Directive 2001/83/EC or shall adopt a list of medicinal products Regulation (EC) No 726/2004 which it authorised in accordance with Directive considers as critical during the major event 2001/83/EC or Regulation (EC) No (‘the major event critical medicines list ’). 726/2004 which it considers as critical The list shall be updated whenever during the major event (‘the major event necessary until the major event has been critical medicines list ’). The list shall be sufficiently addressed. updated whenever necessary until the major event has been sufficiently addressed.

Or. en

Amendment 173 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 6 – paragraph 3

Text proposed by the Commission Amendment

3. The Medicines Steering Group 3. The Medicines Steering Group shall adopt a set of information necessary shall adopt a set of information necessary to monitor the supply and demand of to monitor the supply and demand of medicinal products included on the lists medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the referred to in paragraphs 1 and 2 (‘the

PE691.131v01-00 64/137 AM\1227699EN.docx EN critical medicines lists’) and inform its critical medicines lists’) and inform its working party thereof. working party thereof. Union or national entities that are engaged in stockpiling of medicinal products should be informed accordingly.

Or. en

Justification

As the Commission plans to issue a legislative proposal for a new EU agency HERA which should engage, inter alia, in stockpiling, it is appropriate to address future developments in this regulation.

Amendment 174 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 6 – paragraph 3

Text proposed by the Commission Amendment

3. The Medicines Steering Group 3. The Medicines Steering Group shall adopt a set of information necessary shall adopt a set of information necessary to monitor the supply and demand of to monitor the supply and demand of medicinal products included on the lists medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its critical medicines lists’) and inform its working party thereof. working party and the pharmaceutical operators concerned thereof.

Or. en

Amendment 175 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 6 – paragraph 4

Text proposed by the Commission Amendment

4. The Agency shall immediately 4. Access to the critical medicines lists publish the critical medicines lists and any and any updates to those lists should be updates to those lists on its web-portal granted to Member State representatives

AM\1227699EN.docx 65/137 PE691.131v01-00 EN referred to in Article 26 of Regulation (EC) and the European Commission on a No 726/2004. confidential basis, via the Agency’s web- portal referred to in Article 26 of Regulation (EC) No 726/2004.

Or. en

Amendment 176 Carlo Calenda

Proposal for a regulation Article 6 – paragraph 4

Text proposed by the Commission Amendment

4. The Agency shall immediately 4. The Agency shall make publish the critical medicines lists and available to the representatives of the any updates to those lists on its web-portal Member States and the Commission the referred to in Article 26 of Regulation critical medicines lists and any updates to (EC) No 726/2004. those lists;

Or. it

Amendment 177 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 6 – paragraph 4 a (new)

Text proposed by the Commission Amendment

4 a. The Medicines Steering Group together with the industry (via the industry single points of contacts - iSPOCs) will determine the list of critical products and any future actions taken for the molecules included on the critical product list.

Or. en

Amendment 178

PE691.131v01-00 66/137 AM\1227699EN.docx EN Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 7 – paragraph 1

Text proposed by the Commission Amendment

On the basis of the critical medicines lists On the basis of the critical medicines lists and the information and data provided in and the information and data provided in accordance with Articles 10 and 11, the accordance with Articles 10 and 11, the Medicines Steering Group shall monitor Medicines Steering Group shall monitor supply and demand of medicinal products supply and demand of medicinal products included on those lists with a view to included on those lists with a view to identifying any potential or actual identifying any potential or actual shortages of those medicinal products. As shortages of those medicinal products. part of that monitoring, the Medicines Monitoring shall be conducted during Steering Group shall liaise, where relevant, health crises as well as before, after and with the Health Security Committee outside these crises in order to identify established in Article 4 of Regulation (EU) potential shortages before they can affect 2020/[…]19 and, in the case of a public health and lives of EU citizens. As part of health emergency, the Advisory Committee that monitoring, the Medicines Steering on public health emergencies established Group shall liaise, where relevant, with the pursuant to Article 24 of that Regulation. Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. ______19 [insert reference to adopted text referred 19 [insert reference to adopted text referred to in footnote 4] to in footnote 4]

Or. en

Amendment 179 Patrizia Toia

Proposal for a regulation Article 7 – paragraph 1

Text proposed by the Commission Amendment

On the basis of the critical medicines lists On the basis of the critical medicines lists, and the information and data provided in the establishment of two way accordance with Articles 10 and 11, the communication line with industry and the Medicines Steering Group shall monitor information and data provided in

AM\1227699EN.docx 67/137 PE691.131v01-00 EN supply and demand of medicinal products accordance with Articles 10 and 11, the included on those lists with a view to Medicines Steering Group shall monitor identifying any potential or actual supply and demand, based on actual shortages of those medicinal products. As patient’s needs at national level, of part of that monitoring, the Medicines medicinal products included on those lists Steering Group shall liaise, where relevant, with a view to identifying any potential or with the Health Security Committee actual shortages of those medicinal established in Article 4 of Regulation (EU) products. As part of that monitoring, the 2020/[…]19 and, in the case of a public Medicines Steering Group shall liaise, health emergency, the Advisory Committee where relevant, with the Health Security on public health emergencies established Committee established in Article 4 of pursuant to Article 24 of that Regulation. Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. ______19 [insert reference to adopted text referred 19 [insert reference to adopted text referred to in footnote 4] to in footnote 4]

Or. en

Amendment 180 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 7 – paragraph 1

Text proposed by the Commission Amendment

On the basis of the critical medicines lists On the basis of the critical medicines lists and the information and data provided in and the information and data provided in accordance with Articles 10 and 11, the accordance with Articles 10 and 11, the Medicines Steering Group shall monitor Medicines Steering Group shall monitor supply and demand of medicinal products supply and demand with demand being included on those lists with a view to based on actual patient need at the identifying any potential or actual Member State level, as perArticle 2(f), of shortages of those medicinal products. As medicinal products included on those lists part of that monitoring, the Medicines with a view to identifying any potential or Steering Group shall liaise, where relevant, actual shortages of those medicinal with the Health Security Committee products. As part of that monitoring, the established in Article 4 of Regulation (EU) Medicines Steering Group shall liaise, 2020/[…]19 and, in the case of a public where relevant, with the Health Security health emergency, the Advisory Committee Committee established in Article 4 of on public health emergencies established Regulation (EU) 2020/[…]19 and, in the pursuant to Article 24 of that Regulation. case of a public health emergency, the

PE691.131v01-00 68/137 AM\1227699EN.docx EN Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. ______19 [insert reference to adopted text referred 19 [insert reference to adopted text referred to in footnote 4] to in footnote 4]

Or. en

Amendment 181 Pietro Fiocchi

Proposal for a regulation Article 7 – paragraph 1

Text proposed by the Commission Amendment

On the basis of the critical medicines lists On the basis of the critical medicines lists, and the information and data provided in the establishment of a two way accordance with Articles 10 and 11, the communication line with industry via the Medicines Steering Group shall monitor industry single point of contacts (iSPOC) supply and demand of medicinal products and the information and data provided in included on those lists with a view to accordance with Articles 10 and 11, the identifying any potential or actual Medicines Steering Group shall monitor shortages of those medicinal products. As supply and demand of medicinal products part of that monitoring, the Medicines included on those lists with a view to Steering Group shall liaise, where relevant, identifying any potential or actual with the Health Security Committee shortages of those medicinal products. established in Article 4 of Regulation (EU) Aspart of that monitoring, the Medicines 2020/[…]19 and, in the case of a public Steering Group shall liaise, where relevant, health emergency, the Advisory Committee with the Health Security Committee on public health emergencies established established in Article 4 of Regulation pursuant to Article 24 of that Regulation. (EU)2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. ______19 [insert reference to adopted text referred to in footnote 4]

Or. en

Amendment 182

AM\1227699EN.docx 69/137 PE691.131v01-00 EN Carlo Calenda

Proposal for a regulation Article 7 – paragraph 1

Text proposed by the Commission Amendment

On the basis of the critical medicines lists On the basis of the critical medicines lists and the information and data provided in and the information and data provided in accordance with Articles 10 and 11, the accordance with Articles 10 and 11, the Medicines Steering Group shall monitor Medicines Steering Group shall monitor supply and demand of medicinal products supply and demand of medicinal products, included on those lists with a view to based on the actual and potential needs of identifying any potential or actual patients, included on those lists with a shortages of those medicinal products. As view to identifying any potential or actual part of that monitoring, the Medicines shortages of those medicinal products. As Steering Group shall liaise, where relevant, part of that monitoring, the Medicines with the Health Security Committee Steering Group shall liaise, where relevant, established in Article 4 of Regulation (EU) with the Health Security Committee 2020/[…]19and, in the case of a public established in Article 4 of Regulation (EU) health emergency, the Advisory Committee 2020/[…]19 and, in the case of a public on public health emergencies established health emergency, the Advisory Committee pursuant to Article 24 of that Regulation. on public health emergencies established pursuant to Article 24 of that Regulation. ______19 [insert reference to adopted text referred 19 [insert reference to adopted text referred to in footnote 4] to in footnote 4]

Or. it

Amendment 183 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 7 – paragraph 1 a (new)

Text proposed by the Commission Amendment

The Medicines Steering Group shall monitor supply and demand of medicinal products included on those across the entire value-chain, from resources to patient;

Or. en

PE691.131v01-00 70/137 AM\1227699EN.docx EN Amendment 184 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 8 – paragraph 1

Text proposed by the Commission Amendment

1. For the duration of a public health 1. For the duration of a public health emergency or following a request for emergency or following a request for assistance referred to in Article 4(3) and assistance referred to in Article 4(3) and until its closure, the Medicines Steering until its closure, the Medicines Steering Group shall regularly report the results of Group shall regularly report the results of its monitoring to the Commission and the its monitoring to the Commission, the sub-network referred to in Article 9(2), pharmaceutical industry, relevant other and, in particular, signal any potential or stake-holders of the pharmaceutical actual shortages of medicinal products supply chain and the sub-network referred included on the critical medicines lists. to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.

Or. en

Amendment 185 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi, Jessica Stegrud

Proposal for a regulation Article 8 – paragraph 1

Text proposed by the Commission Amendment

1. For the duration of a public health 1. For the duration of a public health emergency or following a request for emergency or following a request for assistance referred to in Article 4(3) and assistance referred to in Article 4(3) and until its closure, the Medicines Steering until its closure, the Medicines Steering Group shall regularly report the results of Group shall regularly report the results of its monitoring to the Commission and the its monitoring to the Commission, Member sub-network referred to in Article 9(2), States and the pharmaceutical industry and, in particular, signal any potential or and the sub-network referred to in Article actual shortages of medicinal products 9(2), and, in particular, signal any potential included on the critical medicines lists. or actual shortages of medicinal products included on the critical medicines lists.

AM\1227699EN.docx 71/137 PE691.131v01-00 EN Or. en

Amendment 186 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 8 – paragraph 2

Text proposed by the Commission Amendment

2. Where requested by the 2. Where requested by the Commission or the sub-network referred to Commission or the sub-network referred to in Article 9(2), the Medicines Steering in Article 9(2), the Medicines Steering Group shall provide aggregated data and Group shall provide aggregated data and forecasts of demand to substantiate its forecasts of demand to substantiate its findings. In that regard, the Medicines findings. In that regard, the Medicines Steering Group shall liaise with the Steering Group shall liaise with the European Centre for Disease Prevention European Centre for Disease Prevention and Control to obtain epidemiological data and Control to obtain epidemiological data to help forecast medicinal product needs, to help forecast medicinal product needs, and with the Executive Steering Group on and with the Executive Steering Group on Shortages of Medical Devices referred to Shortages of Medical Devices referred to in Article 19 where medicinal products in Article 19 where medicinal products included on the critical medicines lists are included on the critical medicines lists are administered with a medical device. administered with a medical device. It shall share its findings and conclusions with Union and national entities engaged with stockpiling of medicinal products and medical devices.

Or. en

Justification

As the Commission plans to issue a legislative proposal for a new EU agency HERA which should engage, inter alia, in stockpiling, it is appropriate to address future developments in this regulation.

Amendment 187 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 8 – paragraph 3

PE691.131v01-00 72/137 AM\1227699EN.docx EN Text proposed by the Commission Amendment

3. As part of that reporting, the 3. As part of that reporting, the Medicines Steering Group may also Medicines Steering Group may also provide recommendations on measures, provide recommendations on measures, which may be taken by the Commission, which may be taken by the Commission, Member States, marketing authorisation Member States, marketing authorisation holders and other entities to prevent or holders and other entities, including mitigate potential or actual shortages. In healthcare professionals, to prevent or that regard the Group shall liaise, as mitigate potential or actual shortages. In relevant, with the Health Security that regard the Group shall liaise, as Committee and, in the case of a public relevant, with the Health Security health emergency, the Advisory Committee Committee and, in the case of a public on public health emergencies. health emergency, the Advisory Committee on public health emergencies.

Or. en

Amendment 188 Margarita de la Pisa Carrión on behalf of the ECR Group Jessica Stegrud

Proposal for a regulation Article 8 – paragraph 4

Text proposed by the Commission Amendment

4. The Medicines Steering Group 4. The Medicines Steering Group may, on its own initiative or upon request may, on its own initiative or upon request from the Commission, provide from the Commission or Member states, recommendations on measures, which may provide recommendations on measures, be taken by the Commission, Member which may be taken by the Commission, States, marketing authorisation holders and Member States, marketing authorisation other entities to ensure preparedness to holders and other entities to ensure deal with potential or actual shortages of preparedness to deal with potential or medicinal products caused by public health actual shortages of medicinal products emergencies or major events. caused by public health emergencies or major events.

Or. en

Amendment 189 Margarita de la Pisa Carrión on behalf of the ECR Group

AM\1227699EN.docx 73/137 PE691.131v01-00 EN Proposal for a regulation Article 8 – paragraph 4 a (new)

Text proposed by the Commission Amendment

4 a. Without prejudice to Article 30, reports and recommendations of the Medicines Steering Group will be made available to the public to their greatest extend.

Or. en

Amendment 190 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 8 – paragraph 5

Text proposed by the Commission Amendment

5. The Medicines Steering Group may 5. The Medicines Steering Group may upon request from the Commission upon request from the Commission coordinate measures, where relevant, coordinate measures, where relevant, between the national competent authorities, between the national competent authorities, the marketing authorisation holders and the marketing authorisation holders and other entities to prevent or mitigate other entities, including healthcare potential or actual shortages in the context professionals, to prevent or mitigate of a major event or public health potential or actual shortages in the context emergency. of a major event or public health emergency.

Or. en

Amendment 191 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 8 – paragraph 5 a (new)

Text proposed by the Commission Amendment

5 a. Measures recommended by the Medicines Steering Group to the

PE691.131v01-00 74/137 AM\1227699EN.docx EN Commission, Member States, marketing authorisation holders and other entities, should cover regulatory solutions for addressing potential shortages, e.g., measured aiming at minimizing regulatory administrate burden and facilitating flexible supply chains.

Or. en

Amendment 192 Joëlle Mélin

Proposal for a regulation Article 8 – paragraph 5 a (new)

Text proposed by the Commission Amendment

5a. The measures recommended by the Steering Committee to the Commission, the Member States, the marketing authorisation holders and other stakeholders should include a relaxing of rules to deal with potential shortages.

Or. fr

Amendment 193 Joëlle Mélin

Proposal for a regulation Article 9 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

1. In order to prepare for fulfilling the 1. In order to prepare for fulfilling the tasks referred to in Articles 4 to 8, the tasks referred to in Articles 4 to 8, and Agency shall: after consulting representatives of national authorities and marketing authorisation holders, as well as other stakeholders in the pharmaceutical sector, the Agency shall:

Or. fr

AM\1227699EN.docx 75/137 PE691.131v01-00 EN Amendment 194 Patrizia Toia

Proposal for a regulation Article 9 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

1. In order to prepare for fulfilling the 1. In order to prepare for fulfilling the tasks referred to in Articles 4 to 8, the tasks referred to in Articles 4 to 8 and also Agency shall: consulting representatives from national competent authorities and from industries representatives, as well as other stakeholders in the medicines supply chain, the Agency shall:

Or. en

Amendment 195 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel, Josianne Cutajar

Proposal for a regulation Article 9 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) specify the procedures for (a) specify the procedures and criteria establishing the critical medicines lists; for establishing the critical medicines lists;

Or. en

Amendment 196 Ivars Ijabs, Mauri Pekkarinen, Christophe Grudler, Izaskun Bilbao Barandica

Proposal for a regulation Article 9 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) specify the procedures for (a) specify the criteria and procedures establishing the critical medicines lists; for establishing the critical medicines lists;

PE691.131v01-00 76/137 AM\1227699EN.docx EN Or. en

Amendment 197 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 9 – paragraph 1 – point c

Text proposed by the Commission Amendment

(c) develop streamlined electronic (c) develop streamlined electronic monitoring and reporting systems; monitoring and reporting systems by implementing and building on existing regulatory infrastructure (EU telematics1a). This system will shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the Agency and the National Competent Authorities, as well as a two way communication between the Agency and marketing authorisation holders. In case of public health emergency, aggregated information should be collected by the EMA from national competent authority shortages reporting systems in a harmonised and consolidated way, based on national harmonised data fields across Member States. The Agency can request additional information directly from the Marketing Authorisation Holders via the industry single point of contact (iSPOC), if this information has not been provided yet to the Member States; ______1a https://www.ema.europa.eu/en/human- regulatory/overview/data-medicines-iso- idmp-standards- overview#:~:text=The%20ISO%20IDMP %20standards%20specify,a%20robust%2 0and%20consistent%20manner.

Or. en

AM\1227699EN.docx 77/137 PE691.131v01-00 EN Amendment 198 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 9 – paragraph 1 – point c

Text proposed by the Commission Amendment

(c) develop streamlined electronic (c) develop streamlined electronic monitoring and reporting systems; monitoring and reporting systems by implementing and building on existing regulatory infrastructure (EU telematics). This system shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the Agency and the National Competent Authorities, as well as a two way communication between the Agency and marketing authorisation holders. In case of public health emergency, aggregated information should be collected by the EMA from national competent authority shortages reporting systems in a harmonised and consolidated way, based on harmonised data fields across Member States. The Agency can request additional information directly from the Marketing Authorisation Holders via the industry single point of contact (iSPOC), if this information has not been provided yet to the Member States;

Or. en

Amendment 199 Adam Jarubas

Proposal for a regulation Article 9 – paragraph 1 – point c

Text proposed by the Commission Amendment

PE691.131v01-00 78/137 AM\1227699EN.docx EN (c) develop streamlined electronic (c) develop streamlined electronic monitoring and reporting systems; monitoring and reporting systems, building upon EU telematics regulatory infrastructure, SPOR, into national shortage reporting interoperable system, preventing reporting duplication, using international standards (ISO IDMP) and supporting mutual cooperation of the Agency and National Competent Authorities and via iSPOC with Marketing Authorisation Holders;

Or. en

Amendment 200 Patrizia Toia

Proposal for a regulation Article 9 – paragraph 1 – point c

Text proposed by the Commission Amendment

(c) develop streamlined electronic (c) develop a streamlined and EU monitoring and reporting systems; Harmonized electronic monitoring and reporting systems. The harmonised system prevent any duplication of the reporting process by industry;

Or. en

Amendment 201 Margarita de la Pisa Carrión on behalf of the ECR Group Jessica Stegrud

Proposal for a regulation Article 9 – paragraph 1 – point c

Text proposed by the Commission Amendment

(c) develop streamlined electronic (c) develop a streamlined electronic monitoring and reporting systems; monitoring and reporting systems; accessible by Member State authorities and marketing authorization holders;

Or. en

AM\1227699EN.docx 79/137 PE691.131v01-00 EN Amendment 202 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Josianne Cutajar, Alicia Homs Ginel

Proposal for a regulation Article 9 – paragraph 1 – point c

Text proposed by the Commission Amendment

(c) develop streamlined electronic (c) develop streamlined electronic monitoring and reporting systems; monitoring and reporting systems in coordination with the national competent authorities;

Or. en

Amendment 203 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 9 – paragraph 1 – point e

Text proposed by the Commission Amendment

(e) establish and maintain a list of (e) update the Article 57(1)(l) of single points of contact from marketing Regulation 726/2004 Data base by authorisation holders for all medicinal including the industry single point of products for human use authorised in the contacts (iSPOC), this database should be Union, through the database provided for digital, regularly updated, and compliant in Article 57(1)(l) of Regulation 726/2004; with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)1a; ______1a https://www.ema.europa.eu/en/human- regulatory/overview/data-medicines-iso- idmp-standards- overview#:~:text=The%20ISO%20IDMP %20standards%20specify,a%20robust%2 0and%20consistent%20manner.

Or. en

PE691.131v01-00 80/137 AM\1227699EN.docx EN Amendment 204 Adam Jarubas

Proposal for a regulation Article 9 – paragraph 1 – point e

Text proposed by the Commission Amendment

(e) establish and maintain a list of (e) establish and maintain a list of single points of contact from marketing single points of contact from marketing authorisation holders for all medicinal authorisation holders for all medicinal products for human use authorised in the products for human use authorised in the Union, through the database provided for Union, through the database provided for in Article 57(1)(l) of Regulation 726/2004; in Article 57(1)(l) of Regulation 726/2004 after updating it by including the industry single point of contacts (iSPOC) maintaining compliance with ISO IDMP;

Or. en

Amendment 205 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 9 – paragraph 1 – point e

Text proposed by the Commission Amendment

(e) establish and maintain a list of (e) update the Article 57(1)(l) of single points of contact from marketing Regulation 726/2004 database by authorisation holders for all medicinal including the industry single point of products for human use authorised in the contact (iSPOC); this database should be Union, through the database provided for digital, regularly updated, and compliant in Article 57(1)(l) of Regulation 726/2004; with the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)1a;

______1a https://www.ema.europa.eu/en/human- regulatory/overview/data-medicines-iso- idmp-standards- overview#:~:text=The%20ISO%20IDMP %20standards%20specify,a%20robust%2

AM\1227699EN.docx 81/137 PE691.131v01-00 EN 0and%20consistent%20manner.

Or. en

Amendment 206 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 9 – paragraph 2 – point a

Text proposed by the Commission Amendment

(a) establish and maintain for the (a) establish and maintain for the duration of the public health emergency or duration of the public health emergency or major event, a sub-network of single points major event, a sub-network of single points of contact from marketing authorisation of contact from marketing authorisation holders based on the medicinal products holders from the contacts established included on the critical medicines lists; under Article 9(1) point (e), and of representatives of other relevant supply chain stakeholders involved in the distribution and supply of medicinal products to the public, based on the medicinal products included on the critical medicines lists;

Or. en

Amendment 207 Patrizia Toia

Proposal for a regulation Article 9 – paragraph 2 – point a

Text proposed by the Commission Amendment

(a) establish and maintain for the (a) establish and maintain for the duration of the public health emergency or duration of the public health emergency or major event, a sub-network of single points major event, a sub-network of single points of contact from marketing authorisation of contact from marketing authorisation holders based on the medicinal products holders and of representatives of other included on the critical medicines lists; relevant supply chain stakeholders involved in the distribution and supply of medicinal products to the public, based the medicinal products included on the critical medicines lists;

PE691.131v01-00 82/137 AM\1227699EN.docx EN Or. en

Amendment 208 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 9 – paragraph 2 – point a

Text proposed by the Commission Amendment

(a) establish and maintain for the (a) establish and maintain for the duration of the public health emergency or duration of the public health emergency or major event, a sub-network of single points major event, a sub-network of single points of contact from marketing authorisation of contact from marketing authorisation holders based on the medicinal products holders and wholesalers based on the included on the critical medicines lists; medicinal products included on the critical medicines lists;

Or. en

Amendment 209 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 9 – paragraph 3 – introductory part

Text proposed by the Commission Amendment

3. The information referred to in point 3. The information referred to in point (b) of paragraph 2 shall include at least: (b) of paragraph 2 (as determined in Article 9(1)(c) and Article 11 shall not include any information available to the Agency via collection of information submitted by industry to the national competent authority shortages systems in a harmonised and consolidated way by means of common data fields for each Member State. The system at the Agency will be interoperable with the national shortages reporting to prevent any duplication of the reporting process by industry via Industry Single Points of Contact (iSPOC).

AM\1227699EN.docx 83/137 PE691.131v01-00 EN Or. en

Amendment 210 Adam Jarubas

Proposal for a regulation Article 9 – paragraph 3 – introductory part

Text proposed by the Commission Amendment

3. The information referred to in point 3. The information referred to in point (b) of paragraph 2 shall include at least: (b) of paragraph 2, without duplicating information available to the Agency via collection of information submitted by industry to the national competent authority shortages systems, shall include at least:

Or. en

Amendment 211 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 9 – paragraph 3 – point d

Text proposed by the Commission Amendment

(d) details of the potential or actual (d) details of the potential or actual shortage such as actual or estimated start shortage such as actual or estimated start and end dates and suspected or known and end dates and suspected or known cause; cause as well as information on potential bottlenecks in the supply chain;

Or. en

Amendment 212 Ivars Ijabs, Mauri Pekkarinen, Christophe Grudler, Izaskun Bilbao Barandica

Proposal for a regulation Article 9 – paragraph 3 – point d

Text proposed by the Commission Amendment

PE691.131v01-00 84/137 AM\1227699EN.docx EN (d) details of the potential or actual (d) details of the potential or actual shortage such as actual or estimated start shortage such as actual or estimated start and end dates and suspected or known and end dates and suspected or known cause; cause at each stage of the supply chain;

Or. en

Amendment 213 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 9 – paragraph 3 – point d a (new)

Text proposed by the Commission Amendment

(d a) information on active substance manufacturing sites, where relevant;

Or. en

Amendment 214 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 9 – paragraph 3 – point e

Text proposed by the Commission Amendment

(e) sales and market share data; (e) production, sales and market share data;

Or. en

Amendment 215 Ivars Ijabs, Mauri Pekkarinen, Christophe Grudler, Izaskun Bilbao Barandica

Proposal for a regulation Article 9 – paragraph 3 – point g

Text proposed by the Commission Amendment

(g) mitigation plans including (g) mitigation plans including production and supply capacity; enhanced production, supply capacity

AM\1227699EN.docx 85/137 PE691.131v01-00 EN sourcing diversification and where applicable outsourcing plans;

Or. en

Amendment 216 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 9 – paragraph 3 – point g

Text proposed by the Commission Amendment

(g) mitigation plans including (g) mitigation plans including location- production and supply capacity; specific manufacturing, production and supply capacity;

Or. en

Amendment 217 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 9 – paragraph 3 – point h a (new)

Text proposed by the Commission Amendment

(h a) update the format and content of the article 57 database to include the industry Single Point of contact (iSPOC) names as reported by industry. Industry should be able to digitally update the iSPOC names in the article 57 database if needed and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)1a; ______1a https://www.ema.europa.eu/en/human- regulatory/overview/data-medicines-iso- idmp-standards- overview#:~:text=The%20ISO%20IDMP

PE691.131v01-00 86/137 AM\1227699EN.docx EN %20standards%20specify,a%20robust%2 0and%20consistent%20manner

Or. en

Amendment 218 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 9 – paragraph 3 a (new)

Text proposed by the Commission Amendment

3 a. The information referred to in point (c) of paragraph 2 shall include at least details of (a) available alternative medicinal products; (b) information from the wholesale distributors and legal person entitled to supply the medicinal product to the public.

Or. en

Amendment 219 Ivars Ijabs, Mauri Pekkarinen, Christophe Grudler, Izaskun Bilbao Barandica

Proposal for a regulation Article 10 – paragraph 1

Text proposed by the Commission Amendment

1. In order to facilitate the monitoring 1. In order to facilitate the monitoring referred to in Article 7 and following a referred to in Article 7 and following a request from the Agency, marketing request from the Agency, marketing authorisation holders for medicinal authorisation holders for medicinal products included on the critical medicines products included on the critical medicines lists shall submit the information referred lists shall submit the information referred to in Article 9(3) by the deadline set by the to in Article 9(3) by the deadline set by the Agency. They shall submit the Agency. information through the points of contact designated in accordance with Article 9(2) and using the reporting methods and system established pursuant to Article 9(1). They shall provide updates where

AM\1227699EN.docx 87/137 PE691.131v01-00 EN necessary.

Or. en

Amendment 220 Joëlle Mélin

Proposal for a regulation Article 10 – paragraph 1

Text proposed by the Commission Amendment

1. In order to facilitate the monitoring 1. In order to facilitate the monitoring referred to in Article 7 and following a referred to in Article 7 and following a request from the Agency, marketing request from the Agency, marketing authorisation holders for medicinal authorisation holders for medicinal products included on the critical medicines products included on the critical medicines lists shall submit the information referred lists, and all distributors legally to in Article 9(3) by the deadline set by the authorised to supply medicines to the Agency. They shall submit the information public, shall submit the information through the points of contact designated in referred to in Article 9(3) by the deadline accordance with Article 9(2) and using the set by the Agency. They shall submit the reporting methods and system established information through the points of contact pursuant to Article 9(1). They shall provide designated in accordance with Article 9(2) updates where necessary. and using the reporting methods and system established pursuant to Article 9(1). They shall provide updates where necessary.

Or. fr

Amendment 221 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 10 – paragraph 1

Text proposed by the Commission Amendment

1. In order to facilitate the monitoring 1. In order to facilitate the monitoring referred to in Article 7 and following a referred to in Article 7 and following a request from the Agency, marketing request from the Agency, marketing authorisation holders for medicinal authorisation holders for medicinal products included on the critical medicines products included on the critical medicines

PE691.131v01-00 88/137 AM\1227699EN.docx EN lists shall submit the information referred lists shall submit the information referred to in Article 9(3) by the deadline set by the to in Article 9(3) by the deadline set by the Agency. They shall submit the information Agency, if the information is not available through the points of contact designated via the interoperable system connected in accordance with Article 9(2) and using with the national shortages reporting the reporting methods and system systems established in the Article 9(1)(c). established pursuant to Article 9(1). They shall provide updates where necessary.

Or. en

Amendment 222 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 10 – paragraph 1

Text proposed by the Commission Amendment

1. In order to facilitate the monitoring 1. In order to facilitate the monitoring referred to in Article 7 and following a referred to in Article 7 and following a request from the Agency, marketing request from the Agency, marketing authorisation holders for medicinal authorisation holders for medicinal products included on the critical medicines products included on the critical medicines lists shall submit the information referred lists shall submit the information referred to in Article 9(3) by the deadline set by the to in Article 9(3) by the deadline set by the Agency. They shall submit the information Agency. They shall submit the information through the points of contact designated in through the points of contact designated in accordance with Article 9(2) and using the accordance with Article 9(2) and using the reporting methods and system established reporting methods and system established pursuant to Article 9(1). They shall provide pursuant to Article 9(1). They shall provide updates where necessary. updates whenever necessary or upon request.

Or. en

Amendment 223 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 10 – paragraph 2

Text proposed by the Commission Amendment

AM\1227699EN.docx 89/137 PE691.131v01-00 EN 2. Marketing authorisation holders of 2. Marketing authorisation holders of medicinal products authorised in the Union medicinal products authorised in the Union shall, within 6 months from the date of shall, within 12-24 from the date of application of this Regulation, provide the application of this Regulation, provide the information required pursuant to Article information required pursuant to Article 9(1)(e) in the form of an electronic 9(1)(e) in the form of an electronic submission in the database referred to in submission in the database referred to in Article 57(1)(l) of Regulation (EC) No Article 57(1)(l) of Regulation (EC) No 726/2004. Those marketing authorisation 726/2004 and compliant with the holders shall update their submission standards of the International wherever necessary. Organization for Standardization (ISO) for the identification of medicinal products (IDMP)5. Those marketing authorisation holders shall update their submission wherever necessary.

Or. en

Amendment 224 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 10 – paragraph 3

Text proposed by the Commission Amendment

3. Marketing authorisation holders 3. Marketing authorisation holders shall justify the absence of any requested shall justify the absence of any requested information and any delays in providing it information and any delays in providing it by the deadline set by the Agency. by the deadline set by the Agency after consultation and agreement with industry on a case by case scenario.

Or. en

Amendment 225 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 10 – paragraph 4

Text proposed by the Commission Amendment

4. Where marketing authorisation 4. Where marketing authorisation

PE691.131v01-00 90/137 AM\1227699EN.docx EN holders for medicinal products included on holders for medicinal products included on the critical medicines lists indicate that the the critical medicines lists indicate that the submitted information contains submitted information might contain information of a commercially confidential information of a commercially confidential nature, they shall identify the relevant parts nature, they shall identify the relevant and clarify the reasons for such an parts, clarify the reasons for such an indication. The Agency shall assess the indication and offer sufficient, actual and merits of each request and protect specific evidence of harm stemming from commercially confidential information disclosure. The Agency shall assess the against unjustified disclosure. merits of each request, considering the benefits for public health of disclosure and act accordingly.

Or. en

Amendment 226 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 10 – paragraph 4

Text proposed by the Commission Amendment

4. Where marketing authorisation 4. Where marketing authorisation holders for medicinal products included on holders for medicinal products included on the critical medicines lists indicate that the the critical medicines lists indicate that the submitted information contains information submitted information contains information of a commercially confidential nature, they of a commercially confidential nature, they shall identify the relevant parts and clarify shall identify the relevant parts and clarify the reasons for such an indication. The the reasons for such an indication. The Agency shall assess the merits of each Agency shall assess the merits of each request and protect commercially request and protect commercially confidential information against unjustified confidential information against unjustified disclosure. disclosure, unless the information is in the public interest. Marketing authorisation holders failing to comply with their reporting obligations shall be subject to sanctions to be determined by the Commission.

Or. en

Amendment 227 Margarita de la Pisa Carrión on behalf of the ECR Group

AM\1227699EN.docx 91/137 PE691.131v01-00 EN Pietro Fiocchi

Proposal for a regulation Article 10 – paragraph 4

Text proposed by the Commission Amendment

4. Where marketing authorisation 4. Where marketing authorisation holders for medicinal products included on holders for medicinal products included on the critical medicines lists indicate that the the critical medicines lists indicate that the submitted information contains information submitted information contains information of a commercially confidential nature, they of a commercially confidential nature, they shall identify the relevant parts and clarify shall identify the relevant parts and clarify the reasons for such an indication. The the reasons for such an indication. It Agency shall assess the merits of each should be determined upfront what request and protect commercially information is commercially confident, confidential information against unjustified based on this the Agency shall assess the disclosure. merits of each request and protect commercially confidential information against unjustified disclosure.

Or. en

Amendment 228 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 11 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

1. In order to facilitate the monitoring 1. In order to facilitate the monitoring referred to in Article 7 and following a referred to in Article 7 and following a request from the Agency, Member States request from the Agency, Member States shall, by the deadline set by the Agency: shall, by the deadline set by the Agency, where relevant, following the creation of a harmonized pan-European interoperable and digital National Competent Authorities (NCAs) shortages reporting system based on common data fields;

Or. en

Amendment 229

PE691.131v01-00 92/137 AM\1227699EN.docx EN Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 11 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) submit the set of information (a) submit the set of information requested by the Agency including requested by the Agency in Chapter 2 available and estimated data on volume of Article 9(4) including available and demand, through its designated point of estimated data on volume of demand, contact and using the reporting methods through its designated point of contact and and system established pursuant to Article using the reporting methods and system 9(1); established pursuant to Article 9(1);

Or. en

Amendment 230 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 12 – paragraph 1 – point b

Text proposed by the Commission Amendment

(b) consider the need for guidelines (b) consider the need for guidelines addressed to Member States, marketing addressed to Member States, marketing authorisation holders, and other entities; authorisation holders, and other entities, including healthcare professionals;

Or. en

Justification

For the monitoring and mitigation of shortages of medicinal products during a public health emergency or a major event guidelines should also be considered for healthcare professionals.

Amendment 231 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

AM\1227699EN.docx 93/137 PE691.131v01-00 EN Proposal for a regulation Article 12 – paragraph 1 – point c

Text proposed by the Commission Amendment

(c) inform the Medicines Steering (c) inform the Medicines Steering Group of any measures taken and report on Group and industry (via the trade the results; associations) of any measures taken and report on the results;

Or. en

Amendment 232 Ivars Ijabs, Mauri Pekkarinen, Christophe Grudler, Izaskun Bilbao Barandica

Proposal for a regulation Article 12 – paragraph 1 – point f

Text proposed by the Commission Amendment

(f) liaise with third countries and (f) liaise with third countries and relevant international organisations, as relevant international organisations, as appropriate, to mitigate potential or actual appropriate, to mitigate potential or actual shortages of medicinal products included shortages of medicinal products included on the critical medicines list or their active on the critical medicines list or their active pharmaceutical ingredients, where those pharmaceutical ingredients, where those products or ingredients are imported into products or ingredients are imported into the Union and where such potential or or exported from the Union and where actual shortages have international such potential or actual shortages have implications. international implications, including potential introduction of temporary export transparency and export authorisation mechanisms.

Or. en

Amendment 233 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 12 – paragraph 1 – point f a (new)

Text proposed by the Commission Amendment

(f a) The Commission shall provide

PE691.131v01-00 94/137 AM\1227699EN.docx EN answers to (priority) written questions from Members of the European Parliament within the deadline.

Or. en

Amendment 234 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 13 – paragraph -1 (new)

Text proposed by the Commission Amendment

-1 The Agency shall establish an early warning system to inform relevant stakeholders, including doctors and community and hospital pharmacists of any supply problems and potential or actual shortages of medicines included on the critical medicines lists.

Or. en

Justification

Besides the measure proposed by the Commissionin Article 13, a dedicated early warning system should be established to informthe relevant stakeholders, including doctors and community and hospitalpharmacists of any problems related to the supply of medicines included by theMedicines Steering Group on the critical medicines lists.

Amendment 235 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 13 – paragraph 1

Text proposed by the Commission Amendment

The Agency shall, via its web-portal and The Agency shall, via its web-portal and other appropriate means, in conjunction other appropriate means, in conjunction with national competent authorities, inform with national competent authorities, inform the public and interest groups with regard the public and interest groups with regard to the work of the Medicines Steering to the work and the data used and its Group. sources based on which the

AM\1227699EN.docx 95/137 PE691.131v01-00 EN recommendations of the Medicines Steering Group are taken. Proceedings and recommendations, including dissenting views, shall be documented and made publicly available.

Or. en

Amendment 236 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 13 – paragraph 1

Text proposed by the Commission Amendment

The Agency shall, via its web-portal and The Agency shall, via its web-portal and other appropriate means, in conjunction other appropriate means, in conjunction with national competent authorities, inform with national competent authorities, inform the public and interest groups with regard the public and interest groups in a timely to the work of the Medicines Steering manner with regard to the work of the Group. Medicines Steering Group, including the recommendations, opinions and decisions made by the Medicines Steering Group as well as agendas and minutes of the Group’s meetings.

Or. en

Amendment 237 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 13 – paragraph 1

Text proposed by the Commission Amendment

The Agency shall, via its web-portal and The Agency shall, via its web-portal and other appropriate means, in conjunction other appropriate means, in conjunction with national competent authorities, inform with national competent authorities, inform the public and interest groups with regard the public and interest groups with regard to the work of the Medicines Steering to the work, advices and findings of the Group. Medicines Steering Group.

PE691.131v01-00 96/137 AM\1227699EN.docx EN Or. en

Amendment 238 Carlo Calenda

Proposal for a regulation Article 14 – paragraph 1

Text proposed by the Commission Amendment

1. The Emergency Task Force is 1. The permanent Emergency Task hereby established as part of the Agency. It Force is hereby established as part of the shall be convened during public health Agency. It shall be convened either in emergencies, either in person or remotely. person or remotely. The Agency shall The Agency shall provide its secretariat. provide its secretariat. The Emergency Task Force shall cooperate with EU bodies and agencies, the World Health Organisation, third countries and international scientific organisations in preparing timely and appropriate responses to health emergencies. The Agency, working together with the Member States, shall apply itself to developing the protocols and expertise necessary for a timely and appropriate response to health crises, including for sectors other than the health sector, in order to improve crisis response capacity.

Or. it

Amendment 239 Patrizia Toia

Proposal for a regulation Article 14 – paragraph 1

Text proposed by the Commission Amendment

1. The Emergency Task Force is 1. The Emergency Task Force is hereby established as part of the Agency. It hereby established as a permanent shall be convened during public health structure as part of the Agency It shall be emergencies, either in person or remotely. convened during public health The Agency shall provide its secretariat. emergencies, either in person or remotely. The Agency shall provide its secretariat.

AM\1227699EN.docx 97/137 PE691.131v01-00 EN Or. en

Amendment 240 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 14 – paragraph 1

Text proposed by the Commission Amendment

1. The Emergency Task Force is 1. The Emergency Task Force is hereby established as part of the Agency. It hereby established as part of the Agency. It shall be convened during public health shall be convened in preparation for or emergencies, either in person or remotely. during public health emergencies, either in The Agency shall provide its secretariat. person or remotely. The Agency shall provide its secretariat.

Or. en

Amendment 241 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 14 – paragraph 1

Text proposed by the Commission Amendment

1. The Emergency Task Force is 1. The Emergency Task Force is hereby established as part of the Agency. It hereby established as part of the Agency. It shall be convened during public health shall be convened during the declared emergencies, either in person or remotely. public health emergencies, either in person The Agency shall provide its secretariat. or remotely. The Agency shall provide its secretariat.

Or. en

Amendment 242 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 14 – paragraph 2 – point a a (new)

PE691.131v01-00 98/137 AM\1227699EN.docx EN Text proposed by the Commission Amendment

(a a) The Emergency Task Force shall define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials in order to guide the trials towards meeting the criteria for effective public health interventions.

Or. en

Amendment 243 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 14 – paragraph 2 – point b

Text proposed by the Commission Amendment

(b) reviewing clinical trial protocols (b) reviewing clinical trial protocols and providing advice to developers on and providing advice and guidance to clinical trials to be conducted in the Union developers on clinical trials to be for medicinal products intended to treat, conducted in the Union for medicinal prevent, or diagnose the disease causing products intended to treat, prevent, or the public health emergency, in accordance diagnose the disease causing the public with Article 15; health emergency, in accordance with Article 15;

Or. en

Amendment 244 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 14 – paragraph 2 – point c

Text proposed by the Commission Amendment

(c) providing scientific support to (c) providing scientific support to facilitate clinical trials to be conducted in facilitate clinical trials to be conducted in the Union for medicinal products intended the Union for medicinal products intended to treat, prevent, or diagnose the disease to treat, prevent, or diagnose the disease causing the public health emergency. Such causing the public health emergency. Such

AM\1227699EN.docx 99/137 PE691.131v01-00 EN support shall include advice to sponsors of support shall include advice to sponsors of similar or linked planned clinical trials on similar or linked planned clinical trials on the establishment, in their place, of joint the establishment, in their place, of joint clinical trials and may include advice on clinical trials and may include advice on establishing agreements to act as a sponsor establishing agreements to act as a sponsor or as co-sponsor in accordance with or as co-sponsor in accordance with Articles 2(14) and 72 of Regulation (EU) Articles 2(14) and 72 of Regulation (EU) 536/2014; 536/2014 and on developing suitable protocols;

Or. en

Amendment 245 Marc Botenga, Manuel Bompard, Giorgos Georgiou, Marisa Matias, Sira Rego

Proposal for a regulation Article 14 – paragraph 2 – point e

Text proposed by the Commission Amendment

(e) providing scientific (e) providing, by making publicly recommendations with regard to the use of available, scientific recommendations with any medicinal product, which may have the regard to the use of any medicinal product, potential to address public health which may have the potential to address emergencies, in accordance with Article public health emergencies, in accordance 16; with Article 16;

Or. en

Amendment 246 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 14 – paragraph 2 – point e

Text proposed by the Commission Amendment

(e) providing scientific (e) providing scientific recommendations with regard to the use of recommendations with regard to the use of any medicinal product, which may have the any human and veterinary medicinal potential to address public health product, which may have the potential to emergencies, in accordance with Article address public health emergencies, in 16; accordance with Article 16.

Or. en

PE691.131v01-00 100/137 AM\1227699EN.docx EN Amendment 247 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Josianne Cutajar, Alicia Homs Ginel

Proposal for a regulation Article 14 – paragraph 2 – point f

Text proposed by the Commission Amendment

(f) cooperating with Union bodies and (f) cooperating with national agencies, the World Health Organization, competent authorities, Union bodies and third countries, and international scientific agencies, the World Health Organization, organisations on scientific and technical third countries, and international scientific issues relating to the public health organisations on scientific and technical emergency and to medicinal products issues relating to the public health which may have the potential to address emergency and to medicinal products public health emergencies, as necessary. which may have the potential to address public health emergencies, as necessary.

Or. en

Amendment 248 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 14 – paragraph 3

Text proposed by the Commission Amendment

3. The Emergency Task Force shall be 3. The Emergency Task Force shall be composed of representatives of the composed of representatives of the scientific committees, working parties, and scientific committees, working parties, and staff members of the Agency, the staff members of the Agency, the coordination group established in coordination group established in accordance with Article 27 of Directive accordance with Article 27 of Directive 2001/83/EC, and the Clinical Trials 2001/83/EC, and the Clinical Trials Coordination and Advisory Group Coordination and Advisory Group established in accordance with Article 85 established in accordance with Article 85 of Regulation (EU) 536/2014.21 External of Regulation (EU) 536/2014.21 External experts may be appointed and experts may be appointed and representatives of other Union bodies and representatives of other Union bodies and agencies be invited on an ad hoc basis, as agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the necessary. It shall be chaired by the Agency. Agency. Members of the Emergency Task Force, including external experts, shall

AM\1227699EN.docx 101/137 PE691.131v01-00 EN not have financial or other interests in the health industry which could affect their independence and impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests which shall be published. Members of the Emergency Task Force shall declare, at each meeting, any potential conflict of interest with respect to the items on the agenda. In the event of such a conflict of interest, the concerned member shall withdraw from the meeting. ______21 Regulation (EU) No 536/2014 of the 21 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 249 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 14 – paragraph 3 a (new)

Text proposed by the Commission Amendment

3 a. The Emergency Task Force will be empowered to coordinate and exchange information and best practices with the health authorities of the Member States and the pharmaceutical industry in order to generate new synergies.

Or. en

Amendment 250 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

PE691.131v01-00 102/137 AM\1227699EN.docx EN Proposal for a regulation Article 14 – paragraph 4

Text proposed by the Commission Amendment

4. The composition of the Emergency 4. The composition of the Emergency Task Force shall be approved by the Task Force shall be approved by the Management Board of the Agency. The Management Board of the Agency and Executive Director of the Agency or their made publicly available. The Executive representative and representatives of the Director of the Agency or their Commission shall be entitled to attend all representative and representatives of the meetings. Commission shall be entitled to attend all meetings.

Or. en

Amendment 251 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 14 – paragraph 5

Text proposed by the Commission Amendment

5. The Chair may invite 5. The Chair may invite representatives of Member States, representatives of Member States, members of scientific committees of the members of scientific committees of the Agency and working parties, and third Agency and working parties to attend its parties, including representatives of meetings, and decide to hear third parties, medicinal product interest groups, including marketing authorisation holders, marketing authorisation holders, developers of medicinal products, clinical developers of medicinal products, clinical trial experts, public health advocacy trial sponsors, representatives of clinical groups, sectoral trade unions, consumer trial networks, and interest groups and patient organisations, as well as representing patients and healthcare healthcare professionals. professionals to attend its meetings.

Or. en

Amendment 252 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 14 – paragraph 5

AM\1227699EN.docx 103/137 PE691.131v01-00 EN Text proposed by the Commission Amendment

5. The Chair may invite 5. The Chair may invite representatives of Member States, representatives of Member States, members of scientific committees of the members of scientific committees of the Agency and working parties, and third Agency and working parties, and third parties, including representatives of parties, including representatives of medicinal product interest groups, medicinal product interest groups, marketing authorisation holders, marketing authorisation holders, developers of medicinal products, clinical developers of medicinal products, clinical trial sponsors, representatives of clinical trial sponsors, representatives of clinical trial networks, and interest groups trial networks, researchers, and interest representing patients and healthcare groups representing patients and healthcare professionals to attend its meetings. professionals to attend its meetings.

Or. en

Amendment 253 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 14 – paragraph 8

Text proposed by the Commission Amendment

8. Article 63 of Regulation (EC) No 8. Article 63 of Regulation (EC) No 726/2004 shall apply to the Emergency 726/2004 shall apply to the Emergency Task Force as regards transparency and the Task Force as regards transparency and the independence of its members. independence of its members. Declarations of interest shall be made publicly available for all stakeholders and experts consulted. Stakeholders and experts with conflicts of interest shall not participate in the process.

Or. en

Amendment 254 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 14 – paragraph 9

Text proposed by the Commission Amendment

PE691.131v01-00 104/137 AM\1227699EN.docx EN 9. The Agency shall publish 9. The Agency shall publish information about the medicinal products information about the medicinal products that the Emergency Task Force considers that the Emergency Task Force considers may have the potential to address public may have the potential to address public health emergencies and any updates on its health emergencies and any updates on its web-portal. web-portal. The Agency shall also publish clinical trials data on medicines and vaccines reviewed by the Emergency Task Force and clinical trials protocols on which the Emergency Task Force provided advise to developers, in line with the provisions of the Regulation (EU) No 536/2014.

Or. en

Amendment 255 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 14 – paragraph 9

Text proposed by the Commission Amendment

9. The Agency shall publish 9. The Agency shall rapidly publish information about the medicinal products all information about the medicinal that the Emergency Task Force considers products that the Emergency Task Force may have the potential to address public considers may have the potential to address health emergencies and any updates on its public health emergencies and any updates web-portal. on its web-portal.

Or. en

Amendment 256 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 15 – title

Text proposed by the Commission Amendment

Advice on clinical trials Advice and guidance on clinical trials

Or. en

AM\1227699EN.docx 105/137 PE691.131v01-00 EN Amendment 257 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 15 – paragraph -1 (new)

Text proposed by the Commission Amendment

-1. The Emergency Task Force shall define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials in order to ensure that these trials meet the criteria for effective public health interventions. These targets shall provide guidance for developers of medicinal products and underpin the scientific advice process outlined in this article.

Or. en

Amendment 258 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 15 – paragraph 1

Text proposed by the Commission Amendment

1. During a public health emergency, 1. During a public health emergency, the Emergency Task Force shall review the Emergency Task Force shall review clinical trial protocols submitted or clinical trial protocols submitted or intended to be submitted in a clinical trial intended to be submitted in a clinical trial application by developers of medicinal application by developers of medicinal products as part of an accelerated scientific products as part of an accelerated scientific advice process. advice process based on targets referred to in Article 15.(-1). When providing scientific advice, a balance shall always be maintained between necessary facilitation in a crisis situation and patients’ safety.

Or. en

PE691.131v01-00 106/137 AM\1227699EN.docx EN Amendment 259 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 15 – paragraph 2

Text proposed by the Commission Amendment

2. Where a developer engages in an 2. Where a developer engages in an accelerated scientific advice process, the accelerated scientific advice process, the Emergency Task force shall provide such Emergency Task force shall provide such advice free of charge at the latest 20 days advice free of charge . The advice shall be following the submission to the Agency of endorsed by the Committee for Medicinal a complete set of requested information Products for Human Use at the latest 20 and data by the developer. The advice days following the submission to the shall be endorsed by the Committee for Agency of a complete set of requested Medicinal Products for Human Use. information and data by the developer.

Or. en

Amendment 260 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 15 – paragraph 3

Text proposed by the Commission Amendment

3. The Emergency Task Force shall 3. The Emergency Task Force shall establish procedures for the request and establish and update procedures for the submission of the set of information and request and submission of the set of data required, including information on information and data required, in the Member State or States where an cooperation with the Member States where application for authorisation of a clinical an application for authorisation of a trial is submitted or is intended to be clinical trial is submitted or is intended to submitted. be submitted in accordance with Article 4 of the Regulation 536/2014on clinical trials on medicinal products for human use. These procedures shall become public.

Or. en

AM\1227699EN.docx 107/137 PE691.131v01-00 EN Amendment 261 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 15 – paragraph 6

Text proposed by the Commission Amendment

6. Where a developer is the recipient 6. Where a developer is the recipient of scientific advice, the developer shall of scientific advice, the developer shall subsequently submit the data resulting subsequently submit the data resulting from clinical trials to the Agency following from clinical trials to the Agency following a request made pursuant to Article 16. a request made pursuant to Article 16 and awaiting the launch of the Clinical Trials Information System (CTIS) in accordance with Art. 80 and 81 of Regulation (EU) No 536/2014.

Or. en

Amendment 262 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel

Proposal for a regulation Article 15 – paragraph 6

Text proposed by the Commission Amendment

6. Where a developer is the recipient 6. Where a developer is the recipient of scientific advice, the developer shall of scientific advice, the developer shall subsequently submit the data resulting subsequently submit the data resulting from clinical trials to the Agency following from clinical trials to the Agency following a request made pursuant to Article 16. a request made pursuant to Article 16. In order to ensure the protection of sensitive data a state-of-the-art pseudonymisation shall apply, including encryption.

Or. en

Amendment 263 Jutta Paulus on behalf of the Verts/ALE Group

PE691.131v01-00 108/137 AM\1227699EN.docx EN Proposal for a regulation Article 15 – paragraph 6

Text proposed by the Commission Amendment

6. Where a developer is the recipient 6. Where a developer is the recipient of scientific advice, the developer shall of scientific advice, the developer shall subsequently submit the data resulting subsequently submit the data resulting from clinical trials to the Agency following from clinical trials to the Agency following a request made pursuant to Article 16. a request made pursuant to Article 16. Due to the sensitive nature of this data, it shall be pseudonymised in line with the requirements of Article 89 of GDPR.

Or. en

Amendment 264 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 15 – paragraph 6

Text proposed by the Commission Amendment

6. Where a developer is the recipient 6. Where a developer is the recipient of scientific advice, the developer shall of scientific advice, the developer shall subsequently submit the data resulting subsequently and continuously submit all from clinical trials to the Agency following the data resulting from clinical trials to the a request made pursuant to Article 16. Agency following a request made pursuant to Article 16.

Or. en

Amendment 265 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 16 – paragraph 1

Text proposed by the Commission Amendment

1. Following the recognition of a 1. Following the recognition of a public health emergency, the Emergency public health emergency, the Emergency Task Force shall undertake a review of the Task Force shall undertake a review of the available scientific data on medicinal available scientific data on human and

AM\1227699EN.docx 109/137 PE691.131v01-00 EN products, which may have the potential to veterinary medicinal products, which may be used to address the public health have the potential to be used to address the emergency. The review shall be regularly public health emergency. The review shall updated during the public health be regularly updated and published during emergency. the public health emergency.

Or. en

Amendment 266 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 16 – paragraph 2

Text proposed by the Commission Amendment

2. In preparation of the review, the 2. In preparation of the review, the Emergency Task Force may request Emergency Task Force may request all information and data from marketing relevant information and data from authorisation holders and from developers marketing authorisation holders and from and engage with them in preliminary developers and engage with them in discussions. The Emergency Task Force preliminary discussions. The Emergency may also, where available, make use of Task Force shall use the results of observational studies of health data comparative randomized controlled trials generated outside of clinical studies taking when available, but, if not, may also, when into account their reliability. necessary, make use of real world data including pragmatic trials as in “close to everyday practice” taking into account their reliability as supportive evidence or signal-eliciting evidence.

Or. en

Amendment 267 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 16 – paragraph 2

Text proposed by the Commission Amendment

2. In preparation of the review, the 2. In preparation of the review, the Emergency Task Force may request Emergency Task Force may request information and data from marketing information and data from marketing authorisation holders and from developers authorisation holders and from developers

PE691.131v01-00 110/137 AM\1227699EN.docx EN and engage with them in preliminary and engage with them in preliminary discussions. The Emergency Task Force discussions. The Emergency Task Force may also, where available, make use of may also, where available, make use of observational studies of health data observational studies of health data generated outside of clinical studies taking generated outside of clinical studies taking into account their reliability. into account their reliability. The Emergency Task Force should liaise with agencies of third countries that authorise medicinal products for additional information and data.

Or. en

Justification

Data exchange with agencies like US FDA or Indian CDSCO can increase speed and improve knowledge and should be addressed as a possibility.

Amendment 268 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel

Proposal for a regulation Article 16 – paragraph 2

Text proposed by the Commission Amendment

2. In preparation of the review, the 2. In preparation of the review, the Emergency Task Force may request Emergency Task Force may request information and data from marketing information and data from marketing authorisation holders and from developers authorisation holders and from developers and engage with them in preliminary and engage with them in preliminary discussions. The Emergency Task Force discussions. The Emergency Task Force may also, where available, make use of may also, where available, make use of observational studies of health data observational studies of health data generated outside of clinical studies taking generated outside of clinical studies taking into account their reliability. into account their reliability, while applying state-of-the-art pseudonymisation, including encryption.

Or. en

Amendment 269 Margarita de la Pisa Carrión on behalf of the ECR Group

AM\1227699EN.docx 111/137 PE691.131v01-00 EN Proposal for a regulation Article 16 – paragraph 2

Text proposed by the Commission Amendment

2. In preparation of the review, the 2. In preparation of there view, the Emergency Task Force may request Emergency Task Force shall engage information and data from marketing marketing authorisation holders and authorisation holders and from developers developers in preliminary discussions and and engage with them in preliminary may subsequently request information and discussions. The Emergency Task Force data from marketing authorisation holders may also, where available, make use of and from developers. The Emergency Task observational studies of health data Force may also, where available, make use generated outside of clinical studies taking of observational studies of health data into account their reliability. generated outside of clinical studies taking into account their reliability.

Or. en

Amendment 270 Joëlle Mélin

Proposal for a regulation Article 16 – paragraph 2

Text proposed by the Commission Amendment

2. In preparation of the review, the 2. In preparation of the review, the Emergency Task Force may request Emergency Task Force shall request information and data from marketing information and data from marketing authorisation holders and from developers authorisation holders and from developers and engage with them in preliminary and engage with them in preliminary discussions. The Emergency Task Force discussions. The Emergency Task Force may also, where available, make use of may also, where available, make use of observational studies of health data observational studies of health data generated outside of clinical studies taking generated outside of clinical studies taking into account their reliability. into account their reliability.

Or. fr

Amendment 271 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 16 – paragraph 3 – introductory part

PE691.131v01-00 112/137 AM\1227699EN.docx EN Text proposed by the Commission Amendment

3. Based on a request from one or 3. Based on a request from one or more Member States, or the Commission, more Member States, or the Commission, the Emergency Task Force shall provide the Emergency Task Force shall provide recommendations to the Committee for independent recommendations, driven Medicinal Products for Human Use for an only by public-health needs and not by opinion in accordance with paragraph 4 on other interests, to the Committee for the following: Medicinal Products for Human Use for an opinion in accordance with paragraph 4 on the following:

Or. en

Amendment 272 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 16 – paragraph 6

Text proposed by the Commission Amendment

6. In the preparation of its 6. In the preparation of its recommendations provided pursuant to recommendations provided pursuant to paragraphs 3, the Emergency Task Force paragraphs 3, the Emergency Task Force may consult the concerned Member State may consult the concerned Member State and request it to provide any information and request it to provide any information and data, which informed the Member and data, which influenced the Member State’s decision to make the medicinal State’s decision to make the medicinal product available for compassionate use. product available for compassionate use. Following such a request, the Member Following such a request, the Member State shall provide all of the requested State shall provide all of the requested information. information.

Or. en

Amendment 273 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 16 – paragraph 7 a (new)

AM\1227699EN.docx 113/137 PE691.131v01-00 EN Text proposed by the Commission Amendment

7 a. Marketing Authorisation Holders or developers may suggest medicinal products which may have the potential to be used to address the public health emergency. The Emergency Taskforce shall take these suggestions into account and, given that the suggestion is accompanied with sufficient scientific data that the medicinal products have the potential to halt the public health emergency, give an appropriate reaction to the suggestion. The reaction shall be public.

Or. en

Amendment 274 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 17 – paragraph 1

Text proposed by the Commission Amendment

The Agency shall, via its web-portal and The Agency shall, via its web-portal and other appropriate means and, in other appropriate means and, in conjunction with national competent conjunction with national competent authorities, inform the public and relevant authorities, inform the public and relevant interest groups with regard to the work of interest groups with regard to the work and the Emergency Task Force. the data and sources used in the decision- making process of the Emergency Task Force.

Or. en

Amendment 275 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Josianne Cutajar, Alicia Homs Ginel

Proposal for a regulation Article 18 – paragraph 1 – point a

PE691.131v01-00 114/137 AM\1227699EN.docx EN Text proposed by the Commission Amendment

(a) develop and maintain electronic (a) develop and maintain electronic tools for the submission of information and tools for the submission of information and data, including electronic health data data, including electronic health data generated outside the scope of clinical generated outside the scope of clinical studies; studies, while ensuring processing of patients' personal data is in compliance with the European data protection framework;

Or. en

Amendment 276 Ivars Ijabs, Mauri Pekkarinen, Christophe Grudler, Izaskun Bilbao Barandica

Proposal for a regulation Article 18 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) develop and maintain electronic (a) develop and maintain highly secure tools for the submission of information and and resilient electronic tools for the data, including electronic health data submission of information and data, generated outside the scope of clinical including electronic health data generated studies; outside the scope of clinical studies;

Or. en

Amendment 277 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Josianne Cutajar, Alicia Homs Ginel

Proposal for a regulation Article 18 – paragraph 1 – point b

Text proposed by the Commission Amendment

(b) coordinate independent vaccine (b) coordinate independent vaccine effectiveness and safety monitoring studies effectiveness and safety monitoring studies using relevant data held by public using relevant data held by public authorities. Such coordination shall be authorities, while taking into conducted jointly with the European Centre consideration the priority for Disease Prevention and Control and recommendations of the HMA-EMA joint notably through a new vaccine monitoring Big Data Task Force. Such coordination

AM\1227699EN.docx 115/137 PE691.131v01-00 EN platform; shall be conducted jointly with the European Centre for Disease Prevention and Control and notably through a new vaccine monitoring platform;

Or. en

Amendment 278 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel, Josianne Cutajar

Proposal for a regulation Article 18 – paragraph 1 – point c

Text proposed by the Commission Amendment

(c) as part of its regulatory tasks, make (c) as part of its regulatory tasks, make use of digital infrastructures or tools, to use of digital infrastructures or tools, to facilitate the rapid access to or analysis of facilitate the rapid access to or analysis of available electronic health data generated available electronic health data generated outside the scope of clinical studies, and outside the scope of clinical studies, and the exchange of such data between the exchange of such data between Member States, the Agency, and other Member States, the Agency, and other Union bodies; Union bodies; underlines in this regard the need to speed up the deployment of a secure quantum communication infrastructure (QCI), which would allow the transmission of sensitive information, using an ultra-secure form of encryption to shield against cyberattacks;

Or. en

Amendment 279 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel

Proposal for a regulation Article 18 – paragraph 1 – point c a (new)

Text proposed by the Commission Amendment

(c a) The Agency shall be equipped with a high level of security against cyber-

PE691.131v01-00 116/137 AM\1227699EN.docx EN attacks and cyber-espionage at all times, especially during major events and public health emergencies at Union level. Binding rules on security information and cybersecurity shall apply in line with the Security Union Strategy.

Or. en

Amendment 280 Adam Jarubas

Proposal for a regulation Article 18 – paragraph 1 – point d a (new)

Text proposed by the Commission Amendment

(d a) develop IT tools interoperable with harmonized shortages reporting systems of National Competent Authorities (NCAs) by building on the existing digital regulatory infrastructure and ongoing projects on data management and implement AI technics to among others forecast crisis development, prepare responses and proactively initiate optimisation of resources management.

Or. en

Amendment 281 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 18 – paragraph 1 – point d a (new)

Text proposed by the Commission Amendment

(d a) take urgent and appropriate measures to ensure the protection of health data from cyber intrusions. These measures should be built on combination of regular penetration testing, decentralised solutions and security by design principles.

AM\1227699EN.docx 117/137 PE691.131v01-00 EN Or. en

Amendment 282 Margarita de la Pisa Carrión on behalf of the ECR Group Pietro Fiocchi

Proposal for a regulation Article 18 – paragraph 1 – point d a (new)

Text proposed by the Commission Amendment

(d a) develop IT tools interoperable with harmonized shortages reporting systems of National Competent Authorities (NCAs) by building on the existing digital regulatory infrastructure and ongoing projects on data management.

Or. en

Amendment 283 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 19 – paragraph 1

Text proposed by the Commission Amendment

1. The Executive Steering Group on 1. The Executive Steering Group on Medical Devices (‘the Medical Devices Medical Devices (‘the Medical Devices Steering Group’) is hereby established as Steering Group’) is hereby established as part of the Agency. It shall meet either in part of the Agency. It shall meet either in person or remotely, in preparation for or person or remotely, in preparation for or during a public health emergency. The during a public health emergency, or upon Agency shall provide its secretariat. request of a Member State affected by a shortage. The Agency shall provide its secretariat.

Or. en

Amendment 284 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

PE691.131v01-00 118/137 AM\1227699EN.docx EN Proposal for a regulation Article 19 – paragraph 2

Text proposed by the Commission Amendment

2. The Medical Devices Steering 2. The Medical Devices Steering Group shall be composed of a Group shall be composed of a representative of the Agency, a representative of the Agency, a representative of the Commission and one representative of the Commission and one senior representative per Member State. senior representative per Member State. Each Member State shall appoint their Each Member State shall appoint their representative. Members may be representative. Members may be accompanied by experts in specific accompanied by experts in specific scientific or technical fields. scientific or technical fields. The declarations of interests of all experts must be made public and all necessary restrictions shall apply where conflicts of interest occur.

Or. en

Amendment 285 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 19 – paragraph 2 a (new)

Text proposed by the Commission Amendment

2 a. The membership of the Medical Devices Steering Group shall be made public. Members of the Medical Devices Steering Group and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall vow to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to the industry shall be entered in a register held by the Agency and shall be accessible to the public, on request.

Or. en

AM\1227699EN.docx 119/137 PE691.131v01-00 EN Amendment 286 Marc Botenga, Marisa Matias, Manuel Bompard, Giorgos Georgiou, Sira Rego

Proposal for a regulation Article 19 – paragraph 3

Text proposed by the Commission Amendment

3. The Medical Devices Steering 3. The Medical Devices Steering Group shall be chaired by the Agency. The Group shall be chaired by the Agency. The Chair may invite third parties, including Chair may decide to hear third parties, representatives of medical device interest including developers and producers of groups to attend its meetings. medical devices, public-health advocacy groups, sectoral trade unions, consumer and patient organisations, as well as healthcare professionals.

Or. en

Amendment 287 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 19 – paragraph 3

Text proposed by the Commission Amendment

3. The Medical Devices Steering 3. The Medical Devices Steering Group shall be chaired by the Agency. The Group shall be chaired by the Agency. The Chair may invite third parties, including Chair may invite third parties, including representatives of medical device interest representatives of medical device interest groups to attend its meetings. groups, healthcare professionals as well as representatives of patients and consumers to attend its meetings.

Or. en

Amendment 288 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 19 – paragraph 5 a (new)

PE691.131v01-00 120/137 AM\1227699EN.docx EN Text proposed by the Commission Amendment

5 a. The Medical Devices Steering Group will establish the basis for strengthened cooperation with national health authorities and the pharmaceutical industry.

Or. en

Amendment 289 Joëlle Mélin

Proposal for a regulation Article 20 – paragraph 1

Text proposed by the Commission Amendment

1. Immediately following the 1. Immediately following the recognition of a public health emergency recognition of a public health emergency and after consultation of its working party, and after consultation of its working party, the Medical Devices Steering Group shall the Medical Devices Steering Group, after adopt a list of medical devices which it consulting the marketing authorisation considers as critical during the public holders and representatives of health emergency (‘the public health stakeholders in the sector, shall adopt a emergency critical devices list’). The list list of medical devices which it considers shall be updated whenever necessary until as critical during the public health the termination of the recognition of the emergency (‘the public health emergency public health emergency. critical devices list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.

Or. fr

Amendment 290 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 20 – paragraph 3

Text proposed by the Commission Amendment

3. The Agency shall publish the public 3. The Agency shall publish on an

AM\1227699EN.docx 121/137 PE691.131v01-00 EN health emergency critical devices list and accessible way, the public health any updates to that list on its web-portal. emergency critical devices list and any updates to that list on its web-portal.

Or. en

Amendment 291 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 20 – paragraph 3

Text proposed by the Commission Amendment

3. The Agency shall publish the public 3. The Agency shall publish the public health emergency critical devices list and health emergency critical devices list and any updates to that list on its web-portal. any updates to that list in a timely manner on its web-portal.

Or. en

Amendment 292 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 21 – paragraph 1

Text proposed by the Commission Amendment

1. On the basis of the public health 1. On the basis of the public health emergency critical devices list and the emergency critical devices list and the information and data provided in information and data provided in accordance with Articles 24 and 25, the accordance with Articles 24 and 25, the Medical Devices Steering Group shall Medical Devices Steering Group shall monitor supply and demand of medical monitor supply and demand of medical devices included on that list with a view to devices included on that list with a view to identifying any potential or actual identifying any potential or actual shortages of those medical devices. As part shortages of those medical devices. As part of that monitoring, the Medical Devices of that monitoring, the Medical Devices Steering Group shall liaise, where relevant, Steering Group shall liaise, where relevant, with the Health Security Committee with the Health Security Committee established in Article 4 of Regulation (EU) established in Article 4 of Regulation (EU) 2020/[…]22 and the Advisory Committee 2020/[…]22 and the Advisory Committee on public health emergencies established on public health emergencies established

PE691.131v01-00 122/137 AM\1227699EN.docx EN pursuant to Article 24 of that Regulation. pursuant to Article 24 of that Regulation as well as with Union and national entities engaged with stockpiling of medical devices. ______22 [insert reference to adopted text referred 22 [insert reference to adopted text referred to in footnote 4] to in footnote 4]

Or. en

Justification

As the Commission plans to issue a legislative proposal for a new EU agency HERA which should engage, inter alia, in stockpiling, it is appropriate to address future developments in this regulation.

Amendment 293 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 22 – paragraph 2

Text proposed by the Commission Amendment

2. Where requested by the 2. Where requested by the Commission or the sub-network referred to Commission or the sub-network referred to in Article 23(2)(b), the Medical Devices in Article 23(2)(b), the Medical Devices Steering Group shall provide aggregated Steering Group shall provide aggregated data and forecasts of demand to support its data and forecasts of demand to support its findings. In that regard, the Steering Group findings. In that regard, the Steering Group shall liaise with the European Centre for shall liaise with the European Centre for Disease Prevention and Control to obtain Disease Prevention and Control to obtain epidemiological data to help forecast epidemiological data to help forecast medical device needs, and with the medical device needs, and with the Medicines Steering Group referred to in Medicines Steering Group referred to in Article 3 where medical devices included Article 3 where medical devices included on the public health emergency critical on the public health emergency critical devices list are used to jointly with a devices list are used to jointly with a medicinal product. medicinal product as well as with Union and national entities engaged with stockpiling of medical devices.

Or. en

AM\1227699EN.docx 123/137 PE691.131v01-00 EN Justification

As the Commission plans to issue a legislative proposal for a new EU agency HERA which should engage, inter alia, in stockpiling, it is appropriate to address future developments in this regulation.

Amendment 294 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 22 – paragraph 4

Text proposed by the Commission Amendment

4. The Medical Devices Steering 4. The Medical Devices Steering Group may, on its own initiative or upon Group may, on its own initiative or upon request from the Commission, provide request from the Commission, provide recommendations on measures which may recommendations on measures which may be taken by the Commission, Member be taken by the Commission, Member States, medical device manufacturers, States, medical device manufacturers, notified bodies and other entities to ensure notified bodies and other entities, preparedness to deal with potential or including healthcare professionals, to actual shortages of medical devices caused ensure preparedness to deal with potential by public health emergencies. or actual shortages of medical devices caused by public health emergencies.

Or. en

Amendment 295 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 22 – paragraph 5

Text proposed by the Commission Amendment

5. The Medical Devices Steering 5. The Medical Devices Steering Group may, upon request from the Group may, upon request from the Commission coordinate measures, where Commission coordinate measures, where relevant, between the national competent relevant, between the national competent authorities, manufacturers of medical authorities, manufacturers of medical devices, notified bodies, and other entities devices, notified bodies, and other entities, to prevent or mitigate potential or actual including healthcare professionals, to shortages in the context of a public health prevent or mitigate potential or actual shortages in the context of a public health

PE691.131v01-00 124/137 AM\1227699EN.docx EN emergency. emergency.

Or. en

Amendment 296 Joëlle Mélin

Proposal for a regulation Article 22 – paragraph 5 a (new)

Text proposed by the Commission Amendment

5a. The measures recommended by the Steering Committee to the Commission, the Member States, the marketing authorisation holders and other stakeholders should include a relaxing of rules to deal with potential shortages.

Or. fr

Amendment 297 Marc Botenga, Manuel Bompard, Giorgos Georgiou, Marisa Matias, Sira Rego

Proposal for a regulation Article 22 – paragraph 5 a (new)

Text proposed by the Commission Amendment

5 a. All the recommendations made by the Medical Devices Steering Group shall be made publicly available.

Or. en

Amendment 298 Joëlle Mélin

Proposal for a regulation Article 23 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

AM\1227699EN.docx 125/137 PE691.131v01-00 EN 1. In order to prepare for fulfilling the 1. In order to prepare for fulfilling the tasks referred to in Articles 20, 21, and 22, tasks referred to in Articles 20, 21 and 22, the Agency shall: and after consulting the representatives of national authorities and marketing authorisation holders, as well as other stakeholders in the pharmaceutical sector, the Agency shall:

Or. fr

Amendment 299 Margarita de la Pisa Carrión on behalf of the ECR Group Jessica Stegrud

Proposal for a regulation Article 23 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) specify the procedures for (a) after consultation with all relevant establishing the public health emergency stakeholders specify the procedures for critical devices list; establishing the public health emergency critical devices list;

Or. en

Amendment 300 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel, Josianne Cutajar

Proposal for a regulation Article 23 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) specify the procedures for (a) specify the procedures and criteria establishing the public health emergency for establishing the public health critical devices list; emergency critical devices list;

Or. en

Amendment 301

PE691.131v01-00 126/137 AM\1227699EN.docx EN Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel, Josianne Cutajar

Proposal for a regulation Article 23 – paragraph 1 – point b

Text proposed by the Commission Amendment

(b) develop streamlined electronic (b) develop streamlined electronic monitoring and reporting systems; monitoring and reporting systems in coordination with the national competent authorities;

Or. en

Amendment 302 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 23 – paragraph 1 – point d

Text proposed by the Commission Amendment

(d) establish and maintain a list of deleted single points of contact from medical device manufacturers, authorised representatives and notified bodies;

Or. en

Justification

It will be difficult for the EMA to manually set-up and maintain a list of contact points for medical devices manufacturers, authorised representatives and NBs as proposed in article 23.1(d). However, since there exists a database of medical device manufacturers ie EUDAMED, which is being established by the Commission pursuant to art 33 of the MD regulation and art 30 of the IVD MD regulation, it would be much more efficient to include such contact details in this database. It is therefore proposed to remove requirement (d) from Article 23.1 and to add a reference to EUDAMED in Article 23.2.

Amendment 303 Jutta Paulus on behalf of the Verts/ALE Group

AM\1227699EN.docx 127/137 PE691.131v01-00 EN Proposal for a regulation Article 23 – paragraph 2 – point a

Text proposed by the Commission Amendment

(a) establish and maintain for the (a) establish and maintain for the duration of the public health emergency, a duration of the public health emergency, a sub-network of single points of contact sub-network of single points of contact from medical device manufacturers and from medical device manufacturers and notified bodies based on the medical notified bodies based on the medical devices included on the public health devices included on the public health emergency critical devices list; emergency critical devices list based on single points of contact to be included for all medical device manufacturers in the database referred to in Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746;

Or. en

Justification

It will be difficult for the EMA to manually set-up and maintain a list of contact points for medical devices manufacturers, authorised representatives and NBs as proposed in article 23.1(d). However, since there exists a database of medical device manufacturers ie EUDAMED, which is being established by the Commission pursuant to art 33 of the MD regulation and art 30 of the IVD MD regulation, it would be much more efficient to include such contact details in this database. It is therefore proposed to remove requirement (d) from Article 23.1 and to add a reference to EUDAMED in Article 23.2.

Amendment 304 Ivars Ijabs, Mauri Pekkarinen, Christophe Grudler, Izaskun Bilbao Barandica

Proposal for a regulation Article 23 – paragraph 3 – point d

Text proposed by the Commission Amendment

(d) details of the potential or actual (d) details of the potential or actual shortage such as actual or estimated start shortage such as actual or estimated start and end dates, and the known or suspected and end dates, and the known or suspected cause; cause at each level of the supply chain;

Or. en

Amendment 305

PE691.131v01-00 128/137 AM\1227699EN.docx EN Ivars Ijabs, Mauri Pekkarinen, Christophe Grudler, Izaskun Bilbao Barandica

Proposal for a regulation Article 23 – paragraph 3 – point f

Text proposed by the Commission Amendment

(f) mitigation plans including (f) mitigation plans including production and supply capacity; enhanced production, supply capacity, sourcing diversification and where applicable outsourcing plans;

Or. en

Amendment 306 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 23 – paragraph 3 – point i

Text proposed by the Commission Amendment

(i) where conformity assessments are (i) where conformity assessments are on-going, the status of the conformity on-going, the status of the conformity assessment by the concerned notified assessment by the concerned notified bodies in relation to medical devices bodies in relation to medical devices included in the public health emergency included in the public health emergency critical devices list and possible issues critical devices list and possible issues which need to be resolved in order to which need to be resolved in order complete the conformity assessment to speedily complete the conformity process. assessment process.

Or. en

Amendment 307 Joëlle Mélin

Proposal for a regulation Article 24 – paragraph 1

Text proposed by the Commission Amendment

1. In order to facilitate the monitoring 1. In order to facilitate the monitoring referred to in Article 21 and following a referred to in Article 21 and following a request from the Agency, medical device request from the Agency, medical device

AM\1227699EN.docx 129/137 PE691.131v01-00 EN manufacturers of the medical devices manufacturers of the medical devices included on the public health emergency included on the public health emergency critical devices list and, where necessary, critical devices list and all distributors concerned notified bodies, shall submit the legally authorised to supply medical information requested by the deadline set devices to the public, and, where by the Agency. They shall submit the necessary, concerned notified bodies, shall information requested through the points of submit the information requested by the contact designated in accordance with deadline set by the Agency. They shall Article 23(2) and using the reporting submit the information requested through methods and system established pursuant the points of contact designated in to Article 23(1). They shall provide accordance with Article 23(2) and using updates wherever necessary. the reporting methods and system established pursuant to Article 23(1). They shall provide updates wherever necessary.

Or. fr

Amendment 308 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 24 – paragraph 3

Text proposed by the Commission Amendment

3. Where manufacturers of medical 3. Where manufacturers of medical devices included on the public health devices included on the public health emergency critical devices list and emergency critical devices list and concerned notified bodies indicate that the concerned notified bodies indicate that the submitted information contains information submitted information contains information of a commercially confidential nature, they of a commercially confidential nature, they shall identify the relevant parts and clarify shall identify the relevant parts and clarify the reasons for such an indication. The the reasons for such an indication. The Agency shall assess the merits of each Agency shall assess the merits of each request and protect such commercially request and protect such commercially confidential information against unjustified confidential information against unjustified disclosure. disclosure unless the information is in the public interest.

Or. en

Amendment 309 Jutta Paulus on behalf of the Verts/ALE Group

PE691.131v01-00 130/137 AM\1227699EN.docx EN Proposal for a regulation Article 25 – paragraph 2

Text proposed by the Commission Amendment

2. Where necessary to fulfil their 2. Where necessary to fulfil their reporting obligations set out in paragraph reporting obligations set out in paragraph 1, Member States shall gather information 1, Member States shall gather information from manufacturers, importers, distributors from manufacturers, importers, and notified bodies on medical devices distributors, health care professionals and included on the public health emergency notified bodies on medical devices critical devices list. included on the public health emergency critical devices list.

Or. en

Amendment 310 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 25 – paragraph 4 – point a

Text proposed by the Commission Amendment

(a) consider the need to provide for (a) consider the need to provide for temporary exemptions at Member State temporary exemptions at Member State level pursuant to Article 59(1) of level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view of Regulation (EU) 2017/746 with a view to mitigating potential or actual shortages to mitigating potential or actual shortages of medical devices included on the public of medical devices included on the public health emergency critical devices list; health emergency critical devices list while at the same time ensuring both patient and product safety;

Or. en

Amendment 311 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 26 – paragraph 1 – point a

AM\1227699EN.docx 131/137 PE691.131v01-00 EN Text proposed by the Commission Amendment

(a) take all necessary action within the (a) take all necessary action within the limits of the powers conferred on it, with a limits of the powers conferred on it, with a view to mitigating potential or actual view to mitigating potential or actual shortages of medical devices included on shortages of medical devices included on the public health emergency critical the public health emergency critical devices list, including, where necessary, devices list, including, where necessary, granting temporary exemptions at Union granting temporary exemptions at Union level pursuant to Article 59(3) of level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746; of Regulation (EU) 2017/746 while at the same time ensuring both patient and product safety;

Or. en

Amendment 312 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 26 – paragraph 1 – point a a (new)

Text proposed by the Commission Amendment

(a a) The Commission shall provide answers to (priority) written questions from Members of the European Parliament within the deadline.

Or. en

Amendment 313 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 26 – paragraph 1 – point b

Text proposed by the Commission Amendment

(b) consider the need for guidelines (b) consider the need for guidelines addressed to Member States, medical addressed to Member States, medical device manufacturers, notified bodies and device manufacturers, notified bodies, other entities; health care professionals and other

PE691.131v01-00 132/137 AM\1227699EN.docx EN entities;

Or. en

Amendment 314 Ivars Ijabs, Mauri Pekkarinen, Christophe Grudler, Izaskun Bilbao Barandica

Proposal for a regulation Article 26 – paragraph 1 – point e

Text proposed by the Commission Amendment

(e) liaise with third countries and (e) liaise with third countries and relevant international organisations, as relevant international organisations, as appropriate, to mitigate potential or actual appropriate, to mitigate potential or actual shortages of medical devices included on shortages of medical devices included on the critical devices list or their component the critical devices list or their component parts, where those devices or parts are parts, where those devices or parts are imported into the Union, and where such imported into or exported from the Union, potential or actual shortages have and where such potential or actual international implications. shortages have international implications, including potential introduction of temporary export transparency and export authorisation mechanisms.

Or. en

Amendment 315 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 27 – paragraph 1

Text proposed by the Commission Amendment

The Agency shall, via its web-portal and The Agency shall, via its web-portal and other appropriate means and, in other appropriate means and, in conjunction with national competent conjunction with national competent authorities, inform the public and relevant authorities, inform the public and relevant interest groups with regard to the work of interest groups with regard to the work of the Medical Devices Steering Group. the Medical Devices Steering Group, including the recommendations, opinions and decisions made by the Medical Devices Steering Group as well as agendas and minutes of the Group’s

AM\1227699EN.docx 133/137 PE691.131v01-00 EN meetings.

Or. en

Amendment 316 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 28 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) provide administrative and (a) provide administrative, scientific technical support to the expert panels for and technical support to the expert panels the provision of scientific opinions, views for the provision of scientific opinions, and advice; views and advice;

Or. en

Amendment 317 Margarita de la Pisa Carrión on behalf of the ECR Group Jessica Stegrud

Proposal for a regulation Article 29 – paragraph 3 a (new)

Text proposed by the Commission Amendment

3 a. The Commission shall carry out an impact assessment prior to the entry into force of this Regulation.

Or. en

Amendment 318 Margarita de la Pisa Carrión on behalf of the ECR Group

Proposal for a regulation Article 30 – paragraph 1 – introductory part

PE691.131v01-00 134/137 AM\1227699EN.docx EN Text proposed by the Commission Amendment

1. Unless otherwise provided for in 1. Without prejudice to Regulation this Regulation and without prejudice to (EC) No 1049/200124 and existing national Regulation (EC) No 1049/200124 and provisions and practices in the Member existing national provisions and practices States on confidentiality, all parties in the Member States on confidentiality, all involved in the application of this parties involved in the application of this Regulation shall respect the confidentiality Regulation shall respect the confidentiality of information and data obtained in of information and data obtained in carrying out their tasks in order to protect carrying out their tasks in order to protect the following: the following: ______24 Regulation (EC) No 1049/2001 of the 24 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of European Parliament and of the Council of 30 May 2001 regarding public access to 30 May 2001 regarding public access to European Parliament, Council and European Parliament, Council and Commission documents, OJ L 145, Commission documents, OJ L 145, 31.05.2001, p. 43 31.05.2001, p. 43

Or. en

Amendment 319 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel

Proposal for a regulation Article 30 – paragraph 1 – point a

Text proposed by the Commission Amendment

(a) personal data in accordance with (a) personal data in accordance with Article 32; Article 32 and Article 4(1) of Regulation (EU) 2016/679 (‘GDPR’) and Article 3(1) EUDPR;

Or. en

Amendment 320 Aldo Patriciello, Ioan-Rareş Bogdan, Cristian-Silviu Buşoi, Massimiliano Salini, Antonio Tajani, Maria da Graça Carvalho

Proposal for a regulation Article 30 – paragraph 1 – point a

AM\1227699EN.docx 135/137 PE691.131v01-00 EN Text proposed by the Commission Amendment

(a) personal data in accordance with (a) personal data in accordance with Article 32; the definition contained in the Article 4 of GDPR and Article 3(1) EUDPR;

Or. en

Amendment 321 Ivo Hristov, Nicolás González Casares, Maria-Manuel Leitão-Marques, Lina Gálvez Muñoz, Romana Jerković, Carlos Zorrinho, Robert Hajšel, Tsvetelina Penkova, Alicia Homs Ginel

Proposal for a regulation Article 30 – paragraph 5

Text proposed by the Commission Amendment

5. The Commission, the Agency, and 5. The Commission, the Agency, and Member States may exchange Member States may exchange commercially confidential information and, commercially confidential information and, where necessary to protect public health, where necessary to protect public health, personal data, with regulatory authorities personal data, with regulatory authorities of third countries with which they have of third countries with which they have concluded bilateral or multilateral concluded bilateral or multilateral confidentiality arrangements. confidentiality arrangements. Recalls that transfers of personal data to third countries or international organisations must comply with Chapter V of the EUDPR, relevant provisions of the GDPR, the LED and the Charter of Fundamental Rights and take into account the recommendations and guidelines of the EDPB.

Or. en

Amendment 322 Jutta Paulus on behalf of the Verts/ALE Group

Proposal for a regulation Article 30 – paragraph 5

PE691.131v01-00 136/137 AM\1227699EN.docx EN Text proposed by the Commission Amendment

5. The Commission, the Agency, and 5. The Commission, the Agency, and Member States may exchange Member States may exchange commercially confidential information and, commercially confidential information and, where necessary to protect public health, where necessary to protect public health, personal data, with regulatory authorities personal data, with regulatory authorities of third countries with which they have of third countries with which they have concluded bilateral or multilateral concluded legally binding and enforceable confidentiality arrangements. bilateral or multilateral confidentiality arrangements.

Or. en

AM\1227699EN.docx 137/137 PE691.131v01-00 EN