Activities of Joëlle MÉLIN related to 2020/0321(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
Opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
Amendments (86)
Amendment 71 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(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 clear stance to be taken by the EMA;
Amendment 72 #
Proposal for a regulation
Recital 3 b (new)
Recital 3 b (new)
(3b) the essential free movement of goods must be possible with a revised border management;
Amendment 112 #
Proposal for a regulation
Recital 1
Recital 1
(1) Pursuant to Articles 9 and 168 of the Treaty on the Functioning of the European Union (‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union the Union is to ensure a high level of human health protection in the definition and implementation of all Union policies and activities, within the strict limit defined by those two articles.
Amendment 120 #
Proposal for a regulation
Recital 2
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that, due to the significant risks posed by emerging zoonoses, the Union should be more effective in managing the availability of human or veterinary medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. 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 limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.
Amendment 131 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(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 clear stance by the EMA.
Amendment 132 #
Proposal for a regulation
Recital 3 b (new)
Recital 3 b (new)
(3b) The essential free movement of goods should be possible with revised border management.
Amendment 137 #
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) The COVID-19 pandemic has clearly illustrated that human health is linked to animal health and the environment, and that action to tackle health threats should take account of all three dimensions.
Amendment 154 #
Proposal for a regulation
Recital 7
Recital 7
(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions amongst Member States and other national protective measures, which can seriously impact the functioning of the internal market. Furthermore, shortages of medicinal products can result in serious risks to the health of patients in the Union due to their lack of availability, which can cause, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits. It is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical human and veterinary medicinal products and medical devices.
Amendment 162 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency, in coordination with the ECDC, shall continuously monitor any event that is likely to lead to a major event or a public health emergency.
Amendment 170 #
Proposal for a regulation
Recital 10
Recital 10
(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of human and veterinary medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises.
Amendment 171 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group, after consulting the marketing authorisation holders and representatives of stakeholders in the sector, shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list ’). The list shall be updated whenever necessary until the major event has been sufficiently addressed.
Amendment 171 #
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to facilitate the research and development of human and veterinary medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause serious public health events, including emerging zoonoses that particularly stem from human and animal environmental changes.
Amendment 173 #
Proposal for a regulation
Recital 11
Recital 11
(11) This Regulation aims to ensure the smooth functioning of the internal market as regards human and veterinary medicinal products and medical devices, with a high level of human health protection being fundamental in those aims. Moreover, this Regulation aims to ensure the quality, safety and efficacy of medicinal products with the potential to address public health emergencies. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 TFEU, this Regulation establishes a framework for the monitoring and reporting on shortages of human and veterinary medicinal products and medical devices during public health crises. As regards Article 168(4)(c) TFEU, this Regulation provides for a strengthened Union framework ensuring the quality and safety of medicinal products and medical devices.
Amendment 180 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to improve crisis preparedness and management for human and veterinary medicinal products and medical devices and increase resilience and solidarity across the Union, the procedures and the respective roles and obligations of different concerned entities involved should be clarified. The framework should build on the ad hoc solutions identified so far in the response to the COVID-19 pandemic.
Amendment 185 #
Proposal for a regulation
Recital 13
Recital 13
(13) A harmonised system of monitoring of shortages of medicinal products and medical devices should be established, which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events, which may have a serious impact on public health. That system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to address public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of human or veterinary medicinal products and medical devices, the Agency should be able to ask and obtain information and data from the concerned marketing authorisation holders, manufacturers and Member States through designated points of contact.
Amendment 192 #
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
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.
Amendment 193 #
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. In order to prepare for fulfilling the tasks referred to in Articles 4 to 8, and after consulting representatives of national authorities and marketing authorisation holders, as well as other stakeholders in the pharmaceutical sector, the Agency shall:
Amendment 194 #
Proposal for a regulation
Recital 15
Recital 15
(15) With respect to medicinal products, an executive steering group should be established within the Agency to ensure a robust response to major events and to coordinate urgent actions within the Union in relation to the management of issues relating to the supply of medicinal products. The Steering Group should establish lists of critical human and veterinary medicinal products to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality, safety, and efficacy of those medicinal products and ensure a high level of human health protection.
Amendment 195 #
Proposal for a regulation
Recital 16
Recital 16
(16) The Executive Steering Group on Shortages and Safety of Human and Veterinary Medicinal Products should benefit from the Agency’s extensive scientific expertise as regards the evaluation and supervision of medicinal products and should further develop the Agency’s leading role in coordinating and supporting the response to shortages during the COVID-19 pandemic.
Amendment 200 #
Proposal for a regulation
Recital 17
Recital 17
(17) In order to ensure that safe, high quality, and efficacious human and veterinary medicinal products, which have the potential to address public health emergencies, can be developed and made available within the Union as soon as possible during public health emergencies, an emergency task force should be established within the Agency to provide advice on such medicinal products. The Emergency Task Force should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols, to those organisations involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their exact role in the development of such medicinal products.
Amendment 204 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) In order to ensure the full application of Article 35 of Regulation (EU) no.536/2014 of the European Parliament and of the Council 1a, with regard to emergency clinical trials on subjects unable to provide informed consent, a special independent monitoring committee for emergency clinical trials is setup, in order to avoid the duplication of similar studies that could harm the human dignity and to ensure closer pharmacovigilance due to the particularity of the trial in question. _________________ 1a Regulation (EU) no 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official Journal of the European Union L 158/1, p. 34. https://ec.europa.eu/health/sites/health/fil es/files/eudralex/vol- 1/reg_2014_536/reg_2014_536_en.pdf
Amendment 220 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, marketing authorisation holders for medicinal products included on the critical medicines lists, and all distributors legally authorised to supply medicines to the public, shall submit the information referred to in Article 9(3) by the deadline set by the Agency. They shall submit the 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 necessary.
Amendment 224 #
Proposal for a regulation
Recital 27
Recital 27
(27) During a temporary public health emergency or in relation to a major event, the Agency should ensure cooperation with the European Centre for Disease Prevention and Control and other Union Agencies as appropriate. Such cooperation should include data sharing, including data on epidemiological forecasting, regular communication at an executive level, and invitations to representatives of the European Centre for Disease Prevention and Control and other Union Agencies to attend meetings of the Emergency Task Force, the Medicines Steering Group, and the Medical Devices Steering Group, as appropriate.
Amendment 231 #
Proposal for a regulation
Recital 31 a (new)
Recital 31 a (new)
(31a) In the specific case of the COVID- 19 epidemic, the shortage of adjuvant treatments for the disease had a variety of causes, ranging from production difficulties in third countries to logistical or production difficulties, whilst the shortage of vaccines was due to a rarer cause, namely an unexpectedly high and rising demand.
Amendment 236 #
Proposal for a regulation
Recital 31 b (new)
Recital 31 b (new)
(31b) It is important to take into account, in the assessment of potential health emergencies, the contribution of zoonoses and the role of veterinary services where they are involved.
Amendment 241 #
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) prepare for and manage the impact of major events on medicinal products for human and veterinary use and of public health emergencies on medicinal products for human and veterinary use and on medical devices;
Amendment 255 #
Proposal for a regulation
Article 1 – paragraph 1 – point c
Article 1 – paragraph 1 – point c
(c) provide advice on medicinal products for human and veterinary use with the potential to address public health emergencies;
Amendment 258 #
Proposal for a regulation
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) ‘public health emergency’ means a temporary public health emergency at Union level recognised by the European Commission in accordance with Article 23(1) of Regulation (EU) 2020/[…]17; _________________ 17[insert reference to the Regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU] OJ C […], […], p. […].
Amendment 263 #
Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)
Article 2 – paragraph 1 – point c a (new)
(ca) ‘veterinary medicinal product’ means a veterinary medicinal product as defined in paragraph 1(b) of Article 1 of Directive 2004/28/EC of the European Parliament and of the Council;
Amendment 266 #
Proposal for a regulation
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) ‘shortage’ means that supply of a medicinal product for human or veterinary use or a medical device does not meet demand, i.e. patient needs plus appropriate buffer stocks, for that medicinal product or medical device, no matter the cause;
Amendment 270 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. In preparation of the review, the Emergency Task Force mayshall request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability.
Amendment 286 #
Proposal for a regulation
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to human and veterinary medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the supply or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.
Amendment 289 #
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medical Devices Steering Group, after consulting the marketing authorisation holders and representatives of stakeholders in the sector, shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.
Amendment 291 #
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Article 2 – paragraph 1 – point f a (new)
(fa) ‘critical medicinal product’ means any medicinal product for human and veterinary use within the meaning of Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council, or a constituent thereof, that is considered necessary for the management of a public health emergency and until such time as the emergency is resolved.
Amendment 296 #
Proposal for a regulation
Article 22 – paragraph 5 a (new)
Article 22 – paragraph 5 a (new)
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.
Amendment 298 #
Proposal for a regulation
Article 23 – paragraph 1 – introductory part
Article 23 – paragraph 1 – introductory part
1. In order to prepare for fulfilling the tasks referred to in Articles 20, 21, and 22, and after consulting the representatives of national authorities and marketing authorisation holders, as well as other stakeholders in the pharmaceutical sector, the Agency shall:
Amendment 307 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. In order to facilitate the monitoring referred to in Article 21 and following a request from the Agency, medical device manufacturers of the medical devices included on the public health emergency critical devices list and all distributors legally authorised to supply medical devices to the public, and, where necessary, concerned notified bodies, shall submit the information requested by the deadline set by the Agency. They shall submit the information requested through the points of contact designated in accordance with Article 23(2) and using the reporting methods and system established pursuant to Article 23(1). They shall provide updates wherever necessary.
Amendment 308 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Executive Steering Group on Shortages and Safety of Human and Veterinary Medicinal Products (‘the Medicines Steering Group’) is hereby established as part of the Agency. It shall meet either in person or remotely, in preparation for or during a public health emergency or following a request for assistance referred to in Article 4(3). The Agency shall provide its secretariat.
Amendment 331 #
Proposal for a regulation
Article 3 – paragraph 3 a (new)
Article 3 – paragraph 3 a (new)
3a. The Medicines Steering Group shall regularly invite representatives of interest groups in the field of medicinal products and marketing authorisation holders, as well as other stakeholders in the pharmaceutical industry to exchange regularly on the situation of medicine production in Europe and worldwide. On the basis of these exchanges, the Medicines Steering Group shall draw up strategic recommendations which it shall address to the Member States during the public health emergency period.
Amendment 340 #
Proposal for a regulation
Article 3 – paragraph 6 a (new)
Article 3 – paragraph 6 a (new)
Amendment 345 #
Proposal for a regulation
Article 4 - title
Article 4 - title
Monitoring of events and preparedness for temporary major events and public health emergencies
Amendment 351 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency, in coordination with the ECDC, shall continuously monitor any event that is likely to lead to a major event or a public health emergency.
Amendment 353 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. To facilitate the monitoring task referred to in paragraph 1, the national competent authorities, through the single points of contact referred to in Article 3(5), shall, based on the reporting criteria specified by the Agency pursuant to Article 9(1)(b), report to the Agency on any event, including a shortage of a human or veterinary medicinal product in a given Member State, that is likely to lead to a major event or a public health emergency in other Member States. Where a national competent authority informs the Agency of a shortage of a medicinal product in a given Member State, it shall provide the Agency with any information received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC, as well as any relevant additional information provided by stakeholders and actors in the pharmaceutical industry, with due regard for confidentiality and privacy, as provided for in Regulation (EU) 2016/769 of the European Parliament and of the Council (General Data Protection Regulation – GDPR). Based on a report of an event from a national competent authority and in order to understand and, in particular, anticipate the impact of the event in other Member States, the Agency may request information from the national competent authorities, through the working party referred to in Article 3(5).
Amendment 371 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group, after consulting the marketing authorisation holders and representatives of stakeholders in the sector, shall adopt a list of human and veterinary medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list’). The list shall be updated whenever necessary until the major event has been sufficiently addressed, and shall cease to apply at the end of the major event.
Amendment 378 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medicines Steering Group shall adopt a list of human and veterinary medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency, and shall cease to apply at the end of the public health emergency.
Amendment 384 #
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Medicines Steering Group shall adopt a set of information necessary to monitor the supply and demand of human and veterinary medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof.
Amendment 385 #
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. The Agency shall immediately publish the critical medicines lists and any updates to those lists on its web-portal referred to in Article 26 of Regulation (EC) No 726/2004. This list shall be published in a clear and accessible way so that Member States, actors in the pharmaceutical supply chain and all stakeholders can easily access this information and, where appropriate, can easily report possible changes or publication problems.
Amendment 393 #
Proposal for a regulation
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4a. The Agency, in cooperation with the Commission and the national competent authorities of the Member States, shall work with representatives of the European medicinal product industry to ensure that medicinal products included on the critical medicines list made available in one Member State are equally available in all Member States, in one form or another, and in particular in smaller Member States.
Amendment 400 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
On the basis of the critical medicines lists and the information and data provided in accordance with Articles 10 and 11 of this Regulation, the Medicines Steering Group shall meet regularly throughout the major event or public health emergency with the working group of designated national contact points for medicines shortages within the national competent authorities for medicines and with representatives of the medicines production and distribution sectors in order to monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products and to adapt the list as well as possible throughout the major event or emergency. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the 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 to in footnote 4]
Amendment 410 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until its closure, the Medicines Steering Group shall regularly report the results of its monitoring to the Commission, national public health authorities and the sub- network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.
Amendment 419 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Where requested by the Commission, one or more national public health authorities or the sub-network referred to in Article 9(2), the Medicines Steering Group shall provide aggregated data and forecasts of demand to substantiate its findings. In that regard, the Medicines Steering Group shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medicinal product needs, and with the Executive Steering Group on Shortages of Medical Devices referred to in Article 19 where medicinal products included on the critical medicines lists are administered with a medical device.
Amendment 429 #
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The Medicines Steering Group may, on its own initiative or upon request from the Commission, provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities to ensure preparedness to deal with potential or actual shortages of human and veterinary medicinal products caused by public health emergencies or major events.
Amendment 439 #
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5a. The measures recommended by the Steering Group to the Commission, Member States, marketing authorisation holders and other stakeholders should include a relaxing of rules to deal with potential shortages.
Amendment 442 #
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. In order to prepare for fulfilling the tasks referred to in Articles 4 to 8, and after consulting representatives of national authorities and marketing authorisation holders, as well as other stakeholders in the pharmaceutical sector, the Agency shall:
Amendment 476 #
Proposal for a regulation
Article 9 – paragraph 3 – point e
Article 9 – paragraph 3 – point e
Amendment 500 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, marketing authorisation holders for medicinal products included on the critical medicines lists, and all distributors legally authorised to supply medicines to the public, shall submit the information referred to in Article 9(3) by the deadline set by the Agency. They shall submit the 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 necessary.
Amendment 508 #
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information contains information of a commercially confidential nature, they shall identify the relevant parts and clarify the reasons for such an indication. The Agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure, in accordance with Article 30 of this Regulation.
Amendment 514 #
Proposal for a regulation
Article 10 – paragraph 6 – point a
Article 10 – paragraph 6 – point a
(a) provide any comments they have to the Agency, in accordance with Article 30 of this Regulation;
Amendment 543 #
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities where this is proportionate, justified and necessary;
Amendment 564 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Emergency Task Force is hereby established as part of the Agency. It shall be convened only during public health emergencies, either in person or remotely. The Agency shall provide its secretariat.
Amendment 565 #
Proposal for a regulation
Article 14 – paragraph 2 – point a
Article 14 – paragraph 2 – point a
(a) providing scientific advice and reviewing the available scientific data on human and veterinary medicinal products with the potential to address the public health emergency, including requesting data from developers and engaging with them in preliminary discussions;
Amendment 570 #
Proposal for a regulation
Article 14 – paragraph 2 – point e
Article 14 – paragraph 2 – point e
(e) providing scientific recommendations with regard to the use of any human or veterinary medicinal product, which may have the potential to address public health emergencies, in accordance with Article 16;
Amendment 578 #
5. The Chair mayshall invite, to Emergency Task Force meetings throughout the public health emergency, representatives of Member States, members of scientific committees of the Agency and working parties, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, and interest groups representing patients and healthcare professionals to attend its meetings, in order to provide the Emergency Task Force with the broadest and most detailed view of the situation at all times throughout the public health emergency.
Amendment 585 #
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The Emergency Task Force shall establish its rules of procedure including, which shall include rules relating to its formation, structure and confidentiality, including potential conflicts of interest. These rules of procedure shall also include rules on the adoption of recommendations. The rules of procedures shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency.
Amendment 594 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. Following the recognition of a public health emergency, the Emergency Task Force shall undertake a review of the available scientific data on human or veterinary medicinal products, which may have the potential to be used to address the public health emergency. The review shall be regularly updated during the public health emergency.
Amendment 596 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. In preparation of the review, the Emergency Task Force mayshall request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability.
Amendment 597 #
Proposal for a regulation
Article 16 – paragraph 3 – introductory part
Article 16 – paragraph 3 – introductory part
3. Based on a request from one or more Member States, or the Commission, the Emergency Task Force shall provide recommendations to the Committee for Medicinal Products for Human and Veterinary Use for an opinion in accordance with paragraph 4 on the following:
Amendment 598 #
Proposal for a regulation
Article 16 – paragraph 3 – point a
Article 16 – paragraph 3 – point a
(a) the compassionate use of medicinal products falling under the scope of Directive 2001/83/EC or Regulation (EC) No 726/2004 and the whole production and distribution chain, as well as the adapted prescription by carers in accordance with Article 83(8) of Regulation (EC) No 726/2004;
Amendment 611 #
Proposal for a regulation
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
(a) develop and maintain European- designed electronic tools for the submission of information and data, including electronic health data generated outside the scope of clinical studies, in strict compliance with Union law on personal data and the GDPR;
Amendment 615 #
Proposal for a regulation
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
(c) as part of its regulatory tasks, make use of digital infrastructures or tools, to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies, and the exchange of such data between Member States, the Agency, and other Union bodies, in strict compliance with Union law on personal data and the GDPR;
Amendment 624 #
Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)
Article 18 – paragraph 1 – point d a (new)
(da) ensure that it has the necessary resources to secure and protect the data flow within the Agency, and in particular to resist and/or counter cyberattacks and human leaks of documentation;
Amendment 642 #
Proposal for a regulation
Article 19 – paragraph 3 a (new)
Article 19 – paragraph 3 a (new)
Amendment 649 #
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medical Devices Steering Group, after consulting marketing authorisation holders and representatives of stakeholders in the sector, shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency, and shall cease to apply at the end of the public health emergency.
Amendment 653 #
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. The Agency shall publish the public health emergency critical devices list and any updates to that list on its web-portal. This list shall be published in a clear and accessible way so that Member States, actors in the pharmaceutical supply chain and all stakeholders can easily access this information and, where appropriate, can easily report possible changes or publication problems.
Amendment 654 #
Proposal for a regulation
Article 20 – paragraph 3 a (new)
Article 20 – paragraph 3 a (new)
3a. The Agency, in cooperation with the Commission and the national competent authorities of the Member States, shall work with representatives of the European medical device industry to ensure that medical devices included on the critical devices list made available in one Member State are equally available in all Member States, in one form or another, and in particular in smaller Member States.
Amendment 658 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. On the basis of the public health emergency critical devices list and the information and data provided in accordance with Articles 24 and 25 of this Regulation, the Medical Devices Steering Group shall meet regularly throughout the major event or public health emergency with the working group of designated national contact points for medicines shortages within the national competent authorities for medicines and with representatives of the medicines production and distribution sectors in order to monitor supply and demand of medical devices included on that list with a view to identifying any potential or actual shortages of those medical devices and to adapt the list as best as possible throughout the major event or emergency. As part of that monitoring, the Medical Devices Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]22[1] and the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 22[1] [insérert refeéférence to adopted text referred to in footnotau texte adopté mentionné à la note de bas de page 4]
Amendment 661 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. For the duration of the public health emergency, the Medical Devices Steering Group shall regularly report the results of its monitoring to the Commission, national public health authorities and the sub- network referred to in Article 23(1)(b), and, in particular, signal any potential or actual shortages of medical devices included on the public health emergency critical devices list.
Amendment 662 #
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
2. Where requested by the Commission, one or more national public health authorities or the sub-network referred to in Article 23(2)(b), the Medical Devices Steering Group shall provide aggregated data and forecasts of demand to support its findings. In that regard, the Steering Group shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medical device needs, and with the Medicines Steering Group referred to in Article 3 where medical devices included on the public health emergency critical devices list are used to jointly with a medicinal product.
Amendment 666 #
Proposal for a regulation
Article 22 – paragraph 5 a (new)
Article 22 – paragraph 5 a (new)
5a. The measures recommended by the Steering Group to the Commission, Member States, marketing authorisation holders and other stakeholders should include a relaxing of rules to deal with potential shortages.
Amendment 667 #
Proposal for a regulation
Article 23 – paragraph 1 – introductory part
Article 23 – paragraph 1 – introductory part
1. In order to prepare for fulfilling the tasks referred to in Articles 20, 21, and 22, and after consulting representatives of national authorities and marketing authorisation holders, as well as other stakeholders in the pharmaceutical sector, the Agency shall:
Amendment 678 #
Proposal for a regulation
Article 23 – paragraph 3 – point e
Article 23 – paragraph 3 – point e
Amendment 687 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. In order to facilitate the monitoring referred to in Article 21 and following a request from the Agency, medical device manufacturers of the medical devices included on the public health emergency critical devices list, and all distributors legally authorised to supply medical devices to the public and, where necessary, concerned notified bodies, shall submit the information requested by the deadline set by the Agency. They shall submit the information requested through the points of contact designated in accordance with Article 23(2) and using the reporting methods and system established pursuant to Article 23(1). They shall provide updates wherever necessary.
Amendment 693 #
Proposal for a regulation
Article 25 – paragraph 1 – point b
Article 25 – paragraph 1 – point b
(b) indicate the existence of any commercially confidential information, and, clarify the reasons for such an indication, in accordance with Article 30 of this Regulation;
Amendment 703 #
Proposal for a regulation
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
(b) consider the need for guidelines addressed to Member States, medical device manufacturers, notified bodies and other entities where this is proportionate, justified and necessary;
Amendment 721 #
Proposal for a regulation
Article 30 – paragraph 1 – introductory part
Article 30 – paragraph 1 – introductory part
1. Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/200124 and all existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: _________________ 24Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.05.2001, p. 43
Amendment 723 #
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) personal data in accordance with Article 32as defined in Article 4(1) of the GDPR;