81 Amendments of Tilly METZ related to 2020/0321(COD)
Amendment 113 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) The COVID-19 pandemic has highlighted risks to human health posed by over-exploitation of wildlife and other natural resources and accelerated loss of biodiversity. As health of humans, animals and the environment are inextricably linked and similar medicines and medical devices are used for humans and animals, it is crucial to take the ‘One Health’ approach to address current and emerging crises. This is paramount as the majority (72%) of emerging diseases of humans, including COVID-19, influenza and HIV/AIDS, are caused by zoonotic pathogens.
Amendment 121 #
Proposal for a regulation
Recital 2
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of 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, insufficient mandates of its health agencies and also by the limited degree of Union and Member States preparedness in case of a public health emergency impacting a majority of Member States.
Amendment 134 #
Proposal for a regulation
Recital 4
Recital 4
(4) Dealing with the issue of shortages of medicinal products has been a long- standing prioritybut unresolved problem for the Member States and European Parliament as illustrated by several reports from the European Parliament11 as well as discussions under recent Presidencies of the Council of the European Union. _________________ 11European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (2020/2071(INI))
Amendment 138 #
Proposal for a regulation
Recital 5
Recital 5
(5) The COVID-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic, and has highlighted the structural limitations in the Union’s and Member States' ability to rapidly and effectively react to such challenges during public health crises. Effective communication among Member States about both anticipated and actual shortages and available stocks is essential. To ensure such information exchange, the Single Point of Contact Network (SPOC) should become an established monitoring system.
Amendment 149 #
Proposal for a regulation
Recital 6
Recital 6
(6) The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators, surgical masks, and COVID-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices, led to a negative impact on supply. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of over-priced, non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency.
Amendment 155 #
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 fatalities, 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 medicinal products and medical devices.
Amendment 157 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Experience with clinical trials during the Covid-19 pandemic revealed a tremendous amount of duplication of investigations on the same interventions, many small trials, under-representation of important population subgroups, based on gender, age, ethnicity or medical comorbidities, and a lack of collaboration, posing a risk of research waste. To improve the clinical research agenda, international regulators pointed out the need for robust evidence on quality, efficacy and safety of medicinal products. The main way to obtain reliable evidence is through co-ordinated, well-designed, well-powered large randomised controlled trials. Clinical trial results and data should be made public.
Amendment 159 #
Proposal for a regulation
Recital 8 b (new)
Recital 8 b (new)
(8b) To accelerate, facilitate and coordinate the launch and development of clinical trials in Europe, the Agency should make full use of existing networks, including the Heads of Medicines Agencies (HMA), the Clinical Trials Facilitation and Coordination Group (CTFG), and the European Clinical Research Infrastructure Network (ECRIN).
Amendment 176 #
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) 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 are a persistent problem that has been increasingly affecting health and lives of EU citizens for decades. Therefore, this Regulation should be a first step towards improving the EU response to this long-lasting issue. The Commission should subsequently propose the expansion of this framework to ensure that the issue of shortages is broadly and permanently tackled in the upcoming revision of Regulation (EC) 726/2004 and Directive 2001/83/EC.
Amendment 183 #
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 addressmitigate public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices, the Agency should be able to ask and obtain information and data from the concerned marketing authorisation holders, manufacturers, wholesalers and Member States through designated points of contact. The Agency should also establish a system for the exchange of information on the availability of medicines and medical devices with healthcare professionals, in particular medical doctors and community and hospital pharmacists, consumers and patients facilitated through national medicines agencies.
Amendment 202 #
Proposal for a regulation
Recital 18
Recital 18
(18) The work of the Emergency Task Force should be separate from the work of the scientific committees of the Agency and should be carried out without prejudice to the scientific assessments of those committees. The Emergency Task Force should provide recommendations with regard to the use of medicinal products in the fight against the disease that is responsible forto overcome the public health crisis. The Committee for Medicinal Products for 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.
Amendment 205 #
Proposal for a regulation
Recital 20
Recital 20
(20) Individual research entities may agree together, or with another party, to act as a sponsor in order to prepare one harmonised Union-wide clinical trial protocol, yet experience during the COVID-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the Union, while interacting with multiple Member States. It is therefore appropriate for the Agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or, where applicable, to define respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) 536/2014 and coordinate the development of clinical trial protocols. 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. Such an approach would strengthen the research environment in the Union, and promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. A Union sponsor could benefit from Union research funding 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.
Amendment 209 #
Proposal for a regulation
Recital 24
Recital 24
(24) Given the Agency’s long-standing and proven record of expertise in the field of medicinal products and considering the Agency’s experience from working with a multitude of groups of experts, it is appropriate to establish the appropriate structures within the Agency to monitor potential shortages of medical devices in the context of a public health emergency and to provide the Agency with a mandate to host the expert panels on medical devices. In this regard, all national and, eventually, Union entities engaged in stockpiling of medical devices, should report their stocks to the Agency. This would allow for long-term sustainability for the functioning of the panels and provide clear synergies with related crisis preparedness work for medicinal products. Those structures would in no way change the regulatory system or 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.
Amendment 216 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) Due to the sensitive nature of health data, the Agency should safeguard and guarantee its processing operations respect the data protection principles of lawfulness, fairness, transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality. The Agency should strictly respect the principles of data protection as defined in Article 27 of Regulation (EU)2018/1725 EUDPR, while also determining appropriate technical and organisational security measures in accordance with Article 33 EUDPR.
Amendment 219 #
Proposal for a regulation
Recital 26 b (new)
Recital 26 b (new)
(26b) Where processing of personal data is not necessary to perform the activities of the Agency, measures should be put in place to ensure use of anonymous data in line with the principle of data minimisation. Where anonymisation would not allow to achieve the specific purpose of the processing, the data should be pseudonymised. Where it is necessary for the purposes of this Regulation to process personal data, this should be carried out in accordance with Union law on the protection of personal data. Any processing of personal data based on this Regulation shall take place in accordance with Regulation 2018/1725 (EUDPR).
Amendment 220 #
Proposal for a regulation
Recital 26 c (new)
Recital 26 c (new)
Amendment 221 #
Proposal for a regulation
Recital 26 d (new)
Recital 26 d (new)
(26d) Credibility of the Agency and public trust in its decisions relies on a high degree of transparency. Therefore, proactive engagement of adequate communication tools with the general public should be foreseen. In addition, strengthened and accelerated transparency standards and measures regarding the Agency’s working bodies and clinical data assessed for the evaluation and surveillance of medicinal products and medical devices are paramount to gain and upheld public trust. This Regulation establishes a framework for these strengthened transparency standards and measures, based on the EMA’s efforts, standards and measures put in place during the Covid-19 pandemic.
Amendment 253 #
(b) prevent, monitor and report on shortages of medicinal products for human use and medical devices;
Amendment 274 #
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 use or a medical device does not meet the anticipated demand for that medicinal product or medical device, no matter the cause;
Amendment 295 #
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Article 2 – paragraph 1 – point f a (new)
(fa) ‘demand’ relates to the request for a medicinal product or a medical device by a healthcare professional or patient in response to a clinical need. For demand to be satisfactorily met, the medical product will need to be acquired in time and sufficient quantity to allow continuity of best care of patients.
Amendment 298 #
Proposal for a regulation
Article 2 – paragraph 1 – point f b (new)
Article 2 – paragraph 1 – point f b (new)
(fb) ‘supply’ refers to the total volume of stock of an individual medicinal product or a medical device that is placed on the market by the Marketing Authorisation Holder or the producer, including situations in which a product is withdrawn from the market for commercial reasons.
Amendment 312 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission and, one senior representative per Member State, a representative of the Patients' and Consumers' Working Party (PCWP) and a representative of the Healthcare Professionals' Working Party (HCPWP). Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The list of members of the Steering Group shall be made public on the EMA web-portal.
Amendment 318 #
Proposal for a regulation
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2 a. Members of the Medicines Steering Group must have no financial or other interests that could affect their impartiality. They shall act in the public interest and in an independent manner and 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 be accessible to the public, upon request.
Amendment 322 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. The Chair mayAll members of the Medicines Steering Group may propose to the Chair to invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings, in particular healthcare professionals, patients, consumers and marketing authorisation holders to attend its meetings when their contribution may inform the discussions of the Steering Group.
Amendment 333 #
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. The Medicines Steering Group shall establish its rules of procedure including procedures relating to the working party referred to the paragraph 5 and on the adoption of lists, sets of information, and recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. Agendas and minutes of the Steering Group as well as the rules of procedure and recommendations shall be made available to the public via the EMA web-portal.
Amendment 346 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency shall continuously monitor any event that is likelyhas the potential to 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 (ECDC) and other Union agencies, where relevant.
Amendment 359 #
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 medicinal product in a given Member State, that is likelyhas the potential to lead to a major event or a public health emergency. 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. Based on a report of an event from a national competent authority and in order to understand 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 362 #
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Where the Agency considers that an actual or imminent major event needs to be addressed, it shall inform the Commission and the Member States thereof. The Commission, on its own initiative or following a request from one or more Member States, or the Executive Director of the Agency may shall then request the assistance of the Medicines Steering Group to address the major event.
Amendment 383 #
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 medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof. Union or national entities that are engaged in stockpiling of medicinal products shall be informed accordingly.
Amendment 390 #
Proposal for a regulation
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
Amendment 407 #
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
The Single Point of Contact Network (SPOC) shall be extended to become a reliable monitoring system for shortages of medicines and other medical counter.
Amendment 408 #
Proposal for a regulation
Article 7 – paragraph 1 b (new)
Article 7 – paragraph 1 b (new)
As shortage of medicines outside of the critical lists established in a public health emergency or a major event are outside of the scope of this Regulation and yet pose a persistent challenge that has been increasingly affecting health and well- being of EU citizens for the past decades, this Regulation should be a first step towards improving the EU response to this long-lasting issue. The Commission shall subsequently propose the expansion of this framework to ensure that the issue of shortages is broadly and permanently tackled in the upcoming revision of Regulation (EC) 726/2004 and Directive 2001/83/EC.
Amendment 417 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Where requested by the Commission 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. It shall share its findings and conclusions with Union and national entities engaged with stockpiling of medicinal products and medical devices.
Amendment 421 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals, consumers and patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.
Amendment 428 #
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, including healthcare professionals, to ensure preparedness to deal with potential or actual shortages of medicinal products caused by public health emergencies or major events.
Amendment 443 #
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) specify the procedures for establishing the critical medicines lists, , ensuring adequate consultation with healthcare professionals, consumers, patients a high level of transparency in decision-making;
Amendment 464 #
Proposal for a regulation
Article 9 – paragraph 1 – point f a (new)
Article 9 – paragraph 1 – point f a (new)
(fa) publish information referred to in paragraph (1) (a), (b) and (f) on its web- portal.
Amendment 474 #
Proposal for a regulation
Article 9 – paragraph 3 – point d
Article 9 – paragraph 3 – point d
(d) details of the potential or actual shortage such as actual or estimated start and end dates and suspected or known cause as well as information on potential bottlenecks in the supply chain;
Amendment 475 #
Proposal for a regulation
Article 9 – paragraph 3 – point d a (new)
Article 9 – paragraph 3 – point d a (new)
(da) information on active substance manufacturing sites, where relevant;
Amendment 479 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) prevention and mitigation plans including production and supply capacitybut not limited to information on production and supply capacity, production sites of finished pharmaceutical products and active pharmaceutical ingredients and raw materials, potential alternative production sites, minimum stock levels;[PA1] such plans shall contain preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains;
Amendment 496 #
Proposal for a regulation
Article 10 – title
Article 10 – title
Obligations on marketing authorisation holders and other actors in the supply chain
Amendment 505 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the Agency. Marketing authorisation holders failing to comply with their reporting obligations shall be subject to proportionate sanctions set by the Commission in a delegated act.
Amendment 516 #
Proposal for a regulation
Article 10 – paragraph 6 a (new)
Article 10 – paragraph 6 a (new)
6 a. In order to supplement the shortage prevention and mitigation plans of critical products, the Agency and national competent authorities may request additional information from wholesale distributors and other relevant actors regarding any logistical challenges incurred by the wholesale supply chain.
Amendment 519 #
Proposal for a regulation
Article 10 – paragraph 6 b (new)
Article 10 – paragraph 6 b (new)
6 b. The Commission shall exercise its power to lay down rules on sanctions for non-compliance with the obligations established under this Article in a delegated act.
Amendment 534 #
Proposal for a regulation
Article 11 – paragraph 4 a (new)
Article 11 – paragraph 4 a (new)
4 a. National medicines agencies in Member States shall facilitate patient and consumer reporting of medicine shortages through the provision of alternative reporting formats in addition to web- based formats. Aggregated data from these reports shall be shared by the sub- network of single points of contact from national competent authorities referred to in Article 3 (5) with the Medicines Steering Group to inform recommendations on medicine shortage impact and management.
Amendment 538 #
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, including healthcare professionals, to support them in their work and in the communication with patients;
Amendment 554 #
Proposal for a regulation
Article 13 – paragraph -1 (new)
Article 13 – paragraph -1 (new)
-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 list.
Amendment 555 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform the public and interest groups in a timely manner with regard to the work of the Medicines Steering Group, and ensure adequate consultation with the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP). The list of the members of the Medicines Steering Group, the rules of procedure, agendas and minutes of the meetings and recommendations shall be published on the Agency’s web-portal.
Amendment 563 #
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 in preparation for and during public health emergencies, either in person or remotely. The Agency shall provide its secretariat.
Amendment 567 #
Proposal for a regulation
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) reviewing clinical trial protocols and providing advice to developers on clinical trials to be conducted in the Union, in particular on large multi-centre trials, for medicinal products intended to treat, prevent, or diagnose the disease causing the public health emergency, in accordance with Article 15;
Amendment 576 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The Emergency Task Force shall be composed of representatives of the scientific committees, working parties, namely representatives of the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party, and staff members of the Agency, the coordination group established in accordance with Article 27 of Directive 2001/83/EC, and the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) 536/2014.21 External experts may be appointed and representatives of other Union bodies and agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the Agency. _________________ 21Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1
Amendment 580 #
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
5. The Chair may invite 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, independent clinical trials experts and researchers, and interest groups representing patients and healthcare professionals to attend its meetings.
Amendment 584 #
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The Emergency Task Force shall establish its rules of procedure including rules on the adoption of recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. The rules of procedure including rules on the adoption of recommendations, as well as the opinions meeting minutes and agendas should be made public on the Agency web-portal.
Amendment 595 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. In preparation of the review, the Emergency Task Force may 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. The Emergency Task Force shall liaise with medicine agencies of third countries for additional information and data exchange.
Amendment 604 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work of the Emergency Task Force, and ensure adequate consultation with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party. The list of the members of the Emergency Task Force, the rules of procedure, agendas and minutes of the meetings and recommendations shall be published on the Agency’s web-portal.
Amendment 620 #
Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)
Article 18 – paragraph 1 – point d a (new)
(da) take urgent and appropriate measures to ensure the protection of health data from attacks against information systems. These measures should be built on combination of regular penetration testing, decentralised solutions and security by design principles.
Amendment 631 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. The Medical Devices Steering Group shall be composed of a representative of the Agency, a representative of the Commission and, one senior representative per Member State, a representative of the Patients' and Consumers' Working Party (PCWP) and a representative of the Healthcare Professionals' Working Party (HCPWP). Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The list of members of the Steering Group shall be made public on the Agency web-portal.
Amendment 635 #
Proposal for a regulation
Article 19 – paragraph 2 a (new)
Article 19 – paragraph 2 a (new)
2 a. Members of the Medical Devices Steering Group must have no financial or other interests that could affect their impartiality. They shall act in the public interest and in an independent manner and 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 be accessible to the public, upon request.
Amendment 638 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair mayAll members of the Medicines Steering Group may propose to the Chair to invite third parties, including representatives of medical device interest groups to attend its meetings, in particular healthcare professionals, consumers and patients, to attend its meetings when their contribution may inform the discussions of the Steering Group.
Amendment 643 #
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. The Medical Devices Steering Group shall establish its rules of procedure including procedures relating to the working party referred to in paragraph 5, and on the adoption of lists, sets of information and recommendations. The rules of procedures shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. Agendas and minutes of the Steering Group as well as the rules of procedure and recommendations should be made available to the public via the Agency web-portal.
Amendment 655 #
Proposal for a regulation
Article 20 – paragraph 3 a (new)
Article 20 – paragraph 3 a (new)
3 a. The Agency shall report about the shortage of public health emergency critical devices through the database referred to in Article 6 (4a).
Amendment 668 #
Proposal for a regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
(a) specify the procedures for establishing the public health emergency critical devices list, ensuring adequate consultation with healthcare professionals, consumers, patients and a high level of transparency indecision- making;
Amendment 675 #
Proposal for a regulation
Article 23 – paragraph 1 – point d
Article 23 – paragraph 1 – point d
Amendment 676 #
Proposal for a regulation
Article 23 – paragraph 2 – point a
Article 23 – paragraph 2 – point a
(a) establish and maintain for the duration of the public health emergency, a sub-network of single points of contact from medical device manufacturers and notified bodies based on the medical devices included on the public health 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;
Amendment 680 #
Proposal for a regulation
Article 23 – paragraph 3 – point f
Article 23 – paragraph 3 – point f
(f) prevention and mitigation plans including production and supply capacity; such plans shall contain preventative measures that help ensure the continued supply of critical medical devices;
Amendment 691 #
Proposal for a regulation
Article 24 – paragraph 6 a (new)
Article 24 – paragraph 6 a (new)
6 a. The Commission shall exercise its power to lay down rules on sanctions for non-compliance with the obligations established under this Article in a delegated act.
Amendment 697 #
Proposal for a regulation
Article 25 – paragraph 4 – point a
Article 25 – paragraph 4 – point a
(a) consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, while at the same time ensuring both patient and product safety;
Amendment 705 #
Proposal for a regulation
Article 27 – paragraph -1 (new)
Article 27 – paragraph -1 (new)
-1 The Agency shall establish an early warning system to inform relevant stakeholders, including healthcare professionals of any supply problems and potential or actual shortages of medicinal products included on the critical products list.
Amendment 706 #
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work of the Medical Devices Steering Group, and ensure adequate consultation with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party. The list of the members of the Medical Devices Steering Group, the rules of procedure, agendas and minutes of the meetings and recommendations shall be published on the Agency’s web-portal.
Amendment 711 #
Proposal for a regulation
Article 28 – paragraph 1 – introductory part
Article 28 – paragraph 1 – introductory part
The Agency shall, on behalf of the Commission, from 1 March 2022 onwards, provide the secretariat of the expert panels designated in accordance with Implementing Decision (EU) 2019/1396 and provide the support necessary to ensure that those panels can efficiently perform their tasks as set out in Article 106(9) and (10) of Regulation (EU) 2017/745. The Agency shall:
Amendment 713 #
Proposal for a regulation
Article 28 – paragraph 1 – point a
Article 28 – paragraph 1 – point a
(a) provide administrative, scientific and technical support to the expert panels for the provision of scientific opinions, views and advice;
Amendment 717 #
Proposal for a regulation
Article 29 a (new)
Article 29 a (new)
Article 29 a Transparency and publication of clinical data 1. For the duration of a public health emergency, the sponsors of clinical trials related to products linked to the disease in question, shall: (a) publish the study protocol at the start of the trial through the EU clinical trials register; (b) publish the summary of the results through the EU clinical trials register within two months after marketing authorisation. 2. The Agency shall implement exceptional measures with regard to medicinal products, including vaccines, and medical devices falling under the scope of this Regulation, strengthening transparency measures and speeding up standard publication timelines and providing more information. These measures include: (a) Publication of the product information with details of the conditions of use at the time of marketing authorisation; (b) Expedited publication of the full European Public Assessment Reports (EPAR), within 7days after marketing authorisation. The EPARs should include a description of received scientific advice; (c) Expedited publication, within a period of 2 months after marketing authorisation, of clinical data submitted to the Agency in support of the applications for medicines, after personal data have been anonymised and any commercially confidential information redacted. Access shall be provided to all independent individual participant level data along with protocols and analytic codes; (d) Publication of the full risk management plan for authorised medicines; (e) Publication of news announcements within 1 day of the start of initial rolling reviews or the evaluation of new evidence or applications for extension of indication. 3. The Agency shall make agendas and minutes of all meetings public, as well as the recommendations, opinions and decisions from the Steering Groups and the Emergency Task Force on its web- portal. 4. The membership of the Emergency Task Force, Steering Groups and Working Parties shall be made public. Members of the Emergency Task Force, Steering Groups and experts shall not have financial or other interests in the pharmaceutical or medical device industry which could affect their impartiality. They shall act in the public interest 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, which is accessible to the public, upon request. Members of the Emergency Task Force, Steering Groups and Working Parties, and experts who participate in meetings or working groups of the Agency shall declare, at each meeting, any specific interests which could be considered to be prejudicial to their independence with respect to the items on the agenda. These declarations shall be made available to the public.
Amendment 719 #
Proposal for a regulation
Article 30 – title
Article 30 – title
Confidentiality and data privacy
Amendment 720 #
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 on the legal protection of persons who report breaches of Union law, and 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 722 #
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) personal data in accordance with Article 32the definitions contained in Article 4(1) of Regulation (EU) 2016/679 (GDPR) and Article3(1) of Regulation (EU) 2018/1725 (EUDPR);
Amendment 724 #
Proposal for a regulation
Article 30 – paragraph 1 – point b
Article 30 – paragraph 1 – point b
(b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights accordance with Directive 2016/943 and without prejudice to Directive 2019/1937, as well as intellectual property rights, unless there is an overriding public interest in disclosure;
Amendment 728 #
Proposal for a regulation
Article 30 – paragraph 5
Article 30 – paragraph 5
5. The Commission, the Agency, and Member States may, in compliance with Chapter V of the EUDPR, exchange commercially confidential information and, where necessary to protect public health, personal data, with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Amendment 730 #
Proposal for a regulation
Article 30 – paragraph 5 a (new)
Article 30 – paragraph 5 a (new)
5 a. All parties involved in the application of this Regulation shall ensure that the concept of commercially confidential information is interpreted narrowly, and information of public interest is, to the extent possible, proactively disclosed.
Amendment 733 #
Proposal for a regulation
Article 30 – paragraph 5 b (new)
Article 30 – paragraph 5 b (new)
5 b. This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Regulation (EU) No 2016/679 and Directive 2002/58/EC on privacy and electronic communications, or the obligations of the Agency and the Commission relating to their processing of personal data under Regulation (EU) No 2018/1725, when fulfilling their responsibilities.
Amendment 735 #
Proposal for a regulation
Article 31 – title
Article 31 – title
31 Entry into Force and application
Amendment 737 #
Proposal for a regulation
Article 31 – paragraph 2 a (new)
Article 31 – paragraph 2 a (new)
Chapters I, II and III shall apply from [date of entry into force]. Chapter IV shall apply from [date of entry into force + 3 months].