Activities of Jutta PAULUS related to 2020/0321(COD)
Plenary speeches (1)
European Medicines Agency (continuation of debate)
Shadow 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 (73)
Amendment 69 #
Proposal for a regulation
Recital 2
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union shouldmust 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 73 #
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 75 #
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 the Member States’ ability to rapidly and effectively react to such challenges during public health crises.
Amendment 77 #
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 overpriced, 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 80 #
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 or being protected doing so. 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 81 #
Proposal for a regulation
Recital 8
Recital 8
(8) Safe and efficacious medicinal products that treat, prevent or diagnose diseases which cause public health emergencies, should be developed, if necessary, and made available within the Union as soon as possible during such emergencies. The COVID-19 pandemic has also highlighted sub-optimallacking coordination and decision- making as regards multinational clinical trials, and missing Union-level advice on the use of medicinal products in national compassionate use programmes or outside of their authorised indications in the Union, causing delays in the adoption of research outcomes and in the development and availability of new or repurposed medicines.
Amendment 85 #
Proposal for a regulation
Recital 11
Recital 11
(11) This Regulation aims to ensure the smooth functioning of the internal market as regards 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, but quality, safety and efficacy of medical products should be a paramount priority. As regards Article 114 TFEU, this Regulation establishes a framework for the monitoring and reporting on shortages of 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 86 #
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(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 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.
Amendment 87 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to improve crisis preparedness and management for 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 and on experiences and examples in other countries.
Amendment 89 #
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.
Amendment 90 #
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 medicinal producta general list of critical medicinal products applicable to any major event or public health emergency, such as those related to emergency care, surgical operations and intensive medical care. This list would serve as the basis for more specific lists of critical medicinal products, applicable in specific health crises to ensure monitoring of those products and it. 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 protection.
Amendment 93 #
Proposal for a regulation
Recital 17
Recital 17
(17) In order to ensure that safe, high quality, and efficacious medicinal products, which have the potential to address public health emergencies, can be developed, if necessary, 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 95 #
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 98 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
Amendment 100 #
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. 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 or other non- commercial entities.
Amendment 101 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(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.
Amendment 102 #
Proposal for a regulation
Recital 21
Recital 21
(21) With respect to medical devices, an executive steering group on medical devices should be established to coordinate urgent actions within the Union in relation to the management of supply and demand issues of medical devices, and to establish a list of critical devices infor the most probable cases of a public health emergencyies.
Amendment 104 #
(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.
Amendment 105 #
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 that are 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 113 #
Proposal for a regulation
Recital 26
Recital 26
(26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, is essential to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the 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.
Amendment 115 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26 a) It is imperative to have in place 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;
Amendment 131 #
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
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.
Amendment 134 #
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 demandpatients' demand plus appropriate buffer stock for that medicinal product or medical device at national level;
Amendment 143 #
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 medicinal products in more than onone or more Member States. 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 and availability or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of medicinal products in more than onand/or medical devices in one or more Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.
Amendment 147 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Steering Group’) is hereby established as part of the Agency. It shall meet either in person or remotely,. Meetings may be scheduled in preparation for or during a public health emergency or following a request for assistance referred 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.
Amendment 150 #
Proposal for a regulation
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
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.
Amendment 152 #
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 may invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meeting, 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.
Amendment 160 #
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 or other Union agencies, where relevant.
Amendment 165 #
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 173 #
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 should be informed accordingly.
Amendment 178 #
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, the Medicines Steering Group shall 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. Monitoring shall be conducted during health crises as well as before, after and outside these crises in order to identify potential shortages before they can affect health and lives of EU citizens. 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 186 #
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 187 #
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, 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 190 #
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Medicines Steering Group may upon request from the Commission coordinate measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
Amendment 208 #
Proposal for a regulation
Article 9 – paragraph 2 – point a
Article 9 – paragraph 2 – point a
(a) establish and maintain for the duration of the public health emergency or major event, a sub-network of single points of contact from marketing authorisation holders and wholesalers based on the medicinal products included on the critical medicines lists;
Amendment 211 #
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 213 #
Proposal for a regulation
Article 9 – paragraph 3 – point d a (new)
Article 9 – paragraph 3 – point d a (new)
(d a) information on active substance manufacturing sites, where relevant;
Amendment 226 #
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, 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.
Amendment 230 #
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;
Amendment 234 #
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 lists.
Amendment 236 #
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, including the recommendations, opinions and decisions made by the Medicines Steering Group as well as agendas and minutes of the Group’s meetings.
Amendment 240 #
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 or during public health emergencies, either in person or remotely. The Agency shall provide its secretariat.
Amendment 242 #
Proposal for a regulation
Article 14 – paragraph 2 – point a a (new)
Article 14 – paragraph 2 – point a a (new)
(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.
Amendment 243 #
Proposal for a regulation
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) reviewing clinical trial protocols and providing advice and guidance to developers on clinical trials to be conducted in the Union for medicinal products intended to treat, prevent, or diagnose the disease causing the public health emergency, in accordance with Article 15;
Amendment 244 #
Proposal for a regulation
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c
(c) providing scientific support to facilitate clinical trials to be conducted in the Union for medicinal products intended to treat, prevent, or diagnose the disease causing the public health emergency. Such support shall include advice to sponsors of similar or linked planned clinical trials on the establishment, in their place, of joint clinical trials and may include advice on establishing agreements to act as a sponsor or as co-sponsor in accordance with Articles 2(14) and 72 of Regulation (EU) 536/2014 and on developing suitable protocols;
Amendment 252 #
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, researchers, and interest groups representing patients and healthcare professionals to attend its meetings.
Amendment 254 #
Proposal for a regulation
Article 14 – paragraph 9
Article 14 – paragraph 9
9. The Agency shall publish information about the medicinal products that the Emergency Task Force considers may have the potential to address public health emergencies and any updates on its 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.
Amendment 256 #
Proposal for a regulation
Article 15 – title
Article 15 – title
Advice and guidance on clinical trials
Amendment 257 #
Proposal for a regulation
Article 15 – paragraph -1 (new)
Article 15 – paragraph -1 (new)
-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.
Amendment 258 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. During a public health emergency, the Emergency Task Force shall review clinical trial protocols submitted or intended to be submitted in a clinical trial application by developers of medicinal products as part of an accelerated scientific 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.
Amendment 263 #
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
6. Where a developer is the recipient of scientific advice, the developer shall subsequently submit the data resulting from clinical trials to the Agency following 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.
Amendment 267 #
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 should liaise with agencies of third countries that authorise medicinal products for additional information and data.
Amendment 272 #
Proposal for a regulation
Article 16 – paragraph 6
Article 16 – paragraph 6
6. In the preparation of its recommendations provided pursuant to paragraphs 3, the Emergency Task Force may consult the concerned Member State and request it to provide any information and data, which informluenced the Member State’s decision to make the medicinal product available for compassionate use. Following such a request, the Member State shall provide all of the requested information.
Amendment 281 #
Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)
Article 18 – paragraph 1 – point d a (new)
(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.
Amendment 283 #
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The Executive Steering Group on Medical Devices (‘the Medical Devices 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 upon request of a Member State affected by a shortage. The Agency shall provide its secretariat.
Amendment 285 #
Proposal for a regulation
Article 19 – paragraph 2 a (new)
Article 19 – paragraph 2 a (new)
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.
Amendment 287 #
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 may invite third parties, including representatives of medical device interest groups, healthcare professionals as well as representatives of patients and consumers to attend its meetings.
Amendment 291 #
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 in a timely manner on its web-portal.
Amendment 292 #
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, the Medical Devices Steering Group shall 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. 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 and the Advisory Committee on public health emergencies established 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 to in footnote 4]
Amendment 293 #
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
2. Where requested by the Commission 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 as well as with Union and national entities engaged with stockpiling of medical devices.
Amendment 294 #
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The Medical Devices 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, medical device manufacturers, notified bodies and other entities, including healthcare professionals, to ensure preparedness to deal with potential or actual shortages of medical devices caused by public health emergencies.
Amendment 295 #
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
5. The Medical Devices Steering Group may, upon request from the Commission coordinate measures, where relevant, between the national competent authorities, manufacturers of medical devices, notified bodies, and other entities, including healthcare professionals, to prevent or mitigate potential or actual shortages in the context of a public health emergency.
Amendment 302 #
Proposal for a regulation
Article 23 – paragraph 1 – point d
Article 23 – paragraph 1 – point d
Amendment 303 #
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 306 #
Proposal for a regulation
Article 23 – paragraph 3 – point i
Article 23 – paragraph 3 – point i
(i) where conformity assessments are on-going, the status of the conformity assessment by the concerned notified bodies in relation to medical devices included in the public health emergency critical devices list and possible issues which need to be resolved in order to speedily complete the conformity assessment process.
Amendment 308 #
Proposal for a regulation
Article 24 – paragraph 3
Article 24 – paragraph 3
3. Where manufacturers of medical devices included on the public health emergency critical devices list and concerned notified bodies 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 such commercially confidential information against unjustified disclosure unless the information is in the public interest.
Amendment 309 #
Proposal for a regulation
Article 25 – paragraph 2
Article 25 – paragraph 2
2. Where necessary to fulfil their reporting obligations set out in paragraph 1, Member States shall gather information from manufacturers, importers, distributors, health care professionals and notified bodies on medical devices included on the public health emergency critical devices list.
Amendment 310 #
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 311 #
Proposal for a regulation
Article 26 – paragraph 1 – point a
Article 26 – paragraph 1 – point a
(a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746 while at the same time ensuring both patient and product safety;
Amendment 313 #
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, health care professionals and other entities;
Amendment 315 #
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, including the recommendations, opinions and decisions made by the Medical Devices Steering Group as well as agendas and minutes of the Group’s meetings.
Amendment 316 #
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 322 #
Proposal for a regulation
Article 30 – paragraph 5
Article 30 – paragraph 5
5. The Commission, the Agency, and Member States may exchange commercially confidential information and, where necessary to protect public health, personal data, with regulatory authorities of third countries with which they have concluded legally binding and enforceable bilateral or multilateral confidentiality arrangements.