60 Amendments of Antoni COMÍN I OLIVERES related to 2020/0321(COD)
Amendment 114 #
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 healthshown the difficulties of Member States to cope with a cross-border or global health emergency, and has therefore demonstrated the need to strengthen the competences of the Union in order to be more effective, efficient and expeditious in managing the availability of medicinal products and medical devices, in asserting supply chains of medicinal products and medical devices, and in developing medical countermeasures to address the threats posed to public health. The unprecedented experience of the COVID- 19 pandemic has also underlined the risks to human health posed by zoonotic spill- overs triggered by global biodiversity loss and wildlife over-exploitation. 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 125 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) It is therefore necessary that the Union be a full-fledged complementary component of European health systems, providing a guarantee or a last-resource stakeholder in case of serious cross- border health threats. For this reason, the know-how, expertise and capabilities of Union agencies should be strengthened accordingly.
Amendment 142 #
Proposal for a regulation
Recital 5
Recital 5
(5) The COVID-19 pandemic has exacerbated the problem of shortages for certain medicinal products, devices and services considered as critical in addressing the pandemic, and has highlighted the structural limitations in the Union’s ability to rapidly, efficiently and effectively react to such challenges during public health crises.
Amendment 144 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) It is therefore necessary that the Agency assist the Commission in assessing the supply chain resilience of these products and devices in order to achieve a sufficient strategic autonomy of the Union in health products and devices. Ensuring supply chain resilience across the Union is not a primordial mission of the Agency, yet the European Medicines Agency (EMA) should provide data, knowledge, and skills, to the Commission and the ECDC in order to ensure supply chain resilience in Europe. Supply chain resilience is part of the four working groups of the COVID–19 taskforce of the EMA, alongside the therapeutic response, business continuity and impact, and human resources.
Amendment 147 #
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 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. These structures should, among other obligations, assess supply chain resilience and reliance.
Amendment 161 #
Proposal for a regulation
Recital 9
Recital 9
(9) During the COVID-19 pandemic ad hoc solutions, including contingent arrangements between the Commission, the European Medicines Agency (‘the Agency’), marketing authorisation holders, manufacturers and Member States, had to be found to achieve the objective of making available safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and to facilitate and speed up the development and marketing authorisation of treatments and vaccines. These ad-hoc solutions should be taken into account as well as all the lessons learned during the pandemic in order to better use the Agency’s potential to face future outbreaks.
Amendment 166 #
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 medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises. The Union's actions should be consistent with the WHO’s One Health approach, as well as with the Health in All Policies principle, recognising the interconnections between human and animal health and the environment and the cross-sectoral character of health policies.
Amendment 174 #
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, withas well as 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 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 178 #
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 that have proven effective and operative and that can provide foundational protocols on which to build upon.
Amendment 182 #
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 access to critical medicinal products, devices and applications in 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, innovation 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 medicinal products and medical devices, the Agency should be able to ask demand and obtain information and data from the concerned marketing authorisation holders, manufacturers and Member States through designated points of contact. Should any of the aforementioned stakeholders not give information to the Agency in the time lapse established by the Agency, the Commission should assist the Agency in obtaining such information, with the prospect of an eventual sanction, which should also be duly made available to the public.
Amendment 188 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) The Agency, together with the Commission, should also do its upmost to counterbalance smear campaigns and disinformation on medicines, medical products, devices or applications, in order to ensure proper information to the public.
Amendment 192 #
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 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 medicinal products and ensure a high level of human health protection. The World Health Organization Model List of Essential Medicines for adults and for children is the best base for the identification of critical medicinal products at Union level.
Amendment 196 #
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) In order to facilitate the prevention, monitoring and reporting of shortages of medicinal products, devices and applications, the Agency and the Commission should establish an electronic platform to track and follow medicinal products, devices and applications throughout the supply chain. This platform should also be a one-stop shop for marketing authorisation holders and wholesale distributors to provide required information during major health events. This platform should use the distributed ledger technology (DLT) and include data from national and regional competent authorities. The platform should, among other duties, determine the volume of stock, the capabilities of all stakeholders linked in the supply chain or chains, the actual, current and foreseeable level of demand. This platform should also obtain, record and share information.
Amendment 197 #
Proposal for a regulation
Recital 16 b (new)
Recital 16 b (new)
(16b) Finally, this platform should also be linked to the Health data space and managed by the Agency and the Commission.
Amendment 198 #
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 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. The lessons learned during the COVID pandemic should be taken into account in order to better use the Agency’s potential to face future health crises.
Amendment 201 #
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, although communication between these two bodies should be guaranteed. The Emergency Task Force should provide recommendations with regard to the use of medicinal products in the fight against the disease that is responsible for 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 206 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) The Emergency Task Force should build on the trial networks to ensure that adequate data on new medicinal products, devices and applications, and it could build also upon the HERA Incubator, presented by Communication of 17 February 2021 “HERA Incubator: Anticipating together the threat of COVID-19 variants” [COM(2021) 78 final].
Amendment 207 #
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 in the case of a public health emergency. The executive steering group on medical devices should be managed by the Commission and the Agency.
Amendment 254 #
Proposal for a regulation
Article 1 – paragraph 1 – point b a (new)
Article 1 – paragraph 1 – point b a (new)
(ba) set up an interoperable and digital database at Union level to track, monitor, report and share information on shortages of medicinal products, devices and applications;
Amendment 297 #
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Article 2 – paragraph 1 – point f a (new)
(fa) ‘Health in all policies’ means health in all policies as defined in Regulation (EU) .../... EU 4 Health [OJ: ...]
Amendment 300 #
Proposal for a regulation
Article 2 – paragraph 1 – point f b (new)
Article 2 – paragraph 1 – point f b (new)
(fb) ‘One Health approach’ means One health approach as defined in Regulation(EU) .../... EU 4 Health [OJ: ...]
Amendment 301 #
Proposal for a regulation
Article 2 – paragraph 1 – point f c (new)
Article 2 – paragraph 1 – point f c (new)
(fc) ‘zoonosis’ means an infectious disease that has jumped from a non- human animal to humans through zoonotic spill-over;
Amendment 302 #
Proposal for a regulation
Article 2 – paragraph 1 – point f d (new)
Article 2 – paragraph 1 – point f d (new)
(fd) ‘zoonotic spill-over’ is the spread of a non-human disease to humans resulting in zoonosis;
Amendment 303 #
Proposal for a regulation
Article 2 – paragraph 1 – point f e (new)
Article 2 – paragraph 1 – point f e (new)
(fe) 'veterinary medicinal product' means a medicinal product as defined in point (1) of Article 4 of Regulation (EU) 2019/6 of the European Parliament and the Council;
Amendment 304 #
(ff) 'supply' means total volume of stock of a medicinal product, a medical device, or a medical application, that is placed on the market by a marketing authorisation holder or a manufacturer;
Amendment 305 #
Proposal for a regulation
Article 2 – paragraph 1 – point f g (new)
Article 2 – paragraph 1 – point f g (new)
(fg) ‘supply chain’ is a steps-based network of activities, information and resources between a manufacturer company and its suppliers willing to produce and distribute a specific product to the final buyer;
Amendment 311 #
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. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fieldThose Member States with devolved competences in health may appoint a representative from a regional competent authority who will represent the whole Member State. Members may be accompanied by experts in specific scientific or technical fields. The Steering Group shall also include a representative of the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers.
Amendment 336 #
Proposal for a regulation
Article 3 – paragraph 5
Article 3 – paragraph 5
5. The Medicines Steering Group shall be supported in its work by a working party comprised of single points of contact related to shortages from national, and where applicable regional, competent authorities for medicinal products established in accordance with Article 9(1).
Amendment 349 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency in coordination with the national and regional competent authorities.
Amendment 354 #
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, and where applicable regional, competent authorities, through the single points of contact referred to in Article 3(5) or the digital interoperable database referred to in Article 1(b) and Article 12(g), 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 likely to lead to a major event or a public health emergency. Where a national, and where applicable regional, 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 or regional competent authority and in order to understand the impact of the event in other Member States, the Agency may request information from the national and where applicable regional, competent authorities, through the working party referred to in Article 3(5).
Amendment 364 #
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 mayshall request the assistance of the Medicines Steering Group to address the major event.
Amendment 365 #
Proposal for a regulation
Article 4 – paragraph 5 – point a
Article 4 – paragraph 5 – point a
(a) where the major event or public health emergency may affect the production, manufacturing, safety, quality, distribution and efficacy of medicinal products, devices and applications Article 5 shall apply;
Amendment 366 #
Proposal for a regulation
Article 5 – title
Article 5 – title
Evaluation of information and the provision of advice on action in relation to the production, manufacturing, safety, quality, distribution and efficacy of medicinal products, devices and applications related to public health emergencies and major events
Amendment 368 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Following the recognition of a public health emergency or a request for assistance referred to in Article 4(3), the Medicines Steering Group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the production, manufacturing, safety, quality, distribution and efficacy of the medicinal products, devices and applications concerned.
Amendment 377 #
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 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 World Health Organization Model List of Essential Medicines for adults and for children shall be used as the base for its identification of critical medicinal products at Union level. The Agency shall make the public health emergency critical medicines list within 12 months after the entry into force of this Regulation. The list shall be updated whenever necessary until the termination of the recognition of the public health emergency as well as with the Commission and the European Centre for Disease Prevention and Control.
Amendment 381 #
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. In case of an eventual zoonotic spill-over, the Medicines Steering Group shall work with the other relevant bodies of the Agency in order to counter it as soon as possible.
Amendment 389 #
Proposal for a regulation
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4 a. The Agency, under its own assessment, shall establish an open, digital and interoperable database with information on expected and actual shortages of critical medical products, devices and applications. The database shall contain information on but not limited to: a. Trade name and international non- proprietary name; b. Indication; c. Reason for the shortage; d. Start and end dates; e. Member States and/or regions affected, especially cross-border regions; f. Possible consequences to non- communicable diseases or conditions, such as mental health and possible medical solutions and other measures; g. Information for healthcare professionals and patients, including information on alternative treatments. This database shall be accessible to the public. The Agency shall include the national, and where applicable regional, registries on medicine shortages on its web-portal.
Amendment 402 #
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. 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. The Medicines Steering Group shall provide the aggregated data and demand forecasts from the digital interoperable platform referred to in Article1(b) and Article 12(g). _________________ 19 [insert reference to adopted text referred to in footnote 4]
Amendment 436 #
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, and where applicable regional, competent authorities, the marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
Amendment 438 #
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5 a. In case any of the aforementioned stakeholders does not give information to the Agency in the time lapse established by the Agency, the Commission shall assist the Agency in obtaining such information, with the prospect of an eventual sanction, which should also be duly informed to the public. This sanction shall be established in an implementing regulation.
Amendment 440 #
Proposal for a regulation
Article 8 – paragraph 5 b (new)
Article 8 – paragraph 5 b (new)
Amendment 446 #
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 consumers, patients and healthcare professionals and a high level of transparency;
Amendment 457 #
Proposal for a regulation
Article 9 – paragraph 1 – point d
Article 9 – paragraph 1 – point d
(d) establish and maintain membership of the working party referred to in Article 3(5) comprised of single points of contacts from national, and where applicable regional, competent authorities for medicinal products;
Amendment 470 #
Proposal for a regulation
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
(c) request information from the single points of contact from Member States’ national, and where applicable regional, competent authorities based on the set of information agreed on by the Medicines Steering Group and set a deadline for its submission.
Amendment 484 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) mitigation plans containing preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains, as well as including production and supply capacity;
Amendment 511 #
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
Amendment 550 #
Proposal for a regulation
Article 12 – paragraph 1 – point f a (new)
Article 12 – paragraph 1 – point f a (new)
(fa) assist the Agency in building the digital and interoperable database referred to in Article 1(b) and Article12(g), with the following main tasks: i. facilitate the prevention, monitoring and reporting of shortages of medicinal products, devices and applications, ii. track and follow medicinal products, devices and applications throughout the supply chain, iii. determine the volume of stock, the capabilities of all stakeholders linked in the supply chain or chains, the actual, current and foreseeable level of demand obtain, iv. record and share information about innovative medicinal products, devices, applications or developments that are still not harmonised throughout the Union, such as plasma-derived products.
Amendment 551 #
Proposal for a regulation
Article 12 – paragraph 1 – point f b (new)
Article 12 – paragraph 1 – point f b (new)
(fb) sanction those marketing authorisation holders, manufacturers or Member States that do not comply with the demands of information by the Agency;
Amendment 556 #
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, or where applicable regional, competent authorities, inform the public and interest groups with regard to the work of the Medicines Steering Group, ensuring the sharing of information by the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers. The Agency shall assess the transparency of the undertakings of the Medicines Steering Group, taking into account principles of transparency and accountability.
Amendment 588 #
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, taking into account possible innovative medicinal products, devices, applications or developments that are still not harmonised throughout the Union, such as plasma-derived products.
Amendment 625 #
Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)
Article 18 – paragraph 1 – point d a (new)
(da) build the digital and interoperable database as referred to in Article1(b) and Article 12(g).
Amendment 630 #
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. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The Steering Group shall also include a representative of the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers. The Agency shall assess the transparency of the undertakings of the Executive Steering Group on Medical Devices, taking into account principles of transparency and accountability.
Amendment 637 #
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 to attend its meetings ensuring the sharing of information by the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers.
Amendment 644 #
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. The Medical Devices Steering Group shall be supported in its work by a working party comprised of single points of contact from national, and where applicable regional, competent authorities for medical devices established in accordance with Article 23(1).
Amendment 665 #
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
Amendment 671 #
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 consumers, patients and healthcare professionals and a high level of transparency;
Amendment 674 #
Proposal for a regulation
Article 23 – paragraph 1 – point c
Article 23 – paragraph 1 – point c
(c) establish and maintain membership of the working party referred to in Article 19(5) comprised of single points of contact from Member States’ national, and where applicable regional, competent authorities for medical devices;
Amendment 677 #
Proposal for a regulation
Article 23 – paragraph 2 – point c
Article 23 – paragraph 2 – point c
(c) request information from the single points of contact from Member States’ national, and where applicable regional, competent authorities based on the set of information agreed on by the Medical Devices Steering Group and set a deadline for its submission.
Amendment 684 #
Proposal for a regulation
Article 23 – paragraph 3 – point f
Article 23 – paragraph 3 – point f
(f) mitigation plans, containing preventative measures to ensure the continued supply of critical medical devices as well as including production and supply capacity;
Amendment 694 #
Proposal for a regulation
Article 25 – paragraph 1 – point c a (new)
Article 25 – paragraph 1 – point c a (new)
(ca) regional authorities with devolved health policy competences shall also comply with Article 25 and provide this information both to the national competent authority and to the Agency.