13 Amendments of Nils TORVALDS related to 2020/0321(COD)
Amendment 119 #
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 from an early stage and in coordination with the national authorities, the industry and other entities of the pharmaceutical supply chain. 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 145 #
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 and placed Member States in competition with each other to respond to the legitimate needs of their citizens, contributing to uncoordinated actions at national levels such as national hoarding and stockpiling. Those issues further resulted in new entities being involved in the rushed 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, as well as increased and early dialogue with the industry to prevent and mitigate these shortages.
Amendment 179 #
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, while remaining flexible enough to tackle any future health crisis in the most efficient way to the benefit of public health and patients.
Amendment 193 #
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 single European lists of critical medicinal products in consultation with the industry and healthcare professionals, 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.
Amendment 223 #
Proposal for a regulation
Recital 27
Recital 27
(27) During a public health emergency or in relation to a major event, the Agency should ensure cooperation with the European Centre for Disease Prevention and Control and other Union Agencies as appropriate. Such cooperation should include data sharing, including data on epidemiological forecasting, regular communication at an executive level, and invitations to representatives of the European Centre for Disease Prevention and Control and other Union Agencies to attend meetings of the Emergency Task Force, the Medicines Steering Group, and the Medical Devices Steering Group, as appropriate. This cooperation should also include strategic discussions with relevant entities of the Union in a position to boost the research and development of appropriate solutions and technologies to mitigate the effects of the public health emergency or major event, or prevent future similar public health emergencies or major events, such as the proposed European Health Emergency Preparedness and Response Authority (HERA).
Amendment 372 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list ’). The list shall be updated whenever necessary until the major event has been sufficiently addressed and it is confirmed that the assistance of the Medicines Steering group is no longer needed as per Article 4(4).
Amendment 379 #
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 industry and representatives of health professionals, 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 list shall be updated whenever necessary until the termination of the recognition of the public health emergency.
Amendment 434 #
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 485 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) mitigation plans, including production and supply capacity, with a view to guarantee continued supply and prevent shortages of medicinal products included on the critical medicines lists;
Amendment 581 #
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 trial experts and researchers, and interest groups representing patients and healthcare professionals to attend its meetings.
Amendment 592 #
Proposal for a regulation
Article 15 – paragraph 5 a (new)
Article 15 – paragraph 5 a (new)
5 a. Where a clinical trial reviewed as part of an accelerated scientific advice process is authorised, the developer of the clinical trial shall: (a) publish the study protocol at the start of the trial through the European Union clinical trials register; (b) publish the summary of the results of the trial through the European Union clinical trials register by a deadline set by the Agency shorter than that laid down in Article 37 of Regulation (EU) No 536/2014, taking into consideration the public interest and nature of the health emergency.
Amendment 614 #
Proposal for a regulation
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
(b) coordinate independent vaccineutilisation, effectiveness and safety monitoring studies of medicinal products intended to treat, prevent or diagnose a disease using relevant data held by public authorities. S; for vaccines, such coordination shall be conducted jointly with the European Centre for Disease Prevention and Control and notably through a new vaccine monitoring platform;
Amendment 681 #
Proposal for a regulation
Article 23 – paragraph 3 – point f
Article 23 – paragraph 3 – point f
(f) mitigation plans including production and supply capacity, with a view to guarantee continued supply and prevent shortages of medicinal products included on the critical medicines lists;