17 Amendments of Ondřej KNOTEK 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 227 #
Proposal for a regulation
Recital 29
Recital 29
(29) In order to ensure that sufficient resources, including appropriate staffing and adequate expertise, are available for the work provided for under this Regulation, expenditure of the Agency should be covered by the contribution from the Union to the Agency’s revenue.
Amendment 261 #
Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)
Article 2 – paragraph 1 – point c a (new)
(ca) 'supply' means total volume of stock of an individual medicinal product or medical device that is placed on the national market by a marketing authorisation holder, a manufacturer, a distributor, or any other actor in the distribution chain respectively;
Amendment 326 #
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, representatives of healthcare professionals, patients and consumers to attend its meetings.
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 425 #
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 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 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 545 #
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 575 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The Emergency Task Force shall be composed of representatives of the Member States, of the scientific committees, working parties, 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. 1under Heads of Medicines Agencies. Each Member State may appoint one representative. A Member State may delegate its tasks in the Emergency Task Force to another Member State. 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.
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 591 #
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. When authorising a clinical trial application for which scientific advice has been given, Member States shall take that advice duly into account. The scientific advice provided by the Emergency Task Force and endorsed by the Committee for Medicinal Products for Human Use referred to in paragraph 2 shall have no binding force on the opinion of an independent Ethics Committee issued within authorisation of a clinical trial application.
Amendment 601 #
Proposal for a regulation
Article 16 – paragraph 7
Article 16 – paragraph 7
7. The Agency shall publish the recommendations provided pursuant to paragraph 3 and the opinions adopted pursuant to paragraph 4 including any updates on its web-portal.
Amendment 618 #
Proposal for a regulation
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
(c) as part of its regulatory tasks, make use of digital infrastructures or tools, to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of interventional clinical studies, and the exchange of such data between Member States, the Agency, and other Union bodies;
Amendment 641 #
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, representatives of patients and healthcare professionals, to attend its meetings.
Amendment 695 #
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 a high level of patient and product safety;
Amendment 699 #
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 a high level of patient and product safety;
Amendment 729 #
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, anonymised and aggregated sensitive personal data, with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.