Activities of Joanna KOPCIŃSKA related to 2020/0321(COD)
Plenary speeches (1)
European Medicines Agency (continuation of debate)
Shadow reports (1)
REPORT 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 (24)
Amendment 228 #
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
(29a) The Commission retains the right to adjust the Agency's proposed resources and staffing allocation following the upcoming publication of the legislative proposal to establish a European Biomedical Research and Development Agency (BARDA) / European Health Emergency Preparedness and Response Authority (HERA).
Amendment 292 #
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Article 2 – paragraph 1 – point f a (new)
(fa) ‘major non-communicable disease’ means a chronic disease which tends to be of long duration and is the result of a combination of genetic, physiological, environmental and behavioural factors, such as a cardiovascular disease, cancer, respiratory disease, diabetes or mental illness, and which affects a significant number of people in the Union.
Amendment 317 #
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 authorised senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields.
Amendment 334 #
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. The agenda, minutes and recommendations of the Medicines Steering Group shall be made available to the public through the Agency's online portal.
Amendment 344 #
Proposal for a regulation
Article 3 – paragraph 6 a (new)
Article 3 – paragraph 6 a (new)
6 a. The Medicines Steering Group shall exercise its competencies in full compliance with the principles of proportionality and subsidiarity;
Amendment 413 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until its closure, the Medicines Steering Group shall regularly reportport on a systematic, structured, and timely basis the results of its monitoring to the Commission and the sub-network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.
Amendment 420 #
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 patient organisations, 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 431 #
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Medicines Steering Group may upon request from the Commission coordinated measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals and patient organisations, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
Amendment 503 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
Amendment 525 #
Proposal for a regulation
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(a) submit the set of available information to Member States requested by the Agency including available and estimated data on volume of demand, through its designated point of contact and using the reporting methods and system established pursuant to Article 9(1);
Amendment 527 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
Amendment 532 #
Proposal for a regulation
Article 11 – paragraph 4 – point a
Article 11 – paragraph 4 – point a
(a) take into accountacknowledge any recommendations and guidelines and comply with any measures taken at Union- level pursuant to Article 12;
Amendment 542 #
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, in order to support their work and communication with patients;
Amendment 586 #
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 agenda and minutes of the Task Force shall be made public through the Agency's online portal.
Amendment 600 #
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 informed 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 best available requested information.
Amendment 645 #
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. The Medical Devices Steering Group shallmay be supported in its work by a working party comprised of single points of contact from national competent authorities for medical devices established in accordance with Article 23(1).
Amendment 652 #
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. The Medical Devices Steering Group shall adopt a set of information necessary to only monitor the supply and demanddata for the long-term safety assessment of medical devices included on the public health emergency critical devices list and inform its working party thereof.
Amendment 659 #
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 ofupdate the medical devices included on thate list compiled by the Medical Device Coordination Group (MDCG) 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. _________________ 22 [insert reference to adopted text referred to in footnote 4]
Amendment 660 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
Amendment 663 #
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
Amendment 664 #
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
Amendment 688 #
Proposal for a regulation
Article 24 – paragraph 4
Article 24 – paragraph 4
Amendment 704 #
Proposal for a regulation
Article 26 – paragraph 1 – point d a (new)
Article 26 – paragraph 1 – point d a (new)
(da) work in conjunction with the European Centre for Disease Prevention and Control (ECDC) to categorise and establish different priority levels for the medicinal products identified as critical.
Amendment 716 #
Proposal for a regulation
Article 29 – paragraph 3 a (new)
Article 29 – paragraph 3 a (new)
3 a. The Commission shall carry out an impact assessment prior to the entry into force of this Regulation.