Activities of Kateřina KONEČNÁ 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 (47)
Amendment 158 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Experience with clinical trials during the Covid-19 pandemic revealed a tremendous amount of duplication of investigations on the same interventions, many small trials, underrepresentation of important population groups and a lack of collaboration putting a risk of research waste. To improve the clinical research agenda, international regulators pointed out the need for robust evidence on quality, efficacy and safety of medicinal products. The main way to obtain reliable evidence is through co-ordinated, well- designed, well powered large randomised controlled trials. Clinical trial results and data should be made public.
Amendment 160 #
Proposal for a regulation
Recital 8 b (new)
Recital 8 b (new)
(8b) To speed up, facilitate and coordinate the development and launch of clinical trials in Europe, the Agency should make full use of existing networks like the Heads of Medicines Agencies (HMA), the Clinical Trials Facilitation and Coordination Group (CTFG), and the European Clinical Research Infrastructure Network (ECRIN).
Amendment 225 #
Proposal for a regulation
Recital 27 a (new)
Recital 27 a (new)
(27a) Public trust relies on full transparency. Pro-active engagement with adequate communication tools with the general public should be foreseen. Strengthened and accelerated transparency standards and measures regarding the Agency working bodies and clinical data assessed for the evaluation and surveillance of medicinal products and medical devices are paramount to gain and upheld public trust. The EMA has put in place strengthened and accelerated transparency standards and measures during the Covid-19 pandemic. This Regulation establishes a framework for these strengthened transparency standards and measures.
Amendment 252 #
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) prevent, monitor and report on shortages of medicinal products for human use and medical devices;
Amendment 279 #
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 demand for that medicinal product or medical device, no matter the cause;
Amendment 294 #
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Article 2 – paragraph 1 – point f a (new)
(fa) ‘demand’ relates to the request for a medicinal product or a medical device by a healthcare professional or patient in response to a clinical need. For demand to be satisfactorily met, the medicinal product will need to be acquired in time and sufficient quantity to allow continuity of best care of patients.
Amendment 299 #
Proposal for a regulation
Article 2 – paragraph 1 – point f b (new)
Article 2 – paragraph 1 – point f b (new)
(fb) ‘supply’ refers to the total volume of stock of an individual medicinal product or a medical device that is placed on the market by the Marketing Authorisation Holder or the producer, including situations in which a product is withdrawn from the market for commercial reasons.
Amendment 314 #
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 fields. The Steering Group shall also include a representative of the Patients’ and Consumers’ Working Party and a representative of the Healthcare Professionals’ Working Party.
Amendment 327 #
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 patients, consumers and healthcare professionals to attend its meetings.
Amendment 332 #
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 and minutes of the Steering Group as well as the rules of procedure and recommendations shall be made available to the public via the EMA web-portal.
Amendment 343 #
Proposal for a regulation
Article 3 – paragraph 6 a (new)
Article 3 – paragraph 6 a (new)
6 a. The members of the Medicines Steering Group must have no financial or other interests that could affect their impartiality. The list of members shall be published on the EMA’s website.
Amendment 361 #
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 may shall then request the assistance of the Medicines Steering Group to address the major event.
Amendment 391 #
Proposal for a regulation
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4 a. The Agency shall establish a database with information on expected and actual shortages of critical medicines. 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 affected; (f) Information for healthcare professionals and patients, including information on alternative treatments.
Amendment 396 #
Proposal for a regulation
Article 6 – paragraph 4 b (new)
Article 6 – paragraph 4 b (new)
4 b. The database shall be accessible to the public.
Amendment 398 #
Proposal for a regulation
Article 6 – paragraph 4 c (new)
Article 6 – paragraph 4 c (new)
4 c. The Agency shall list on its web- portal the national registries on medicine shortages.
Amendment 426 #
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 437 #
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 444 #
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 patients, consumers and healthcare professionals and a high level of transparency;
Amendment 463 #
Proposal for a regulation
Article 9 – paragraph 1 – point f a (new)
Article 9 – paragraph 1 – point f a (new)
(fa) The Agency shall publish information referred to in paragraph (1) (a), (b), (f) on its web-portal.
Amendment 481 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) prevention and mitigation plans including information on production and supply capacity; production sites of the finished pharmaceutical product and of active pharmaceutical ingredients, potential alternative production sites, minimum stock levels, etc;
Amendment 512 #
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. Where marketing authorisation holders for medicinal products included on the critical medicines lists are in possession of any additional information, which provides evidence of a potential or actual shortage they shall immediately provide such information to the Agency. In the absence of notification of essential information, the Agency, the Commission and Member States should enact sanctions, e.g. financial penalties, extending compulsory license or removing intellectual property rights to allow that other actors can minimise the shortage.
Amendment 518 #
Proposal for a regulation
Article 10 – paragraph 6 a (new)
Article 10 – paragraph 6 a (new)
6 a. The Commission and Member States shall lay down rules on sanctions for non-compliance with the obligations established under this Article. These sanctions shall be dissuasive.
Amendment 535 #
Proposal for a regulation
Article 11 – paragraph 4 a (new)
Article 11 – paragraph 4 a (new)
4 a. Member States shall facilitate patient and consumer reporting of medicine shortages through the provision of alternative reporting formats in addition to web-based formats. Aggregated data from these reports shall be shared by the sub-network of single points of contact from national competent authorities referred to in Article 3 (5) with the Steering Group to inform recommendations on medicine shortage management.
Amendment 540 #
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 to support them in their work and in the communication with patients;
Amendment 557 #
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 with regard to the work of the Medicines Steering Group, and ensure adequate consultation with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party.
Amendment 568 #
Proposal for a regulation
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) reviewing clinical trial protocols and providing advice to developers on clinical trials to be conducted in the Union, in particular on large multicentre clinical trials, for medicinal products intended to treat, prevent, or diagnose the disease causing the public health emergency, in accordance with Article 15;
Amendment 573 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The Emergency Task Force shall be composed of representatives of the scientific committees, working parties, including a representative of the Patients’ and Consumers’ Working Party and a representative of the Healthcare Professionals’ Working Party, 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. 1
Amendment 582 #
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 583 #
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 rules of procedure including rules on the adoption of recommendations as well as the opinions should be made public on the Agency web-portal. The agenda and minutes of the Task Force shall be made public via the Agency web-portal.
Amendment 602 #
Proposal for a regulation
Article 16 – paragraph 7
Article 16 – paragraph 7
7. The Agency shall publish the recommendations provided pursuant to paragraph3 and opinions adopted pursuant to paragraph 4 including any updates on its web-portal.
Amendment 605 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – 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 Emergency Task Force, and ensure adequate consultation with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party.
Amendment 613 #
Proposal for a regulation
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
(a) develop and maintain electronic tools for the submission of information and data, including electronic health data generated outside the scope of interventional clinical studies;
Amendment 617 #
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 the Member States, the Agency, and the other Union bodies;.
Amendment 627 #
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Amendment 633 #
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 the Patients’ and Consumers’ Working Party and a representative of the Healthcare Professionals’ Working Party.
Amendment 639 #
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 and representatives of patients, consumers and healthcare professionals to attend its meetings.
Amendment 647 #
Proposal for a regulation
Article 19 – paragraph 6 a (new)
Article 19 – paragraph 6 a (new)
6 a. The members of the Medicines Steering Group must have no financial or other interests that could affect their impartiality. The list of members shall be published on the Agency website.
Amendment 657 #
Proposal for a regulation
Article 20 – paragraph 3 a (new)
Article 20 – paragraph 3 a (new)
3 a. The Agency shall report about the shortage of public health emergency critical devices through the database referred to in Article 6(5).
Amendment 670 #
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 683 #
Proposal for a regulation
Article 23 – paragraph 3 – point f
Article 23 – paragraph 3 – point f
(f) mitigation plans including production and supply capacity; these plans shall contain preventative measures that help ensure the continued supply of critical medical devices;
Amendment 689 #
Proposal for a regulation
Article 24 – paragraph 6 a (new)
Article 24 – paragraph 6 a (new)
6 a. The Commission and Member States shall lay down rules on sanctions for non-compliance with the obligations established under this Article. These sanctions shall be dissuasive.
Amendment 698 #
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 702 #
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 707 #
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. and ensure adequate consultation with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party.
Amendment 726 #
Proposal for a regulation
Article 30 – paragraph 1 – point b
Article 30 – paragraph 1 – point b
(b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights, unless there is an overriding public interest in disclosure;
Amendment 727 #
Proposal for a regulation
Article 30 – paragraph 5
Article 30 – paragraph 5
5. The Commission, the Agency, and the Member States may exchange commercially confidential information and, where necessary to protect public health, anonymised and aggregated personal and sensitive personal data, with regulatory authorities of the third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Amendment 731 #
Proposal for a regulation
Article 30 – paragraph 5 a (new)
Article 30 – paragraph 5 a (new)
5 a. All parties involved in the application of this Regulation shall ensure that the concept of commercially confidential information is interpreted narrowly, and information of public interest is, to the extent possible, proactively disclosed.