26 Amendments of Dan-Ştefan MOTREANU related to 2020/0321(COD)
Amendment 315 #
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 the Patients’ and Consumers’ Working Party and a representative of the Healthcare Professionals’ Working Party.
Amendment 328 #
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 342 #
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 363 #
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 392 #
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 395 #
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 397 #
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 445 #
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 483 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) mitigation plans including production and supply capacity; these plans shall contain preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains;
Amendment 517 #
Proposal for a regulation
Article 10 – paragraph 6 a (new)
Article 10 – paragraph 6 a (new)
6 a. 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 533 #
Proposal for a regulation
Article 11 – paragraph 4 – subparagraph 1 (new)
Article 11 – paragraph 4 – subparagraph 1 (new)
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 558 #
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 566 #
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 574 #
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 606 #
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 628 #
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Amendment 632 #
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 640 #
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 648 #
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 656 #
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 669 #
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 682 #
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 690 #
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 708 #
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 725 #
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 732 #
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.