26 Amendments of Sira REGO related to 2020/0321(COD)
Amendment 68 #
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 and transparent in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by austerity measures affecting public health services, insufficient public control on production, and 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 92 #
Proposal for a regulation
Recital 17
Recital 17
(17) In order to ensure that safe, high quality, and efficacious medicinal products, which have the potential to address public health emergencies, can be developed and made available within the Union as soon as possible during public health emergencies, an emergency task force driven by public-health needs only should be established within the Agency to provide advice on such medicinal products. The Emergency Task Force should provide independent advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols, to those organisations involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their exact role in the development of such medicinal products.
Amendment 94 #
Proposal for a regulation
Recital 18
Recital 18
(18) TWhile guaranteeing the independence of any subsequent evaluations, the work of the Emergency Task Force should be separate from the work of the scientific committees of the Agency and should be carried out without prejudice to the scientific assessments of those committees. The Emergency Task Force should provide recommendations driven only by science and public-health needs and not by other interests, with regard to the use of medicinal products in the fight against the disease that is responsible for the public health crisis. The Committee for Medicinal Products for Human Use should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation.
Amendment 97 #
Proposal for a regulation
Recital 19
Recital 19
(19) The establishment of the Emergency Task Force should build on the support provided by the Agency during the COVID-19 pandemic, notably as regards scientific advice on clinical trials design and product development, the transparency of related activities, including the rapid publishing clinical data for the products in question, as well as the ‘rolling’ review i.e. on an on-going basis, of emerging evidence to allow a more efficient assessment of medicinal products including vaccines during public health emergencies.
Amendment 103 #
Proposal for a regulation
Recital 22
Recital 22
(22) This Regulation also provides the Agency with a role to support the expert panels on medical devices designated under Commission Implementing Decision (EU) 2019/139612 to provide independent scientific and technical assistance to the Member States, the Commission, the Medical Device Coordination Group (MDCG), notified bodies and manufacturers, while upholding maximum transparency as a condition for fostering trust and confidence in the EU regulatory system. _________________ 12Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices OJ L 234, 11.9.2019, p. 23
Amendment 114 #
Proposal for a regulation
Recital 26
Recital 26
(26) Rapid access and exchange of health data, including when generated with appropriate quality criteria, real world data i.e. health data generated outside of clinical studies, iscan be essential as supportive evidence or signal-eliciting evidence to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure.
Amendment 149 #
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 declarations of interests of all experts shall be made public and all necessary restrictions shall apply where conflicts of interest occur.
Amendment 154 #
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 invitedecide to hear third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetingmarketing authorisation holders, developers of medicinal products, clinical trial experts, public-health advocacy groups, sectoral trade unions, consumer and patient organisations, as well as healthcare professionals.
Amendment 155 #
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. After being established, these rules shall be made publicly available.
Amendment 214 #
Proposal for a regulation
Article 9 – paragraph 3 – point e
Article 9 – paragraph 3 – point e
(e) production, sales and market share data;
Amendment 216 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) mitigation plans including location- specific manufacturing, production and supply capacity;
Amendment 222 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, marketing authorisation holders for medicinal products included on the critical medicines lists shall submit the information referred to in Article 9(3) by the deadline set by the Agency. They shall submit the information through the points of contact designated in accordance with Article 9(2) and using the reporting methods and system established pursuant to Article 9(1). They shall provide updates whenevere necessary or upon request.
Amendment 225 #
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information might contains information of a commercially confidential nature, they shall identify the relevant parts and, clarify the reasons for such an indication. The Agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure and offer sufficient, actual and specific evidence of harm stemming from disclosure. The Agency shall assess the merits of each request, considering the benefits for public health of disclosure and act accordingly.
Amendment 235 #
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 the data used and its sources based on which the recommendations of the Medicines Steering Group are taken. Proceedings and recommendations, including dissenting views, shall be documented and made publicly available.
Amendment 245 #
Proposal for a regulation
Article 14 – paragraph 2 – point e
Article 14 – paragraph 2 – point e
(e) providing, by making publicly available, scientific recommendations with regard to the use of any medicinal product, which may have the potential to address public health emergencies, in accordance with Article 16;
Amendment 248 #
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, 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. Members of the Emergency Task Force, including external experts, shall not have financial or other interests in the health industry which could affect their independence and impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests which shall be published. Members of the Emergency Task Force shall declare, at each meeting, any potential conflict of interest with respect to the items on the agenda. In the event of such a conflict of interest, the concerned member shall withdraw from the meeting. _________________ 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 250 #
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. The composition of the Emergency Task Force shall be approved by the Management Board of the Agency and made publicly available. The Executive Director of the Agency or their representative and representatives of the Commission shall be entitled to attend all meetings.
Amendment 251 #
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 representa to attend its meetings, and decide to hear third partives of medicinal product interest groups,, including marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, and interest groups representing patients andexperts, public health advocacy groups, sectoral trade unions, consumer and patient organisations, as well as healthcare professionals to attend its meetings.
Amendment 253 #
Proposal for a regulation
Article 14 – paragraph 8
Article 14 – paragraph 8
8. Article 63 of Regulation (EC) No 726/2004 shall apply to the Emergency Task Force as regards transparency and the independence of its members. Declarations of interest shall be made publicly available for all stakeholders and experts consulted. Stakeholders and experts with conflicts of interest shall not participate in the process.
Amendment 264 #
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
6. Where a developer is the recipient of scientific advice, the developer shall subsequently and continuously submit all the data resulting from clinical trials to the Agency following a request made pursuant to Article 16.
Amendment 266 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. In preparation of the review, the Emergency Task Force may request all relevant information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliabilityshall use the results of comparative randomized controlled trials when available, but, if not, may also, when necessary, make use of real world data including pragmatic trials as in “close to everyday practice” taking into account their reliability as supportive evidence or signal-eliciting evidence.
Amendment 271 #
Proposal for a regulation
Article 16 – paragraph 3 – introductory part
Article 16 – paragraph 3 – introductory part
3. Based on a request from one or more Member States, or the Commission, the Emergency Task Force shall provide independent recommendations, driven only by public-health needs and not by other interests, to the Committee for Medicinal Products for Human Use for an opinion in accordance with paragraph 4 on the following:
Amendment 274 #
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 and the data and sources used in the decision- making process of the Emergency Task Force.
Amendment 284 #
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 declarations of interests of all experts must be made public and all necessary restrictions shall apply where conflicts of interest occur.
Amendment 286 #
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 invitedecide to hear third parties, including representatives of medical device interest groups to attend its meetingdevelopers and producers of medical devices, public-health advocacy groups, sectoral trade unions, consumer and patient organisations, as well as healthcare professionals.
Amendment 297 #
Proposal for a regulation
Article 22 – paragraph 5 a (new)
Article 22 – paragraph 5 a (new)
5 a. All the recommendations made by the Medical Devices Steering Group shall be made publicly available.