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Фармацевтична стратегия за Европа и законодателно предложение за промяна на мандата на Европейската агенция по лекарствата (EMA)

Opinion Number: CDR 5525/2020
Rapporteur: SACRÉDEUS Birgitta
Commission: NAT
Status: Adopted
Date: 07/05/2021
to draw attention to the critical role played by the local and regional levels in countries' crisis preparedness and to the need to involve them in framing measures to strengthen security of supply of medicines and reduce vulnerability
to consider the objectives and the flagship initiatives of the pharmaceutical strategy from the local/regional point of view as the healthcare systems are decentralised to varying degrees in 19 of the 27 Member States and local and regional authorities are also involved in funding healthcare in many Member States
to ensure that the legal framework for the future European Health Union recognises local and regional authorities' responsibility for public health and builds on lessons learned from crises at the levels of governance closest to ordinary people
to consider whether the practical facilities are there for Member States to provide the EMA with the information requested, and whether the proposal creates excessive red tape for Member States and the healthcare system

On 15 May 2021, the Council reached an agreement on draft rules to reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices. The text will form the basis for discussions with the European Commission and the Parliament.
The Member States agree that a stronger European Medicines Agency will play a key role in helping to prevent shortages of critical medicines and medical devices and be faster in developing medicines to fight any disease causing a crisis.
They stress that transfers of personal data in the context of the new EMA mandate will be subject to EU data protection rules such as the General Data Protection Regulation.
Other changes relate to the composition and functioning of the Emergency Task Force, in particular its advisory role when it comes to developing clinical trials for medicinal products intended to deal with a health emergency

On 22 June, the EP ENVI committee adopted their position (scheduled for the July Plenary) with calls corresponding to the CoR calls in terms of increased capacity for crisis preparedness and management of medical devices and products, more powers to monitor drug shortages, more transparency in the activies of EMA and its working parties, as well as encouraging synergies and cooperation between EU agencies.
In its follow-up report published in November 2021, the European Commission
agreed with the CoR that local and regional levels should be involved as much as possible while maintaining that that when it comes ot the evaluation of medicinal products, pricing and procurement, it belongs to national competence.
agreed and confirmed that any processing of personal health data must ensure compliance with the EU data protection regulatory framework and that the legislative proposals foreseen in the Commission Communication for a pharmaceutical strategy for Europe will fully take those requirements into account.
with regard to the call for measures to stimulate access to generics and biosimilars, the Commission plans to continue to work, including through the exchange of best practices, on the uptake of biosimilars.
on the medicine shortages, their root causes, and proposals to ensure strategic autonomy, the commission confirmed that securing the supply of medicines across the EU is an important objective of the strategy, and it recognises that the root causes of shortages are complex and that diversification of supply must be part of the solution. While the concept of ‘open strategic autonomy’ is key when it comes to resilience of supply, it also recognises that the EU will never be self-sufficient and therefore this goal can only be achieved in combination with the EU’s commitment to open trade and international partnerships. The strategy launched a ‘structured dialogue’ with the actors in the pharmaceuticals manufacturing value chain, public authorities, patient and health nongovernmental organisations and the research community, which has reached a second phase, serving to present a set of possible measures to address the identified vulnerabilities and formulate policy options by the Commission to ensure the security of supply and the availability of critical medicines, active pharmaceutical ingredients and raw materials.

EP ENVI Commission report on the Pharmaceutical strategy, adopted on 6 December, 2021 echoes CoR calls and concerns, including with regard to the need to ensure equal access to affordable medicinal products to all EU citizens, incentivise research and development of new medicines for unmet needs, address the root causes of shortages of pharmaceuticals, promote the development and production of essential medicines in Europe, as well as the need for the pharmaceutical industry to be environmentally friendly and contribute to climate neutrality throughout the lifecycles of medicinal products, while ensuring access to safe and effective pharmaceutical treatments for patients.

- welcomes the proposal for a regulation reinforcing the European Medicines Agency's mandate for crisis preparedness and management of medicinal products and medical devices; calls for the greatest possible transparency in the activities of the EMA and its working parties;

- calls for a coordinated approach to the development, production and distribution of medicinal products and medical devices with the potential to prevent, diagnose or treat diseases that present a threat to public health; finds it imperative to ensure that the needs at local and regional level can be expressed and met, and that there are communication channels between the executive steering groups and local and regional authorities;

- strongly supports the Pharmaceutical Strategy for Europe as everyone should have access to safe and effective medicines at affordable prices; cooperation between Member States with the involvement of local and regional level is vital on the evaluation, pricing and procurement of medicinal products;

- supports the strategy seeking to promote competition in the pharmaceutical market, and emphasises that measures to stimulate access to generic and biosimilar medicines are urgently needed; supports an in-depth mapping of the causes of medicine shortages and looks forward to robust proposals for measures to ensure access to medicines both in normal circumstances and in a crisis;

- considers it vital to create the conditions for innovation and use of new technologies for the EU to maintain a competitive pharmaceutical industry, while ensuring that there is sufficient clinical evidence on safety and efficacy when authorising new medicines;

 advocates learning from the COVID-19 pandemic in order to achieve robust multilateral cooperation to support the development and production of safe and effective vaccines, diagnostics and treatments, and for fair and efficient funding and distribution of future vaccines and medicines
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