09 February 2021
CARE, - Healthcare, - Medicines

Following the EU’s plan for a European Health Union (EHU), the European Commission Directorate General For Health and Food Safety (DG SANTE) opened a public consultation on a proposal to strengthen the role of the European Medicines Agency (EMA).

The EMA is the central authority responsible for the evaluation and the supervision of medicines in the EU.

EFA fully supports a stronger EMA!

EFA maintains strong links with EMA on all matters affecting our patient community. As member of the EMA Patients’ and Consumers’ Working Party (PCWP), we have participated in numerous EMA-driven events and procedures, including joint meetings, trainings, webinars, public consultations, medicine overviews and scientific processes. Meanwhile, we have followed the agency’s evolution towards an ever-closer stakeholder engagement.

Therefore, we firmly welcome the proposal for the reinforcement of the EMA. Today more than ever, a stronger EMA is vital in facilitating effective development of medical products and devices for the protection of public health in the EU.

Deepening and expanding EMA’s role

While the proposal moves in the right direction, there are several aspects which can be further reinforced. The main priorities of the EFA, as outlined in our response, are listed below:

  • A strengthened mandate for EMA to curb shortages: Given the systemic nature of shortages, EMA’s increased monitoring role should not apply only to health emergencies but also to ordinary times. Information exchange should fully involve patients from an early stage. Besides, there should be a solid framework of cooperation between PCWP and the 2 new Steering Groups in charge of monitoring medicine and medical devices shortages.
  • Increasing EMA’s capacity to address critical medical devices: It would be important to determine what a critical medical device means, and if life-saving medication such as Adrenaline Auto-Injectors, would fall under this category. Moreover, it would be useful to define a minimum composition of the newly established Emergency Task Force, including allergologists, lung specialists, and patient representatives from eligible organisations.
  • Upgrading EMA’s role in promoting effective research: We are glad to see EMA becoming a key advisor on issues around clinical trial sponsorship. We would welcome EMA to have such a role during non-critical situations too, thus becoming a medicines hub, with a central role in advancing research. Areas of high unmet needs, such as COPD where there is no known treatment, would greatly benefit.
  • Maximising vaccine effectiveness: EFA welcomes the enhanced coordination between EMA and the European Centre for Disease Prevention and Control (ECDC), including in the context of a new vaccine monitoring platform.
  • Improving the communication of EMA’s work: Building on its successful record of stakeholder engagement, EMA has the opportunity to further evolve its external communications. Tighter cooperation with Member States; a greater capacity building role; and the dissemination of more targeted material and patient-centred information would be excellent approaches for moving forward.
  • Access to medicines: At EFA we hope that the proposal can be a first step towards greater transparency in pricing and reimbursement for centrally authorised medicines and medical devices, thus ensuring better access at the national level.

Published in November 2020, the EHU communication responds to calls and proposals from various actors, from civil society organisations and public health campaigns to political groups, for an increased EU role in health policy.

In the face of the COVID-19 pandemic, the strategy aims to reinforce the EU’s resilience, crisis preparedness and response capacity to public health crises, and EMA has a crucial role in this.

For the full EFA response, please see here.

More information on the European Health Union.