A stronger European Medicine Agency (EMA) with a reinforced transparency, participation, coordination and prevention - this is, in short, the core and the importance of the report voted today in the environment committee in the European Parliament under the leadership of S&D Euro MP Nicolás González Casares.
Rapporteur and S&D MEP, Nicolás González Casares, said:
“A stronger European Medicine Agency means a stronger resilience for the EU to tackle possible future challenges of the magnitude of the Covid-19 pandemic. Thanks to the vote on ‘the reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products’ report in the environment committee today, and the leading drive by the S&D Group, the EU took a crucial further step towards making the Health Union a reality.
“The pandemic has shown that the EU, its member states and the EMA did not have the adequate mandate or sufficient resources. This cannot happen again.
“This report aims to strengthening EMA’s capacity to deal with future emergencies by supporting the role of healthcare professionals and the synergies between EU agencies. We also want to avoid possibly shortages of medicines by providing the Agency with new tools - such as the creation of a European medicines supply database - which will always ensure a comprehensive overview of the volume of stock at member states and European level.
“We promote clinical trials for the development of vaccines and treatments, reinforcing public information about them."
S&D coordinator in the environment committee, Jytte Guteland, added:
“It is clear that we need to enforce EU heath crisis management to be prepared for future challenges. After all, to borrow the words of Albert Einstein, doing the same thing over and over again and expecting a different result is the definition of insanity. By enabling the EMA to monitor and mitigate the risk of shortages of critical medicines and ensuring efficiency and safety in the development of vaccines, we stand better protected for the future.
“A stronger EMA, in short, means a stronger protection of our citizens and a healthier EU.”
The compromises approved include all the priorities set by our Group:
- Reinforcement of the preventive nature of this regulation;
- Strengthening of synergies between the different steering groups and the task force;
- Strengthening transparency, with publication of agendas, minutes, internal operating rules and recommendations of these steering groups;
- Strengthening the role of healthcare professionals and patients;
- A sanction regime for marketing authorization holders and medical device manufacturers that do not comply with the obligations established in this regulation;
- Measures to protect against cyber-attacks;
- Public information on clinical trials and market authorization decisions;
- Creation of the European Medicines Supply Database.
Note for editors:
On 11 November 2020, the European Commission adopted a legislative proposal to extend the mandate of the EMA. This initiative is one of the first one taken to build the European Health Union announced by President Ursula von der Leyen in her State of the Union address.
