Deal on Stronger Role for EU Medicines Regulator
The EU Parliament and Council have today reached a provisional agreement to make the European Medicines Agency (EMA) more effective in tackling shortages of medicines and medical devices. The aim of the agreement is:
- To leave the EU better equipped to manage future health crises after COVID-19 lessons learned
- Improve effectiveness in managing shortages of medicines and medical devices
- Create a new EU platform to monitor and report medicine shortages
The EU Commission proposed in November 2020 a new health security framework fit for future health challenges, based on lessons learnt from combatting the coronavirus, which included a proposal to strengthen the mandate of the European Medicines Agency.
The EMA’s capacity to manage the availability of medicinal products and medical devices will be strengthened with the creation of two “shortages steering groups”, for medicines and medical devices respectively. These steering groups will meet regularly and whenever the situation requires, in preparation for or during a public health emergency. They will welcome expert advice from observers representing patients and medical professionals, as well as marketing authorisation holders, wholesale distributors or any other relevant healthcare stakeholders.
During negotiations, Parliament successfully insisted that the members of these groups must not have interests in related industry sectors that could affect their impartiality. Summaries of the proceedings and recommendations must be made publicly available.
Based on Parliament’s proposal, the EMA will set up and manage a European Shortages Monitoring Platform to facilitate the collection of information on shortages, supply and demand of medicinal products. The agency will also establish a public webpage with information on shortages of critical medicines and medical devices.
Amongst the proposals in the provisional agreement is that during future public health emergencies, sponsors of clinical trials conducted in the EU will be required to make the study protocol publicly available in the EU clinical trials register at the start of the trial, as well as a summary of the results.
When a medicinal product is granted marketing authorisation, the EMA will publish, among others, product information with details of the conditions of use and clinical data received.
Rapporteur and MEP Nicolás González Casares said, “With this agreement, Parliament makes both the Agency and all actors in the supply chain more transparent, involving them more in the process and fostering synergies between EU agencies. Moreover, we pave the way to promoting clinical trials for the development of vaccines and treatments, boosting transparency on those issues. And, with the new European Shortages Monitoring Platform, we provide the Agency with a key tool to monitor medicines supply and prevent shortages. In short, more transparency, more participation, more coordination, more effective monitoring and more prevention.”
It is expected that Parliament and Council will endorse the content of the agreement before it can be entered into force.