Brussels (Brussels Morning) The EU drugs regulator will soon play a stronger role to better respond to health crisis and to increase the management of medicinal products and medical devices. The European Medicines Agency (EMA) will have a prominent role in countering medicine shortages by implementing a new EU platform to monitor and report on the lack of drugs.
EMA was equally entrusted with increasing transparency on shortages, clinical trials, and marketing authorisations.
The decision for a stronger mandate was finally endorsed on by MEPs during the first plenary session of 2022, on 20 January, when the Parliament endorsed the previous agreement reached by the Council with 655 votes in favour, 31 against, and 8 abstentions.
“The new regulation 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”, said MEP Nicolás González Casares (S&D).
European Health Union
The reinforcement of EMA’s mandate is part of the European Commission’s European Health Union, announced late in 2020, which intends to create a new European health framework more fit for future health challenges.
The decision to boost health’s framework across the bloc came from the dramatic lessons that several healthcare systems across the EU had to learn when combatting COVID-19, with a massive lack of personal protective equipment (PPE) or even life-saving ventilators.
However, with a new mandate comes added workload and the industry is calling on the EU to properly endow EMA with the necessary resources.
A report published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) on the state of EU medicines regulation, flagged several other areas of activity where EMA has been doing more work in recent years, in particular, EMA has been asked to provide scientific advice around the development of treatments, from just over 400 times in 2011 to almost 800 times in 2020.
“To ensure Europe maintains a sustainable regulatory system, more efficient processes, strategic resourcing, and enhanced capabilities are required within the EMA and EU network of experts to handle the increased number and complexity of regulatory tasks”, warned EFPIA.
Critical medicines
Under EMA’s new mandate, special attention will be given to critical medicine, the Parliament noted. Under the new rules, EMA is expected to be better equipped to monitor and mitigate shortages of medicinal products and medical devices considered to be key in order to address public health emergencies.
To deliver on that, two “shortages steering groups”, for medicines and medical devices respectively, will be created and EMA will set up and manage the European Shortages Monitoring Platform to facilitate data collection.
“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”, added Casares.
Public information
All actors in the supply chain will be involved more closely, including expert advice from observers representing patients and medical professionals, as well as marketing authorisation holders, wholesale distributors or any other relevant healthcare stakeholders.
Citizens will also have access to a public website with information providing information on shortages. In addition, data related to clinical trials and product information on authorised medicinal products will be made available more timely and transparently.
