Reform of EU medicines agency: Where do EU institutions stand?

julio 19, 2021


MEPs endorsed their amendments to the proposal to reinforce the EMA mandate, presented by the Commission in November 2020 as part of the efforts to ensure better preparedness for future health emergencies.

The previous day, the EU’s Health Commissioner Stella Kyriakides told the parliament that while EMA is being “absolutely central to our collective efforts to tackle [pandemic]”, a stronger mandate is needed to be “better equipped for the future crisis”.

Starting from this week, the Parliament’s negotiators and the Slovenian rotating EU Council presidency on behalf of the EU-27 health ministers will kick off talks to agree on the changes to the Commission’s proposal.

Once a compromise agreement is reached in this inter-institutional discussion, known as trilogue, and is confirmed by Parliament’s plenary and the EU Council, the regulation will enter into force.

“We need to permanently monitor the shortages of critical medicines, we need to report on the risk of shortages of medical devices during a crisis [and] to catalyse the development and fast approval of medicines with fast track scientific advice and rolling reviews,” Kyriakides said. 

The proposal includes the creation of two new steering groups: one on medicines and one on medical devices. Both would work during public health emergencies to ensure urgent and coordinated action with regards to the safety, quality, and efficacy of the medicinal products and devices.

Council calls for financial clarity and data protection

The Council, representing the 27 member states, agreed on its negotiating mandate on 15 June and does not seem to have included many changes to the Commission’s proposal. 

Several requests from member states focus on clarity of the financial and data protection provisions. It is highlighted that transfers of personal data in the context of the new EMA mandate should 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.

“[EMA] will help us to prevent shortages of critical medicines and medical devices and be faster in developing medicines to fight any disease causing a crisis,” Portuguese Health Minister Marta Temido said in June, just before Portugal’s six-month stint at the helm of the Council ended.

Parliament wants more transparency and an EU medicines supply database

In the meantime, Parliament’s amendments are wider and may stir more discussions in the upcoming trilogue. Amendments cover the establishment of a new European medicines supply database, the call for better coordinated and more transparent large-scale clinical trials and publication of marketing authorisation decisions. 

Parliament’s rapporteur, Spanish socialist Nicolás González Casares, summed up the amendments in the plenary as “more transparency, more participation, more coordination, and more prevention”.

MEPs call for setting up the European medicines supply database (EUMSD) that could determine the volume of stocks existing at any given moment, as well as detect, predict, and prevent shortages of medicinal products.

The new database would facilitate, on a permanent basis, access and exchange of information between the EMA and corresponding national authorities.

It would operate not only during public health emergencies and major events but also under normal circumstances, providing simultaneous access for EMA and member states to their database. 

Additionally, parliament requires EMA to establish a publicly accessible web page with information on actual shortages of critical medicinal products.

“We are committed to providing the agency with new tools to enable it to carry out active monitoring in order to prevent medicines shortages,” González Casares said.

Another parliamentary amendment focuses on more coordinated, well-designed, and transparent clinical trials to avoid duplication of efforts, the under-representation of important population subgroups and a lack of collaboration between trials.

MEPs also call for information on clinical trials and marketing authorisation decisions to be publicised.

“We want to promote clinical trials for the development of vaccines and treatments, reinforcing public information about them,” said rapporteur. 

Parliament also voted in favour of having permanent observers from bodies representing patients and medical professionals, as well as inviting contributions from third parties including marketing authorisation holders, wholesale distributors, at the Medicines Steering Group and the Medical Devices Steering Group. 

Casares added that “parliament wants to make the work of the steering groups more transparent and to strengthen the role of healthcare professionals, as well as encourage synergies between EU agencies.”

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