2025 is shaping up to be a busy year in health policy - from the massive pharmaceutical package already under consideration in the EU to the Critical Medicines Act, which will be passed early this year.
Health Commissioner Oliver Varhei has been tasked with presenting a Critical Medicines Act in early 2025. The groundwork for this has already been laid with the creation of the Critical Medicines Alliance in 2024, made up of stakeholders from national administrations, the pharmaceutical industry, civil society and the scientific community.
The Polish Presidency of the Council will seek to go into detail and is already planning a CMA conference in Brussels on 19 February.
"This is very much expected from our side, a priority element," confirmed Ewa Magdalena Piaseka, Health Attaché at the Permanent Representation of Poland to the EU, quoted by Euroactiv.
The law will aim to tackle the shortage of medicines that is seen across the EU. Although the full scope of the act has not yet been revealed, it is likely to affect EU production support, warehousing and joint supply.
A senior EU diplomat said that the CMA could also play a role in the pharmaceutical package negotiations by addressing issues of access and affordability of authorised medicines, and would thus reduce some of the tensions in the more complex elements of these discussions.
Pharmaceutical Package
The Council is dealing with more than 400 members of the pharmaceutical package presented in 2023. The wide-ranging review of the 20-year-old legislation aims to tackle the affordability of medicines and support innovation.
One of the key elements of the package - the idea of incentives - is hotly contested and divides opinion. However, there is a will to overcome differences and significant progress has been made during the Hungarian Presidency.
The European Parliament has already adopted its position at first reading. The broad support portends a compromise in 2025 if the European Council reaches a common position.
In the meantime, Varhei called on health ministers to "be flexible and ready to find compromises".
Medical devices
Pressure is mounting on the Commission to launch a review of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Ahead of the last Health Council meeting in December, the French and German governments presented a paper which then received the support of seven other countries.
The governments want to speed up and facilitate the search for approval for the devices by centralising certain elements of the approval process, giving the European Medicines Agency (EMA) a greater role.
Instead of tearing up existing legislation, some of the problems can be solved quickly and in the short term through delegated legislation.
Tobacco
Expected updates to tobacco legislation have been repeatedly delayed. The Tobacco Taxation Directive and the legal framework for the cross-border purchase of tobacco by individuals were tabled for revision in 2022, following a public consultation in 2021. Similarly, the Tobacco Products Directive (TPD) was due for revision in 2024.
Sixteen Member States, led by the Netherlands, are calling on the Commission to "act decisively and swiftly" on the issue. The signatories want the review to be "a key priority for its next mandate, presenting its proposal no later than spring 2025".
Tobacco has been the subject of intense lobbying, as evidenced by the deep divisions in Parliament caused by a non-binding resolution on smoke and aerosol free environments. One of the most difficult areas is adapting legislation to include alternatives to tobacco, such as e-cigarettes and vaping.
Biotechnology Act
In her policy guidelines, Commission President Ursula von der Leyen said, "To facilitate the transfer of biotechnology from the lab to the factory and then to the market, we will propose a new European Biotechnology Act in 2025."
This is another ambitious plan for 2025, with the aim of completing a study by mid-year on how to reduce regulatory fragmentation and red tape for the sector. The law is inspired by the EU's Chip Act, which aims to mobilise €43bn of investment.
Overall, it has been a busy year for new legislation, but also an important one for implementation. The Health Technology Assessment and Clinical Trials Regulations reach important deadlines in 2025 and the introduction of the European Health Data Space, agreed last year, is also progressing. | BGNES
