From the weighty Pharmaceutical Package, already in the EU’s legislative pipeline, to a Critical Medicines Act due at the start of the year, 2025 is shaping up to be a busy year in the field of health policy. We’ve picked the top five legislative developments to follow.
Critical Medicines Act
Health Commissioner Olivér Várhelyi has been tasked with presenting a Critical Medicines Act (CMA) at the start of 2025. The groundwork has already started with the creation of a Critical Medicines Alliance in 2024, made up of stakeholders from national administrations, pharma, civil society and the scientific community.
The Polish presidency of the Council will be keen to get their teeth into the detail and is already planning a conference on the CMA in Brussels for 19 February.
“This is highly anticipated on our side; it’s a priority element,” confirmed Ewa Magdalena Piasecka, health attaché at the Permanent Representation of Poland to the EU, at a European Policy Centre event in Brussels.
The act will aim to address medicine shortages experienced across the EU. While the full scope of the act is yet to be revealed, it will likely touch on supporting EU production, stockpiling and joint procurement.
A senior EU diplomat told Euractiv that the CMA could also play a part in the negotiations on the Pharmaceutical Package by addressing issues of access and affordability for authorised medicines, taking some of the heat out of the trickier elements of those discussions.
Pharmaceutical Package
The Council has been slogging through the more than 400 articles of the Pharma Package presented in 2023. The extensive revision of 20-year-old legislation aims to address affordability and accessibility of medicines while supporting innovation.
One of the main planks of the package – the idea of incentives – has been hotly contested, dividing opinion both in and outside the Council. Nevertheless, there is some will to overcome differences and significant progress was made under the Hungarian presidency.
The European Parliament has already adopted its position at first reading. The broad support bodes well for a compromise in 2025, should the Council reach a common position.
Várhelyi, meanwhile, has urged health ministers to “be flexible and willing to find compromises.”
Medical Devices
Pressure has been mounting on the Commission to launch a revision of the medical devices regulation (MDR) and the in vitro diagnostics medical devices regulation (IVDR). The French and German governments put forward a paper ahead of the last Health Council in December, which received support from seven other countries at the time.
The governments want to make it faster and easier to seek approval for devices by centralising some elements of the approval process, with a greater role given to the European Medicines Agency (EMA).
Rather than ripping up existing legislation, there could be possible quick fixes to some of the problems, in the shorter term, through delegated legislation.
At his confirmation hearing, MEPs pushed Várhelyi to revise the medical device rules without delay. The Commission is currently carrying out an assessment, but the EPP has pressed for an expedited review.
Tobacco
There have been many delays to expected updates of tobacco legislation. The Tobacco Taxation Directive (TTD) and the legal framework on cross-border tobacco purchases of tobacco by private individuals were tabled for review in 2022, following a public consultation in 2021. Likewise, the Tobacco Products Directive (TPD) was meant to be reviewed in 2024.
Sixteen member states, led by the Netherlands, are calling for “decisive and swift action” from the Commission to revise the TTD. The signatories want the revision to be “a key priority for its next term, presenting its proposal no later than spring 2025.”
Tobacco is the subject of intense lobbying, as evidenced by the deep divisions in the Parliament prompted by a non-binding resolution on smoke and aerosol free environments. One of the most difficult areas is adjusting the legislation to include tobacco alternatives, such as e-cigarettes and vaping.
Biotech Act
In her political guidelines, Commission President Ursula von der Leyen said: “In order to make it easier to bring biotech from the laboratory to factory and then onto the market we will propose a new European Biotech Act in 2025.”
It’s another ambitious plan for 2025, aiming by mid-year to complete a study on how to reduce regulatory fragmentation and bureaucracy for the sector. The act is inspired by the EU’s Chips Act, which aims to mobilise €43 billion in investment.
All-in-all, then, a busy year for new legislation – but also an important one for implementation. The Health Technology Assessment and Clinical Trials Regulations both reach important deadlines in 2025, while the rollout of the European Health Data Space, agreed last year, also moves on.