16/12/2025
Insights Blog

In a joint press conference on 16 December, Commissioners Várhelyi (Commissioner for Health and Animal Welfare) and Dombrovskis (Commissioner for Economy and Productivity; Implementation and Simplification) announced a number of keenly awaited measures that look set to dominate the agenda in 2026. These were formally adopted by the European Commission (“the Commission”) earlier on the same day. 

In a suite of items labelled the “Health Package”, the following were announced: 

  • A Biotech Act; 
  • Revised rules for medical devices;

The measures comprise a mixture of simplification and new initiatives. 

Biotech Act 

This takes the form of a draft Regulation which is intended to be a catalyst in the drive for competitiveness in Europe’s life sciences sector, flowing from the recommendations of the Draghi Report. It aims to “turn Europe into a biotech powerhouse” with recognition that Europe is not where it needs to be, for example in terms of venture capital investment and share of clinical trials.  

The Biotech Act sets out a bold vision for Europe’s health biotech sector. At its core, it aims to create a globally competitive industry that delivers breakthrough therapies for patients. To achieve this, the legislation introduces incentives, such as an extension of 12 months of the Supplementary Protection Certificate for medicinal products developed by means of biotechnology processed and for ATMPs (advanced therapy medicinal products). It amends the Clinical Trials Regulation, aiming to accelerate and shorten timelines and establish single regulatory pathways for complex, innovative products. By leveraging AI, data-driven tools, and regulatory sandboxes, the Act fast-tracks the development of next-generation treatments. Together, these measures aim to position Europe as a leader in health innovation. 

On the investment side, on the same date and in a linked initiative, the European Commission and the European Investment Bank (EIB) Group announced an initiative to mobilise €10 billion in investment in 2026-27 into the biotech and life sciences sector, known as “BioTechEU.” 

Accompanying the proposed Biotech Act is a proposal for a Directive to place genetically modified micro-organisms and the processing of organs on the market. 

Medical Devices 

The Commission has also published the long awaited proposal for a Regulation which seeks to simplify the rules for medical devices and which sees an enhanced role for the European Medicines Agency. Similar to the EMA’s list of critical medicines, a corresponding list of essential medical devices will be established. The proposal also aims to increase digitalization, to open up conformity assessment for low and medium risk devices and to support breakthrough technologies. 

The proposed Biotech Act and medical devices legislation will need to go to the European Parliament and Council so that interinstitutional negotiations can begin. The Safe Hearts plan will require work with Member States. 

Food and Feed 

A Food and Feed Safety Omnibus proposal was also announced, with a particular focus on biopesticides. The Food and Feed Safety package was a key deliverable from the Vision for Agriculture and Food presented by the Commission earlier in 2025. For more overall context on this see Towards 2030: The EU’s vision for life sciences and food innovation. As well as the separate proposal on genetically modified micro-organisms, the proposals in the text of the Biotech Act itself are of relevance to the food sector in a number of ways and the draft legislation also seeks to amend the EU’s General Food Law. 

For further information, please contact our Life Sciences Group.