A significant development on the pan-European life sciences front, was the July publication by the European Commission (the “Commission”) of its long-awaited Life Sciences Strategy. Entitled ‘Choose Europe for Life Sciences’ (the “Strategy”), aims “to position the EU as the world’s most attractive place for life sciences by 2030.” The life sciences sector was seen as one of the key areas of focus in Mario Draghi’s 2024 report on the future of European competitiveness and the subsequent 2025 EU Competitiveness Compass. Further, the making of the Strategy was called out by President von der Leyen as a focus for the then incoming 2024-2029 Commission.
Of note is the broad scope of the Strategy, with life sciences expressed as being as a scientific study of life and living organisms, intersecting with health, food, agriculture & fisheries, bio-based and environmental activities.
The Strategy proposes action in 3 interconnected phases which all underpin what the Commission deems the “life science innovation journey”. These are:
- R&I ecosystem optimisation
- Smooth, rapid access for life science innovation
- Boosting uptake and use of life science innovation
One other stand out point within the Strategy is the announcement that a Life Science Co-Ordination Group is to be set up within the Commission. It is envisaged that this will involve interaction with stakeholders from industry, academia and civil society. It will also support the development of an AI powered interactive tool to assist researchers and innovators, in navigating the regulatory landscape. This should provide governance and support for the many various initiatives set out in the document.
Enabling rapid market access
The proposed EU Biotech Act which is expected to be published in 2026 is a key plank of the Strategy and it is expected that it, will create a more innovation-friendly framework across biotech sectors to enable quicker and easier access to the market for new innovations. The Commission sees the proposed Act as making it faster and easier for spin-offs, start-ups and scale-ups to bring biotechnologies “from the laboratory to the factory and onto the market.” The Commission will also leverage the European Innovation Council portfolio and its Trusted Investors Network by launching a matchmaking interface to connect startups, industry and investors to further support this aim. Also of note is the commitment to a legislative proposal simplifying the current medical device and in vitro diagnostic medical device regulatory regime – stakeholders will be aware that the Commission started an evaluation of both legislative frameworks at the end of 2024.
Food innovation
The Strategy places heavy emphasis on the importance of innovation in the food sector and its potential impact on citizen wellbeing and the climate. The Strategy recognises that public understanding is “particularly critical in areas like agriculture and food technology, where innovation intersects with health and sustainability considerations.”
The Strategy aims to further support the food innovation industry with a simplified system of approval for foods coming into focus. There is recognition that regulatory procedures for food (as well as health and medical devices) could be more “agile and proportionate, without compromising safety or scientific rigour”. Although not specifically called out in the Strategy, this would appear, in the main, to relate to novel foods which require pre-market approval from the European Food Safety Authority (“EFSA”). Novel foods are broadly defined as foods which were not used for human consumption to a significant degree before May 1997, but can also include foods with new molecular structures, engineered nanomaterials or new production processes (for a full definition see Regulation 2015/2283). Since 1 February 2025, updated EFSA guidance has applied on the scientific requirements for an application for their authorisation.
The Strategy also commits to the development of a strategic R&I agenda on food systems which will link in with the Vision for Agriculture and Food published earlier this year.
Next steps
The Strategy is ambitious, broad and forward looking. It will be evaluated by the Commission, with a report due by 2028.
The Irish Government revealed plans to propose our own National Life Sciences Strategy as part of the Programme for Government published in January 2025. The Government has recently published an Action Plan on Competitiveness and Productivity aiming to enhance competitiveness and productivity through 85 actions across six thematic areas. The plan indicates that the national Life Sciences Strategy promised in the Programme for Government looks due to be published in 2026.
This is an area which should be closely monitored, as it remains to be seen how the Irish plan will fit within the recently published EU Strategy. This is particularly salient given that the EU Strategy anticipates “active involvement” from Member States, in terms of implementation.
For more information, contact our Life Sciences Group or Food and Agri Group.