NXTin.Health puts the question to key stakeholders – those in the know: What’s brewing in the EU Biotech Act pipeline for health-related industries?
The EU Biotech Act has sparked lively debate across Europe’s life sciences ecosystem, with policymakers, industry representatives, investors and patient organisations weighing how it can strengthen Europe’s biotech competitiveness while delivering tangible benefits for patients.
The European Commission notes that its proposal, presented in December 2025, is currently with the co-legislators, the European Parliament and the Council of the EU.
MEP Wouter Beke, representing the European People’s Party (Christian Democrats) and Belgium’s Christen-Democratisch & Vlaams (CD&V), has been working on the Biotech Act. His starting point, therefore, is the patient.
He told NXTin.Health: ”We want discoveries made in Europe to become new treatments that reach European patients faster. That is why my priorities are faster clinical trials, simpler rules and better access to finance, alongside strong protection for innovation. Europe has excellent researchers and companies, but too many struggle to find the money and the right conditions to grow here. The warning signs from our pharmaceutical and medical biotech sectors are worrying. We are losing ground, and we cannot afford to lose more time. We need to make it easier to run trials across several Member States and more attractive to invest in developing and producing treatments in Europe.”
MEP Beke stresses that the biggest challenge is ensuring that the Biotech Act delivers tangible improvements for researchers, companies and patients: “It must not become a paper monster that adds complexity to an already complicated system.” As he explains, Member States have different systems and priorities, but the Act must lead to simpler procedures, faster decisions and better coordination.
He also underlines the importance of striking the right balance between rewarding innovation and ensuring patient access: “And we should be honest: the Act alone cannot fix Europe’s shortage of growth capital or its fragmented single market. Those wider reforms need to move forward too, with the same urgency.”
On the Act’s potential impact on Europe’s biotech sector, MEP Beke says: “If we get this right, more biotech companies will be able to stay and grow in Europe, from their first research breakthrough through to clinical development and production.”
In his assessment, this means retaining investment, expertise and skilled jobs, while strengthening our ability to develop and produce the medicines we need.
The geopolitical stakes are high, MEP Beke warns: “The United States and China are attracting investment and gaining ground while Europe is falling behind. That comes at a cost to our prosperity, our jobs and potentially our patients’ access to new treatments. Europe cannot afford to make the discoveries while others reap the benefits.” MEP Beke believes that this Act is an opportunity to turn that around.
Lithuania’s Ministry of Health Vice-Minister Daniel Naumovas commented to NXTin.Health that Lithuania’s life sciences sector is a strategic national priority, contributing 3.7% of GDP in 2025, with a target of 5% by 2030.
D.Naumovas points out: “We strongly support the European Biotechnology Act I as an opportunity to boost Europe’s competitiveness, innovation, and resilience. In particular, we welcome efforts to modernise regulation, attract investment and strengthen research and innovation. A more enabling framework will accelerate the development and uptake of innovative medicines, improve patient access, and enhance the EU’s health security and supply resilience.”
He promises that Lithuania will place particular emphasis on advancing the European biotechnology agenda during its Presidency of the Council of the EU in the first half of 2027, making it a key priority for the country.
Signe Jantone, Executive Director of the Latvian Pharmaceutical Manufacturers Association, comments to NXTin.Health:
“Europe’s pharmaceutical competitiveness starts with Europe’s ability to manufacture its own medicines. Most critical medicines are off-patent, or generic, medicines, and the technologies required to produce them are well established. However, low prices and intense competition have driven the relocation of medicine production outside Europe. As a result, Europe is becoming increasingly dependent on suppliers in Asia, particularly for active pharmaceutical ingredients. Therefore, the Critical Medicines Act is a crucial step towards strengthening Europe’s manufacturing capacity, reducing supply risks and ensuring the availability of medicines even in times of crisis.
Latvia has several distinct advantages in this process. We already have pharmaceutical manufacturers with decades of expertise, established infrastructure, experience in the production of active pharmaceutical ingredients and the ability to compete in international markets. Therefore, it is in Latvia’s interest, first and foremost, to ensure that European investment instruments help existing manufacturers modernise their production facilities, expand their product portfolios and increase the output of critical medicines within the European Union.
At the same time, the European Biotech Act creates opportunities for the next stage of pharmaceutical development. Therefore, it would be a mistake to pit innovation against traditional medicine manufacturing by directing all investment towards biotechnology.
The development of generic medicines also requires investment in research, technology, manufacturing processes and product registration. Furthermore, the laboratories, expertise and industrial infrastructure of existing manufacturers can become the foundation for the development of new biotechnological products and bringing them to market. Therefore, Latvia must ensure that the investment and support opportunities offered by the Biotech Act are also accessible to existing pharmaceutical companies developing new products and manufacturing processes, and not only to new biotechnology companies.
It is in Latvia’s interest to ensure that the two European regulatory frameworks complement each other. The Critical Medicines Act should strengthen the existing manufacturing base and security of medicine supply, while the Biotech Act would open up opportunities for the development of new technologies and products. The Latvian Association of Pharmaceutical Manufacturers is ready to cooperate with the government and research institutions to ensure that these interests are represented at the European level. Our aim is to see more medicines developed and manufactured in Latvia, while reducing European patients’ reliance on supplies from third countries.”
Naveed Siddiqi, Senior Partner at Novo Holdings, shares his perspective, arguing that the Biotech Act is helpful, but it’s not yet the solution. “One structural issue is the lack of strong public markets. Europe has roughly €10 trillion in pension assets, but even if the Commission encourages funds to invest, many are not set up to do so because of structural barriers. Underinvestment is a major weakness, and growing competition could accelerate Europe’s relative decline.”
He also highlights that one problem is the lack of specialist expertise: “But the market already offers solutions, such as fund-of-funds structures, which invest in specialist funds and could help channel more capital into life sciences. A dedicated life sciences fund of funds would be very useful.”
“What’s been missing is the political will to drive a common European effort. It’s high time Europe got its Act together,” N. Siddiqi concludes.
Otello Stampacchia, Founder of Omega Funds, points out that Europe has traditionally prioritised consumer protection: “So while individuals can invest in crypto, insurance companies and pension funds face major barriers to investing in venture capital.”
He also emphasises that two-thirds of all clinical trials worldwide are run by small companies. “They need venture capital early on and public-market funding once they scale. Most of our companies ultimately have to list on Nasdaq because Europe lacks a viable alternative. Ironically, when European pension funds invest in alternative assets, they often do so through US funds.” O.Stampacchia observes.
The European RNA Alliance (ERA) is of the view that initiatives from the European Commission, such as Choose Europe for Life Sciences, the Biotech Act, and the recent announcement of the Innovation Act, are all steps in the right direction, designed to address some of the main issues affecting innovation in Europe: access to capital, bureaucratic hurdles, and the ability of European companies, particularly SMEs, to compete fairly in their own market against much larger non-European players.
The European Patients’ Forum (EPF) has called for patient access, affordability and safety to remain central to the EU Biotech Act during a meeting with Members of the European Parliament Vytenis Andriukaitis (Group of the Progressive Alliance of Socialists and Democrats in the European Parliament, Lithuania) and Stine Bosse (Renew Europe Group, Denmark), as well as several Parliamentary Assistants and Groups’ advisors.
“Europe’s competitiveness should be measured not only by the investment it attracts, but by the improvements it delivers in patients’ lives”, said Claudia Louati, Head of Policy and Capacity Building at EPF. As negotiations continue, EPF urges policymakers to ensure that the Biotech Act strengthens innovation and clinical research while safeguarding affordability, equitable access and patient safety.
Should you wish to share your perspective, please contact d.skadina@nxtin.health.
