Europe is one step closer to adopting its first law focused on health biotechnology. For patients with allergy, asthma, COPD and atopic eczema the question is not only how Europe can become more competitive in biotechnology, but whether innovation will translate into safe, effective and affordable care.
In August 2026, EFA replied to the European Commission’s latest public consultation on its proposal for a European Biotech Act.
Our response builds on priorities identified together with EFA Community of members in 2025, ahead of the Commission proposal.
Now that the proposal is on the table, EFA believes that it still does not address patient’s needs. We are calling for action in three main areas:
Make biotechnology accessible to patients
Biologic treatments and other biotechnology-based innovations are already transforming care for asthma, COPD, atopic eczema, food allergy and other allergic diseases. Yet high costs, slow access and inequalities between countries continue to prevent many patients from benefiting.
EFA supports efforts to improve and accelerate clinical trial processes, but faster procedures must go hand in hand with patient safety, robust evidence and adequate resources for authorities and ethics committees. Patients should also be more meaningfully involved in clinical trials and medicine development across the whole development process.
Invest in research without shifting the cost to patients
Europe needs a strong biotechnology research environment, particularly in areas such as food allergy, atopic eczema and respiratory diseases.
However, incentives for innovation should not make medicines less affordable. We are concerned that the proposed additional one-year Supplementary Protection Certificate extension for certain advanced therapies may increase costs for healthcare systems and delay access to cheaper biosimilar medicines if it does not take access into consideration everywhere in Europe.
The Biotech Act should support innovation while strengthening patient-centered co-design, scientific education and an inclusive biotechnology ecosystem, without placing the cost of innovation on patients.
Recognise biotechnology’s role in prevention
Biotechnology can also contribute to preventing disease and addressing health risks linked to climate change, including through earlier diagnostics, personalised approaches, and more climate-resilient healthcare solutions.
EFA Community welcomes measures supporting biotechnology products adaptable to climate change but believes the proposal does not go far enough in recognising the links between environmental factors and health.
We also regret that an impact assessment could not have been delivered in the timeframe available before the proposal’s adoption as healthcare policy decisions need to be made using robust evidence.
The European Parliament and Council are now considering the proposal through the ordinary legislative procedure. EFA will continue engaging on the file to ensure that patient access, safety and involvement remain central as the legislation develops.
Read more about our consultation reply in our latest position paper here.
Read our reply to the consultation here.
Read our earlier response to the call for evidence here.