For someone living with a digestive cancer, a new treatment can offer hope. Whether it is available where they live, and whether their healthcare system can afford it, can determine what that progress means in practice.

These questions sit at the heart of the European Biotech Act, proposed by the European Commission in December 2025 to encourage research, clinical trials and manufacturing in Europe.[1] One contested provision would give certain medicines an additional year of protection from competition.[2]

Supporters see an incentive for the next medical breakthrough. Critics see a risk of higher costs and a longer wait for more affordable alternatives. For patients, the outcome matters on both counts.

What an extra year would change

Developing a medicine takes years, including clinical studies and regulatory approval. A supplementary protection certificate, or SPC, can compensate a company for some of the patent time used up during that process. Under current EU rules, it generally provides up to five additional years of protection after the underlying patent expires.

The Commission proposes adding 12 months for qualifying biotechnology medicines, including some cell and gene therapies. Companies would have to meet conditions relating to innovation, clinical trials in at least three EU countries and at least one manufacturing step in the EU. Packaging, quality testing and certification alone would not qualify.[2]

The extra protection could apply while the original medicine is already on sale. It could delay the arrival of cheaper competitors, leaving healthcare systems waiting longer for potential savings.

Why patients have a stake

Supporters argue that longer protection could attract investment, bring more clinical trials to Europe and encourage new treatments. For people with limited treatment options, those are important goals. The question is whether this incentive would deliver them, and whether the benefits would reach patients across Europe.

The European Patients’ Forum has called for the extension to be removed or tightly limited, citing concerns about timely access to medicines and the sustainability of healthcare systems.[3]

Many cancer treatments are biological medicines, made using living cells. Other manufacturers can develop biosimilars: highly similar versions of an existing biological medicine, with no clinically meaningful differences in quality, safety or effectiveness. They must meet strict EU standards. Once the relevant protections expire, competition from biosimilars can help lower costs and improve access.[4]

The debate therefore reaches beyond the price of a single medicine. It concerns how Europe supports future treatments while helping healthcare systems provide the care patients need today.

A divided political debate

The European Parliament’s Public Health (SANT) and Industry, Research and Energy (ITRE) committees are jointly leading the file, with Vytenis Andriukaitis (S&D) and Wouter Beke (EPP) as lead negotiators. Their initial draft retained the Commission’s 12-month proposal, although Beke has argued for 24 months and more flexible eligibility rules.

Amendments range from extending protection by up to two years to shortening the incentive to six months or removing it altogether. These are negotiating proposals; Parliament has not agreed its final position.[5]

Other committees have highlighted different priorities. The Environment Committee (ENVI) has raised concerns about longer protection. The Legal Affairs Committee (JURI) supported a conditional 12-month extension, alongside measures to help biosimilar manufacturers prepare for competition.[6,7]

EU governments are also divided. In a June 2026 debate, Spain supported extending SPC protection to attract investment. Malta questioned the fairness of asking taxpayers to pay more while smaller markets still face supply gaps. Estonia stressed affordability and sustainable healthcare budgets, while Poland questioned whether the measure would achieve its industrial aims. France and several other countries called for stronger support for biosimilars.[8]

These differences bring the patient question into focus: would more investment translate into better access, including in countries that already struggle to secure new medicines?

The evidence behind the promise

Answering that question requires robust evidence. Yet the Commission presented the Biotech Act without the usual impact assessment examining potential benefits, costs and risks. Its supporting analysis followed in May 2026, five months after the proposal.[9]

In one modelled scenario, the Commission estimated that the extension could add around €210 million a year to public healthcare spending. The model assumes three qualifying medicines per year and uses list prices, which do not reflect confidential discounts. It is an estimate under specific assumptions, rather than a forecast of the final cost.[9]

Industry-commissioned modelling published by EFPIA points to potential gains in research investment and clinical trial participation.[10] Such projections depend on the scope of the incentive and the assumptions used. Independent scrutiny is needed to assess what the proposed rules could deliver for patients and at what cost.

Patients need a place in the debate

According to POLITICO, MEPs asked the European Parliamentary Research Service to assess the impact of extending SPC protection independently, but the study could not be completed within the available time. The lead negotiators instead arranged a roundtable for 29 September 2026 with experts, medicine companies and EU officials.[11]

The discussion brought perspectives from both innovative pharmaceutical companies and the generics and biosimilars sector. However, patient groups criticised their exclusion from the panels.[12]

Industry expertise can inform legislation, but a roundtable cannot replace independent analysis or meaningful patient involvement. Patients and their organisations can help lawmakers assess what the proposals would mean for access to treatment and inequalities between countries. The European Patients’ Forum has called for their involvement to be built into the Act’s implementation.[3]

What happens next

The Parliament and EU governments must still reach agreement before any extension becomes law.[5] For people affected by digestive cancers, the measure of success should be whether the final rules support effective new treatments and fair, timely access to care.

DiCE will continue to follow the negotiations and advocate for decisions grounded in robust evidence, clear benefits for patients and equitable access across Europe. An extra year of protection needs a clear explanation of what patients would gain in return.

References

1. 1. European Commission (2025). European Biotech Act: overview and objectives.
   2. European Commission (16 December 2025). Proposal for a European Biotech Act, COM(2025) 1022, Article 27.
   3. European Patients’ Forum (2026). Recommendations for the upcoming negotiations in the European Parliament on the EU Biotech Act.
   4. European Medicines Agency. Biosimilar medicines: overview and EU regulatory standards.
   5. European Parliament. Legislative Observatory, 2025/0406(COD), including committee opinions and amendments.
   6. European Parliament (2 October 2026). ENVI opinion, PE788.881.
   7. European Parliament (9 September 2026). JURI opinion, PE789.902.
   8. Peseckyte, G. (17 June 2026). Drug monopoly extension splits EU ministers in Biotech Act debate. Euronews.
   9. European Commission (26 May 2026). Staff Working Document, SWD(2026) 450, supporting analysis of the Biotech Act.
   10. EFPIA (10 June 2026). Extending supplementary protection certificate (SPC) could increase European R&D investment tenfold. Industry-commissioned modelling on SPC extension and R&D investment.
   11. Chiappa, C. (15 September 2026, 19:05). “MEPs to meet with industry, Commission to tackle patent debate.” POLITICO Pro Health Care.
   12. POLITICO Morning Health Care (30 September 2026). “Time to get tough on food, booze and tobacco”, section on the Biotech Act roundtable.