Drug Monopoly Extension Sparks Division Among EU Ministers in Biotech Act Discussions
Poinews.com – As the Council of the European Union’s rotating presidency transitions to the end of June 2026, Cypriot representatives have initiated debates on the Commission’s proposed Biotech Act. The measure, which aims to extend patent protections for certain treatments, has revealed varying stances among EU nations. While some see it as a means to secure access to advanced therapies, others caution it may hinder competition and strain healthcare budgets.
Proposal Details and Industry Rationale
The Biotech Act’s proposed extension of monopoly rights—referred to as Supplementary Protection Certificates—would provide an extra year of protection for treatments meeting specific criteria. These include containing a novel active substance, differing in mechanism of action from existing therapies, conducting trials in more than two EU countries, and involving at least one EU-based manufacturing step, such as packaging or quality testing. Proponents argue this would incentivize biotech investment and research within Europe.
“We support the idea of incentivising technology in Europe and we support the idea to extend the protection certification system,” said Spain’s health minister, Mónica García Gómez, during discussions with fellow ministers.
Despite this, concerns have emerged about the long-term impact on patient access. Several countries warned that prolonged exclusivity could delay the introduction of biosimilars and push healthcare costs higher. Malta, in particular, highlighted disparities in medicine availability, noting only 17 innovative treatments were approved between 2020 and 2023 compared to 156 in Germany and 142 in Italy.
“We are … reluctant to direct taxpayer money into an industry which refuses to supply small markets or that expects us to pay substantially higher prices than large member states with a higher GDP,” Christopher Farrugia, Malta’s deputy representative in the EU, stated, emphasizing the nation’s reservations.
The debate has also focused on the adequacy of evidence supporting the measure. Without a dedicated impact assessment, the proposal relies on prior pharmaceutical legislation analysis. Katarzyna Kacperczyk, a deputy health minister, questioned whether the instrument aligns with the EU’s broader industrial and biotech goals.
“It is still not clear whether this instrument will be fit to the goals of the industrial and biotech policies of the EU,” Kacperczyk remarked, citing concerns over economic effects, competition, and product availability.
Commission’s Defense and Path Forward
EU Health Commissioner Várhelyi addressed these concerns at a press briefing, arguing that without the extension, many treatments might never reach European markets after their patents expire. He downplayed financial worries, urging ministers to prioritize prevention to generate budget savings for future therapies.
“If we push for prevention, it means that we can make significant savings in care; if we do that, it means we will have more funds available for the latest therapies,” Várhelyi told journalists.
While disagreements persist on the monopoly extension, ministers largely agree on streamlining clinical trials and reducing administrative hurdles. This consensus aims to maintain biotech innovation in Europe without compromising patient safety or product quality. The incoming Irish Presidency of the Council has emphasized the need for swift progress on the Biotech Act, urging nations to finalize their positions ahead of upcoming discussions.
