Belgium used the June 16 meeting of EU health ministers in Luxembourg to press for a united European front on drug prices, urging member states to coordinate their response to US “most favored nation” (MFN) price demands.
At the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), Belgian Deputy Prime Minister and Health Minister Frank Vandenbroucke pushed for coordinated national pricing policies and a more active role for the European Commission, ahead of a closed-door ministerial lunch on pharmaceutical resilience and strategic autonomy.
While Belgium focused on drug prices, Greece called for a more ambitious European Biotechnology strategy, arguing that stronger manufacturing capacity, investment and innovation are essential for the bloc’s pharmaceutical sustainability and long-term competitiveness.
A price coalition
Vandenbroucke made his case upon arrival. He called the challenge “serious and even threatening” and said Europe needs “unity and solidarity” to serve its patients and citizens.
His starting point was access. Europe must guarantee citizens “equal access to high-quality healthcare, to high-quality pharmaceuticals, to innovative pharmaceuticals,” he said, a goal now under pressure from US strategy.
The answer, he argued, is to build the sustainability and external competitiveness of Europe’s pharmaceutical system “based on internal solidarity”, a principle he traced back to Jacques Delors, who told him some 40 years ago that “Europe’s external competitiveness is fundamentally premised on its internal solidarity”.
His plan begins with information. Member states should share data on prices, shortages and market withdrawals, he argued, and then coordinate their national pricing policies. Health technology assessment and the Biotechnology Act are helpful steps, he said, but others are needed. The European Commission, he added, has “a proactive role to play”.
The push is based on the Benelux, the five-country price cooperation group that Belgium co-founded in 2015 with the Netherlands, Luxembourg, Austria and Ireland. On 10 June, the group called for unity and coordination in pharmaceutical policy and welcomed action “within a European framework rather than through uncoordinated individual national responses”.
Four requirements for Biotechnology Law
In the policy debate on the regulation of the Biotech Act, Belgium presented a detailed list of demands.
Vandenbroucke wants “faster, more predictable and truly European” clinical trials, with simpler procedures, reinforced division of labor and shorter timelines for multinational trials, plus targeted actions to make the EU more attractive for phase one trials. He called for deeper harmonization on ethics, including model contracts and support mechanisms for ethical reviews among member states. And he supported a single entry point for regulatory sandboxes, run on a “one project, one procedure” basis, along with an EU-level mechanism to give binding classification opinions on border products.
His most distinctive question concerned substances of human origin (SoHO). Belgium wants harmonized European restrictions and a central registry, or interoperable national registries, to track the cross-border use of donor-derived material. The goal, he said, is to prevent overuse of individual donors, close regulatory loopholes and protect “public trust and posterity.”
As for the most contested element of the regulation, a proposal to extend some biotech patents by up to a year through additional protection certificates, Vandenbroucke gave little. “In general, we support the development of the Biotechnology Act, so there is no difficulty with us,” he told reporters.
Directive support
Belgium supported the Council’s new negotiating position on the Biotechnology Act directive, which updates the rules on genetically modified microorganisms (GMM) and organ processing.
For the bodies, Vandenbroucke defined three principles: proportionality, legal certainty and alignment with clinical practice and insisted that the competent national authorities maintain their role. He welcomed closer coordination between these authorities, with cross-border exchanges subject to prior authorization and enforced by EU data protection rules. Regarding GMOs, he supported a risk-based approach that he called science-based and innovation-friendly, and one that reduces the administrative burden for authorities and notifiers alike.
Equipment and Ebola
In the parallel reform of medical equipment rules, Belgium supported the future Irish presidency’s aim for a Council position and emphasized the need to ensure the supply of critical equipment.
Belgium also spoke about the Ebola outbreak in the Democratic Republic of Congo and Uganda. Vandenbroucke said Belgium takes precautions and remains “extremely vigilant” but is keeping its response “science-led”.
WHO and ECDC advise against blanket travel or trade bans, he noted, “as these create a false sense of security and can be counterproductive.” Like other European countries with direct flights to the region, Belgium does not carry out systematic health checks of arriving passengers, but has installed a number of protocols. The most effective response, he argued, is action at the source, supporting affected countries through development cooperation and capacity building.
Greece’s push for strategic autonomy
Greek Health Minister Adonis Georgiadis used the EPSCO discussions on the Biotechnology Act to argue for a stronger European biotech ecosystem, greater pharmaceutical resilience and faster patient access to innovation.
Georgiadis said Europe must do more to turn scientific excellence into commercial success, warning that innovations developed in the EU are often produced and commercialized elsewhere. Greece supported a framework covering the entire biotechnology value chain, from clinical research and development to manufacturing and patient access.
Athens set out three priorities for the legislation: simplifying regulations to speed up clinical trials and product development through initiatives such as FAST-EU and COMBINE; strengthening support for high-scale financing, strategic investments and biomanufacturing infrastructure to help innovative companies remain in Europe; and promoting strategic projects focused on unmet medical needs, security of supply and long-term competitiveness.
Greece also highlighted the need to strengthen Europe’s biosimilars sector.
Regarding pharmaceutical policy, Georgiadis argued that access to medicines should be treated as a matter of strategic autonomy, resilience and European security. He called for stronger manufacturing capacity within the EU and more diversified supply chains to reduce vulnerabilities. According to Georgiadis, the success of the Biotech Act should ultimately be measured by its impact on patients.
(VA, BM)
