BRUSSELS — Negotiations among EU institutions regarding a comprehensive strategy to address drug shortages and reduce dependency on foreign pharmaceuticals are set to commence next week. The discussions are expected to be dominated by contentious issues surrounding the procurement and stockpiling of medications.
Initially proposed by the European Commission in March 2025, the Critical Medicines Act seeks to mitigate Europe’s reliance on pharmaceutical products and chemicals produced in countries like China and India. The initiative aims to encourage the relocation of drug manufacturing back to Europe, enhance supply chain collaborations with allied nations, create stockpiles of essential medicines, and facilitate cooperative purchasing among member states.
This legislative effort has gained urgency, spurred by the EU’s imperative to boost self-sufficiency following the Covid-19 pandemic and ongoing trade tensions with the U.S., compounded by potential tariff threats. Lawmakers are under pressure to finalize the negotiations swiftly.
Contentious stockpiling proposals
Cyprus, currently presiding over the Council of the EU, is keen on concluding these discussions before its term ends in late June. Health Commissioner Olivér Várhelyi has emphasized the need to expedite the legislative process, urging for a rapid resolution to the negotiations.
However, significant disparities among the proposals from the European Commission, the Council, and the European Parliament suggest that reaching a consensus may be challenging. A major sticking point centers on the issue of stockpiling. While the Commission and the Council proposed a lack of detailed regulations regarding the stockpiling of critical medicines—with the Commission stating that national stockpiles should not have adverse effects on other nations—the European Parliament has proposed more stringent measures.
“There are differing positions between different member states on that,”
noted Tomislav Sokol, a conservative MEP and leader of the Parliament’s work on the Critical Medicines Act. He highlighted that smaller member states might be more inclined to support redistribution mechanisms for stockpiled medicines compared to larger nations engaged in stockpiling.
Joint procurement challenges
Another critical point of debate pertains to procurement processes. The Commission’s proposal seeks to broaden the rules to allow collective purchasing of medications among multiple countries, known as joint procurement, effectively increasing their bargaining power. This initiative covers not only low-cost generic drugs, such as antibiotics and pain relievers, which are deemed critical, but also innovative treatments for rare diseases, raising concerns within the pharmaceutical industry.
The proposal allows the Commission to partake in joint medicine purchases, a feature retained by the European Parliament but opposed by the Council, which altogether eliminated this provision. This decision has sparked dissatisfaction among several nations, notably in Southern and Eastern Europe, as well as Belgium, which was among the first to advocate for a European Critical Medicines Act.
Regarding joint procurement facilitated by the Commission, there remains divergence among EU institutions on the minimum number of participating countries required to activate this mechanism. The Commission suggests a collective of nine nations, while the Council proposes six, and the Parliament advocates for just five.
As Sokol explained, “This is always a sensitive issue, not the concept itself … but how it will be organized, the number of the countries, conditions, etc.”
Additionally, on public procurement tenders, the Commission has advised that countries give priority to critical medicines with “a significant proportion” of ingredients manufactured within the EU, as opposed to solely opting for the lowest-priced options. The Parliament has gone further by defining the term “significant proportion,” stipulating that at least 50 percent of the active ingredient or 50 percent of the final product must be produced within the EU.
“We have a very strong mandate from the Parliament, more than 500 members of Parliament voted in favor, both from left and right,” Sokol added. “That gives us a strong manner to insist on things that are crucial for us.”
The discussions are set to commence on Monday, with high stakes involved in the negotiation outcomes.