EU officials and lawmakers reached a tentative deal early on Tuesday on the bloc’s key legislation to tackle chronic drug shortages, after overnight negotiations rejected some of the European Parliament’s most ambitious demands for domestic stockpiling and production.
The Critical Medicines Act, unveiled by the European Commission last year, aims to reduce Europe’s dependence on China and India for key medicines and pharmaceutical ingredients by diversifying supply chains and increasing domestic manufacturing capacity. The push has gained urgency amid rising trade tensions with the US and recurring shortages of antibiotics and painkillers across the bloc.
Negotiators reached the deal shortly after 6am Brussels time, roughly a year after the Commission first proposed the legislation.
Sharing the secrets
One of the main sticking points was stockpiling. Parliament, led on the file by the center-right MEP Tomislav Sokol, had adjourned for compulsory separation of stockpiles of medicines between EU states during crises, alongside the creation of a bloc-wide stockpile and a dedicated medicines safety fund to support production.
EU governments resisted mandatory obligations to share national reserves, reflecting broader sensitivities over national competences and crisis preparedness. Instead, the final compromise commits countries to share information on contingency stocks and coordinate stockpiling efforts.
Tiemo Wölken, a Socialist MEP involved in the negotiations, welcomed the EU states’ deal, saying it would ensure “that accumulation in one country does not create shortages in another”.
Purchase changes
The legislation also reforms public procurement rules for critical drugs and expands the scope for joint purchasing, a mechanism intended to strengthen the bargaining power of smaller states with pharmaceutical companies.
One dispute centered on how strongly the EU should favor domestic production in public tenders. Parliament had proposed requiring suppliers to source at least 50% of their production value from within the EU, a threshold opposed by parts of the pharmaceutical industry and trade-dependent states.
The final text appears to remove the fixed target in favor of a rating system that gives preference to suppliers with the largest production capacity in Europe.
Sokol said the deal was “a clear signal that Europe is committed to strengthening its pharmaceutical manufacturing base”.
Countries will also be able to jointly buy critical medicines through enhanced EU procurement schemes. Negotiators backed Parliament’s proposal that requires at least five countries to start the process, although only the Commission can initiate it.
Increased production
The law also creates a framework for “strategic projects” designed to expand pharmaceutical manufacturing capacity closer to EU borders. Negotiators agreed to speed up permit procedures for such projects, but rejected Parliament’s attempt to extend support to a wider range of medicines.
Member states also pushed for more flexible language on future EU funding, avoiding commitments that could complicate negotiations over the bloc’s next long-term budget for 2028-2034.
The deal marks an early political victory for Health Commissioner Olivér Várhelyi, who fast-tracked the legislation within his first 100 days in office and bypassed a formal impact assessment — a move critics said undermined the dossier’s original ambition.
The interim agreement still requires formal approval from capitals and the European Parliament.
(cz, sma)
