As the U.S. focuses on beefing up its biopharma manufacturing infrastructure this year, a similar effort toward improved drug shortage resilience has been playing out across the pond.
Now, following a proposal earlier this year to safeguard against disruptions to critical medicine supplies, the EU is inching closer to a formal strategy.
Tuesday, the European Council—which helps drive the policy of the EU but does not itself negotiate or enforce EU laws—gathered behind new regulations that seek to diversify European supply chains, support collaborative drug procurement models and devise incentives to bolster drug production in the bloc.
Next up, the European Parliament will need to formalize its position on the so-called critical medicines act (CMA), at which point the two bodies can come together to negotiate the final text of the legislation, the European Council said in a Dec. 2 press release.
The European Parliament is slated to vote on its CMA position Dec. 15, teeing up discussions between the two institutions come spring, according to European news outlet Euractiv.
“Today, we have taken an important step towards ensuring that European patients have access to the medicines they need,” Sophie Løhde, Denmark’s health minister and minister for the interior, said in a statement addressing the council’s position. “The critical medicines act will strengthen the availability of vital medicines, reduce shortages, and build a more resilient supply chain for critical health products across Europe.”
The council’s take on the CMA proposes changes to the way EU member states procure critical therapies and their active ingredients across five main pillars.
First, the council wants the European Commission to issue guidance and provide help to EU member states in determining whether critical drugs or active ingredients have been produced in the EU. Secondly, the EU body is jockeying for a better framework for the bloc to exchange information on contingency stocks of medicinal products.
The council also wants to streamline EU provisions on collaborative drug procurement and reduce the minimum number of member states needed to submit a joint procurement request to the European Commission from nine members to six.
Lastly, the council is hoping to favor “resilience criteria” over price during the public procurement of critical meds, and it aims to improve the “legal clarity and coherence” of EU regulations by aligning their terminology with that of the bloc’s public procurement directive.
Influential trade association the European Federation of Pharmaceutical Industries and Associations (EFPIA) said in a statement Tuesday that it welcomed the council’s general approach on the CMA as an “important step toward strengthening the availability, accessibility and security of supply of medicines for patients across Europe.” Still, the trade group stated that the council’s position has room for improvement.
Specifically, the EFPIA warned that for the CMA to be effective, the act must “remain proportionate and avoid broad mechanisms that risk stretching resources and blurring the lines between supply issues and wider medicine access challenges.”
“In this context, EFPIA continues to seek a more precise definition of medicinal products of common interest, limited to cases of clear market failure,” the EFPIA’s statement continued.
Further, on the matter of contingency stock requirements, the EFPIA noted that it does “not believe that the Council’s position goes far enough in enhancing measures to harmonize the growing trend of uncoordinated national contingency stock obligations.” The organization suggested more consistent EU-wide rules could align national approaches while avoiding market distortions.
The EU’s drug regulator, the European Medicines Agency (EMA), defines critical medicines according to the seriousness of the diseases they treat and the availability of alternative treatments. Drugs commonly included on that critical registry include antibiotics, insulin, painkillers, vaccines and therapeutics for chronic and acute diseases like diabetes or cancer, according to the European Council.
The CMA overall aims to improve the “availability, security and resilience” of Europe’s essential medicine supply chain by diversifying those supply lines, creating incentives for collaborative procurement initiatives and bolstering local drug production itself.
The European Commission first proposed the act in March following an increasing spate of “severe shortages of key medicines” in the bloc, the council noted in its press announcement.
Europe’s efforts to steel its medicine supply chains come amid a similar domestic production zeal in the U.S., which has been driven most visibly by biopharma investment pledges designed to get around the Trump administration’s import duties. Industry pledges in the U.S.—which have frequently included of a mix of manufacturing, R&D and business development commitments—have topped $370 billion this year, contractor and construction manager DPR noted in a recent report.
The FDA has also attempted to encourage domestic manufacturing this year through draft programs like FDA PreCheck—which seeks to streamline U.S. facility build-outs through increased agency-industry communication—and a pilot prioritization program unveiled in October that aims to hasten approval review times for generic drugmakers that test and manufacture their products in the States.
Meanwhile, a group of bipartisan U.S. lawmakers late last month introduced a bill that strives to establish a U.S. center of excellence for biopharma manufacturing. The production hub would be designed to “facilitate and accelerate manufacturing innovation, support good manufacturing practices” and provide training for workers to “bolster talent” throughout the industry, according to the bill.