Belgium wanted a drug shortages bill. It’s not happy with the EU’s plan.

Belgium was the architect of a European plan to tackle chronic drug shortages. But it views the EU’s long-awaited fix announced Tuesday as a letdown.

Even before the European Commission presented its Critical Medicines Act — which focuses on an overhaul of procurement rules and subsidies to boost domestic drugs production — the country’s health minister lamented that the proposal “does not meet the gravity” of Europe’s supply crisis.

“It lacks the urgency required to safeguard our health care and security,” Frank Vandenbroucke, who is also Belgium’s deputy prime minister, told POLITICO, commenting on a leaked version of the CMA text.

While he acknowledged the act is an “important step forward,” he added that the “proposed funding is insufficient, and there is no common strategy for stockpiling essential medicines.” Belgium has called for the act to be partly funded by Europe’s defense strategy.

It’s a moment of disappointment for Vandenbroucke, who in 2023 led the charge in calling for a Critical Medicines Act, which was supported almost unanimously by member capitals.

To other observers, however, the Commission’s bill is a welcome fix for long-standing issues that have driven medicines production overseas, and will help rebuild resilient supply chains and improve access not only to critical medicines but also to high-priced novel remedies such as rare-disease drugs.

Purchasing power

The executive proposed an overhaul of procurement rules so countries don’t simply opt for the cheapest drug available but award contracts based on security of supply. There are also provisions for joint procurement by countries or by the Commission on their behalf, and these extend beyond everyday critical medicines to newer and more expensive therapies such as cancer drugs and antimicrobials.

It includes an appropriation of €88.5 million from the Commission’s 2021-2027 budget, and gives countries more latitude to invest in making critical medicines. It also says measures to protect one country’s supplies shouldn’t damage those of another, especially when countries require that companies hold contingency stocks of a product. 

Health Commissioner Olivér Várhelyi met an ambitious self-imposed deadline to deliver the text in the first 100 days of the executive’s mandate. “The Critical Medicines Act ensures that EU patients have access to the medicines they need, when and where they need them at an affordable price. In the current geopolitical context, this has become an even bigger priority,” he told members of the European Parliament.

It has the “potential to significantly increase the resilience of our health care systems,” he added.

The pharmacy sector, for one, is happy with the text. The Pharmaceutical Group of the European Union, representing community pharmacists, said the act “targets most of the root causes of shortages” and would help optimize national stockpiles.

Cancer groups are also thrilled. The Association of European Cancer Leagues non-profit was effusive in its praise of joint procurement as allowing countries to expand access to much-needed cancer drugs by joining forces.

“By further institutionalising joint procurement at the EU level, the Critical Medicines Act can help prevent shortages and [can] lower prices for all member states, making smaller markets more appealing for pharmaceutical companies and ensuring fairer access for all patients,” the group said.

Damp squib

While Renew MEP Stine Bosse said the proposal “looks good,” predicting it would work for both citizens and industry, other politicians questioned whether the provisions on stockpiling were strong enough.

“There is nothing that would bring real solutions,” said Greens MEP Tilly Metz, while European People’s Party MEP Laurent Castillo said he had expected the proposal to include measures to establish a European stock of medicines for hospital pharmacies.

One Commission official, granted anonymity to speak freely, told POLITICO: “I personally think it’s quite weak, and might not really bring any change or incentive to improve dependencies and manage vulnerabilities on critical medicines.”

As for the sustainability of pharma supply chains — another talking point in the drug shortages debate — the act says countries can back projects that improve sustainability, and gives them the option of prioritizing environmental concerns in procurement criteria. Luna Dayekh, a project officer at the Health Care Without Harm NGO, said environmental criteria should be mandatory for public procurement and should include measurable standards.

The Commission’s effort to streamline environmental impact assessments in the name of efficiency is also concerning, Dayekh said. The act says countries should complete assessments for strategic projects within 45 days, whereas such assessments typically take months or years, she explained.

Maggie Saykali, director of European Fine Chemicals Group, told POLITICO that the Commission should go further toward closing a competitiveness gap and require that all manufacturers worldwide comply with its environmental standards.