Belgium, a driving force behind a European initiative aimed at resolving persistent drug shortages, has expressed disappointment with the European Union’s recently unveiled solution. The EU’s Critical Medicines Act, announced on Tuesday, has been deemed inadequate by Belgian officials who feel it falls short of addressing the severity of Europe’s supply crisis.
Health Minister’s Concerns
Frank Vandenbroucke, Belgium’s health minister and deputy prime minister, voiced his discontent prior to the official presentation of the act. He stated that the proposal “does not meet the gravity” of the crisis, emphasizing that it “lacks the urgency required to safeguard our health care and security.” While he acknowledged the act as an “important step forward,” he criticized the funding as “insufficient” and highlighted the absence of a unified strategy for stockpiling essential medicines. Vandenbroucke has advocated for the act to receive partial funding from Europe’s defense strategy, underscoring its critical importance.
Mixed Reactions to the Proposal
This moment is particularly poignant for Vandenbroucke, who championed the call for the Critical Medicines Act in 2023, garnering nearly unanimous support from member capitals. Conversely, other stakeholders view the Commission’s proposal as a constructive measure to rectify enduring issues that have driven medicine production abroad. The act is expected to contribute to the rebuilding of resilient supply chains and enhance access to essential medicines, including high-cost treatments for rare diseases.
The proposal introduces a comprehensive overhaul of procurement protocols, designed to encourage countries to prioritize security of supply over simply opting for the cheapest drugs. It allows for joint procurement by countries or through the Commission, extending beyond critical medicines to include newer, pricier therapies such as cancer treatments and antimicrobials.
The act allocates €88.5 million from the Commission’s 2021-2027 budget to enable countries to invest in critical medicines. Furthermore, it stipulates that measures to protect one nation’s supplies should not adversely affect another, particularly when companies are required to maintain contingency stocks of products.
Health Commissioner Olivér Várhelyi, who met a self-imposed deadline to deliver the act within his first 100 days, remarked that the Critical Medicines Act ensures that EU patients have access to necessary medications at affordable prices. He emphasized that, given the current geopolitical climate, this objective has gained paramount importance.
The pharmacy sector has responded positively to the act. The Pharmaceutical Group of the European Union, representing community pharmacists, commended the legislation for targeting the root causes of shortages and enhancing national stockpile optimization. Additionally, cancer advocacy organizations have praised the joint procurement provisions, which they believe will improve access to vital cancer drugs by fostering collaboration among member states.
However, not all feedback has been favorable. Some politicians have raised concerns regarding the strength of stockpiling provisions. Greens MEP Tilly Metz expressed skepticism, stating, “There is nothing that would bring real solutions,” while European People’s Party MEP Laurent Castillo anticipated stronger measures aimed at establishing a European stock of medicines for hospital pharmacies.
A Commission official, speaking on condition of anonymity, shared a critical assessment of the proposal, stating, “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.”
On the sustainability front, the act allows countries to support projects that enhance sustainability and empowers them to prioritize environmental considerations in their procurement processes. Luna Dayekh from the NGO Health Care Without Harm argued that environmental criteria should be compulsory for public procurement and include measurable standards. Concerns have also been raised regarding the Commission’s push to expedite environmental impact assessments, which typically require extensive timeframes, as the act mandates that strategic projects be assessed within 45 days.
Maggie Saykali, director of the European Fine Chemicals Group, urged the Commission to take more robust action toward closing the competitiveness gap, advocating for all global manufacturers to adhere to the EU’s environmental standards.