On Monday, (15 December), the European Parliament’s Committee on Public Health (SANT) held an extraordinary meeting in Strasbourg. As expected, the Critical Medicines Act (CMA) was adopted. All compromise amendments were approved by a show of hands. The final text was adopted with 27 votes in favour, 1 against and 8 abstentions. The file will now move to the next stage of the legislative process, with trilogue negotiations expected to begin in January.
Speaking on the Act, Rapporteur MEP Sokol (HR/EPP) thanked all shadow rapporteurs for their essential contribution and underlined that the Critical Medicines Act demonstrates the EU’s determination to secure access to medicines for European patients. He stressed the importance of strategic autonomy and warned that international competition for pharmaceutical investment, particularly from the United States, poses a risk to Europe. According to Sokol, the Act strengthens security of supply and reduces vulnerabilities, while making the EU a more attractive market through European preference, public procurement and support for pharmaceutical manufacturing.
In addition, during the SANT Committee debate, the rapporteurs reported the outcome of the final trilogue in the General Pharmaceutical Legislation (GPL), highlighting a strong team effort and a balanced compromise for patients, industry and Member States.
On the regulation, the agreement strengthens patient security through enhanced shortage prevention, requiring companies to notify potential shortages six months in advance for prescription medicines, with the possibility for the EMA to extend the scope if risks are identified for other products. It also introduces new incentives to address microbial resistance, notably a transferable data exclusivity voucher and a subscription model and aims to streamline EMA procedures while maintaining scientific rigour and patient safety.
On the Directive, the compromise on data and market protection was presented as improving access while preserving incentives. A fixed data protection period is followed by one fixed year of market protection, which may be extended by one year if the medicine addresses an unmet medical need or if a comparative clinical trial is carried out within set conditions.
A new article was added to facilitate access for Member States requesting a medicine, allowing for the withdrawal of market protection in a specific Member State if the product is not supplied within three years. Patent linkage provisions were clarified, environmental risk assessment requirements were strengthened with a review clause allowing future extension to manufacturing processes, and antimicrobials will be prescription-only in all Member States.
Meanwhile, EUCOPE has spoken out about SANT’s position on the CMA, stating disagreements with many of the measures, including procurement, which is favouring EU manufacturing, stockpiling and EU funding for strategic projects, as well as “medicinal products of common interest.”
The SANT Committee vote confirms strong political momentum behind the CMA, showing that we can expect trilogues to also move quickly, as stated by Health Commissioner Várhelyi. However, EUCOPE’s public criticism against the Act highlights industry’s concerns about the EU preference and medicines of common interest.
