With the date of publication for a Critical Medicines Act fast approaching, the EU’s pharma industry is urging the Commission to slow down rather than keeping to a promise made by Health Commissioner Oliver Várhelyi to launch the proposal within the first 100 days of his mandate.
In an effort to fulfil its 100-day pledge, the Commission is rushing to present the Act on 11 March in Strasbourg, but this has raised concerns among European pharma companies, who claim the process has bypassed proper evaluation.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), representing small and medium-sized pharmaceutical companies, urged the Commission “to reconsider the haste with which the act is to be drafted, in a reply to a Commission call for feedback.
The deadline for this call for stakeholder feedback fell on Thursday, the timing of which also attracted criticism.
The Act is designed to address severe shortages of essential medicines in the EU, including antibiotics, insulin, and painkillers, particularly those that are difficult to source or depend on limited manufacturers or suppliers.
“We urge the Commission to carefully consider the Critical Medicines Act’s drafting timeline and to conduct a thorough impact assessment prior to its publication,” a feedback note from German pharma giant Bayer stated. Bayer is a member of the Critical Medicines Alliance, a consultation body of 250 stakeholders established in April 2024 to analyse supply chain vulnerabilities.
Impact assessments are intended to ensure evidence-based policymaking and were introduced in 2022 under the EU’s Better Regulation principles.
Swiss pharma company Roche also considered the lack of an impact assessment “a serious omission” in the analysis of the possible environmental, social, competitiveness and economic impacts of the future Act.
“The analysis of these aspects should be covered in a proper impact assessment and not rely solely on learnings from pilots, ad hoc reports and the strategic report of the CM Alliance,” Roche’s statement said.
The Commission argues that the urgency of addressing medicine shortages justifies bypassing the assessment. However, industry leaders claim that the evidence gathered does not fully capture the wider impact of the proposal.
“We specifically cannot condone publication the act without a proper impact assessment,” added EUCOPE.
Among other voices calling for a full impact assessment are the European Federation for Pharmaceutical Industries and Associations (EFPIA) and Japanese pharmaco company Takeda.
