Commission cuts feedback amid races to push Critical Medicines Act
Health Commissioner Olivér Várhelyi's determination to deliver the Critical Medicines Act within a 100-day timeframe has left no space for an impact assessment raising concerns among stakeholders concerned that speed will trump consultation and evidence gathering in the process.
The Critical Medicines 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.
Várhelyi committed to deliver the proposed legislation within the rapid timeline during his initial appearance as Health Commissioner, despite no deadline being set by Commission President Ursula von der Leyen.
But stakeholders have raised doubts about the feasibility of an expedited process on such a complex issue, and whether due process such as an impact assessment and proper consultation will be by-passed.
The latest Commission agenda tentatively schedules the Act for release on 11 March - exactly 100 days after the new Commission took office - barely meeting the self-imposed deadline.
Call for high-speed evidence
The Commission published its call for evidence - typically a key step in gathering feedback before a legislative initiative is presented - meaning that the executive intends to proceed without an impact assessment. Such assessments are intended to ensure evidence-based policymaking and were introduced in 2022 under the EU's Better Regulation principles.
'As there is pressing urgency to address the policy problem identified, the act will be adopted without an impact assessment,' the Commission stated in its paperwork, adding that a staff working paper will be published within three months of the proposal's adoption to provide evidence and analysis of its expected impacts.
To justify this, the Commission points to the final recommendations of the Critical Medicines Alliance, a consultation body of 250 stakeholders established in April 2024 to analyze supply chain vulnerabilities. These recommendations are expected on 12 February 2025, and will supposedly inform the development of the Critical Medicines Act.
Meanwhile the call for evidence will only be open for four weeks, closing at the end of February - roughly 10 days before the expected publication of the act.
Among the stakeholders invited to provide feedback are EU member states, civil society and patient organizations, business and trade associations, public health sector procurers, academia, international organizations, and the general public.
The interservice process—where all relevant directorates within the Commission review and give formal opinions—usually takes at least 10 working days, a former senior Commission official told Euronews. The source added that this could be shortened to just four days if pushed through for political reasons by von der Leyen's cabinet.
Additional time is also required for the so-called 'legal scrubbing' and translations into all official EU languages, making it clear that the text will likely be finalised only a few days after the Critical Medicines Alliance's conclusions - and well before the consultation period ends.
'That means that, in a cynical move, the call for evidence will be a pure formality, and stakeholders won't be heard at all,' the former Commission official told Euronews.
'We deeply rely on comprehensive engagement of our members and advisors and the formulation of detailed, consensus-based positions to effectively influence policy,' Alessandro Gallina, Senior Policy Manager at European Public Health Alliance (EPHA) told Euronews.
He added that quick turnarounds can strain capacity to mobilise resources, gather expert opinions, and forge a unified stance, resulting in less effective advocacy and potentially leading to policies that do not fully address the nuances of public health needs.
Similarly, the European Patients Forum (EPF), together with EPHA members of the Critical Medicines Alliance, told Euronews that they do not consider the timeframe sufficient for meaningful stakeholder participation or for the European Commission to develop a legislative act "grounded in robust evidence and a comprehensive impact assessment."
While recognising the importance of addressing medicines shortages, the patients' organisation added that any legislative initiative must be carefully designed to ensure it effectively tackles the issue and provides tangible benefits to patients.
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