On 28 May 2025, in collaboration with the European Biosafety Network, SANT Committee Group Coordinator Margarita de la Pisa Carrión MEP submitted a Written Question to the Commission. You can find the full text of the question here.
The text of the question highlighted continuing gaps in training, personal protective equipment and risk-assessment protocols, despite new legal requirements introduced in 2024, and asked what further guidance would be provided.
The question reflected concerns previously raised by the EBN in its engagement with policymakers.
On July 10, the European Commission published its reply to a written parliamentary question on the protection of healthcare workers who handle hazardous medicinal products (HMPs). You can find the full text of the response here.
What does the Commission say?
- Legal framework: The Commission underlines that Directive 2004/37/EC already obliges employers to assess and minimise exposure to carcinogenic, mutagenic and reprotoxic (CMR) substances, a category that includes HMPs.
- Support tools: The Commission pointed to two non-binding instruments:
- an indicative EU list of HMPs published in February 2025; and
- the 2023 Guidance for the safe management of HMPs at work. The guidance covers “risk assessment, training, personal protective equipment and the use of closed systems” throughout the HMP life-cycle.
- Assessment of adequacy: The Commission stated that these initiatives “help prevent and control risks from occupational exposure to HMPs, especially in the healthcare sector”. It did not announce additional binding measures at this stage.
EBN view
EBN welcomes the Commission’s clarification of employers’ obligations and the practical emphasis in the 2023 guidance. The explicit reference to closed systems reinforces their recognised role in the hierarchy of controls and will inform EBN’s ongoing work with Members of the European Parliament and other stakeholders as new reports and recommendations are drafted.
