On Wednesday 3 December, the European Biosafety Network (EBN) presented to the European Parliament’s Committee on Employment and Social Affairs (EMPL) on the implementation gap in protecting healthcare workers from hazardous medicinal products (HMPs). 

Josh Cobb, Secretary of the EBN, addressed the Committee during a public hearing on health and safety measures for workers in high-risk professions. The hearing brought together experts and stakeholders to examine emerging risks and preventive measures across various sectors. The full session can be found here, with the EBN presentation beginning at 10.14 : https://multimedia.europarl.europa.eu/en/webstreaming/committee-on-employment-and-social-affairs-ordinary-meeting_20251203-0900-COMMITTEE-EMPL

The Implementation Challenge 

Mr Cobb highlighted the disconnect between existing EU legal requirements and workplace realities. Whilst the Carcinogens, Mutagens and Reprotoxic Substances Directive (CMRD 2022) provides a reasonably robust framework, the reality on the ground is that implementation across Member States remains inadequate.  

Many healthcare workers are unaware that the medicines they prepare and administer are hazardous to their own health, or that EU law has been updated to require their employers to protect them from occupational exposure. 

Since March 2022, all medicinal products containing Category 1A or 1B carcinogenic, mutagenic, or reprotoxic substances have been formally included within the scope of the CMRD. From 5 April 2024, these substances must be manufactured and used in closed systems where substitution is not possible. 

The European Commission estimates approximately 1.8 million workers are exposed to HMPs in the EU. The European Trade Union Institute suggests this figure may reach 12.7 million when ancillary staff and indirect exposures are included. 

Parliamentary Response 

Nikola Bartušek MEP from the Patriots for Europe group raised questions about strengthening worker protection through mandatory closed systems and supporting safe staffing levels to ensure full compliance with safety protocols. Johan Danielsson MEP from the Progressive Alliance of Socialists and Democrats enquired whether including a definition of HMPs in the current CMRD revision would be sufficient, or whether additional legislative measures were needed to mandate closed systems. 

In his response, Mr Cobb emphasised that safe exposure thresholds for these substances cannot be determined and that working towards zero exposure was the only appropriate goal. He stressed the importance of enforcement mechanisms for closed systems implementation, enhanced testing and reporting, including biological monitoring, and proper risk assessments in healthcare settings. 

Jan Goudriaan, General Secretary of the European Federation of Public Service Unions (EPSU), echoed concerns about implementation, noting the need for strengthened legislation on psychosocial risks, heat exposure, and third-party violence. He emphasised Parliament’s role in ensuring the Commission follows through on guidelines and enforcement. 

Next Steps 

The EBN is calling for: 

  • The explicit inclusion of a definition of hazardous medicinal products in the recast of the CMRD; 
  • stronger enforcement mechanisms for current CMRD provisions; 
  • Inclusion of mandatory exposure risk assessments for oncology settings;  
  • and mandatory training for any healthcare workers handling HMPs.  

Mr Cobb emphasised that whilst the regulations are strong and the science is clear, the challenge lies in implementation, education, and awareness. 

The hearing contributed to the Committee’s ongoing work on occupational health and safety, including preparation for a planned initiative report on the effects of extreme temperatures in the workplace.