Hazardous medicinal products (HMPs)—including many anti-cancer agents, antivirals, and immunosuppressants—are integral to treating serious diseases but can also pose risks to healthcare professionals. These drugs can cause cancer or reproductive disorders in exposed workers, underlining the urgent need for effective safeguards.
To address these concerns, the European Commission recently issued a communication with an indicative list of HMPs classified as carcinogenic, mutagenic, or reprotoxic substances (CMRs). This official list follows the groundwork undertaken by the European Trade Union Institute (ETUI) in 2022, whose review highlighted HMPs already covered under the Carcinogens, Mutagens and Reprotoxic Substances Directive (CMRD) since its fourth revision.
By 5 April 2024, all EU Member States had to transpose into national law the CMRD’s legal requirements—now explicitly extended to include HMPs. Under this framework, employers and workers in the healthcare sector are expected to:
- Increase awareness of how specific HMPs can endanger health.
- Conduct thorough risk assessments and put in place suitable prevention and protection measures.
- Follow the hierarchy of controls (avoid or replace hazardous substances if possible; otherwise, implement closed systems and the highest feasible engineering controls).
In tandem with the new indicative list of HMPs, these obligations are designed to foster far better identification of hazardous drugs and significantly reduce occupational exposures.
Crucially, Annex 1 of the European Commission’s list mirrors Annex I of the list compiled by the ETUI—238 groups or individual substances are included, based on the latest scientific evidence. For more than a decade, scientific studies have repeatedly demonstrated that healthcare personnel face increased risks when handling cytotoxic drugs:
- Hospital workers who handle cytotoxic agents can be three times more likely to develop malignancies.
- Nurses exposed to cytotoxic drugs face twice the risk of miscarriage compared to workers in other sectors.
Healthcare facilities therefore need to systematically identify and manage any hazardous medicinal products used in day-to-day care.
According to the Commission, around 12.7 million healthcare workers in the EU (including 7.3 million nurses) should benefit from the new European guidance and better protections. The overarching goal is to eliminate or minimize workplace contamination and associated health risks.
By calling on national legislators to implement the CMRD without delay and adopt the Commission’s updated list of hazardous medicinal products:
- Healthcare employers will be able to perform more accurate risk assessments.
- Workers will be better informed on how to handle hazardous drugs.
- Preventive measures—such as closed-system transfer devices (CSTDs), biological safety cabinets, and protective equipment—can be used more consistently.
The European Biosafety Network (EBN) urges every EU Member State to swiftly transpose the CMRD’s requirements into local legislation, ensuring that all healthcare workers receive the training and protection they need when handling hazardous medicinal products. The recently published list of HMPs must be leveraged to enhance safety policies in hospitals, pharmacies, care homes, and all other environments where healthcare staff come into contact with these drugs.
Through these combined efforts—legislative action, EU-wide cooperation, and ongoing awareness-raising—Europe can safeguard the millions of healthcare professionals who dedicate themselves to patient care, while reinforcing safe handling practices for the next generation of life-saving treatments.
