European Biosafety Network

The European Biosafety Network (EBN) and the European Federation of Nurses Associations (EFN) welcome the work of the European Parliament’s EMPL and SANT committees on the own initiative report “An EU health workforce crisis plan: sustainability of healthcare systems and employment and working conditions in the healthcare sector”.

The EU has an estimated shortage of 1.2 million healthcare professionals, which not only threatens patients’ safety but also the safety of frontline healthcare professionals and the resilience of health systems across the EU.

The lack of safe staffing levels across all healthcare settings, coupled with inadequate safety measures, especially in oncology settings, has resulted in nurses and other professionals being exposed to hazardous medicinal products (HMPs) – medicinal products that can cause serious long-term health effects, such as miscarriages, cancer, and other serious health problems. Consequently, many professionals are leaving the sector.

All EU member states were required to bring into force the laws, regulations and administrative provisions necessary to comply with the Carcinogens, Mutagens or Reprotoxic substances Directive (CMRD 2022) by April 2024. The specific legal articles and prevention measures contained in the CMRD replicate the universal hierarchy of controls and must now be applied by employers to all category 1A or 1B CMR HMPs.

Legally, this meant that now, following a risk assessment, HMPs – which cannot usually be eliminated, replaced or substituted because of their vital therapeutic use for human health – must be manufactured and used in a closed system.

Despite the 5 April 2024 transposition deadline for the CMRD 2022, implementation is weak or non-existent in many Member States. Healthcare professionals across Europe are still being exposed to HMPs, negatively affecting the retention and sustainability of healthcare systems. Healthcare employers must do more to ensure safer working conditions and reduce occupational exposure to HMPs.

EBN and EFN, therefore, urge MEPs to integrate the following recommendations into the INI report:

  1. Legislate safe staffing levels: Staff shortages are an Occupational Health and Safety (OHS) Hazard, as the lack of safe staffing levels increases the rate of errors, including accidents, spillages, and mishandling – leading to increased exposure to HMPs. As such, in line with the competences grounded in Article 153 of the Treaty on the Functioning of the European Union, the European Commission should develop EU framework legislation on Safe Staffing Levels, with stipulated nurse-to-patient ratios. This will enable nurses and allied healthcare professionals to follow safety protocols (use of closed systems, donning personal protective equipment, safe waste disposal) and to attend the training necessary to remain up-to-date with the latest safety protocols.
  2. Recognise the implementation gap: Despite transposition of the CMRD into national law, hospitals across the EU and Europe are still not using fully closed systems when handling HMPs, and training and awareness levels remain low. The INI report must acknowledge this gap and call for swift enforcement of the CMRD. Strong implementation of the CMRD, together with implementing safe staffing levels, will ensure frontline nurses are protected not only from HMPs, but also from other occupational hazards such as needlestick injuries, improving retention rates significantly.
  3. Mandate the use of closed systems, including closed system transfer devices (CSTDs): The CMRD 2022 requires the use of closed systems as the primary engineering control to prevent exposure, which in practicality means the use of biological safety cabinets, containment isolators and CSTDs. The EBN and EFN call for the explicit inclusion of closed systems, including CSTDs, as well as clear timelines and enforcement strategies, to ensure that all healthcare facilities adopt closed systems for the preparation and administration of HMPs quickly.
  4. Training, monitoring and surveillance: Employers must provide regular, paid, in-service training on safe handling of HMPs, conduct risk assessments and monitor exposure (both surface contamination and biological monitoring). The INI report should recommend EU-level guidelines and require Member States to report on implementation. Furthermore, by calling for the implementation of mandated nurse-to-patient ratios, the INI Report can ensure stronger employers’ accountability when accidents, spillages, and mishandling are the result of the lack of safe staffing levels.
  5. Collect and share up-to-date data: Comprehensive data on staffing levels, exposure incidents, and their impact on workforce attrition and retention should be collected and shared to inform evidence-based policies.

Safe staffing levels and the prevention of exposure to HMPs are inextricably linked: protecting nurses and healthcare professionals from harm is essential to retaining them, and adequate staffing is essential to carrying out safety protocols. Therefore, without decisive action to implement the CMRD Directive and to implement safe staffing levels with stipulated nurse-to-patient ratios, the EU’s health workforce crisis will continue to spiral, with devastating consequences for patients and professionals.  Importantly, EU legislation on Safe Staffing Levels should not lead to establishing unified safe staffing levels on the EU level but to developing and implementing national safe staffing levels taking into account different regulations and experiences of Member States.

The EBN and the EFN stand ready to collaborate with the European Parliament, the Commission and Member States to ensure that the final INI report leads to concrete, enforceable measures that protect healthcare professionals, improve patient care and build resilient, sustainable health systems for all EU citizens.

The European Biosafety Network (EBN) is a pan-European coalition founded in 2010 to improve biological, occupational and patient safety in healthcare. Working with governments, EU institutions, professional bodies and unions, EBN drives policy change, publishes guidance and hosts high-level events to protect healthcare workers and patients from risks such as sharps injuries and hazardous medicinal products.

The European Federation of Nurses Associations (EFN) was established in 1971. The EFN represents over 36 National Nurses Associations, and its work has an effect on the daily work of 3 million nurses throughout the European Union and 6 million in Europe. The EFN is the independent voice of the nursing profession, and its mission is to strengthen the status and practice of the profession of nursing for the benefit of the health of the citizens and the interests of nurses in the EU and Europe.