The existing Carcinogens and Mutagens (CMD) Directive 2004/37/EC) sets general minimum requirements to eliminate or reduce exposure to the chemical agents falling within its scope. It establishes occupational exposure limit values (OELs) for certain carcinogens and mutagens with a view to protecting workers. Employers must identify and assess exposure-associated risks for workers; where risk occurs, exposure must be prevented.
The European Commission is gradually amending and updating the Directive by expanding its scope and by including and/or revising occupational exposure limit values for a number of cancer- or mutation-causing substances. The initiative is proceeding in steps. The first proposal of May 2016 covered 13 priority chemical agents, the second, of January 2017, a further seven.
The European Parliament, the European Council and the European Commission have reached a provisional agreement on the Commission's third proposal to broaden the list of recognised cancer-causing chemicals in the workplace. The current (third) proposal covers an additional five substances, including formaldehyde which is widely used in the healthcare sector.
After final ratification, Member States will have five years to comply with the new exposure limits for formaldehyde.
Most importantly, the Commission proposes to assess, by mid-2020, the possibility of extending the scope of the CMD to a list of hazardous medicines, including cytotoxic drugs widely used in cancer care.
This assessment will be highly relevant to the NHS. Cytotoxic medicines are primarily used in the treatment of cancer and can pose risks to those preparing, administering or disposing of the substance, as well as people coming into contact with materials such as laundry or waste that could be contaminated.
In England, the Health and Safety Executive (HSE) has issued guidance recently (November 2019) ) on handling cytotoxics. Any forthcoming European legislation will not apply in the UK now that the UK is no longer an EU member state, though inevitably practice “norms” across Europe will influence practice in the UK even after we have left the EU.
EU study looking at further action to protect workers from exposure to hazardous medicines
According to the new Directive: “No later than 30 June 2020 the Commission shall, taking into account the latest developments in scientific knowledge, and after appropriate consultation with relevant stakeholders, in particular health practitioners and health professionals, assess the option of amending this Directive in order to include hazardous drugs, including cytotoxic drugs, or to propose a more appropriate instrument for the purpose of ensuring the occupational safety of workers exposed to such drugs. On that basis, the Commission shall present, if appropriate, and after consulting management and labour, a legislative proposal.” The text adds that “In doing so, access to the best available treatments for patients should not be jeopardised”.
The Commission has commissioned a consultancy (COWI) to conduct a wide-ranging study looking at current practice across the EU and assessing future options, including the possibility of new legislation to include cytotoxic medicines in the scope of existing EU legislation. This would entail stricter rules and inspection than at present.
About the study and definitions used: the study commissioned by the Directorate-General for Employment and Social Affairs is intended to provide the most recent, updated and robust information on hazardous medicinal products (referred to as HMPs), including cytotoxic medicinal products, to identify the risks to workers' health that arise from exposure to such medicinal products at the workplace. Furthermore, the study is intended to explore and analyse the best ways to address such risks, including possible amendments to the EU legal basis.
The Commission is consulting social partners (including HOSPEEM and CEEP, of which the NHS European Office is a member) before considering whether to present a legislative proposal, which provides the opportunity for the NHS European Office to feed in to and shape the consultation response.