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Amendments to CMD3 and implications

The European Parliament unanimously approved amendments to Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work on 19 February 2019 and these changes, requiring the Commission to consult and do the necessary scientific work to justify the inclusion of hazardous drugs, are expected to be formally approved by the European Council in March or April without further changes.

The amendments to the CMD in this third batch confirm that hazardous drugs, including cytotoxic drugs that are primarily used for cancer treatment, could have genotoxic, carcinogenic or mutagenic properties and it is therefore important to protect workers exposed to such drugs resulting from the preparation, administration or disposal of hazardous drugs, including cytotoxic drugs, or from work involving services related to cleaning, transport, laundry or waste disposal of (materials contaminated by) hazardous drugs, or personal care for patients treated with hazardous drugs.  The amendments further confirm that the Commission shall, taking into account the latest developments in scientific knowledge and after appropriate consultation, assess whether to amend the Directive to include a list of hazardous drugs, including cytotoxic drugs, no later than the end of the second quarter of 2020.

The European Biosafety Network (EBN) is confident that the scientific evidence and consultation with employers, workers and healthcare professionals over the course of the next year will justify and confirm the European Commission’s anticipated action to include a list of hazardous drugs when it publishes its report and legislative proposal for the fourth batch of amendments to the CMD in 2020.  The EBN expects that a limited number of individual hazardous drugs, including cytotoxic drugs, will be put forward by the Commission and the Parliament for inclusion in the CMD. 

Thus, the Member States and healthcare system in Europe need to be prepared to transpose and meet the new requirements of the CMD in relation to how they manage these hazardous drugs now and in the future.