The brochure, titled Amendments to the Carcinogens and Mutagens Directive on hazardous drugs and implications for change to the healthcare system in Europe to ensure compliance with its requirements, was initially published in English, but has now been translated into Spanish, Dutch, French, Italian, Portuguese, Polish and German. The brochure can be accessed at the bottom of this article, or via the resources page.
It covers the recent amendments to the Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work, which were were unanimously approved by the European Parliament in Plenary on 27 March 2019. 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 April without further changes.
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.
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.
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.Amendments and Implications of CMD3 – English Amendments and Implications of CMD3 – Spanish Amendments and Implications of CMD3 – French Amendments and Implications of CMD3 – Italian Amendments and Implications of CMD3 – Polish Amendments and Implications of CMD3 – Dutch Amendments and Implications of CMD3 – German Amendments and Implications of CMD3 – Portuguese