Brussels, 3 April 2019: The European CanCer Organisation (ECCO), and partner organisations, today congratulated the European Parliament in securing important amendments to EU health and safety legislation to protect healthcare professionals in the cancer sector.
In reviewing a European Commission proposal for updating the Carcinogens and Mutagens Directive, the Parliament identified the need to improve protection for those healthcare professionals working regularly with cytotoxic and other hazardous medicines. Such treatments are associated with cancer care across Europe, and pose some potential safety risks to healthcare professionals if adequate risk control measures are not in place.
The Employment and Social Affairs Committee of the Parliament therefore consistently pressed for action on this matter. As a result of this pressure, amendments to the proposal have been secured that mandate the European Commission to conduct an evidence based review of the fitness for purpose of existing legislation and regulation in this area, and any potential need for new action at the European level. This new review will help to ensure that the highest standard of protection for healthcare professionals working with cytotoxic and other hazardous medicines, are in place in all European countries.
The Parliament’s position on the topic was informed by two years of representations by the European CanCer Organisation (ECCO), alongside ECCO members the European Society of Oncology Pharmacy (ESOP), the European Oncology Nursing Society (EONS) and the European Society for Paediatric Oncology (SIOP Europe). ECCO also worked in close collaboration with the European Association of Hospital Pharmacists (EAHP) and the Dutch Association of Hospital Pharmacists (NVZA) on this campaign.
Professor Klaus Meier, President of ESOP and Chair of the ECCO Oncopolicy Committee, said:
“This is EU democracy in action. The elected representatives in the European Parliament listened to the evidence provided to them by civil society groups and obtained new EU action on the pressing topic of cytotoxic safety.
It is also a demonstration of how important it is for different healthcare professionals to come together on matters of joint concern, which is at the heart of what we do at ECCO. We will now inform the forthcoming European Commission report on cytotoxic safety with the range of evidence we can present from our societies and members. Better education of healthcare professionals about cytotoxic safety, enforcement of good handling procedures, and stronger awareness within the health system about these matters, are all key to improving our management of the risks.”
Dr Lena Sharp, President of EONS, said:
"EONS will be working closely with ECCO, ESOP and others over the next months to raise with the Commission how best to protect healthcare professionals in respect to cytotoxic and hazardous medicines. This includes the importance of rigorously applied safety standards, and considering special measures that may be required for particular groups, such as individuals who are pregnant.”
NOTES TO EDITORS
1. Cytotoxic drugs are used widely in healthcare settings as well as in the community in the treatment of cancers as well as other diseases. Cytotoxic drugs (sometimes known as antineoplastics) describe a group of medicines that contain chemicals which are toxic to cells, preventing their replication or growth, and so are used to treat cancer. They can also be used to treat a number of other disorders such as rheumatoid arthritis and multiple sclerosis. Once inside the body, their action is not generally tightly targeted, and they can produce side effects both to the patients and others who become exposed. They are used in range of settings including; hospitals, specialist oncology units, hospices, care homes, charitable organisations, and domestic homes. They may also be used in veterinary clinics. Occupational exposure can occur when control measures are inadequate. Exposure may be through skin contact, skin absorption, inhalation of aerosols and drug particles, ingestion and needle stick injuries. Some more general information about CMD 3 here.
2. The Carcinogens and Mutagens Directive has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens or mutagens at work. The European Commission has been updating the Directive via a series of proposals over the past 3 years. Last week’s plenary session of the European Parliament voted on the 3rd updating proposal of the Commission (‘CMD 3’) at the conclusion of the European Parliament’s scrutiny process. More information about ‘CMD 3’ here.
3. An important amendment to ‘CMD 3’ secured by the European Parliament was to obtain a formal investigation by the European Commission into the suitability or otherwise of existing EU approaches in respect to protecting workers from cytotoxic and hazardous medicines safety risks. The relevant amendment states:
“Directive 2004/37/EC is amended as follows:
(1) In Article 18a, the following subparagraphs are added:
" No later than the end of the second quarter of 2020, the Commission shall, taking into account the latest developments in scientific knowledge, and after appropriate consultation, assess whether to amend this Directive to include hazardous drugs, including cytotoxic drugs, or to propose a more appropriate instrument for the purpose of ensuring occupational safety of workers from exposure to such drugs. On that basis, the Commission shall present, if appropriate, and after consulting management and labour, as well as health practitioners and health professionals, a legislative proposal."
A provisional agreement between the Parliament and representatives of national governments on this amendment was made in January, with last week’s plenary vote in Strasbourg formalising the accord. More information here.
4. A coalition of healthcare professionals led by the European CanCer Organisation (ECCO) and European Society of Oncology Pharmacy (ESOP) was formed to ensure not only attention to the matter of cytotoxic safety, but also to safeguard against any potential mandatory measures not informed by healthcare professional experience and evidence. Organisations involved in the coalition are:
a. The European CanCer Organisation (ECCO) www.ecco-org.eu
b. The European Society of Oncology Pharmacy (ESOP) http://esop.li
c. The European Oncology Nursing Society (EONS) www.cancernurse.eu
d. The European Society for Paediatric Oncology (SIOP Europe) www.siope.eu
e. The European Association of Hospital Pharmacy (EAHP) www.eahp.eu
f. The Dutch Association of Hospital Pharmacists (NVZA) https://nvza.nl
More information here.
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5. To arrange discussion with Professor Klaus Meier, lead representative of the coalition, or any other member organisation described, please contact Richard.Price@ecco-org.eu (+32 2 775 02 02) in the first instance.