The Alliance joined with other UK charities and the European organsiation Health Care Without Harm in writing a letter to the Secretary of State for Environment, Food and Rural Affairs, Elizabeth Truss MP.
The letter outlines concerns about the discussions on the proposed Medical Devices Regulation in successive meetings of the Council Working Party on Pharmaceuticals and Medical Devices. The discussions seek to reach agreement between the position of the Council and the European Parliament (EP) with a view to reaching an agreement by 30th June, still under the auspices of the Dutch Presidency.
One of the outstanding issues, where an agreement must be reached with the EP, appears to be the provision on the phasing-out of Carcinogenic, Mutagenic and Reprotoxic substances (CMRs) and Endocrine Disrupting Chemicals (EDCs) contained in medical devices. The letter draws attention to the amendment 355 to the proposed Medical Devices Regulation that was adopted by the European Parliament in April 2014. This amendment seeks to phase out CMRs and EDCs contained in medical devices when safer alternatives are available, technically feasible, and do not compromise the safety of patients. As you know, there is a growing scientific consensus about the harmful effects of these hazardous chemicals on human health.
To us, the proposed amendment has a clear merit: it meets the substitution objectives of REACH in ensuring that toxic substances are replaced by safer alternatives. It additionally provides for a derogation period that would allow the medical device industry to substitute CMRs and EDCs with safer alternatives. The groups want to join with HCWH in reiterating the call to the Council in particular to rise to the occasion in reaching an agreement that complies with the objectives of REACH, thus ensuring that in the future toxic substances are indeed replaced by safer alternatives.
It is worth pointing out that DEHP, an EDC, will be phased out under REACH and it would therefore seem inconsistent and confusing to allow continued exposure to DEHP through medical devices.
The letter can be seen here.
A recent report from HCWH on Non-Toxic Healthcare and alternatives to the EDCs Phthalates and Bisphenol A used in certain medical devices can be accessed here.
The full Healt Care Without Hram infogram can be viewed here.