Sunday, 15 January 2012

EU rules prevented checks for faulty implants

EU rules prevented checks for faulty implants

Britain's Medicines and Healthcare products Regulatory Agency (MHRA), in some circumstances, is prevented by legislation from carrying out full checks on medical products, including PIP breast implants. UKIP's Chairman in Scotland, Mike Scott-Hayward, is quoting work done by UKIP MEP Paul Nuttall.

"Paul has found that under EU law, national regulatory authorities can grant their own companies and products a CE (European Conformity) mark, which provides a guarantee of quality. EU law then forbids other national regulatory authorities, from conducting further checks.

"Apparently, in the case of the PIP implants, the French authorities granted the appropriate status. MHRA was obliged to permit the import and marketing of the implants as they bore the CE mark, and could not carry out their own checks.

"French Authorities did finally shut down PIP, but not before 40,000 British women had been fitted with these faulty implants. The MHRA is forced, under EU law, to permit the import and marketing of any device which bears a CE mark, even though it has no direct jurisdiction over the manufacturer.

Mr Nuttall said: "The blame is not with the clinics, nor is it with the British regulators - the Medicines and Healthcare products Regulatory Agency (MHRA). The real responsibility lies in a combination of regulatory failure in France, and then EU laws that prevent British authorities from protecting British consumers."

Mr Nuttall added: "I am writing to the European Commission to demand that in the future British authorities be allowed to make quality control border and spot checks on imported CE marked products, in order that they can in future do their job and protect the interests of British consumers." He is also calling on the Government to require the French authorities to provide compensation that will allow private clinics to remove and replace implants without being driven to bankruptcy through no fault of their own.

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