Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-13-Speech-3-610-000"
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"en.20120613.33.3-610-000"2
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"Madam President, six months after the PIP breast implant scandal hit the headlines, the European Parliament is finally getting round to addressing this appalling case of medical malpractice.
It is staggering to comprehend how PIP, once the world’s third largest supplier of breast implants, could disregard the law for almost ten years.
It is important we learn from public health incidents such as this. However, it is also vital that we examine all the facts before drawing conclusions on how a system might need to change to prevent such malpractice happening again.
In addition, we must stress that the PIP scandal does not illustrate a failure of the current compliance system. This was a criminal offence that involved manufacturers placing a substandard product on the market.
Although the committee resolution contains plenty of positive measures that will improve the regulatory framework for medical devices, the text also includes demands for a pre-market authorisation. This duplicates existing laws and standards and is needlessly disproportionate in my view.
Paragraph 22, for example, tabled by the Greens, calls for toxicology assessments on all medical devices. Do we really think that by nitpicking over the toxicity of everything, from elastic bandages to pacemakers, people will stop breaking the law?
Care should always be taken not to use a sledgehammer to crack a nut and I caution against knee-jerking responses that could fundamentally alter a regulatory system that has been protecting patients for more than 20 years.
My group has therefore tabled an amendment and several requests for split and separate votes, in the hope that we can iron out these inconsistencies."@en1
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