ANALYSIS | REGULATORY STANDARDS | EXPERIENCE:


LEARNING FROM


EUROPE PUTS ITS HOUSE IN ORDER


Crisis management it may be, but the EU is working hard in the wake of the PIP scandal to get its house in order as far as cosmetic surgery


regulation and standard-setting are concerned. Opinion is divided as to the best course to take, but the consensus now is that the opportunity to establish a regulatory basis must not be missed. Ashley Yeo reports


ASHLEY YEO, Principal Analyst, Informa Business Information


email ashley.yeo@ informa.com


at hand is dispensed in efforts to reach ® quickly ® the solution that should have been broached some considerable time earlier. In the regulatory arena, the consequences donÕ t bear thinking about. Why is it that we put off resolving


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potentially serious issues? Too much to do? Possibly. But more likely in many cases, it is the thought of endless time spent in meetings explaining, revising, reworking, proposing and debating solutions to fellow delegates who may neither share the sense of urgency nor rate the solutions on offer. There is nothing like a crisis to focus the


mind and hone the debating skills. Crises, of course, often result from collateral damage, or worse, in which case the appointed decision-makers have only


July/August 2012 | prime-journal.com


T IS OFTEN HUMAN NATURE to avoid addressing a looming problem until it is almost too late. Sometimes it actually is too late, by which time the dignified approach to sorting out the issue


one choice as to how to allocate their time. And the issue, finally, is dealt with. Human nature.


Learning from experience In the case of the EU scandal over the manufacture of fraudulent breast implants by French company Poly Implant Proth’ se (PIP), now being dealt with by the law, matters did not quite add up as far as the UK Medicines and Healthcare products Regulatory Agency (MHRA) was concerned, when, in 2007, the agency referred concerns about PIPÕs handling of adverse incidents to TÜV Rheinland, the German notified body which had responsibility for assessing PIP. A review of the MHRAÕs handling of the


issue ordered by junior UK Health Minister Lord Howe, and issued in May 2012, largely cleared the agency (regarding any role it may have had in protecting UK health in the PIP episode) of any blame. Certain areas could be tightened, however, and that was the measured


Crises often


result from collateral damage, or worse, in which case the appointed decision-makers have only one choice as to how to allocate their time.


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