It 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 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 don’t bear thinking about.
Why is it that we put off resolving 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 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 Prothèse (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 PIP’s handling of adverse incidents to TÜV Rheinland, the German notified body which had responsibility for assessing PIP.
A review of the MHRA’s 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 reaction of MHRA chief executive Professor Sir Kent Woods, who vowed ‘to act quickly to implement the recommendations and use the lessons learned to improve the regulatory system for medical devices in the UK and Europe’.
A second, more in-depth review of cosmetic surgery regulation in the UK is being authored by NHS medical director Professor Sir Bruce Keogh, and is targeted for release in March 2013. It will look at whether the cosmetic surgery industry needs to be more effectively regulated.
No direct blame has been attributed to the MHRA, which was found to its job, but could these two studies have been commission before the crisis — which had been brewing for a number of years — reached its peak? Possibly, but the conclusions might have been weak, reached with little conviction or subsequently insufficiently followed through. In contrast, certain reactions since the crisis have been strong and decisive.
In Germany, for instance, the authorities have recently been given greater powers to police manufacturers, including the ability to make unannounced visits to manufacturers’ premises. On 30 March 2012, the German upper house passed the Allgemeine Verwaltungsvorschrift zur Durchführung des Medizinproduktegesetzes (MPGVwV), a law that allows the authorities to intervene in cases of suspected medical device fraud, for instance. The law will come into force on 1 January 2013.
Tighter controls needed
Notified bodies (NBs) have been criticised as being too variable in their performance, generally, and too numerous. Improved surveillance of device product safety will be taken up in the forthcoming EU medical devices directives review, due in autumn 2012, which is likely to introduce comprehensive supervision of NBs, often in the past identified as the ‘weak link’ in the EU’s ‘new approach’ to medical device legislation.
Many feel that in order to retain the largely successful ‘non-prescriptive’ risk‑based system of medical device (and breast implant) regulation, NBs must be seen to be more tightly controlled.
In France, where the PIP scandal originated, support for the EU medical device directives remains strong, even though in January 2012 the then health minister, Xavier Bertrand, spoke in favour of a pre-market authorisation (AMM) for implants. The Mediator scandal in 2011, when insufficient oversight of off-label use of the Servier drug as an appetite suppressant led to hundreds of deaths from heart valve insufficiency, saw the regulatory agency, Afssaps, reformed and renamed (as ANSM).
But an AMM for implants — as proposed by the European Parliament’s Committee on Environment, Public Health, and Food Safety (ENVI), and endorsed by the European Parliament (EP) on 13 June, for all high-risk (class III) devices — would not have prevented the PIP scandal, as the manufacturer was knowingly contravening the rules.
Hence the belief among device users themselves that the best means of regulation for implants and, more widely, devices, in the EU remains the system in place at present, as strengthened by new legal instruments (Regulations rather than Directives) and, as the icing on the cake, a new standard covering cosmetic surgery services, known as CEN/TC403 (Aesthetic Surgery Services Standard), under the European Committee for Standardisation (CEN).
The proposal from the Austrian Standards Institute (ASI) to create a project committee on aesthetic surgery services targets the development of an EU-wide standard for aesthetic surgery services. In the UK, BAAPS (the British Association of Aesthetic Plastic Surgery), the CQC (Care Quality Commission), the Royal College of Ophthalmologists, and the British Association of Oral and Maxillofacial Surgeons are among those involved in this standard-setting process.