Reform of regulatory regimes will be the hallmark of 2012, as policy makers res-pond to health crises. Dr Josephine Perry's interview shows how leading organisations such as Nuffield are already positioning themselves in this vital debate. What's crucial is understanding the global context.
The PiP breast implant scandal will colour the European-level regulation of medical devices due this year. It has thrown into relief some processes that public opinion will not tolerate.
First, having a single CE (European compliance marking) system for everything from soft toys, to cigarette lighters, to devices planted into the body now seems untenable.
Second, the mutual recognition of another European regulator's inspection regime has been challenged - in particular, it was the German regulator who failed to uncover the problems at the PiP plant in France. A more nationalistic response by member states, especially if this becomes an issue in the French Presidential election, could impose different conditions in different countries.
At Westminster, Earl Howe's rapid review of the Department of Health's and the MHRA's response to PiP is due to report within the month to enable the UK to provide policy input to the European debate.
His review is likely to reveal how limited data keeping is on implants when compared to drugs. Expect comment on previous voluntary registry regimes that have failed through lack of compliance. Compulsion looms. A case will also be put for re-regulation of potentially the next scandal, lasers and fillers - Botox parties and the like.
Sir Bruce Keogh's separate review of the cosmetic surgery industry running to 2013 will also set the landscape for this market. Here policy ideas such as an ABTA-style compulsory insurance for those undergoing cosmetic surgery in the UK will be tested. We may see the introduction of a UK- recognised training and regulatory regime for plastic surgeons, within a fully accredited professional body. The role of NHS GPs and their referral practice, compared with other forms of advertising, may come to the fore.
The experience of the US may be instructive. There, a 14-year ban on silicone implants only ended in 2006 with a restriction to those aged under 21 and a commitment by providers to a ten-year follow-up study. However, it has proved difficult to track patients, so a different enforcement protocol may be developed here that could affect both manufacturers and providers.
All three UK reviews are likely to be uncomfortable for the MHRA. When it comes to having to trust their regulatory colleagues in other European jurisdictions, they may be the local fall guy. British politicians have been frustrated by the slowness of the MHRA and the lack of evidence available on which to make decisions; this frustration may lead to formal reform.
True insight here needs recognition of both the globalisation of the cosmetic surgery industry and the power of social media. Facebook groups of cosmetic surgery users are alive to debates about the relative risks and benefits of various breast implants. Those approved by the American FDA, which is perceived as tough, are favoured.
At the same time the costs and risks of going abroad to less regulated countries is a topic of discussion. An effective European policy for both governments and responsible cosmetic providers needs to factor in the rise of 'beauty breaks' and 'new look holidays', the surgical parts of which are not, and will not be, covered by ABTA's, or any potential future, insurance.
Views in brief
What must you consider when devising a strategy to communicate risk?
Sensible reporting on risk in the traditional media is rare, as their inherent tendency is to report something as either 100 per cent safe or 100 per cent dangerous. Patients are sometimes willing to accept significant risk if it is presented in an open and engaging way. Here social media win hands down.
On which healthcare comms project are you most proud of working?
Developing front of packet traffic light food labelling proposals at the Department of Health in 2004. Helping consumers get simple information to make healthier choices, without waiting for European agreement, and in partnership with many in the food industry was worthwhile and rewarding.