Steve Bates is a director in APCO’s health care practice and is based in our London office. This piece originally appeared in PR Week.
Compulsion looms in response to health crises arising from voluntary surgical procedures.
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…
Read the full post in PRWeek’s healthcare supplement, March 2012.