Re: A licence to cure
The "licensing" process works quite well to protect patients from pharmaceutical companies promoting ineffective or unsafe products. This regulatory system is not intended to and nor should it, regulate clinical practice. In the UK the GMC has taken a position that uses the industry regulation system and applied it to clinical practice, thus discouraging if not essentially forbidding, clinicians from prescribing safe and effective products but for which the drug companies, for profit reasons, have not applied for a marketing authorisation. The regulatory system (the province of the MHRA and EMA) does not need changing for this purpose. It is the GMC that must first change, and then NICE (not bound in law to only recommend products in indications where there is a marketing authorisation- MA) can make untrammelled decisions on cost-effective products. It has had pressure to restrict advice to products with an MA but it does not need to do so. Change GMC advice first, then change NICE advice, based on good evidence. The sad thing is that the pharmaceutical industry continues to damage its public reputation by opposing this thinking.
Competing interests: I am a European Commission appointed Independent Expert Member of the Pharmacovigilance and Risk Assessment Committee at the European Medicines Agency which assesses safety of drugs and vaccines that are marketed in the EU.