The borderline between different classes of products has always been a contentious area but arguably in the past it was relatively simple. Twenty years ago the main areas of difficulty were between medical devices and pharmaceutical products, and between food supplements, herbal medicines and pharmaceuticals. These borderlines remain but the advance of technology has brought into play a range of other critical interfaces. We now have nutriceuticals, cosmoceuticals and recently another term of electroceuticals. The latter is an interesting area where molecules are being developed that will modify electro transmission circuits and/or can be used with mechanical electro stimulation applied either externally or locally to induce physiological changes. The world is indeed becoming complex.
The definitions of a medical device and of a pharmaceutical appeared clear and robust. However, as time has passed, we have come to understand much more about mechanisms of action. This means that what was once simple is no longer so simple. Some compounds which appear to act chemically may indeed act physically. Similarly, some apparent physical effects are really brought about by release of chemical mediators etc. Does this matter? The answer is most definitely “Yes”, because there are very different controls for medicines devices with implications on the cost of developing the product, of establishing an authorisation dossier, reimbursement policies and on subsequent maintenance of the licence. Indeed, some of these disputes have found their way to the Courts and to the European Court of Justice.
The borderline between cosmetics and pharmaceuticals is also controversial with some products having claims very close to medicinal ones, whilst other products are seeking to take themselves out of the more rigorous medicines controls. Similarly, the borderline between foods can have enormous economic consequences. Under the proposed Medical Device Regulation there will be enhanced procedures for giving early advice on the borderline and for making public decisions. As our understanding and science advances a range of new opportunities are being opened up which are increasingly challenging the neat compartments of the present legislation. Increasingly these topics are being discussed in MF meetings and will be the subject of specific future conferences and workshops. This is a topic which will not go away.
Seminars which may be of interest:
The Borderlines Between Medicines and Food – Please click here for more information.
The EU Cosmetics Regulation (EC) No 1223/2009 of the European Parliament and of the Council of November 2009 - Please click here for more information.
Drug/Device and Device/Drug Combinations – to be held on 28 Nov 2013. Further details to follow.
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