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FEATURE: Andrew Jack Bitter pills BMJ 2007; 335: 1120-1121 [Full text]

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Hurrah - an anti-counterfeiting strategy

Jim Thomson   (8 December 2007)

Hurrah - an anti-counterfeiting strategy 8 December 2007
Jim Thomson, Chair, European Alliance for Access to Safe Medicines 26 Thames Drive SS9 2XD Send response to journal: Re: Hurrah - an anti-counterfeiting strategy	Andrew Jacks’ article in the BMJ (2007;335;1120-1121 BMJ) is extremely timely, as is the BMA’s increasing interest at Council level, in counterfeit medicines. It is abundantly clear that society will only defeat the scourge of fake medicines if all stakeholders become actively involved. Doctors and their representative bodies are key stakeholders and it is encouraging that the BMA has responded not just to recent increases in counterfeit incidents, but to the views (voiced in a recent MHRA- commissioned survey) of its members. Well done! However, there are a few issues in the article that, perhaps, merit further comment and clarification. First, whilst it is true that the MHRA conducts spot-checks, this has, in the last ten years or so, meant that an infinitesimal number of packs of medicine have actually been checked – some 0.000357%. Random testing is not the way to beat counterfeits. A strategic approach IS the way forward and the MHRA is to be applauded for launching its new anti- counterfeiting strategy. Turning to the FDA/IMPACT suggestion that 1% of medicines in the developed world may be counterfeit, it is all too easy to assume that 1% is a tiny percentage, as indeed it is. However, 1% of 700 million (the number of prescriptions filled in the UK last year) is more sobering. It equates to 7,000,000 prescriptions, and that means that there could be an awful lot of patients taking medicines that might be ineffective, dangerous or toxic. It would be interesting to see a projection of the likely healthcare costs of such an equation (something that is, of course, impossible, as we do not know where these fakes might be). The article also draws attention to the 1992 US legislation requiring medicines to have a pedigree. In a little over three weeks, the calendar will record yet another year passing without that legislation being implemented. This is a national disgrace for the USA, and successive Governments have failed patients in this regard. It is high time that any interests other than patient safety were put to one side. The Federal Government needs to follow the example of some of the more enlightened states. While it is entirely correct to say that currently available (and cost-effective) technologies offer only a partial solution, it is important that pharmaceutical companies continue to invest in new technologies that improve patient safety. However, any technology, new or current, is rendered totally useless by parallel traders when they repackage medicines for export around Europe. With this in mind, what is needed most is a low-cost mechanism that patients – the last barrier to harm and those with the greatest vested interest in their own care – can use to verify their medicines. Finally, the article offers the opinion that the internet is the real threat, which of course it is. However, it is entirely wrong to state in the context of parallel trade that “where it is legal and regulated, there is scant evidence that it has led to coun­terfeits entering the legitimate medicines sup­ply chain“. On the contrary, just this year, the MHRA (generally accepted as Europe’s most effective Regulator) issued four separate Class 1 Recalls of medicines that had entered the legitimate supply chain via parallel trade routes. 30,000 packs reached patients, and all contained sub-optimal levels of the API. They were not so-called “lifestyle” drugs, but were for the treatment of extremely serious conditions. On the 20th November this year, the European Alliance for Access to Safe Medicines (EAASM) presented to MEPs a report entitled “European Patient Safety and Parallel Pharmaceutical Trade – a potential public health disaster?”. The report, written by Dr Jonathan Harper, details exactly why parallel trade is NOT the highly regulated, safe and financially beneficial practise that it purports to be. It is a clear and present risk to every European patient. Unfortunately, we can no longer refer to it as a possible weak point in the supply chain because, earlier this year, 30,000 patients experienced that possibility becoming reality. Competing interests: None declared