A fourth case of counterfeit medicine - a second batch of Sanofi-Aventis and Bristol-Myers Squibb’s Plavix - has been identified in the UK supply chain, fuelling concern over the safety of parallel imports.
The Medicines and Healthcare products Regulatory Agency is recalling any parallel- distributed stock of Plavix (clopidogrel) 75mg film coated tablets, 3103/1 to 3103/20 inclusive, following the discovery of counterfeit versions in the supply chain.
Batch 3103 is a genuine sanofi-aventis and Bristol-Myers Squibb batch number, for which the original unchanged cartons were supplied to France in French livery, the Agency said, adding that stock not parallel distributed and in UK-branded livery has not been affected.
This is the fourth such incident in under two weeks, and follows fake, parallel-imported versions of AstraZeneca's prostate cancer treatment Casodex (bicalutamide), Eli Lilly's antipsychotic Zyprexa (olanzapine) and another batch of Sanofi-Aventis and Bristol-Myers Squibb's clotbuster Plavix (clopidogrel), setting off alarm bells across the whole of Europe.
But an MHRA spokesman told PharmaTimes that it’s important to look at the overall context with regard to the amount of counterfeit drugs penetrating the legitimate supply chain. “There’s no real evidence to suggest it’s being flooded with fake drugs.” And, although he could not be more specific because of the sensitive nature of the information, he said a couple of the cases may be linked and possibly stem from the same source.
The movement of medicines around Europe through parallel-importing has long been practised, but many believe that the legal requirement of re-labelling the product in the local language creates a weak point in the supply chain at which counterfeits could be injected.
The MHRA has, to date, always maintained that it is “statistically incorrect” to say that parallel imports have increased the chances of fake drugs entering the supply chain, but the facts would seem to suggest otherwise, says the UK’s Centre for Mental Health.
“The time has come for the MHRA to stop defending the indefensible, and to start regulating the medicines supply chain. If it can’t protect patients given the present trading environment, then the MHRA has a duty of care to rationalise that environment so that that it can protect patients,” said Jim Thomson, Chief Executive of The Centre for Mental Health and European Liaison, The Partnership for Safe Medicines. “These recent events clearly show that parallel imports present a way for fake life-saving medicines reaching UK patients with the obvious risks and consequences for life-threatening conditions,” he added.
In response, the MHRA spokesman told PharmaTimes that, previously, there was no concrete evidence to suggest that parallel importing increased the change of counterfeit penetration of the supply chain. However, given this latest batch of breaches, “this is an area we are going to be looking into, we are not going to be complacent,” he assured.
More than 500,000 counterfeit medicines were seized at Europe's borders in 2005, twice the rate of 2004.