With the growing threat of counterfeit, adulterated and diverted medicines, parallel pharmaceutical trade (PPT) represents “a clear and present danger to the safety of every European patient,” warns a report presented to Members of the European Parliament (MEPs) this week by the European Alliance for Access to Safe Medicines.

The European Union pharmaceutical market is suffering from the “potential public health disaster syndrome of invisibility, biohazard and system failure,” particularly with respect to regulation of distribution and supply chain security, claims the report’s author, Jonathan Harper.

Europe’s pharmaceutical distribution system is extremely complex, confusing and unregulated, with multiple and parallel layers of distribution and this potentially puts patients at risk, he warns; EU citizens receive medicines which may have passed through 20 different hands, through countries with different languages and licensing systems, sporadic reporting and minimal enforcement. Given that medicines should be highly regulated for public health reasons, it should be possible to know where any particular product is at any particular time, but this is not the case, he adds.

Globally, PPT is not permitted, but, in the EU it is defined as a lawful form of trade, except in the case of eight of the 10 new member states which joined the EU in 2004, due to the need to harmonise their intellectual patent protections related to medicines. However, the PPT restrictions on these nations are soon to be lifted, and the report says this will not only worsen the already-complicated EU distribution system against a background of supply chain insecurity, but “will also likely raise the tensions between the European research-based industry on the one side and national healthcare purchasers and PPT trackers on the other side".

Dr Harper is dismissive of claims that PPT provides savings to payers; in fact, the value added largely goes to intermediary traders, he says. Nor does the trade drive EU pharmaceutical price convergence – it results in the import of cost control systems from other countries. Moreover, the parallel traders’ practice of repacking and relabeling undermines supply chain security, he warns, adding that there is evidence of PPT being an entry point of counterfeit medicines in to the legitimate supply chain.

2.7 million fakes seized at EU borders

The European Commission recently estimated that more than 2.7 million fake medicines were seized at EU borders last year, a rise of 384% on 560,568’s total of 2005. Moreover, counterfeit medicines have this year reached UK patients via PPT, resulting in four Class I recalls by the Medicines and Healthcare products Regulatory Agency (MHRA); these were for Eli Lilly’s antipsychotic Zyprexa (olanzapine), AstraZeneca’s prostate cancer treatment Casodex (bicalutamine) and Sanofi-Aventis/Bristol-Myers Squibb’s antiplatelet agent Plavix (clopidogrel) – the latter had two separate recalls.

In his recommendations, Dr Harper calls for “de-boxing” to be prohibited, and says the repacking and relabeling of products destined for parallel trade should be conducted under the supervision of the original trademark holder. Moreover, he calls for the right of research-based manufacturers to simplify the distribution of their products, for example via sole/selected distributorship arrangement, to be considered, in light of supply chain security concerns and also because of, “arguably, market failure” in terms of achieving a single European pharmaceutical market.

However, he also points out that the industry has been criticised by the European Commission for creating “artificial partitioning of the market,” through the process of placing an identical product on the market in several EU states in various forms of packaging and/or under a different trademark, and banning the pack sold in the exporting country from being marketed in the country of destination.

The industry needs to be seen to be making efforts to achieve single European pricing; once this is achieved, it can better focus on doing its job of pharmaceutical R&D, says Dr Harper. He adds: “European patients need new and better products, not pharmaceutical pricing wars in Europe between “big pharma” and “big bureaucracy.” By Lynne Taylor