The European Alliance for Access to Safe Medicines (EAASM) has responded vigorously to criticisms from the parallel trade sector of its warnings to the European Parliament, in a newly-published report, that parallel pharmaceutical trade (PPT) represents “a clear and present danger to the safety of every European patient”.

Earlier this week, the EAASM report was attacked by Heinz Kobert, secretary-general of the parallel importers’ group, the European Association of Euro-Pharmaceutical Companies (EAEPC), who claimed that it made no contribution to the patient safety debate and was about discrediting the “legitimate and safe practice of EU-internal distribution of medicines which introduces price competition for manufacturers”.

However, EAASM chairman Jim Thomson has now commented to PharmaTimes World News that parallel trade is certainly legal, but whether it is legitimate is open to question. The Alliance report demonstrates quite clearly that, “overwhelmingly, the benefit of PPT is primarily accrued by the trader,” says Mr Thomson, adding: “as for safety, Dr Kobelt conveniently neglects to mention the tens of thousands of packs of counterfeit medicines that reached UK patients this summer via PPT.” All four drugs subject to a Class 1 recall by the Medicines and Healthcare products Regulatory Agency (MHRA) – 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 having two separate recalls - entered the legitimate supply chain via PPT, he points out.

Moreover, Mr Thomson says, the EAEPC is the same organisation that has spent the past year assuring all stakeholders that de-boxing (ie, the practice of removing of security mechanisms, which the Alliance report says should be banned) in fact adds a layer of security to the distribution chain.

The EAASM report is undoubtedly the most thorough investigation to date of the patient safety implications of PPT and its recommendations represent a massive contribution to the future safety of European patients, says Mr Thomson. He adds that author Dr Jonathan Harper (who also wrote also the Council of Europe’s February 2006 report on counterfeit medicines) looked in great detail at every aspect of PPT in the three months it took him to write the report. However, he says: “Dr Kobelt appears to have been able to form an opinion sufficiently strong enough to rubbish the EAASM and Dr Harper in a little over 24 hours. If he had spent a little more time reading and digesting the full report he would, for example, have read recommendations relating to the desirability of European pharmaceutical price harmonisation, an area that the pharmaceutical industry may find uncomfortable.”