Articles from February 2008

Warning over medicine bought online

Seizures of illegal medicines coming into Ireland have increased four fold, according to the Irish Medicines Board. The Board’s Chief Executive, Dr Pat O’Mahony, said the threat posed by illegal medicines arriving from abroad posed a growing challenge to the enforcement agency. The vast majority of seizures in recent months were individual imports – people buying counterfeit medicines for personal use over the internet. ‘‘There is no safe way to buy medicines off the internet. Right now, you may come across sites that look as though they are operated from the Netherlands. In fact, the site is being operated from Jamaica, the product is dispensed in India and the money ends up in the Cayman Islands. Criminal gangs are involved in this,” O’Mahony said. He continued: ‘‘People living in Ireland are not permitted to import – or have sent to them via the post – prescription-only medicines for personal use. It is vital that people understand they should not purchase medicines from internet sites. They should also understand there are possible health risks associated with using these products.”

O’Mahony said it was impossible to verify what medicines bought online contained, or whether they did the job they purported to do. But he said these internet pharmacies were often outside the reach of Irish law. The most common illegal medicines found in recent months were Viagra and Cialis, drugs used to treat erectile dysfunction. Significant quantities of anabolic steroids, dangerous and controversial drugs used by body builders to build muscle, were also recovered, as were antidepressants and antibiotics. According to O’Mahony, most counterfeit medicines arriving in Ireland contained no active ingredients, but he expressed concern that medicines containing dangerous ingredients would reach Ireland. (24 February 2008, The Sunday Business Post, Ireland)

EU states urged to adopt tougher copyright protection rules

The European Parliament has urged member states to adopt newly drafted EU rules on copyright protection, introducing harmonised criminal sanctions across Europe for activities ranging from illegal downloading to the sale of counterfeit medicines. In July 2005, the European Commission presented a double proposal for a directive and a Council framework decision aimed at introducing criminal sanctions for copyright infringements. The proposal was amended by Parliament in April 2006. The draft foresees the introduction of a number of measures to curb the violation of intellectual property rights, including custodial sentences, fines, destruction of fake goods, closure of establishments used to commit an offence, bans on engaging in commercial activities, or bans on access to public assistance or subsidies. (20 February 2008, European Parliament)

Does parallel trade make Europe safer? 

This was the question posed (and answered in the positive) by Heinz Kobelt, secretary general of Europe’s parallel trade association (EAEPC), yesterday as he moved to convince delegates at SMI’s 2nd Annual Parallel Trade Conference that the authorities should give traders more room to manoeuvre.

“We have a different commercial model, but we share the same safety concerns as the [innovative pharma] industry,” he said during a presentation which sought to clarify how the practice of parallel trade (PT) can serve to enhance the protection of Europe’s patients from counterfeit products, as well as manufacturer errors.

Some in the room, including Jim Thomson of the European Alliance for Access to Safe Medicines (EAASM), expressed empathy and even support for PT’s challenge in dealing with a regulatory system which dictates how medicines should be repackaged and relabelled, yet forbids traders to attach any ‘safety seals’ of the kind removed during box opening.

The Association was also praised for its fresh endeavours to develop a supply system based on a set of standards put together by the QPs (Qualified Persons) of leading importers, as the “next step” to improve the security of Europe’s supply chain.

However, a bullish Thomson was also keen to put the record straight over recent ‘mud-slinging’ by the EAEPC with reference to a report written by academic and analyst Dr Jonathan Harper (and published by the EAASM in November 2007), in which the ‘value’ of PT was challenged – and the hazards spotlighted – in no small measure.

The report focused heavily on the iniquities and vulnerabilities PT purportedly brings to the European pharmaceutical distribution system, a position supported openly in recent weeks by Günter Verheugen, vice-president of the European Commission, responsible for enterprise and industry.

In response to the Harper report, the EAEPC is understood to have threatened the EAASM with legal action, branding the report’s contents as “black propaganda”. At the SMi meeting yesterday, Thomson sought to restore a clearer perspective between the author’s findings and the aims of the EAASM, which he said is not an anti-PT organisation per se but simply a pro-patient safety group.

He criticised the EAEPC for “going into media overdrive” in its reaction, reiterating that the author was writing as an independent academic rather than a direct representative of the EAASM. However, he also concurred openly with several of Harper’s conclusions about the links between PT and counterfeit medicines entering regulated markets in Europe, as well as the perceived risks to patient safety imparted through re-boxing and re-labelling.

As for the argument that PT makes medicines safer in Europe, Thomson concluded, it is “illogical and a high-risk bluff”. He noted that there was no mention of ‘patient safety’ anywhere in the EAEPC’s mission statement, whereas it is the EAASM’s – and Dr Harper’s – primary concern.

Kobelt admitted that the EAEPC member which inadvertently introduced counterfeit pharmaceuticals to the UK market last year was “not careful enough in its sourcing” and had “fallen into a trap”. He reassured delegates that the association is taking measures to enhance its role in supply chain security, and that the president of the EAEPC (and head of the British Association of European Pharmaceutical Distributors), Richard Freudenberg, is keen to discuss the options with all other stakeholders, including industry and generics associations as well as the EAASM. (14 February 2008, Pharma Marketing online)

Fake antimalarial drugs analysis highlights threat to global health

A unique collaboration between scientists, public health workers and police has led the Chinese authorities to arrest a fake antimalarial drugs trader in southern China. Chinese police seized 240,000 blister packs of counterfeit artesunate tablets – one of the most effective antimalarial drugs. Fake antimalarial drugs are an increasingly serious problem, particularly in South-east Asia and Africa, where as many as half of all artesunate is counterfeit.

The operation, involving teams from across the globe, has highlighted both the growing threat posed by fake pharmaceuticals and the complexities of tracking down those responsible for the trade. Most of the fakes examined as part of the operation contained no artesunate, and some contained a wide range of potentially toxic wrong active ingredients. Also of grave concern was the fact that counterfeiters sometimes included dangerously small amounts of artesunate in the tablets. This may be done to foil screening tests of drug quality, but these doses are too low to be efficacious. However, worryingly, these doses are high enough to contribute to malaria parasites becoming resistant to this class of drugs, which would have a catastrophic effect on public health in the tropics. (12 February 2008, Wellcome Trust)