Industry seeks strict anti-counterfeiting measures
pharmafile | July 9, 2008 | News story | Manufacturing and Production |Â Â parallel tradeÂ
European pharma leaders have proposed a series of tough new measures to prevent counterfeit drugs from entering the supply chain.
The detection of counterfeits in Europe rose by 51% in the last year according to EFPIA, which is concerned that patient safety will be compromised and pharma's own image tarnished.
The European industry association has backing from the European Commission for a ban on repackaging drugs, a move aimed at tackling counterfeits but which would also have serious implications for parallel trade.
Nevertheless it was counterfeiting that was the primary issue at EFPIA's recent annual meeting, where leaders said the problem had spiralled to a level of organised crime that was potentially lethal to patients.
Jean Francois Dehecq, vice president of EFPIA and chairman of Sanofi-Aventis, sought a strong response from his audience as he spoke heatedly and extensively without script on the subject, accusing those infiltrating the supply chain of terrorism.
But Brian Ager, the EFPIA director general, explained to Pharmafocus that he did not want to incite fear in the public, just make them aware of a very real danger.
He said: "Why can't we ensure our supply chain is watertight? It seems so intuitive that we should do that. And now we've got examples where the bad guys are infiltrating it.
"Medicines can pass between 20 to 30 pairs of hands between factory and pharmacy – you wouldn't accept that in the food chain," he added.
But their suggested solution of tightening the supply chain has some rankled some in the industry, who believe they have a secondary agenda to put a stop to the entirely legal practice of parallel trade.
Current European free trade rules allow multiple distributors to exist in the supply chain. Parallel traders are thus able to import medicines before selling them on at a higher price, though the law also requires that they re-box and re-blister the drugs before dispensing them.
But this process that allows counterfeits into the system, according to EFPIA and the Commission. The European Directorate-General for Enterprise and Industry is expected to release draft legislation in October calling for a ban, which would then be voted upon by the European parliament next year.
EFPIA also has plans for a further clamp down that would see all European states adopt a new security system.
The association wants boxes of medicines to display an individual code put there by the manufacturer that would have to be scanned by the dispensing pharmacist and thus reveal whether or not the pack has been intercepted by counterfeiters.
But by EFPIA's own admission, this secondary scheme is useless if medicines continue to be re-boxed, but it says this only strengthens its argument that an all out ban is essential.
Impact on parallel trade 'unintended'
If made law a ban on repackaging would also effectively cut out all legal parallel trade in Europe, and destroy a sideline industry that legitimately employs thousands.
There are some links between parallel trade (PT) and counterfeiting, because the former opens up the channels of distribution and weakens the ability to monitor medicines, but some see the proposed ban as treating the two issues as one.
The Commission had originally called for separate reports on PT and counterfeiting, but now, to the dismay of Europe's parallel traders who potentially face redundancy, both are being tackled together.
European associations for pharma and PT admit they do not see eye to eye. Parallel importers make money from drugs where their manufacturers cannot. Eliminating repackaging, and consequently PT, would provide a boost for pharma during the current period of poor growth.
But EFPIA told Pharmafocus this was not its agenda, nor that of the Commission, and only a consequence of the only real solution to the problem of counterfeits.
EFPIA's Brian Ager commented: "We are concentrating on improving the supply chain, almost in a blinkered fashion. Of course parallel trade has been a long-standing thorn in our side, but this isn't what this is primarily about. It is about cleaning up the supply chain."
But dissent and confusion as to EFPIA's motives still exists and a leading UK pharma figure said that sooner or later a political decision would have to be made as to the agenda behind the ban – whether it was for security reason or to squeeze out imports.
Whatever the motives of EFPIA and the Commission, they admit any radical change will take a substantial amount of time to come about. A further delay is likely with next year's re-election of the European parliament, which would have to vote on the policy changes.
Brit sentenced for counterfeit dealing
Meanwhile in the UK a man has been sentenced for dealing in counterfeit medicines to the value of at least £1.8 million.
Viraj Shah pleaded guilty to trading counterfeits of the prescription drugs Nexium, Diovan, Propecia, Actonel, Lipitor, Ezetrol and Hyzaar.
Mick Deats, group manager of enforcement at the MHRA, said: "Anybody engaged in the distribution of counterfeit medicines represents a significant threat to public health, both to individual patients and in undermining the health system. The MHRA will not hesitate to take action against those involved in this serious criminal activity."
Shah's case began when during routine examinations at Heathrow in May 2006, HM Revenue & Customs officers found suspicious packages linked to his home address.
Officers were conducting a random examination of a shipment destined for the Bahamas, when they discovered a number of unmarked boxes containing branded medicines.
The colouring of the packaging was inconsistent and on further analysis all were found to be counterfeit. MHRA investigators then found more evidence of counterfeiting at Mr Shah's address.
He pleaded guilty and received a sentence of 51 weeks imprisonment, suspended for two years, and 40 hours community service.
Related Content
Parallel trading restricting medicine access, says ABPI
The ABPI has blamed parallel trading by a minority of pharmacists as the root cause …
Greece’s crisis could hit European prices
GlaxoSmithKline’s chief executive Andrew Witty has warned that the economic crisis in Greece could have …
Stricter monitoring for UK supply chain
New measures to ensure that the UK doesn’t suffer from shortages of prescription medicines have …
