Rapid surge

Almost any article written in the past 12 months about counterfeit medicines, in magazines like this, in national newspapers throughout Europe or presented worldwide on the internet, has carried alarming warnings of a rising tide.

The media regularly reports a dismaying intensification in the rate of recurrence and magnitude of incidences where fake medicines have breached security walls and invaded Europe's markets, to the severe misfortune of any patients relying on what should be life-saving medicines delivered as the manufacturer intended.

The pervasion of danger across Europe from this offensive practice, which not only puts lives at risk but also assaults the trust patients have in their healthcare systems and regulatory authorities, has become so acute that in May this year Brussels hosted the first European parliamentary symposium on drug counterfeiting.

Jean-FranÁois Dehecq, chairman of sanofi-aventis, opened the discussion, remarking that drug counterfeiting should be acknowledged as a cruel public health menace and that the time has come to stop its rapid proliferation around the world. For too long, we have underestimated the drug counterfeiting situation, he told attendees, including G¸nter Verheugen, European Commissioner for Enterprise and Industry Policy. It used to be marginal, it is now totally industrialised.

The latest information we have on the incursion of counterfeit pharmaceuticals tells a disquieting story: the volume of fake drugs seized in Europe has increased exponentially in recent years, with more than 500,000 products discovered in 2005 - twice the rate of 2004. In 2006, this figure had increased by five times, to 2.5 million, as cited by the UK's BBC Radio Four Today programme. The Centre for Medicines in the Public Interest (CFPI), based in the US, predicts that counterfeit drug sales will reach about EUR 55.5bn globally by 2010 - an increase of more than 90 per cent over just five years, from 2005.

It is understandably difficult to make an accurate estimation of the actual cash 'value' of the counterfeits operation. Though it is generally accepted that in developed markets such as the European Union (EU) about 1 per cent of products are fake, this should be seen in context as it is highly significant. If every person working for Pfizer, for example (around 100,000 worldwide), needed to take a medicine made by any firm, it could be that as many as - or even more than - 1,000 people take a counterfeit product.

Looking at it another way, Eurostat (European Commission) predicts that by 2010 the population of the EU will be in the region of 464.1 million: if even, for argument's sake, only half of these people needed to take medication, at a counterfeit product frequency of just 1 per cent, it could mean that more than 4.6 million people ingest a fake product - probably under-strength in terms of its active ingredient and/or containing a harmful chemical element. This one per cent level is also understood by the authorities to be on the increase.

This raises vital questions about current European policy and its ability to protect patients, physicians and manufacturers.

New legislation required?
In the eyes of medicine counterfeiters it seems that jumbo profits can be made, while the punishment handed out by law if they get caught - some current operations are run by quite sophisticated organised crime syndicates - is so languid in some areas as to provide little deterrent.

From 2008, following the conclusion of a study, the EC is expected to make a decision on whether to fortify EU regulations to assuage patients from the health risks created through the worsening perforation of Europe's legitimate trade channels, and to protect manufacturers from loss of reputation and revenue.

Speaking to Pharmaceutical Marketing Europe, EC officials confirmed that the body is considering seriously the prospect of introducing new, further reaching measures: The Commission is currently conducting a study, in which the problem of counterfeit medicines will be analysed further. Should the analysis reveal gaps in pharmaceutical legislation, policy options will be developed to address these gaps.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) was satisfied that an important political message had been sent out at the forum. Europe must use all the weight it possibly can in this fight. The EC also highlighted that European pharma firms had been asked to present their ideas for improving co-operation between the EC and stakeholders: Enhanced co-operation and communication is crucial for a successful fight against counterfeit medicines, it noted.

The harmonisation of aspects regarding pharmaceutical market authorisations, manufacturing, importation and distribution has been in process since the late 1960s, but the rapid emergence of drug counterfeiting across EU markets in recent years has reinvigorated the EC's interest in providing a secure and legitimate marketplace. The information and data for the new analysis was provided by EU States and stakeholders by April 2007. Based on its conclusions, the EC will announce its intentions next year.

Unified solution
Recent events have spurred a separate channel of controversy regarding the professed detrimental effect imbued on supply chain security by the practice of parallel trade.

Delegates at the recent European parliament symposium on counterfeits heard Dehecq describe parallel trade circuits as some of the major vectors used by counterfeiters to sell their fake products. This has been denied fervently in the past by Heinz Kobelt, secretary general of the parallel trade association European Association of Euro-Pharmaceutical Companies (EAEPC), but his case for defence was challenged more vehemently than before when, in May 2007, fake Zyprexa in the UK market was officially identified as having entered through a parallel trade organisation. This was a very regrettable incident, the EAEPC admitted.

Kobelt wasn't invited to attend the parliamentary event, though he is very keen that the EAEPC and its members are integrated as part of any anti-counterfeit solutions the EC might devise to protect European manufacturers. The EAEPC insists that it was a parallel trade organisation which first identified counterfeit packs of Zyprexa entering the UK market, and informed the authorities. Unfortunately, other EAEPC members had not noticed the suspect packaging and had released the product to UK pharmacies.

It is very regrettable that it has happened and we are taking it very seriously as a trade association which for 25 years had had a clean track record among its members, Kobelt said in an interview with PM Europe. It is certainly a point of concern and we will hold a general assembly to discuss what can and should be done within our membership to avoid such cases.

He said that parallel trade organisations have every interest in maintaining the integrity of the European supply chain, and highlighted track and trace technology as a valuable security measure which would allow parallel trade to continue while enabling validation of a medicine's supply journey from factory to pharmacy. However, he has concerns regarding the 2D data-matrix barcode technology, which EFPIA champions as a reliable and cost-effective way to make the supply chain more transparent and, hence, safer.

The encrypted 2D barcode technology allows unique numbers to be attributed to a medicine pack. By using a hand-held barcode reader, common in most EU pharmacies, the dispenser will be able to check vital data, such as recall information and the details of every trader, including EAEPC members, which has handled that pack. While parallel trade is legal, there is little doubt that patient safety is being undermined, EFPIA stated. That intermediaries can open and remove original packaging jeopardises industry efforts in securing supply chain integrity and renders ineffective any anti-counterfeit features incorporated into the original packaging. This makes it more diffcult to detect counterfeits... only a ban on repackaging would limit the danger.

Kobelt notes: Our main concern regards the ownership of the information that is contained within the barcodes. If the manufacturer owns the data on wholesaler and parallel trader transactions for every drug pack, I am concerned that this information will be used to further streamline the already borderline supply restrictions in place. He feels that EAEPC members would suffer collateral damage as not only would the barcoding make it more difficult for counterfeiters to sell fake batches, thereby achieving its primary objective, but manufacturers might also limit distribution to wholesalers and markets on the basis of
the information contained within the 2D barcode.

I would have no problem if an independent third party agency collected the information and made it available when appropriate to investigators, that's fair and workable. But ownership of the information by the manufacturers alone I think would make clear the true objective of such technologies.

Naturally, manufacturers throughout Europe consider the EAEPC's reasoning merely sophistry. At the parliamentary event, Dehecq made clear his belief that Europe's efforts to stamp out counterfeiting should reassess the practice of parallel trade by considering the 'solution' of a ban on medicines repackaging.

Indeed, the EC is running a separate project on 'safe medicines in parallel trade', which it said is meant to reveal further information on any relationship.

In general, to improve security it may be that a variety of security technologies are applied in relation to their place of use in Europe. Director general of DG Enterprise and Industry, Heinz Zourek, confirmed recently that there might not be one technical solution applied universally.

Different products and regions may need different technical solutions. However, joint activities of various services on Radio Frequency Identification Systems (RFID) and other track and trace solutions are meant to already prepare today for the options of the future.

Fighting back
Europe's attempts to control the problem of medicine faking must match their increasing sophistication. The vast majority of imitation products are still solely available from unscrupulous and unnamed internet providers, however it is also true that some ersatz offerings are now produced to such a high 'visual standard', that pharmacists and physicians cannot discern between those and legitimate manufacturer packs.

A recent study in the Lancet propounded that the ability of counterfeiters to reproduce holograms and other elaborate printing techniques had improved dramatically between 2001 and 2005. With international organised crime now covering many of the expenses of some operations, it is a significant risk that any security measures put in place on medicine packs may soon be sidestepped or reproduced to a sufficiently high standard as to escape discovery.

Dr Thomas Zimmer, chairman of the adhoc group on anti-counterfeiting with EFPIA, hopes that the combination of the 2D data-matrix barcode and tamper-proof boxes (with features that show when they have been opened) will form the basis of improved security. Existing national coding systems follow different formats and, according to EFPIA, do not allow the pedigree of medicines imported across national boundaries to be checked. An agreement of responsibility in deploying a unified track and trace system in EU States would mean replacing these.

Dr Valerio Reggi, coordinator of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), told members of European parliament (MEPs) in May that his efforts are focused on developing an internationally agreed set of principles to use in building national anti-counterfeit legislation. This approach - rather than a more costly and time-consuming international convention, as proposed by MEPs in 2006 - is seen as preferable by several member countries of the World Health Organisation, he claimed. Dr Reggi aims to act quickly, seeking to get the principles drawn up and endorsed by the end of 2007.

New technology applied to medicine packs will certainly assist in the fight, but it may be that to truly deter and prevent drug counterfeiters more biting legislation will be required; perhaps in addition to a campaign to educate those consumers in Europe who are still buying medicines from the wrong internet sites. Through a combination of reduced demand and tougher laws and penalties, as agreed internationally, pharma might confidently expect to see the growth in counterfeits cut back significantly by 2010. Time will tell.