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Published on 1 May 2005

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The challenge of counterfeit medicines

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David Taylor
BSc FFPH
Professor of Pharmaceutical and Public Health Policy
The School of Pharmacy
University of London
London
UK
E:david.taylor@ulsop.ac.uk

To professionals working in the orderly environment of pharmacy in western Europe, dangerous words such as that of “the Russian mafia” may seem to present no more of a real threat than that posed by reports of children dying of treatable diseases in remote parts of Africa. But the global community is changing fast.

Comfortable assumptions of immunity from the hazards experienced elsewhere may prove false. The increasing risk of illicit drug smuggling in today’s Europe is now becoming widely recognised. In its 2005 Annual Report, the UN’s International Narcotics Control Board warned that the porosity of the extended new eastern borders of the EU has opened the way to a rapid increase in the amount of heroin flowing into the Union from Afghanistan.(1)

Some experts also believe that, where illegal drugs have led, high-value modern medicines (or at least counterfeit and substandard copies of such products) will inevitably follow. They argue that if the leaders of Europe and its pharmacy community are unduly complacent, the cost will ultimately have to be measured not merely in terms of lost revenues for European industry but in patients’ lives.

A rising trend
In 2004 the Stockholm Network published a study entitled A Sick Business,(2) in which the author, Graham Satchwell, documents a series of serious instances involving pharmaceutical counterfeiting. His work reveals how substandard and fake products ranging from contraceptives to antibiotics have entered legitimate pharmaceutical supply chains around the world.

Most of the documented cases illustrative of this trend have occurred in the USA and the less developed countries. But research undertaken under the auspices of the Council of Europe is indicative of an emergent problem in the EU.(3) Recently, a counterfeit batch of the erectile dysfunction drug Cialis was discovered in Holland.(4) Although this incident was not life-threatening, it is unlikely that it was an isolated case. Other forms of counterfeiting could have more serious outcomes.

Satchwell is a former British police superintendent who has specialised in the areas of brand forgery and illegal medicines supply. In the European context he particularly stressed the avoidable risks that the parallel importing of medicines may create, as products are repackaged and resold in ways that create opportunities not only for accidental error but also for improper substitution.

The policy recommendations Satchwell offers reflect his experience in policing, as well as knowledge of the realities of organised crime. They range from introducing sophisticated tracking technologies into medicines packaging to controlling repackaging activities further within the borders of the EU. The purpose of the latter would be to ensure that safeguards designed to protect medicine pack integrity cannot be removed by parallel traders after products have left their original manufacturers’ factory gates.

Critics of EU policies point to the fact that the fake Cialis found in Holland was a parallel import (PI). However, the EU’s record of regulating parallel importing has so far been good, in that its inherent risks have, in the main, been controlled. The advocates of PI say that it has saved money for taxpayers and healthcare providers in countries such as the UK and Germany, albeit most of the financial resources freed seem to have gone to the traders involved.(5) They can also argue that, although individual patients may have had problems with medicines recognition or information provision, this has not compromised safety at a population level. And the spectre of counterfeit drugs, they may claim, is more one of future possibility than of present substance.

Care perspectives
Leading hospital pharmacists in western Europe can be relatively confident that the systems of medicines purchasing and quality control they are accountable for act as an additional check against substandard medicine use, over and above the controls provided by national and EU-level regulatory bodies. If adequate investments continue to be made in pharmacy (sufficient to allow it both to protect drug supply standards and to strengthen the profession’s clinical care contributions further), patients being cared for in European hospitals are very unlikely to be treated with fake or otherwise grossly inferior medicines.

But as the expansion of the EU continues, it should not blindly be assumed that this will always be the case, especially in less well-funded and less sophisticated institutions. Nor should it be forgotten that recovering patients leave hospital, to return to their lives in the community. Modern pharmacists are concerned with the totality of pharmaceutical care available to their patients. It is in the community setting that threats such as that of drug counterfeiting deserve the most rigorous consideration.

One likely future trend is towards an increased emphasis on self-care. The availability of comprehensive tax or universal social insurance funded services in the established EU countries have, to date, ensured that virtually everyone in need of drug treatments has had good access to professionally facilitated pharmaceutical care. That is in large part why phenomena such as consumer-initiated internet medicines purchasing from uncertain domestic and foreign sources have not developed as they have in the USA. But as countries with less comprehensive public services join the EU, and at the same time patterns of treatment shift more towards lifestyle modification and consumer choice-led strategies, this situation may well change.

Another underlying reason why the risks of medicines counterfeiting associated with practices such as parallel importing deserve ongoing and careful attention relates to the viability of the European industry. While the net health service savings generated by PI medicine use have been relatively small, it can be doubted that its costs to research-based companies are higher.(6) Hence the price of parallel importing may eventually have to be counted in terms of economic harm to Europe as a whole, in addition to the direct damage that could in time be done to the EU’s pharmaceutical supply chain.

Conclusion
In many less fortunate parts of the world, medicines counterfeiting is already a major cause of harm. Most pharmacists do not, of course, regard avoidable deaths amongst children or adults in regions such as sub-Saharan Africa as unimportant, even if the welfare of European or American citizens is not immediately affected. Seen from this perspective, the global problems caused by the supply of fake drugs demand urgent attention and coherent action today.

From a EU standpoint, medicines counterfeiting may not be so serious a hazard as it is in other regions. Yet the logical conclusion to draw is that it would be unwise for anyone involved in European pharmacy to dismiss out of hand the potential threat it poses. A precautionary approach would demand that this should be confronted before significant harm results. Pharmacists have an important part to play in conveying this fact to managers and policymakers, while communicating the vital importance of maintaining public and patient confidence in all aspects of the safe and effective use of medicines.

References

  1. Report of the International Narcotics Control Board for 2004.  New York: United Nations; 2005.
  2. Satchwell G. A sick business. Counterfeit medicines and organised crime. London: Stockholm Network; 2004.
  3. Harper J. Draft report on counterfeiting medicines presented to the CoE ad hoc Committee on Counterfeit Medicines, December 2004.
  4. Croonen H. Nep-Cialis bevat Sildenafil. Pharmaceutisch Weekblad 2004;139:1300-2.
  5. Kanavos P, Holmes P. Pharmaceutical parallel trade in the UK. Civitas: London; In press 2005.
  6. Szymanski S. Intellectual property rights and parallel trading in pharmaceuticals. London: Imperial College; 2004.


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