Counterfeit drugs: a growing global threat

Abstract

Last week, the US Food and Drug Administration (FDA) warned that 19 medical practices had bought counterfeit versions of Roche's cancer drug bevacizumab (Avastin) from an overseas supplier. This was not the first alarm over counterfeit drugs this year. In January, the FDA warned health-care providers about direct-to-clinic promotions and sales of potentially counterfeit injectable cancer medications, such as fulvestrant, from unlicensed sources. Counterfeit drugs are rarely efficacious. Worse, they can have serious adverse effects. The contamination of heparin by Chinese counterfeiters in 2007 and 2008, killed 149 patients in the USA. Counterfeit anti-infective drugs might also increase the risks of drug resistance. These products have traditionally been more of a concern in developing regions (mostly Africa and Asia), where regulatory and enforcement systems for medicines are weak. However, counterfeiting has become more and more prevalent in developed countries as drug supply chains increasingly cross continents. In 2009, the European Union seized 34 million fake tablets in just 2 months, including antibiotics, cancer treatments, and sildenafil citrate (Viagra). Most studies indicate that all forms of fake drugs are more prevalent in absolute terms in developing and middle-income markets. In high-income countries, counterfeit versions of lifestyle drugs like Viagra or cancer medicines are more dominant than anti-infectives. Unfortunately, it is difficult to define the scale of the problem precisely because of the variety of information sources, which include authorities, enforcement agencies, and drug companies, as well as the heterogeneous methods used in reports and studies. WHO has stated that, “counterfeit drugs may erode public confidence in health care systems, health care professionals, the suppliers and sellers of genuine drugs, the pharmaceutical industry and national Drug Regulatory Authorities”. So what should be done to tackle the growing problem of counterfeit medicines? The consequences of counterfeit drugs are diverse, as are the solutions, which lie in collective involvement, responsibility, and responses of all interested parties: health professionals, drug regulatory authorities, judicial entities, and drug companies at both national and international levels. Critical to this effort is strengthening of drug regulatory authorities, which should not only be responsible for improving drug standards, but also provide effective recognition of counterfeit drugs and assist other agencies in stopping their trade. This is especially needed in those countries that have either no drug regulation at all or an impaired or corrupted system. Additionally, enactment and enforcement of new laws for prohibiting counterfeit drugs is vital. The counterfeit drug trade has reached global proportions, and solving the problem needs a global approach. In 2010, the Council of Europe drafted the Medicrime Convention, which constituted, for the first time, a binding international standard for criminalising the manufacture and distribution of counterfeited medicine. However, as Roger Bate and Amir Attaran stated in a Comment in The Lancet in 2010, “European officials lack credibility to pursue this treaty globally as they would like. Only a treaty initiated by WHO will suffice.” In 2006, WHO created a global initiative—the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). So why is there not yet an international fake drug treaty? Debates persist over the definition of counterfeit drugs and what should be done about them. The Indian and Brazilian Governments and some non-governmental organisations, have opposed the work of IMPACT. The principal reason is they believe it would confuse quality and intellectual property rights issues and thus undermine access to legitimate and much lower-cost generic medicines consumed mostly in poor areas. Although enforcement of trademarks is often one way that dangerous fake medicines are stopped, overzealous interpretation of intellectual property laws can reduce access to good medicines. For example, Kenya's Anti-Counterfeit Act, enacted in 2009, has been criticised for not clearly distinguishing the difference between generic and counterfeit drugs. The Act was challenged as a violation of the right to life by three patients with HIV/AIDS, because they were denied affordable generic medicines after the enforcement of the law. The fight against counterfeit drugs must be strengthened without further delay. It needs consensus among all countries and interested parties, and requires wise and bold leadership from WHO. An indispensable goal of the campaign is ensuring the availability of genuine and affordable essential medicines in developing countries. For The Lancet Comment by Roger Bate and Amir Attaran see Lancet 2010; 376: 1446For more on Kenya's Anti-Counterfeit Act debate see World Report Lancet 2010; 375: 542 For The Lancet Comment by Roger Bate and Amir Attaran see Lancet 2010; 376: 1446 For more on Kenya's Anti-Counterfeit Act debate see World Report Lancet 2010; 375: 542