The World Health Organization (WHO) calls for immediate concrete action against the growing epidemic of counterfeit medicines. In a bid to accelerate the war on fake drugs, the agency will push for stronger global cooperation, political commitment and creative solutions at a meeting in Rome from 16 to 18 February.
WHO aims to create a global task force involving all major interested parties. The task force will focus on legislation and law enforcement, trade, risk communications and innovative technology solutions, including public-private initiatives for applying new technologies to the detection of counterfeits and technology transfer to developing countries.
The counterfeiting of medicines is present in all countries and is thought to represent 10% of the global medicines trade. Particularly insidious, counterfeit medicines dupe sick people into believing they are taking something which will make them well, when it may instead make them sicker or even kill them.
"People don’t die from carrying a fake handbag or wearing a fake t-shirt. They can die from taking a counterfeit medicine,” says Howard Zucker, Assistant Director General for Health Technology and Pharmaceuticals at WHO. “International police action against the factories and distribution networks should be as uncompromising as that applied to the pursuit of narcotic smuggling.”
Counterfeit medicines are part of the broader phenomenon of substandard pharmaceuticals. The difference is that they are deliberately and fraudulently mislabelled with respect to identity and/or source. These products mostly have no therapeutic benefit; they can cause drug resistance and death.
Trade in counterfeits is extremely lucrative, thus making it more attractive to criminal networks. A report released by the Centre for Medicines in the Public Interest, in the United States, projects counterfeit drug sales to reach US$ 75 billion in 2010, a 92 % increase from 2005.
The presence of fake drugs is more prevalent in countries with weak drug regulation control and enforcement. However, no single country is immune to the problem. Reports from the pharmaceutical industry and governments clearly indicate that the methods and channels used by counterfeiters are becoming more sophisticated, making detection more difficult. Measures for combating counterfeit medicines so far have included support to under-resourced drug regulatory authorities; simple, easily interpretable and cheap markers of authenticity such as barcoding; transnational surveillance for fake and substandard drugs; and education of patients, healthcare workers, and pharmacists.
“These measures need to be intensified,” adds Dr Zucker. “Countries should think about ways to make the necessary technological, legislative and financial adjustments as quickly as possible to guarantee the availability of quality assured essential drugs.”
WHO would also like to see more developments in the areas of innovative high and low tech solutions for prevention at the manufacturing stage and for detection in the distribution chain.
Simple, inexpensive methods to identify fakes can be effective. For example, simple colorimetric assays developed for artemisinins have been used successfully to identify fake artesunate antimalarials.
WHO set up the world's first web-based system for tracking the activities of drug cheats in the Western Pacific Region in 2005. The Rapid Alert System (RAS) communications network transmits reports on the distribution of counterfeit medicines to the relevant authorities for them to take rapid countermeasures. That system should be expanded to include all regions.
Radio frequency identification (RFID) and more sophisticated technologies for product tracking within supply chain management systems are being experimented in some countries. Means must be sought to make these more sophisticated tools available and workable in developing countries.
Information on fake drug identity and distribution needs to be shared nationally and internationally between government drug regulatory authorities, customs and police organizations, pharmaceutical companies, non-governmental organizations, and consumer groups. Risk communications, involving the media, should be practised to raise public awareness.
The Rome conference is hosted by the Italian Pharmaceutical Agency (AIFA) and Italian Cooperation, and organized with the support of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the German Government. Participants in the conference include experts from national governments and regulatory authorities, industry, intergovernmental organizations, and consumer and patient groups.