The age-old problem of fake drugs has now developed into a multi-billion dollar “global criminal industry”, say experts in a report published this month by the Wellcome Trust and the American Pharmaceutical Group (APG).

 

But efforts to tackle it have stumbled on confusion over definitions, and the complexities of dealing with global trade, law enforcement, and attracting the public’s attention. “As with all complex problems, there will be no simple or short-term solutions,” write the Wellcome Trust and APG.

 

The report summarises the proceedings of an international conference that took place on 26 October in London, UK. On the same day, the US Agency for International Development (USAID) and the US Pharmacopeial (USP) Convention jointly announced a five-year, $35 million programme designed to tackle counterfeit and substandard drugs in developing countries, where the problem is most pronounced.

 

“Without good quality, safe medicines to treat diseases such as malaria and tuberculosis, the impact of other health initiatives is severely weakened if not negated completely,” said Gloria Steele, USAID Acting Assistant Administrator for Global Health, in a press release.

 

Medicines produced illegally may have no active ingredients, or may instead contain harmful substances. People tricked into buying them can seriously endanger their health. Antimalarial drugs with small amounts of the active ingredient artesunate have fuelled the emergence and spread of drug-resistant disease in South-East Asia, putting malaria-control efforts in jeopardy. Adulterated paracetamol has caused thousands of deaths in China.  

 

Sham medicines are often confused with substandard or generic ones, according to the report. While all counterfeits are substandard, even genuine drugs can be below par if not properly manufactured and stored, or when they are out of date. Mix-ups between fake and generic medicines can cause a problem with customs checks to block trade of illegal products, if customs officers mistaken unbranded products for counterfeits.

 

Fakes are less common than substandard drugs, but carry greater risks and are a growing problem, said the experts. Good data on how widely they circulate are difficult to come by. In developed countries, counterfeits probably make up around 1% of drugs on the market. Although estimates vary between developing countries, they range from 10% to 30% and are thought to be even higher in South-East Asia.

 

Globally, the fake drugs industry will be worth $75 billion by 2010 — a rise of more than 90% since 2005, says the USAID. The problem has grown for many reasons, according to the report, including efficient trade routes, a mismatch between supply and demand of legitimate drugs, the high profits made by those who trade counterfeits, and deficiencies in legal systems and in the enforcement of legislation.

 

The International Medical Products Anti-Counterfeiting Taskforce (IMPACT), a body associated with the World Health Organization (WHO), has been leading efforts to tackle the problem. Major reports prepared by the taskforce are planned for discussion in the 2010 World Health Assembly.

 

At last month’s conference the experts stressed that international collaboration will be key for the success of any initiative to combat trade in counterfeit medicines. The report also lists more specific actions, which overlap with suggestions made by USAID and the WHO in the areas of improving regulation, advancing drug-testing technologies, and raising awareness with better communication.

 

With packaging designed to look authentic down to batch numbers or other unique identifiers, fake drugs are difficult to spot without chemical analysis. The report highlights some promising technological fixes that could be used to catch illegal products along the supply chain. In a system used by some European countries, a label unique to each drug is read with a scanner as the medicine is handed out to a patient. The scan will inform the pharmacist of any problems with the drug’s authenticity or sell-by date “in less than a second”.

 

In developing countries without well-established systems to distribute medicines, a mobile-phone camera could be adapted to read these labels. Alternatively, as is the case in Kenya, patients can use their phone’s texting facility to authenticate their medicines, according to the report. But more innovative equipment should be developed to make this easier. “There is an urgent need for cheap, reliable and portable devices to support enforcement in the field.”

 

Acting to block trade of fake drugs is also in the interest of pharmaceutical companies, say the experts, as the industry is eating away at their profits. “Most companies can consider counterfeit manufacturers collectively to be their biggest competitor.”