Counterfeit pharmaceuticals are flooding regional markets. This not only provides a ‘hard pill to swallow' to health and pharmaceutical boards but also to law enforcement authorities. An ISS research study on organised crime in southern Africa has identified the trafficking and trade of fake medicines as an emerging concern. The Southern African Regional Police Chiefs Cooperating Organisation (SARPCCO) and INTERPOL recognises it as a priority crime, which has led to a number of regional initiatives to stamp out the trade.
A 2006 report by the World Health Organisation (WHO) estimated that in developing countries in Africa, parts of Asia and Latin America, up to 30 percent of pharmaceutical drugs are counterfeit. Sub-Saharan Africa is particularly affected as weaknesses of health-care systems in many countries have created the vacuum into which merchants of counterfeit pharmaceuticals have been slipping in. The United Nations Office on Drugs and Crime (UNODC) estimates that 50 to 60 percent of all medications used in West Africa may be substandard or counterfeit. This increases health risks in a region with a high demand for anti-infection and anti-malarial drugs, apart from promoting the development of drug-resistant strains, which are a hazard to the entire world. The true extent of the problem is unknown since no global or regional study exists.
According to the WHO, counterfeit medicine is ‘one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, with insufficient active ingredients or with fake packaging.' In the past, bogus pills used to be blank replicas of the originals. But counterfeiters nowadays often add other active ingredients, such as mild pain relievers such as acetaminophen into pills that might make patients temporarily feel better. This was the case with fake Tamiflu seized from UK pharmacies in 2007. In 2004, Médecins Sans Frontières (MSF) discovered counterfeits ARVs on markets in the Democratic Republic of Congo (DRC) containing anti-depressants and muscle relaxants.
The addition of false active ingredients to counterfeit pharmaceuticals alarms health professionals. More worrisome is the substitution of real active ingredients with potentially life-threatening chemicals. The antifreeze component diethylene glycol has been used in place of glycerine in cough medicines, killing hundreds of people in Nigeria, Panama and Bangladesh in recent years.
Any pharmaceutical product can be counterfeited: expensive lifestyle and anticancer medicines, antibiotics, medicines for hyper-tension and cholesterol-lowering medicines, hormones, steroids and generic versions of simple pain killers and antihistamines, vitamins and nutritional supplements and pills in treatment of erectile dysfunction or sex-enhancing drugs. The proliferation of fake anti-malarial and anti retroviral drugs (ARVs) for people living with HIV/Aids is of particular concern in sub-Saharan Africa. The consequences are dire since a person may die if they do not access the genuine drug. Inefficacy of counterfeit drugs also makes people loose confidence in such drugs.
The trade in fake drugs is extremely lucrative and with the escalating cost of medicines, the trade in counterfeits is likely to grow. For example, the profit margin from counterfeit Viagra is 10 times higher than for the narcotic drug heroin. Pharmaceuticals are high value items in relation to their size and the demand for them is indefinite. For the counterfeiter, ingredient costs can be low if cheap substitutes are used or vital ingredients may be omitted altogether. Little infrastructure is required as the counterfeiter can produce the fake medicines in a backyard. Overhead costs due to quality assurance or meeting Good Manufacturing Practices (GMP) standards are not applicable. Global counterfeit syndicates use evolving consumer technologies that make it easier to imitate legitimate drugs. The law in quite a few countries has not yet caught up with the seriousness of counterfeiting of medical drugs. While traffickers in ‘hard' drugs face severe penalties of imprisonment, counterfeiters face trademark and fraud charges, for which the penalties are usually financial.
Developing countries are particularly vulnerable to the proliferation of fake dugs because of inadequate regulatory capacity or political will to curb distribution. And while legitimate drugs can be expensive, poor consumers fuel the demand by knowingly or unwittingly purchasing cheaper fake variations. Price controls also cause shortages in medicines, creating a gap that counterfeiters then fill. Price caps in South Africa resulted in the closure of more than 100 small rural pharmacies because they had to charge more than large urban shops. In the past, the rural poor could choose whether to pay more locally or travel into the cities for cheaper drugs. Now they have to travel or buy them cheaply from peddlers that often sell fakes.
In 2008 and 2009, INTERPOL conducted raids on the pharmaceutical and cosmetics sector in east Africa. During Operation Mamba I, 100 varieties of illegal products were found in 191 facilities searched in Tanzania. 44 police cases were opened, 4 pharmacies and 18 drug shops were closed during the raid. Operation Mamba II, which took place throughout August 2009, involved raids across Uganda, Tanzania and Kenya. The operation resulted in 83 police cases and a few convictions. Of the Tanzanian traders, 9% were found to be selling expired medicines, 18% sold medicines which are restricted to government handling, 28% had in their possession medicines strictly for prescription only, but found in undesignated shops, while 46% stocked unregistered medicines.
Beyond the INTERPOL initiatives, what is to be done to deal with the proliferation of fake drugs? Countries may choose to enact special national legislation. Kenya, Tanzania and Uganda are at various stages of implementing laws against counterfeit medicines. They realise that enacting laws will not solve the problem, as the laws need to be enforced. More resources should also be dedicated to drug regulation. At the same time, a comprehensive study that looks at the supply chains and assesses the size of the industry should be undertaken.
Written by: Annette Hübschle, Senior Researcher: Organised Crime and Money Laundering Programme, ISS Cape Town