The deadly scourge of fake drugs: counterfeit drugs, which are not only ineffective in treating illnesses but can and do actually kill patients, now form 25% of all medicines in the developing world. The menace is increasing in Africa, as Tom Nevin reports.

According to the World Health Organisation (WHO), 25% of all medicines in less developed countries (LDCs) are counterfeit. In some countries, the prevalence is far higher.

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The report Counterfeit medicines in less developed countries: problems and solutions by the International Policy Network's (IPN) executive director Julian Morris and health programme director Philip Stevens says the majority of counterfeit medicines originates in LDCs, including the bogus drugs that end up in the US and European Union. "Much of the debate surrounding counterfeit medicines to date has focused on how to prevent them seeping into the supply chain of developed country markets," they say.

Statistics assembled by Morris and Stevens make frightening reading:

* Counterfeit medicines comprise 40% to 50% of total supply in Nigeria and Pakistan

* Some products in China have a counterfeit constituent of 50% to 85%

* Some 37% of antibiotics and anti-malarials on the WHO essential drugs list in Nigeria and Thailand are substandard

* A recent survey by the WHO of seven African countries found that between 20% and 90% of all anti-malarials failed quality testing.

"In spite of a lack of hard data, it is clear that counterfeit medicines are not confined to a handful of therapeutic classes," the IPN researchers say. "This is especially true in LDCs where the range of fakes on the markets encompass treatments for a diverse range of conditions and ailments." The top five counterfeited medicines in the Philippines, considered representative of the global trade, are blood pressure tablets, anti-asthma drugs, analgesics, anti-diarrhoea treatments and vitamin pills. Other favourites for counterfeiting include drugs for treating anaemia, HIV, schizophrenia and growth promotion hormones.

Such medical consumables as non-sterile syringes and gauze, and even substandard electronic medical equipment are also on the counterfeiters' list.

Morris and Stevens believe that most of the world's counterfeit medicines originate in Asia, with China a principal supplier. "In 2001 it was reported that China had 500 illegal medicine factories, and while no newer data is available, it is safe to assume that number has since increased," they maintain. "Also in 2001 it was reported that Chinese authorities 'closed 1,300 factories while investigating 48,000 cases of drugs worth $57m' according to the San Francisco Examiner."

Around 15,000 manufacturers of generic medicines operate in India and while the majority are legitimate, "a small minority are 'fly-by-night' operations that do not comply with proper regulatory standards," they say. "Most of the counterfeit medicines in Nigeria originate in India, a fact that led the authorities to threaten to ban the import of all drugs from India in 2003." Pre-shipment checks of medicine cargoes in India and other countries have helped Nigeria to sharply reduce the flow of bogus drugs. The manufacture of fake medicines also flourishes in such Latin American countries as Mexico, Brazil, Argentina and Venezuela. In Russia it is estimated that counterfeits make up between 5% and 10% of the total market.

Deadly doses

Martin and Stevens assert that counterfeit medicines cause harm in various ways. Toxic chemicals can cause injury or death, inappropriate delivery systems and inadequate amounts of active ingredients prevent drugs from working effectively, while under-dosage can lead to resistance--a major worry for HIV/Aids and malaria sufferers.

Evidence of the fatal effects of counterfeit medicine was experienced in Nigeria in 1995 when 109 children died after ingesting fake cough medicine. A year later, also in Nigeria, some 2,500 people died after being inoculated with counterfeit meningitis vaccine.

"Counterfeit medicines typically provide inadequate doses of drugs, either too little active ingredient is included in pills or because the delivery vehicles are inappropriate," say the researchers.

The South China Business Journal reported in 2002 that between 200,000 and 300,000 people die each year because of counterfeit or substandard medicine. "Perhaps one of the most worrying implications of the global boom in counterfeit medicines is the acceleration of new, drug resistant strains of viruses, parasites and bacteria," say Martin and Stevens. "If drugs contain too little of the active ingredient, not all the disease agents are killed and resistant strains are likely to multiply and spread.

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"This effect is already being observed in the treatment of malaria. Counterfeiters around the world have cashed in on the massive demand for the latest and most effective anti-malarial drug, artemisinin. A field survey in 2004 showed that 53% of artemisinin-based anti-malarials in a range of Southeast Asian countries contained incorrect levels of the active ingredient, implying that swathes of patients are receiving the incorrect dose."

Even though artemisinin has been available only since the late 1990s, scientists are already reporting cases of resistance by the malaria parasite, due to inadequate levels of the active ingredient. According to Dr Dora Akunyili, head of Nigeria's National Agency of Food and Drug Administration (NAFDAC), the racket in fake medicines is directly responsible for this resistance, and contributes to the doubling of malaria deaths over the past 20 years.

HIV/Aids treatment is also under threat from counterfeit medicines. The discovery recently of counterfeit antiretrovirals in the Republic of Congo "raises the prospect that the most advanced drugs for the treatment of HIV/Aids could be rendered useless", say Martin and Stevens. "With few new research leads in the pipeline, this could have serious consequences for the people of sub-Saharan Africa."

Bogus drugs' rapid reaction

Of concern is the speed with which counterfeiters react to new health crises, and the ways they could be undermining formal medicine's ability to treat new epidemics, such as the current wave of avian flu. As demand grows for the anti-viral drug, Tamiflu, one of the best current treatments for bird flu, counterfeiters have begun churning out illegitimate versions.

"Already the internet is awash with spurious Tamiflu, while consignments have been discovered as far apart as New York and Beijing. The risk is that copies containing sub-therapeutic levels of active ingredient could facilitate the development of drug resistant forms of the avian flu virus, leaving very few tools to contain a potential pandemic," the researchers say.

Conditions that encourage the proliferation of counterfeit medicines in the LDCs include the absence of effective intellectual property protection, a lack of adequate enforcement to crack down on defective medicines, inefficient, weak and corrupt criminal justice systems, and taxes and tariffs that hike the price of legitimate drugs and stimulate demand for cheaper fakes.

"The counterfeiting of drugs is a global problem that will not be eliminated until the supply-side issues are addressed," Morris and Stevens maintain. "The majority of counterfeit drugs are manufactured in LDCs, so reform in these countries is absolutely vital if progress is to be made. The most pressing area for reform in the majority of the LDCs is the application of the rule of law, the definition and enforceability of property rights and the enforceability of contracts.

"Without such reforms, the counterfeiters will continue to kill hundreds and thousands of people every year."

How duties push up the price of legal drugs

Country       Combined duties and taxes

Sierra Leone  40%
Nigeria       34%
Pakistan      33%
Bangladesh    29%
Jamaica       27%
Morocco       25%
Mexico        24%

Source: European Commission 2003