Counterfeit drugs take hefty toll in developing world

A new report analysing the trade in counterfeit and substandard medicines has drawn attention to the shocking scale of the problem in less-developed countries (LDCs), where fake malaria and tuberculosis drugs alone kill 700,000 people each year.

The Keeping It Real report, which is authored by Julian Harris of the non-profit International Policy Network, is peppered with alarming statistics, most of which come from studies conducted in sub-Saharan Africa and Asia.

It notes, for example, that nearly half of all medicines in countries such as Ghana, Nigeria, Angola, Burundi and Congo are substandard, while citing a 2006 study which found that 68 per cent of artesunate – an important antimalarial drug – in southeast Asia (Laos, Myanmar, Vietnam and Cambodia) did not have the correct levels of active ingredient.

The human cost of the trade lies in the failure of these products to provide effective treatment, direct harm from toxic components and perhaps most seriously from a public health perspective, the generation of drug resistance in infectious agents such as HIV, malaria and TB.

As well as painting a bleak picture of the trade in LDCs, the report also identifies some critical problem areas and offers some recommendations for curbing the trade.

One problem in LDCs lies in defective legal systems with little or no civil liability to protect consumers against mis-sold or defective groups, slow legal process and a lack of constitutional provisions, according to the report.

Harris believes current attempts to deal with the problem through tougher regulation and criminal penalties do not address the root causes of counterfeiting. Many countries have corrupt regulatory and legal systems that are easily exploited by criminal counterfeiters, and additional rules will only increase corruption.

He recommends measures aimed at strengthening local institutions, and particularly the rule of law, for example by making it easier for manufacturers to protect their trademarks and brands.

“Although highly desirable from the perspective of wider economic development, bolstering the rule of law in LDCs is a long term and uncertain process.

Meanwhile, governments also exacerbate the problem by making legitimate drugs more expensive through taxes, tariffs, price controls and arbitrary regulations, says Harris.

“Many existing licensing systems for pharmaceuticals in LDCs serve practically no purpose other than to restrict the sale of legitimate products manufactured by foreign companies. As such, they offer a boon to suppliers of fakes.”

Governments can alleviate this by intervening less in the pharmaceutical market, he suggests.

 “The most fundamental cause of the spread of fake drugs in less developed countries has been the inability of manufacturers to protect the identity of their products,” argues the report. While this also stems from the lack of functioning rule of law, greater use of technologies could also provide a solution, it says.

Early attempts by the private sector to prevent counterfeiting relied on trademarked branding and idiosyncratic pill shapes and colours, which in time graduated to technologies such as holograms. However, even these are now routinely copied by counterfeiters and attention has moved on to “barcodes, RFID tag systems or simple scratch panels.”

The report cites the use of scratch panels on medicines carrying codes that can be sent via SMS as an interesting authenticity technology with application in LDCs, where mobile phone access can be considered “near-universal.”

One such system, developed by Ghanaian company mPedigree, was featured in an earlier article on SecuringPharma.com which can be read here.

The fight against fake medicines has the advantage that many criminals involved are unlikely to have a particular commitment to this activity, says the report, and by tackling the root causes their incentives to participate can be diminished “reclaiming the market for high quality medicines.”

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International Policy Network