Fighting Fake Drugs With Technology

On July 23rd, 2008, the first National Dialogue on Counterfeit Products closed at Alisa hotel, and its sponsors: the Food & Drugs Board, the EU BizClim Facility, and the Institute of Packaging (the last two acting through the Coalition Against Counterfeiting & Illicit Trade) set about to deliver on the commitments made in the final communiqué.

The communiqué identified 4 major areas in which significant improvement will lead to significant results in the fight against counterfeiting in Ghana. These areas are: 1. Sub-regional cooperation across West Africa; 2. Inter-Agency collaboration within Ghana; 3. The Development of a national standard on technology; and 4. The formation of a National Anti-Counterfeiting Task Force to harmonise existing regulatory frameworks.

The need for these actions was based on the considerable danger posed to national life by counterfeiting. The EU Study that was unveiled during the dialogue asserted that Ghana lost about $200 million as a result of counterfeiting impacts on revenue collection alone every year. The counterfeiting of such products as building components, automotive spares, beverages and other consumable goods also adversely affect the viability of legitimate local manufacturers and authorised distributors.

But the figure quoted above does not include the human costs, which are, obviously, unquantifiable. This is particularly critical when it comes to the most sensitive products of them all: pharmaceuticals and medical devices. A snapshot of the effects of counterfeiting in this area from around the world shows the gravity of the situation:**

- During a meningitis epidemic in Niger in 1995, more than 50 000 people were inoculated with fake vaccines resulting in 2 500 deaths. The vaccines were received as a gift from a country which thought they were safe. - 89 children died in Haiti in 1995 and 30 infants died in India in 1998 due to the consumption of paracetamol cough syrup prepared with diethylene glycol (a toxic chemical used in antifreeze). - In 2001, in South-East Asia, a Wellcome Trust study revealed that 38% of 104 anti-malarial drugs on sale in pharmacies did not contain any active ingredients. - In Cambodia, in 1999, at least 30 people died after taking counterfeit anti-malarials prepared with sulphadoxine-pyrimethamine (an older, less effective anti-malarial) which were sold as artesunate. - A study by the US based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach *US$ 75 billion globally in 2010, an increase of more than 90% from 2005*. - Many countries in Africa and parts of Asia and Latin America have areas where more that 30% of the medicines on sale can be counterfeit, while other developing markets have less than 10%; overall, a reasonable range is between 10% and 30% - Many of the former Soviet republics have a proportion of counterfeit medicines which is above 20% of market value — this falls into the developing country range - Medicines purchased over the Internet from sites that conceal their physical address are counterfeit in over 50% of cases. - In Angola, according to the National Department of Intellectual Copyright Crime of the Economic Police, approximately 70% of medicines used by the Angolan population were forgeries. - In Nigeria, the Ebonyi State Task Force on Counterfeit and Fake Drugs reported that approximately 48% of goods and drugs imported into the country were substandard or counterfeit. - In 2003, The Philippine's Bureau of Food and Drug (BFAD) reported that 30% of drug store outlets visited by food and drug deregulation officers carry and sell counterfeit drugs. - An AFM study in 2007 discovered that as much as 35% of the anti-malarials found in several countries in Africa were sub-therapeutic (i.e. sub-standard).

(Credit: World Health Organisation and Africa Fighting Malaria)

It is thus a healthy development that the four actions recommended in the communiqué mentioned above have already begun to receive attention. The Food & Drugs Board and the Coalition Against Counterfeiting & Illicit Trade are already producing follow-up reports to ensure that the momentum achieved by the July Dialogue will not dissipate.

The action point on technology has also seen remarkable progress. There is now an active proposal that the mPedigree platform which was established and piloted in January through March 2008 be extended to encompass the sub-region with Nigeria and Ghana as the pivots.

The platform allows drug buyers and/or consumers to check whether their purchases are genuine or not, *for free*, by making it possible for them to use their mobile phones to send special, non-duplicable, codes embossed on drugs and to receive in a few seconds a response confirming or denying the authenticity of the product concerned. Expiry dates and other alerts may also be communicated to consumers in this way. All telecom carriers in Ghana are participating.

Other upgrades to the system may include electronic product registration across the sub-region (eliminating the current hurdles faced by manufacturers and distributors who sell across borders), rapid response mechanisms for regulators across the ECOWAS region, and clinical trial modules to improve on the drug testing and pharmacovigilance processes in Ghana and farther afield.

By linking producers and distributors on the one had, with consumers and regulators on the other hand, the mPedigree system is designed to eliminate the information blockages on which counterfeiters thrive.

A stakeholder governance mechanism involving institutional players like the FDB, CACIT, PMAG and others will ensure that the mPedigree remains the public service platform it was designed to be, free to consumers and convenient to manufacturers and other supply chain actors.

Another interesting aspect of the platform is that it is being fully developed right here in Ghana, and will, once comprehensively operational, be the world's first consumer protection system of its kind.