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Drug Quality &Pharmacovigilence &Private Sector &Treatment Bill Brieger | 14 Jan 2010 09:28 am


dscn5015sm.JPGBBC’s Focus on Africa has identified Africa as the dumping ground for counterfeit goods. Some are cheap knock-offs of branded luxury goods that consumers know are not the real deal. Electronics are another area where the customer should beware. Others camouflage as the original product with packaging that is indistinguishable from the authentic item.

Toothpaste is a good example where the fake, which retailers call ‘Chinese’ contains a poison known as diethylene glycol which is used in anti-freeze.  The retailers sell both products for about the same price, but the incentive for pushing the fakes is profit.

On the genuine product he has made a 13% mark-up, on the counterfeit an impressive 50%. Fair play to him, some might say – after all it is only toothpaste.

But one cannot say ‘it is only medicine’ when drugs are fake. BBC notes that, “According to the World Health Organization (WHO), 30% of medicines sold in developing countries are fakes, and a major problem is that high numbers of government-owned drugs are being illegally obtained and then sold on for profit in the private sector.” BBC worries that …

… with the rising number of direct trade routes between Africa and China, together with porous border controls, outdated legislation and weak enforcement mechanisms, the continent has become fair game for counterfeiters – and the recession has made it worse.

dscn5837sm.JPGFurthermore, “A UN report published in July 2009 reveals that revenues gained from 45 million counterfeit anti-malarial medicines were worth $438m – more than the annual gross domestic product of Guinea-Bissau.” keeps an update of fake medicine reports. For example in Ghana, “A citizen brought suspect antimalarial medication to a sentinel site set up by the U.S. Agency for International Development (USAID)’s Drug Quality Information Program (DQI).” This was reported July 22, 2009, and involved a fake of Novartis Pharmaceuticals’ malaria product Coartem.

Researchers at Georgia Tech University shared information on the magnitude of the problem. “The percentage of over-the-counter counterfeit artesunate tablets containing no artesunate apparently increased from 38 to 53 percent in southeast Asia between 1999 and 2004.”

Fake drugs kill directly with dangerous ingredients or indirectly when inadequate or no active ingredients are present. They also may drive legitimate manufacturers out of business.  The threat is real and widespread in its impact.

The new funding program, Affordable Medicines Facility malaria (AMFm) aims to enable countries to place quality low-cost antimalarials into the private sector at prices that will supposedly compete favorably with inappropriate and fake medicines. Careful monitoring will be needed to see if this really happens.

Considering the profit margins mentioned above, the fake drugs may still out-compete the subsidized ones.  In short, nothing can replace a vigorous drug regulatory system and donors need to strengthen technical assistance to countries to regulatory capabilities actually work.

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