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Counterfeit Drugs: The Silent Epidemic

May 27, 2012

A third of malaria drugs in the world are counterfeit. These are the findings of the Lancet Infectious Diseases research (reported by BBC here). These findings spur concern because counterfeit malaria drugs not only make the treatment of malaria not effective but are also likely to cause drug resistant malaria strains. This problem, however, is not limited to malaria drugs.

As much as 15% of medicines in the world are counterfeit thus causing 100,000 deaths worldwide according to the WHO. The increase of counterfeit drugs across the world in the last decade is both a consequence and a symptom of one phenomenon: the globalization of drugs production and distribution. The supply chain of medicines has become increasingly fragmented and scattered across the globe with raw material extraction taking place in one country and ingredients synthesis and formulation in another country. This globalized supply chain has two implications:

1. It makes the counterfeit drugs problem not an exclusivity of developing countries: developed countries are as much exposed to this risk as least developed countries.

2. If the problem is global, the solution has to be global too. As long as pharmaceutical companies source their active pharmaceuticals ingredients (APIs) in other countries any regulation which  is purely domestic is bound to be ineffective.

One of the key obstacles to designing purposeful solutions to counter this problem is that the definition itself of counterfeit is fraught upon. Take the case of Uganda: the government drafted an Anti-Counterfeit Goods bill with the intent to stamp out fake goods. Good news for the health of the public hence. The definition of counterfeit however was all encompassing and it identified any drugs produced in breach of patents laws (i.e. copying without the permission of the patent holder) as counterfeit. The point is that a significant chunk of generic drugs which ensures an affordable access to treatment for millions of people in Uganda could have fallen within this broad category. Opponents of the legislation argue that this definition misses the point (counterfeit implies deliberate misslabeling not patent breaching) and leaves room for missapplicaiton as any batch of generic drugs stands the risk of being sezied by authorities on the ground of being allegedly counterfeit. This however would be dramatic as it would slow down and interrupt the already fragile medicine supply chain in least developed countries.

The debate in Uganda mirrors the discussion at the global level with the WHO- sponsored- IMPACT (International Medical Products Anti-Counterfeiting Task-force)  initiative blocked on the same ground: it intends to address the problem safety and reliability of those drugs while risking to undermine the affordable and reliable access to life saving drugs. For this reason, China and India (two major producers of generic drugs) have stalled the IMPACT initiative on the ground that it is beyond the mandate of the WHO. So what is the way out of this deadlock? Laurie Garrett of Council on Foreign Relations and Tim Mackey and colleagues in Foreign Affairs have some interesting ideas (see here and here).

The fundamental idea that one has to keep in mind is that the confusion about the the definition of counterfeit brings to the fore two competing and clashing interests: business versus public health. As any agreement on counterfeit drugs will include trade regulations, the balance of forces is likely to tip in favor of the business interest. If people around the world are to be ensured of an affordable access to safe and reliable life saving drugs intellectual property rights and public health interests must be both taken into account. From this perspective substandard and counterfeit drugs, and not generic drugs, are the enemy .

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