Counterfeit Drugs: Definitions Matter, but Not as Much as Quality and Safety

 Dr. Kristina M. Lybecker

The safety and efficacy of medicines is something that most patients in developed countries take for granted.  Whether it’s a vaccination, prescription, or over the counter drug, most people assume that the medicines they’re getting are legitimate.  While bogus drugs are most frequently found in the most vulnerable markets – those of developing nations that all too often lack access to medicines –  this is certainly not always the case. 

Over the past year, many developed countries have placed a greater focus on ensuring the safety of the drug supply chain.  Brought to the fore by the deaths of a number of patients in the United States who received a counterfeit batch of the blood thinner heparin in early 2007, drug regulators in North America and Europe in particular have been placing a greater focus on ensuring the safety of the drug supply chain.  One of the great challenges facing regulators is the global scope of drug production and distribution.  No single country can effectively address this problem.

According to the US-based Centre for Medicines in the Public Interest (CMPI), counterfeit drug commerce is estimated to grow 13% annually through 2010.  “That means counterfeit drug sales will grow at nearly twice the rate of legitimate pharmaceutical commerce,” states Peter Pitts, President of CMPI.  “In 2010 this illegal business will generate $75 billion in revenues – a 92% increase from 2005.  The profits are high and the risks are low.  That’s a deadly combination.”

Earlier this year, a draft resolution on counterfeit medical products was submitted to the World Health Assembly by the nations of Gambia, Ghana, Nigeria, Tunisia and the United Arab Emirates.  Their efforts clearly bring a critical public health challenge to the WHA agenda, and yet special interest groups have side-tracked this initiative into a great debate over the definition of ‘counterfeit’. 

This is not to suggest that definitions don’t matter.  Certainly they do.  But those who are quibbling over words seem to have lost track of the bigger picture:  quality medicines and safe drugs.  Implicit in all efforts to eliminate counterfeiting is the recognition that drugs should be safe and consumers should have accurate information about their pharmaceutical choices.

Counterfeit and substandard drugs are dangerous not only to the patients who take them, but to the global community as a whole through the drug resistance that they propagate.  Antimalarial drugs are an unfortunate example of this situation.  In a recent article published by PLoS One, antimalarial drugs from the major cities of six African nations were purchased and chemically analyzed.  Thirty five percent of all samples failed to register active pharmaceutical ingredient content against internationally acceptable standards.  The case of malaria is particularly troubling given the limited therapies available.  As described in the article, the drug resistance fostered by substandard products “places the future of malaria treatment at risk globally”.  

Delegates at the 61st World Health Assembly spent much of their time discussing the recommendations of an Intergovernmental Working Group on ways to encourage research and development for neglected diseases and improve access to medicines for developing nations.   Unfortunately, the issue of counterfeit medicines was not considered in these discussions.

If the World Health Organization and the global community are serious about improving access to medicines, they must aggressively tackle combating counterfeit drugs.  It is essential to move beyond fine tuning definitions to establishing an effective, global anti-counterfeiting strategy.   Ensuring quality in pharmaceutical manufacturing begins with the ingredients or APIs (active pharmaceutical ingredients) and must be safeguarded through to final products.   Effective oversight and a secure pharmaceutical supply chain will help to protect consumers from counterfeits as well as substandard production.

The United States, European Union and Australia recently announced a joint venture to improve the inspection processes of pharmaceutical manufacturing facilities around the world.  While this is an encouraging start, a more comprehensive effort is required to truly improve global health and to eliminate all barriers to access, including counterfeits.  

Lybecker is an Assistant Professor in the Department of Economics and Business at Colorado College.  She has consulted for the US FDA, Reconnaissance International, the World Bank, PhRMA, as well as several multinational pharmaceutical firms on the issues of pharmaceutical counterfeiting, access to medicines, corruption, and innovation.