Defining the Problem

Bryan A.  Liang, MD, PhD, JD

Often understanding a problem begins with a definition.  The World Health Assembly, the decision-making body of the World Health Organization (WHO), meets each May to discuss public health issues and determine future WHO policies.  This year, WHO’s constituted International Medical Products Anti-Counterfeiting Taskforce (IMPACT) introduced a resolution to update WHO’s definition of a counterfeit medicine.  IMPACT proposed changing the definition from “deliberately and fraudulently” mislabeling a medicine’s identity and source to the “false representation” of a medical product’s identity, history or source.

This change seems pretty innocuous. However, IMPACT’s proposal encountered strong resistance from India, claiming that the new definition went too far and would jeopardize exports from its generic drug makers.

According to an Indian newspaper article, Indian “experts” argued that IMPACT’s definition was too broad since it included medical devices, diagnostic tools, accessories and active pharmaceutical ingredients, in addition to finished medicines. They also argued that proposed definition could be used to brand genuine generics as counterfeit if they are similar either in look or color to the original, branded product.

Well, genuine generic medicines (which are clearly not medical devices, diagnostic tools, or accessories), don’t make any “false representation” of their identity, history, or source. It’s only counterfeits that attempt to pass themselves off as real and legitimate and would fall within the definition. So who and what interests are these Indian “experts” protecting?

But the most disturbing argument these Indian “experts” put forth was that counterfeiting is only an issue of trademark violations and not a public health issue.

Not a public health issue? Would the counterfeit drugs ingested by Marcia Bergeron that killed her be just a “trademark” issue and not relate to public health? I think her family would disagree, as well all the other families whose loved ones who were harmed, left untreated, and killed by counterfeit drugs.

India’s opposition to IMPACT’s resolution is a tremendous set back for the international community, and especially for the developing world. We know that counterfeiting is rampant in countries with poor government oversight or that lack the resources to enforce their anti-counterfeiting laws. And it is their citizens that are exploited by these nefarious characters peddling fakes who are powerless to engage in the niceties of arguing with Indian “experts” in this debate.

Individual countries are beginning to understand that counterfeit drugs are a global public health hazard that requires an international solution. Until we are unified in our fight against counterfeit drugs, these criminals will continue to take advantage of the developing world’s need for vital medications to treat diseases such as malaria, bacterial infections and influenza. WHO’s IMPACT efforts are a part of this effort. But the Indian reaction indicates we must vigorously continue our efforts because powerful stakeholders and interests are in play.

In the meantime, keep visiting to learn how we can work together to protect the safety of our prescription medicines.