HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Thursday, September 1, 2011

Guest Blogger Jan OseiTutu: Counterfeit Medicines & Intellectual Property Enforcement

Jan OseiTutu
The global sale and trafficking of “counterfeit” medicines is dangerous, and the effects can be devastating. The World Health Organization (WHO) International Medical Products Anti-Counterfeiting Task Force  (IMPACT) is part of an international effort, led by WHO, to tackle the problem of counterfeit medicines. These fake medicines are a threat to public health in both developed and developing countries. However, it is estimated that the percentage of counterfeit drugs is higher where the regulatory structure is weaker. Intellectual property advocates and pharmaceutical company representatives portray the poor global enforcement of intellectual property rights as part of the problem. On the other hand, some scholars suggest that intellectual property rights are the very reason that counterfeiting is profitable.

here is no doubt that fake medicines pose an unacceptable public health risk. But, it is not always clear what is meant by the term “counterfeit” medicines, and this can obscure the line between private intellectual property rights and public health matters. When the term “counterfeit” is used, it could mean a number of things. The medications may be understood to be “counterfeit” in the intellectual property sense. Indeed, trademarks, copyright or patents may be infringed when medicines are sold using the packaging or drug formulations that belong to legitimate innovator or generic companies. Sometimes generic drugs are also confused with counterfeit medicines. However, a generic medicine is not the same as a counterfeit medicine, but rather is a less expensive equivalent[1] to the brand (innovator) medication. The reference to “counterfeit” drugs could also mean that the medication is “fake” because it contains toxic ingredients, or insufficient therapeutic ingredients, and has been manufactured under dangerous conditions. This medication is “counterfeit” in the sense that it is fake medication that can be harmful or even fatal. The sale of these fake medications normally involves the infringement of intellectual property rights as the counterfeiter attempts to have the fake drug pass as the real thing. This is why the global intellectual property enforcement agenda has been linked to public health.

Arguably, the challenge of dealing with fake or “counterfeit” drugs would be most appropriately addressed by national health institutions, relying on health based criminal penalties rather than on intellectual property offenses. Naturally, the health authorities would need to cooperate with criminal and border enforcement agencies, working in concert with their global counterparts. While increased border enforcement could focus on some health-oriented criteria, it could equally mean heightened monitoring and enforcement of intellectual property rights. My current project explores whether, bearing in mind the concern about the impact of intellectual property rights on access to medicines in developing countries, the need to protect the public health presents a strong case for increased global enforcement of intellectual property rights.

-  J. Janewa OseiTutu

[1] A generic medication is not necessarily identical to the medication manufactured by the innovator company. However, depending on the applicable law of the country in which it is being sold, it would have been determined to be sufficiently equivalent to be used as a substitute for the brand.

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