Por: Shilpa Modi Pandav

The Interpol media release dated 26 August 2010 announces seizure of at least 10 tons of counterfeit and illicit medical products and arrests of 80 individuals suspected of involvement in the illegal manufacture, trafficking or sale of counterfeit and diverted medical products under East Africa’s Operation Mamba III.

In the release it is stated that the Operation Mamba III (July-August 2010) was coordinated by INTERPOL and was undertaken under the umbrella of the World Health Organization’s (WHO) International Medical Products Anti-Counterfeiting Taskforce (IMPACT). The Operation involved police, customs and drug regulatory authorities across Burundi, Kenya, Rwanda, Tanzania, Uganda and Zanzibar. Forensic assistance was provided by the laboratories of the Singaporean Health Science Authority. The operation also included support from the World Customs Organization.

The Operation raises questions about the definition of “counterfeit medicines” adopted by Operation Mamba III. The agencies involved have conflicting definitions of counterfeit. Although the definition of counterfeit is still being debated by IMPACT Taskforce’s partners, there is a clear consensus amongst them that “counterfeit” medicines should not be confused with issues relating to medicines that are not authorized for marketing in a given country, nor with patents violations or disputes. The word “counterfeit” is also commonly used in relation to goods that infringe trademarks. Falsified or counterfeit medical products may infringe intellectual property rights, but whether a good is considered counterfeit from a public health perspective is independent of whether the product infringes intellectual property rights. According to its mandate, WHO is working on the issue of counterfeit medical products from a public health perspective (WHO 2010)

This is in contrast to how counterfeit has been defined by the World Customs Organization in Provisional Standards Employed by Customs for Uniform Rights Enforcement (SECURE) dated June 2007. The definition links IP infringement to counterfeit. The confusion over IP and safety issues is reflected in the introduction, in which erroneously IP violations are identified as serious threat to the “health, safety and economic interests of the entire world.” Patents or trademarks have no relationship with quality, safety and efficacy of medicines. It states that the WCO will co-operate and co-ordinate its IPR enforcement efforts with Interpol, WIPO, OECD, WHO and other regional or international organizations having IPR responsibilities.

A recent report from the Organization of Economic Co-operation and Development that purported to measure the economic impact of counterfeiting and piracy went a step further by contending that “patent rights are also infringed when a patented process or method is employed by the counterfeiters, as unauthorised users, to produce the active ingredient(s), excipient(s) or finished product(s)” (OECD 2008) This extends the definition to include the patent status of the raw materials used as well.

While, the Operation Mamba III might be technically sound, there is a need of transparency on if the goods were also seized on the basis of IP infringement. The medicines of poor quality represent a threat to public health. However, confusing counterfeit medicines with legitimate generic medicines or generic medicines that may be patent infringing in ‘third’ countries is also a threat to public health by curtailing access to legitimate medicines.

In absence of transparency the question in the interest of public health is how were counterfeits defined under Operation Mamba III?

*References*

World Health Organization (2010). Counterfeit medical products International Medical Products Anti-Counterfeiting Taskforce Report by the Secretariat Sixty-third World Health Assembly. Provisional agenda item 11. 20 22 April 2010 A63/inf.doc./3

Organisation for Economic Cooperation and Development (2008). The Economic Impact of Counterfeiting and Piracy. Paris: OECD.

World Customs Organization (2007) SECURE, Provisional Standards Employed by Customs for Uniform Rights Enforcement (SECURE), [Provisional Global Customs Standards to Counter Intellectual Property Rights Infringements], June 2007

Interpol media release dated 26 August 2010, East Africa’s Operation Mamba III bolsters fight against counterfeit medicines with INTERPOL-IMPACT support, http://www.interpol.int/Public/ICPO/PressReleases/PR2010/PR065.asp