[Ip-health] Public Health in the hands of Non-Health Agencies?

Shilpa Modi Pandav smodipandav at gmail.com
Wed Sep 29 03:28:17 PDT 2010


*Public Health in the hands of Non-Health Agencies?*

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



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