Substandard, Falsified Medicines Not About IP, Geneva Experts Say

Falsified and substandard medical products continue to be a global concern, and how those products are characterised is important to avoid confusion, particularly with intellectual property rights infringement. A panel convened by Brazil, India and South Africa yesterday at the World Trade Organization looked at the implications of a new definition of such products at the neighbouring World Health Organization.

WHO members at their 2017 World Health Assembly simplified the definition of what had been called “substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC)” medical products. At issue was the inclusion in the definition of “counterfeit,” a term that relates to trademark infringement under WTO rules.

The new working definition [pdf] is “substandard and falsified medical products” and includes three descriptions: substandard medical products, unregistered/unlicensed medical products, and falsified medical products.

Michael Deats, group lead for Substandard and Falsified Medical Products at the WHO, said that during the controversy about the definition of substandard and falsified medical products, in 2012, the WHA established the Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit/medical products. He added that the mechanism excludes all IP and trade considerations. At the time it was recognised that WHO does not have expertise in those areas and deferred to the WTO.

He mentioned two reports published last year on the issue: a report on the WHO Global Surveillance and Monitoring System [pdf] for Substandard and Falsified Medical Products, and a study [pdf] on the public health and socioeconomic impact of substandard and falsified medical products.

[For the full story, please see Intellectual Property Watch.]

 

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