WHO Members Meet This Week On Poor Quality Medicines

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World Health Organization members are meeting this week to advance the international mechanism against substandard and counterfeit medicines.

The 23-24 July meeting at the WHO is the “Open-ended Working Group to Identify the Actions, Activities and Behaviours that result in substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products”.

Meeting documents, including the draft agenda and a report by the secretariat, are available on the WHO website here.

The 16 July secretariat report includes in an annex a “non-paper” from Brazil on “Practices of Health Authorities and WHO in the Process of Ensuring the Quality, Safety and Effectiveness of Medical Products.”

According to the secretariat report, there have been comments on this paper submitted by Argentina, Mali, the United States, and possibly others, but they do not appear to be public.

The SSFFC issue has historically been sensitive among member states, making agreement difficult (as exemplified by the complex SSFFC name itself). All countries seek to prevent these types of medicines in their markets, but some have been concerned that measures taken not interfere with the flow of legitimate and affordable generic versions of the more expensive brand-name drugs.

This year, the mechanism is expected to move forward on: establishing the working group on the actions, activities, and behaviours that result in SSFFC medical products; convening a technical consultation on the work plan; and a steering committee meeting.

The WHO member-state mechanism on SSFFCs was established at the May 2012 World Health Assembly but started slowly last year. The mechanism is mandated to look at the problem from a health perspective, and not consider intellectual property or trade. The expert group held its first meeting in Buenos Aires in November 2012 and agreed on a roadmap (IPW, WHO, 22 November 2012), but disagreement over selection of a chair slowed progress. It was proposed by Brazil to have a rotating chair, which was accepted in a breakthrough at the May 2013 Assembly (IPW, WHO, 26 May 2013).

At this week’s meeting the chair is Brazil.

The Brazilian non-paper includes a list of “premises to characterize the necessary measures to guarantee the safety, effectiveness and quality of medicines offered to the population.” It states that it is up health authorities to ensure that only medicines meeting the requirements of quality, safety and efficacy are produced.”

It recommended that the focus on health surveillance be on the problematic activities and behaviour, rather than on definitions, which can be left to the national level (e.g., “false products/counterfeit/falsified/fake”). Definitions of activities and behaviours must involve a descriptive exercise (such as to produce, commercialise, distribute, or store), Brazil said.

The non-paper also says health authorities’ focus (with WHO support) should be on prevention and control. It describes measures for health registration of medical products (making the distinction that this does not apply to trademarks).

For instance, activities in production that: violate the registered formula, fail to comply with good manufacturing practices, modify packaging with compliance with health regulations and without authorisation from the health authority; or repack the product in order avoid inspection or change the expiration date.

The non-paper similarly describes violating activities by third parties, and in product distribution.

The non-paper explicitly states that activities and behaviours relating to ownership of patents or to trademark infringement are irrelevant to these discussions, as they are not under health registration and authorisation.

William New may be reached at wnew@ip-watch.ch.

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