• Home
  • About Us
    • About Us
    • Subscribe
    • Privacy Policy
  • Advertise
    • Advertise On IP Watch
    • Editorial Calendar
  • Videos
  • Links
  • Help

Intellectual Property Watch

Original news and analysis on international IP policy

  • Copyright
  • Patents
  • Trademarks
  • Opinions
  • People News
  • Venues
    • Bilateral/Regional Negotiations
    • ITU/ICANN
    • United Nations – other
    • WHO
    • WIPO
    • WTO/TRIPS
    • Africa
    • Asia/Pacific
    • Europe
    • Latin America/Caribbean
    • North America
  • Themes
    • Access to Knowledge/ Open Innovation & Science
    • Food Security/ Agriculture/ Genetic Resources
    • Finance
    • Health & IP
    • Human Rights
    • Internet Governance/ Digital Economy/ Cyberspace
    • Lobbying
    • Technical Cooperation/ Technology Transfer
  • Health Policy Watch

WHO Members Meet This Week On Poor Quality Medicines

22/07/2013 by William New, Intellectual Property Watch Leave a Comment

Share this:

  • Click to share on Twitter (Opens in new window)
  • Click to share on LinkedIn (Opens in new window)
  • Click to share on Facebook (Opens in new window)
  • Click to email this to a friend (Opens in new window)
  • Click to print (Opens in new window)

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.

Share this:

  • Click to share on Twitter (Opens in new window)
  • Click to share on LinkedIn (Opens in new window)
  • Click to share on Facebook (Opens in new window)
  • Click to email this to a friend (Opens in new window)
  • Click to print (Opens in new window)

Related

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

Creative Commons License"WHO Members Meet This Week On Poor Quality Medicines" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Filed Under: IP Policies, Language, Themes, Venues, Access to Knowledge/ Education, Enforcement, English, Patents/Designs/Trade Secrets, WHO

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

  • Email
  • Facebook
  • LinkedIn
  • RSS
  • Twitter
  • Vimeo
My Tweets

IPW News Briefs

Saudis Seek Alternative Energy Partners Through WIPO Green Program

Chinese IP Officials Complete Study Of UK, European IP Law

Perspectives on the US

In US, No Remedies For Growing IP Infringements

US IP Law – Big Developments On The Horizon In 2019

More perspectives on the US...

Supported Series: Civil Society And TRIPS Flexibilities

Civil Society And TRIPS Flexibilities Series – Translations Now Available

The Myth Of IP Incentives For All Nations – Q&A With Carlos Correa

Read the TRIPS flexibilities series...

Paid Content

Interview With Peter Vanderheyden, CEO Of Article One Partners

More paid content...

IP Delegates in Geneva

  • IP Delegates in Geneva
  • Guide to Geneva-based Public Health and IP Organisations

All Story Categories

Other Languages

  • Français
  • Español
  • 中文
  • اللغة العربية

Archives

  • Archives
  • Monthly Reporter

Staff Access

  • Writers

Sign up for free news alerts

This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy

Copyright © 2022 · Global Policy Reporting

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.