ENVIRONMENT & HEALTH

Intellectual Property

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Health and Intellectual Property: WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property

On May, 2003, at the Fifty-sixth World Health Assembly, the World Health Organization (WHO) adopted Resolution WHA56.27 creating the Commission on Intellectual Property Rights, Innovation and Public Health. The resolution requested that the WHO establish the terms of reference for an appropriate time-limited body to collect data and proposals from the different actors involved and produce an analysis of intellectual property rights, innovation, and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products against diseases that disproportionately affect developing countries, and to submit a progress report with concrete proposals to the Executive Board at its 116th session.

A small secretariat was established in the WHO to manage the work of the Commission. The members of the Commission were selected on the basis of demonstrated expertise and wide experience in the issues under consideration, geographical distribution, and diversity such as gender, occupational mix, and discipline.

The Terms of Reference for the work of the Commission included:

  • Summarizing the existing evidence on the prevalence of diseases of public health importance with an emphasis on those that particularly affect poor people and their social and economic impact;
  • Reviewing the volume and distribution of existing research, development, and innovation efforts directed at these diseases;
  • Considering the importance and effectiveness of intellectual property regimes and other incentive and funding mechanisms in stimulating research and the creation of new medicines and other products against these diseases;
  • Analyzing proposals for improvements to the current incentive and funding regimes, including intellectual property rights, designed to stimulate the creation of new medicines and other products, and facilitate access to them; and
  • Producing concrete proposals for action by national and international stakeholders.


The Commission issued its Final Report in April 2006.

On May 27, 2006, the Fifty-ninth World Health Assembly adopted Resolution WHA59.24 establishing an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) that would “draw up a global strategy and plan of action in order to provide a medium-term framework based on the recommendations of the Commission; such strategy and plan of action would aim, inter alia, at securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area.”

An article describing the creation and early work of the IGWG explains that:

“Before the IGWG held its first official meetings in December, the United States government reportedly sent a demarche to several developing nations with which it has trade agreements, explaining that much of what is being proposed at the IGWG may not be in the long term best interest of developing countries. The demarche observed that WHO had likely overstepped its expertise by attempting to influence international trade and intellectual property related agreements with the pending IGWG plan of action. Moreover, the demarche noted that other intergovernmental organizations, specifically the WTO and WIPO, have been established to deal with the subject matter of the IGWG and those issues should and would be taken up by those organizations.”

On April 5, 2007, at the Sixtieth World Health Assembly, the WHO Secretariat submitted “Public health, innovation, and intellectual property: progress made by the Intergovernmental Working Group.”

On July 31, 2007, the IGWG published its “Draft global strategy and plan of action on public health, innovation and intellectual property.”

The Draft global strategy explains that the global strategy, designed to promote innovation, build capacity, and improve access, will:

  • Establish a research and development agenda that covers the health needs of developing countries;
  • Propose mechanisms to carry out the above research and development agenda, including increasing worldwide capacity for research and development, particularly in developing countries, into diseases affecting those countries;
  • Secure financing for the activities resulting from the research and development agenda, including exploring innovative financial mechanisms; and
  • Seek to increase the availability, accessibility and uptake of health products (in particular, medicines, vaccines, and diagnostics) in developing countries.


After the publication of the Draft global strategy and plan of action, a global coalition of concerned civil society groups published a Civil Society commentary on the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property: Elements of a global strategy and draft plan of action.

Of particular interest to the global governance movement is the Draft global strategy’s call to support further discussion of a medical research and development (R&D) treaty.

On May 3, 2008, the 61st World Health Assembly adopted the final version of the Global strategy and plan of action on public health, innovation and intellectual property (Resolution WHA61.21). The document names eight “elements” that will be implemented to ensure “access and innovation for needed health products and medical devices,” with particular emphasis on the needs of developing countries. The eight elements detailed in the Global strategy are:

  1. Prioritizing research and development needs by “identifying gaps in research and development on diseases that disproportionately affect developing countries” and encouraging R&D in traditional medicine;
  2. Promoting research and development through national health research programs and access to knowledge and technology transfers;
  3. Building and improving innovative capacity through investment in technology, local pharmaceutical production, regulation, clinical trials, intellectual property, and traditional medicine;
  4. Transfer of technology through “North-South and South-South development cooperation, partnerships and networks;”
  5. Application and management of intellectual property to contribute to innovation and promote public health by encouraging the use of the TRIPS flexibilities and providing alternative “incentive schemes” for diseases in developing countries;
  6. Improving delivery and access through regulations, the production of generic medicines and the use of differential pricing policies by pharmaceutical companies;
  7. Promoting sustainable financing mechanisms for R&D and health products, including through public-private partnerships; and
  8. Establishing monitoring and reporting systems in regards to the goals detailed in the IGWG Global strategy and plan of action.


Implementation of the Global strategy will be largely directed by the WHO.

In November 2008, the WHO established an Expert Working Group on R&D Financing. The Working Group is responsible for examining “current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific R&D needs of developing countries in relation to Type I diseases.” The group consists of 24 experts and policy makers, and will present a final report to the World Health Assembly in May 2010.


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