TWN Info Service on WTO and Trade Issues (June08/02)
04 June 2008
Third World Network

WHO: WHA strengthens WHO's mandate on IP and Health
Published in SUNS #6482 dated 27 May 2008

Geneva, 25 May (Sangeeta Shashikant) -- The highlight of the 61st World Health Assembly was the adoption of a resolution that strengthens the mandate of the WHO to undertake work on the inter-related issues of public heath, intellectual property, innovation and access to medicines.

The resolution, adopted at the end of the WHA during the plenary session, last Saturday afternoon, covers the Global Strategy (GS) and agreed parts of the Plan of Action (POA) on Public Health, Innovation & Intellectual Property.

The Resolution has come after two years of negotiating the GS & POA in an Intergovernmental Working Group (IGWG) and five days of almost non-stop negotiations in an informal open-ended drafting group throughout the period of the WHA that began on 19 May.

The drafting group that began meeting on Tuesday and met throughout the week often until midnight, had the task of resolving 16-bracketed paragraphs of the GS, the POA and the Resolution that would adopt the GS & POA.

On more than one occasion, the discussions ended up taking place in "green-room" type of meetings (i. e. meetings open to only some key delegations e. g. India, Brazil, EU, US, Thailand, Norway, South Africa, and Kenya) to the dissatisfaction of other delegations left out of the negotiations.

Negotiations on the text on IP and the role of WHO were the most difficult areas to resolve.

However, most delegates and NGOs seem pleased with the outcomes, in particular, that the GS appears to strengthen the role of WHO in the area of IP and Public Health.

On this, a principle in the adopted GS underscores that "the WHO shall play a strategic and central role in the relationship between public health, innovation and intellectual property within its mandates (including those contained in relevant WHA resolutions), capacities and constitutional objectives, bearing in mind those of other relevant intergovernmental organizations. In this context, the WHO including the regional and, when appropriate country offices, need to strengthen its institutional competencies and relevant programs in order to play its role in implementing this global strategy and its plan of action".

A diplomat from Brazil, which was a key player in the negotiations on the Global Strategy, called the Resolution an "achievement" in terms of IP and public health. He said that the GS reaffirms as well as widens the mandate of the WHO in the area of IP and public health, and there is now no dispute that WHO has a role to play in the area of IP.

Dr. Tido von Schoen-Angerer, Director of MSF's Access to Essential Medicines Campaign, said "What is encouraging is that governments have clearly called for the WHO to play a strategic and central role in intellectual property".

The atmosphere in the final plenary, which ended three hours past the time set for the closing of the WHA, was extremely tense and delicate as some countries tried to exclude implementation of the most hard fought language on IP by insisting that the WHO Director-General only implement actions in the GS where the role of WHO in the POA had been agreed.

The Resolution urges member states to implement the specific actions recommended in the GS and POA, to support actively the wide implementation of the GS and POA and to consider providing adequate resources for its implementation.

In paragraph 4, it further requests the DG, in implementing the global strategy and agreed parts of the POA, without prejudice to the existing mandates, to:

(1) provide support for member states upon request in implementing the GS & POA;

(2) support effective promotion and implementation of the GS & POA;

(3) continue to implement mandates contained in existing WHA resolutions;

(4) finalise urgently the outstanding components of the POA, including time-frames, progress indicators, estimated funding needs and to submit the final plan of action for consideration by the 62nd WHA through the Executive Board;

(5) coordinate with other relevant international intergovernmental organizations including WIPO, WTO and UNCTAD, to effectively implement the GS & POA;

(6) prepare a Quick Start programme with adequate budget provision and to begin immediately to implement the elements of the GS & POA that fall under the responsibility of the WHO;

(7) establish urgently a "results-oriented and time-limited" experts' working group to examine current financing and coordination of R&D as well as proposals for new and innovative sources of funding to stimulate R&D needs of developing countries and open to consider proposals from Member states;

(8) include adequate resources in the forthcoming proposed programme budgets for effective implementation of the GS & POA; and

(9) monitor performance and progress in implementing the GS & POA.

Bolivia during the Committee meeting (before the plenary session) declared that the Terms of Reference of the expert group (referred to in 7 above) should be sufficiently broad to include the possible consideration of proposals for new incentive schemes to stimulate R&D. Bolivia reserved its right to present proposals to the expert group, adding that the resolution should be read in the context of this understanding.

Barbados and Bolivia have submitted six proposals, some of which are on incentive schemes, which have yet to be discussed.

Controversy over the chapeau of paragraph 4 led to a delay in adopting the Resolution.

Switzerland, in a committee before the plenary, unexpectedly pushed for an amendment to the Resolution wherein the WHO DG would only implement the agreed parts of the POA where the role of WHO, as a stakeholder, had been agreed. The matter could not be resolved during the Committee meeting and was pushed over to the plenary.

During the official plenary, Brazil argued that the language proposed by Switzerland would limit WHO's work in areas where it already had mandates through existing Resolutions, adding that the main contention among Member States was not whether WHO had a role or not. It said that there was agreement that WHO had a role, the disagreement was whether "WHO" should be stated in the POA for some of the specific actions as a "lead" stakeholder.

Following some suggestions by other countries including the US, the language, which was agreed to, was "in implementing the global strategy and agreed parts of the POA without prejudice to the existing mandates".

However, the US attempted in the last minutes prior to the adoption of the Resolution to propose changes to paragraph 4 as follows "in implementing provisions of the GS and in a manner consistent with the POA", which threatened to derail the entire process.

However, after a plea by Brazil and by the WHO Director-General, Dr. Margaret Chan, the US dropped its request.

In her appeal to the US, Dr Chan said that "I am well aware of your thinking", adding that she had sat through the informal deliberations. She further said that she will deliver nothing more or less than what is required.

According to an expert within the WHO, the language that has been agreed upon gives WHO all the mandate it needs to implement the GS since in the agreed parts of the POA, the disagreement is simply over whether WHO should be the "lead" stakeholder. However, there is agreement that WHO should play some role.

The GS adopted by the Resolution contains consensus text on "The context", "The aim", "The principles", and specific actions on eight Elements, i. e. on Prioritising research and development needs (Element 1); Promoting research and development (Element 2); Building and improving innovative capacity (Element 3); Transfer of technology (Element 4); Application and management of intellectual property to contribute to innovation and to promote public health (Element 5); Improving delivery and access (Element 6) ; Promoting sustainable financing mechanisms (Element 7); Establishing monitoring and reporting systems (Element 8).

The POA contains four columns. Two columns contain the Elements and specific actions found in the GS, while two other columns list the stakeholders and the time frame. Lead stakeholders are highlighted in bold.

Some parts of the "stakeholders" especially in the area of IP are still in brackets (i. e not agreed) and the main contention is whether WHO should be the "lead" stakeholder.

According to sources, during the week, there were strong attempts by several developed countries to remove WHO as a "stakeholder" especially where it concerned IP. However, this attempt was not successful. Sources say that there is agreement that WHO should play some role, but contention remains as to whether WHO should be stated as a "lead" stakeholder.

Despite week-long informal negotiations on the 16 bracketed paragraphs of the GS, consensus on the full text of the GS was only achieved on Saturday morning in the Committee, wherein two remaining bracketed paragraphs were cleared.

Bolivia, Cuba, Nicaragua, Dominican Republic, Argentina, Honduras, Ecuador, and Venezuela were keen to reflect in the GS that the right to health takes precedence over commercial interests.

However, due to significant opposition to its inclusion particularly from the developed countries, this addition was dropped. However, Venezuela insisted that it be recorded that the issue of the right to health over commercial interests is a topic that continues to be relevant, further adding that the WHO is the natural forum.

Ecuador also dropped its proposal to include reference to the WIPO Development Agenda under a specific action in Element 5 (on application and management of IP).

Of the entire GS, Elements 5 and 6 were the most controversial. Some specific actions under these elements (such as on anti-competitive measures, TRIPS-plus) took hours of negotiations before agreement was achieved.

Areas where no agreement could be reached and thus have been deleted from the GS are on data exclusivity and developing guidelines for patent examiners on applying patentability criteria and counterfeiting of medical products.

Another major achievement is the removal of specific listing of diseases. Previously under the part on "Aims", what remained in brackets was a footnote which referred to Type I, II and III diseases, and which mentioned the "specific diseases" on which the draft strategy will focus.

The final version of the GS removed the list of diseases and states as follows under Aims: "For the purposes of this strategy, the definitions of Type I, II and III diseases are as referred to by the Commission on Macroeconomics and Health and further elaborated in the CIPIH report:

Type I diseases are incident in both rich and poor countries, with large numbers of vulnerable populations in each. Type II diseases are incident in rich and poor countries, but with a substantial proportion of the cases in poor countries. Type III diseases are those that are overwhelmingly or exclusively incident in developing countries. The prevalence of diseases and thereby their categorization in the typology can evolve over time."

Overall, some key parts in Element 5 that have been agreed to in the GS are:

(1) development of user-friendly global databases which contain information on the administrative status of health related patents;

(2) promote active and effective participation of health representatives in IP related negotiations;

(3) providing as appropriate upon request in collaboration with other competent international organizations technical support to countries that intend to make use of TRIPS flexibilities;

(4) take into account where appropriate the impact on public health when considering adopting or implementing more extensive intellectual property protection than is required by TRIPS (TRIPS plus);

(5)  encourage finding ways in ongoing discussions, to prevent misappropriation of health related traditional knowledge and consider where appropriate legislative and other measures to prevent misappropriation;

(6) explore and promote a range of incentives for R&D including addressing where appropriate the de-linkage between the costs of R&D and the price of health products.

Under Element 6 (on improving delivery and access), some key areas reflected in the GS are:

(1) invest in developing health delivery infrastructure and encourage financing of health products;

(2) encourage pool procurement mechanisms;

(3) promote ethical principles for clinical trials involving human beings as a requirement of registration of medicines and health related technologies;

(4) support the production and introduction of generic version in developing countries, through the development of national legislation and/or policies that encourage generic production and entry including a regulatory exception or Bolar type provision;

(5) frame and implement policies to improve access to safe and effective health products;

(6) consider where appropriate the development of policies to monitor pricing and to improve affordability of health products;

(7) consider where necessary taking appropriate measures to prevent the abuse of IP by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology. +