TWN Info Service on Health Issues (December 06/08)

14 December 2006

WHO’s mandate on IPRs under US attack

At the recent meeting of WHO’s international working group on public health, innovation and intellectual property, the US challenged WHO’s work on the impact of Intellectual Property Rights (IPRs).

Before the working group meeting, the US had tried to influence some developing countries’ position in the WHO alleging that the WHO was attempting to go beyond its competency in dealing with IPRs and trade issues and that these issues should be discussed at the WTO and WIPO.

However the US position was strongly opposed by several developing countries including Brazil, Iran, Chile and Cuba.

The report below highlights the discussions at the meeting.

It is reproduced with the permission of South-North Development Monitor (SUNS) # 6161, 13 December 2006.

With best wishes
Evelyne Hong

Health: WHO's mandate on IPRs defended by South against US attack

By Riaz K Tayob, Geneva, 12 December 2006

The United States seemed to be challenging the mandate of the World Health Organisation to deal with issues relating to intellectual property rights and public health, when the WHO's inter-governmental working group on public health, innovation and intellectual property met here last week.

It was the latest in a series of recent US actions to counter the WHO's work on the impact of IPRs on public health.

At the working group's meeting last Thursday, the US argued that the group should take into consideration the mandate of the World Trade Organisation and the World Intellectual Property Organisation, and that the WHO group's work should not "creep into" the mandate of these other two organisations.

It was an apparent attempt by the US to limit the scope of the working group's mandate, discussion and conclusions.

The US position was strongly opposed by several developing countries, including Brazil, Iran, Chile and Cuba. They stressed not only that the WHO had a legitimate role but the leading role (among international organisations) in the area of IPRs and health, and opposed suggestions (including in a WHO secretariat paper) that the WHO group should take into consideration the work and mandates of the WTO and WIPO.

The clash on the mandate of the WHO's group, and by proxy of the WHO itself, in dealing with IP issues was reflective of the underlying differences among member states during the working group's initial meeting, held on 4-8 December.

When the meeting ended last Friday, it could not agree on establishing "areas of early implementation", and this inability to reach a decision will be reported to the WHO's Executive Board next January.

Another evidence that the US would like to confine IPR issues to the WTO and WIPO and to limit and reduce the WHO's mandate in this area of work is in an email document sent by the US to selected developing countries before the working group's meeting, informing them that the WHO was attempting to go beyond its competency in dealing with IPRs and trade issues, and that the WTO and WIPO were the right fora to deal with these.

A report in the internet-based IP-Watch information service dated 11 December revealed that the US appears to be using the bilateral free trade agreements (FTAs) it has signed with developing countries to influence these countries' positions in the WHO.

Developing countries that have FTAs with the US received an email in the form of a "demarche" from the US government before the WHO working group meeting, which stated that it had become apparent that the WHO was trying to go beyond its competency and address intellectual property rights and trade, which could have impact on the scope and effect of FTAs, according to the IP-Watch report.

The email added that this and the proposed global framework described in this year's World Health Assembly resolution WHA59.24 could potentially harm the patent system. The US was therefore proposing a more "pragmatic" solution, as it appeared that the WHO tried to go beyond its technical expertise. The email noted that these issues should be discussed at the WTO and WIPO.

[In bilateral FTAs involving the US, the countries typically take on obligations to have IPR standards higher than those required by the WTO's TRIPS agreement, and agree to restrictions in the use of flexibilities such as compulsory license that are allowed by TRIPS.]

The existence of the US' email "demarche" as revealed in the IP-Watch report throws more light on the exchange that took place at the working group's meeting on 7 December.

One of the papers discussed by the group was "Elements of a plan of action" redrafted by the WHO Secretariat. A paragraph on "Building innovative capacity" stated that "activities proposed should take into consideration the work and mandates of other agencies such as WIPO and WTO."

Several developing countries questioned this wording, as they felt that the issue before the group should be dealt with by the WHO and that the group should not have to refer to WIPO and WTO.

Brazil asked for further elaboration on what the paragraph meant. Stating that the mandate of WIPO is intellectual property per se and that of the World Trade Organisation is trade liberalisation, Brazil said that WHO deals with access to health, and that this is the priority.

Brazil added that the WHO should do its work based on its own mandate from its own decision-making body, with the main objective being access to health. The group should not import mandates from other agencies. The WHO should analyse IP as it relates to health concerns, and take a health perspective on IP as the objective should be "access to health."

Cuba and Iran expressed full support for Brazil's position. Iran on behalf of the Eastern Mediterranean Region (EMRO) said it was not necessary to make reference to other agencies. It proposed deletion of this section of the text because "we are talking about health, not trade." Iran added that the mandate of WHO may sometimes conflict with the mandates of WIPO and the WTO, which may create obstacles for access to medicines. In this context, the priority should be the WHO mandate, that is, health.

Chile said that it is quite normal in WHO to address intellectual property. It pointed out that no committee in WIPO addresses public health.

In contrast to the developing countries, the US said the language of paragraph 4 is not strong enough to make sure that the Group's work does take into consideration the mandate of WIPO and WTO, adding that the WHO group's work should not "creep" onto the other two organisations' mandates.

The European Commission said that the WHO "can and should have an active role in such a way that it can add value to the work done in other agencies, and should not aim at duplicating the work."

Brazil said, regarding the duplication of work, that it is not a concern for WIPO nor WTO to look at IPRs in the light of access to affordable medicines and affordable health treatment in developing countries. It is not within their mandates or work programs. Members, Brazil added, should not be concerned about duplication in those other UN agencies.

Brazil stressed that this particular working group has its own mandate given by the World Health Assembly and it must give consideration to public health, innovation and intellectual property. It does have mandate, Brazil said, and should "not place health at the mercy of concerns of IP-holders."

Delegations that seek to pursue an approach "compatible with the mandate and with the mission" should show dissatisfaction at the way this issue has been addressed in other bodies, Brazil said.

In addition, Brazil said it cannot support "relations of subordination." It said that the agencies are equal in respect of their mission. By referring to the mandate of third organisations, we are "actually saying who is subordinated." This group has received a mandate on its own and "the mission is access to health and no other objectives are more important than this one." WHO can and should make recommendations to other agencies.

The mandate is not just IP but "also research funding, the mechanism, the works" and the overriding concern is to promote better access to health for developing countries. Brazil stressed that issues of affordability and access to medicine are overriding issues.

Brazil expressed concern that the documents did not refer to medicines as being considered a public good or that access to health is an overriding human right. Brazil expressed support for patent pools and said they should be included in the document.

In addition, Brazil said that in specific relevant areas, "there really isn't any work being done by other agencies." On test data exclusivity, Brazil said that this is being negotiated in bilateral agreements and extends patents beyond the 20-year international standard for medicines. A similar problem occurs with "me too" patents and "ever greening" where patents that should have fallen into the public domain have not. Brazil added that the WHO could look at whether the enforcement of the WTO's TRIPS agreement and its flexibilities is done in a way that provides greater access.

The health NGO Medecins Sans Frontieres, which was invited to be a member of the working group as an expert, said that WHO "should not shy away from making recommendations to WIPO and WTO."

Canada proposed that "each of the above actions is a challenge and requires further action from WIPO, WTO and other bodies."

The US criticised Canada and said the language was far too weak. Finland, on behalf of the European Union, said that WHO should engage with other agencies and try to improve their understanding.

Brazil added that it is concerned about not importing the WIPO agenda into the WHO or from other agencies. Brazil said this is "not respectful of the specialised concerns of the agencies."

Another issue of contention was whether the working group should be taking up the issue of counterfeit drugs.

Brazil said it opposed the attempt to have the working group deal with the issue of enforcement against counterfeit medicines, saying that said this was not within the purview of the group.

Such an attempt would amount to importing a mandate. Brazil said that this issue is thoroughly dealt with at WIPO and is raised regularly in the WTO TRIPS Council. This issue of enforcement, it said, is duplicative and falls outside the mandate of this group and the WHO.

A representative of the WHO Secretariat said that WHO is working with an international task force to look at counterfeit medicines and products. The task force is interdisciplinary and the work is "moving very nicely."

Brazil said the question (before the working group) is not about counterfeit drugs. It said that the main issue for WHO is a process to guarantee access to quality drugs and it is not about having a "police section" for counterfeited drugs.

Finland, on behalf of the EU, said that they would like to see an improvement in regulation and quality control instead of a "mere emphasis on counterfeiting."

The discussions at the working group and the email document of the US to selected countries show that there are deep divisions at how some of the member states view not only the work of the group, but of the WHO as an organisation, on the issue of IPRs and access to medicines.