Healthy Skepticism Library item: 10179

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Publication type: news

Gerhardsen TIS.
World Health Assembly Agrees On IP And Innovation; US Abstains
Intellectual Property Watch 2007 May 23
http://www.ip-watch.org/weblog/index.php?p=630&res=1280&print=0

Full text:

After much discussion and hard-won willingness to shift positions on what a chair referred to as a “difficult resolution,” member states concluded the 2007 World Health Assembly on 23 May with the adoption of an agreement on innovation of medicines and intellectual property. But it was done without support from the United States, the biggest medicines innovator.

The resolution requests the World Health Organization (WHO) to get more involved in supporting member states using trade law to improve access to treatments, and to encourage discussion of new incentive mechanisms for research and development (R&D), such as addressing the link between the cost of R&D and the price of medicines.

The agreement is related to an ongoing intergovernmental process at WHO on public health, innovation and intellectual property, referred to as IGWG. It has been asked to come up with a strategy and plan of action for boosting R&D of medicines for neglected diseases mainly found in developing countries. The deadline is the May 2008 assembly (IPW, WHO, 27 May 2006).

Brazil introduced the draft resolution on 15 May. It was meant to “support the work of IGWG and enforce it,” a Brazilian official told Intellectual Property Watch. One year after the establishment of the IGWG, a progress report was presented and the resolution was introduced as part of this agenda item at the assembly (IPW, WHO, 17 May 2007).

The adopted resolution requests WHO to provide “as appropriate, technical and policy support” to member states that intend to use the flexibilities in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It states that WHO should do this “in collaboration with other competent international organisations,” which include the WTO and the World Intellectual Property Organization, but the resolution gives WHO a mandate to also deal with this issue. This has previously, especially in the IGWG process, been contested by some countries (IPW, Public Health, 7 December 2006).

The resolution was adopted by plenary (the full assembly) after having been discussed for two days in a drafting group, from which the United States walked out twice, sources said. When the agreed draft was discussed in a committee on 23 May, the United States returned to the discussions and proposed amendments especially related to TRIPS, but at that point a majority of member states said it was not acceptable that the United States, which had chosen not to be part of the drafting group, should be able to suggest amendments. Some smaller changes were made on 23 May.

The US reservation came against a background of a number of countries and regions having moved from starting positions that were “miles apart,” according to the drafting group chair from Namibia, who said the agreement had been “painfully negotiated and agreed upon.”

At first, there also appeared to be divisions among the developing countries regarding the draft resolution, but later both the African group, Australia, Canada, Chile, European Union, Switzerland and Norway showed support, sources said. A developed country official told Intellectual Property Watch that at first the EU had been opposed to the resolution but then it decided to negotiate in order to go into the November final IGWG meeting well prepared and “under ideal circumstances.”

The United States said in plenary that, “The United States cannot accept this resolution.” When adopted in the committee, the United States said it wanted to “disassociate from consensus.”

It was unclear what the US objection was, as the United States declined to comment further. The first, four-hour drafting group from which the US walked out did not make much progress, and the chair reported back that it had been adjourned “mainly due to lack of progress.”

The US move caused tension at the 14-23 May World Health Assembly, the annual meeting of the WHO member states, which this year adopted a record number of resolutions, including one on the sharing of influenza viruses [see related IPW story to come]. A resolution suggests changes to international public health practice and to the policies and priorities of WHO.

What Does It All Mean for IGWG?

The overarching question seems to be what the US disagreement will mean for the IGWG process ahead and the November meeting, with some arguing that the resolution was a step forward and others arguing that the process would have been better served without it.

“We have a consensus,” a Brazilian official told Intellectual Property Watch, saying that everybody had agreed and was again talking about the “spirit of Geneva,” referring to the cooperative spirit on which the IGWG was founded. He said the resolution had “definitely” helped as everybody was now going in the same direction, and had agreed on process, principles and are willing to work together.

The United States said in its reservation in plenary that it did not consider the resolution consensus text, but said it hoped for a “successful outcome” of the November IGWG. It said it hoped all member states would join the US in “working constructively together towards that end.”

The pharmaceutical industry agreed with the United States in that the resolution was not useful. On 22 May, while it was still being debated in the drafting group, Director General Harvey Bale of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) told Intellectual Property Watch that the resolution was an attempt to “pre-write the conclusions of the IGWG at the assembly level.” He said the move abrogated the WHO approach and was moving the process without a basis in evidence. For example, Bale said a nongovernmental organisation (NGO) had argued that there are no tuberculosis products in development, while there are in fact 17 drugs in development.

Bale said that the proposal to separate R&D costs from the prices of drugs was not “necessarily realistic.”

Ellen ‘t Hoen of Médecins Sans Frontières told Intellectual Property Watch that the adoption of the resolution was, “very good news for IGWG,” as it reflected “strong consensus.” She said there is more clarity now on where the IGWG is heading, and the resolution gave IGWG some substantive recommendations. She mentioned particularly the idea of separating the cost of R&D from the price of medicines.

Content and Process

The 15 May resolution was revised quite a bit in formal as well as informal drafting groups, and the final version focuses mostly on the process of IGWG, but also contains some “content” on what the IGWG end product should contain.

The most noteworthy language relates to TRIPS. The resolution requests WHO, “to provide as appropriate, upon request, in collaboration with other competent international organizations, technical and policy support to countries that intend to make use of the flexibilities contained in [TRIPS] and other international agreements in order to promote access to pharmaceutical products, and to implement the Doha Ministerial Declaration on the TRIPS Agreement and Public Health and other WTO instruments.”

After “pharmaceutical products” there is a footnote, referring to the Doha Declaration. This was also used in a malaria resolution adopted at the assembly, leading one official to say that the malaria resolution would set a standard for the future (IPW, WHO, 21 May 2007).

While some countries, including Canada and Norway according to sources, supported earlier language in the resolution requesting WHO to encourage proposals and discussion at the IGWG on a range of R&D incentive mechanisms “including those that separate paying for the cost of research and development from the price of medicines, vaccines, diagnostic tools and other healthcare products,” this was suggested amended by Switzerland and backed by Japan and others. It now reads: “… a range of incentive mechanisms including also addressing the linkage of the cost of research and development and the prices of medicines …”

The idea of financing R&D of medicines through a prize fund to which governments could contribute instead of using high prices has been advocated by, among others, the NGO Knowledge Ecology International.

On process, the resolution urges member states to “support fully and actively” the IGWG process and “provide adequate resources” to WHO. Members appear to agree that the first meeting of the IGWG in December 2006 was less constructive and Brazil is among the countries that want to speed up the process.

The agreement also says that technical and financial support should be given to regional consultative meetings before the November meeting. During the assembly, it was particularly the African and Latin American regions that called for such support.

The resolution also calls on WHO to prepare background documents on the elements IGWG has been discussing so far, including an overview of who is doing what, gaps, and financial implications. This was particularly suggested by the European Union, a source said, which also raised this issue in a consultation round on IGWG earlier this spring.

The resolution also captures WHO Director General Margaret Chan’s statement at the assembly that she is committed to the IGWG process and encourages her “to guide the process.” Chan has been following the discussions on this issue closely at the assembly, and in her closing remarks said she is “fully committed” and has “noted your desire to move faster.”

At press time, the resolution was only available in hard copy as A60/B/Conf.Paper No.3 Rev.2.

Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.