WHO: Tough negotiations on IP and health to continue at WHA

by Sangeeta Shashikant
Published in South-North Development Monitor (SUNS) #6475

Geneva, 15 May (Sangeeta Shashikant) — The gruelling negotiations over the Draft Global Strategy (GS) on public health, innovation and intellectual property that took place a fortnight ago at the Inter-governmental Working Group on Intellectual Property, Innovation and Public Health (IGWG) are expected to continue next week at the World Health Assembly.

According to a WHO official, there is a move to set up a drafting group on the first day of the Assembly that begins on 19 May. The drafting group is to try to resolve deep differences among the member states in 16 places in the text that are within brackets on the Draft GS. The mandate of the IGWG has come to an end, and the WHA is now expected to take over the process.

The IGWG was set up following Resolution WHA59.24 (adopted in May 2006) and was tasked with drawing up a global strategy and plan of action (POA) to provide a medium-term framework based on the recommendations of the Commission on Public Health, Innovation and IP (CIPIH).

Its main aim is to secure an enhanced and sustainable basis for needs-driven, essential health research and evelopment relevant to diseases that disproportionately affect developing countries, and to propose clear objectives and priorities for research and development, and estimating funding needs in this area.

The IGWG was to submit the final GS and POA to this year’s 61st WHA, but these two documents are not yet ready. The Working Group and a Sub-Working Group have met a total of 4 times – in December 2006 (First Session of IGWG), November 2007 (Second Session of IGWG), March 2007 (meeting of sub-group of IGWG); and 28 April-3 May (Resumed Second session of IGWG).

Sources also indicate that some delegations may put forward a draft resolution for the WHA to adopt the Global Strategy (if it is finalized during the WHA) and to outline the way forward.

There is also likely to be a push for early implementation of some items in the Global Strategy as part of the draft Resolution. This may cause significant debate.

Negotiations on the issues within the 16 brackets of the GS will doubtless be a major challenge for delegations from developing countries, in light of the recent IGWG meeting which was characterized by the inflexible attitudes of developed countries, particularly the United States and Japan.

It is not clear what will be the way forward if there is no agreement on the GS. According to some sources, if there are paragraphs on which there is consensus except for the US, there could be a situation similar to that at the last WHA, with regards WHA Resolution 60.30 on taking forward the work of the IGWG. Despite strong objections by the US, this resolution was eventually adopted as it enjoyed the support of all other delegations.

Out of the 16 remaining bracketed text, five have the status of enjoying consensus but pending approval from the US.

There is also much work to be done to finalize the Draft POA that emerged from the last negotiations. The Draft of 3 May 2008 with the heading “Chair’s text” contains text on stakeholders and time-frames discussed by the drafting group; there is consensus on only some parts of this.

According to sources, some parts of the Draft POA, such as the role of lead stakeholders for the specific actions agreed in the Strategy, may also be discussed during the WHA. It may be proposed that other parts of the Draft POA – such as the progress indicators which were discussed at the sub-group meeting that took place prior to the IGWG’s May meeting – should be developed by the Secretariat after the WHA.

Also, an estimation of the funding needed to implement the Strategy and POA has yet to be done. It may be proposed that the Secretariat undertake the costing after the WHA. It is expected that the Draft POA and the funding estimates will be presented at the WHO’s Executive Board meeting in January 2009.

The WHA will have to deal with bracketed texts in the GS, which are in the following parts of the draft: the “context”, the “aim”; the “principles”, “transfer of technology”; “application and management of intellectual property to contribute to innovation and promote public health” and “improving delivery and access”. The last two sections have the most bracketed text.

Delegates from developing countries expect a tough battle, given their experience at the last IGWG meeting where developed countries, particularly the US and Japan, showed no or little inclination to accommodate the developing countries’ interests on the issues that really matter.

Several developing country negotiators felt that these developed countries came to the IGWG meeting with nothing to offer, and their aim was simply to delete text proposed or supported by developing countries, or else to dilute some text through use of terms such as “where appropriate”, “voluntary”, “where possible”. In some cases, the developed countries succeeded in injecting these terms several times in one sentence.

During the negotiations, 5 of the 16 bracketed paragraphs achieved the status of “consensus but pending approval by the US.” Two other paragraphs have consensus but pending approval from Suriname (for one) and Ecuador (for the other).

Several developing country delegates as well as public-interest NGOs felt that there was little desire on the part of developed countries such as Switzerland, EU, US and Japan to make concrete commitments in the GS and POA despite an urgent call in the CIPIH report and public health groups to think differently and to take immediate concrete action to resolve health problems of developing countries with regard to innovation and access.

James Love from Knowledge Ecology International, based in Washington, said that “the EU and US were basically in a mode to defend the status quo and to keep their pharmaceutical industry lobbyists at bay. There were no profiles of courage among the high income country delegates.”

Ethan Guillen, Executive Director of Universities Allied for Essential Medicines said “the fact that there had to be stiff negotiations on the idea that the cost of medicines impedes access in the developing world makes you wonder if some negotiators hadn’t noticed that busloads of American retirees have to hop across the US border to Canada to get drugs they can afford. New incentive mechanisms are obviously necessary to promote R&D for medicines that don’t have a market in the developed world.”

Sarah Rimmington from Essential Action was of the view that urgently needed new incentive mechanisms were not agreed to because of resistance from developed countries. She added: “Significant time was lost debating core principles such as the role of patents in creating barriers to access to medicines, and the importance of promoting the use of already-agreed to flexibilities under international trade law to promote access to affordable generic medicines where patent protections remain a problem.

“It is hard not to wonder if pressure from the brand-name pharmaceutical industry – which is based in developed countries and remains ideologically committed to patent monopolies – influenced this disappointing outcome.”

However, despite the obstacles, developing countries such as Brazil, India, Suriname, Thailand, Bolivia, Barbados and Africa Group, determinedly pushed forward. The result is that a heavily bracketed draft presented at the start of the IGWG meeting is now reduced to 16 areas.

The bracketed paragraphs in the part on application and management of IP include language on:

(1) the creation of user friendly global databases on the status of health related patents [para 5.1 ( c)];

(2) countries avoiding the incorporation of TRIPS-plus measures in any trade agreements and in national legislation that negatively impact on access to health products [para 5.2 (b)];

(3) assessing the impact of data exclusivity on access to medicines [para 5.3 (b)];

(4) adopting and/or effectively implementing competition policies in order to prevent or correct anti-competitive practices related to health products; [para 5.3 ( c)];

(5) consider developing guidelines for patent examiners on how properly to apply patentability criteria in a way that promotes high quality patents and a public health perspective [para 5.3 (d)];

(6) avoiding restrictions for the use of or reliance on undisclosed test data in ways that would exclude fair competition or impede the use of flexibilities built into TRIPS [para 5.3(e)].

Some developed countries objected to paragraphs (2), (4), (5) and (6) above although they reflect recommendations of the CIPIH report and in some cases even what is being practised in developed countries.

According to some sources, several developed countries and in particular the US would like to dilute the mandate of WHO in the area of IP and public health and to restrict the mandate on public health related technical assistance to the WTO and WIPO, which have a more commercial orientation.

There is a real risk that the bracketed language in this section will be further diluted or deleted during the upcoming WHA as the alternative option to paragraphs (2), (3), (5) and (6) is to delete the bracketed paragraphs, said the sources.

In the section on improving delivery and access, bracketed paragraphs include language on:

(1) developing and strengthening, where appropriate, legislative, regulatory oversight mechanisms and other measures to minimize the risks to public health resulting from the [production, trafficking and] use of drugs which have been counterfeited, adulterated, [have expired or are substandard, including by prohibiting the production and trafficking of counterfeit and substandard products]/[ have expired, through health promotion, surveillance and health regulation. [para 6.2 (e)];

(2) encourage pharmaceutical companies to continue or to adopt pricing policies, including differential pricing policies, that are conducive to promoting access to quality, safe, efficacious and affordable health products in developing countries, consistent with national law [para 6.3(d)];

(3) stimulate the development of policies to monitor pricing to improve affordability of health products and strengthen WHO’s ongoing work on pharmaceutical pricing [para 6.3 (e)].

On para (1) above, a main issue is the definition of “counterfeit”. To date, no official definition has been adopted by Member States although there are 2 different definitions being used by WHO.

Another issue is what is the appropriate scope that should be a part of the GS. Some developing countries argue that the main problem is substandard products, which relates to strengthening regulatory capacity, an element that is already mentioned in the GS and so the language in (1) above should be deleted. However, developed countries, and some other developing (e. g. Africa Group) would like to see language on counterfeit products.

On paragraphs (2) and (3), there is consensus but pending approval from the US.

Other parts that have bracketed texts are “the context”, “the aim”, “the principles” and “transfer of technology”.

Under the part on “context”, 2 paragraphs and a footnote are bracketed. One of the paragraphs is “Proposals should be developed for health-needs driven research and development that include a range of incentive mechanisms, including also addressing the linkage between the cost of research and development and the price of medicines, vaccines, diagnostic kits and other health-care products and a method for tailoring the optimal mix of incentives to a particular condition or product with the objective of addressing diseases that disproportionately affect developing countries.” [para 4]

This paragraph (which is in brackets, pending US approval) reflects language in Resolution 60.30 (on advancing the IGWG’s work) adopted by the WHA last year. The US vehemently objected to this language then, but it was unable to frustrate the eventual adoption of this Resolution.

In the part on principles, bracketed text is in the following two areas:

(1) “The WHO Constitution states that “the objective of WHO shall be the attainment by all peoples of the highest possible level of health”. Accordingly, WHO shall play a strategic and pro-active role in contributing to pursue the agenda on “public health, innovation and intellectual property”, within its mandate and its constitutional objectives. To achieve this, WHO, including the regional and country offices, shall strengthen institutional competencies and programmes to implement this strategy and plan of action as well as the existing mandates given by relevant WHA resolutions.” [para 15]

(2) “The objectives of public health and the interests of trade should be appropriately coordinated and mutually supportive/balanced and coordinated” or “The right to health takes precedence over commercial interests.” [para 18]

Some key developing countries see immense value in having para (1) as part of the Strategy as it speaks of WHO playing a more “strategic and pro-active role” in relation to public health innovation and IP.

Presently, all except for the US have agreed to the text although some sources indicate that other developed countries may want to reopen the text. However, this is unlikely to be acceptable to most countries.

Under the part on “aims”, what remains in brackets is a footnote which refers to Type I, II and III diseases, and mentions the “specific diseases” on which the draft strategy will focus.

These specific diseases are Type I diseases which are increasingly prevalence in developing countries, for example, diabetes, cardiovascular diseases and cancer; Type II diseases where a substantial proportion of the cases are in poor countries (mentioning a focus on HIV/AIDS and TB); and Type III diseases which are overwhelmingly or exclusively incident in developing countries (mentioning a focus on chagas disease, dengue and dengue haemorrhagic fever, leishmaniasis, leprosy, lymphatic filariasis, malaria, onchocerciasis, schistosomiasis and human African trypanosomiasis. The footnote adds that “nevertheless, Member States can either expand or narrow the list of diseases as appropriate.”

The specifying of diseases under each of the types of is opposed by many developing countries. They believe that the listing would limit the overall application of the GS & POA and it would also prejudge the outcome of one of the agreed aims of the GS, i. e. to provide an assessment of the public health needs of developing countries and identifying R&D priorities at the national, regional and international levels.

Several NGOs also oppose such a listing of diseases. They recall that there was a strong push by developed countries to limit the scope of the Doha Declaration on TRIPS and Public Health and the related 30th August Decision in WTO, by specifying that these relate only to a limited list of diseases. This attempt failed and the Doha Declaration and the 30 August Decision do not limit the scope of diseases. The NGOs also do not want the scope of the GS to be limited by a list.

Under transfer of technology, there is agreement except for the US on language to “promote transfer of technology and production of health products in developing countries through investment and capacity building including by providing guidance on appropriate technologies”.

This is a compromise text, as developing countries also originally advocated establishing a “reference list of echnologies”, but this was simply unacceptable to developed countries. +