TWN Info Service on Intellectual Property Issues (Jan10/02)
22 January 2010
Third World Network

WHO: Expert report on R&D financing triggers inquiry, consultations
Published in SUNS #6847 dated 22 January 2010

Geneva, 21 Jan (Sangeeta Shashikant) -- Discussions at the meeting this week of Executive Board Members of the World Heaalth Organization (WHO) on the outcomes of an Expert Working Group on Research and Development Financing (EWG) saw many developing countries voicing concerns ranging from the method of work employed by the EWG to apparent undue influence exerted by the pharmaceutical industry over the EWG's outcomes.

In their interventions, many developing countries highlighted amongst others the gaps in the outcomes of the EWG, and inconsistencies with the Report of the Commission on IP, Innovation and Public Health (CIPIH) and the WHO Global Strategy and Plan of Action on IP, Innovation and Public Health (GSPOA).

Concerns were also raised over the method of work employed by the EWG, and the apparent undue influence of the transnational pharmaceutical industry over the EWG's outcomes, following news reports about "leakage" of confidential EWG documents to the industry.

The discussion took place under the agenda item on public health, innovation and intellectual property: global strategy and plan of action, at the 126th session of the Executive Board (18-23 January).

(The Executive Board is composed of 34 individuals, each one designated by a WHO Member State. It meets twice a year with the aim of giving effect to the decisions and policies of the World Health Assembly, to advise it and generally facilitate its work).

In the discussions, several developing countries also pointed to the WHO's failure to follow the requirement of WHA Resolution 61.21 that set outs the mandate of the EWG - i. e. that the final report will be submitted to the sixty-third World Health Assembly through the Executive Board. The WHO Secretariat only presented to the Executive Board (EB) an Executive Summary of the final report. The final report (available presently only in English) was released online last Friday evening, before the EB commenced this Monday.

These events triggered a call for an enquiry into the "leakage" of confidential EWG documents, including the draft final report to the pharmaceutical industry, as well as for inter-sessional consultations on the final report before the World Health Assembly (WHA) in May.

It was finally agreed by the EB Members that a face-to-face meeting will be held on 13 May, a few days before the 63rd WHA begins on 17 May. There will also be opportunities for web submissions on the EWG report. The final report is expected to be made available in all six official languages of the WHO by the end of February.

The Director-General of the WHO Dr Margaret Chan also committed to launch an investigation into the issue of "leakage" to the pharmaceutical industry.

On the issue of public health, innovation and intellectual property: global strategy and plan of action, documents before the EB Members included a Secretariat report on implementation of the GSPOA, including progress on the "Quick Start Programme" intended to kick-start implementation of specific GSPOA recommendations (EB 126/6) and an Executive Summary of the EWG report (EB126/6 Add. 1).

Several developing countries pointed to the lack of detail in the progress report, including information on activities undertaken at the regional level.

Precious Matsotso, a WHO director coordinating this issue, said that the Secretariat had a compact disc with further details about implementation. She also mentioned that GSPOA must be aligned with the research strategy presently on the EB agenda. She further stressed that WHO was working on a monitoring and reporting framework. On TRIPS flexibilities, Matsotso said that there was a work plan between the Directors-General of the WHO, the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO).

However, the most contentious point during the EB session under this agenda item was the EWG and its outcomes.

The members of the EWG were appointed by Dr Chan following the adoption of the GSPOA through WHA Resolution 61.21 in 2008, which also requested the Director-General to establish such a working group to "examine 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 research and development needs of developing countries in relation to Type I diseases".

The EWG has long been the subject of criticism due to process-related issues. It attracted further controversy recently when it emerged particularly in the medical journal The Lancet that confidential EWG documents had been leaked to IFPMA (an association of transnational pharmaceutical companies), with IFPMA publishing on its website, its satisfaction with the documents.

This was subsequently followed by a 15 January letter by a Member of the EWG Cecilia Lopez Montano (also a senator of the Colombian Congress) to the EB Members, urging the Members to refuse endorsement of the EWG's report, stating that the method of work of the EWG was not transparent or participatory, and that she was utilized to legitimize the EWG process. She also pointed to the absence of terms of reference for the EWG and of attempts in the EWG to avoid issues pertaining to IPRs (intellectual property rights).

Such a turn of events surrounding the EWG led several developing countries to raise concerns over the process-related issues, with Thailand requesting an investigation over the leaking of the draft EWG report to IFPMA.

Dr Chan said that she was troubled over the leakage of the document and promised an inquiry into the matter.

She also committed to take appropriate action, to the extent that if there were an internal breach, she would waive diplomatic immunity to facilitate proper investigation. However, she also said that she would not accept any criticism until there was evidence that the group of experts was being influenced by the pharmaceutical industry, adding that she attaches great importance to avoidance of conflict of interest.

It was generally expected that the EWG would work on the basis of building blocks set out by the GSPOA and the CIPIH report. However, the EWG outcomes sparked comments from many developing countries pointing particularly to: inadequate discussion about IPRs and issues related to access to products of innovation; lack of discussion about the de-linking of the cost of R&D from the price of products; the mistreatment of proposals submitted by some developing countries; insufficient information about criteria used to assess R&D incentive proposals; as well as findings contradicting the CIPIH report and the GSPOA.

The Chair of the EWG, Sir George Alleyne of Barbados, strongly defended the work of the EWG, stating that maybe the EWG took too rigidly a constructionist approach to the mandate. He added that in the view of the EWG, issues of IP and access were not within the mandate of the expert working group.

On the issue of transparency, the Chair remarked that he was sensitive to the accusation of lack of transparency, adding that he has never been accused of not being transparent. He also rejected the allegation of undue influence by the pharmaceutical industry, adding that he was disappointed with the Lancet report.

The identified preliminary problems with the EWG outcomes, in addition to the inadequate time given to the EB to consider the final report, as well as the lack of availability of the final report in the six official languages of the WHO, made a compelling case for an inter-sessional process before the WHA to consider the report.

Brazil and India proposed that the Director-General consider convening an open-ended informal consultation on the EWG before the 63rd WHA, as an opportunity to exchange views on the complete report and assist the Director-General to consider these views in her report to the WHA.

Numerous exchanges took place at the EB over the nature, length and date of such consultation. Some developed countries resisted the idea, preferring instead that the matter be sent to the WHA for discussion and direction. Canada sought an understanding that if consultations took place, it would be agreed that the EWG report would be transmitted to the WHA.

However, several developing countries reiterated the need for the EB to examine the report, as mandated by WHA Resolution 61.21 before it was sent to the WHA. Brazil suggested the possibility of convening another EB before the WHA to discuss the report.

Members finally settled for a one-day consultation on the report prior to the WHA in May and a web-based consultation.

On the EWG report, India noted that the report did not provide any road map or guidance for greater access and wider dissemination of the technologies already available for addressing the disease burdens in the developing countries. It added that the greatest impediment to access to medicines has been their high cost and the encumbrances posed by IPRs. The report falls short of suggesting practical ways of promoting technology transfer and access to medicines.

The WHO should be a "catalyst in facilitating delivery rather than theorizing on solutions," said India, adding that it should work on "obtaining royalty free licenses which could later be provided to developing countries on mutually agreed terms and conditions" and "should assist developing countries in making use of flexibilities granted by the TRIPS Agreement".

India also stressed the need for an incentive structure to stimulate R&D of knowledge and technologies for problems afflicting developing countries and to track resources for an understanding of the distribution and coordination of R&D financing. It pointed out that the report falls way short of a decisive plan for augmenting research in the Type II and Type III diseases.

India suggested that a clear mechanism for R&D funding by the developed world needs to be outlined; taxation proposals, including the Brazilian proposal of taxing profits repatriated by the big pharma companies could be considered; there should be no attempt to prise open layers of countries in the developing country block by asking some to bear more burden and cost of R&D than others; the limitations imposed by IPRs require mechanisms to address this problem; and a mechanism to fund and facilitate access to essential medicines in the developing world.

India also requested that a further dialogue be initiated on the report leading to the WHA and that the WHO Director-General invite the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health to address the May WHA on his findings on the role of IPRs in promoting public health and access to medicines in his report presented to the 11th session of the UN Human Rights Council.

Brazil recalled that both it and Kenya were the main sponsors of the process that led to the approval of the GSPOA, adding that such agreement was only possible because of the commitment to tackle inequities within and among countries. Unbalanced distribution of wealth has a dramatic impact on public health and affects the poor in a disproportionate manner and something has to be done to change this picture, it said, adding that this was not only a legal issue, but a moral and ethical matter as well.

Brazil said that the "international community must join efforts now to support the implementation of identified measures and initiatives in the field of public health", adding that the "time has come for WHO - Member States and the Secretariat - to turn words into concrete action" and that WHO as one of the main stakeholders should implement the GSPOA from a purely public health perspective. Access to medication is a critical issue, it further said, adding that medicines are not like other products - strategies to reduce the price of drugs must be pursued, including proposals to de-link the costs of R&D from the price of drugs.

Brazil stressed that "We are not rewriting or renegotiating the TRIPS Agreement", adding that TRIPS must be interpreted and implemented in a manner supportive of our obligation as States to protect public health and that the flexibilities of the Agreement are fully applied. The WHO must provide political and technical support to countries which intend to use them, it said.

On the progress report, Brazil pointed out the need for more detail, adding that it would have expected a greater focus on IP, access to medicines and health products, since the GSPOA negotiations were mainly about the impact of IPRs on access to health products by developing countries. It also called for a better linkage between the indicators of the plan of action and the activities carried, saying that the report could have been more comprehensive in terms of reporting all the initiatives implemented by regions.

With regard to the report of the EWG, Brazil pointed out that there seems to be a contradiction between the work done by CIPIH and the IGWG (Inter-governmental Working Group) regarding the impact of IPRs on R&D. It further said that elements not agreed upon during the IGWG process, such as tax exemptions, were reintroduced by the EWG. It added that the report doesn't contain references on documents it is based on and it is also not clear what criteria was used to select proposals that meet the developing countries' needs.

It also pointed out that the report lays responsibility for establishing new mechanisms of financing R&D on governments and consumers, without any reference to private sector contribution/participation, adding that it would have appreciated the inclusion of the proposal made by Brazil related to the remittance of profits of the pharmaceutical industry.

Noting that the final report was only made available online over the weekend, it proposed that the Director-General convene intergovernmental consultations before the WHA to examine and discuss the document and the recommendations therein. It also showed support for India's proposal regarding the invitation to the UN Special Rapporteur on the Right to Health to address the WHA.

Uganda, on behalf of the 46 members of the Africa Regional Office (AFRO), said that efficient and effective implementation of CIPIH is not only a priority for African members but a core function of the WHO with regard to the core needs of developing countries that constitute 80% of the world's population. It proposed to conduct discussions on the EWG report at the 63rd WHA, and if that was not possible, it proposed a side meeting of the EB to avail time to discuss this issue before the WHA.

It requested WHO to provide support to member states in having informal consultations on this matter. It also stressed that access to health products and technologies must be a top priority in the GSPOA Quick Start Programme.

Syria, on behalf of the Eastern Mediterranean Regional Office (EMRO), suggested that a consultative group be set up to monitor the Quick Start Programme.

In respect of the EWG, Bangladesh said that it expected bolder recommendations from the Expert Working Group, adding that many of the CIPIH's important observations were not addressed in the EWG. It also pointed to the omission by the EWG to incorporate the de-linking of the cost of R&D from the price of the product, as well as to address issues of access. It said that innovation is meaningful only if the results of innovation are accessible.

It also expressed disappointment that the EWG report did not take on board the three proposals on an incentive mechanism made by Bangladesh, Bolivia and Barbados, adding that it would like the benefit of further understanding the methodology that underlined the conclusion of the report on this matter. It also supported the need to have another opportunity to review the report.

Thailand expressed disappointment over the issue of "timeliness", since the EB was supposed to consider the full report and not the Executive Summary. This road map was defined two years ago, long enough to have better management than this, it added. The full final report was just distributed two days ago, yet there is a call to the EB to adopt this 86-page report. This is not far from signing a blank cheque, it said, stressing support to set up an informal open-ended consultation to discuss the EWG report before the WHA.

It further expressed disappointment with the process of the EWG, adding that it is not confident that the IP issue, which should be a vital issue for the Working Group, has been extensively and adequately discussed, including the de-linking cost of R&D from the price of the product. Referring to the Lancet article, it expressed unhappiness and requested the Director-General to set up an investigation with regard to the leaking of the report.

Bolivia also reiterated the concerns over the lack of time to review the final EWG report and in not meeting the mandate set out in WHA Resolution 61.21 that the final report of the EWG should go to the WHA through the EB. It also supported the idea of an inter-sessional process to discuss the report, which interested entities can also participate in.

Bolivia also stressed the need to avoid in the future sensitivities that decrease the credibility of the work being carried out, adding that some journals have reported the EWG report being leaked to some private institutions before member states receiving it.

It also recalled that Bangladesh, Bolivia, Barbados and Suriname presented to the EWG a set of four proposals for innovative and alternative funding for research and development, and sought to know how these proposals were treated by the EWG.

It further stressed that the proposals attempted to address one of the main objectives of this process, which is promoting innovative sources of funding to support R&D in a way that de-links the cost of R&D from the prices of medicines for diseases that affect developing countries which by their nature are not attractive to traditional incentive mechanisms for promoting innovation. It added that the concept of de-linking is set out in paragraph 4 of the "context" of the item WHA Resolution 61.21 and 5.3(a) of the GSPOA.

Japan said that there are a wide range of factors - health systems, the delivery system, supply chain that individually and collectively impact medicines development. On the issue of IPRs, it stressed its importance as a tool for contributing to the promotion of R&D that imposes enormous costs on researchers.

The US and Canada associated themselves with Japan's statement. The US also expressed ambivalence about informal consultations over the report, voicing concerns over the number of consultations being held before the WHA. +