[Ip-health] Health Action International (Global) Event Memo- 126th WHO Executive Board: The Expert Working Group on R&D financing

[Terri - Louise Beswick]

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Health Action International (Global)

EVENT MEMO 126th WHO Executive Board: The Expert Working Group on R&D finan=
cing. 18-19 January 2010

Overview

On Monday 18 January 2010, Members of the Board were presented with the Exe=
cutive Summary from the report of the Expert Working Group (EWG) on Researc=
h & Development financing; the committee charged with evaluating alternate =
financing mechanisms for research & development (R&D).

The report is the product of a controversial process that has suffered from=
 a number of alleged leaks, from both the EWG itself and the pharmaceutical=
 industry, who appear to have had access to the EWG conclusions even before=
 the document had been officially published.

As well as doubts about the transparency of the EWG process, the report's c=
onclusions have disappointed many Member States and nongovernmental (NGO) s=
takeholders by adhering staunchly to the status quo on innovation, which de=
pends heavily on the existing intellectual property and R&D system.

Initial criticisms of the EWG report and its process

After the initial presentation by the Chair of EWG, Sir George Alleyne, on =
Monday afternoon, India and Brazil made strong statements expressing their =
dissatisfacton with the analysis and recommendations of the report.

India gave the first response, stating that the conclusions fell short of t=
he decisive plan in the GSPA (Global Strategy and Plan of Action on intelle=
ctual property, innovation and public health) and that the WHO should play =
a greater role in assisting developing countries to use the TRIPS (World Tr=
ade Organization Agreement on Trade-related Aspects of Intellectual Propert=
y) flexibilities that allow for States to prioritise public health above co=
mmercial IP interests. Brazil's statement reiterated the point that "medici=
nes cannot be treated like other products" and that there was a lack of lin=
kage between the report and the Global Strategy and Plan of Action on Publi=
c Health, Innovation and Intellectual Property (GSPA).

These interventions marked the end of the day's discussions and the agenda =
item was carried over to Tuesday morning for further interventions from EB =
members, other WHO Member States and NGOs.

Response from the WHO Director-General

In response to the previous day's criticism that only the Executive Summary=
 in English had been made available to EB members for them to consider for =
approval, Director-General (D-G) Dr. Margaret Chan opened the Tuesday morni=
ng session with an apology to the Board for confusion surrounding the docum=
ent. Dr. Chan told members that the Executive Summary would no longer be pu=
t forward for approval at this session of the EB, and that more time would =
be allowed for members to review the full report, which would be translated=
 into all six official languages. She instead suggested that it be discusse=
d at the World Health Assembly (WHA) in May.

Comments from Executive Board Members

The summary report attracted criticism, even from within the ranks of the E=
WG,  and during the discussions on Monday and Tuesday, WHO members from Ind=
ia, Brazil, Bangladesh, Uganda (on behalf of the forty-six Africa nations),=
 Bolivia, and Thailand all voiced less than enthusiastic responses to the a=
nalysis and recommendations in the report.

Main criticisms

The interventions outlined similar concerns, noting that the report margina=
lised the role of technology transfer in improving access to medicine; negl=
ected to discuss the delinking of R&D costs from the price of medicines; an=
d that the analysis was not based on the conclusions on IP and public healt=
h contained in WHA resolution 6121. Many countries also reiterated the obli=
gation for States to protect the public health of their citizens and the hu=
man right to "the enjoyment of the highest attainable standard of health". =
Bolivia and India called for the Special Rapporteur on the right to health,=
 Anand Grover, to address the WHA this year, to present valuable insights f=
rom his report, presented to the Human Rights Council in March last year.

In a follow-up to their earlier statements, Brazil and India made a proposa=
l to have an inter-sessional, open-ended consultation on the full report at=
 government level, before discussing it at the WHA. The idea of the consult=
ation was supported by Bangladesh, Uganda (on behalf of the 46 African coun=
tries), Thailand, Chile, Paraguay, Indonesia and Bolivia, who also proposed=
 the inclusion of interested parties in the consultation.

Bangladesh made an intervention in the Tuesday session, supporting the Braz=
il and India proposal, and expressing their concern about the process and t=
he conclusions of the EWG's Executive Summary. With regards to the conclusi=
ons and dismissal of some of the proposals on prize funds, submitted in par=
t by Bangladesh, they asked that the EWG clarify their rejection of the pri=
ze fund proposal, stating that they "would like to have the benefit of unde=
rstanding how the EWG arrived at this conclusion". Their statement also ref=
erred to the omission of a reference to the R&D treaty, which was submitted=
 as a proposal by Bangladesh, Brazil and Bolivia.

Thailand expressed their disappointment with the working process of the EWG=
. They commented on the timeliness of the report, stating that the WHA Reso=
lution had clearly defined the mandate of the EWG, which required (in the r=
oadmap established two years ago) that the full report be presented to the =
EB, not just an Executive Summary. The Thai representative also stated that=
 they unhappy with the transparency of the process and called on the D-G an=
d EB Chairman to instigate an investigation into allegations of the leak of=
 the report.

Uganda emphasised access to technology as a core priority in the Quick Star=
t Programme of the GSPA implementation. They also requested that the D-G co=
nvene a high-level consultative meeting with the Directors-General of the W=
TO and the World Intellectual Property Organization, donor countries, and o=
ther stakeholders to find possible sources of financing for the Quick start=
 programme.

Aside from substantive short-comings, serious concerns about the transparen=
cy and integrity of the process were raised several times by Member States,=
 referring to allegations that some confidential EWG draft documents were l=
eaked to the international pharmaceutical industry association, IFPMA. Thes=
e allegations have been widely reported and were the subject of an editoria=
l in the Lancet.

Further comments from Member States

Statements from the Japanese and Canadian EB delegations presented an inter=
mediate position on the EWG report. Both countries stressed the need to pri=
oritise access, the important role of the GSPA in the process, but did not =
express any critique of the report itself.

The United States representative expressed ambivalence toward India and Bra=
zil's proposal for an open-ended consultation on the full report. They were=
 concerned that the number of consultations that might be requested between=
 now and the WHA in May could place an undue financial and time burden on s=
ome Member States and the WHO secretariat.

Hungary's statement on behalf of European Union Member States, commented on=
 the efforts towards the implementation of the GSPA and did not express cri=
ticism of the report or the process. The statement recognised the usefulnes=
s of a consultation but saw the place for it 'within the context of the WHA=
', and proposed that it be held just before the WHA.

NGO statements from M=E9decins Sans Fronti=E8res and HAI Global

M=E9decins Sans Fronti=E8res (MSF) both presented statements to the Executi=
ve Board in their capacity as NGOs with official relations with the WHO. Bo=
th statements echoed some of the concerns raised by Bangadesh, Brazil, Indi=
a, Thailand and Uganda.

MSF's intervention outlined several areas of concern about the EWG report a=
nd process, the first being that the Executive Summary did not build on con=
clusions of the CIPIH (Commission on Intellectual Property Rights, Innovati=
on and Public Health) report and the GSPA, particularly with regard to prop=
osals on de-linking the cost of R&D from the price of medicines. They also =
noted that the report appeared to endorse role of IP in research, against t=
he findings of the CIPIH report; the criteria used to evaluate proposals wa=
s not modified following input from the public consultation and that the re=
commendations favoured existing organisations and companies involved in R&D=
. MSF also touched on the alleged pharmaceutical industry access to the EWG=
 and called for a review of the EWG findings to assess the compatibility wi=
th elements contained in the GSPA.

HAI's intervention noted a number of short-comings in the conclusions and p=
rocess of the Expert Working Group. The Executive Summary "fell short of ma=
ny expectations with regard to truly original financing mechanisms that can=
 respond to public health needs in developing countries". We also reiterate=
d the findings of the CIPIH report and GSPA, which established that "the cu=
rrent system of innovation incentives...based on various forms of IP protec=
tion...has failed to meet the needs of developing countries." The statement=
 also discussed the omission of the proposal for a Biomedical R&D treaty an=
d referred back to previous concerns expressed by Member States and NGOs ab=
out the process by which the EWG report has been produced.

Dr. Chan's response to comments

Dr. Chan addressed the issue of transparency and the allegations that docum=
ents were leaked by taking a tough line. She stated, "I take it extremely s=
eriously...I have started an investigation. However, she maintained that cr=
iticisms about these allegations should not be accepted until there was evi=
dence that the group of experts were being influenced, but committed to wai=
ving the diplomatic immunity of all staff to help her investigation.

Agreement on an open consultation on the full report

On Tuesday afternoon, a significant amount of time was spent on finalising =
a date and general format for an open consultation that was agreeable to al=
l EB Members. Having noted a general consensus among EB members to hold a c=
onsultation on the final EWG report, the EB Chairman, Dr. Zaramba asked for=
 proposals on a suitable time to conduct the consultation. Whilst the India=
n and Brazilian delegates asked for the consultation to be held sometime in=
 advance of the WHA to allow sufficient time for all views to be discussed,=
 the United States, Japan, and Hungary (on behalf of the EU) all requested =
that it be held as close to the WHA as possible. They expressed concern tha=
t smaller, developing country governments may not have the resources to att=
end a consultation in Geneva in addition to the WHA. Both the suggestion of=
 Chile for an early web based consultation, and the idea of a one day consu=
ltation, were adopted as a solution to the divergent proposals. Dr. Chan an=
d Dr. Zaramba opted for a one day consultation to be held on Thursday 13 Ma=
y, five days before the opening of the WHA this year. The extent to which t=
his consultation will be conducted in the public domain, and the degree by =
which comments will be invited from all stakeholders, remains to be seen.

Conclusions

The debate around the EWG report proved to be a contentious agenda item tha=
t, in the end, was discussed over two days and provoked numerous responses.=
 The main points of criticism surrounding the report were the general diver=
sion away from the conclusions on IP and public health contained in WHA res=
olution 6121 and the CIPIH report, and concerns about the transparency and =
integrity of the EWG process. Other concerns were related to notable omissi=
ons on: the role of technology transfer in improving access to medicine; th=
e de-linking of R&D costs from the price of medicines; the report's compati=
bility with the human right to health.

The debate brought to light significant differences in the positions of som=
e Member States and the discussions about the next steps for the report wer=
e influenced heavily by these divergent points of view. The agreement to ho=
ld a consultation prior to the next World Health Assembly was reached grudg=
ingly, and it is clear that the discussion about the EWG and the implementa=
tion of the Global Strategy and Plan of Action is far from settled.

For more information, please contact Sophie Bloemen, Projects Officer, soph=
ie@haiweb.org