WHO Director-General Chan throws down the gauntlet on the CEWG process: “Let’s fight this out at the Assembly!”

* The author thanks Belinda Townsend, Katy Athersuch, Judit Rius Sanjuan and Alice Fabbri for their comprehensive notes during the WHO Executive Board discussion of the CEWG agenda item.

On Friday, 25 January 2013, the 132nd session of the WHO Executive Board held a rich and heated discussion on the Director-General’s report (EB132/21) of the proceedings of the open-ended meeting (26-28 November 2012) on the follow-up of the Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). At the ill-fated November 2012 meeting, industrialized countries including the US, members of the European Union, Japan and Switzerland conducted an assiduous campaign of attrition to weaken support for WHO’s future work on the de-linkage paradigm to decouple the costs of R&D from the price of health technologies in lieu of the current system of patent monopolies. The open-ended meeting achieved an ill-gotten consensus (around 2:30 AM on Thursday morning, 29 November 2012 with only 25 countries and no official interpretation in the 6 UN languages) which resulted in the dismal draft resolution contained in EB132/21.

However, like a phoenix rising from the ashes, the promise of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA) to secure “an enhanced and sustainable basis for needs-driven, essential health research and development” can be realized if WHO Member States show leadership at WHA66. The understanding reached at the end of Friday’s deliberations on the CEWG was that the Executive Board would take note of EB/132/21 (containing the Report by the Director-General and draft resolution) and submit the document in open form to WHA66 for consideration along with a record of the EB’s rich discussion of the item showing that there was no consensus reached. At WHA66, as confirmed by WHO’s Legal Counsel, Gian Luca Burci, WHO Member States can comment on the draft CEWG resolution including submitting textual changes to amend and strengthen the Organization’s mandate to work on a de-linkage paradigm for biomedical R&D.

The disappointing outcome of the November open-ended meeting galvanized various actors including the Lancet, Dr. Suerie Moon and the following public health groups (Health Action International Knowledge Ecology International, Médecins Sans Frontières- Access Campaign, Oxfam, Peoples’ Health Movement, Stop AIDS Campaign and Third World Network) to call upon WHO and its Member States to exert more leadership, ambition and imagination in developing new paradigms to reconcile the twin objectives of stimulating medical innovation and ensuring access for all. No one, however, had an inkling that the EB 132’s consideration of the follow-up to the CEWG would mark such a crisis of conscience at the WHO. To get a quick picture of the unfolding events, please see the compilation of various tweets at the end of this piece.

At around 15:59 Geneva time on Friday, discussion began on agenda item 10.2 on the Report by the Director-General on CEWG follow-up. Seychelles, speaking on behalf of the 46 member states of the African region, got the ball rolling and stated,

it is evident that African countries need to reinforce our capacity for R&D. Regional integration mechanisms that exist on our continent are a bulwark for our initiatives. We have studied resolution with greater detail. Our region looks forward to an international R&D treaty. We support the resolution.

Lithuania, speaking on behalf of the European Union, expressed support for the Director-General’s report and draft resolution noting that it set a strategic workplan for addressing the GSPOA. Lithuania noted that the draft resolution was a balanced compromise agreed by consensus and thus urged the EB to forward the draft CEWG resolution to WHA66 without reopening it. Lithuania argued that the current text allowed the WHO Secretariat to “take immediate action” as “effective coordination was a prerequisite to addressing the problem” of unmet R&D needs. For the EU, the draft resolution anticipated “demonstration projects from which to draw lessons” in light of the fact that an Observatory would be set up to monitor and analyse data.

Switzerland reinforced the EU’s position by urging the WHO membership to adopt the CEWG text without reopening it at the WHA. Switzerland reiterated its support for the new Observatory which would “make it possible to provide a better allocation of resources”. In Switzerland’s view, the pilot projects on neglected tropical diseases (NTDs) would “make it possible to test the efficacy of this model”.

Ecuador (Francisco Vallejo, Subsecretario Nacional de Gobernanza de la Salud), speaking on behalf of the 11 member states of UNASUR (Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guyana, Peru, Suriname, Uruguay and Venezuela) issued the following statement which proved to be a spanner in the works of the supporters of the November 2012 draft resolution.

Thank you. on this occasion it is an honour to speak on behalf of UNASUR. We support the draft report of the November open-ended meeting. It provides for a number of solutions to important challenges to our health systems. The current paradigm of providing incentives is insufficient to address the health needs of developing countries, as the current system is based on commercial incentives. We note with concern the lack of consistency between preambular part and operative part of resolution. We must continue searching for coordination strategies to bring us beyond the status quo. Given the importance of coordination and monitoring we would like to call upon the EB to strengthen language in operative paragraphs 5 and 6 of the resolution to strengthen coordination and funding. We call upon the EB to consider submitting to WHA the text in a very open way bearing in mind the principles of democracy. WHA is the highest body of the WHO. We propose an amendment to operative paragraph 7 of the resolution to ensure open discussions. We request to move up the next open-ended meeting of member states to meet prior to the WHA in May 2015.

Mexico, on the other hand, supported the November consensus and urged WHO member states not to re-open the text.

China noted that “financing coordination mechanisms are very important” and supported the resolution and its adoption by the WHA. However, it sought to clarify a procedural question. China noted that paragraph 6 of the Director-General’s report stated the following,

[t]he open-ended meeting of Member States strongly recommends that the Executive Board considers this report and its attached draft resolution with a view to recommending the adoption of the resolution by the World Health Assembly without reopening it.

China asked if the decision point referred to in this paragraph referred to the EB or the WHA. China reiterated that even though the November 2012 meeting was open-ended, “not all WHO Member States took part in the discussion”. China underscored the point that the WHA is the paramount decision-making body of the Organization. China expressed its view that it was the prerogative of Member States at the WHA to decide whether or not to discuss the report and draft resolution. China noted that it had a few friendly revisions to the text of the resolution specifically on the Observatory and the pilot projects. In operative paragraph 4(3, China sought to amend the text by inserting the word share so that the text would read, “to establish a global health R&D observatory within the WHO’s Secretariat in order to monitor, analyse and share relevant information on health R&D”. The current text states:

to establish a global health R&D observatory within WHO’s Secretariat in order to monitor and analyse relevant information on health R&D, building on national and regional observatories (or equivalent functions) and existing data collection mechanisms with a view to contributing to the identification of gaps and opportunities for health R&D and defining priorities in consultation with Member States, as well as, in collaboration with other relevant stakeholders, as appropriate, in order to support coordinated actions.

Cuba followed by noting that the CEWG report findings indicated that market mechanisms were insufficient to address unmet health needs. Cuba stated that an “agreement could have a great impact for people affected; a more dynamic multilateral approach will help us improve lives”. Cuba supported UNASUR’s and China’s contention that the draft resolution on the CEWG be fully considered at the WHA noting that “the resolution can be enriched with the input of the WHA”.

The United States (Nils Daulaire) entered the fray.

We have a question on governance of WHO and the process in which agreements are reached and maintained. In November we held an open ended group in which all Member States were invited. We nearly failed to get a consensus resolution. In reaching this, there was a great deal of give and take on both sides. Our understanding and commitment in accepting this and moving forward was that, despite the inclusion of certain elements we don’t agree with, we realized that this was a way of moving forward, to more and better R&D investments in diseases affecting the poor. It’s questionable why we have these open-ended meetings when we have specialists fly in from capital, only to find it-well I wouldn’t say tossed out-but the process opened up on the basis that someone didn’t like part of it. I have no problems with the wording introduced by China, but I do not want to re-open any part of the resolution.

At this stage, the Chair (Dr J. St. John, Barbados) asked the WHO Legal Counsel (Gian Luca Burci) for advice. The Legal Counsel said, “I don’t want to comment on the policy aspect. The draft resolution is the result of the resolution adopted by WHA65.22 which required the Director-General to hold an open-ended meeting in November 2012 to present its outcome “to WHA through the EB”.

He stated,

[t]he Board can make comments and bring these comments to the attention of the WHA, but the outcome of the work of the CEWG has been commissioned by WHA65 for consideration at the subsequent WHA. The WHA remains free to further discuss the Director-General’s report and the draft resolution, but I would question if the EB has the authority to amend the resolution.

Then Director-General Margaret Chan intervened:

I want to raise one point, if the spirit is not to reopen anything, i suggest even the proposal by China is not acceptable. It has to be a package going to WHA to look at what has been discussed and agreed by IGWG, but you are free to express your opinion on certain issues.

During the latter part debate, your blogger spotted a WHO official approach the delegation of Thailand (a non-EB member). At around this time, certain delegates from Australia, the European Union and the United States were working the room.

At this point, the Chair said,

We are at the point in the discussion where amendments are being propsoed on the resolution. We have heard that the previous WHA has commissioned a process for a product through the Board. The board’s comments can apear in the record in an attachment – but not in the resolution. The DG supports this legal interpretation. Perhaps members seeking to amend to include comments in the summary discussion”.

At this point, Dr. Viroj Tangcharoensathien (Thailand, and chair of the November 2012 open-ended meeting of member states) entered the Executive Board room. The Chair asked the the Board (upon the prompting of Dr. Chan), “EB members will you allow Dr. Viroj to speak”. China intervened and said, “Let other EB members speak first”.

Panama stated that it believed it was the “right time to move forward on health innovation for the poor and needy in particular”. Panama highlighted that financial support was vital and supported the work plan outlined in the draft resolution.

At this stage, China demanded assurances that Member States would be able to make amendments to the draft resolution at the WHA. In China’s own words, “Surely we can make amendments in WHA? Please be clear, are you saying that we can’t even speak at WHA?”. China underscored the point that while its delegation could refrain from making amendments at the Executive Board, it noted that it was impossible to ask Member States not to speak at the WHA noting that all Member States had this right. China mentioned that amendments to the text suggested by Member States could be forwarded to the WHO Secretariat to facilitate efficient discussion at the WHA. The Chair confirmed China’s understanding on this matter.

At this point Dr. Viroj (Thailand) intervened.

I note the concern expressed by Ecuador regarding operative paragraph 4(7) of the draft resolution. As explained by the United States, we worked hard til 2:30 AM on Thursday, 29 November to achieve this result. This was a total package. I wish to see that Member States honor what we discussed. That’s why paragraph 6 of the Director-General’s report explicitly calls upon the WHA not to re-open the text. As a Member States, I would have to tell the Executive Board to “mind its business” by honoring, the outcome reached at the open-ended meeting. The WHA must trust the outcome of the open-ended meeting; this is the best outcome we could reach and I urge that we honor the November discussions and move forward. I recommend that the WHA not re-open the text.

Ecuador clarified its statement by noting that it sought to strengthen the language of the draft resolution.

Bolivia highlighted its constitutional obligation to provide medicines to its citizens. Bolivia supported Ecuador’s call for a 2015 open-ended meeting of Member States. Bolivia called upon the WHO and its member states to embrace the de-linkage concept that promoted milestone prizes and open innovation to produce global public goods. Bolivia reiterated China’s concern that the EB transmit draft resolution on the CEWG in open form to the WHA.

The United States pointed out that UNASUR called for an open-ended meeting of Member States in 2015. The United States said,

It strikes me that if the November meeting had so little effect as to re-open the debate, there is little reason for the open-ended meeting in the future. We should stick with the agreement we reached in November. The EB has a clear choice-it can accept the resolution and report, or it can reject them and not send anything forward to the WHA.

Norway said,

We took part in the November meeting. Like others have pointed out, the negotiations were lengthy. The compromise was hard to reach. Like the US, the Director-General and Dr. Viroj (Thailand), we also believe we should honor what we agreed to in November. We caution against re-opening the package deal.

Lithuania, on behalf of the European Union, supported the US intervention and indicated that the text should not be re-opened.

Indonesia spoke,

We would like to thank Dr. Viroj for his leadership for the last meeting in November, and we would like thank the DG. Current R&D programs are not sufficient as the private sector often does not have a commercial incentive to invest in medicines that address the unmet health needs of developing countries.

We strongly support the CEWG’s call for strengthening global coordination and de-linkage the costs of R&D from the prices of health products. We are of the view that a legally binding mechanism is importance to secure funding for such measures. We would like to register our support for an R&D health Observatory within WHO to monitor and analyse information.

Seychelles (speaking on behalf of AFRO) reiterated calls not to open the document.

Australia (Jane Halton) noted,

We support the possible that this is obviously a very difficult issue. It has exhausted people. The compromise reached meets the benchmark test. Everyone is unhappy so it’s probably the best you can do. I would make the point that we have have a long conversation about how we manage our business. I would encourage the “Spirit of Geneva”. There is a point we have to recognize that this is extremely difficult. We support moving this forward. Everyone should think just how long we should spend on this; perhaps there maybe be better uses of our time.

The Director-General then stepped in:

This is very difficult, I hope Member States accept that both views should be reflected to the WHA but that the whole package is given to WHA to express their opinions. The EB has a lot of work to do. It is worthwhile to consider to move on; the next battleground is the Assembly, Without consensus, you can’t reopen it hear. I must sing it is clear. I respect sovereign states’ positions, but it takes time with 194 questions. It takes time getting to know you.

The Director-General concluded her monologue by breaking into song singing the first few lines of the Rodgers and Hammerstein show tune, “Getting to Know You“.

Argentina intervened,

Moving forward on equitable access to medicines requires R&D free from monopolies. We support, Ecuador, Indonesia, China and Bolivia. Coordination and prioritization of R&D are necessary. Sustainable solutions require prolonged Member State discussion among ourselves. We support Ecuador’s contention that the EB just takes note of this report without re-opening it.

Japan and Mexico both followed Argentina indicating that they did not want to re-open discussions at the WHA. This was followed by 4 civil society interventions: 1) MSF, 2) IFPMA, 3) MMI/PHM/TWN and 4) HAI.

As mentioned before, the understanding reached at the end of Friday’s lengthy debate (lasting around 90 minutes) on the CEWG was that the Executive Board would take note of EB/132/21 (containing the Report by the Director-General and draft resolution) and submit the document in open form to WHA66 for consideration along with a record of the EB’s discussion of the item showing that there was no consensus reached. At WHA66, as confirmed by WHO’s Legal Counsel, Gian Luca Burci, WHO Member States can comment on the draft CEWG resolution including submitting textual changes to amend and strengthen the Organization’s mandate to work on a de-linkage paradigm for biomedical R&D.

A compilation of tweets follows.

@ellenthoen Lancet: #WHO #CEWG plans not ambitious enough. Calls for Medical R&D treaty to be put back on 2013 WHA agenda http://t.co/RQ62LHls

@Kathersuch #EB132 Joint NGO letter condemns inaction on fixing broken R&D system for developing countries. Read here: http://t.co/SlToPYYD #CEWG

@Kathersuch #EB132 Member States now discussing #NTDs. US calls for more link between #CEWG work & NTD resolution

@ThiruGeneva #EB132: Brazil calls for the #NTD resolution to have references WHO GSPOA and #CEWG.

@juditrius #EB132 The US, Norway, Switzerland, the EU.. all support the proposed CEWG resolution to postpone R&D treaty discussions until 2016

@juditrius #EB132 Ecuador (on behalf of UNASUR) is making a very powerful statement. Asking for the resolution to be re-open and for more ambition

@juditrius #EB132 Mexico supports resolution & does not want to re-open it. China just asked for amendments to the resolution & discussions in May 2013

@Kathersuch #EB132 discussing #CEWG. Ecuador for UNASUR countries say we must go beyond the status quo. Not enough being done.

@Kathersuch #EB132 US arguing strongly for #CEWG not to be reopened. Chair asks WHO Legal Counsel for advice.

@juditrius #EB132 WHO legal counsel says the resolution can be reopened at the WHA in may 2013 if Member States want

@Kathersuch #EB132 DG Chan intervenes: Cannot open now. It goes to WHA for their consideration as a package. Not to open now. #CEWG

@juditrius #EB132 China wants assurances that member states will be able to make amendments in 2013 WHA. Chair says that this is her understanding

@Kathersuch #EB132 China demands: surely we can make amendments in WHA? Please be clear, are you saying that we can’t even speak at WHA??

@Kathersuch #EB132 Chair clarifies: my interpretation is that at WHA no holes are barred.

@juditrius Ecuador (UNASUR) insists that #EB132 strengthen resolution to improve R&D cooperation & coordination & wants R&D treaty discussion earlier

@Kathersuch #EB132 Bolivia: resolution is not as ambitious as we would have liked. WHO & MSs should focus on solutions proposed by #CEWG

@Kathersuch #EB132 Bolivia: new alternatives for R&D should be explored- not just to continue with market-based approaches.

@Kathersuch #EB132 #CEWG text should go in open form to the WHA as others have called for.

@juditrius #EB132 Unasur, China and Cuba asking for an discussion on the CEWG at the upcoming May WHA. The US government opposing

@juditrius #EB132 US – no possibility to reopen. we reached an agreement. Accept it or reject it & so send nothing to the WHA

@ThiruGeneva #EB132: Indonesia underscores the importance of de-linkage.

@juditrius #EB132 Indonesia – we are very supportive of CEWG. The principle of delinkage is fundamental. Legally binding mechanism is important.

@ThiruGeneva #EB132: Indonesia-“legally binding agreement” is crucial in securing R&D.

#EB132 Australia – very difficult discussion and we should not reopen it. If everybody is equally unhappy, maybe best consensus we can reach

@Kathersuch #EB132 Cuba, China and UNASUR states ask for draft #CEWG resolution to be considered openly at WHA in May

@Kathersuch #EB132 Bolivia: resolution is not as ambitious as we would have liked. WHO & MSs should focus on solutions proposed by #CEWG

@Kathersuch #EB132 #CEWG text should go in open form to the WHA as others have called for.

@juditrius #EB132 Japan – supports draft resolution & US/Norway and others not to reopen discussion

@ThiruGeneva #EB132: UNASUR and China have made strong interventions proposing that #WHA66 have the possibility to re-open #CEWG text.

@ThiruGeneva WHO EB heating up on #CEWG. UNASUR and China insist that #WHA66 retain the authority to reopen CEWG text.

@morningsimon Now @WHO EB arguing whether can or should re-open working group compromise on R&D. Clearly they can, so silly to argue they cannot.

@Kathersuch #EB132 DG Chan: We all want to go home tonight. Let’s fight this out @ WHA. If you don’t agree I’ll sing! #CEWG

@juditrius #EB132 DG Chan is signing “getting to know you” .. I am not joking.

@juditrius #EB132 DG Chan asking not to reopen discussion and accept CEWG resolution as it is.

@juditrius Chair/Barbados saying there has been many serious national consultations on this. Please do not reopen now. What national consultations?

@juditrius #EB132 Argentina now reading a powerful statement. Supports UNASUR, Indonesia, China and Bolivia. The resolution is not ambitious enough.

@juditrius #EB132 Argentina – we can do better. We need to have a discussion on the R&D treaty before 2016

@juditrius #EB132 Japan – supports draft resolution & US/Norway and others not to reopen discussion

@ThiruGeneva #EB132: Not all member states had the opportunity to participate in the open-ended member states meeting.

@ThiruGeneva #EB132: The broken R&D system highlighted in #fireintheblood can be fixed if #WHA66 can open text on #CEWG outcome document.

@jarottingen #Lancet calls for more progress on neglected diseases including the R&D agenda set forth by #CEWG http://t.co/CfkpVyAx

@ifmsa #CEWG #EB132 Discussions about the process (inter-governmental) and amendments being discussed, regarding the consensus.

@Kathersuch #EB132 PHM, TWN, Medicus Mundi: draft resolution represents a piecemeal description of #CEWG recommendations.

@Kathersuch #EB132 PHM, TWN, MMI: #CEWG report= milestone in global efforts to address multiple problems inherent in commercially driven Med. R&D system

@MarioOttiglio @ifpma statement on #CEWG at #EB132.We need a mix of vision and pragmatism. This is a good time to move forward onto a concrete path. #NTDs

@Kathersuch #EB132 PHM, TWN, MMI: #CEWG report= milestone in global efforts to address multiple problems inherent in commercially driven Med. R&D system

@MSF_access Full text of #MSF Intervention on #CEWG: Financing & Coordination at WHO Executive Board http://t.co/FokaWoZL #EB132

@ThiruGeneva #EB132: #WHA66 (May 2013) will have the authority to re-open #CEWG text. More #fireintheblood!

@jarottingen Suerie Moon challenges BRICS countries to commit to sustainable financing of health R&D in accordance with #CEWG http://t.co/RPqiXQtc

@iversen_jh #CEWG on WHO EB agenda today- will they endorse the agreed upon resolution on R&D for #NTDs, or think #publichealth & re-open the point?

@UAEMNorge WHA should put back proposal for new global rules to secure sustainable financing for health R&D via @TheLancet http://t.co/sfD1RpmR #CEWG

@iversen_jh #WHA66 will have authorithy to re-open discussion on #CEWG report! Let`s work towards a bold framework 2 ensure access 2 treatment for all!

@pharmfreefellow @MSF_Access Intervention of #CEWG report. @WHO DO NOT POSTPONE THIS…. http://t.co/4s7FsFKO

@joanna_keenan #MSF is ‘deeply disappointed with… the extremely weak Resolution which threatens to change nothing on R&D’ bit.ly/WVwmZr #EB132

@tesselmellema #eb132 HAI: a draft resolution adopted by a small number of Member States under less than ideal conditions is unacceptable

@tesselmellema Good news: #eb132 #WHA66: will have authority to re-open discussions on the CEWG: let’s work towards a global framework for health R&D!