UNITAID – 13th Executive Board Meeting 10th-11th November 2010, WHO, Geneva, Switzerland Civil Society Delegations Communiqué Outline of this Communiqué: 1. Delegation activities around the 13th UNITAID Executive Board meeting: What is this communiqué for? How did the Civil Society delegations prepare for the Board meeting? 2. What were the Civil Society delegates’ key issues at the 13th UNITAID Board meeting? 1. Delegation activities around the 13th UNITAID Executive Board meeting What is this communiqué for? This communiqué is to report back about the activities of the Civil Society delegates at the recent 13th UNITAID Board meeting (10th-11th November). This is part of the transparency and accountability mechanism set up by Communities’ and NGOs representatives on UNITAID Board, and those who follow UNITAID closely. Please see annex 1 for a reminder about UNITAID, and the UNITAID Civil Society delegations. How did the Civil Society delegations prepare for the 13th UNITAID Executive Board meeting? The 13th Executive Board of UNITAID convened in Geneva on 10th-11th November 2010. The Civil Society delegations held pre-meetings on 7th-9th November to prepare for the Board meeting, attended by eleven additional people from a wide range of NGOs and community- based organisations1. Participants were selected from stakeholder networks of the UNITAID CS Delegations, by assessing potential participants against 5 criteria2. A process of document review with the delegation’s Advisory Group was also conducted and utilised in pre-meeting discussions. From the discussions held during the delegations’ pre-meetings, ‘talking points’ were formulated to use at the Board meeting3. Pre-meeting attendees were also able to observe the Board meeting, with 3 additional participants able to be in the Boardroom at any one time, and an observer room with a listen-in service arranged for those outside. In addition, a teleconference was held on November 4th to discuss the key issues at the 13th Board meeting with CS constituencies. 8 additional members of the Advisory Group and Communities’ Support Team joined this call. 1 A full list of attendees is available on request from the Liaison Officer. 2 1. Specific issue knowledge related to the Board agenda. 2. Significant input in the preparation of the Board/committee meetings via reading and commenting on the meeting documents. 3. Balanced geographic coverage (Northern vs. Southern experts). 4. Balance between NGO and Communities representatives. 5. Balance between ensuring building and retaining knowledge and expertise of the delegations (by selecting some people who have been for board meetings before) and opening the door for including new people in order to build and expand new circle of experts . 3 A full list of ‘talking points’ is available on request from the Liaison Officer. 2. What were the Civil Society delegates’ key issues at the thirteenth UNITAID Board meeting? a) UNITAID Operations Update A full operations update was given by the Secretariat at EB13, reporting on the status of UNITAID’s current project portfolio for HIV and TB (both with 5 projects at end of 2010), malaria (4 projects at end of 2010) and cross-cutting projects (2, both WHO pre- qualification project support, at the end of 2010). Some updates were also given on the market intelligence system. b) Election of Board Chair Philippe Douste-Blazy was unanimously re-elected as UNITAID Board Chair. See annex 2 for UNITAID’s press release. c) Funding for 2011 and Budget At the Finance and Administration Committee (FAC) held in October, it was noted that UNITAID faced a difficult situation where only USD $23 million was available to fund projects. At EB13, a restricted pledging session was held, during which some countries made their pledges; others could not confirm their pledges due to national processes. France committed an annual minimum pledge of USD $150 million for the next three years, signifying a welcome move from UNITAID’s biggest donor to multi-year contributions (see annex 3 for UNITAID press release). Korea also pledged USD $7 million for 2011, with Brazil anticipating a pledge later in the year of USD $11 million. This left UNITAID with USD $180 million for funding of 2011 projects in the 13 th Board meeting. Some specific areas were discussed as part of the 2011 budget, which was approved: i) Support for the Civil Society delegations: UNITAID has supported the participation activities of the Civil Society delegations (including Liaison Officer, pre-Board meetings, communications costs e.g. teleconferences, and website development) since January 2010. The CS delegations’ 2011 funding request (for $147,500) was approved at EB13, to enable CS to further the aims of UNITAID. A full budget and work plan are available from the Liaison Officer on request, and will be published on the CS delegations’ website. ii) Support for the Medicines Patent Pool: Funds for 2011 were set-aside for the Patent Pool, as part of the approval of the overall 2011 budget. For details of the budget and all other resolutions approved at EB13, please see http://www.unitaid.eu/en/Thirteen-Executive-Board-meeting-adopted-resolutions.html d) Resource Mobilisation A resource mobilisation taskforce has been established, with the mandate of developing and implementing a resource mobilisation strategy to increase long-term and sustainable sources of funding to UNITAID. During the discussion on resource mobilisation, the NGOs delegation spoke of the value of innovative financing, and highlighted the potential value of new mechanisms like the ‘Robin Hood tax’ (or financial transactions tax) to contribute to global health funding. The Communities’ delegation also highlighted the possibility of using a portion of the air tax in developing countries to support transition of UNITAID programmes to alternative, long-term funding sources, and ensure a steady supply of vital drugs and diagnostics is maintained. e) Prioritisation of UNITAID activities A major issue raised during the 13th UNITAID Board meeting was the effective prioritisation of UNITAID’s funding. UNITAID’s new Market Dynamics team spoke about the need for improved definition of the markets UNITAID’s programmes seek to impact (and their shortcomings), and improved definition of what UNITAID wants markets to look like after its interventions. The need to have a common understanding on the definition of market impact was stressed, and to ensure improved processes and frameworks are developed to support this. Outcome: A resolution was adopted requesting the Secretariat to develop a prioritisation framework in the coming six months. This work will feature consultations with Board members, the Proposal Review Committee (which has established a working group to support this), a review of lessons learned from prioritisation activities in other Global Public Health organisations, and the review of the forms for proposals and concept notes in line with the UNITAID Strategy 2010-2012. f) KPIs and monitoring and evaluation framework Progress was made on both the key performance indicators (KPIs) and UNITAID’s monitoring and evaluation framework at EB13, including: The approval of the baselines for the 2010 KPIs following the approval of KPIs 2010- 2012 at last EB session. At EB14 in 2011, UNITAID will report on the 2010 KPIs. The Board will then again discuss the KPIs themselves/make adjustments as appropriate. The endorsement of the framework for monitoring and evaluation (M & E), which the Board requested the Secretariat implement. Notably it was stipulated that the M & E framework corresponded to UNITAID’s Strategy as this evolved. g) Transition of CHAI programmes The 13th UNITAID Board meeting was attended by a representative of CHAI, who gave a presentation on the transition of UNITAID-CHAI programmes. The representative highlighted that most CHAI country programmes were to transition to alternative sources of funding in 2011, with the remainder aiming to transition in 2012. Key lessons learned were highlighted, including: The difficulties of transitioning in the small and fragmented paediatric ARV market Transition needs to be considered before the inception of the project. There are opportunities to continue to impact the market even during transition/the bridge funding period. The NGOs delegation stressed that pooled procurement must be sustained when projects utilising this mechanism are being transitioned, and emphasised that it is vital to sustain market impact leveraged by UNITAID, particularly in small and fragmented markets like the market for paediatric ARVs. h) Governance Issues Two major governance issues were discussed at EB13: i. Advisory Group on Funding Priorities An expert ‘Advisory Group on Funding Priorities’ (AGFP) is to be established, based on terms of reference (TORs) modified and approved at the 13th UNITAID Board. The AGFP will assist in identifying potential priority niches of high market and public health impact to be funded by UNITAID (the niches will be the basis for issuing of Requests For Proposals - RFPs). It will be a small group of experts, meeting once a year and producing an annual funding priorities paper. The AGFP will be separate from the work stream of the Proposal Review Committee or PRC4, but members will be selected by the same sub-committee formed to select PRC members. The NGOs delegation sought clarification on the AGFP’s relationship with the market dynamics and operations teams in the UNITAID Secretariat, emphasising that this needed to be strong. Language on the close collaboration between the two teams was added to the TORs as a result. Some board delegations (including NGOs) strongly felt it should be the role of the PRC to receive and review unsolicited concept notes as opposed to the AGFP (as suggested in the group’s TORs). NGOs stressed the importance of keeping a provision for UNITAID’s receipt and review of unsolicited concept notes to ‘encourage innovation and out of the box thinking’ as is written in the current UNITAID Strategy5. Other Board delegations were strongly opposed to this however, and disagreed with the principle of funding projects external to the RFP system. Outcome: A resolution adopting the modified Advisory Group on Funding Priorities’ terms of reference was passed. Language was added to the resolution, which stipulated that the Policy and Strategy Committee must review the AGFP TORs within 6 months of the AGFP’s first meeting. ii. Board Operating Procedures The final edited text of the UNITAID Board Operating Procedures was approved. NGOs highlighted one outstanding issue, which would need to be addressed in future: that of constituency seats within the UNITAID Board, at the time it next expands to accommodate new donors. i) Medicines Patent Pool Update Key updates from the Medicines Patent Pool included: 4 The Proposal Review Committee reviews proposals and is equivalent to the TRP at Global Fund 5 The current procedure for receipt and review of unsolicited concept notes involves the Secretariat initially screening concept notes to ensure they meet public health and market impact criteria as outlined in the UNITAID Strategy. If concept notes meet these criteria they are then sent to the PRC for review, who submit recommendations to the Board on whether a full proposal should be requested from the proponent of the concept note. The Medicines Patent Pool has been established as an independent Swiss foundation on 16th July 2010, with the team formerly based in UNITAID transitioning to the new entity. The 1st patent license agreement on patents related to darunavir was reached with the US National Institutes of Health in September, and was hailed as a great step forward for the Pool. The license is royalty-free, has all low and middle-income countries as its geographical scope and is publicly available. However, this license is not sufficient to facilitate the production of the product concerned, as additional patents held by J&J are required. Many statements were issued in support of this first step for the Medicines Patent Pool, by Global Fund, UNAIDS etc. See http://www.unitaid.eu/en/20101001296/News/Supporting-Statements-for-the-Medicines- Patent-Pool/NIH-Announcement.html for details of supportive statements and http://www.medicinespatentpool.org/ for more information. The UN Human Rights Council has welcomed the creation of the Medicines Patent Pool by UNITAID in a resolution adopted in September 2010. Chair of the UNITAID Board, Philippe Douste-Blazy suggested holding a one-day event, potentially in London, bringing together key actors in medical research e.g. universities, research institutes, WHO etc. j) Project Funding Requests Several project funding requests were discussed at EB13: Extension: Paediatric ARV treatment project 2011-2012 This funding request is for UNITAID’s successful paediatric ARV project, which supports 2 out of 3 children provided with ARVs worldwide. The project is transitioning to alternative sources of funding to comply with UNITAID’s mandate of time-limited interventions, leveraging market impact. This funding request is to support countries through transition and those who have not yet secured alternative sources of funding. Outcome: A resolution was approved committing up to USD $81,116,440 for 2011, with a guaranteed amount of USD $54,000,000 for countries where no alternatives for funding have been secured (Cameroon, Burkina Faso, DRC, Kenya, Malawi, Mozambique, Nigeria, Uganda, Zambia). For the remaining countries, where transition funding has been identified but there is a cash flow problem, the UNITAID Board invites CHAI to explore credit, guarantee, or other mechanisms. For 2012 funding, the UNITAID Board gives ‘green light status’ for funding up to USD $62,800,000. Second UNITAID Paediatric TB Project 2012-2016 This project aims to address the shortcomings in the paediatric TB market, and in particular aims to facilitate new fixed-dose combinations (FDCs) and appropriate paediatric dosages for paediatric TB treatments, according to new WHO recommendations. The Proposal Review Committee saw this project’s potential contribution to the paediatric TB market as potentially very significant The NGOs delegation expressed support for this important proposal, but requested more clarity on when new FDCs would be available, and on the potential market impact the proposal will leverage (based on the criteria in the UNITAID Strategy). Outcome: The proposal was approved subject to the availability of funds (for up to USD $23,465,000). This is also subject to receiving clarifications requested by the PRC and Board members. Viral Load – WHO and PASCAL proposals Following a request by the Board at EB11 in December 2009 that the three original proponents responding to the Viral Load RFP collaborate around a resubmission of their proposals, UNITAID received 2 linked proposals from WHO and PASCAL looking at a wider geographic scope for consideration at EB13. Some Board delegations were supportive of funding the Viral Load proposals. The NGOs delegation emphasised that supporting Viral Load testing should be a priority for UNITAID, (highlighting the ethical implications of treating patients with the right drugs), and expressed support for innovative approaches that decrease prices, such as those seen in the PASCAL proposal. The Communities’ delegation stressed the importance of supporting Viral Load testing also, highlighting the implications of UNITAID’s support for 2nd line ARVs, which may incur extra expense without accurate diagnostic equipment pinpointing when those on 1st line treatment regimens should transfer to 2nd line. They also highlighted the importance of implementing WHO treatment guidelines and ensuring a better quality of life for PLWHA. Other delegations expressed concerns that this proposal would be the best use of UNITAID’s money at this time. Outcome: Although both Viral Load proposals were rejected at this time, a new RFP on Viral Load, with clear proposal guidance, will be issued in quarter 1 - quarter 2 of 2011 for which the original proponents will be invited to apply to. Both the NGOs and Communities delegation (amongst others) emphasised the need to encourage proponents to resubmit to this, and worked for the inclusion of language on the issuing of a new RFP in the final Viral Load resolutions. Concept Notes The PRC considered two new concept notes for EB13: the first looking to expand Point of Care (POC) viral load testing and early infant diagnosis using SAMBA (Simple Amplification Based) technology, and the second seeking funding for the field testing and roll-out of a new diagnostic for TB and MDR-TB. The PRC was supportive of the technology in both proposals, but sought clarifications on several issues. Four concept notes from EB12 (on expanding access to the female condom, scale-up of rapid diagnostic tests for malaria, improving access to diagnosis and treatment of malaria through scale-up of community health workers, and a single step diagnosis for TB/MDR-TB at the point of treatment) were also considered again at EB13. The NGOs and Communities delegations questioned why UNITAID was not moving on and funding the female condom proposal, having seen support for this at the 12th Board meeting in June. The Communities delegation highlighted the importance of funding a female-controlled method of prevention in a feminised epidemic. A number of other Board delegations expressed concerns around the process for unsolicited concept notes, and the question as to whether the concept notes received represent the best investment in each particular market. Outcome: No resolution was issued on concept notes. It was agreed discussions on the relevant issues would continue, and that targets for new RFPs would be clearly defined (through the work on prioritisation and proposal guidelines reform/redrafting to be carried out by the Secretariat) in the next quarter. The NGOs delegation stressed the importance of the UNITAID Strategy in relation to unsolicited concept notes as a way of harnessing innovation. k) Additional issues at EB13 The UNICEF Mother-Baby pack was launched in Kenya on October 29th. The pack is intended to contain ARVs for the prevention of mother-child transmission, with clear pictorial instructions showing at what stage in the pregnancy/birth the medicines should be taken, and at what times of day. NGOs raised the issue of transparency policy during EB13, and requested a date as to when Board documents would be published online. l) Board Retreat The Board Retreat has been scheduled for 29th-31st March 2011, with a 1-day partnership forum held beforehand. The retreat will include sessions on the recommendations made at the UNITAID Implementers Meeting (October 2009), and on funding and funding predictability. The work of the Secretariat on prioritisation will also be discussed and revised proposal forms will be available for review at this meeting. Next Board Meeting: 7th-8th June 2011 (TBC) Other key meeting dates suggested at EB13 include (TBC): Board Retreat and Partnership Forum: 29th-31st March 2011 Finance and Administration Committee (FAC): 10th May 2011 Policy and Strategy Committee (PSC): 11th May 2011 Governance Working Group (GWG): 12th May 2011 The Consultative Forum was also tentatively scheduled for June 28th 2011. The Civil Society delegations’ to UNITAID Board will be holding a teleconference to provide updates on the outcomes of the 13th UNITAID Board meeting for all interested NGOs or communities’ representatives, on Friday 3rd December, at 5pm UK time. Please do RSVP to the Liaison Officer if you wish to join the teleconference, and dial-in details will be sent to you. Alternatively, please provide details of a number to be dialled out to on for the call. For any further information, or if you have any feedback for the Delegations (or to RSVP to the teleconference), please contact UNITAID Civil Society delegations’ Liaison Officer, Jessica Hamer, on JHamer@oxfam.org.uk Annex 1: Reminder: What is UNITAID? What are the UNITAID Civil Society Delegations? What is UNITAID? UNITAID is an international drug-purchasing facility, intervening for market impact to scale up access to prevention, diagnostic, and treatment products for HIV and AIDS, TB and malaria in developing countries. UNITAID raises money through a combination of taxes on airline tickets and long-term government funding. UNITAID is also a vehicle to encourage follow-on innovation, to ensure medicines are available in formulations and combinations that are best suited to the target populations and treatment conditions in developing countries. What are the UNITAID Civil Society Delegations? The UNITAID Board has 12 seats, including a seat for communities affected by HIV, TB or malaria, and another seat for NGOs involved in the global fight against these diseases. The Communities’ and NGO delegates to the UNITAID Board form the Civil Society delegations. Communities’ and NGOs on the Board choose to work together a great deal, but constitute two distinct delegations, each with its own voice and strengths. The official representatives were selected by an open and transparent process. Please contact the delegations’ Liaison Officer, or see ‘Civil Society and UNITAID – An introduction’ for more information: (available at http://www.oxfam.org.uk/resources/policy/health/civil-society-unitaid.html) How can Civil Society actors engage with the UNITAID Civil Society delegations? There are three groups civil society actors can join to engage with the UNITAID Civil Society delegations. These are: Contact Group: A broad group of stakeholders who receive regular updates on the activities of the UNITAID Civil Society delegations. Any person living with HIV or TB or from a community affected by malaria, or from an NGO involved in the global fight against these three diseases, can join the Contact Group. Communities’ Support Team: A small group consisting of local community treatment- access activists and people living with the diseases, established to help the communities’ delegation connect with the needs of people in communities, and to expand awareness of issues relating to UNITAID. Advisory Group: A group of Northern and Southern NGO and communities experts with particular knowledge of medicines policies, supply-chain, diagnostics, medicines formulations, patents and Intellectual Property rules. Members of this group commit to reviewing key UNITAID documents prior to meetings, and may participate in pre- meetings and teleconferences on specific issues. Any member of the ‘Contact Group’ or ‘Communities’ Support Team’ may request to join the ‘Advisory Group’. Annex 2: UNITAID press release on re-election of Philippe Douste-Blazy as UNITAID Board Chair (11/11/10) PHILIPPE DOUSTE-BLAZY REELECTED AS CHAIR OF UNITAID — promises to promote innovative financing to world's leaders Geneva, 11 November 2010 — The UNITAID Executive Board today unanimously re- elected Philippe Douste-Blazy as Chair of UNITAID for another two years. In his acceptance speech, Mr Douste-Blazy stated that he would double his efforts to ensure that globalisation work for the poor through UNITAID's specific focus on shaping markets for patient treatments in developing countries. He also pledged to take innovative financing advocacy and actions to a higher level, thereby increasing support for UNITAID, other existing mechanisms, and new innovative financing initiatives such as the Currency Transaction Tax and the Global Tobacco Tax. "I will work more closely with partners," he said, "so that we ensure a high return on investments for major impact on people's health. I will also take the UNITAID business model to world leaders, to show that innovative financing is a vital contribution to health and development financing." The UNITAID Board - made up of the Governments of Brazil, Chile, France, Norway, South Korea, Spain, the African Union, the Bill &Melinda Gates Foundation, Civil Society and the World Health Organization - congratulated Mr Douste-Blazy for his successful track record in promoting better access to better medicines for people affected by AIDS, TB and malaria. As UN Under-Secretary General for Innovative Financing for Development, Mr Douste-Blazy was also saluted for his tireless work in promoting innovative financing globally as a crucial factor in reaching the Millennium Development Goals. Annex 3: UNITAID press release on funding commitments made at the 13th Board Meeting (12/11/10) Donors pledge to UNITAID in renewed effort to provide sustainable, predictable funding for access to treatment Geneva, 12 November 2010 — UNITAID's main donor country, France, has pledged a yearly sum of USD 150 million (EUROS 110 million) for the next three years in a bid to strengthen the agency's capacity to continue to impact on medicines markets for better patient access. The Republic of Korea also made a firm pledge, committing USD 7 million to UNITAID for 2011. The Brazilian delegate advanced his government's intention of providing USD 11 million for 2011. At present, total commitments to UNITAID stand at USD 180 million for the next year. "We will need much more high-level political advocacy to secure at least USD 350 million for next year," said Philippe Douste-Blazy, the newly elected Chair of UNITAID's Executive Board. "Our business model is based on long term funding which is crucial for sustainable impact." "We hope our three-year commitment will have a ripple effect and incite other countries to make multi-year pledges," said the French Delegate to the UNITAID Executive Board, Ambassador Patrice Debré. France and Korea both collect funds through a small air solidarity levy from passengers taking off from their airports. Part of those funds are given to UNITAID. The air levy, a small sum that makes no difference to individual travellers has a huge impact on spending for health commodities. "A dollar or two extra makes little difference to a traveller, but it can be the difference between life or death for a child suffering from malaria," stated Jorge Bermudez, Executive Secretary of UNITAID. Multi-year commitments from donors are at the core of the UNITAID business model, which needs funding predictability to shape markets in developing countries for better access to medicines and testing equipment for AIDS, TB and malaria. Other major donor countries such as the United Kingdom and Norway declared their willingness to continue to support UNITAID. Spain, which signed a three year agreement with UNITAID in 2009, could not commit beyond 2011 due to the current economic crisis.
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