UNITAID – 15th Executive Board Meeting
12th-13th December 2011, Ministry of Foreign and European Affairs, Paris, France
Civil Society Delegations Communiqué
UNITAID is an international drug-purchasing facility, supporting projects which use UNITAID’s long-term sustainable funding to positively impact the market for medicines and other health products for HIV/AIDS, TB and Malaria. 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.
The Civil Society delegations to UNITAID Board (representing NGOs and Communities affected by HIV/AIDS, TB and Malaria at Board level) recently attended the 15th UNITAID Executive Board Meeting, held 12th-13th December 2011, in Paris. This communiqué is the report from the Civil Society delegations at the Board meeting. It reports back on how the two delegations’ prepared for this meeting, the main outcomes of the meeting, and what input the NGOs and Communities Board members gave. The communiqué is part of the transparency and accountability mechanism set up by Communities’ and NGOs representatives on UNITAID Board, and those who follow UNITAID closely.
Reminder: 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 (LO) at [email protected] for more information.
How can Civil Society actors engage with the UNITAID Civil Society delegations?
Having previously had three groups civil society actors can join to engage with the UNITAID Civil Society delegations, the delegations have recently taken the decision to merge these into two, in order to be more open and transparent in their processes. These are:
· Contact Group: This merges the Advisory and Contact Groups the delegations previously had, and is a broad group of stakeholders who receive regular updates on the activities of the UNITAID Civil Society delegations, opportunities to apply to attend pre-Board meetings, opportunities to comment on Board documents, and invitations to delegations’ consultation teleconferences. 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. Contact Group members must commit to maintaining confidentiality around Board documents.
· 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, monitor UNITAID treatments reaching people on the ground, and to expand awareness of issues relating to UNITAID at country level.
Please email [email protected] if you are interested in joining the CS delegations’ to UNITAID Contact Group or Communities Support Team. A call for new Contact Group membership will also be issued in the coming weeks, and details of the change in groups circulated to existing members.
How did the Civil Society delegations prepare for the 15th UNITAID Executive Board meeting?
The Civil Society delegations held pre-meetings on 9th-11th December to prepare for the Board meeting, attended by additional people from a wide range of NGOs and community-based organisations*. Participants were selected from stakeholder networks of the UNITAID CS Delegations. A call for expressions of interest was circulated to the delegations’ 3 groups (Advisory Group, Communities’ Support Team, and Contact Group), and applicants were assessed against 5 selection criteria, to shortlist up to 8 attendees to receive funding support to attend the meeting, and up to 8 additional who could self-fund their attendance**. A process of document review with the delegation’s Advisory Group was also conducted in the week prior to the Board meeting.
From the discussions held during the delegations’ pre-meetings, ‘talking points’ were formulated to use on issues at the Board meeting***. Pre-meeting attendees were also able to observe the Board meeting, with 5 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.
What were the key issues at the 15th UNITAID Board meeting, and what were the outcomes?
The issues listed below are listed in order of agenda item. Resolutions from the Board meeting are available at: http://www.unitaid.eu/en/governance-mainmenu-4/resolutions-mainmenu-34/381.
1) Finance and Administrative Committee (FAC), and Policy and Strategy Committee (PSC) issues
a) Budget 2012 (FAC)
The budget for 2012 was presented for approval, at a total of $196 million.
It was highlighted that anticipated revenues for 2012 are USD 288 million, with France contributing 52% of this, and the UK making the second-largest contribution at 29%. The majority of commitments to UNITAID are now made on a multiyear basis.
The Communities delegation called on donors who had not fulfilled their pledges to ensure these were made, including Spain and Brazil, hoping for progress with Brazil’s pledges now the airtax law was in process. Brazil affirmed paperwork for multi-year contributions is in process. Spain highlighted they may need to compromise on commitments, though it was affirmed the new Spanish Prime Minister is interested in continuing Spain’s contribution.
Outcome: A budget for 2012 was approved of US$192,706,000 including approval of the Civil Society delegations 2012 grant of $159,950 for coordination and consultation activities, including pre-Board meetings. A copy of the full proposal and budget for 2012 for the CS delegations’ is available from the LO on request.
b) Funding Decision Framework (FAC)
A funding decision framework was discussed, giving guidance for cost/time overruns for UNITAID projects, Secretariat initiatives (e.g. the market intelligence database) and special projects (e.g. Medicines Patent Pool).
Outcome: It was agreed all cost extension requests exceeding the original ceiling set by the Board should go back to the Board for approval, as should all no-cost extensions exceeding 1 year beyond the original time period. If a project change request alters the original scope of the project significantly (e.g. disease scope, product area, countries covered) a new project proposal must be submitted.
c) Terms of Reference for the FAC, PSC, and Vice-Chair of PSC (FAC/PSC)
New terms of reference (TORs) for the FAC and PSC were discussed. The TORs suggested the FAC work will constitute management of financial policies, planning, and monitoring, ethics and fraud, as well as review of UNITAID’s Key Performance Indicators (KPIs). It was agreed the FAC should maintain oversight of UNITAID’s HR plan also. The new PSC TORs suggest the workflow of the PSC will be to manage the UNITAID Strategy drafting process, partnership policy, a transition/sustainability framework, and to review the portfolio of projects’ performance.
In addition, it was suggested that the name of the FAC be updated to ‘Finance and Audit’ committee.
It was also proposed that UNITAID Board committees/working groups (excluding the FAC and PSC) should be abolished to streamline workflows****.
Outcome: The new FAC and PSC TORs were approved, and it was agreed the listed Board committees and working groups will be abolished. The FAC’s undertaking of audit functions will be discussed further at the next meeting.
d) Risk Management (FAC)
Outcome: Risk management activities were approved, including developing a risk management policy, and looking at risks in forecasting, procurement, storage and distribution of UNITAID-funded products. Oversight of risk management activities was delegated to the FAC.
e) Transition of UNITAID projects to alternative sources of funding, and next calls for letters of intent (PSC)
The NGOs delegation requested some analysis of the entire UNITAID portfolio take place over a longer period of time post-project, to map out realistically the transition of projects to alternative sources of funding.
It was also noted that a reactive window for submission of letters of intent will be opened at the end of March 2012, with the next proactive call for letters of intent, for medicines in the three diseases, to be held in quarter 3 in 2012. The outcome of the first proactive call (on diagnostics), issued during quarter 3 2011, is to be determined in March/April 2012, at an extraordinary Board meeting.
2) Update on UNITAID 5 year evaluation
Activities for the evaluation of the first 5 years of UNITAID’s activities have been initiated, including appointment of an Independent Steering Committee of 3 members, development of a budget of approximately US$500,000, and recruitment for the group to conduct the evaluation. It is anticipated a final 5-year evaluation report will be finalised in August 2012.
The Communities delegation stressed the importance of the evaluation assessing whether UNITAID-funded products reach end users in the communities.
3) Processes to update Strategy 2013-2015
Processes to update the UNITAID Strategy for 2013-2015 were discussed. The Gates Foundation will support in the drafting of the new UNITAID Strategy. The NGOs delegation volunteered to develop additional key questions to assist in the Strategy development.
Outcome: The new Strategy will be discussed further, including identifying key questions for UNITAID to address 2013-15, and reviewing current objectives and developments, at the UNITAID Board Retreat in April 2012. The Board requested the Strategy update for 2013-15 be completed by December 2012. The draft Strategy will incorporate lessons learned from the 5-year evaluation, prioritisation process and landscape analyses.
4) Operations Update
An update on UNITAID operations was given for 2011. The top 10 countries benefiting from UNITAID funding in 2011 were: Nigeria, Zambia, Uganda, Kenya, India, DRC, Mozambique, Zimbabwe, Sudan, and Ethiopia.
It was highlighted that 6 UNITAID projects will be completed as of the end of December 2011. In HIV, this includes the 2nd line CHAI project, though a no-cost extension will be provided to this project due to delays to Global Fund Round 10, delaying the project’s transition process, and PMTCT I, a UNICEF project, also granted a no-cost extension. In TB, two Global Drug Facility (GDF) projects are ending, including the 1st line treatments project, and the paediatric project, where a no-cost extension has been granted. In addition, no-cost extensions have been granted in malaria, to the ACT scale-up project, and to support to Global Fund Round 6. Deliveries of products funded by UNITAID will continue into 2012 for both these projects therefore.
Key lessons learned in 2011 highlighted include:
- In HIV: ongoing support for transition in the paediatric market is vital to ensure market impact is sustained; there remains a need for new paediatric formulations, point-of-care diagnostics and early-infant diagnosis tools; UNITAID should monitor the ability of other purchasers to access price reductions leveraged by UNITAID, especially in the 2nd line ARVs market.
- In TB: ensuring MDR-TB diagnostics are scaled-up at the same time as MDR-TB treatments; new fixed-dose combinations are required in paediatric TB in order to meet new WHO guidelines; there is also a need to improve national planning and global forecasting.
- In malaria: there is need to scale up use of rapid-diagnostic tests (RDTs) alongside the scale-up of ACTs; there is need for continued work on ACT forecasting and artemisinin supply monitoring; there is also need to support the adoption of semi-synthetic artemisinin in 2012 to provide supply security, and stabilise prices.
5) Diagnostics Letters of Intent (LOIs)
An update was given on UNITAID’s call for letters of intent (LOIs) for new diagnostics projects. The call was issued in September 2011, following UNITAID’s published analysis of the diagnostics landscape in HIV, TB and malaria.
54 LOIs were submitted as part of this call, 89% of which were from new potential partners (and 11% from existing partners).
10 of the submitted letters of intent had been invited to submit full proposals to UNITAID (the remaining 44 did not fit with UNITAID’s business model, and were unsuccessful). These comprised:
- 4 HIV LOIs (2 of which are large-scale purchasing of pipeline products),
- 1 TB LOI (applying for large-scale purchase of geneXpert, which proponents were going through price negotiations for),
- 3 malaria LOIs (1 seeking to create a private market for rapid-diagnostic tests (RDTs), 1 to develop a sustainable quality-assurance mechanism for RDTs, and 1 for technology transfer in Africa and market intelligence)
- 2 cross-cutting LOIs (1 on quality assurance, and 1 on market intelligence incentives and entry of new products).
9 of the unsuccessful LOIs focused on late-stage field evaluation and other market entry activities for new and pipeline HIV point-of-care diagnostics (see point 6 below for next steps on these LOIs, focusing on the ‘missing middle’ of bringing new products to market).
It was stressed by one Board seat that the opportunity afforded by the new LOIs should be used for UNITAID to fund a ‘best package of interventions’, e.g. scale-up of RDTs in the private sector, to complement the Affordable Medicines Facility – malaria (AMFm) initiative.
Next steps: Full proposals will be submitted by potential partners in January 2012. These will then undergo technical review by the Proposal Review Committee (PRC) ahead of a Board decision on which projects will be funded, to be made at an extraordinary Board meeting in April 2012 (TBC).
6) Supporting products market entry (for products in late stage field evaluation and registration: the ‘missing middle’)
As mentioned above, UNITAID received 9 letters of intent (LOIs) dealing with market entry activities for diagnostics products, in response to the call for LOIs. These LOIs cover a substantial proportion of diagnostic products for HIV in the pipeline currently.
It was highlighted that the cost to support market entry of diagnostic products for HIV, TB, and malaria (including final field evaluation and other activities) is estimated at between 1-15 million USD. Grants often fund the initial development of products only, and private funding for late-stage development activities may be difficult to access. The gap in funding for market entry has negative implications for the market as a whole, including meaning valuable products may never get to market, and limiting competition (as the first-to-market product can more easily capture market share). It was proposed therefore that UNITAID look at intervening in this ‘missing middle’ in future.
The NGOs delegation stated that it would be worthwhile UNITAID funding companies and trials, if this was required to bring new, valuable products to market, though they stressed this was under the condition that satisfactory pricing and licensing were included. The NGOs delegation questioned the need for regulatory support, as there are no registration requirements in most developing countries, and it is not UNITAID’s role to build this capacity.
Outcome: The Board endorsed the Secretariat recommendation to include support for late-stage field evaluation and registration of products as part of the UNITAID business model. The Secretariat will prepare details of UNITAID’s proposed approach to support market entry of diagnostics and medicines for discussion at the April 2012 Board retreat. This approach will initially build on the diagnostics LOIs already received by UNITAID in the recent call.
7) Update on WHO Pre-Qualification (WHO PQ) Programme Strategy
A presentation was made by WHO on their strategy for the pre-qualification programme. The WHO pre-qualification programme has been supported by UNITAID since 2006.
Key challenges with WHO PQ were highlighted, including: the growing workload for WHO, financial constraints (WHO PQ is not self-sustaining), and some process inefficiencies (including length of pre-qualification process, risk mitigation, administrative and staffing inefficiencies), and unclear prioritisation of products for WHO PQ.
It was stressed the new WHO PQ strategy should be pro-poor and not based on market demand. WHO PQ should be self-sustaining, diversifying outside of funding support via grants, and attracting new funding. PQ for diagnostics should also be strengthened.
In addition, it was recommended that the activities of WHO PQ should be transitioned to National Regulatory Authorities (NRAs), or a regional network of NRAs, in the long-term.
Concerns were raised by Board members over this, especially for countries with weak or non-existent regulatory frameworks. NGOs stressed that the functioning of WHO PQ is essential, and has been the building block of all of the work of UNITAID. NGOs agreed with the vision of regional PQ platforms, but stressed this is a long way off. The NGOs delegation also raised the importance of having a strong and well-functioning Essential Medicines department at WHO, and called on WHO to prioritise this function, and UNITAID to ensure continued support.
The Communities delegation expressed support for the long-term move to support countries to implement their own policies for quality assurance, to complement the work of WHO.
WHO gave assurances that PQ would function as long as there was need, but that it would continue to work to strengthen national regulatory authorities and regional initiatives going forward.
8 ) Artemisinin-based Combination Therapy for malaria (ACTs) forecasting
An update on ACT forecasting was presented by the Boston Consulting Group (BCG), which had undertaken work on this in collaboration with UNITAID, in order to identify market shortcomings and possible interventions in the market for ACTs.
The huge increase in demand in the private sector for ACTs, as a result of the Affordable Medicines Facility – malaria (AMFm) initiative, was noted, with overall demand for ACTs increasing to 295m treatments in 2012, from 217m in 2010. It was also noted that the price of artemisinin had tripled since the launch of AMFm phase I, from $300 per kilo to $900 per kilo. Major challenges with ACTs were outlined, including the substantial portion of malaria treatments still on the market that are chloroquine, SP, artemisinin mono formulations, non quality assured ACTs etc, and that ACTs are still substantially more expensive than other malaria treatments, even in AMFm countries (e.g. Uganda, where AMFm ACTs are still 2.2 times more expensive than SP).
BCG stressed the importance of completing phase I of AMFm in order to stabilise the market, but suggested phase II may require improvements, including rollout of rapid diagnostic tests (RDTs) co-packaged with ACTs. Manufacturers of ACTs also need more support, it was highlighted, especially accurate information on demand and available funding, so investments can be planned in accordance.
Suggested market interventions UNITAID might consider in future were presented, including: structure up-stream artemisinin supply chain through the A2S2 project, extend AMFm to fund RDTs, push for minimum guarantees for long-term funding of malaria treatments to support manufacturer forecasting, support adoption of semi-synthetic artemisinin, and potentially stabilise artemisinin prices through an international price bank.
The NGOs delegation raised very grave concerns over the tripling of raw material prices this year, and suggested the role of AMFm (and therefore UNITAID) should be considered very carefully in this. The huge sudden and uncontrolled influx of orders from AMFm this year, only capped in September, destabilised the market, leading to the threat of shortages and speculation on the raw material market. This could have been avoided through a phased and gradual management of orders, NGOs stated. Overall, this has resulted in negative market impact by AMFm on raw material prices this year, raising issues around AMFm management and oversight, and requiring careful consideration by UNITAID.
The Communities delegation asked what could be done to push out monotherapies in AMFm countries, and stated they were happy to see the private sector responding to the high prices of ACTs, to make ACTs more affordable in remote communities.
It was argued the fear of a global ACT shortage this summer was caused by a sudden upsurge in demand as AMFm took off, as manufacturers had not previously had confidence in (or ordered in line with) AMFm forecasts.
Board delegations requested more analysis on the cyclical nature of the artemisinin market in future, and on the impact the introduction of semi-synthetic artemisinin may have on this.
9) Medicines Patent Pool (MPP) update
An update was given by the Medicines Patent Pool on progress made in the first year of its operations. The MPP highlighted that the milestones for year 1 (as in UNITAID’s original MOU with the Pool), had been met. These included that license agreements covering 5 products should be concluded by September 2011 (2 licence agreements covering 6 products have been signed with Gilead Sciences, and NIH), and 3 patent-holding entities should commit in writing to licensing to the Pool by July 2011 (7 patent-holding entities have committed in writing to formal negotiations with the Pool to date).
Based on the 5-year MOU with UNITAID, a mutually acceptable business plan and budget for the following 4 years of the Medicines Patent Pool, should be agreed upon by MPP and UNITAID Secretariat and Board, provided the MPP met its first-year milestones*****.
The MPP presented on the Gilead licence agreement, signed in July, and in particular highlighted their concerns over the restrictions to geographic scope of the licenses, limitations of licensees to Indian companies, and restrictions on the sourcing of Active Pharmaceutical Ingredient (API). They flagged two amendments to the Gilead licence that have been signed since the original licence agreement was signed in July.
The NGOs delegation raised the point that the limitations of the Gilead licence agreements signed to date, especially the exclusion of a number of middle-income countries, had triggered significant discontent within the NGO delegation. They asked MPP to work to include all MICs, and also asked to drop the royalty system (where the MPP receives royalties as a percentage of licence agreements, to help it become financially self-sustaining), to remove any even perceived MPP conflict of interest here.
The Brazilian delegation raised a number of concerns in relation to the Gilead licence agreement, especially the limitation of production to Indian manufacturers, but also the limits to geographic scope of licence coverage. Brazil referenced a letter written to the Chairs of MPP and UNITAID Boards, expressing these concerns, sent in July 2011.
The MPP responded to comments and queries, stating that they were continuing to work to increase geographic scope of the Gilead licence, to include all lower- and middle-income countries. They are also working on appropriate incentives for companies to increase geographic scope, including tiered royalties for example. However, they stressed that the MPP remains a voluntary mechanism for negotiating voluntary licences, which has and will continue to have some limitations. The MPP also stated it would be happy to forego royalty payments to MPP from licensors to remove any perceived conflict of interest.
10) Funding Decisions
Three important funding decisions were made at the 15th Board meeting, following a proposal review process conducted by the UNITAID Proposal Review Committee (PRC). In addition to the funding decisions listed below, the PRC also highlighted an A2S2 project extension request had been submitted, but which requires some clarifications before any recommendation on funding is made to the Board******.
a) Paediatric HIV/AIDS treatment project extension for 2012 (CHAI)
The CHAI paediatric HIV/AIDS treatment project has been supported by UNITAID since 2006, and has leveraged dramatic reductions in the costs of HIV/AIDS treatments for children (over 80% price decrease for some ARV formulations since the outset of the project). CHAI is working to transition the project to alternative sources of funding, and had submitted a funding request to UNITAID for US$62.8 million for the remaining 11 countries which have not yet successfully transitioned, for the period 2012*******.
The NGOs supported the approval of the CHAI project extension proposal. NGOs requested a realistic assessment of transition timing for the project however, looking beyond 2012 (at 2013-14), and looking more strategically at needs in the paediatric market going forward including development of paediatric formulations, on a longer-term basis, as UNITAID needs to stay engaged in this fragile market.
It was agreed that the 2012 funding request was unlikely to be the final funding required for the paediatric ARVs project, and highlighted that there is a real need for strong coordination in the paediatric market from the end of 2012, coordinating procurement and sustaining the market impact achieved to date.
The Communities delegation stressed the need to coordinate continuation of paediatric ARVs supply with national governments.
Outcome: The CHAI paediatric HIV/AIDS treatment project funding extension, of up to $62,800,000 for 2012, was approved. The approval is subject to clarifications being provided by CHAI on the following questions/issues: 1. How will the financing of health services and the purchasing of commodities be managed once decentralisation is implemented? 2. How will the growing need to switch to second-line regimens impact markets and public health? 3. How will the increased coverage of PMTCT affect the paediatric ARV market and forecasting? 4. Further analysis of the risks of transitioning in 2012 5. How will commodity costs be revised during the procurement process and how they might affect the budget?
b) Affordable Medicines Facility – malaria (AMFm): phase I cost extension
The Affordable Medicines Facility – malaria (AMFm), is supported by UNITAID and the UK (DfID), and is hosted and managed by the Global Fund. It aims to expand access to ACTs by substantially reducing prices, through price negotiations with manufacturers and subsidising ACTs purchased.
It was recommended the extension of phase I be funded by UNITAID, despite there being concerns around the need for roll-out of rapid-diagnostic tests (RDTs) for malaria to ensure rational use of ACTs. There was agreement amongst Board delegations that any funding decision made at the Board meeting should have no implications beyond phase I, until the phase I evaluation had been completed and its results shared.
The NGOs delegation reiterated that the disruption of the raw material market for ACTs seen in the summer of 2011 could have been prevented with better phasing of AMFm orders (highlighting the tripling of raw material prices and narrow avoiding of a global ACT shortage at this time), and expressed serious concerns over poor budget management. The NGOs strongly recommended that AMFm should be encouraged to spend their remaining funds more slowly (e.g. by not initiating activities in new countries), whilst waiting for the results of the phase I evaluation, before being assigned further UNITAID funds. A decision on this could be taken at the April 2011 Board meeting, NGOs suggested.
Some Board delegations also raised concerns over the need for UNITAID to have direct participation in the governance of AMFm, following the dissolution of the AMFm ad-hoc committee (as part of the restructuring of the Global Fund’s governance mechanisms), where the Vice-Chair serving had been a UNITAID nominee.
The Communities delegation (and other Board members), stressed the need for AMFm to ensure access for the most vulnerable populations. Highlighting their own initiatives to track UNITAID medicines reaching populations on the ground (through the delegations’ Communities’ Support Team), Communities expressed strong support for the extension of phase I, whilst ensuring continued work on the challenges the AMFm is facing.
Outcome: The Board approved the request for up to $50,000,000 of funds for the AMFm phase 1 cost extension proposal, subject to: 1) written confirmation that funds disbursed will be used for phase I of AMFm only; 2) written confirmation from other donors that UNITAID’s contribution to phase I will be matched (to ensure adequate funding for the completion of phase I), 3) written confirmation that by the end of quarter 1 2012 a governance structure for AMFm will be created to take over the role of the AMFm ad-hoc committee, which has been dissolved, and that UNITAID will be a full participant in that structure, and 4) that a first draft of scenario planning for transition of AMFm to other funding sources, should be provided to UNITAID Board by the 16th Board meeting (in June 2012) for review at that time.
c) Medicines Patent Pool (MPP): 4 year budget
The Medicines Patent Pool (MPP) gave an update on its 1st year of operations earlier in the Board meeting (see point 9 above), ahead of the funding decision on 4 years of funding. The MPP budget for 2012-15 requested $26,248,170 over the 4-year period 2012-2015.
The UNITAID Secretariat and the Proposal Review Committee deemed the Pool’s performance against the year 1 milestones as satisfactory, and recommended the Board fund the 4-year budget requested by MPP.
The NGOs delegation and Board Chair raised letters which had been sent to Board members overnight, from NGOs/Communities organizations. The Civil Society delegations to the Board highlighted they have shared with the entire Board their approach to the MPP as a result of the civil society debates, including how the delegations see the way forward on this issue********. The NGOs delegation stated that NGOs want the Patent Pool to work and deliver, but that there is dissatisfaction, as the recent letters have indicated, with what the MPP has achieved so far. NGOs raised concerns about the limits to the geographic scope in the first commercial licence, restrictions on production and sourcing of API, and the signing of side licences by Gilead. NGOs further stated that the MPP has to engage more directly with civil society at large. The NGOs also stressed that MPP should be one strategy for access to medicines, and that the use of TRIPS flexibilities must continue to be supported by UNITAID and its members. Governments must not use their support for the MPP as a way of saying that they are performing adequately on access to medicines, while negotiating Free Trade Agreements with negative impacts on access to medicines.
The NGOs delegation also recommended dropping royalty payments made by licensors to the MPP, to remove any perceived or potential conflict of interest. NGOs also suggested standard terms and conditions for licence agreements should be developed, to enable MPP to enter negotiations with patent-holders starting from an ideal standard.
The NGOs delegation emphasised that they wanted to see the MPP succeed however, and that a multi-year funding commitment is important to be credible in negotiations with patent holders and licensees.
Some Board delegations requested that reference be made to satisfactory performance in relation to the principles and issues in the annex of the resolution from the February 2010 special Board session on the Patent Pool, in the resolution agreeing to 4 years of funding*********. There was also a request for some further honing of the MPP budget every year (including with input from the Board).
The Communities delegation expressed support for not restricting production to India. Communities stressed that PLWHIV are following the MPP very closely, and that MPP remains an important tool, and key for aspirations of access for PLWHIV. The Communities delegation were happy that MPP had met its year 1 milestones, and that UNITAID could commit to the 4 years of funding.
Outcome: The Board approved the 4 years of funding for the MPP, of up to $26,298,170, and the 4-year extension of the MOU. Funding support for the MPP is conditional on: 1) satisfactory performance, based on the annual workplan and milestones, and full consideration of the principles stipulated in annex I of the February 2010 Board special session on the Patent Pool resolution (see above for details), 2) the provision of an annually updated workplan including budget, staffing levels and financial performance, an annual financial audit, and satisfactory performance based on the annual milestones, 3) the provision of a framework of reporting by MPP to UNITAID, to include annual and semi-annual operational and financial reports, and 4) an independent operational review to be commissioned by UNITAID at the end of 2012.
It was clarified the approved resolution does not require the Board to annually approve the MPP’s budget.
11) Medicines landscape update
As part of UNITAID’s ongoing prioritisation activities, the UNITAID Secretariat is currently conducting a detailed landscape analysis on medicine in the three diseases, ahead of issuing of a call for letters of intent in the second half of 2012.
An update was given by UNITAID on potential opportunities for UNITAID in medicines in each of the three diseases, identified through the work on the landscape analysis to date. For HIV, potential opportunities listed included: securing API supply, to protect and scale-up in the paediatric market, further decrease prices for second line treatments, and create incentives for new formulations. For TB, potential opportunities for medicine interventions included: securing the API supply and reducing API costs for second line drugs, to improve the market-share of quality-assured products for second line drugs, to develop ‘centres of excellence’ for the development of paediatric TB medicines (see below), and to link new diagnostics coming to market to treatment. For malaria, opportunities listed included: securing the API (artemisinin) supply further, including through supporting the adoption of semi-synthetic artemisinin, support entry of new, cost-effective medicines, and of injectable artesunate, and ensure appropriate use of ACTs through accelerated scale-up of RDTs.
12) Future opportunities in TB niche
A presentation was given by the TB Alliance – Global Alliance for TB Drug Development, on opportunities going forward in the TB niche. The TB Alliance’s aim is to see new, better TB regimens which are affordable, adopted for use, and widely available.
The potential of the PaMZ regimen (containing PA-824, moxifloxacin and pyrazinamide, assessed in the TB Alliance’s NC001 phase II study) was highlighted. It was suggested that this regimen could potentially be equally effective against drug sensitive and a subset of MDR TB, have no interactions with ARVs, and be 10% less expensive than current MDR-TB regimens. However, adequate new diagnostics will need to be co-developed in parallel.
It was stressed that market entry for new TB treatment regimens will require significant advance work, and that market intelligence should be improved, especially for high burden countries. The development of resistance should be minimised by ensuring appropriate use of TB regimens, and diagnostics being an integral component of new TB regimens.
The TB Alliance also emphasised the challenges in the neglected and complex area of paediatric TB, where market dynamics do not justify almost any commercial investment. The suggestion of developing a ‘paediatric centre of excellence’ was made, bringing together actors from the pharmaceutical sector, regulatory authorities, academic centres, WHO, funders and national TB programmes, to lower market entry barriers.
The NGOs delegation said they were encouraged to hear about the PaMZ trial, if accompanied with the right diagnostic tool, as in each patient resistance to pyrazinamide and moxifloxacin must be ruled before such a regimen can be given (it will not be a universal regimen for all patients). The NGOs backed the idea of a ‘paediatric centre of excellence’ but stressed that it should be built based on practical projects to address current urgent needs, e.g. a paediatric 1st line FDC for TB.
13) Resource mobilisation update
An update was given on UNITAID’s resource mobilisation activities, highlighting a recent visit to Japan where consensus is developing around implementing the airtax there.
The resource mobilisation strategy UNITAID will employ will include: 1) securing and preserving the existing resource base, 2) exploring potential new donors (including those who already have an airtax of sorts which does not contribute to UNITAID, e.g. India, Benin, Cote d’Ivoire, those who have agreed to join but have not yet passed a law, e.g. Morocco, South Africa, Senegal, and potential new donors, including Japan, Australia, Kenya, Cambodia and others), 3) prudently and progressively pushing the frontiers of other innovative financing mechanisms, including a financial transactions tax (FTT), and 4) collaborate with the private corporate sector through the Millennium Foundation, particularly in the travel and tourism industry in emerging economies (see point 14, below), in generating additional revenue for UNITAID
14) Millennium Foundation for Innovative Finance for Health – update
As mentioned above, the Millennium Foundation for Innovative Finance for Health is moving in a new strategic direction, soliciting funding support from the corporate private sector for UNITAID, particularly from within the travel and tourism sectors in emerging economies. The Millennium Foundation Board agreed to move in this direction, away from its original remit of micro-donations made by consumers when booking travel tickets, through ‘MassiveGood’.
A pipeline of investment opportunities in this new area is under development. It was highlighted corporate donations made to UNITAID through MF would be tax-free.
At the close of the Board meeting a US$800,000 cheque was presented to the MF (represented by the Board Chair) by the HNA Group, China, the largest private air company in China.
A more detailed update on the Millennium Foundation will be circulated shortly.
Next Board Meeting: 12th-13th June 2012
Other forthcoming dates of key UNITAID meetings include:
- UNITAID Board Retreat/Strategy Planning – April (date TBC)
- Finance and Administration Committee (FAC): 8th May 2012
- Policy and Strategy Committee (PSC): 9th May 2012
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 [email protected]
* For a full list of attendees, please contact the Liaison Officer.
** The 5 selection criteria are: 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. Due to criteria 5 above, and the need to ensure some continuity within the delegations, it was anticipated around 60% of the total number of participants would have previously attended a UNITAID Board meeting.
*** A full list of talking points is available from the Liaison Officer on request.
**** Committees/working groups to be abolished include: KPI sub-committee, communications committee, ethics committee, (the functions of which will now be managed by the FAC), sub-nominations committee of the PSC (which has managed recruitment of the Proposal Review Committee and the Advisory Group on Funding Priorities) and resource mobilisation taskforce.
***** See article 6.1 of the MOU: ‘Provided that the performance of the Foundation [in year 1] is judged satisfactory by UNITAID, UNITAID shall, with the approval of the UNITAID Board, commit to funding for an additional four years’ subject to UNITAID’s annual evaluation of the satisfactory performance of MPP in accordance with article 7.7 of the MOU, which states ‘at the end of the first funding year, UNITAID shall evaluate the performance of the MPP according to the applicable milestones and bi-annual and any other reports submitted to it by the Foundation. If the performance of the MPPF is deemed satisfactory by UNITAID after the first year of the project period, UNITAID and MPPF will use best efforts to agree on a mutually acceptable revision of the milestones, business plan, budget and schedule of disbursements and reporting in Annexes 1-5 for purposes of UNITAID’s annual review for the following four years’
****** A2S2 provides loans to artemisinin extractors to make the purchasing of Artemisia (for ACTs) more predictable, therefore providing incentives to growers, and securing supply.
******* Countries which have not yet transitioned/which were considered for funding for 2012, were: Burundi, Cameroon, Cote d’Ivoire, DRC, Malawi, Mozambique, Nigeria, Swaziland, Tanzania, Uganda and Zimbabwe.
******** A copy of the Civil Society delegations statement on the Medicines Patent Pool, sent to UNITAID Board and on civil society listservs (ITPC, Health GAP) on 16/11/11,is available from the LO on request.
********* The February 2010 special session resolution is available at: http://www.unitaid.eu/images/EB11/EB11_SSPP_Resolution1_signed.pdf