Matthew Robinson, MA

This coming week the “who’s who” of the global health community (as well as some much more modest global health advocates such as your humble author) will make the annual trek to Geneva, Switzerland, for the 69th World Health Assembly (WHA), where World Health Organization (WHO) member states will collectively decide WHO’s plans for the coming year. This year’s agenda is packed and includes many topics that could impact global health research and development (R&D). Below are the agenda items GHTC will be tracking in Geneva and topics we’ll dig into in more detail at a May 23 side event and webinar we are cohosting with the Geneva Centre for Security Policy, Global Health R&D: What’s at stake during the 69th WHA? Framework of engagement with non-State actors WHO routinely engages with a variety of non-State actors (NSAs)—any organization other than a member state. These collaborations support core components of WHO’s global health strategy. Some have argued, however, that WHO’s current ad-hoc approach to managing such engagements undermines its independence and impartiality. As I have written previously, the current draft framework runs the very real risk of excluding key WHO partners and actors in the global health R&D community. Given the significant member state pushback against the proposal, it will be fascinating to see how the tension is resolved.   Health in the 2030 Agenda for Sustainable Development With the approval of the Sustainable Development Goals (SDGs) in September 2015, the global development community has been trying to sort out how to implement and measure programming to achieve what are, by all admissions, extremely ambitious targets. WHO is no different, and has been hard at work laying out strategies to achieve the various components of goal 3, the “health SDG.” It is particularly heartening that target 3.b specifically commits member states to supporting health R&D. What shape this will take, and how WHO will engage are definitely hot topics to watch at this WHA.   Global Action Plan on Antimicrobial Resistance Following the 68th WHA’s adoption of the Global Action Plan on Antimicrobial Resistance (AMR), WHO has been working to develop strategic options to achieve the plan’s goals and will be presenting a progress update and an options paper to WHA this year for input. GHTC is closely monitoring plans for the R&D objective, which states: “… develop the economic case for sustainable investment that takes account of the needs of all countries, and increase investment in new medicines, diagnostic tools, vaccines and other interventions.” While the options paper is quite broad, in the R&D space the WHO Secretariat is specifically asking for input on methods to de-link R&D costs from sale price, how best to support access to innovative antimicrobials, and how to develop a prioritization mechanism to support appropriate R&D on AMR specifically. Given the danger that the global rise of AMR represents, the discussion is likely to be extensive and intense.   Follow-up to the report of the Consultative Expert Working Group (CEWG) on Research and Development: Financing and Coordination (Report of the open-ended meeting of Member States) GHTC has been following the CEWG process for some time as it winds its way forward after what has already been a decade-long process. The prototype R&D observatory is now online, and the demonstration projects are returning their progress reports. The WHO Special Program for Research and Training in Tropical Diseases (TDR) has prepared an analysis that outlines how a pooled fund and R&D observatory could work to identify unmet needs and channel funds to those R&D projects. While almost everyone agrees that additional funds and greater coordination are sorely needed, as we heard at GHTC’s webinar on CEWG, the jury is still split on the CEWG’s specific proposals. While it is unlikely that the CEWG process will come to an end at this WHA, the number of concerns that can be ironed out with all the decision-makers in the room will be telling in regards to future prospects.   For more analysis on these subjects, read GHTC’s fact sheet on Research and development at the 69th World Health Assembly.  

Photo: PATH/Will BoaseLast week, GHTC convened a panel of experts to dissect and discuss a proposal for pooled funding for global health research and development (R&D). The result of many years of brainstorming and negotiating by the World Health Organization (WHO) Consultative Expert Working Group on Research and Development (CEWG), the fund would finance neglected disease R&D at WHO’s Special Program for Research and Training in Tropical Diseases (WHO-TDR).Based on the discussion, here are my five key takeaways.1. It has been a long process and the proposal has shifted over time. A pooled R&D fund and global health observatory are the end products of a decade-long debate rooted in the struggle to expand access to antiretroviral treatment in the early 2000s. This movement led to the Doha Declaration on TRIPS and Public Health—which permitted member states to circumvent patents to expand access to medicine. Rachel Cohen, Regional Executive Director at Drugs for Neglected Diseases initiative North America, noted, “There was a growing recognition in the early 2000s of the failure of the R&D system to deliver, particularly for diseases that really fell outside the market.” Cohen further remarked, “That really produced the political impulse to start the process.” As a result of this movement, the CEWG was established in 2010 to look at ways to finance R&D for neglected diseases. The CEWG initially proposed establishing a global treaty requiring member states to dedicate .02 percent of their gross domestic product to health R&D with 20 percent of the amount raised through the treaty going to a pooled fund for neglected diseases. Over time the challenges of a treaty became clear, and the goal shifted to the current proposal to create a voluntary fund.2. The current proposal fulfills two distinct and separate functions—financing and coordination. While much of the public discussion has focused on the pooled fund, there are actually two components to the proposal: the pooled fund and an R&D observatory. The observatory would serve as an online compendium of all target product profiles (TPPs) for neglected disease products in the global pipeline. Given that TPPs contain comprehensive information on product candidates, including target pricing, target markets, access considerations, and other details, the observatory would give a comprehensive picture of the gaps in the global product development pipeline. Having identified these gaps, the public health community could then convene a dialogue to determine the most pressing priorities for research. Once those priorities are identified, the pooled fund would be deployed to fund R&D for products addressing the needs identified.3. Sufficient funding is not guaranteed, and the space is already crowded. WHO-TDR has modelled a variety of scenarios on what the fund could finance. Depending on the level of resources raised, the pooled fund could support R&D projects ranging from developing a limited number of simple repurposed drugs for around US$15 million per year to developing novel biologics and new chemical entities for around $500 million per year. While the hope is that a pooled fund would attract contributions from low- and middle-income countries that might not be able to fund their own freestanding R&D programs, it is unclear how much the fund could raise even with matching funds from existing donors. Furthermore, given that all contributions are voluntary, the fund would need to actively fundraise to support its work, which requires additional staff and resources purely devoted to these activities.According to Andrea Lucard, Executive Vice President of Medicines for Malaria Venture, concerns persist that “this actually may increase fragmentation” for R&D funding. Lucard asks further, “Are we at risk of siphoning off funds that exist from donors that are already there or donors that are close to being able to fund [existing] dynamic successful organizations?”Credit: WHO TRD4. The necessity of fundraising risks mixing the technical with the political. With the shift from a treaty to voluntary contributions comes growing tension between the observatory and pooled fund. The observatory must be driven by technical public health analyses such that the priorities it sets are credible, and the pooled fund must actively fundraise from individual donor nations. With fundraising comes the question of the level of influence the donor gets for its money. As we have seen in other pooled funds, the struggle between political and technical considerations is a very real problem. If the fundraising activities to support the pooled fund end up casting doubts on the observatory’s credibility, the observatory will have largely lost its ability to fill its mandate. In addition, tying the observatory to the fund runs the risk of losing the benefits of the observatory should the fund fail to raise sufficient funds and force the closure of the observatory as well through lack of funding.5. The observatory and pooled fund are only one approach to increasing access to medicines. While the pooled fund and observatory could potentially improve access to medicines by mobilizing more funds to directly finance R&D for neglected diseases, they would still operate within the existing overarching framework governing global health R&D. Rachel Cohen commented that the only way the pooled fund would be successful is if it is “based on a financing of R&D that disconnects, or de-links the cost of R&D from the pricing of final products.” This reflects the broader debate within the global health R&D community over exactly how to reform current policies to better promote access to medicines.The next step in the process is an open-ended meeting on May 2-4 where WHO-TDR will formally present its proposal for the observatory and pooled fund to WHO member states, who will then decide whether to move forward with a World Health Assembly resolution. Prior to that meeting, we expect that the full report and dataset underpinning WHO-TDR’s analysis will be published on March 17th.

WHO EB meets in Geneva. Photo: GHTC/Jana ArmstrongThere’s an old adage about political negotiating: “You need to be in the room when things are happening if you want to have an impact.” At its recent meeting, the World Health Organization (WHO) Executive Board (EB) discussed precisely who would be allowed in the room in the future under the proposed new Framework for Engagement with Non-State Actors (FENSA), which, if passed by the World Health Assembly (WHA), would set strict new rules and processes for WHO to follow in engaging with non-state actors (NSA)—including nongovernmental organizations (NGOs), civil society organizations (CSOs), the private sector, and philanthropic foundations. These new policies impact everything from who is allowed to participate in governance meetings to the ways WHO can collaborate with local NGOs. To provide some context for the proposed changes, below is an overview of the current rules, the proposed new regulations, and some of the implications of particular concern for the global health research and development (R&D) world.Current rules governing engagement with NSAs The current rules governing WHO’s collaboration with NSAs derive from “Principles Governing Relations Between the World Health Organization and Nongovernmental Organizations.” The Principles recognize three levels of relations between WHO and NSAs: informal, working, and official. Informal relations consist of “…exchanges of information and reciprocal participation in technical meetings” and are designed to build a platform of shared priorities. They can continue on an ad-hoc basis for as long as necessary without any written agreement.If the relationship elevates to the level of specific joint programming and activities, WHO and the NSA can enter into a 2-year period of working relations. The two organizations exchange formal letters of commitment and agree to evaluate the outcome of the collaboration at the end of the joint activities. These types of collaboration do not require any decisions by the EB and can occur with WHO Secretariat staff approval; they do not grant any formal participation rights at the EB or WHA.To receive formal recognition and participation rights at the EB and WHA, an NSA must complete a successful period of working relations and submit an application to the EB. If admitted into formal relations, the NSA’s relationship with WHO is then subject to review every three years. If the application is rejected, the NSA cannot reapply until it has completed another period of working relations.Proposed new regulations The new proposed FENSA rules take a far different approach. Rather than recognizing three different categories of relations, it features only two: official relations and “engagement.” Unlike the current regulations, however, it does specify different rules of engagement depending on the type of NSA; NGOs/nonprofits are treated differently than philanthropic foundations, which are treated differently than academic institutions, which are in turn treated differently than the private sector. Of particular note for the R&D community, private-sector entities would be barred from official relations, as would any entities not “at arm’s length” from commercial sponsors or members. This could be interpreted to include some product development partnerships.Under FENSA, WHO would be required to create a publicly-available online register of every NSA it engages with at the global, regional, or country level. A pilot version of this register is currently available here. Each NSA that wished to engage with WHO would be required to populate all of the information shown in the link above as well as a to-be-determined section detailing the precise nature and funding of the engagement. For the purpose of registration requirements, engagements are defined as: participation in meetings, donation of resources, information/evidence sharing, advocacy efforts, and technical or programmatic collaboration. Essentially, as currently written, this category requires registration for almost any type of collaboration.When an organization proposes engagement(s), WHO Secretariat staff would be required to review both the organization’s information and the proposed activity in the register, as well as conduct a full due diligence assessment on risk management and potential conflicts of interest. Only after these processes have completed would the activity move forward. The staff burden of these processes is hard to overstate; the European WHO region had over 5,000 individual engagements with over 1,500 NSAs in 2014 alone.As shocking as it sounds, all of the above scrutiny would be required for simple “engagement,” not for official relations. In order to guarantee the right of representation at EB and WHA meetings, an organization would still need to submit a separate application with even more extensive documentation.Implications for the health R&D community Ultimately, FENSA, if implemented as it currently stands, does not seem likely to fix any problems, while it would likely create additional hurdles for the R&D community by: Greatly hindering the ability of WHO to collaborate with outside organizations by imposing a burdensome registration and review process for every type of engagement (no matter how small or informal). Potentially disenfranchising significant sectors of the global health R&D community by imposing stricter requirements that might redefine some product development partnerships as private-sector organizations that are not entitled to representation. The WHO working group revising FENSA will meet again in early April to attempt to reach an agreement so that they can present a consensus resolution to the WHA in May. We will be following the process very closely, and will provide further updates on this blog as they happen.

With the New Year underway, GHTC is looking forward to a busy spring of multilateral organization meetings—with a number of them impacting global health research and development (R&D). First on the agenda is the World Health Organization (WHO) Executive Board (EB) meeting on January 25–30 in Geneva, where the EB will receive updates on a number of topics and make important decisions, particularly around how to proceed with the next steps of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) process. The full provisional agenda is available here, but below, GHTC’s Matt Robinson highlights what you can expect on global health R&D related topics. WHO Executive Board (Photo: NCD Alliance) Agenda item #7 – Promoting health through the life course – Tuesday, January 26 7.1 – Monitoring of the achievement of the health-related Millennium Development Goals (MDGs) – Update to the Board The development of indicators to monitor progress toward the health-related MDGs has been a key priority for the WHO. This update to the Board outlines the current slate of health indicators, including indicator 8.E on affordable access to medicines. 7.2 – Health in the 2030 agenda for sustainable development – Update to the Board In this session the WHO Secretariat will present a report tracing the development of the Sustainable Development Goals (SDGs), outlining key differences from the MDGs, and highlighting potential changes required at WHO to ensure a leading role for health in the new SDG framework. As the lead United Nations agency on health, how effectively WHO can continue to advocate for the role of health in achieving the broader SDGs will shape the global health landscape. GHTC has been tracking progress on the SDG monitoring framework and proposed specific indicators to measure global health R&D in our report, “ Measuring Global Health R&D for the Post-2015 Development Agenda.” GHTC also produced a factsheet and a webinar on innovation in the SDGs. Agenda item #8 – Preparedness, surveillance and response – Wednesday, January 27 8.5 – Global action plan on antimicrobial resistance – Update to the Board Following on two previous World Health Assembly (WHA) resolutions on antimicrobial resistance, the Secretariat will propose either a summit at the opening of the 2016 General Assembly or a high-level side event on the margins of the same. Given the dramatic rise in antimicrobial resistance globally, WHO hopes to use this high-level event to mobilize global support and resources both to develop new antibiotics and to ensure that current drugs are used appropriately. Agenda item #9 – Communicable diseases – Tuesday, January 26 9.1 – 2014 Ebola virus disease outbreak and issues raised: follow-up to the Special Session of the Executive Board on the Ebola Emergency (resolution EBSS3.R1) and the Sixty-eighth World Health Assembly (decision WHA68(10)) Unfortunately the text of this report is not yet available, stay tuned for our post-EB blog and more information! Agenda item #10 – Health systems – Thursday, January 28 10.2 – Comprehensive evaluation of the global strategy and plan of action on public health, innovation and intellectual property: progress update – Update to the Board The 2015 WHA directed the WHO Director-General to undertake an evaluation of the global strategy and plan of action on health, innovation, and intellectual property. The Secretariat will present a report outlining the work conducted so far, as well as an addendum containing key points from the evaluation inception report, including the principles that will be used in developing the full evaluation plan and design. 10.3 – Follow-up to the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination – Planning for an open-ended meeting of Member States to discuss progress – Board Decision This report and decision point are two key items on the EB agenda. The CEWG on Research and Development: Financing and Coordination process continues moving forward and faces some key decisions in the coming months. At the meeting, the EB will decide if civil society will be able to participate consultative open-ended meetings scheduled for March, which will determine what resolution is put forward to the WHA. GHTC is a strong advocate for civil society’s inclusion in the process. 10.4 – Substandard/spurious/falsely-labelled/falsified/counterfeit medical products – Update to the Board The Director-General of the WHO was directed to convene a series of expert consultations on possible methods to counteract substandard as well as falsified medical products by a 2012 WHA resolution. To that end, a number of expert committees have met and produced the priority recommendation of creating a global network of focal points to tackle issues in the quality of the drug supply. These focal points would then be responsible for linking existing quality-assurance networks to a global one to ensure collaboration. Although there is no decision point in the document, work on this issue clearly continues apace. While GHTC will follow these agenda items closely, we will also keep an eye out for other late-breaking resolutions or developments and will post a follow-up blog after the EB with updates on the actual happenings! Matt Robinson in GHTC's Policy & Advocacy Officer.