Matthew Robinson, MA

The annual cycle of World Health Organization (WHO) governance meetings continues, with many WHO member states and advocates convening in Geneva this week for the 140th WHO Executive Board (EB) meeting where they will shape the agenda and resolutions for May’s World Health Assembly (WHA). The agenda is extensive, and covers everything from narrowing the field of WHO Director-General (DG) candidates to a short list in preparation for a vote at WHA, to addressing routine administrative matters. In discussions with other stakeholders and member states, the agenda items receiving the most attention are those on WHO reform and the DG election. But there are also two key resolutions that will directly impact global health research and development (R&D): Follow-up to the Consultative Expert Working Group on R&D: Financing and Coordination (CEWG) The long-running CEWG process continues soldiering forward from its inception in a movement to create a treaty to fund R&D for neglected diseases and conditions in the early 2000s. After many years of negotiations, in 2015, WHA approved five “demonstration projects” designed to test the feasibility of establishing a multilateral pooled fund to finance R&D, as well as the establishment of an R&D observatory to identify areas of unmet R&D need and inform the priorities of such a fund. In 2016, a sixth demonstration project was added, though these projects have yet to be fully funded and face a shortfall of roughly US$73 million to complete their programs. The policies currently on the table this governance cycle are approval of a plan to operationalize the global health R&D observatory, as well as solicitation of member state guidance into developing the principles that will guide a pooled fund for R&D. The observatory plan has been thoroughly vetted and would consist of a database documenting worldwide global health R&D projects and initiatives, with an expert committee responsible for ensuring that insights are gleaned from the database through data mining. There appears to be broad consensus among member states and advocates that this repository of data would be helpful in coordinating and organizing R&D, but it has yet to receive full funding from member states. The pooled fund proposal is much less developed. At this point, member states are only being asked to weigh in on broad principles and terms of reference. Overall the fund is proposed to disperse $100 million per year over 10 years, supporting 35 to 40 R&D projects of varying complexity (from simple repurposing of existing drugs to possibly developing new chemical entities). One key advantage many advocates see to the proposal is that access requirements could be baked into the mechanism from the very beginning so there is a strategy in place to ensure the availability and affordability of resulting products. What is much less clear is how the pooled fund would be sustainably financed in the long term. The paper outlines a number of options, including a cyclical replenishment and voluntary contributions, though these are all untested at this point. R&D for potentially epidemic diseases The WHO Secretariat will present a progress report and request for input on its efforts to develop and execute an R&D blueprint to combat potentially epidemic diseases in response to lessons learned and challenges faced during the Ebola outbreak. The goal of the blueprint overall is to reduce delays between the identification of an outbreak and the deployment of effective medical interventions. To support this goal, the WHO Secretariat has developed roadmaps or blueprints to support R&D projects for both Middle East respiratory syndrome coronavirus (MERS-CoV) and Zika. The Secretariat will also outline their future plans in supporting platform technologies, building regulatory capacity, and encouraging coordination among global health stakeholders in epidemic scenarios. These future activities are much more malleable, and stakeholders will have the chance to help shape them as work continues. Given the uncertainties around how a pooled fund and R&D observatory will be fully operationalized and sustainability funded and the necessity of enhancing global preparedness to address future disease outbreaks, it will be important to see what comes out of these EB discussions since they will set the stage for what will be voted on and address at WHA in May. GHTC will continue tracking these processes closely to ensure that the concerns of the global health R&D community remain front and center. For more information about the policy issues that will be addresses at the 140th WHO EB meeting, check out an archived video of webinar briefing on the topic organized by the Global Health Council.

Researchers examine onchocerciasis (river blindness) diagnostic tests. PATH/Patrick McKernWithout the right diagnostics, we can’t effectively treat diseases. It’s an obvious statement. But in many low- and middle-income countries, doctors and health care workers don’t have access to the diagnostic tools they need, often because existing tests are too costly and not appropriate for low-resource settings or tests don’t exist at all. Without the right tests, doctors end up relying on patient symptoms, which can be remarkably similar across different diseases. The result can be devastating: A wrong diagnosis can lead to the wrong treatment or a failure to recognize the presence of disease with pandemic potential. This problem is a common one: in half of African countries, more than 80 percent of those treated for malaria receive medicine without confirmation of a diagnostics, and during the 2014–2015 Ebola outbreak, efforts to contain the outbreak were hampered by a lack of rapid, point-of-care tests that could be deployed easily in the field.In a recent New England Journal of Medicine article, a group of scientists and doctors suggested an innovative idea to improve global access to critically-needed diagnostic tools: create a list.More specifically, they’re calling for the creation of an essential diagnostics list to complement the World Health Organization’s (WHO) Model List of Essential Medicines (EML). The EML provides guidance to countries on what drugs, therapies, and treatments should be made available to citizens to meet basic public health needs. Likewise, an essential diagnostics list would provide guidance on the vital diagnostics tests that should be available in each country, depending on its disease burden. In this way, the two lists would support and complement each other, with the diagnostics list identifying the tests needed to enable appropriate use of medicines on the EML.The transformative potential of an essential diagnostics listThe authors of the article have detailed the many ways an essential diagnostics list could be a transformative force for improving diagnostic capacity and access. By setting global guidance on the diagnostics tests recommended to countries to address basic health needs, an essential diagnostics list could provide a forceful policy argument for governments to invest in making existing diagnostics more broadly available. A list could also encourage governments to make further improvements to health systems to support diagnostic use, including laboratory training programs and strengthening health infrastructure and supply chains.But what GHTC is most excited about is one of the lesser-discussed aspects of an essential diagnostics list: its potential to catalyze research and development (R&D) of new diagnostic tools. A patient gets tested for malaria. PATH/Gena Morgan Diagnostic R&D is a significantly underfunded area of research, accounting for less than 5 percent of global funding of neglected disease R&D. The result is a lack of diagnostic tools targeting the specific health needs of low- and middle-income countries, such as easy-to-use platform technologies or rapid, point-of-care tests that can be used in remote, rural clinics.By detailing which diagnostics are necessary to support health interventions on the EML, an essential diagnostics list would readily expose health areas where we today lack appropriate and effective tools. In this way, the list could signal to product developers, industry, and donors where funding and attention is needed to facilitate diagnostic R&D.The impact of improved diagnostic access and capacity would be considerable: better care and treatment for patients, reduction in the inappropriate use of medicines which is contributing to drug resistance, and improved ability to detect emerging diseases like Zika and Ebola early before they become epidemics.Joining the call for an essential diagnostics listOn Wednesday, GHTC sent a letter, signed by 11 of our member organizations, to WHO’s assistant director-general for Health Systems and Innovation calling for WHO to spearhead the creation of an essential diagnostics list. Given WHO’s experience in administering the EML and its ongoing work in providing guidance on diagnostic testing and laboratory accreditation; we believe the organization is uniquely positioned to lead on the development and implementation of this list. But making this initiative a reality will require the support of civil society and member states, as well as additional funding to stand-up the program at WHO.It is clear that treatment can be improved with essential diagnostics—ones we have today and others yet to be developed. We urge WHO and its member states to heed this call to establish an essential diagnostics list. It’s a smart, cost-effective idea that could advance diagnostic R&D and access.Update: On November 18, Dr. Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation, replied to GHTC's letter indicating that WHO is pursuing analysis of the idea and outlining next steps. GHTC will continue to monitor progress and engage with WHO in support of this initiative.

As always at this time of year, the international diplomatic community is dealing with the adrenaline letdown following the conclusion of two weeks of mayhem in midtown for the United Nations General Assembly (UNGA). Attendees left with renewed inspiration, a few new political commitments, and for many, a nasty sinus infection that spread all too easily given the diplomatic necessity of copious hand-shaking. In our hyper-connected world where a single international event can spark a global outbreak of something far more deadly, it was apropos that two global health R&D topics received significant attention at this year’s assembly. Antimicrobial ResistanceAs GHTC has previously discussed, the assembly included a special High-Level Meeting on Antimicrobial Resistance (AMR), which was marked by an unusual level of agreement and commitment among member states and United Nations (UN) agencies on what actions are needed to address this challenge. The meeting concluded with the adoption of a political declaration, which among other priorities, acknowledges the importance of catalyzing R&D for the new diagnostics, vaccines, and antibiotics needed to combat AMR.The declaration specifically addresses R&D at three levels: National: Countries should include resources and policies to support R&D in their national AMR plans. Regional: Regional groups should develop regional AMR plans that leverage innovative partnership and incentive mechanisms to support R&D. Global: The UN system should include in its global AMR strategy sufficient policies to encourage global R&D efforts; the entire multilateral system (including development banks) should provide resources to support the above AMR plans, including for R&D; and the UN Secretary-General should establish an oversight group to ensure that all of these efforts are coordinated. We were pleased to see a dedicated call for all stakeholders in global health to ensure that R&D is a key part of addressing AMR and that sufficient resources are allocated to incentive mechanisms. Yet as one panelist rightly noted during the summit, “If I have three key points, they are implementation, implementation, implementation!” As the global community has seen far too frequently in the past, normative agreements reached at the UN require programming to translate them into progress on the ground. It will take civil society pressuring national governments to keep their commitments to this very progressive framework for it to have the impact it can and should. Access to Medicines TB medicines. Photo credit: PATH/Matthew DakinLess than one week before UNGA, the UN Secretary-General’s High-Level Panel on Access to Medicines (HLP) released its long-anticipated final report, which outlines dozens of recommendations from the panel in response to its mandate “to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”Both the mandate and the process of developing the report was controversial, as evidenced by the dissenting commentaries contained in an annex to the report. As outlined in the HLP cochairs’ letter to the Secretary-General, the dozens of agreed recommendations fall into four broad categories: Governments must urgently increase their current levels of investment in health technology innovation to meet unmet needs and should enter into negotiations for a binding global R&D treaty that delinks the costs of innovation from the end prices of health technologies in order to address issues that existing innovation mechanisms have failed to adequately remedy. There must be much greater transparency to ensure that the costs of R&D, production, marketing, and distribution, as well as the end prices of health technologies are clear to consumers and governments. Governments and the private sector must refrain from explicit or implicit threats, tactics, or strategies that undermine the right of World Trade Organization (WTO) members to use flexibilities as reaffirmed in the Doha Declaration on TRIPS [WTO Agreement on Trade-Related Aspects of Intellectual Property] and Public Health. WTO members must register complaints against undue political and economic pressure, and take punitive measures against offending members. The Secretary-General should establish an independent review body tasked with assessing progress on health technology innovation and access, and a High-Level meeting on Health Technology Innovation and Access should be convened by 2018.  In this environment, given the timing of the release of the report, the UN Development Programme convened at the last minute an invite-only panel discussion on the final day of UNGA. The session featured forceful remarks from the panelists and advocates, in addition to a lone dissenting statement from a member state government reiterating their concerns over the mandate of the panel.Ultimately, however, the takeaway from the event was the same as from the AMR meeting earlier in the week: the panelists unanimously agreed that the HLP’s work is done and that the Secretary-General now holds responsibility for moving the agenda forward. As a group convened without a member state mandate, the HLP had no binding authority to enact or enforce its recommendations and can only advise on what possible solutions might be. Advocates in the room noted that civil society activism can help hold governments to account and drive forward the recommendations to implementation.Overall, UNGA 2016 showed both the strength and the weakness of our multilateral governance structures. The UN can dream big, convene the world’s most senior leaders, and get them to agree to normative statements. However, implementing those norms requires the full support of its member states. This is not to minimize the importance of such a convening role; we would not have made the progress we have against HIV and AIDS, for example, without the UN’s forceful leadership. What remains to be seen, however, is whether the is a similar confluence of civil society, member state government, and multilateral organization support to move forward the AMR and access agendas over the coming years.

For only the fourth time, the United Nations General Assembly (UNGA) convened a high-level meeting focused on health, which was held during the recent 71st UNGA. Following on the footsteps of the recently released “Review on Antimicrobial Resistance” report (commonly referred to as the O’Neill report), member states gathered to discuss antimicrobial resistance (AMR) and global and national commitments to address this threat. The report estimates that by 2050, 10 million people will die every year because of AMR and the rise of “superbugs.”  At the heart of the high-level meeting was an acknowledgement that the threat of AMR is very real, with multidrug-resistant tuberculosis accounting for one-third of AMR deaths every year and some infections, such as gonorrhea, now only treatable using the last class of antibiotics available. Member states want to address today the overuse of antibiotics, both in human and animal health, improvements in infection prevention and control, and supporting R&D that brings new medicines to market, in order to prevent a return to the days when a scraped knee could kill a child. Before diving into the outcomes of the high-level meeting, it is worth noting a few things that characterized the conversation. First, it is clear that there was a conscious effort on the part of the meeting organizers to use the platform of the General Assembly to reframe AMR as a “One Health” issue where agriculture, animal health, and human health are all aspects to be addressed in an AMR response. And while the World Health Organization (WHO) does not have the authority to direct policy for the Food and Agriculture Organization (FAO) or the World Organization for Animal Health (OIE), the General Assembly does, and it was clear (both from the framing of the summit and the text of the political declaration) that expectations are that the three United Nations (UN) agencies will work together for a coordinated response. Second, the sense of unanimous agreement in the room is something rarely seen at the UN. While there may have been some discussions around the edges of specific technical language, the impression was that member states and UN agencies are on the same page and committed to addressing AMR (unlike HIV and AIDS, for example, where even countries who endorsed the declaration had concerns around some of the action points). The political declaration on AMR, universally endorsed and formally adopted by member states, specifically calls for: Countries to commit to: Developing appropriate action plans and policies to address AMR. Mobilizing additional resources, including for innovative approaches and R&D. Ensuring that surveillance is part of these plans. Undertaking public awareness and education activities on AMR and the dynamics that drive it (including a focus on patient-driven demand for antibiotics). Utilizing a multisectoral model incorporating innovative partnerships and incentive mechanisms to pursue the “One Health” approach. WHO, FAO, and OIE should finalize a global development and stewardship framework to both protect the effectiveness of current technologies as well as to support the development of new technologies. WHO, FAO, OIE, the UN, multilateral development banks, and all other stakeholders should support the national, regional, and global action plans described above. The Secretary-General should establish a cross-UN coordinating group cochaired by WHO and the Secretary-General’s office to guide efforts on AMR, as well as to prepare a report for the 73rd General Assembly outlining progress and recommendations to accelerate it. In the context of the recent release of the report of the High-Level Panel on Access to Medicines (HLP), it is also worth noting that concerns around access to medicines are also evident in the AMR declaration. Unlike the broader access to medicines debate, however, there is a clear acknowledgment of the need to discourage overuse of antibiotics to preserve their effectiveness while ensuring that those who need them have access. Overall, the future implications of the high-level meeting and declaration will depend on what happens next. AMR is squarely on the international agenda and the meeting brought the global community together in an expression of shared desire to fix the problem, which is entirely positive. Unfortunately, shared desire is by no means sufficient to address a problem as complex as AMR. As one panelist said, “If I have three key points, they are implementation, implementation, implementation!” The determinant of the meeting’s success lies in whether the action plans are developed and then acted upon. As for the role of civil society and nongovernmental organizations, holding governments accountable over this is precisely where the global health community can step up through advocacy and mobilizing public pressure to create political will. 

United Nations General Assembly. Photo: UN Photo/Loey FelipeEvery year in mid-September, the world’s diplomatic corps descends upon midtown Manhattan for two weeks of snarled traffic, road closures, and general mayhem. The cause of this paralysis? The United Nations General Assembly (UNGA)—a gathering of all the highest levels of the world’s governments to address those issues so pressing that only a global response will suffice.In recent years, global development, including global health, has featured prominently on both the UNGA formal and side-event agendas. This year the bulk of the formal agenda—set by Fiji which holds the Presidency of the General Assembly—focuses on oceans, climate change, and refugees and migration. However, the assembly also includes a full-day, high-level summit on antimicrobial resistance (AMR) scheduled by the outgoing Norwegian General Assembly President. Though other global health issues may not feature on the formal agenda, there are a number of hot topics that will certainly be highlighted at side events throughout the week. Here are the major global health policy issues GHTC will be tracking:Antimicrobial Resistance A CDC scientist studies a drug resistant strain of bacteria. Photo: James Gathany With the publication of the Review on Antimicrobial Resistance (also known as the O’Neill report), which was commissioned by government of the United Kingdom to comprehensively examine the global problem of AMR, the full scale of the human and economic cost of the rise of AMR is becoming clear. Seven hundred thousand people die each year globally from AMR infections, and the United States alone spends an extra US$20 billion on health due to AMR. As a result, global attention has focused on how best to both support development of novel antibiotics and conserve antibiotics of last resort to prevent the development of further resistance. At the full-day summit on September 21, world leaders will convene to discuss how the global community can collectively address AMR. A number of organizations are also sponsoring side events and conferences devoted to the myriad ways to stem the tide. It will remain to be seen whether any political commitments or new bilateral AMR initiatives emerge. Zika/Ebola/Pandemic preparedness/Global Health Security AgendaThe West African Ebola outbreak and the ongoing Zika pandemic have focused the world’s attention on the fundamental weakness of international pandemic preparedness efforts. With the continuing international spread of Zika, strengthening the international community’s ability to prevent, detect, and respond to outbreaks remains a global priority. The gathering of so many world leaders in one place for UNGA will create a ripe environment to foster novel partnership models to strengthen health systems to stand up to future outbreaks. While not featured on the formal agenda, a number of high-level side events on health systems strengthening and partnerships could spur interesting new initiatives post-UNGA. Access to MedicinesOn Wednesday, the United Nations Secretary-General’s High-Level Panel on Access to Medicines (HLP), convened in late 2015 by Secretary-General Ban Ki-moon, published its final report offering recommendations for “remedying the policy incoherence between the justifiable rights of inventors, human rights law, trade rules, and public health in the context of health technologies.” The issues tackled in the report and the panel’s recommendations for improving access to health technologies are highly contentious with health advocates, industry, and other trade and intellectual property stakeholders holding divergent viewpoints on how best to achieve this aim. This tension is reflected in the final report itself, which though released as a consensus document, also contains six separate commentaries by HLP members advocating positions other than those taken in the report.Given the timing of this report release, it should be a central topic of discussion at UNGA as various groups choose whether to lend their support to carrying forward the recommendations or criticize the panel for going too far or not far enough. Looking further forward, this issue will also feature prominently at a March special session of the United Nations Human Rights Council.While your author expects that these will be the key global health policy issues addressed at this year’s UNGA, there are always a few last-minute surprises. Needless to say, GHTC will keep you informed of exactly what is going on in the midst of the midtown Manhattan mayhem all week long.

As happens every May, the World Health Organization’s (WHO) highest governing body, the World Health Assembly (WHA), met last week for its 69th annual meeting in Geneva, Switzerland. The agenda was the most packed in recent memory, consisting of more than 70 discussion items, many of which were controversial. As a result, the agenda did not conclude until the eleventh hour on Saturday, May 28. Despite the lengthy agenda and difficult conversations, the WHA made two key decisions impacting global health research and development (R&D). This post will focus on those agenda items then GHTC will publish a full report covering the entire WHA R&D debate the week of June 6.   In the meantime, you can watch a recording of the panel discussion and webinar hosted by GHTC and the Geneva Centre for Security Policy on May 23, which provides a broad overview of many of the R&D issues discussed at WHA. Framework of engagement with non-State actors (FENSA) Discussions around revising WHO’s policies and procedures for engaging with non-State actors (any group other than a member state) have been highly contentious. Advocates for the proposed framework have argued that WHO needs to insulate its normative functions from undue influence by outside groups, while others have argued that the unintended consequences of the pre-WHA draft framework could be dramatic for some of WHO’s partners by inappropriately categorizing some partnerships as commercial entities. The intensive negotiation process at WHA resulted in a compromise decision that addresses concerns previously discussed by GHTC regarding FENSA’s impact on product development partnerships, while also maintaining some of the more stringent restrictions on how WHO engages with for-profit companies. As such, FENSA will move forward into implementation with the following key adjustments:   Assessments of any proposed engagement with non-State actors will be guided by an implementation guide prepared by the WHO Director-General, which lays out clear criteria and guidelines. Evaluation of new engagements will be conducted by a specialized risk assessment staff to remove as much of the burden as possible from program staff. Ongoing or repetitive engagements can be classified as low-risk and subjected to a streamlined evaluation process, so long as a full risk assessment has been conducted on a substantively similar project in the past. The private sector is prohibited from providing staff secondments to WHO and is dramatically restricted in how it can provide in-kind or financial contributions.  Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) The CEWG is a continuation of the Expert Working Group (EWG), which was convened more than a decade ago to chart how WHO could better support R&D for neglected diseases. This WHA marked an opportunity for the global health community to approve the plan set forth by the WHO Special Programme for Research and Training in Tropical Diseases (TDR) to create a pooled fund to support R&D and a global health R&D observatory to develop and recommend global research priorities. After extensive negotiations, the WHA’s decision calls on the WHO to:    Expedite the further development of a global health R&D observatory. Develop terms of reference and a costed work plan for the observatory for consideration at the 70th WHA. Develop an operational plan for a voluntary pooled fund for consideration at the 70th WHA. Advocate for sustainable funding for the new mechanisms. Convene a series of expert working groups to inform the new mechanisms’ policies and procedures. In combination, these directives make clear the concern that many member states shared regarding TDR’s ability to raise the additional funding needed to support its ambitious proposals, as well as a desire to better understand how the observatory would prioritize research project recommendations across the global health R&D portfolio. Given the debate regarding these two items, the WHA declined to give it the green light at this year’s assembly, preferring instead to ask for more detailed operational proposals for consideration next year.   Given all of the unanswered questions on both CEWG and FENSA heading into WHA, it was important to see compromises come out of the discussion; both processes will go forward, but in a measured fashion to allow the development of concrete workplans and guidelines to shape their implementation. GHTC will continue following both processes closely, and looks forward to helping ensure that the concerns of the global health R&D community are front and center in both initiatives.