Breakthroughs Blog: United Nations

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.

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.