Matthew Robinson, MA

The 2019 global health multilateral calendar kicked off as it always does with the World Health Organization (WHO) Executive Board (EB) meeting in late January in Geneva. Opening the meeting, WHO Director-General Dr. Tedros Adhanom Ghebreyesus continued his emphasis on framing global health discussions as being about how to achieve universal health coverage and further emphasized the importance of innovation and data-driven approaches to achieving this ambitious goal. In this context, it is not surprising that this year’s session featured a packed agenda with significant implications for research and development (R&D).2020-2021 Program BudgetOne of the first and most important items on the agenda was WHO’s budget for the coming two years, which will directly impact R&D-related programs including the essential medicines and diagnostic lists and prequalification.WHO proposed an overall budget (base, polio, and emergency fund) of US$4.79billion—an 8 percent increase over the 2018‒2019 level of $4.42 billion. The base program budget—which covers funding for the essential lists and prequalification, among other items—would see a 13 percent increase over 2018‒2019 levels.In welcome news, the secretariat laid out five key priority areas in the budget, including one focused on increasing WHO’s investment to support innovation and data. How this focus translates concretely and what it means in terms of resources allocated remains unclear. It also remains to be seen whether WHO will be able to marshal the voluntary contributions needed from member states to reach this increased budget target.Access to MedicinesThe EB again took up the issue of access to medicines, which has been a controversial topic at EB meetings for several years. As directed by a 2018 World Health Assembly (WHA) resolution, the secretariat produced a draft roadmap outlining the organization’s proposed activities on access to medicines.Generally speaking, the plan was well received by member states, with the marked exception of activities related to intellectual property (IP) and pricing. A number of countries, led by the United States, argued that the only role WHO should play in these areas is as a member of the tripartite agreement with the World Intellectual Property Organization, and the World Trade Organization, and that any expansion of WHO’s mandate beyond this is inappropriate. On the opposite side, Brazil and aligned countries argued that IP and pricing impacts the right to health and that WHO therefore has a unique and outsized role to play. It appears that neither side is willing to budge, so we expect this to remain an area of friction as the plan undergoes further refinement before it is expected to be voted on at the WHA in May.Antimicrobial ResistanceFollowing on the 2016 United Nations High-Level Meeting (HLM) on Antimicrobial Resistance (AMR), EB members heard a progress report on commitments made in the HLM political declaration. Overall, progress has been steady although a number of areas lag behind, particularly regarding the overuse of antibiotics in agriculture and livestock.While there was no resolution anticipated on this topic, several member states including the United States jointly proposed a resolution containing very positive language for R&D.The resolution urged member states to “enhance cooperation at all levels for concrete action towards combatting AMR, including through…research and regulatory capacity and technical assistance, including, where appropriate through twinning programs that build on best practices, emerging evidence and innovation.” Additionally, it called on WHO’s Director-General to “support member states to mobilize adequate predictable and sustained funding and human and financial resources and investment through national, bilateral and multilateral channels to support…research and development on existing and new antimicrobial medicines, diagnostics, and vaccines, and other technologies.”It is fair to say that R&D fared well over the course of this year’s EB, and GHTC looks forward to moving these conversations forward heading into the WHA in May.

Health ministers of the G20 nations, representing the world’s leading economies, met earlier this month in Mar del Plata, Argentina to chart a course of action on global health for the upcoming year. Under the leadership of Argentina, the meeting and its resulting outcome declaration focused on four themes: antimicrobial resistance (AMR), malnutrition and child obesity, health systems strengthening, and public health preparedness. While the language that found its way into the final declaration is worthy of note and analysis, so too are the items left on the cutting room floor. GHTC was pleased to see health ministers recognize the critical role of research and development (R&D) in combating AMR but was also disappointed to see further commitments on health R&D absent from the declaration. Here we take a closer look at the good, the bad, and the unknown for global health R&D under the G20. The Good Following the precedent set last year under the German presidency, G20 health ministers reaffirmed their commitment to tackling AMR, emphasizing the role of new technologies in confronting this challenge. Importantly, the health ministers encouraged investment in R&D across a range of interventions—including antimicrobials, diagnostics, and vaccines—while “promoting affordable and equitable access to all individuals in need.” Although this inclusion of language on access is not surprising, the framing of R&D in a broad sense is quite positive given the dire need for treatment-supporting technologies that are relevant to low- and middle-income country (LMIC) settings. Ministers also welcomed the work of product development partnerships (PDPs), including the Global Antibiotic Research and Development Partnership and TB Alliance. This call out of PDPs is important because it serves both as a validation of the PDP model and demonstrates that there are ways to support innovation while also working to ensure equitable access, concepts frequently seen as being in tension. GHTC was also pleased to see the declaration define AMR broadly and note its “growing threat among…fungal infections and drug-resistant HIV, malaria and tuberculosis.” While in wealthy countries concerns around AMR primarily center on “superbugs” and facility-acquired infections, the inclusion of health issues predominantly impacting LMICs is a long-overdue acknowledgment of the dangers of AMR in low-resource settings. It was also positive to see health ministers voice support for the 2017 commitment by G20 leaders to “further examine practical market incentives” to encourage stakeholders, including industry, to develop new antimicrobials. One of the key dynamics at play in the global health R&D ecosystem is the reality that there are a number of regions, diseases, and technologies for which there are not functioning commercial markets and as a result people do not have access to the health tools they need. New policies or incentives to help address these market barriers, while ensuring health equity, have the potential to dramatically accelerate progress towards universal access. It is positive that the G20 has committed to moving this agenda forward. While GHTC was pleased to see the G20 continue to shine a spotlight on the role of R&D in addressing AMR, we were disappointed to see the G20 fail to acknowledge the importance of R&D in improving epidemic preparedness—particularly given that under the German presidency, the G20 pledged strong support for collaborative research initiatives, including the World Health Organization R&D Blueprint and the Coalition for Epidemic Preparedness Innovation. The Bad Unfortunately, the declaration takes a narrow approach to improving our ability to prevent, detect, and respond to outbreaks, focusing solely on health system strengthening. It is clear that being better prepared requires having both strong health systems in place and the right technologies on hand to prevent an outbreak from becoming a deadly crisis. We saw with the 2014-2015 Ebola epidemic, the 2015-2016 Zika epidemic, and the recent outbreaks of Nipah virus how the lack of available interventions like vaccines and diagnostics hampered response efforts. These crises have taught us that when it comes to fighting outbreaks, health system strengthening and R&D must go hand in hand. Given the important signaling power of the G20 forum to its members and to the world, it is disappointing to see the G20, under the Argentinian presidency, take such a limited view of health security that fails to include research and product development. We hope future presidencies will take a more comprehensive view. The known and unknown While the G20 Leaders’ Summit will not take place until November, with this declaration, we now know what they will say on health. As such, our attention as advocates now turns to the next holder of the G20 Presidency, Japan, and prognosticating how the G20 will choose to prioritize global health under its presidency.  Given that Japan has a long-documented history of prioritizing universal health coverage, as well as supporting global health R&D, we can be cautiously optimistic that the positive statements under Argentina will be expanded upon, and that we will see a more holistic view of the importance of innovation and R&D in global health at this time next year.   Photo credits: PATH/Georgina Goodwin, G20.

The 71st World Health Assembly (WHA), held from May 21-26 in Geneva, featured all the expected verbal jousting over policy positions on key issues facing the World Health Organization (WHO) and the broader global health community, though the resolutions touching on research and development (R&D) ultimately passed by consensus. In particular, three items stood out.Access to medicinesAs anticipated, the debate on access to medicines featured some aggressive verbal sparring by member states, but in the end, all this talk produced only incremental action: Member states passed a resolution tasking the WHO secretariat with developing a roadmap to address access to medicines to be presented at next year’s WHA.Member states have long agreed on the importance of improving access to medicines, but have long struggled to achieve consensus on actions WHO should take in pursuit of this aim, despite many working groups and expert committees offering their own sets of recommendations. Countries used this WHA agenda item as another opportunity to pontificate on their disparate and entrenched views. The US representative was particularly bullish in her remarks this year, stating that senior WHO officials should focus on WHO’s core mandate rather than becoming “political activists” on topics like intellectual property (IP) and arguing that other countries are “free riding” on the health R&D investments of US taxpayers.Despite these verbal fireworks, it was clear that no country was willing to be the one to upset the carefully negotiated resolution language from the January Executive Board (EB) meeting calling for the WHO secretariat to establish this roadmap. As result, while strong language was the order of the day, the resolution passed unanimously without any textual changes. Per the resolution, WHO will now undertake a consultation process to develop a consensus work plan for consideration at next year’s EB and WHA. The team tasked with developing this plan has a tall order ahead of them, and it will remain to be seen whether they can forge a consensus path forward in an area where others before them have faltered. It is also unclear whether nongovernmental organizations in official relations with WHO will be included in the consultation process, but GHTC will continue to call for an appropriate role for civil society.Global Strategy and Plan of Action on Public Health, Innovation and Intellectual PropertyA close companion to the agenda item on access to medicines was WHA’s consideration of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA-IP), which is the current iteration of a more than decade-long process to define WHO’s role in governing IP within the United Nations system. Up for debate was whether WHO should implement a diverse range of recommendations put forward by a WHO expert review panel—recommendations that have received mixed support among different member states. Coming out of the EB meeting, board members had hammered out what they saw as a compromise resolution—the text called for WHO to implement items from the report that were already “consistent with WHO’s existing mandate and authorities” to ensure some steps would move forward, while essentially tabling the other recommendations which lacked consensus. Many wondered going into WHA whether this consensus would stand or whether member states would attempt to re-litigate the resolution text.Like the access agenda item, this debate also saw a lot of verbal jousting. Clashing comments from the United States and India provided—in microcosm—a view of the state of the debate on WHO’s mandate in IP. On one side, member states including India, Brazil, Colombia, and others argued for a robust and expansive embrace of the more far-reaching recommendations contained in the expert report. These include a call for a percentage of GDP spending target for R&D to support health in low- and middle-income countries, full implementation of the recommendations from the UN Secretary-General’s High-Level Panel on Access to Medicines, and the pursuit of mechanisms to move the global innovation ecosystem to delink pricing from R&D costs.On the other side, the United States and other countries argued for a more limited mandate for WHO and supported the compromise resolution text calling for WHO to only implement recommendations already aligned with its strategy and mandate. Under this view, WHO could proceed to implement those points on which there is clear consensus, effectively confining future activities to the scope of existing ones. On a more positive note, the US statement also called out strong support for WHO’s regulatory strengthening and harmonization activities and for strengthening R&D capacity globally overall.Despite the widely incongruent views of which direction WHO should take over the coming years, countries were not willing to take the risk of reopening the text of the resolution, fearing that they might very well have more to lose than they could possibly gain by re-litigating the text. As a result, WHO’s path forward in this space remains muddled and largely the status quo.Preparations for the High-Level Meeting on TuberculosisIn a refreshing change from the contentious debates on access and IP, the assembly also considered a number of documents and plans related to WHO’s input into preparations for the upcoming High-Level Meeting (HLM) on Tuberculosis (TB) in September. Of particular note, the draft multisectoral accountability framework cited, among example actions that should be taken, the “development and implementation of a global strategy for tuberculosis research and development, including the development and facilitation of international tuberculosis research networks.” While this language does not represent a concrete WHO commitment and no organization was identified as responsible for the strategy, it is still a positive acknowledgment of the need for R&D for TB technologies.In addition, in his remarks concluding the debate on TB, WHO Director-General Dr. Tedros Ghebreyesus made a strong statement of his support for R&D to address drug-resistant TB and antimicrobial resistance (AMR) more broadly. He noted that one cannot talk about AMR without talking about TB and vice versa, and that one cannot talk about TB nor AMR without talking about R&D. He then singled out cross-sector collaboration on R&D as being particularly important, remarking that “FENSA [the Framework of Engagement with Non-State Actors] is not meant to be a fence,” and that he hoped to bring the private sector to the table in an appropriate fashion. The ways in which Dr. Tedros’ desire to foster cross-sector collaboration manifests (or not) in the preparations for the HLM will be highly indicative of whether FENSA will actually serve to foster or conversely hinder collaboration moving forward.Key takeawaysUltimately, debate at this year’s WHA reinforced what many watching the global R&D ecosystem already knew; there is a fundamental tension over the very foundation of how global health R&D should be supported, and this tension was in no way resolved. On the one hand are proponents for moving toward delinkage and mechanisms to reshape incentives for R&D in ways that separate the costs of R&D from the sale price of products. On the other are those who argue that access is a much larger question than simply IP and trade laws and that focusing on those topics to the exclusion of other issues like regulatory barriers does a disservice to the dialogue. The one thing we can all agree on is that this dialogue will certainly continue, and GHTC will continue keeping you up to speed.

As is always the case with the approach of summer, the global health community is gearing up for another session of the World Health Assembly (WHA), which will be held in Geneva from May 21–26. WHA brings together the World Health Organization’s (WHO) 194 member states, civil society, and the United Nations system to review WHO’s progress against previous commitments and chart the course for the next 12 months. This 71st session of WHA will see a number of debates on topics affecting global health research and development (R&D). 13th General Program of Work Perhaps most significantly, this year’s WHA will see the approval of the next General Program of Work (GPW 13), which will set WHO’s strategic objectives and activities for 2019–2023. Reflecting Director-General (DG) Dr. Tedros Adhanom Ghebreyesus’ first real opportunity to legislate a course change for WHO and put his stamp on the organization, the draft GPW 13 is framed around an ambitious “triple billion” set of targets, aiming to: Cover 1 billion more people with universal health care, Better protect 1 billion more people from health emergencies, and Ensure that 1 billion more people enjoy better health and well-being. Encouragingly, the current draft of the GPW 13 includes a concrete cross-cutting workstream across these three broad targets to support R&D by strengthening coordination and collaboration, stepping up WHO’s normative work to encourage uptake of new innovations, and by using WHO’s convening authority to ensure best practices and the latest techniques to support R&D are shared across geographies. The three ambitious targets will require significant additional investment by member states, as well as a significant reprioritization of WHO’s existing staff and resources—both of which are heavy political lifts for the DG and his team. The extent to which WHO succeeds in mobilizing additional resources will largely determine whether GPW 13 achieves its ambitious vision to fundamentally change the way WHO does business. Access to Medicines The debate on how WHO should engage in activities to address concerns around access to medicines continues unabated. The January Executive Board (EB) meeting saw intensely heated debate, with the Brazilian delegate challenging the United States representative by stating, “We have been debating this for five years. You say everything ‘poses implementation issues.” To move past this stalemate, the EB ultimately recommended a compromise solution calling for WHO to undertake a strategic consultation and strategy development process over the course of 2018 and to present the resulting strategic roadmap to the EB in January 2019. Notably, the current draft resolution specifically calls out the need for WHO to consult with member states, but excludes mention of non-state actors in official relations with WHO. GHTC will work to ensure that the final resolution includes a provision for civil society to be consulted. Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Following the spirited discussion at the EB meeting regarding the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA-IP) and the appropriate role of WHO in advancing policies around intellectual property for health products, the EB proposed a compromise resolution. It calls on member states and WHO to implement those recommendations from the Expert Review Panel that align with the existing elements of the Strategy and Plan of Action, while continuing to discuss those recommendations that fall outside the current scope. Having led the charge for an expansive view of the GSPOA-IP mandate at the EB, Brazil will almost certainly take a very active role on this item at WHA as well. Much like the EB debate, the focus for WHA will be on the more aggressive recommendations proposed by the Expert Review Panel that some countries argue fall outside the scope of the original GSPOA-IP. Key recommendations include: The WHO Secretariat to identify mechanisms to increase health technology transfer in the context of the Technology Facilitation Mechanism established by the Sustainable Development Goals The WHO Secretariat, in collaboration with other international organizations working in intellectual property, to advocate for the development of national legislation to fully reflect the flexibilities provided in the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health and the Doha Declaration          Member States to commit to dedicating at least 0.01 percent of their gross domestic product to basic and applied research relevant to the health needs of developing countries Member States to encourage the implementation of schemes which partially or wholly delink product prices from research and development costs As a result, this agenda item will likely require a drafting group to convene to litigate line-by-line language changes given the profound disagreement among member states on whether recommendations that fall outside of the GSPOA-IP’s current scope should be implemented or not. GHTC will follow these negotiations closely given that the recommendations currently viewed as out of scope include provisions on a percentage of GDP target funding level for R&D, initiatives on price transparency, and local R&D capacity building.

Last week’s World Health Organization (WHO) Executive Board (EB) meeting featured a packed agenda covering diverse topics ranging from WHO’s overall plan of work for 2019-2023 to the global burden of snakebite envenoming—as well as some unexpected chicken dancing by delegates. Given that the EB sets the agenda for May’s World Health Assembly (WHA), the inclusion of an agenda item on access to medicines and WHO’s plan on intellectual property (IP) indicates that we can expect a contentious few months leading to the WHA. Here is how debates on these agenda items shook out:Access to medicines For the third consecutive year, the EB addressed the issue of access to medicines and health technologies—a topic that has received much attention in recent years and sparked strong, diverse opinions from member states on how best to address. Last year at the WHA, member states reached a compromise to allow consideration of the findings of the United Nations Secretary-General’s High-Level Panel on Access to Medicines (HLP) at this year’s EB. For the meeting, the Secretariat produced a comprehensive report mapping out WHO’s current activities against the specific HLP recommendations. Though a number of countries objected to this approach on the grounds that it implicitly endorsed the findings of the HLP report, there was broad consensus in the room that access to medicines is a global problem that requires WHO action and that the agency could not afford to delay any longer.As a result, the EB agreed on a decision point calling for WHO to develop a “roadmap report” outlining WHO’s work plans on access as part of the process of finalizing the overall 2019-2023 plan of work. This report will be submitted to the 2019 WHA.Intellectual property Speakers at the EB, 2018 (Photo: GHTC/Matt Robinson) While the access to medicines agenda item reached a consensus decision more quickly than expected, the debate on IP raged over multiple days during both formal and informal sessions at the EB. The debate ultimately boils down to a divergence between high-income countries—countries with significant pharmaceutical industries—and low- and middle-income countries on whether WHO is an appropriate forum to address IP. Those against WHO taking an active role on IP (including the United States and Japan) argue that the World Trade Organization and the World Intellectual Property Organization are the appropriate forums. On the other side, a coalition of countries led by Brazil and India argue that IP in medicines is a unique category and that international policy must be set with a health perspective first. As the global normative organization for health, WHO is thus the appropriate venue to address IP.After many days of closed-door negotiations, the board ultimately decided to move forward with a consensus resolution text. It called for member states to implement recommendations from the new WHO report on IP and public health as appropriate for their national contexts and to continue further discussions and for the Director-General to begin implementing the recommendations and submit a progress report to WHA in 2020. Notably, the following provisions were stripped out of the resolution, including calls for member states to:1. Promote transparency and understanding of research and development costs2. Identify essential products at risk of shortages and take measures to prevent stock outs3. Commit to dedicating at least .01 percent of gross domestic product to basic and applied research relevant to developing countriesGHTC will continue tracking these issues over the coming months heading into WHA, and we look forward to what will be a spirited meeting in May!

The 72nd session of the United Nations General Assembly (UNGA) featured a number of firsts: It was the first UNGA for new United Nations (UN) Secretary-General António Guterres, as well as the first for recently elected World Health Organization (WHO) Director-General (DG) Dr. Tedros Adhanom Ghebreyesus. Both used this annual gathering of world leaders to solidify their signature issues in a public forum. DG Ghebreyesus’ signature issue was achieving universal health coverage (UHC), in which all people can access a basic standard of necessary health care without being driven into poverty. DG Ghebreyesus publicly stated at multiple events and in numerous tweets that he views achieving UHC as a political decision to support human rights. Research and development (R&D) and innovations in health care are a vital part of any agenda to achieve UHC. At a US Pharmacopeia event, President Ameenah Gurib of Mauritius discussed drug development as not only a key economic driver in her country, but also as a core part of achieving UHC. South African Minister of Health, Minister Aaron Motsoaledi, speaking at a Stop TB Partnership reception, stated that the fight against tuberculosis (TB) would never be won without accelerated investments in R&D to advance the next generation of tools needed to make treatment more effective. “Research and development (R&D) and innovations in health care are a vital part of any agenda to achieve UHC.” Using the example of TB, it is easy to see that the prospect of achieving overall UHC is dependent on innovations that will increase efficiency and drive down costs. Current analyses indicate that countries would need to spend an average of about 5 percent of their gross domestic product to achieve UHC—a goal that, for many nations, is “aspirational in the short term.” Multi-drug resistant TB (MDR-TB), which typically takes two years or longer to treat, can exact an enormous burden on a country’s financial resources. For example, data from the United States shows that MDR-TB is at least US$100,000 more expensive to treat than standard TB, with an estimated $134,000 spent treating every MDR-TB patient compared to $17,000 for regular TB treatment. Imagine if a new drug regimen could reduce treatment time to under a year. The savings in both human suffering and resources within the health system would be enormous. Fortunately, MDR-TB treatments in development today hold promise to offer faster, simpler, and more affordable solutions. “…It is easy to see that the prospect of achieving UHC overall is dependent on innovations that will increase efficiency and drive down costs.” Beyond the hugely positive impact of new technologies within health systems, global health R&D has other wide-reaching, positive externalities. To explore these, GHTC convened a panel discussion with Dr. Peter Singer of Grand Challenges Canada, Bumpei Tamamura of the GHIT Fund, and Jan-Willem Scheijgrond of Philips. Each of the panelists noted a variety of reasons their organizations view investments in global health R&D as not only the right thing to do, but also as good business. From the perspective of a government-supported innovation agency, Dr. Singer noted that through its investment in global health R&D, Grand Challenges Canada has achieved phenomenal bang for its buck. The agency has supported over 800 innovations with an investment of roughly $200 million. Further, two-thirds of this investment goes directly into low- and middle-income countries (LMICs), where it not only supports technological development, but also builds the human capital and innovation economy that will allow these countries to achieve long-term prosperity. Bumpei Tamamura highlighted how fostering multi-sector, multi-country partnerships can advance a nation’s health technology sector. Supported by both the Japanese government and Japanese pharmaceutical and technology companies, the GHIT Fund views its role as creating the incentives to support partnerships between Japanese companies and their global counterparts to leverage respective strengths. Noting the Fund’s success in supporting product development, Mr. Tamamura explained that the Fund is now looking to expand its portfolio of partnerships into manufacturing and distribution, potentially with developing country counterparts. From Philips’ perspective, Jan-Willem Scheijgrond explained investing in global health R&D is not about charity—it is about good business. He noted that Philips operates under a corporate mandate to improve the lives of 3 billion people worldwide, but can only reach half of those people through operations in developed markets like Europe and the United States. “We need to stop seeing health care as a cost, and instead see it as an investment,” he stressed. For Philips, investing in technologies to serve LMICs is part of meeting its core mandate. By investing in health for low-income groups, Philips helps improve health, create jobs, and lift families out of poverty while simultaneously building a new customer base for other products, especially as income levels rise. This can help build a virtuous cycle for both the public and the company, Scheijgrond explained. “Investing in global health R&D is not about charity—it is about good business.” Ultimately, global health R&D is vital not only to health, but also to achieving overall development in economic and social contexts. It improves the efficiency of health systems, allowing countries to move more quickly toward UHC. It creates jobs and generates economic impact across the world, raising incomes and lifting families out of poverty. It also creates bridges between industry in LMICs and global leaders, setting up the conditions for LMIC entrepreneurs to take their place on the global business stage. When asked to sum up the value of investing in global health R&D, Dr. Singer encapsulated it best: “You can reach your own goals that you’ve set for your own people, working with your own people, better, faster, and cheaper.” “[By investing in global health R&D] you can reach your own goals that you’ve set for your own people, working with your own people, better, faster, and cheaper.” For an UNGA session not explicitly focused on global health, the GHTC secretariat was pleased to see UHC—and the role global health R&D plays in contributing to UHC—recognized so prominently in the multi-stakeholder dialogues. We are looking forward to maintaining this momentum heading into the upcoming WHO Executive Board meeting, where a number of critical issues are on the agenda.