Matthew Robinson, MA

On July 8, G20 leaders committedto work together to combat the rise of antimicrobial resistance (AMR) and potentially pandemic diseases. This includes efforts to foster research and development (R&D) through cooperative initiatives, including a new collaboration hub for AMR R&D. This is a welcomed step forward by G20 leaders, and marks the first time R&D for global health has been featured as part of the G20 declaration. The inclusion of R&D commitments came about as the result of a sustained advocacy campaign by GHTC and our partners, including open letters, calls to action, a roundtable expert discussion event, and direct outreach to policymakers. Why does the G20 matter? The G20 is a leading forum for international coordination on a range of global challenges impacting economic growth and development. In representing the world’s 20 largest economies, it represents nearly two-thirds of the global population. While many world leaders have expressed concerns about global health crises and the rise of AMR, there was no certainty global health—much less health R&D—would be prioritized among tough debates on other pressing global challenges—including climate change, trade, the Syrian conflict, and migration. What was the win for health R&D? In its declaration, the G20 recognized the critical role of R&D in improving pandemic preparedness, tackling priority pathogens, and combatting AMR. It also pledged support for coordinated research initiatives, including existing structures like the World Health Organization (WHO) R&D Blueprint and the Coalition for Epidemic Preparedness Innovation—focused on preventing epidemics—as well as called for a new “R&D Collaboration Hub” for AMR research. The G20 declaration represents a statement of political will to move those initiatives forward, which is an exciting achievement for the global health R&D community. Firstly, support for WHO’s R&D Blueprint is a very welcomed development. The Blueprint lays out a global strategy to ensure the world is prepared to rapidly mobilize R&D activities and resources in response to an outbreak. The goal is to ensure that necessary technologies are available sooner to save lives and avert a large-scale crisis. In the wake of the West African Ebola outbreak—and as the world faces other threats like Zika—ensuring R&D resources and structures are in place to respond to outbreaks quickly is common sense, and GHTC welcomes the G20’s commitment to supporting it. Secondly, in calling for an international collaboration hub for AMR R&D, the G20 takes work that has been stalled by WHO and moves it in a more ambitious direction. As an outcome of the long-running Consultative Expert Working Group on R&D: Financing and Coordination process, WHO established a Global Observatory on Health R&Dto facilitate R&D coordination and prioritization. However, at the last World Health Assembly, WHO announced it will not proceed any further in expanding the observatory without additional funding. With G20 leaders not only committing to R&D coordination and collaboration—which is the goal of the observatory—but also committing to a concrete mechanism and fostering support for that mechanism, they have embraced the goals of the observatory as they relate to AMR. Showing the clear impact that this type of collaborative mechanism has in one area of R&D will greatly strengthen the drive for a global mechanism. That is a very exciting prospect for the continuation of this important work. Why is R&D a priority for the G20 now? Health crises are not simply a challenge for low- and middle-income countries: They increasingly affect the world’s leading economies as well. The rise of AMR not only heightens the threat of untreatable malaria in Africa, but also impacts hospital patients in Europe who could face incurable infections following surgeries. Given that the next disease outbreak could be a single plane flight away from becoming a global pandemic, R&D is vital to ensure we have the tools to respond quickly in all countries. It’s estimated that large-scale disease pandemics could cost the global economy more than US$60 billion per year, while an R&D investment of $1 billion per years could deliver the tools needed to protect against outbreaks. What’s next? Overall, although the G20 focused on R&D through the lenses of AMR and health security—which addresses only a portion of the health challenges for which new tools are needed—the declaration is a very good sign that the global health R&D community is making an effective argument about the need for health R&D to be viewed as a critical aspect of broader global discussions on development, trade, economic growth, and security. It is now imperative that G20 leaders follow through on commitments made at the summit and turn words in a declaration into concrete action, marshaling new resources and stronger incentive, and financing mechanisms to spur critically-needed R&D to unlock the cures and treatments of tomorrow.

As the 70th session of the World Health Assembly (WHA) winds to a close, memberstate delegates and civil society advocates are collectively taking a moment to catch their breath and reflect on an extremely eventful WHA. In a single week, the World Health Organization (WHO) gained a new Director-General—Dr. Tedros Gehbreyesus of Ethiopia—increased mandatory contributions from member states, and passed a landmark cancer resolution, just to name a few key decisions. In addition to these seismic shifts in the landscape of WHO, health research and development (R&D) was also featured prominently across a number of WHA agenda items, some of which saw highly consequential developments. Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) The long-running CEWG process finally appears to have reached its end. After more than a decade of exploring approaches to support R&D for neglected diseases and actions to stand up a voluntary R&D-pooled fund at WHO, Assistant Director-General (ADG) Marie-Paule Kieny notified the Assembly that no further work would be done on either the pooled fund or the initial round of demonstration projects associated with it. Her comments came at the close of a lengthy session in which both member states and civil society organizations universally echoed the call for more resources to enable the fund and demonstration projects to operate effectively, as well as bemoaning the lack of contributions to date. In justifying the decision to cease work on these projects, ADG Kieny noted that no additional funding has been raised for the fund beyond the US$11 million pledged over three years ago. With that level of funding, the programs were simply not sustainable, she explained. On a positive note, the WHO Global Observatory on Health R&D—which was created to facilitate R&D coordination and guide prioritization—was spared the ax. While resources are not available to expand its database of R&D projects and data immediately, it is now operational and can be expanded at any time, as additional data and funding become available. Access to medicines As expected, the debate around access to medicines continued to rage at this year’s WHA. Although there was not a dedicated agenda item on follow-up to the United Nations Secretary General’s High-Level Panel on Access to Medicines (HLP) report, a number of countries, including Brazil, India, and Argentina, took every opportunity to raise the report in their remarks on other agenda items. In particular, agenda item 13.3 Addressing the Global Shortage of, and Access to, Medicines and Vaccines—which has historically focused more on supply chain issues—saw particularly heated debate, as well as intricate parliamentary maneuvering. India and Brazil led a concerted push, supported by South Africa, for the WHO Secretariat to initiate a consultation process that could result in WHA adopting “consensus language” on access to medicines. A number of European countries pushed back, noting that the WHA agenda item simply contained a report from the Secretariat for the Assembly to note, thus there was no need for consensus language. Implicit in this objection was a concern on the part of countries opposed to recommendations within the HLP report that any opening created to develop new language on access to medicines would invariably result in references to the HLP report. After extensive debate, including the intervention of WHO’s legal counsel, member states reached a compromise whereby the issue of access to medicines would be included on the agenda for January’s WHO Executive Board (EB) meeting, although that item would not specify discussion of the HLP report. South Africa further proposed a standing EB and WHA agenda item on access, which was vetoed by the United States. Beyond parliamentary maneuvering, the debate around access centered on many of the arguments that have become familiar to those following this issue over the years. On one end, civil society activists and some member states called for a wholesale rethink of the ways in which countries provide incentives for innovation, typically through some form of “delinkage,” wherein R&D costs are no longer related to the costs of the final product. At the opposite end of the spectrum, industry representatives and countries with significant pharmaceutical industries argued that intellectual property is not the primary barrier to access and that attention is better focused on supply chains and countries’ lack of domestic financing for health. Concluding thoughts Overall, this WHA featured one of the most packed agendas I have seen since I started tracking WHO. It is promising that, despite all of the competing agenda items, R&D remained a central focus of vigorous discussion and received significant attention. Even beyond the specific policy developments, it is clear that R&D and innovation remains a priority for the global health community.

Photo: CDC/ Dr. Scott SmithHealth ministers from G20 nations, meeting for the first time last Thursday and Friday, pledged to work together to combat antimicrobial resistance (AMR) and improve pandemic preparedness, emphasizing the critical role research and development (R&D) plays in confronting these global challenges. “By putting global health on the agenda of the G20, we affirm our role in strengthening the political support for existing initiatives and working to address the economic aspects of global health issues,” stated the declaration released Saturday. “Global health risks, such as infectious disease outbreaks and antimicrobial resistance (AMR), have a severe impact on the lives and well-being of millions of people as well as on the global economy. Since these global challenges cannot be addressed by one country, region or sector alone, they call for a coordinated global response.” In the declaration, G20 health ministers noted the role of new and improved medicines, vaccines, diagnostics, and other health tools in containing infectious disease outbreaks and pledged support for new models for R&D preparedness: “Research and Development (R&D) are necessary for the timely availability and development of new and improved quality medicines, vaccines, diagnostics and medical equipment for containing emergencies. This requires mobilization of national and international research efforts and facilities, and norms and commitments to share data and samples, in accordance with national legislation, and public health benefits in an inclusive, timely and transparent manner. In addition, sustainable funding and effective international R&D coordination is needed.  We welcome and support new models for R&D preparedness including the “WHO R&D Blueprint”, the Global Research Collaboration for Infectious Disease Preparedness (GLOPID-R) and the “Coalition for Epidemic Preparedness Innovations (CEPI)”, which is developing new vaccines for epidemics. We underscore the importance that products emerging from such R&D efforts become accessible to all people in need. In regard to sample and data sharing, we recognize the importance of the WHO global influenza surveillance and response system and Pandemic Influenza Preparedness (PIP) framework, as well as the global initiative on sharing all influenza data.” The declaration also noted concern about the insufficient R&D pipeline of antimicrobial therapies and highlighted the importance of fostering R&D for new antimicrobials and other vital health tools, citing support for incentive mechanisms and global partnerships to spur technology development: “We note with concern that the research and development (R&D) pipeline for developing new antimicrobial therapies against life-threatening and highly resistant organisms has been drying up and does not correspond to the global needs in light of growing antimicrobial resistance during past decades. We highlight the importance of fostering R&D for new antimicrobials, alternative therapies, vaccines and rapid-point-of care diagnostics, in particular for priority pathogens as identified by WHO and for tuberculosis. We recognize the importance of reactivating the R&D pipeline through incentive mechanisms that avoid the reliance on high price/volume combinations. We also recognize the need to promote prudent and responsible use of antimicrobials. In the Hangzhou G20 Leaders’ Communiqué, G20 leaders called on the WHO, FAO, OIE and OECD to collectively report back in 2017. Their report ‘Tackling Antimicrobial Resistance, Ensuring Sustainable R&D’ will be considered by leaders when they meet on 7-8 July. In this context we support ongoing initiatives, examining push and pull mechanisms that take into account needs of all countries and stress the need for a better coordination of existing initiatives. Furthermore, we note the importance of affordable access to new and existing antimicrobial drugs, diagnostic tools, alternative therapies and vaccines of quality to all patients in need. We will preserve the widest possible therapeutic treatment options through avoiding removal of old antibiotics from the market and work for a sustainable solution to address this issue. To reinvigorate research and development in science and industry for antimicrobials, we welcome and build on the work of existing global and regional product development partnerships and funding initiatives such as the Global Antibiotic Research and Development Partnership (GARDP), launched in May 2016 by the WHO and the Drugs for Neglected Diseases initiative (DNDi), UNITAID, the Joint Programming Initiative on AMR (JPIAMR), Combating Antibiotic Resistance Bacteria Biopharmaceutical Accelerator (CARB-X), Innovative Medicines Initiative (IMI), the TB Alliance for new anti-tuberculosis medicines. We commit to broaden the voluntary financial support for these initiatives. We call on other countries, philanthropic organizations, academia and the private sector to support these initiatives. We recognize the necessity of tools such as Target Product Profiles to describe high need products and the importance of prioritization of pathogens, to steer R&D efforts to the most pressing public health needs. Therefore, we welcome the WHO priority pathogen list, which, in addition to existing recommendations for HIV, TB, Malaria and NTDs, should guide R&D for antimicrobials. We recognise drug-resistant tuberculosis as an important threat and therefore commit to address tuberculosis within interventions for AMR. We acknowledge the need to develop and promote access to new drugs, diagnostics and vaccines to tackle drug-resistant tuberculosis consistent with the WHO End TB Strategy. We recognize the importance of other relevant initiatives and plans, such as the STOP TB Partnership. We welcome the decision by Member States to hold a United Nations High-Level Meeting on Tuberculosis in 2018 and the WHO Ministerial Conference on Ending TB in the Sustainable Development Era to be held in Moscow in November 2017.” The inclusion of supportive language for R&D in the health ministers’ declaration follows calls by GHTC and partners for G20 leaders to commit investment in research, innovation, and development of innovative health technologies to counter threats posed by AMR, poverty-related and neglected diseases, and pandemics. The health ministers’ declaration will feed into and inform outcomes of the G20 leaders’ summit in Hamburg, Germany, in July, where G20 leaders will release a final joint communique. While GHTC is very pleased with the health ministers’ clear acknowledgment of the importance of R&D, we also caution that this is not the end of our advocacy efforts for the G20. While the health ministers are clearly on board, the advocacy community must keep pushing to ensure that global health R&D does not get lost in the much larger debate that happens for the full, formal G20 communique. We look forward to working with all of our partners to do so.

As it does every year, the global health community is preparing for our collective trek to Geneva for the World Health Assembly (WHA) where the World Health Organization’s (WHO) 194 member states and various civil society or multilateral observers will come together to review WHO’s programming over the prior year, sets policy and program priorities for the upcoming one, and approve the budget with which to carry them out. As with most WHAs, there are a number of items related or relevant to research and development (R&D) at this year’s assembly: Director-General elections The highest profile issue on the agenda this year is the selection of the next WHO Director-General (DG) to succeed Margaret Chan. The three candidates still in the running are Dr. Tedros Ghebreyesus (Ethiopia), Dr. David Nabarro (United Kingdom), and Dr. Sania Nishtar (Pakistan). Dr. Ghebreyesus has previously served as Minister of Health and Foreign Affairs for Ethiopia, Dr. Nabarro boasts an extensive track record in the United Nations (UN) and other multilateral organizations, and Dr. Nishtar served as Minister of Health for Pakistan, in addition to founding and leading a successful nonprofit. From an R&D perspective, none of the candidates have direct experience in technology development, but all have indicated in general terms that they would be supportive of R&D. As the chief executive of WHO, the DG sets operational policies and priorities across a variety of programs important to R&D, from the pooled fund and observatory, to ongoing discussions around intellectual property and access to medicines. The influence of the DG is hard to overstate. The race remains very open, and member state delegation contacts have indicated that it is anyone’s race, though this was before news reports emerged containing allegations about Dr. Ghebreyesus’ tenure as Ethiopian Minister of Health. It is unclear to what extent these reports have shifted the race, but GHTC will be on the ground in Geneva providing daily updates as the final days of the campaign unfold and the election occurs on May 23. R&D for potentially epidemic diseases In examining the response to the West Africa Ebola outbreak; ongoing yellow fever and dengue outbreaks; and Zika, WHO recognizes the need for R&D to be a central component of the agency’s strategy to combat potentially epidemic diseases. To that end, WHO has undertaken a number of activities and will be presenting progress to date at WHA. One of the most impactful of these activities is the creation of an R&D blueprint for action to prevent epidemics. The blueprint lays out a number of areas that require global attention to prepare for outbreaks, including product development, as well as social science and epidemiology studies. GHTC is very pleased to see R&D getting its fair share of attention in the context of epidemic preparedness. Without the ability to rapidly develop new tools to address emerging diseases, we will not have the necessary tools in place to prevent or curb an epidemic. Although the blueprint is a step in the right direction, GHTC believes that WHO should also address regulatory guidance and health systems strengthening; new technologies won’t help stop outbreaks if they are held up in regulatory review, nor will it be possible to develop the right tools if health systems are too weak to collect the vital data and samples needed when an outbreak occurs. Antimicrobial resistance Another hot topic over the past year has been the global focus on antimicrobial resistance (AMR) coming out of last year’s UN General Assembly High-Level Meeting on AMR. WHO has been at the forefront of this movement to combat AMR and has committed to supporting countries in developing national action plans to fight AMR, setting up global surveillance systems to track AMR, and helping coordinate across the UN system to ensure a unified UN response. Support for R&D has been a central component in these discussions. GHTC welcomes all of these actions, but notes that WHO and member states have been slow to agree on an AMR stewardship and development framework, which is a vital next step. We will not make progress against AMR without the Framework helping guide investments in R&D, and ensuring that the products developed through that R&D remain effective in use. GHTC will continue pushing for the Framework and for WHO and countries to be held accountable to the promises they made at the UN General Assembly. Consultative Expert Working Group on Research and Development: Financing and Coordination The long-running Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) process continues for this year’s WHA, and the progress update report shows some progress, some treading water, and some disappointment. On a positive note, the WHO R&D Observatory—which will serve as a coordination clearinghouse for information on global health R&D—is moving toward implementation. Once active, the Observatory will be a key tool in helping ensure efficient R&D by facilitating coordination, exposing gaps, and helping researchers prioritize according to need. The second piece of the CEWG’s mandate is standing up a pooled fund to support neglected disease R&D. To be housed at the Special Programme for Research and Training in Tropical Diseases (TDR), the pooled fund would operate in a similar fashion to the Global Fund to Fight AIDS, TB and Malaria, accepting contributions from member states and making grants to research institutions pursuing R&D for neglected diseases that are not commercially viable. While TDR has developed a solid set of terms-of-reference for an expert advisory group to prioritize areas for the fund to focus on, it still has not come to grips with the elephant in the room for any funding mechanism—how they are going to raise the money to support it. Unfortunately, even the current set of demonstration projects to pilot the approach remain underfunded, and it does not appear that most member states or other donors are willing to reach into their pockets for this project. GHTC will continue advocating for them to do so, and for more resources to be made available for R&D in general, but it will be interesting to see the dynamics at this year’s WHA. Closing thoughts Overall, this year’s assembly is likely to be dominated by the DG election, with other topics only attracting attention once this heated content is wrapped up. It is not clear how the three DG candidates will approach R&D should they be elected, so it is very hard to predict what impact the decisions at this year’s WHA will have. Will they chart a direction for the new DG or will WHO’s new leader want to make his or her mark and change course entirely? GHTC will be on the ground providing updates as they happen, as well as the analysis of what they could mean for R&D. Follow us on Twitter at @GHTCoalition for live updates over the course of the week and check back here for a wrap-up blog on outcomes from the 70th WHA later this month.

The 140th session of the World Health Organization (WHO) Executive Board (EB) is officially done and dusted. Despite one of the lengthiest agendas in the history of the EB, the meeting actually finished a day early on January 31. As GHTC noted before the meeting, there were several agenda items relevant to global health research and development (R&D), in addition to broader decisions about WHO’s overall future direction. Some resulted in substantive decisions, while others served as an opportunity for delegates to provide input to shape resolutions for the World Health Assembly (WHA) in May. Here are the highlights from the week: Director-General Elections – Decision Point The biggest news out of the EB was the narrowing of the pool of Director-General (DG) candidates from six to three in preparation for a vote at WHA. Contrary to expectations heading into the EB vote, Dr. Sania Nishtar (Pakistan), Dr. Tedros Ghebreyesus (Ethiopia), and Dr. David Nabarro (UK) made the shortlist, while Drs. Flavia Bustreo (Italy) and Philippe Douste-Blazy (France), both of whom many considered to be strong contenders going into the meeting, failed to make the cut. The three have all positioned themselves as reform candidates, committed to continuing many of the reform processes started under outgoing DG Margaret Chan. The campaign now kicks into high gear, and it will be interesting to see if and how the candidates evolve their platforms to respond to priorities from the full membership of WHO now that they have made the shortlist. Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property – Decision Point The EB approved a new terms of reference for the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property (GSPOA), recognizing the need for WHO to consult with private-sector companies and establishing rules for this engagement as set out by the Framework for Engagement with non-State Actors (FENSA). Adopted in 2008, the GSPOA guides WHO’s work on fostering innovation and improving access to medical technologies for people in low- and middle-income countries. It was designed to promote innovation, build capacity, and mobilize resources by positioning WHO in a central and strategic role managing the relationship between public health, innovation, and intellectual property. As it nears its decade anniversary, WHO is undertaking a review of progress, as well as identifying areas for reform moving forward. In line with WHO’s move to put in place more stringent conflict of interest protections, initial drafts of the terms of reference for the review would have limited the agency’s ability to engage with private-sector companies involved in health R&D. The final draft as approved, however, recognizes the need to consult with these groups. Follow up to the Consultative Expert Working Group on R&D: Financing and Coordination and the UN Secretary-General’s High-Level Panel on Access to Medicines – Input/Information Point The EB’s session to review progress on the establishment of an R&D observatory and pooled fund at WHO to finance R&D as recommended by the Consultative Expert Working Group on R&D: Financing and Coordination (CEWG) was largely sidelined by member state debate on how or whether to carry forward recommendations of the United Nations (UN) Secretary-General’s High-Level Panel on Access to Medicines (HLP), which has proved highly controversial among member state delegations. In the run-up to the meeting, the officers of the EB decided not to include a separate item for discussion of the HLP’s findings in the EB agenda. As a compromise, the president of the EB permitted discussion of the HLP findings to occur under the existing CEWG agenda point. A number of countries, including Brazil, India, Iran, and others had strenuously objected to the exclusion of a HLP agenda item, arguing that WHO is relinquishing its global leadership role on a topic fundamental to health in not taking the lead on implementation of the HLP recommendations. Others, including the United States and some European delegations including Switzerland, Germany, and the UK argued that there was no consensus on the panel’s findings, that the report unfairly targeted specific countries, and that the HLP process had been overly narrow from the start in focusing on intellectual property, as opposed to a broader set of factors that impact access. The EB also did review progress on implementation of the CEWG recommendations. The final plan to establish an R&D observatory will be up for approval at this year’s WHA, while the proposal for a pooled fund to compliment the observatory is significantly less advanced, and work is still underway to determine exactly how a fundraising mechanism can be constructed to support it. GHTC delivered a statement at the meeting welcoming progress by WHO on the CEWG process and encouraging full funding of the observatory and ongoing consultation with stakeholders as the process moves forward. Antimicrobial Resistance – Input/Information Point Following on the heels of last year’s political declaration of the high-level meeting of the UN General Assembly on antimicrobial resistance (AMR), the EB reviewed progress made by WHO and other UN technical agencies to establish a plan to operationalize the declaration’s key recommendations, including spurring R&D for new antibiotics and other tools to combat AMR. As GHTC noted in our statement delivered at the EB, the effectiveness of follow up mechanisms to hold stakeholders accountable for their commitments on AMR will be critical to the overall success of the fight. Many delegates’ interventions focused on this need to deliver on commitments, and the tone of the session seemed to indicate that we will see a robust plan approved at WHA, which will be a great win for global health. R&D for Potentially Epidemic Diseases – Input/Information Point The EB reviewed progress by WHO on establishing an R&D blueprint for potentially epidemic diseases to reduce the delay between the identification of an outbreak and the deployment of effective medical interventions, calling for the agency to accelerate its work, given that the next outbreak can happen at any time. GHTC highlighted in its statement the importance of the blueprint addressing platform technologies, frameworks for collaborative R&D, and investing in regulatory/procurement systems strengthening. These efforts by WHO are part of its self-examination following lessons learned in the response to the Ebola outbreak. Heading into WHA in May, the agenda will be very full. In addition to the items above, the Assembly will also consider WHO’s response in crisis situations, polio elimination, immunization, WHO’s overall budget, implementation of the International Health Regulations to enhance global health security, global shortages of medicines and vaccines, and dozens of other items. GHTC will continue monitoring and will provide updates before, during, and after WHA.

A researcher holds onchocerciasis (river blindness) diagnostic tests. Photo: PATH/Patrick McKernLast Thursday, the World Health Organization (WHO) took the first step toward establishing an essential diagnostics list (EDL), releasing a proposal outlining how it intends to develop and operationalize the list by early 2019. This move follows calls by GHTC and other partners for the agency to establish an EDL to provide guidance to countries on the vital diagnostics that should be made available through health systems to complement WHO’s existing Model List of Essential Medicines (EML).As GHTC has previously noted, the need for an EDL to complement the EML is clear and has been compellingly demonstrated. An essential diagnostics list would not only help health care providers, particularly in low- and middle-income countries, improve diagnostic capacity and access, and thus improve patient care, it also holds potential to catalyze research and development (R&D) for new diagnostics by exposing health areas where we today lack appropriate and effective tools. GHTC is pleased to see WHO heed this call from advocates and scientists and begin the process to establish an EDL.A researcher holds onchocerciasis (river blindness) diagnostic tests. Photo: PATH/Patrick McKernThe proposal released by WHO lays out the broad principles the agency will follow in standing up an initial version of the diagnostics list. This includes: Focusing on in vitro diagnostics (IVDs): Given the large number of diagnostic tools, WHO believes that it will be most feasible to focus the first version of the list on IVDs—which are tests on samples derived from the human body—before considering expanding the list at a later date to include other diagnostic methods like radiological tests or x-rays. Targeting the list to support and complement the existing EML: Even limiting the list to IVDs leaves a wide breadth of potential diagnostics to be considered. Therefore, WHO proposes to start with identifying the diagnostics needed to enable appropriate use of medicines on the EML. Making an allowance for IVDs to address outbreak identification and response: While the EDL would be designed initially to complement medicines on the EML, WHO acknowledges that there is a clear need to help countries identify diagnostics necessary to address disease outbreaks with pandemic potential. As such, the EDL could include initially or be expanded later to include these technologies as well. Including diagnostics for various levels of the health care system: Different levels of health care facilities have different capacities and diagnostic needs within clinical care. Therefore, WHO will ensure the EDL includes diagnostics to meet the needs of these different providers and contexts. Designing for ease of use: WHO will focus on presenting the EDL in a format that is easy-to-use and accessible for countries, to facilitate use of the information and uptake of the suggested technologies. WHO is considering a variety of methods to support this goal.  Moving forward, WHO’s essential medicines staff will consult with the Expert Committee on the Selection and Use of Essential Medicines at its meeting in March to gather technical input on how to best operationalize the principles outlined above. Based on this feedback, a pilot group of diagnostics will be evaluated based on existing evidence of programmatic impact, with the goal of completing the development of an initial version of the EDL by early 2019.GHTC will continue to follow this issue closely and work with our members to ensure that the first version of the EDL is solidly grounded in our decades of combined experience with diagnostics and that the process of establishing the list moves forward efficiently. Keep watching this space for updates.