Research Roundup: Antimicrobial R&D, pandemic insurance, and Zika countermeasures

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.

Last week, the Review on Antimicrobial Resistance, commissioned by United Kingdom Prime Minister David Cameron, released its final report, Tackling Drug-Resistant Infections Globally: final report and recommendations. The report details ten recommendations and calls for funding and incentive mechanisms to spur research and development (R&D) for new antibiotics, rapid diagnostic tests, and preventative vaccines. The research, development, and use of new and existing vaccines could limit the dependence on antimicrobials, while rapid diagnostic tests preclude unnecessary antibiotic prescriptions. To stimulate antimicrobial R&D, the report calls for the creation of a global innovation fund to support basic research and market-entry rewards to incentivize pharmaceutical companies to bring new antibiotics to market. The report calls for US$2 billion over five years for the fund, and the United Kingdom and Chinese governments have each pledged $72 million for these efforts. While new antibiotics are critical to combatting the spread of antimicrobial resistance, their use must be restricted and market limited to prevent new drug-resistant infections. Consequently, the report calls for market-entry rewards of $0.8 to $1.3 billion to incentivize the development of new antibiotics. While implementing the report’s recommendations would cost $40 billion over the next decade, current trends suggest that drug-resistant infections will cost the global economy $100 trillion between now and 2050. The White House announced last week the establishment of the National Microbiome Initiative to catalyze and fund research on microbiomes, develop new platforms for curating and sharing microbiome data, and to build the microbiome workforce through training and educational opportunities. The Initiative will be launched with an investment of $121 million from five federal agencies as well as funding from more than 100 private organizations including $100 million from the Bill & Melinda Gates Foundation. A microbiome is the makeup of microorganisms (i.e., bacteria) in a given ecosystem. While the human microbiome is the most well-known, the purview of the Initiative goes much farther, and will even support microbiome research in space.  Researchers in Ireland have created a coating that can be applied to surfaces such as smartphones, door knobs, or countertops which kills 99.99 percent of strains of Methicillin-resistant Staphylococcus aureus (MRSA), Escherichia coli (E. Coli), and Trichophyton rubrum. MRSA and E. Coli spread rapidly within hospitals (MRSA can survive on surfaces for up to five months) and T. rubrum—which causes athlete’s foot and other fungal infections—is primarily transmitted via surfaces or objects (i.e., damp floors, towels). The coating is comprised of titanium oxide, fluoride, and copper and is sprayed and baked onto a surface, after which it becomes indiscernible to the eye. The bacteria and fungi are not able to spread on the coating and die within 24 hours. The team, led by Dr. Suresh Pillai of the Institute of Technology, Sligo, believes the coating could be used in hospitals and laboratories but also on smartphones, ATMs, and even food packaging.