The world commits to the AMR fight

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.

The US Department of Health and Human Services has published new rules intended to improve compliance to a 2007 law intended to increase the public availability of clinical trial data. The law requires researchers to register and share data from clinical trials, grants the US Food and Drug Administration (FDA) the authority to fine pharmaceutical companies up to US$10,000 per day for failure to register or report results, and allows the US National Institutes of Health (NIH) to refuse to disburse funds to noncompliant grantees. Between 2008 and 2015, violations of the law warranted more than $25 billion in fines, however, no such fines have been issued to date. Many advocates have expressed concern that the new rules are only as effective as their enforcement. Neither the FDA nor the NIH plan to hire additional staff to enforce compliance of the law. Facebook CEO Mark Zuckerberg and his wife Dr. Priscilla Chan have committed US$3 billion over the next ten years to “cure, prevent, or manage all disease.” The couple is investing $600 million to launch the “Biohub” at the University of California, San Francisco, which will convene scientists and engineers, supporting collaboration in research and product development. The Biohub’s first two ventures are ambitious: the Cell Atlas, which will involve the characterization of every type of cell found in the human body, and the Infectious Disease Initiative, which will support research and development (R&D) for drugs, diagnostics, and vaccines against infectious diseases. The Initiative will establish a Rapid Response Team with the ability to rapidly mobilize scientists and accelerate R&D during an outbreak. The mosquito-borne Mayaro virus, primarily found in the Amazon, has been reported in Haiti. The symptoms of Mayaro—fever and joint pain—are similar to chikungunya, however, the pain can last for nearly a year and patients often report abdominal pain as well. The virus, which was identified in a blood sample taken from a child suffering from the illness, varied from the strain responsible for the more than 40 cases reported in South America since its discovery in 1954. Researchers are particularly concerned with the presence of Mayaro in the Caribbean in light of the ongoing outbreak of Zika virus, which was discovered several decades ago but has only recently begun to spread rapidly and have a significant health impact. A new report from the World Bank quantifying the economic impact of antimicrobial resistance (AMR) indicates that by 2050, the impact of AMR on the global economy and in particular, the livestock industry, could push nearly 30 million people into extreme poverty. Further, drug-resistant infections are much more difficult and costly to treat, and thus, AMR could increase health spending by $1 trillion per year by 2050. These findings reveal that AMR could have a much greater economic impact than the 2008 financial crisis, particularly for low- and middle-income countries. Gonorrhea, a sexually transmitted infection resulting in nearly 90 million new infections each year, has grown increasingly resistant to antibiotics. A new cluster of cases in Hawaii suggests that the emergence of untreatable strains of the bacteria are closer than ever. Over time, gonorrhea has developed resistance to several common antibiotics including penicillin, tetracycline, and fluoroquinolones; the current treatment, a combination of the antibiotics azithromycin and ceftriaxone, is considered the last resort. The samples identified in Hawaii showed unprecedented levels of resistance to azithromycin and burgeoning resistance to ceftriaxone. While azithromycin and ceftriaxone are the only remaining drugs that are effective against the bacteria and well tolerated by humans, scientists at Louisiana State University are testing a new oral antibiotic that appeared to be safe and effective against gonorrhea in phase 2 clinical trials.