Breakthroughs Blog: WHO

Dr Margaret Chan, WHO director-general opens the assembly. Photo: WHO The 68th World Health Assembly (WHA) in Geneva wrapped up last week after addressing several items that will shape the next few years of global health innovation. While we’re very excited by the progress made, much hinges on the connections between this year’s assembly decisions, the finalization of the post-2015 Sustainable Development Goals (SDGs), and next year’s WHA, which will likely have an even greater focus on global health research and development (R&D). Here are some highlights from the last two weeks: First, there were several decisions that will impact the work of the entire global health community: WHO budget increase approved Member states approved WHO’s proposed program budget for 2016-17, increasing the biennial budget by US$236 million—a five percent increase from the previous cycle. The renewed push for malaria elimination through the Global Technical Strategy for Malaria was mentioned as one of the reasons behind the funding increase. Work on non-State actors’ engagement framework continues The Assembly also welcomed a report on progress of a draft framework for engagement with non-State actors—including nongovernmental organizations, private-sector entities, philanthropic foundations, and academic institutions—noting that it wishes to finalize the framework by the next WHA. Delegates requested that the director-general convene an intergovernmental meeting as soon as possible and submit a finalized draft for adoption at next year’s WHA, as well as submit a register of non-State actors. Delegates acknowledged the importance of WHO engaging with non-State actors, which may facilitate greater alliances between WHO and nonprofit product development organizations, as well as global health innovation advocacy groups. It was also a big week for global health innovation: Pooled R&D fund, CEWG recommendations progress WHO delegates consider draft resolutions. Photo: Pierre Albouy/WHO Member states officially noted a report outlining the role the WHO Special Programme for Research and Training in Tropical Diseases would play in hosting and managing a pooled R&D fund. The fund, which will be financed by voluntary contributions, is intended to support R&D for new technologies to meet the needs of low- and middle-income countries. Priorities areas for the fund will be identified by the WHO Global Health Research Observatory, which will be formally launched in January 2016. It remains to be seen how the structure of the observatory will ultimately be implemented, and how that will impact the work of the pooled fund. The pooled fund and observatory were developed as a result of recommendations from a 2012 report by the WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) which was looking for ways to fund R&D for and achieve access to treatments and technologies for diseases predominantly impacting the poor. To demystify this conversation, GHTC and the Council on Health Research for Development cosponsored a live event and webinar at WHA that examined approaches to incentivizing global health R&D and ensuring access to technologies. The discussion featured panelists from PATH, Médecins Sans Frontières, Cipla, and the Norwegian Institute of Public Health. The webinar is available on demand here. Timeframe for global strategy on public health, innovation, and intellectual property extended Member states also agreed to extend the timeframe for action on The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA) from 2015 to 2022. The GSPA was adopted by members in 2008 “to promote new thinking on innovation and access to medicines.” The agreement also extends the timeframe of an overall program review of the global strategy on its achievement, remaining challenges, and recommendations on the way forward. A panel of experts to conduct the evaluation will not be established until early 2017, with their report to be presented at the 71st WHA in 2018. WHO endorses Global Vaccine Action plan which includes support for R&D During discussion around the Global Vaccine Action Plan (GVAP), member states approved a resolution that includes language directed at strengthening WHO’s prequalification program, which provides tentative evaluation of new vaccines and medicines. The resolution also included a call for increased capacity-building for R&D, technology transfer, and other elements of vaccine development. Ebola epidemic prompts creation of new emergency response capabilities, greater emphasis on development of new technologies As the Ebola outbreak in West Africa winds down, WHO’s efforts and preparedness for future health emergencies was a hot topic at the Assembly. Delegates welcomed WHO's commitment to make important changes in its emergency response work. Through an approved resolution, WHO will establish a new emergency response capability based on all-hazards preparedness with an emphasis on adaptability, flexibility, accountability, humanitarian principles, predictability, opportunity and country ownership. WHO also plans to establish a contingency fund of $100 million to finance emergency field operations for up to three months. R&D language was also included in the resolution, which supports the development of a ‘blueprint’ for accelerating R&D in epidemics or health emergencies where few or no technological solutions exist. WHO approves global malaria strategy which emphasizes importance of research and innovation Delegates showing support for the proceedings. Photo: WHO Member states approved the Global Technical Strategy for Malaria, which aims to eliminate malaria in at least 35 countries by 2030. The strategy emphasizes the importance of research and innovation, and the need for political commitment, sustainable financing, strong health systems, and collaboration across different sectors. Dr. Pedro Alonso, head of the Global Malaria Program, cited R&D as a necessary endeavor to reach the lofty elimination goals outlined in the strategy.WHO adopts global plan to combat antimicrobial resistance   A key item under discussion by governments was the draft WHO Global Action Plan on Antimicrobial Resistance (AMR) which was approve by member states. Angela Merkel, chancellor of Germany, opened the Assembly by calling AMR "an issue of crucial importance to humankind." Germany has made AMR a key priority during their current chairmanship of the G7. The plan calls for countries to put in place by 2017 systems to monitor drug resistance. It also calls for reductions in overuse of antibiotics and for more investment in new drugs and other health technologies. GHTC member RESULTS, along with the Stop TB Partnership and Global Health Advocates, highlighted the need for drug-resistant tuberculosis to be central to the AMR Global Action Plan throughout the Assembly, and the Global Health Council and Global Health Advocates France delivered a statement calling for drug-resistant TB to be central to the plan and included in the Communiqué of the G7 Summit.Role of Health in SDGs discussed As the finalization of the SDGs approaches this fall, the Assembly discussed the need to secure a strong role for health goals in the overarching framework, and adopted a resolution urging member states to emphasize, among other priorities, “medical products, vaccines and technologies.” Through the Global Health Council, GHTC presented a statement highlighting the need to include health innovation targets and indicators in the SDGs. Looking ahead to the 69th WHA: Several R&D topics to be revisited In comparison with last year’s WHA, this year’s agenda did not include as much substantive decision-making regarding global health R&D activities, such as the global health R&D observatory, the ongoing pilot demonstration projects, or the previously proposed R&D treaty. These topics will be revisited at the 69th WHA in 2016. Regulatory strengthening expected to be discussed We also expect that regulatory systems strengthening will be on the agenda in 2016, an area that is of interest to the US delegation in particular. Since the 2014 Ebola outbreak, interest has been revived in strengthening the involvement of stringent regulatory authorities, like the US Food and Drug Administration, in supporting quick review of emergency tools, as well as building capacity for regulation and increasing regulatory harmonization around the world. As you can see, it was a very busy few weeks! We’re pleased with the outcomes from the WHA, but also see a need to ensure that the important agreements and resolutions are carried forward by member state governments and partners. Hopefully with the upcoming final post-2015 discussions and the next WHO Executive Board meeting only six months away, we’ll see the momentum for global health R&D continue.

The French pharmaceutical company Sanofi purchased a priority review voucher (PRV)—which entitles the owner to an expedited review of a future product by the US Food and Drug Administration (FDA)—for US$245 million last week. This particular sale was part of the Rare Pediatric Disease PRV, which was modeled after the Neglected Tropical Disease PRV—a program intended to incentivize research and development (R&D) for neglected diseases, as the market for drugs to treat these conditions is often limited. The voucher significantly expedites the FDA’s review process, from 10–12 months to 6–8 months. This voucher was awarded to Retrophin for approval of a drug to treat bile acid synthesis disorders, which are considered rare pediatric diseases. Only two vouchers have been awarded through a PRV program, the first of which was sold to Sanofi for $67 million and the second to Gilead Sciences for $125 million. Delegates from the World Health Organization’s (WHO) 194 member states approved a resolution at the World Health Assembly—the organization’s annual convening—to address the spread of antimicrobial resistance. The resolution establishes a global strategy to control and prevent the spread of drug-resistant infections, including through the R&D of new antibiotics. Under this new resolution, member states will be required to develop and implement national plans to combat antimicrobial resistance within the next two years. WHO Director-General Dr. Margaret Chan assured delegates at the World Health Assembly that the WHO will provide technical support to national governments as needed, stating “we are going to do our utmost to support you.” The status and progress of these efforts will be reported to the World Health Assembly in May 2017. Photo: World Health Organization The global action plan, presented by the WHO Secretariat during the World Health Assembly, called for improved surveillance; increased awareness; and adequate, sustainable R&D funding surrounding the growing threat of antimicrobial resistance. The plan notes the “serious market failure” for antimicrobial R&D, calling for new mechanisms to incentivize and accelerate the development of new antibiotics. Senators Patrick Leahy (D-VT) and Chuck Grassley (R-IA) recently introduced the bipartisan Patents for Humanity Program Improvement Act, which expands the Patents for Humanity program at the US Patent and Trademark Office (USTPO) to ensure small businesses can participate. Each year, USTPO identifies approximately ten products that have been patented through their office and that have since been used for humanitarian purposes, and provides the winners with a voucher for an expedited patent application, ex parte reexam, or ex parte appeal. The legislation would make the voucher transferable, which would encourage small businesses or individual researchers or inventors—who may not anticipate future patent applications or dealings with USTPO—to participate.

The World Health Organization (WHO) released a statement last week calling for the publication of all data from clinical trials for drugs, vaccines, and medical devices. The pharmaceutical industry has made great strides in reporting the results of clinical trials since the establishment of the WHO International Clinical Trials Registry Platform. However, a report released in conjunction with the WHO statement demonstrates that negative or inconclusive clinical trial results often go unreported, and there is still a need to publish data from older clinical trials. The United States Centers for Disease Control and Prevention (US CDC) is partnering with the African Union to establish an African Centres for Disease Control and Prevention (African CDC) comprised of a Coordinating Center in Addis Ababa, Ethiopia—where the African Union is located—and five Regional Collaborating Centers across the continent. The purpose of the African CDC is to support and connect African ministries of health to monitor and respond to disease outbreaks. The US CDC will provide initial technical expertise and will sponsor ten African epidemiologists and two public health experts from the US CDC to staff the Coordinating Center and Regional Collaborating Centers. Dr. Jack Whitescarver, director of the Office of AIDS Research (OAR) at the National Institutes of Health (NIH), will step down in July after leading the Office for 15 years. Dr. Whitescarver first joined the NIH in 1977 and he was involved in the initial detection and monitoring of the HIV and AIDS epidemic in the United States. He was also a major player in the NIH’s HIV and AIDS outreach and education efforts, prior to the establishment of OAR in 1988. Under his leadership, OAR has supported both international and domestic research efforts, with a focus on HIV and AIDS in minority populations and in women and girls. The United States Patent and Trademark Office (USPTO) at the US Department of Commerce announced the winners of the 2015 Patents for Humanity program. The winners will be granted an expedited patent application, ex parte reexam, or ex parte appeal before USPTO. This year's winners include Sanofi—the manufacturer of a synthetic version of the antimalarial artemisinin—and Novartis, a pharmaceutical company that has discovered a class of compounds that show promise in fighting drug-sensitive and drug-resistant tuberculosis. Sanofi is partnering with GHTC members PATH and the Bill & Melinda Gates Foundation to produce synthetic artemisinin, while Novartis has provided TB Alliance—another member of the GHTC—with the compounds to continue the research and development of treatments for tuberculosis.

India is expected to add all of the drugs currently used in the government’s HIV and AIDS and tuberculosis (TB) control programs to its list of essential medicines within the next six months. These drugs are currently available for free in public clinics; many patients, however, prefer private clinics due to perceived discrepancies in quality of care. The list, which was last updated in 2011, sets price caps to ensure that treatments remain affordable—paramount in a nation where more than 70 percent of the population lives on less than US$2 per day. China’s investments in health-related research and development (R&D) are expected to surpass US funding by 2023. The government of China has invested $1.1 billion in drug development since 2011, due to a policy mandate requiring increased funding for life sciences, including the pharmaceutical industry. Meanwhile, US funding for global health R&D has declined or plateaued each year since 2009. China is currently the world’s biggest manufacturer of active pharmaceutical ingredients and is becoming a leading site for contract research organizations, which support preclinical and clinical research for major pharmaceutical companies. The World Health Organization (WHO) issued a guidance document last week regarding a leading medicine for hepatitis C. The new guidance will inform the design of bioequivalence studies, which determine whether a generic is comparable to a patented product. The drug, sofosbuvir, is patented by Gilead Sciences and can cost up to $1,000 per pill. Proof of bioequivalence will be critical for manufacturers aiming to produce a generic drug and ultimately seek WHO prequalification for their product. In her final speech as commissioner of the US Food and Drug Administration (FDA), Dr. Margaret Hamburg defended the agency’s rigorous drug approval process. “Innovation doesn’t matter if the product doesn’t work,” she noted, highlighting the risks of “unsafe and ineffective medical products.” Hamburg’s remarks come as the House of Representatives Energy and Commerce Committee is in the process of developing legislation—known as 21st Century Cures—that calls on the FDA to expedite the regulatory process using its “breakthrough therapy” designation. This designation, which ensures an accelerated review and increased guidance from the FDA, was granted to 31 drugs in 2014. The 21st Century Cures legislation would allow the FDA to review products based only on preliminary clinical trial data and would allow companies to hold off on long-term safety and efficacy trials until after the product was on the market.