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GHTC delivered the following statement, on the 72nd World Health Assembly (WHA) agenda item 11.7, access to vaccines and medicines, on May 6, 2019 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session: GHTC observes that supporting access to new technologies is complex, and failures to achieve widespread access to health technologies in low-resource settings are rarely due to a single issue. Barriers to access are best overcome when approached holistically, over the long-term, addressing affordability, availability, acceptability, and sustainability. Through its roadmap, the World Health Organization (WHO) has sought to create a broad framework to address the challenges and concerns around access to medicines.We encourage the US delegation to support a comprehensive approach to addressing barriers to accessing essential health technologies. Over recent years, significant progress in addressing regulatory barriers to access has been made, and WHO intends to continue building on their work in this area. Sound regulatory support for access to medicines ensures both timely access to medicines, as well as appropriate safety guidelines and pharmacovigilance activities. Technical standards and assistance supporting systems in achieving these targets have historically been viewed as falling within WHO’s core technical mandate. We also urge the US delegation to support the expansion of the Essential Diagnostic List. Diagnostic tests are critical tools for health care, providing vital information that impacts the prevention, detection, diagnosis, treatment, management of disease, surveillance and epidemiology. We strongly support WHO’s goal of increasing access to appropriate, affordable, quality-assured and effective diagnostics in underserved regions of the world.

GHTC delivered the following statement, on the 72nd World Health Assembly (WHA) agenda item 11.8, follow-up to the high-level meeting of the United Nations General Assembly on antimicrobial resistance, on May 6, 2019 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session:The Global Health Technologies Coalition (GHTC) applauds the USG for its commitments to tackling AMR and its call to mobilize other countries and stakeholders to take action through the CDC’s AMR Challenge. We applaud the recognition of the need for new products, including antimicrobial medicines, diagnostics and vaccines as part of an effective strategy to combat AMR, and we hope that the US delegation will continue its strong collaboration with WHO in follow up to the high-level meeting of the United Nations General Assembly.Further investment is necessary to fight antimicrobial resistance across the globe, as we do not currently have the tools to adequately combat AMR. AMR threatens to roll back progress made against some of the leading killers of children by further complicating diagnosis and treatment of drug resistant strains of tuberculosis, pneumonia, malaria, typhoid, and diarrheal diseases, in addition to hospital-based infections. Innovation and R&D must be at the heart of any agenda to tackle AMR—as the incidence of AMR grows, so does the need for better diagnostics to detect, new drugs to treat, and effective vaccines to prevent emerging resistance.  GHTC encourages the US delegation and other member states to support enhanced cooperation at all levels for concrete action towards combating AMR, and mobilize sustained investments and resources for research and development on existing and new antimicrobial medicines, diagnostics, vaccines, and other technologies.We want to thank the US for taking an active role in the fight against AMR, and encourage the continued participation in global initiatives tackling this challenge. 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. A landmark study found that men whose HIV infection was fully suppressed by antiretroviral drugs had no chance of infecting their partner—suggesting that if everyone with HIV were fully treated, there would be no further infections. Of the nearly 1,000 male couples across Europe who participated in the study, in which one partner with HIV was receiving treatment to suppress the virus, there were no cases of transmission of the infection to the HIV-negative partner during sex without a condom. According to Professor Alison Rodger, co-leader of the paper published in The Lancet, these findings “provide conclusive evidence for gay men that the risk of HIV transmission with suppressive ART [antiretroviral therapy] is zero” and that the study’s findings “support the message of the international U=U campaign that an undetectable viral load makes HIV untransmittable.” The Global Polio Eradication Initiative (GPEI) unveiled a new five-year strategy on Tuesday, which includes the use of novel oral polio vaccines—several of which are being developed by PATH and its partners—as well as the adoption of smartphone technologies to assist in disease surveillance and faster response. GPEI is also planning to establish a regional hub in Amman, Jordan to allow for easier coordination and increased technical support for polio vaccination programs in Afghanistan and Pakistan, two polio-endemic countries. Additionally, as part of the new strategy, GPEI is expanding its partnership with development institutions such as Gavi, the Vaccine Alliance. These new approaches, among others, will be implemented by GPEI under its new strategy from 2019-2023 in the hopes that this new strategy will be its last, with wild poliovirus successfully eliminated by 2023. The new strategy is currently facing a funding gap of US$3.27 billion, which organizers hope to fill with a pledging conference in November. On Wednesday, the US Food and Drug Administration (FDA) approved the first vaccine against dengue fever. The vaccine, Dengvaxia, has generated much controversy in recent months due to post-marketing research performed by its manufacturer, Sanofi Pasteur, which showed that the vaccine offers protection for people who have already had at least one bout of dengue, but increases the risk of severe infection in children who were dengue-naïve, or never infected when they were vaccinated. The FDA ruled that Dengvaxia can only be administered to individuals between the ages of 9-16 living in parts of the United States where the dengue virus is endemic, and that it can only be given to children and young adults who had one previous laboratory-confirmed case of dengue. Identifying these individuals with prior infection is currently a challenge, because there is no point-of-care diagnostic test available, though Sanofi officials say they have to have one ready for FDA submission by late 2020. Sanofi will earn a priority review voucher (PRV) by bringing Dengvaxia to market. A PRV is an incentive created to encourage pharmaceutical companies to develop drugs and vaccines for neglected diseases and, in exchange, allows a company to expedite the review of another product it wants to bring to market or sell the voucher to another company.