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GHTC delivered the following statement, on the 74th World Health Assembly (WHA) agenda item 13.4, global strategy and plan of action on public health, innovation, and intellectual property (GSPOA), on May 13, 2021 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session:The Global Health Technologies Coalition appreciates the opportunity to comment on the global strategy and plan of action on public health, innovation and intellectual property (GSPOA) ahead of the World Health Assembly. As outlined in the WHO review panel’s report, although progress has been made in certain aspects of both innovation and access, many of the challenges that motivated formulation of the GSPOA remain, and the COVID-19 pandemic has exposed both long-standing shortcomings as well as new challenges. These include a lack of new health products in areas of need, the unaffordability of many new medicines and other health technologies, ineffective delivery and supply chain infrastructure, and the absence of robust regulatory frameworks, primarily but not exclusively in low-income countries. To address these challenges, and to ensure faster access for patients to safe and effective products, we urge the US to continue to support the World Health Organization (WHO) and bolster the organization’s ability to strengthen the capacity of national and regional regulatory functions and systems, including improving late-stage clinical trial regulatory review and oversight. Promoting global and regional harmonization of regulatory functions could also be instrumental in ensuring regional resources are coalesced toward meeting shared goals in this area, and hopefully speeding up regulatory approval processes.We also urge the US delegation to support the efforts being advanced to strengthen the local production of medicines and health technologies. The COVID-19 pandemic has underscored the risk of overreliance on international health supply chains, imported medicines and other health technologies and donor support. The current draft resolution being co-sponsored by multiple African countries calls for member states to support regulatory systems strengthening, access to sustainable and affordable financing, and development of skilled human resources. We urge the US to work with other WHO member states and partners to promote sustainable local production to improve access to quality, safe, effective and affordable medicines and other health technologies.Lastly, we support the recommendation outlined by the review panel calling on WHO to develop target product profiles for missing antibiotics, diagnostics tools for priority pathogens, and medical devices including personal protective equipment.

GHTC delivered the following statement, on the 74th World Health Assembly (WHA) agenda item 13.8, Immunization Agenda 2030, on May 13, 2021 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session:The Global Health Technologies Coalition appreciates the opportunity to comment on the agenda item focused on the Immunization Agenda 2030 ahead of the World Health Assembly. Despite continued efforts, coverage of essential vaccines only increased from 84 percent in 2010 to 86 percent in 2018, leaving nearly 20 million children unvaccinated every year. Polio has not been eradicated, and the COVID-19 pandemic threatens to undo decades worth of progress. Dozens of countries have reported disruptions to vital immunization programs, including at least 30 measles programs at risk of being cancelled, which could fuel outbreaks this year and beyond. Improved immunization programs can help counter rising rates of antimicrobial resistance by reducing the need to use antimicrobial drugs, extending the efficacy of existing medicines. Vaccines are an essential prevention tool, and member states must invest in research and development for new vaccine technologies coupled with increased capacity-building for the uptake of existing and new vaccines. We do not have all the vaccines we need to prevent diseases that threaten health and well-being globally. We urge the US to work with WHO and member states to strengthen mechanisms to identify vaccine-related research and priorities for innovation according to community needs, particularly for underserved populations, and ensure that the priorities inform innovations in immunization products, services and practices.We also call on the United States to focus on the full spectrum of innovations that support immunization programs, from storage, to new vaccine administration infrastructure, to co-administration with other health interventions, to novel approaches to service delivery. Vaccines are only useful if they reach those who need them, and many different types of innovation are necessary to achieve universal access. Lastly, the US should continue to invest to accelerate the development of new vaccines, technologies and improved products, services and practices, while ensuring continued progress in the development of vaccines for priority targets, including HIV, TB, malaria and emerging infectious diseases.

GHTC delivered the following statement, on the 74th World Health Assembly (WHA) agenda item 17.3, WHO’s work in health emergencies, on May 13, 2021 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session:The Global Health Technologies Coalition appreciates the opportunity to comment on the agenda item focused on WHO’s work in health emergencies. The COVID-19 pandemic has made clear that there are severe gaps in global health security preparedness. The global community has been slow to build—and adequately resource—coordinated international frameworks or mechanisms to advance the technologies needed to combat potential health emergencies. No global framework currently exists for assessing and strengthening the capacity of countries to develop, approve, manufacture, and deploy vaccines, treatments, diagnostics, and other health technologies—despite the importance of these tools in preparing for and responding to global health challenges. As conversations about World Health Organization (WHO) reform continue, we urge the US to prioritize R&D strengthening as part of the ongoing International Health Regulations (IHR) implementation discussions. The IHR framework must include R&D as a central pillar of preparedness. The recent report by the Review Committee on the Functioning of the International Health Regulations highlighted that the IHR are concerned with early detection, alert, preparedness, and response, but, as the COVID-19 pandemic has shown, much stronger and better coordinated global action is needed to improve both preparedness and response. The IHR make no mention of rapid sharing of genetic information and samples of pathogens of concern, with adequate access to benefit; research coordination; or development of and equitable access to medical countermeasures and other innovations developed during emergencies. An R&D coordination mechanism, which could be a vital part of the currently discussed treaty on pandemics, could facilitate the rapid sharing of scientific findings and samples within the global scientific community and facilitate greater coordination between important stakeholders. We therefore urge the US to ensure that any dialogue focused on a pandemic treaty also integrates R&D and scientific coordination into its framework. 

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. Last week, the US government announced it would support a proposal to temporarily waive intellectual property rights for COVID-19 vaccines. The proposal, first introduced to the World Trade Organization (WTO) last fall by South Africa and India, would cover patents, industrial designs, copyrights, and protection of trade secrets, ultimately making it easier for countries that permit compulsory licensing to allow a manufacturer to export vaccines. In order to pass, the proposal would need support from all WTO members, and the measure is still opposed by a number of high-income countries. Following the US statement, however, several countries announced they are open to discussing the proposal. A decision on whether to grant the waiver is expected next month.An existing, cheap therapy could have potential as a long-acting injectable treatment for COVID-19, according to a recent preclinical study by researchers at the University of Liverpool. The data showed niclosamide, a therapy used to treat tapeworm infestations, to be highly effective against the SARS-CoV-2 virus in multiple laboratory studies. The researchers formed dispersible solid drug nanoparticle formulations of niclosamide that can be stored as solids, reconstituted with water, and then utilized as a long-acting injectable. The research team is looking to move the therapy into human trials and is working with a contract manufacturing organization toward scale up and clinical manufacturing.The Moderna COVID-19 vaccine was 96 percent effective in preventing illness in adolescents aged 12 to 17, according to early data released by the company Thursday. The vaccine was also generally well tolerated, and the majority of adverse events were mild or moderate, according to the statement. The analysis, which came from a study of the vaccine among 3,235 participants in the United States, identified no serious safety concerns. Moderna said it is in discussions with regulators about a potential amendment to expand its regulatory authorization to this younger age group. It is currently authorized for people aged 18 and over in countries where it has been approved.