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The following statement—from Global Health Council, supported by the Global Health Technologies Coalition, Management Sciences for Health, and Partners in Health—was submitted to the 74th World  Health Assembly on agenda items 13.4: Global strategy and plan of action on public health, innovation and intellectual property; 13.6: Substandard and falsified medical products; and 13.7: Standardization of medical devices nomenclature.Global Health Council in collaboration with GHTC, PIH, and MSH would like to provide the following feedback on these agenda items.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 systems, primarily but not exclusively in low-income countries.To address these challenges and ensure faster access for patients to safe and effective products, we urge the WHO and Member States to strengthen the capacity of national and regional regulatory functions and systems, including improving late-stage clinical trial regulatory review and oversight. We also call on Member States to support the resolution being advanced to strengthen the local production of medicines and health technologies. This requires transparency; all data associated with publicly funded R&D should be made publicly available. We urge Member States to also ensure better regional collaboration for regulatory functions and manufacturing. 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 WHO, member states, and partners to promote sustainable local production to improve access to quality, safe, effective and affordable medicines and other health technologies.

The following statement—from Global Health Council, supported by the Global Health Technologies Coalition, American Academy of Pediatrics, DAI Fleming Fund, Infectious Diseases Society of America, Partners in Health, and Management Sciences for Health—was submitted to the 74th World Health Assembly on agenda items 13.1: Global action on patent safety; 13.5: Antimicrobial resistance; and 13.8: Immunization Agenda 2030.Global Health Council in collaboration with the AAP, DAI, GHTC, IDSA, PIH, and MSH are grateful to comment on the IA2030 and AMR agenda items.The COVID-19 pandemic has overwhelmed immunization infrastructure, impacted the global supply chain, increased the incidence of antimicrobial resistance and impacted gains made in immunization campaigns around the world.  Disrupted immunization services and supply chains have left millions at risk and widened inequities and it has never been more important to recover lost ground on immunization progress. Vaccines prevent 4.3 million deaths each year–but they have the potential for an even greater impact, especially in children. Immunization is a pillar of people-centered primary healthcare, and we urge WHO and Member States to strengthen vaccine-related research and innovation with the most vulnerable populations in mind. Achieving vaccine equity will require engaging with communities, including the most marginalized, increasing investments in health workers, and enhancing sustainable financing mechanisms to leave no one behind.We call on WHO and Member States to focus on the full spectrum of innovations that support immunization programs: from storage, manufacturing capacity, new vaccine administration infrastructure, co-administration with other health interventions, to novel service delivery that encourages vaccine confidence. In addition, testing is an essential enabler of vaccine development and crucial for ongoing public health surveillance.We ask Member States to integrate accountability mechanisms for commitments made to IA2030, including an annual mechanism for reporting progress through the EB and wider Assembly.Due to waning private investment in antibiotic development, Member States should invest in new tools, including new quality-assured antimicrobials, novel compounds, diagnostics, and vaccines to fight AMR. Any incentives for R&D should address stewardship, and public investments should be conditioned upon the accessibility of novel technologies to fight AMR. Other proven strategies including infection prevention and control, and surveillance also need similar attention.

The following statement—from Medicines for Malaria Venture and PATH, supported by the Global Health Technologies Coalition, Foundation for Innovative New Diagnostics, and Innovative Vector Control Consortium—was submitted to the 74th World Health Assembly on agenda item 34.1: Progress reports, including the Global Technical Strategy for Malaria 2016–2030.Our organizations, bringing together academia, industry and access partners, are devoted to developing and facilitating access to life-saving malaria prevention tools, diagnostics and medicines. Since the launch of the WHO Strategy, several innovations have helped transform the prevention and treatment of malaria, and saved millions of lives. These innovations include:The massive adoption of seasonal malaria chemoprevention.Improved tools for managing the continuum of care for severe malaria in children in rural settings.The first single-dose treatment and molecular diagnostic test for relapsing malaria, and a test to detect genetic anomalies limiting treatment options.The first wave of second-generation bednets with new insecticide combinations.We concur with WHO that we need to address the fragility of health systems, which leads to stalled progress. Malaria is a disease which is preventable and treatable, with strong primary health care and referral services and with capacity for supply and stockpiling of commodities in rural communities.We also endorse WHO’s statement that the need for investment in better tools is greater than ever. Scaled up investment in innovation also requires efficient processes for prequalification of products and revision of guidelines, along with technical support for early adoption of these new technologies in countries.We have today a robust portfolio of malaria tools in development, including potential vaccines. With sustained support for research and broad roll out of existing innovations in countries, the world will be soon much better equipped to move forward on the path to global malaria elimination.