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May 13, 2021

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.