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May 29, 2021

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.