White smoke emerges from WHO negotiations on a resolution on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination

At around 10 PM on Friday evening, 20 May 2022, member states of the World Health Organization (WHO) negotiating on a resolution titled, Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, reached consensus. To recap, in January 2022, at the 150th session of the WHO Executive Board, the United Kingdom of Great Britain and Northern Ireland proposed a resolution (not formally submitted through the Executive Board), on clinical trials. On 30 March 2022, Knowledge Ecology International (KEI) first published the text of the draft resolution on social media.

Informal consultations on the text, co-chaired by the United Kingdom and Argentina, commenced on 2 March 2022. The final text can be found here: https://www.keionline.org/wp-content/uploads/Strengthening-Clinical-Trials-to-Improve-Public-Health_20May2022_21h30_clean.docx The publication of this resolution as a conference paper for WHA 75 (sans green highlights) is imminent. KEI is still examining the text of this resolution and will provide analysis in due course.

On 24 May 2022, the WHO published the draft text of the clinical trials resolution: A75/A/CONF./9 The co-sponsors of the resolution include Argentina, Peru, and the United Kingdom of Great Britain and Northern Ireland.

Francisco Viegas, Medical Innovation Policy Advisor at the MSF Access Campaign provided the following analysis of the resolution.

The clinical trials (CT) resolution misses the opportunity to embed more ambitious policy recommendations drawing from the lessons learned in the COVID pandemic. The Resolution particularly lacks access conditions and requests for sharing of health technologies developed from clinical trials, particularly publicly funded. These shortcomings have contributed to the ongoing inequity in access to the health technologies developed from trials. The current draft of resolution shies away from including requests for access clauses, affordability considerations, benefit sharing, licensing and transparency of R&D costs early on the CT development. The current draft also does not make concrete commitments to publish clinical trial data within timeframes that are considered the gold standard, reaffirmed by the WHO joint statement on clinical trial transparency in 2017. These aspects should be included in the Resolution and be a part of the best practices to be identified and documented. Also the resolution’s new version removes a relevant mandate for WHO to draft an action plan on the topic of this resolution, being substituted by the preparation of a document of best practices in consultation with relevant stakeholders. Without addressing these missing issues, the resolution would result in a missed opportunity for Member states and NSAs to have a broader and needed discussion to improve the CT policy and status quo framework – which has not ensured access equity due to lacking of access/public health driven mechanisms for clinical trials.