The eleventh meeting of the Member State mechanism on substandard and falsified medical products was held in Geneva, Switzerland on 19 and 20 October 2022.
The WHO Director-General, Dr Tedros Adhanom Ghebreyesus, opened the meeting and underscored the importance of access to safe and quality medical products as a cornerstone of universal health coverage.
The reporting disparity from GSMS (Global Surveillance and Monitoring System) both among WHO regions and in the classification of reported products was noted, along with the ongoing challenges concerning information sharing and transparency, which can act as barriers to reporting. Member States were encouraged to continue to enter their reports into the GSMS system for the benefit of all Member States.
Below are the prioritised activities for 2022-2023.
- Activity A: Strengthen the capacity of national/regional regulatory authorities for the prevention and detection of, and response to, substandard and falsified medical products
- Activity B: Develop, expand and maintain global networks of stakeholders to facilitate cooperation and collaboration
- Activity C: Improve Member States’ understanding and uptake of technologies to screen and detect substandard and falsified medical products, and the implementation of national traceability systems
- Activity D: Leverage the competencies of relevant stakeholders, including policy-makers, procurers, distributors, practitioners, patients and consumers, and good governance to reduce the burden of substandard and falsified medical products
- Activity E: Enhance Member States’ capacity to run effective risk communication campaigns for substandard and falsified medical products
- Activity F: Enhance Member States’ capacity to expand awareness, effectiveness, impact and outreach in their work on substandard and falsified medical products
- Activity G: Identify and develop appropriate strategies to understand and address the distribution or supply of substandard and falsified medical products via the internet
- Activity H: Develop strategies for national regulatory authorities to mitigate public health risks posed by the distribution of substandard and falsified medical products through informal markets
Future work of the Member State mechanism
The Chair emphasized the need to demonstrate the value of the mechanism for Member States that are currently engaged, as well as for those that are not yet actively involved. The need to develop metrics in order to measure what success of the Member State mechanism looks like was emphasized. It was suggested that strategic and longer-term planning would be beneficial and could include important pillars such as capacity-building, cooperation and reporting. Further, suggestions were made for improving accessibility to the documentation, including guidance and training materials. The Member State mechanism agreed on having the Steering Committee develop a strategic plan and on recommending an independent evaluation of the mechanism take place to the Seventy-sixth World Health Assembly through the Executive Board at its 152nd session. .
EB 152 draft decision to be transmitted to the Director-General through the Seventy-sixth World Health Assembly
Based on the report on substandard and falsified medical products, the Executive Board decided to request the Director-General through Seventy-sixth World Health Assembly the facilitation of the conduct of an independent evaluation of the Member State mechanism in accordance with the terms of reference to be developed by the Steering Committee and a report on the outcome of the evaluation to the governing bodies.
Read the full report here.