WHO Member State Mechanism

In 2012, the World Health Assembly established the Member State Mechanism to address the issue of tackling substandard and falsified medical products in a transparent and inclusive way, from a public health perspective and expressly excluding considerations of intellectual property rights.

On 29 May 2017, the World Health Assembly agreed to have “Substandard and Falsified (SF) medical products” as the term to be used in the name of the Member State mechanism and in all future documentation on the subject of medical products of this type.

For more information, please see Resolution 65.19. The Annex to WHA65.19 contains the goal, objectives, and terms of reference.

General goal

In order to protect public health and promote access to affordable, safe, efficacious, and quality medical products, promote through effective collaboration among the Member States and the Secretariat, the prevention and control of SF medical products and associated activities.

Objectives

1. To identify major needs and challenges and make policy recommendations, and develop tools in the area of prevention, detection methodologies, and control of SF medical products in order to strengthen national and regional capacities.
2. To strengthen national and regional capacities in order to ensure the integrity of the supply chain.
3. To exchange experiences, lessons learnt, best practices and information on ongoing activities at National, Regional and Global activities.
4. To identify actions, activities and behaviours that result in SF medical products and make recommendations, including for improving the quality, safety and efficacy of medical products.
5. To strengthen regulatory capacity and quality control laboratories at National and Regional levels, in particular for developing countries and least developed countries.
6. To collaborate with and contribute to the work of other areas of WHO that address access to quality, safe, efficacious and affordable medical products, including, but not limited to, the supply and use of generic medical products, which could complement measures for the prevention and control of SF medical products.
7. To facilitate consultation, cooperation and collaboration with relevant stakeholders in a transparent and coordinated manner, including regional and other global efforts, from a public health perspective.
8. To promote cooperation and collaboration on surveillance and monitoring of SF medical products.
9. To further develop definitions of SF medical products that focus on the protection of public health.

Governance

The Member State Mechanism has a Steering Committee led by a Chairperson who is supported by 11 Vice-Chairpersons, representing the six regions of the WHO.

The term of office of the Chairperson and Vice-Chairpersons will start at the end of a regular session of the mechanism and expire at the end of every second regular session. The Chair rotates amongst the Regions on an alphabetical basis.

Work Plan, Prioritized Activities and Working Groups

A detailed work plan has been agreed by the Member States and specific activities have been prioritized.

The high-level activities contained in the work plan are as follows:

1. Strengthening and capacity building of national and regional regulatory authorities and quality control laboratories
2. Cooperation and collaboration among national and regional authorities and exchange of experiences, lessons learnt, best practices, and information on ongoing activities at national, regional, and global levels.
3. Communication, education and awareness-raising
4. Facilitate consultation, cooperation, and collaboration with relevant stakeholders in a transparent and coordinated manner, including regional and other global efforts, from a public health perspective.
5. Identify actions, activities, and behaviors that result in SF medical products.
6. Strengthen national and regional capacities in order to ensure the integrity of the supply chain
7. Collaboration on surveillance and monitoring
8. Collaboration with and contribution to the work of other areas of WHO that address access to quality, safe, efficacious and affordable medical products, including but not limited to the supply and use of generic medical products, which should complement measures for the prevention and control of SF medical products.

Please see the A/MSM/12/10 ANNEX: List of prioritized activities to implement the work plan of the Member State mechanism for 2024-2025. As needed, working groups are established to progress the prioritized activities.