WHO Member State Mechanism - The World Health Assembly resolution 65.19

In 2012 the World Health Assembly established the Member State Mechanism to address the issue of SSFFC medical products.

This resolution renewed and re-established a mandate for WHO and the Member States in tackling SSFFC 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.

·         Official documentation of Member State mechanism

General Goal

In order to protect public health and promote access to affordable, safe, efficacious, and quality medical products, promote through effective collaboration among 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 Chair supported by 11 vice chairs, representing the six regions of the WHO.

The Chair rotates amongst the Regions on an alphabetical basis and is held for a period of 12 months commencing immediately after the World Health Assembly. Vice chairs retain their position for 3 years.

Chairs

2012-2014 – African Region – Dr Paul Orhii, Nigeria

2014-2015 – Region of the Americas – Ambassador A.P.D’alotto, Argentina

2015-2016 – Eastern Mediterranean Region – Deputy Minister Dr. R. Dinarvand - Islamic Republic of Iran

2017-2018 – European Region – Dr Belén Escribano Romero, Spain

Current Vice Chairs

AFRO	AMRO	EMRO	EURO	SEARO	WPRO
Togo	Brazil	Islamic Republic of Iran	Spain	India	People’s Republic of China
United Republic of Tanzania	United States of America	Morocco	United Kingdom of Great Britain and Northern Ireland	Indonesia	Malaysia

·         Member State Mechanism Governing Bodies

Work Plan, Prioritized Activities and Working Groups

A detailed work plan has been agreed by Member States and 6 specific areas 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 behaviours 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.

·         Member State Mechanism work plan

Annex 2

The Member States have identified a number of key areas for prioritization and Member States and the Secretariat have volunteered to lead the activities:

·         Member state mechanism for prioritized activities
Annex 3

A number of working groups have been established to progress the prioritized activities, some meet face to face and others work virtually circulating draft documents for comment before discussion and approval by the full Member State Mechanism.

·         Identify actions, activities and behaviours that result in SF medical products.

·         Actions, activities and behaviours that result in SF medical products
pdf, 96kb

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·         Recommendations for health authorities to detect and deal with actions, activities and behaviours that result in SF medical products.

·         Recommendations for health authorities to detect and deal with actions, activities and behaviours that results in SF medical products
pdf, 211kb

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·         Develop recommendations for the Health Authorities engaged in the detection of SF medical products and establish a strengthening and tool-generating programme to contribute to Member States’ training

·         Guidance on developing a national plan for preventing, detecting and responding to actions, activities and behaviours that result in SF medical products
pdf, 111kb

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·         Create a focal point network for the exchange of information and consultation at large among Member States and establish an ongoing virtual exchange forum

·         Terms of reference for the Global Focal Point Network for SF medical products
pdf, 196kb

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·         Establish a working group to survey the technologies, methodologies and “track and trace” models in place and to be developed to analyse their advantages and disadvantages and to survey the available authentication and detection technologies and methodologies and analyse their advantages and disadvantages

·         Existing technologies and “track and trace” models in use and to be developed by member states
pdf, 576kb

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·         Available authentication technologies for the prevention and detection of SF medical products
pdf, 864kb

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·         Identify WHO areas working on the issue of access to quality, safe, efficacious and affordable medical products and request a report on the current state of affairs

·         Create a working group to develop and leverage existing recommendations for effective risk communication and recommendations for awareness campaigns on SF medical products and related actions, activities and behaviours

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·         A proposal for a study on the public health and socio-economic impact to SF medical products

·         Governance, management and secretariat costs to support the above activities

·         Modalities and budget implications of a Member State Mechanism working group of experts on refining the SF working definitions, and an update on existing

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·         working definitions

·         Working definitions
pdf, 198kb

http://www.who.int/medicines/regulation/ssffc/mechanism/en/

Republicado por:RM Consult