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.
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
- 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.
- To strengthen national and regional capacities
in order to ensure the integrity of the supply chain.
- To exchange experiences, lessons learnt, best
practices and information on ongoing activities at National, Regional and
Global activities.
- 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.
- To strengthen regulatory capacity and quality
control laboratories at National and Regional levels, in particular for
developing countries and least developed countries.
- 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.
- 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.
- To promote cooperation and collaboration on
surveillance and monitoring of SF medical products.
- 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
|
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:
- Strengthening and capacity building of
national and regional regulatory authorities and quality control
laboratories
- 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.
- Communication,
education and awareness raising
- 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.
- Identify actions, activities and behaviours
that result in SF medical products.
- Strengthen national and regional capacities in
order to ensure the integrity of the supply chain
- Collaboration
on surveillance and monitoring
- 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.
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:
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.
·
· Recommendations
for health authorities to detect and deal with actions, activities and
behaviours that result in SF medical products.
·
· 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
·
· Create
a focal point network for the exchange of information and consultation at large
among Member States and establish an ongoing virtual exchange forum
·
· 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
·
·
· 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
·
· 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
·
· working
definitions