10.1 Substandard/ spurious/ falsely-labelled/ falsified/ counterfeit medical products

Notes by WHO Secretariat

The first meeting of the new Member State mechanism  for Substandard/spurious/falsely-labelled/falsified/ 

counterfeit medical products is scheduled to be held 19–21 November 2012, in Buenos Aires, Argentina. The 
Director-General will transmit the report of the meeting to the Board.

PHM's Comments

This is the report of the first meeting of the member state mechanism held 19-21 November in Argentina.

History – The Member state mechanism (hereafter MSM) was adopted by the WHA resolution 65.19in 2012 following the recommendation of the Working Group of Member States on Substandard/Spurious/Falsely-Labelled/ Falsified/Counterfeit Medical Products in 2011 (which itself was established by decision WHA63 in 2010).The MSM has 9 objectives.

PHM statement at 65TH WHA 2012:

“We welcome the establishment of a MS mechanism to address the issue of QSE of medical products, from a public health perspective, excluding trade and IP considerations…

With the establishment of this mechanism, it is time to dissociate WHO from IMPACT…PHM calls on MS to dissociate WHO from IMPACT; to properly fund the drug regulatory capacity building role of WHO at global, regional and country levels; and to resolve the financial crisis of WHO by increasing assessed contributions and converting tied donor funding to untied donations.

“We urge MS to properly fund WHO so it can carry out its proper role including building drug regulatory capacity at global, regional and country levels…. We urge MS to resolve the financial crisis of WHO by increasing assessed contributions and converting tied donor funding to untied donations”.


The first meeting of the SSFFC considered three reports by the WHO Secretariat on ‘mapping international organisations that are active in the field of SSFFC, options for the structure and governance of the member state mechanism and an overview of the current situation regarding SSFFC medical products’.   The Committee decided on the structure, governance, and funding of the mechanism.The meeting also decided to ‘establish an open-ended working group to identify the actions, activities and behaviours that result in SSFFC medical products’ (WHA65.19 OBJECTIVE 4). The mandate of this proposed group is estimated to be decided within 2 to 6 months of November 2012. The group have a work plan of 8 action areas relating to the 9 objectives in the MS resolution.


In 2013 WHO is still a member of IMPACT.

IMPACT has released this statement in response to the report of the Working Group in 2011 (2011): “IMPACT Planning Group members encourage WHO's and WHO member States' continued and essential involvement in these efforts…In this context, an international multi-stakeholder initiative like IMPACT remains essential to build coordinated efforts in order to protect public health against substandard and SFFC medical products".

Report of the EB discussion

Member States (MS) have agreed on the Chair and Vice Chair for the working group. MS expressed disappointment and regret for the slow progress made so far and supported the urgent need for the Steering Council to be set up before WHA66.  MS supported the Member State Mechanism (MSM) as a way of developing a shared understanding of the scale of the problem of SSFFC, sharing data collection and analysis, and exchanging information on lessons learnt. MS affirmed that SSFFC are a threat to public health. Australia also linked it to ‘global health security’ and anti-microbial resistance, as did the UK. MS called for countries to invest in regulatory capacity, technical support, and the provision of resources. Iran also called for the tracking of medical products from production to consumption.

The EU requested that the Steering Council work in a transparent manner and in coordination with regional offices. The UK argued that the Steering Committee should be open for MS concerns on the work of the mechanism. The EU also included the need to manage potential of conflicts of interests, as did Panama.

Lebanon emphasised ensuring affordable access to quality medical products through technology transfer and the promotion of generics, which was supported by India. Thailand, Brazil, India and Nigeria argued that the work must be public health oriented and should not be confused with IP enforcement.


Monaco identified itself as a candidate for the Steering Committee. It also requested that the cost of this be included in the programme budget 2014-2015. Brazil suggested renaming the MSM to “Mechanism of Buenos Aires”. Nigeria and India emphasised national efforts while India supported Brazil chairing the working group.

The Secretariat committed to provide as much assistance as possible and to do fundraising. The EB took note of the report and MS views.