6.13 Substandard/spurious/falsely-labelled/falsified/counterfeit medical products: report of the Working Group of Member States

Secretariat note 

A second meeting of the Working Group of Member States on Substandard/Spurious/Falsely- Labelled/Falsified/Counterfeit Medical Products was held 25–28 October 2011 in order for the Working Group to complete its work. The report contains specific recommendations by the Working Group for the consideration of the Board and the Sixty-fifth World Health Assembly in line with decisions WHA63(10) and WHA64(10).

Watchers' notes of EB discussion

Substandard/spurious/falsely-labelled/falsified/counterfeit medical products: report of the Working Group of Member States (EB 130/22, EB 130/22 Add.1)

Under this important Agenda Item, EB Members have agreed to the new “Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products” proposed in document EB130/22.

Several developing countries, however, quite strongly pointed out that the mechanism failed to address the WHO’s relationship with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).

On the other hand, interventions by developed countries, such as Canada, Japan, Switzerland and the US, encouraged the involvement of other “stakeholders”, including the private sector, and somehow necessitated and legitimised the existence of IMPACT until the mechanism is put in place.

Argentina announced will host the first conference on SSFFC, and invited all Member States to this meeting in Buenos Aires in October, saying that they bear the cost of the participation of delegates. Its proposal will be finalised by the 65th WHA in May.

Norway, among others who showed some reluctance to accept meeting outside Geneva, suggested that a preparatory meeting be held in Geneva prior to that in Buenos Aires.

The EB took note of the report with the proposed mechanism, and accordingly, a draft resolution will be submitted to the 65th WHA in May 2012 calling for the setting up of this mechanism, and for the WHO to increase its efforts in strengthening regulatory capacities in countries and regions where needed.

India said that IP enforcement should remain outside discussions on QSE (Quality, Safety and Efficacy) at the WHO, attributing the problem of compromised medicines to weak drug regulatory structures, and called for severing any links with IMPACT.

Nigeria, speaking on behalf of the African Region, acknowledged the fact that SSFFC medicines comprise a major public health challenge to the region. Nigeria encouraged the WHO’s work on medicines supply chain security, local production, capacity building, and multisectoral collaboration to ensure access to QSE medicines.

Mexico drew the attention of the EB to the fact that the report only refers to medicines, whereas there are other products on the market, which the media promotes as medical when they are not related to medicines at all. Mexico believed these products should be controlled as well.

Brazil, a non-EB Member, mentioned the emergence of anti-counterfeiting measures linked to TRIPS-plus standards and IP enforcement, giving the example of the Anti-Counterfeiting Trade Agreement (ACTA), and the 19 detentions by customs authorities of medicines in transit through the EU. On IMPACT, Brazil strongly believed that this essential aspect of the deliberations cannot be left unresolved in the proposed mechanism.

Iran, also a non-EB Member, expressed its “deep concern” regarding the lack of finances in the area of QSE at WHO. Bangladesh and Thailand as well were concerned about the mechanism not addressing WHO’s relationship with IMPACT.

The WHO Secretariat responded to queries and concerns by MS, particularly on limited finances directed to QSE work, saying that it would be difficult to mobilise extra budgetary resources for what is considered core work of the WHO.