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

The Assembly will consider Document A64/16, the report of the Working Group of Member States on Substandard/Spurious/FalselyLabelled/Falsified/Counterfeit Medical Products, established by decision WHA63(10), which met in Geneva from 28 February to 2 March 2011 (see Annex).  

The Working Group (i) seeks an extension of its deadline; (ii) recommends that the Secretariat continue to implement resolutions WHA41.16, WHA47.13 and WHA61.21 as these resolutions are not related to IMPACT; and (iii) recommends that the WHO ensure transparency and the avoidance of conflicts of interest.  

This has been a highly contested process, in part because of the efforts of some member states and big pharma to conflate the issue of substandard or fake medicines with generic medicines which are not licensed by IP owners.  It was also highly contest owing to the appointment to the Working Group of a person from a TNPC who had an apparent conflict of interest.

Further background is found at Third World Network (TWN) report, NGOs concerned of WHO's role in "counterfeit" drugs, IMPACT, SUNS #6924 dated 17 May 2010.

See the statement read by TWN at the 64th WHA on this item.

WHA Watch Comment

There is an urgent need to ensure access to medicines with quality, safety and efficacy (QSE);at an affordable price. The first step in this direction is to ensure availability of medicines at affordable price. This would eliminate the incentive for the business of QSE-compromised medicines. Towards this end Member States need to undertake various legal and policy measures. The role of WHO is to provide information and technical assistance to facilitate access to medicines. However, the performance of WHO in this respect has been far below expectation including pushing countries in the opposite direction especially through WHO 's work program to combat counterfeit medicines.
WHO's counterfeit work program and partnership on counterfeit known as International Medical Anticounterfeit Taskforce (IMPACT) are clear example of influence of pharmaceutical multi national corporations along with their host states. For almost 20 years this complex of vested interested groups has conflated quality, safety and efficacy issues with issues of intellectual property enforcement. This was made possible by using the term 'counterfeit' to describe QSE compromised medicines and hushing up the fact that the term counterfeit is a legal term with very specific meanings in the domain of trademark infringement. Thus WHO has promoted IP enforcement measures instead of addressing the root causes for the circulation of QSE compromised medicines such as high prices and lack of effective national regulation. There is an urgent need to reconsider the continuance of WHO's work program on counterfeit medicines.
We urge the Member States to demand the disengagement of WHO from IMPACT, which has not been approved by any governing body of WHO. Member States should also reject WHO's suggestion of replacing the term counterfeit with falsified medicines without changing the approach.


counterfeits_TWN statement_WHA64.pdf28.6 KB