WHO working group drafts resolution on SSFFC medicines

Last week's meeting of the World Health Organization's working group on low-quality and illegal medicines ended with the drawing up of a draft resolution for debate at the World Health Assembly in May 2012.

The draft document - which can be viewed here - backs the WHO's role in ensuring the public's access to safe, effective and affordable medicines of acceptable quality, but indicates that the agency should take something of a back seat on the topic of what have become known as substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products.

Last year, the WHO agreed to set up the intergovernmental working group after months of controversy in which it was accused of being overly influenced by the intellectual property interests of the branded pharmaceutical industry. As a result, it was argued, the trade in legitimate generic drugs of assured quality was coming under threat and access to drugs was being compromised in less developed countries.  

Rather, the resolution calls for the creation of a new 'mechanism' for international collaboration among World Health Assembly member states on the topic of SSFFCs "from a public health perspective [and] excluding trade and intellectual property considerations." The mechanism would be reviewed after three years of operation.

WHO would continue to play a role via its current activities, such as information sharing and awareness creation, setting of standards and providing technical and policy assistance to national governments. The new mechanism would also make use of "existing WHO structures," according to the document.

It would also draw on expert advice and collaborate with the International Conference of Drug Regulatory Authorities (ICDRA) and other stakeholders, according to a report on the working group meeting, which was chaired by Zambian Ambassador Darlington Mwape.

The member state mechanism would identify major needs and challenges in the area of SSFFCs, make policy recommendations and develop tools for prevention, detection and control of these products.

Sadly, there was no progress made on finding a solution to the disagreements on nomenclature which have left us saddled with SSFFC as a working catch-all term for poor-quality medicine, although tackling that issue of definition is among the objectives of the new member state body.

Other objectives include: strengthening national and regional capacities in order to ensure the integrity of the supply chain; exchange of information on national, regional and global initiatives; and boosting the regulatory capacity and quality control labs at national and regional levels. A complete (draft) list of goals and objectives for the new mechanism is available here.

WHO role in IMPACT not resolved

WHO's role in the multi-stakeholder International Medical Products Anti-Counterfeiting Taskforce (IMPACT) has been a source of considerable controversy in the last couple of years.

At one point WHO provided secretariat services to IMPACT, but has since distanced itself from the group by moving its offices away from WHO headquarters in Geneva to the premises of Italy's drug regulator AIFA.

Ahead of the working group meeting on October 25-28, a groups of non-governmental organisation (NGOs) sent an open letter addressed to the chairman taking issue with WHO's involvement in IMPACT, among other concerns (see NGOs petition WHO committee on SSFFCs).

The working group did not reach a consensus on WHO's role in IMPACT, but said the issue may become clearer at the 65th WHA in May 2012.