World Health Organization member governments have been working for several years to agree on ways to prevent the spread of dangerous and misleading substandard and fake medical products. Now, they seem to be moving in the direction of concrete action.
Members working on the issue have adopted a “non-exhaustive” list identifying “actions, activities and behaviours” that result in such products, according to a report of the second meeting of the so-called Member State Mechanism on Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit Medical Products, which took place on 28-29 November.
They also have a workplan on these issues, and have drafted a budget of nearly US$13 million to carry the range of workplan objectives.
These WHO efforts come in the context of other recent initiatives, including one announced this week at the UN Office of Drug Control tying counterfeiting to organised crime (IPW, Public Health, 14 January 2014), and an industry-government-international organisation initiative called “Fight the Fakes” (IPW, Public Health, 26 November 2013). There also is an initiative on a medicines quality database highlighted [pdf] in the January edition of the WHO Bulletin.
WHO Report
The WHO director general’s office has submitted its report on SSFFC – as the issue is called at WHO – to the Executive Board, which will meet from 20-25 January.
The WHO report includes: the November meeting report; the actions, activities and behaviours list; the workplan; and the budget. The Board document on SSFFC dated 3 January is numbered EB134/25. Documents for the 134th Executive Board are here.
The list of actions contains 11 activities that can lead to poor quality or fake products. Examples are manufacturing products in unauthorised establishments, changing packaging or extending expiration dates, substituting contents, and any aspect of distribution without compliance to regulations.
The aim of the list is to ensure that only medical products meeting national or regional regulatory requirements are manufactured, imported, distributed and supplied.
The workplan contains eight multi-layered actions, including: strengthening regulatory authorities and quality control laboratories and increasing their collaboration; awareness-raising; transparent consultation with stakeholders; boosting of the supply chain; and collaboration on surveillance and monitoring.
It also calls for work with 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 SSFFC medical products.”
Argentina and India, which made additional proposals, are going to lead technical discussions on their proposals on an electronic platform hosted by the WHO secretariat, according to the report from the November Member State Mechanism meeting.
The report says that consideration was given to a proposal from Argentina that would develop recommendations for health authorities to “detect and deal with” activities that lead to SSFFC products.
And a proposal by India was considered that addressed activities that fall outside the mandate of the mechanism.
Funding Gap
The November meeting also endorsed the budget, after being “highly concerned by the funding gap at this stage.” They “strongly” recommended the Executive Board request the director general to give a comprehensive update to the May World Health Assembly on the financing of the workplan, and encourage member states and other WHO donors to consider funding the workplan.
The budget lays out estimated costs for each of the 8 objectives, ranging from less than $1 million to about $3 million. But it says that currently, the initiative only has about $500,000 for each of 2014 and 2015, or about 10 percent of the overall budget.
Governance
On governance, a sticky issue in the past, it was agreed to continue a rotating chairmanship of the Mechanism and steering committee among the numerous vice-chairs. The November meeting was chaired by Nigeria, which will continue through the May 2014 World Health Assembly. Then the chair will be one of the vice-chairs from the Americas. According to a list in the report, there are representatives from Argentina and the United States from that region. Also, in meetings, vice-chairs will act on behalf of their governments rather than in their personal capacity.
Finally, the report refers to consideration by the mechanism of topics proposed for discussion by the Open-ended Working Group and the Steering Committee. These were on misleading advertising, corruption and conflict of interest, and lack of effective labelling.
Next SSFFC Group Meeting: October 2014
The WHO steering committee on the SSFFC issue was asked to prioritise proposals for implementation of the workplan, to be reviewed by the third meeting of the Member State Mechanism, which is planned for the week of 27 October 2014.
Background
The WHO Member State Mechanism on SSFFCs was established at the May 2012 World Health Assembly but started slowly. The mechanism is mandated to look at the problem from a health perspective, and not consider intellectual property or trade. The expert group held its first meeting in Buenos Aires in November 2012 and agreed on a roadmap (IPW, WHO, 22 November 2012), but disagreement over selection of a chair slowed progress. It was proposed by Brazil to have a rotating chair, which was accepted in a breakthrough at the May 2013 Assembly (IPW, WHO, 26 May 2013).
Source: Intellectual Property Watch