WHO Board Plan For Fake Medicines Mechanism Excludes Trade And IP

The World Health Organization Executive Board this week agreed to propose to the May World Health Assembly the establishment of a mechanism for international collaboration on counterfeit and substandard medical products, but with the exclusion of trade and intellectual property issues.

The Executive Board resolution would “establish a new Member State mechanism for international collaboration among Member States, from a public health perspective, excluding trade and intellectual property considerations, regarding “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” in accordance with the goals, objectives and terms of reference annexed to the present resolution.”

The next Assembly in May will decide on this resolution. The mechanism would be reviewed by the World Health Assembly after three years, and will submit a progress report after one year.

The Executive Board resolution on “substandard/spurious/falsely-labelled/falsified/counterfeit medical products,” EB130.R13, is available here [pdf].

Documents from 130th Executive Board meeting, held from 16-23 January, are available here.

The resolution as proposed by the board has only one modification from the earlier draft version from the Working Group of Member States on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, as established by decision WHA63(10) from 2010.

The draft version urged member states to: “participate in and collaborate with the Member State mechanism referred to in operative paragraph 4” (which establishes the new member state mechanism). The Board added at the start of the sentence, “on a voluntary basis.” This was suggested by China, according to participants.

Other elements of the resolution include a statement of the role of WHO in these issues, which is: “ensuring the quality, safety and efficacy of medical products; in promoting access to affordable, quality, safe and efficacious medicines; and in supporting national drug regulatory authorities in this area, in particular in developing countries and least-developed countries.”

It also declares that WHO should “continue to focus on and intensify its measures to make medical products more affordable, strengthening national regulatory authorities and health systems which includes national medicine policies, health risk management systems, sustainable financing, human resource development and reliable procurement and supply systems; and to enhance and support work on prequalification and promotion of generics, and efforts in rational selection and use of medical products. In each of these areas, WHO’s function should be: information sharing and awareness creation; norms and standards and technical assistance to countries on country situation assessment; national policy development; and capacity building, supporting product development and domestic production.”

And it calls on WHO to increase its efforts to support members in “strengthening national and regional regulatory infrastructure and capacity.”

A contentious issue around counterfeits has been the suspicion on the part of some developing countries that concerns about counterfeit and substandard medicines are being purposely confused with trade in legitimate generic medicines from those countries. Removing intellectual property and trade from WHO discussions likely minimises the possibility of confusion.

Participants said a lack of agreement persisted during the Executive Board meeting over definitions and the WHO’s involvement in the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).

Meetings of the new mechanism would normally take place in Geneva, but could be held elsewhere. Argentina offered to host the first meeting after the WHA, according to participants. Regional groups will provide input as appropriate, according to the resolution.

The resolution also places the provision of financial resources on member states.

The report on the financial and administrative implications of this resolution, document EB130/122 Add.1, show that over three years (2012-2015) it would cost between US$ 3.56 million and US$4.84 million. This includes staff costs of $2.72- $4 million, and activities of $840,000. This would assume only one annual meeting of the mechanism. These costs were not within the approved 2012-2013 budget, and could not be implemented by existing staff. It would require two professional staff and one general services staff member.

For 2012-2013, funds of $2.37-$3.23 million would be needed from voluntary contributions from interested governments, as it may not fit with donors, the analysis said.

The working group agreed in October on the new mechanism (IPW, WHO, 1 November 2011).