The World Health Organization has not completed negotiations with companies on a formula for contribute toward the new WHO framework for pandemic influenza. But companies are paying to access the virus anyway.

In its meeting this week, the WHO Executive Board has addressed a range of issues such as pandemic influenza, but so far it has delayed discussion on another contentious topic: substandard/counterfeit medical products.

The 132nd WHO Executive Board meeting is taking place from 21-29 January (IPW, WHO, 21 January 2013). All Executive Board documents are here.

On the issue of the Pandemic Influenza Preparedness (PIP) Framework, Executive Board members on the evening of 24 January discussed and took note of the report (EB132/16) from the PIP advisory group.

WHO’s Keiji Fukuda said the negotiations on industry payment methodology are “heavy discussions” involving CEOs and legal entities. He said a “lot of headway” was made in 2012, including with vaccines makers and biotech companies, but as they did not conclude by year’s end, contributions commenced based on market share without a methodology in place.

Chan said industry said it wanted to start paying now and work out the methodology later, and she was advised to accept. Discussions on methodology are continuing. Chan also said the key to the PIP is “transparency and speed.”

The PIP advisory group met in October, and discussions are being held with pharmaceutical industry representatives, civil society members, and other stakeholders to move toward a recommendation on the formula for partnership contributions to determine payment modalities for influenza virus sharing.

The group report said negotiations to sign the standard material transfer agreement 2 (SMTA 2) – a contract that allows the sharing of viruses with entities outside of the traditional WHO system – were being held with as many as six large influenza manufacturers. This week, the WHO announced a deal with GlaxoSmithKline for the first SMTA 2. WHO is seeking legal support from members to help with these agreements.

Ties are being made between fighting future pandemic flu, like the bird or so-called “swine” flu of recent years, and seasonal vaccines. Seasonal vaccine production has increased from 350 million doses in 2006 to about 900 million doses in 2009, with estimates of capacity in 2011 of about 1.4 billion million doses, the report said. Some countries on 24 January called for accelerated manufacturing capacity in developing countries.

Several countries asked for more detail on capacity building efforts, such as regional production, and doses and tracking of contributions, who benefits and what funds are used for. A developing country supported recommendations of the advisory group relating to recipients outside the existing WHO network, and emphasised the importance of predictability.

A representative of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said US$18 million in contributions have been made by its members to the PIP Framework, and called for a consultative approach. A representative of Medicus Mundi called for better transparency, including on participants in the negotiations with the private sector, and urged assurance that companies getting access to the materials would not be able to appropriate them and not share.

Developing countries have frequently expressed concern that if they share their virus strains with the WHO network, they may not benefit from any resulting treatments that are developed, or may be forced to pay high prices for them if a northern company gets a patent.

Fake Medicines Debate Postponed

The contentious (and hard to pronounce) issue of “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” (SSFFC) came up on Friday but was quickly requested by Australia and the United States to be put off to Monday. No reason was given, but some sources said it is related to the selection of a chair for the process. The last meeting was chaired by a Nigerian ambassador, but a new chair is being chosen. According to the report of the last meeting, WHO regional groups were to agree on a chairperson by 15 January. Vice-chairs were also to be submitted by the regions by that date.

The Executive Board is expected to review the report (EB132/20) of the first meeting of the member state mechanism on SSFFC products, which met in Buenos Aires last November (IPW, WHO, 22 November 2012). The member state mechanism agreed on a plan to strengthen regulatory capacities and form a steering committee to monitor country compliance to the plan.

Too Much Earmarked Funding

In other developments during the week, Chan said that a key programme on international health regulations (IHRs) is going to be cut for lack of funding. The problem, she said, is that so much of WHO funding is earmarked by the donor for specific purposes, that WHO has no funds that can be moved to non-earmarked priorities. “It’s a catch-22,” she said. “Extremely important work, unfunded.”

Meanwhile, the United States delegate said of the IHRs that it is “hard to imagine a more important mandate for the WHO.” And in the United States’ opening statement to the week, it said, “Moving toward a more transparent budgeting system does not mean that Member States should begin to micro-manage the organization. We must give the DG the authority to use WHO’s resources to undertake the work we have set out in the GPW [General Program of Work], and the discretion to make changes to budgets when needed.”

Sources and earmarking of funding is a key issue in the debates over the future independence of the WHO (IPW, WHO, 25 January 2013).