WHO Board Approves Resolution On Neglected Diseases; Sets Action On Substandard Medicines

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The World Health Organization Executive Board today approved a modified resolution on neglected tropical diseases – after removing a reference to a working group on R&D for neglected diseases as “irrelevant”. The Board also discussed and took note of a report on poor quality medical products in the supply chain, and agreed to set another meeting on the issue before the May World Health Assembly, as well as set up a separate group on behaviours that lead to this problem.

For neglected tropical diseases (NTDs), those predominantly occurring in developing countries, the Board approved a draft resolution for the May Assembly.

The Board made some changes to the draft text before approving, notably removing a reference to the WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) report and recommendations, which came out last year. The effort to take that report forward in an open-ended meeting in November led to heated debate this week at the Executive Board meeting (IPW, WHO, 28 January 2013). The most recent available document, from 26 January, is available here [pdf].

Sources said Brazil, which along with Cuba had proposed the inclusion of the CEWG in the neglected tropical diseases resolution, agreed to remove it when it met with strong opposition from Europe and the United States.

However, a proposed reference to the WHO Strategy and Plan of Action on Public Health, Innovation and Intellectual Property was kept in. This is the initiative that led to the CEWG, so it could still be considered to include the CEWG report, a source said.

Meanwhile, Australia, the European Union, the United States and others were able to keep numerous proposed changes of their own to the draft document.

The resolution contains a range of recommendations for governments to take, including encouraging initiatives for the discovery and development of new diagnostics, medicines and numerous other means of addressing the problem.

It also calls for expanding and implementing the targets agreed in the 2012 London Declaration on Neglected Tropical Diseases, which included large-scale funder Bill Gates and others.

The sidelining in this neglected tropical disease (NTD) effort of simultaneous efforts to find ways to make medicines for neglected diseases more affordable, such as was the focus of the CEWG, was despairing to some.

A representative from Médecins Sans Frontières (MSF, Doctors without Borders), said afterward that it was not credible for the representative of the European Union to say the CEWG report has no relevance in the elimination and control of NTDs.

“It’s very clear we need additional tools, and better drugs and diagnostics to meet the challenges” of NTDs, the representative said. “It is an absurd position for the EU [to say] the report has no relevance where everyone agrees there are no incentives for the market to carry out R&D.”

The Public Health Side of Poor Quality Medical Products

On poor quality products, the Americas group represented by the United States called for another meeting before the annual World Health Assembly of the so-called member state mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products.

That mechanism held its first meeting in Buenos Aires from 19-21 November, and the Board today took note of the meeting report.

But final agreement on the mechanism was not reached in Buenos Aires, so another meeting is being planned, likely a one-day meeting just prior to the Assembly.

Also, a steering committee is to be set up, but negotiations were ongoing today as to who will be the chairperson.

And the November Buenos Aires meeting agreed to establish an open-ended working group to identify the actions, activities and behaviours the result in SSFFC medical products. Brazil has received support to chair the working group.

The Americas region statement urged the mechanism steering committee to “direct the chair of the open ended working group to begin organizing the work immediately with a view to completing this task within a two- to six- month time-frame. Work on this subject should not preclude the Mechanism from undertaking activities on other priority areas identified within the workplan.”

The member state mechanism, which Brazil today proposed be called the “Buenos Aires Mechanism,” is seen as an “opportunity to collaborate and find solutions together, including strengthening the integrity of the supply chain, understanding the trends and behaviors that contribute to SSFFCs and continuing to build regulatory capacity,” as stated by the US on behalf of the Americas region.

Brazil said the mechanism is inaugurating a “new method of work” within the WHO.

In the Board meeting today, several speakers reinforced the notion that this mechanism is focussed only on the public health perspective of SSFFC medical products, and not the intellectual property rights perspective. IP rights are inherent in the reference to counterfeit products, generally concerning a trademark violation where something is packaged as a known trademark but is not a legitimate product of the trademark owner. This is rather a trade issue for the World Trade Organization.

The WHO mechanism will make it possible to pursue public health policy objectives without linking it to intellectual property rights and enforcement, and differences between members will disappear as they focus on public health only, Brazil said. There has been concern in the past that brand-name pharmaceutical companies may have conflated counterfeit products with legitimate generic versions of their products as an anti-competitive action.

On public health concerns, Australia pointed to a potential problem of microbial resistance that can be caused by substandard medicines. By unknowingly taking medicines of varying strengths or not taking them effectively, people can develop resistance, the Australian delegate said.

Switzerland on behalf of the Euro region urged that work of the mechanism accelerate, and encouraged all members to send the appropriate experts to the working group on actions, activities and behaviours that result in SSFFC products. It called for an outcome of the group within two to six months. It further urged the swift setup of the steering committee, and that it work inclusively and transparently.

The European Union supported this statement and went further to give its vision for the mechanism for the next three years. This includes: develop an understanding on the scale of the problem; share information on methodologies, criteria and tools for data collection and analysis; and address supply chain integrity, control and monitoring. The EU also stressed that the mechanism be “health-led”.

India discussed its case, in which its drugs are exported to some 200 countries around the world with a wide range of production capabilities and an effective system of management and control for quality.

The United Kingdom supported the Euro region statement and said it hoped the committee would build trust on this issue. It said problem is a public health issue and that the WHO has a “legitimate and central role” in it.

Thailand called for a focus on strengthening national and regional capacity and collaboration.

NGO Medicus Mundi said work should be guided by evidence and scientific data, and should be transparent. Quality and affordability should go together, it said.

A WHO official told the Board it would help with fundraising for SSFFC work.

William New may be reached at wnew@ip-watch.ch.

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