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    WHO Experts To Narrow Health R&D Projects For Developing Countries At December Meeting

    Published on 6 November 2013 @ 7:41 pm

    By , Intellectual Property Watch

    Years-old efforts by members of the World Health Organization to come up with viable ways to boost research and development of medical products for diseases primarily affecting poor populations are coming to head, with a key meeting in December. That meeting of experts will be an opportunity to narrow down proposals being developed by the six WHO regional offices.

    The annual World Health Assembly last May adopted a “decision” directing the WHO to consult with regions – with engagement of stakeholders – to identify “demonstration projects” showing details of how proposed ideas might work.

    The WHO has been implementing that decision, according to Zafar Mirza, coordinator of the WHO Department of Public Health, Innovation and Intellectual Property, and all six regional offices have held or are holding consultations.

    More information on the demonstration project process is available on the WHO PHI website here.

    The WHO headquarters will not receive any proposals except from the regional offices, Mirza said. The deadline to do so is this week, and information about the proposed projects will be available on the PHI website after 15 November, he said.

    The effort to set up demonstration projects follows an earlier agreed resolution containing three areas of action. The other two actions were to establish a global health R&D observatory, and to develop norms and standards to better collect data on health R&D. A progress report has been prepared on these other two areas and is part of the overall discussion.

    Decision by Experts

    On the demonstration projects, WHO has instructed regional offices not to send more than four projects for each region. These 24 total proposals will be assessed and reduced down by a group of experts in December.

    The meeting will be held at WHO on 3-5 December to “help us select a ‘few’ projects,” Mirza said, referring to the language of the May decision. Mirza said this is understood to mean between two and 10 projects, with a target of maybe six.

    The December meeting will consist of experts invited by the WHO director general in consultation with regional offices. In choosing the experts, the secretariat is trying to strike a balance based on regions, expertise and other criteria. Some regions have recommended names, he said. The experts will adopt a methodology for deciding which proposals to choose.

    The first two days of the meeting will be open to member states as observers, Mirza said. The final day will likely involve a meeting of member states with experts sitting in and invited to brief member states on the proposals. It was not clear how other stakeholders will participate in the meeting.

    On to EB, WHA

    A report will be prepared on the December meeting outcome and sent to the WHO Executive Board meeting in January. The Board could adopt, reject or suggest changes to the report.

    Then the report goes to the World Health Assembly (WHA) in May. If the Board suggests changes, the work would be done before the Assembly.

    If the WHA approves, those projects will be agreed and implemented by the WHO.

    Background

    The R&D financing issue has a long history at WHO, where it has been the subject of tough negotiations. Members generally agree that there is a market failure in which the financial incentive for companies to invest in research on neglected diseases is lacking. But they have spent years in disagreement over how to solve it.

    The 2012 WHA welcomed a report from the Consultative Expert Working Group (CEWG) and said consultations were needed. A November 2012 meeting led to key recommendations of the group, such as for an R&D treaty, being stripped from the list of possible approaches. Members in the deep of night in the November meeting agreed to a draft resolution that included a strategic workplan for taking forward the CEWG recommendations.

    The CEWG resolution contains three areas of action: establishing a global health R&D observatory; setting up demonstration projects; and developing norms and standards to better collect data on health R&D. The May decision point focusses on advancing the demonstration projects.

    The resolution requires reporting to the 2014 Executive Board in January. A core element of the process is to identify ways to finance R&D into neglected diseases, those predominantly affecting poor populations, for which there is little commercial market.

    “We are trying to understand what others have done in this area,” said Mirza, adding that a meeting with stakeholders was held earlier this year.

    WHO is looking at what different international organisations, agencies and others have been doing on issues such as tracking of financial flows and pipelines for R&D.

    “We are trying to develop a vision,” he said.

    Regional Group Meetings

    The six regions have been holding their meetings, many in the past week or so. The results of the meetings will be posted by WHO on 15 November.

    The Pan-American Health Organization already reported the results of its 22-23 October meeting at its headquarters in Washington, DC. The negotiations led to agreement on four proposals, with several alternatives included. As reported, they are:

    “1. Chagas R & D Accelerator Initiative: a coordination mechanism for accelerating the development of new health tools for Chagas diseases
    2. Development of a vaccine against schistosomiasis based on the recombinant SM14 a member of the fatty acid binding protein: controlling transmission of a disease of poverty
    3. Ecosystem for Financing Development of an Open Source Multiplex Point of Care (POC) Diagnostic Test for the Differential Diagnosis of Fever or Sepsis, Henceforward, this will be referred to as the Open Source Fever Diagnostic Project)
    4. Development of a Class D CPG ODN (D35 as an adjunct to chemotherapy for cutaneous leishmaniasis and post Kala-Azar Dermal Leishmaniasis (PKDL)

    *Alternative projects (in order of priority)*

    5. Affordable Diagnostic Tests for Cancer
    6. Accelerating Innovation and Access to Medicines for Tuberculosis Through Open Collaboration: A Push, Pull, Pool Approach (“The 3 p Project”)
    7. Establishment of Public-Private Partnership for the Development of a Diagnostic Kit for Prenatal and Postpartum)”

     

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

     

    Comments

    1. Medical R&D Projects Proposed By WHO Regions Show Diversity | Intellectual Property Watch says:

      […] The December meeting is the next step in a long process at the WHO to address the problem (IPW, WHO, 6 November 2013). […]


    Leave a Reply

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

    6. You understand and agree that the discussion forums are to be used only for non-commercial purposes. You may not solicit funds, promote commercial entities or otherwise engage in commercial activity in our discussion forums.

    7. You acknowledge and agree that you use and/or rely on any information obtained through the discussion forums at your own risk.

    8. For any content that you post, you hereby grant to IP Watch the royalty-free, irrevocable, perpetual, exclusive and fully sub-licensable license to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform and display such content in whole or in part, world-wide and to incorporate it in other works, in any form, media or technology now known or later developed.

    9. These terms and your posts and contributions shall be governed and interpreted in accordance with the laws of Switzerland (without giving effect to conflict of laws principles thereof) and any dispute exclusively settled by the Courts of the Canton of Geneva.

     

     
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