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    UNITAID Drug Patent Pool Implementation Hinges On Board

    Published on 11 December 2009 @ 3:27 pm

    By , Intellectual Property Watch

    Implementation of a United Nations-related patent pool initiative that independent reviewers say could save millions of lives (and dollars) is set to be approved next week by the initiative’s board, though some observers fear resistance from strong patent beneficiaries, such as the foundation run by Microsoft founder Bill Gates. A confidential report on the initiative prepared for board approval is expected to show multiple benefits to implementation of the pool, but also some concerns, according to informed sources.

    The patent pool was agreed to by the UNITAID Executive Board in July 2008, and in May 2009 the secretariat was asked to draft an implementation plan by the next board meeting, to be held on 14-15 December.

    Adoption of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which governs on trade in patent-protected goods such as brand-name pharmaceuticals, has had an impact on the accessibility of affordable medicines in developing countries. In some cases, patents on medicines lead to higher prices and a limit on the market for lower-priced generics. The 2001 WTO Declaration on TRIPS and Public Health clarified that governments have the sovereign right under TRIPS to use flexibilities in IP rights if they deem it necessary, such as for public health reasons.

    Implementation of the patent pool is expected to improve supplies, generics availability and drug formulations, as well as reduce licensing costs and increase certainty, according to sources. It is anticipated that patent-holders would be compensated. They also would receive a boost to the public reputation of the pharmaceutical industry, which has been lacking in recent years.

    The implementation plan would create a way to make the pool interesting for all sides, and will provide a licensing capability, working with patent owners and generics manufacturers, and specifying which countries are included in the licences. It is expected to address oversight and governance, as well as expertise.

    Médecins Sans Frontières (Doctors Without Borders) issued a statement this week raising concern that “a number of pharmaceutical companies are seeking to exclude developing countries categorised as “middle-income” from benefiting from medicines made under licence from the pool.”

    “If they are successful,” they said, “people living with HIV/AIDS will be made to pay the price.” An MSF pharmacist in Brazil was quoted as saying in that country, one newer drug, atazanavir, “is so expensive that it is eating up most of the government’s budget for AIDS medicines.”

    MSF said it conducted a campaign that led to 280,000 letters being sent to pharmaceutical companies asking them to put their patents into the pool. MSF received responses from nine out of 10 of the companies targeted, and all confirmed they were in discussions with UNITAID. Several companies made positive statements but some said they wish to exclude middle-income countries.

    UNITAID Board

    The UNITAID Executive Board, which makes all organisation decisions and does so by consensus, consists of 11 members: One nominated from each of the five founding countries (Brazil, Chile, France, Norway and the United Kingdom); one from African countries designated by the African Union; one from Asian countries; two from relevant civil society networks (non-governmental organisations and communities living with HIV/AIDS, malaria or tuberculosis); one from the “constituency of foundations”; and one from the World Health Organization. The board is chaired by Dr. Philippe Douste-Blazy, former minister of foreign affairs for France, and the special adviser on innovative financing for development.

    The foundations constituency is represented by the Gates Foundation, which is now governed by Bill Gates himself, having moved over from Microsoft, a company that has long worked influentially in global policymaking to promote strong intellectual property rights. The vast majority of global IP rights are held in a relatively small number of developed economies.

    Douste-Blazy this week issued a statement on the patent pool, stating that the implementation plan fulfils UNITAID’s mission to scale up access to medicines for developing countries. He said that in developing the plan, “UNITAID has consulted widely with a variety of stakeholders, spanning from communities living with the disease to public health and intellectual property experts and pharmaceutical companies.”

    Douste-Blazy sought to assure stakeholders that, in keeping with UNITAID’s constitution, “the patent pool in no way means to replace or override other provisions” contained in the TRIPS Agreement or the Doha Declaration.

    “The patent pool represents an additional tool to increase access to HIV treatment, and an opportunity for patent holders to voluntarily contribute to the attainment of crucial health-related goals endorsed by the international community,” he said.

    But UNITAID’s plan to enable both low- and middle-income countries to benefit from the patent pool might run into some industry resistance as they have fought to discourage the use of compulsory licences in larger developing countries like Thailand or Brazil, where they fear it will undermine markets. Still, Douste-Blazy points out that the organisation’s mandate is “to ensure that medicines are made available according to public health needs, and particularly in countries where the disease is widespread,” and that includes some larger economies.

    Letters of Support for Patent Pool

    Major foundations using private-sector-derived funds to support public health needs have typically been cautious not to push an overt private-sector agenda. But a movement has arisen to guard against any slippage in that neutrality in the case of the patent pool.

    Several letters are circulating on the issue, at least two posted on the ip-health listserv. One letter is addressed directly to the UNITAID board foundations constituency representative, Joe Cerrell, director of global health policy & advocacy at The Bill & Melinda Gates Foundation in Seattle, Washington (US), as well as Todd Summers, the alternate foundations representative.

    Letter signatories include several African groups, Health GAP Global Access Project, and the MSF Campaign for Access to Essential Medicines. Additional signatures were being solicited at unitaidpatentpool@gmail.com.

    The letter strongly supports the patent pool implementation plan, as it will: “allow greater access to affordable HIV medicines of assured quality via promotion of robust competition by generic producers selling in aggregated developing country markets”; provide multiple supply sources; and “incentivise the creation of rational fixed-dose combinations, paediatric formulations, and improved heat-stable and delayed-release formulations that are desperately needed in developing country contexts.”

    But it argues that these benefits will be undermined if all developing countries in need are not eligible. They urged the foundations constituency to support it.

    A second, similar but longer letter from the People’s Health Network, an international NGO network in 80 countries, detailed concerns about negotiations to include larger developing countries, preventing unfair extensions of patents, protecting use of compulsory licences and other tools available under TRIPS, and governance of the patent pool.

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

     

    Comments

    1. Joseph Munyi says:

      The feeling of most people living with hiv is that the drugs they are taking need to be improved to reduce serious side effects which sometimes is killing the clients.Diagnosis especially for extra-pulmonary T.B. is critical for PLWH to reduce the death from T.B.We support the patent pool initiative and will continue to do so.Africa is highly affected with hiv related deaths and the pool will reduce these deaths and make affordable medication to more needy persons.

    2. Jay Purcell says:

      UC Berkeley Law School hosted a workshop on UNITAID’s proposals, on November 6, 2009. The website contains presentations from UNITAID, Gilead, MSF, and others. Video will be posted shortly.

    3. Intellectual Property Watch » Blog Archive » Civil Society, Elected Officials Rally Behind UNITAID Patent Pool says:

      [...] Amid DifficultiesIf we’ve got all the answers already, then there’s… »Jay Purcell on UNITAID Drug Patent Pool Implementation Hinges On BoardUC Berkeley Law School hosted a workshop on UNITAI… »Rev. Edward Massey on Confidential [...]


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    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.

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