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Ten Questions About Internet Governance

On April 23 in Sao Paulo, Brazil, the “Global Multistakeholder Meeting on the Future of Internet Governance,” also known as “NETmundial” in an allusion to the global football event that will occur later in that country, will be convened. Juan Alfonso Fernández González of the Cuban Communications Ministry and a veteran of the UN internet governance meetings, raises 10 questions that need to be answered at NETmundial.


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    WHO Members Near Deal On Framework For Influenza Pandemics

    Published on 15 April 2011 @ 11:37 pm

    By , Intellectual Property Watch

    World Health Organization members trying this week to agree on elements of a framework for helping the world address the next influenza pandemic headed into the final night of the meeting in intensive negotiations. At press time, negotiations were focused on specifics of standard agreements for the transfer of genetic materials related to flu virus strains.

    The last influenza pandemic, H1N1 (the so-called swine flu), left a bitter taste for some developing countries unable to access or afford the needed vaccines for their populations, including the country that provided the virus strain. Intellectual property was one focus of the discussions this week, getting in the way of agreement on text, but the issue appeared to be heading toward resolution on the last day. Diplomats were still negotiating on Friday evening to try to clean up language on the framework and provide a consensus text.

    The WHO Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits (OEWG/PIP) met from 11-15 April.

    The working group was aiming at providing a consensus framework to the 64th World Health Assembly (WHA), taking place from 16-24 May.

    Discussions this week focussed on the standard material transfer agreements (SMTAs), which are contractual documents describing the condition of virus sharing between parties. Two kinds of SMTAs were discussed. The first one concerned sharing of viruses within the WHO Global Influenza Surveillance Network (SMTA 1), and the second dealt with the sharing of viruses outside this network (SMTA 2).

    Numerous documents were issued during the week, many obtained by Intellectual Property Watch.

    Intellectual property issues were at the core of the discussions, with developing countries considering IP rights as a barrier to vaccines access mainly because of associated high prices, and developed countries considering that IP rights stimulate innovation and research, according to sources.

    The last World Health Assembly (May 2010) asked the WHO to provide technical studies to help members of the open-ended working group reach a final agreement on the framework. In the last version of the document [pdf], published on 4 April, the section on IP concluded that “there are no significant patent barriers to the manufacture of any of the marketed types of influenza vaccines.” The document says that although some patents protect specific processes or products, “for each of the types of marketed vaccines, there is a sufficient freedom to operate to permit manufacturers in developing and emerging economies to make the vaccine of their choice.”

    For future vaccines based on new technologies, the document said, “there are potential IP barriers, however it is not known which, if any, of those technologies could make marketable vaccines that could be sustainably produced.”

    In the current situation, under the WHO surveillance network, national influenza centres located in a number of countries around the world collect samples from patients “with influenza-like illness,” according to the WHO website. The samples are shared with WHO Collaborating Centres for influenza (CCs), located mostly in developed countries: Australia, China, Japan, the United Kingdom, and two in the United States. Those CCs perform analyses of samples received from the national influenza centres to determine if current vaccines “answer” the new epidemic strains. The CCs also maintain repositories of different virus strains.

    SMTA 1 concerns the laboratories that have been “designated or recognized by WHO and have accepted to work under agreed WHO terms of reference,” according to a draft document [pdf] issued late on 14 April, and obtained by Intellectual Property Watch. In Article 6 of this SMTA, which is meant for members of the WHO surveillance network, “neither the provider, nor the recipient should seek to obtain any intellectual property rights on Pandemic Influenza Preparedness biological materials.” However, paragraph 6.2 says that “the provider and the recipient acknowledge that any intellectual property rights existing as of the date of adoption of the framework by the WHA will not be affected” by the SMTA.

    A number of versions of SMTA 2 were circulated for discussion this week. In the version published on 14 April [pdf], the recipient of an influenza virus should comply with a number of obligations. Entities not holding IP rights on technology for essential production of influenza vaccines, adjuvants, antivirals and/or diagnostics, would have to choose from a list of options what they would give in exchange for the virus.

    Entities holding IP rights on essential technology for pandemic preparedness and response have the same obligations but mandatorily have to choose one option relating to IP rights. They could choose either option 5, granting developing country licences with affordable royalties, or option 6 on granting royalty-free licences or waiving royalties under licence agreements.

    This version of SMTA 2 was still heavily bracketed. Forcing industry to take an option on IP rights was a problem for some developed countries, a developed country source told Intellectual Property Watch. They would like to be able to choose two options that would not be IP-related, with other options to choose from, such as donations of medical devices, or capacity building for laboratories, production or surveillance.

    Early on 15 April, a new version of the SMTA 2 [pdf] was circulated with new language in Article 4 on “obligations of the recipient,” that did not force IP rights holder to choose benefit sharing in the form of an IP-related option.

    According to several sources, as of the evening of 15 April, it appeared that consensus might have been found on the IP-related language of SMTA 2, but one country still insisted that SMTA 2 retain the obligation for industry to pick one IP-related option, according to a source.

    SMTAs were important to the negotiation, in particular for developing countries, because SMTAs would provide contractual obligations in the framework, a developing country delegate told Intellectual Property Watch. SMTAs would bring more certainty to the process, he said.

    Another issue being discussed this week is the benefit sharing aspect of the framework.

    In a draft text [pdf] issued by the co-chairs on 13 April, pharmaceutical manufactures using the WHO network system would pay an annual partnership contribution, from 2012. The total of all annual contributions would be 50 percent of the running cost of the WHO network, according to the text.

    According to the document, the contribution would be “guided” by an advisory group composed of a number of members to be determined, and the WHO director general would “determine the use of the contributions.” A small working group was set up to discuss the governance and review of the advisory group and presented a document to the meeting plenary on 12 April.

    Accusation of Profit-Seeking over Public Health

    There has been some concern about the objectives of governments in the negotiations.

    Sangeeta Shashikant, legal advisor for Third World Network, said, “This week the developed countries, in particular the US, [have] made all efforts to dilute benefit sharing provisions and to carve key components of biological materials from the scope of the framework. It is apparent in the positions taken that their focus is not public health but the protection of their industries, their profits and the intellectual property they hold.”

    At press time, co-chairs Bente Angell-Hansen of Norway and Juan Jose Gomez-Camacho of Mexico told Intellectual Property Watch they were optimistic about the outcome of the meeting.

    “We are optimistic that we will have a very successful week,” Gomez-Camacho said.

    In the framework, the working group is building a role for civil society and industry in a time of pandemic, said Angell-Hansen. This has been an innovative negotiation, in which channels were open to stakeholders, she said, adding, “This is a modern agreement.”

    One of the aims of the framework was to obtain a strong commitment from industry on vaccines and antivirals, diagnostic kits, capacity building, and surveillance laboratories, she said. Under the framework, the world will be taken to a different level when it comes to preparedness, she said, with a faster response system, more predictability, and transparency.

    Catherine Saez may be reached at info@ip-watch.ch.

     


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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.

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    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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