UNITAID Drug Patent Pool Implementation Hinges On Board11/12/2009 by William New, Intellectual Property Watch 3 Comments Print This Post 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 BoardThe 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 PoolMajor 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 firstname.lastname@example.org.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.Related Articles:UNITAID Patent Pool Budget Approved; Implementation To Begin Civil Society, Elected Officials Rally Behind UNITAID Patent Pool UNITAID-Backed Patent Pool Final; Drug Licence Talks Can Begin William New may be reached at email@example.com.