International Health IP Policy Issues To Be Watched In 200709/01/2007 by Tove Iren S. Gerhardsen for Intellectual Property Watch Leave a CommentShare this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Google+ (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)IP-Watch is a non-profit independent news service, and depends on subscriptions. To access all of our content, please subscribe now. You may also offer additional support with your subscription, or donate.By Tove Iren S. Gerhardsen The year 2006 was a busy one in terms of health policy developments related to intellectual property rights, and a quick look at the events ahead in 2007 shows that the coming year should be no less interesting.The World Health Organization (WHO) stood for many of the main policy developments in this area in 2006, and many of these will be followed up in the coming year. The year begins with a change at the helm at WHO, with Margaret Chan of Hong Kong (who also holds a Canadian passport), took over from interim chief Anders Nordström. He has been acting director general of WHO since the late Dr Lee Jong-wook passed away suddenly in May 2006. Chan said she wants to focus particularly on women’s health and Africa as a region. Although she did not mention intellectual property or access to medicines in her 4 January introductory speech, she did mention it in her 9 November speech to the World Health Assembly.”WHO must influence the research and development agenda,” Chan said. “For these and other diseases, we will not be able to make major strides forward until we have new vaccines, new drugs and new diagnostic tools. In addition, we must find the right balance between the protection of intellectual property rights and access to affordable essential medicines. This is not easy. But we cannot be evasive.” Chan’s six broader priority areas for the WHO are: development for health, health security, building the capacity of health systems, better information and knowledge, enhancing partnerships and improving the performance of the organization, according to the WHO. She also insists that her presence will not lead to significant changes or restructuring at the WHO but is “fine-tuning” the structure and issued a stern warning about inappropriate behaviour (IPW, Public Health, 4 January). Her term of office runs until 30 June 2012.WHO will hold its next Executive Board meeting on 22-30 January, and the Sixtieth World Health Assembly is scheduled for 14-23 May. WHO events calendar click here.WHO IP Working GroupAmong the most interesting WHO activities next year for those following IP will be the developments of the Intergovernmental Working Group On Public Health, Innovation and Intellectual Property (referred to as the “IGWG”) (IPW, Public Health, 11 December 2006). The group dates back to a resolution (WHA59.24) from the World Health Assembly in May 2006. WHO was requested to “immediately” set up an intergovernmental working group, also counting non-governmental organisations and other experts, to come up with a global plan for how research and development of medicines for so-called neglected diseases may be improved. These are diseases for which the markets are too small, or the patients too poor, for there to be a business incentive to develop treatments, and as a result there often are no medicines available, or the medicines are outdated. Some include the “big three,” meaning HIV/AIDS, tuberculosis and malaria, in this category, but others argue that these diseases are already being addressed in initiatives such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, so that neglected diseases rather cover less-well-known afflictions such as sleeping sickness or plague, for example. Chan mentioned neglected diseases in her opening speech. WHO has set up a secretariat for the working group and the first meeting with member states took place in Geneva from 4-8 December, where Peter Oldham of Canada was elected chair. But the group has another year and half (by the Health Assembly in May 2008) to come up with the plan. In the meantime a short report on progress to date will be sent to the Executive Board meeting in January, and members will have until the end of February to submit suggestions for early implementation action for the plan. Based on this as well as a progress paper from the December meeting, WHO will come up with new documents in this process to be available to member states by June 2007. The next working group meeting is scheduled for October 2007.It is unclear whether the global strategy and plan of action will be discussed at the Health Assembly in May 2007. But it is known that the strategy and actions will be based on the roughly 60 recommendations of the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), which published its findings in April 2006 (IPW, Public Health, 3 April 2006). Members seem to disagree, however, about which specific recommendations should form the crust of the plan. Issues that are likely to be the sticking points are the transfer of technology related to research and development from developed to developing countries, the use of so-called “TRIPS-plus” [extending beyond the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights] provisions in bilateral agreements, such as stronger protection of test data for medicines delaying the market entry of cheaper copy medicines, and the use of compulsory licenses by go governments seeking to obtain needed medicines or other public health-related materials. At the December working group meeting, there was discussion about whether WHO should be involved in trade and intellectual property rights issues as they relate to health, or if these issues belong only in the WTO or the World Intellectual Property Organization (WIPO). The issue was not resolved at this meeting and is to be watched during 2007 as an overarching issue of the specific agendas. WTO Doha Agenda and Public HealthEven if the current round of international trade negotiations, referred to as the Doha Development Agenda, dating back to a WTO meeting in Doha, Qatar in 2001, remains stuck, work is proceeding on items already agreed to on public health.The Doha Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001, is still in place, as is an amendment to the TRIPS agreement adopted in December 2005, making permanent a waiver that allows exports of treatments produced under compulsory license to countries without adequate production capacity.There is a 2007 deadline to be monitored, however. By 1 December 2007, two-thirds of the 149 WTO members must have accepted the amendment to the TRIPS agreement for it to come into force. To date, only Switzerland, El Salvador and the United States have done so, according to WTO, which notes that the deadline may be extended. A number of countries have implemented the changes into national law, however, which also is necessary for countries to make use of the regulation. The process can be monitored at WTO’s TRIPS and Public Health website.Bilateral, Regional NegotiationsA key battleground for nations’ intellectual property rights relating to public health continues to occur at the national and regional levels as key countries such as the United States and those in the European Union are expected to continue pursuing higher protections of their rights through bilateral trade negotiations, and they and others conduct examinations and reforms of their internal health systems. This will include further emphasis on issues of research and development. For example, the European Commission has stepped up its focus on neglected diseases. At a 8-9 November 2006 meeting it said that it will be possible to receive grants for research into these diseases as part of its seventh framework programme for research (FP7). The framework programme will be launched in January 2007, will run over seven years, and has some €6.06 billion earmarked health, a source said. Dario Zanon of the EU Directorate General for Research told Intellectual Property Watch during the conference that neglected diseases would indeed be part of the framework programme, but only under the second “call” for funding applications, expected in the summer of 2007. He could not say how much money has been allocated (IPW, European Policy, 9 November 2006).This plan is not expected to change with Germany’s six-month takeover of the rotating EU presidency from Finland on 1 January.G8 and Health, IP PromisesAt the July 2006 meeting of the Group of Eight (G8) biggest economies in the world, health issues, including the fight against infectious diseases such as HIV/AIDS, tuberculosis, malaria, polio and human pandemic influenza, were one of the major items in a 12-page health outcome document. Piracy and counterfeiting was another. For example, it states as priorities the “intensification of scientific research and exchanges in the area of infectious diseases, with a special attention given to involving scientists from developing countries in international scientific research programs,” and “fulfilment of prior G8 commitments on the major infectious diseases, in particular by mobilising support for the Global Fund to Fight AIDS, Tuberculosis, and Malaria; continuing to pursue as close as possible to universal access to HIV/AIDS treatment for all who need it by 2010; supporting the Global Plan to Stop TB; providing resources in cooperation with African countries to scale up action against malaria; continuing to expand the Global HIV Vaccine Enterprise; and continuing our support for the Global Polio Eradication Initiative so that the planet can be declared polio-free within the next few years.”The next G8 meeting will be held in Heiligendamm, Germany, on 6-8 June, and intellectual property rights will be one of the main issues, according to sources. On 1 August 2006, the German G8 office said that energy and climate change and intellectual property rights would likely be priorities at the summit, according to a source. And on 27 July 2006, the Financial Times reported that the central topics would be global economic imbalances, energy and intellectual property protection, the source said.OECD and HealthThe Paris-based Organisation for Economic Co-operation and Development (OECD) may hold a conference on health and research in 2007, and the Netherlands may play a role in the holding of the event, according to one source, but further details were not available by press time. The OECD Health Project, parts of which are measuring and analysing health system performance and explaining variations in performance, will be continued in 2007. For more information, click here.Davos and Health The World Economic Forum annual meeting is scheduled for 24-28 January in Davos, Switzerland. The forum has a Global Health Initiative, launched in 2002 with former United Nations Secretary General, Kofi Annan, to tackle HIV/AIDS, tuberculosis and malaria.Industry, NGO Concerns in 2007One of the issues the pharmaceutical industry will focus on in the coming year is the implementation of its new voluntary ethics code [pdf], which it launched at its General Assembly in 2006 (IPW, Public Health, 20 October 2006).The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) also has a new leader, Fred Hassan, CEO of Schering-Plough, taking over from Daniel Vasella, CEO of Novartis. At the assembly, the director general of IFPMA, Harvey Bale, also indicated that he will be stepping down within the next two years. Also among unresolved issues of concern to industry is the WHO-run system of International Nonproprietary Names (INN). This is the international generic naming of medicine ingredients, which are deemed public property. The industry is concerned about the so-called biosimilar products getting the same generic names, as they are not exactly the same product, it argues. But others hold that unique INN names for each medicine will make it harder to substitute them with cheaper versions, and will link them to trademarks, sources say (IPW, Public Health, 27 November 2006).The European Commission and the European Federation of Pharmaceutical Industries and Associations also will work further on its Innovative Medicines Initiative in 2007.Separately, there are quite a few legal and policy cases in various countries related to IP and health, which are ongoing and for which there will definitely be developments in 2007: Swiss pharmaceutical company Novartis has taken the Indian government to court, arguing that the Indian patent system is not in line with international intellectual property law (IPW, Public Health, 19 October 2006).Pfizer is involved in a similar court case in the Philippines (IPW, Public Health, 13 April 2006).And a bill suggesting changes to the IP Act in Kenya was withdrawn last minute before the Parliament went on recess in December, but activists in the country said they will still closely watch to ensure it is not reintroduced in 2007 as they view the changes as detrimental to public health (IPW, Public Health, 21 December 2006).For non-governmental organisations active in international public health issues, activities are likely to continue in all of the areas of importance cited in this piece. Some will continue to push for new ways of thinking about the existing patent-monopoly-based system for new drug development and distribution (based on a higher pricing model to recover research costs), such as a proposal for prize fund to support research for drugs in the public interest. The Consumer Project on Technology has been a leader on this issue. Médecins Sans Frontières has a targeted programme on access to medicines in developing countries. In other related areas, the Global Fund to Fight AIDS, Tuberculosis and Malaria will likely continue its search for a new director general in 2007; the five-government initiative led by France and known by the name UNITAID will work on raising funds through taxes to put toward the procurement of and access to medicines [the initiative has an IP paragraph in its constitution towards this end (IPW, Public Health, 21 September 2006) and a source also said that the Global Alliance for Vaccines and Immunization had some IP projects coming up in 2007 related to its vaccine development programmes. Avian influenza also is bound to be a focus of health policy discussions in 2007, with countries making sure they have stockpiles of medicines and governments co-operating on monitoring of outbreaks. The virus H5N1 continues to take human lives, and in a November WHO update on Indonesia, one of the worst affected countries, it was stated that the Indonesian Ministry of Health confirmed the country’s 57th death from H5N1 avian influenza. Among the companies working on developing medicines for the bird flu are Roche and GlaxoSmithKline. William New contributed to this report. Tove Gerhardsen may be reached at firstname.lastname@example.org.Share this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Google+ (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)Related"International Health IP Policy Issues To Be Watched In 2007" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.