Special Report: Geneva, Public Health Capital Of The WorldPublished on 30 August 2010 @ 2:56 am
By Kaitlin Mara, Intellectual Property Watch
International public health in Geneva is no longer just the province of the World Health Organization. Dozens of intergovernmental and non-governmental agencies, along with financing organisations and partnerships, have headquartered their operations in Geneva, making the mid-sized Swiss city a public health capital of the world. Many of these organisations are engaged in addressing the critical interface between public health, development and innovation, including intellectual property rights. The following is a backgrounder and guide to many of the organisations working on these issues in town.
The WHO is the United Nations health authority, tasked with “providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends,” according to its website. WHO work related to intellectual property rights, innovation and research and development is spread out across several departments.
The Public Health, Innovation and Intellectual Property programme (PHI) is responsible for carrying out the WHO’s Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. The strategy was approved at the WHO’s annual decision-making World Health Assembly (WHA) in May 2008, after a two year Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). The IGWG in turn grew out of the Commission on Intellectual Property Rights, Innovation and Public Health established by the WHA in 2003 which came out with an independent report on the interplay between IP and access to health products.
PHI carries out its work on the global strategy in collaboration with other departments at the WHO as well as with external actors. Leadership on new research is, for example, shared with the Research Policy and Coordination department, the Tropical Disease Research department and others, according to an Intellectual Property Watch interview with PHI’s former director (IPW, WHO, 23 April 2010).
A monitoring and evaluation platform for this work is in the process of being developed, tracking different work by different stakeholders on eight different elements of the strategy: prioritising research and development needs, promoting research and development, building and improving innovative capacity, transfer of technology, application and management of intellectual property to contribute to innovation and promote public health, improving delivery and access, promoting sustainable financing mechanisms, and establishing monitoring and reporting systems.
WHO also deals with a particularly controversial area of IP under its Medicines programme. WHO’s work on counterfeit medicines started, its site says, after a 1988 WHA in which member states asked the director general “to initiate programmes for the prevention and detection of the export, import and smuggling of falsely labelled, counterfeited or substandard pharmaceutical preparations.” But this was before the 1995 creation of the World Trade Organization, whose Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement defined “counterfeit” in trademark terms. In January 2009, a report created under the auspices of the WHO International Medical Products Anti-Counterfeiting Taskforce (IMPACT) caused controversy among several member states concerned that WHO’s continued use of the word would cause problems for legitimate generic products by confusing an IP issue with a public health one.
Lastly, WHO deals with intellectual property rights under its in-development Pandemic Influenza Preparedness Framework for sharing influenza viruses and access to vaccines and other benefits. This plan was intended to create a fair system to ensure that there is timely transmission of pandemic-potential viruses and other materials into the WHO system, and that vaccines and other benefits from that system come out the other end, especially for countries unable to manufacture or purchase them themselves. The areas of this framework on which it has proved hardest to reach agreement are the intellectual property issues, and issues around a legally-binding Standard Material Transfer Agreement for the transfer of viruses and related materials, which includes IP issues.
UN Conference on Trade and Development
UNCTAD is one of the lead stakeholders under the World Health Assembly’s Resolution 61.21 on a Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. UNCTAD has been requested to analyse transfers of technologies to developing countries regarding the local production of pharmaceutical products. This is part of a broader WHO project and is funded by the European Union.
According to sources, the UNCTAD case studies are identifying key factors in successful transfers to local producers in Argentina, Bangladesh, Colombia, Ethiopia, Indonesia, Jordan, Thailand and Uganda. The Geneva-based International Centre on Trade and Sustainable Development (ICTSD) also is working on the project, which will feed into a methodology for assessing countries’ capacities to undertake local production, as well as their prospects for improving health-related technology transfer.
UNCTAD also was mandated by its Commission on Investment, Technology and Related Financial Issues to work on the local manufacturing and supply of pharmaceutical products in developing countries, in the context of Millennium Development Goal 8, Target 8e [corrected], which states: “In cooperation with pharmaceutical companies, provide access to affordable essential drugs in developing countries.”
In response to this mandate, UNCTAD, with support from Germany and the United Kingdom, has implemented a programme under its Intellectual Property Unit to assist developing countries and least-developed countries to establish domestic IP regimes that facilitate increased access to affordable medicines. It also seeks to create local or regional pharmaceutical production and supply capacities, including in cooperation with investors.
Finally, UNCTAD is actively involved in Geneva-based consensus building activities regarding the issue of IP and public health. More information here.
World Intellectual Property Organization
While health is not normally seen as a large part of WIPO’s regular mandate, the organisation in recent years has shown an increasing interest in the linkage between IP and critical matters of public policy. In a recent draft of its strategic plan for 2010-2015, WIPO mentioned health as one of these critical policy areas. It also mentioned partnering with the WHO on the linkage between the two institutions’ areas of expertise. WIPO also recently hired former lobbyists for the US Pharmaceutical Research and Manufacturers Association and the US biotechnology industry to work in this area (IPW, WIPO, 12 May 2010).
WIPO has also an ongoing committee on new forms of IP protection for traditional knowledge, traditional cultural expressions, and genetic resources. Traditional knowledge may include traditional medicine, and genetic resources often form the basis of new medical innovation, so as talks go on it is likely they will relate to public health. In the “objectives and principles” document serving as the basis for talks on traditional knowledge, is a statement that traditional knowledge “protection should not interfere with household uses and public health uses of traditional medicine,” and the suggestion that more legal text is needed on the issue.
As the primary legally binding multilateral agreement on IP, the WTO TRIPS agreement has been heavily scrutinised for its effect on access to medicines in the developing world. A 2001 Doha Declaration on TRIPS and Public Health states that TRIPS “does not and should not prevent members from taking measures to protect public health … and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.” It then reiterates the right of member governments to use flexibilities within the TRIPS agreement as needed for public health purposes.
Still, some members say political pressures prevent them from using those flexibilities. And a special “paragraph 6” agreement intended to help countries which lack the manufacturing capacity import cheaper versions of patented drugs from countries that manufacture them affordably under a compulsory licence has been called ineffective by several developing countries. Also being examined in the WTO dispute settlement process is a European Union law that caused several shipments of generics medicines to be delayed, primarily in Dutch ports. Two consultation processes – one from Brazil and one from India – are ongoing against the European Union and the Netherlands over whether this law violated the TRIPS agreement. A chief concern of the complainant countries is what effect these delays are having on the trade in generic drugs, and in access to these drugs, especially in developing countries.
WTO members also have debated in recent years the possibility of requiring disclosure of origin of genetic materials in patent applications in order to reduce biopiracy, a measure that could impact public health.
Non-governmental Organisations and Financing Institutions
COHRED, established in 1993 after a WHO report on health research for development, works to improve research aimed at alleviating health concerns in developing countries, and works with countries to assess their health systems and provide policy and priority setting advices and occasional technical support, according to its site. COHRED also works with international organisations to improve understanding of what makes national health research and systems effective and how global health programmes can orient their activities to better meet countries’ needs. The group also does its own research to support the importance of effective national health system.
COHRED also works to share knowledge with countries and is currently developing a Health Research Web platform, begun in 2006, that intends to gather information on the health care systems of low and middle income countries. Information being gathered includes governance and policies, regional and national priorities for health research, key institutions and networks, civil society groups, research financing, information on research regulation and ethics, and other information resources. The site is still in development, but Health Research Web is currently providing hosting to the WHO Global Strategy monitoring and evaluation platform in development, which seems to have taken some of the technique of sharing national level data in its page on TRIPS flexibilities.
DNDi is a drug development partnership programme begun in 2003 that works on developing new treatment for several neglected diseases, including malaria, visceral leishmaniasis (VL), sleeping sickness (human African trypanosomiasis), and Chagas disease. It coordinates projects with the international research community in both the public and private sectors, with the goal of having 6-8 new treatments for these diseases by 2014.
DNDi also engages in advocacy work to encourage the mobilisation of resources towards health innovation, in particular to address the research and development funding gap for neglected tropical diseases, according to its website. Policies are necessary, DNDi says, to “contribute to the development of innovative, needs-based measures such as intellectual property management policies to encourage needs-driven R&D, technology transfer, an enabling regulatory environment and strengthening of research capacities in developing countries.”
Launched in 2003, FIND is a product development and implementation partnership “devoted to developing and implementing diagnostic tools for poverty-related diseases,” according to its website. Its disease portfolio is focussed on tuberculosis, malaria and human African trypanosomiasis, and it aims to create diagnostic tools that are appropriate to the often resource-poor settings where they are most needed. It does this through public private partnerships. FIND employs a “segmented” IP policy intended to overcome the “usual barriers to product availability and ensures affordability and access for the public health sectors in developing countries, while motivating industry partnerships,” according to its website. In it, FIND is granted by industry partners a royalty free licence to use the technology “in public and private nonprofit sectors in high endemic countries” while the industry partner retains rights in the for profit private sector and in developed countries.
GAVI is a global health partnership begun in 2000 which focuses on immunisation. Its members include funds such as the Bill & Melinda Gates Foundation, vaccine manufacturers, researchers, civil society groups and intergovernmental groups like the WHO or the UN Children’s Fund (UNICEF). GAVI aims to improve access to existing vaccines as well as to introduce innovative new vaccines and other immunisation strategies.
GAVI employs innovative financing strategies in the form of advanced market commitments to encourage the development and manufacture of vaccines by guaranteeing that there will be a market once the drugs are made, provided they meet regulatory criteria and previously agreed prices. There is also an International Finance Facility for Immunisation (IFFIm) involving legally-binding commitments from donor countries.
The business coalition is “an unusual NGO, one comprised entirely of businesses,” according to its site. It includes groups such as US-Based Chevron and French Accor and about 200 others that facilitates public private partnerships with health outcomes.
The Global Forum for Health Research is an organisation that aims to demonstrate “the essential role of research and innovation for health and health equity,” according to its website. It was established in 1998 with the intention of helping reduce health research inequality by bringing together stakeholders within the health community from countries around the world. It works to increase collaboration and coherence among these different actors. It hosts annual meetings at which these actors can meet and discuss the way R&D issues affect them. It also undertakes reports to identify research gaps, and makes recommendations on how to fill them. [Note: the Global Forum has become an affiliate of COHRED, above].
The Global Fund is an international financing institution started in 2002 that makes targeted investments to help countries improve their ability to cope with the three major diseases in its name. It has no in-country offices, but instead works in collaboration with in-country partners – governments, civil society, and the private sector – to implement programmes. It uses an innovative financing model, providing access to funding based the health needs and poverty and disease burdens of the financed country and providing regular evaluation to identify areas of its financed programmes that need improvement and reallocating funds if a grantee proves an ineffective performer, according to a recent progress report [pdf].
The Global Fund does not itself make drug purchases, and therefore does not deal with intellectual property issues directly, though a representative said that signalling large amounts of money for the purchasing of drugs keeps prices down (IPW, Public Health, 8 March 2010). However, the prices set by patents are likely to affect how far the Global Funds’ distributed dollars can stretch, especially when new line antiretroviral treatments for HIV/AIDS can no longer be manufactured in now TRIPS-compliant India.
Health Diplomats is a consulting group devoted to global health practices. A “new type of diplomacy is necessary to navigate the changing landscape of international affairs and politics,” the group says, requiring different skill sets than “traditionally provided by career diplomats or professional consultants.”
According to its website, its current work with clients includes “development of HIV/AIDS good practice guidelines for health professionals in resource poor countries, global health security and uncovered regions, and governmental advocacy campaign for [the WHO] International Health Regulations (IHR).”
The IFPMA is “the global non-profit NGO representing the research-based pharmaceutical industry, including the biotech and vaccine sectors,” according to its site. It represents the interests of the pharmaceutical sector at a variety of international organisations in Geneva, representing 25 companies and 46 national and regional associations.
IFPMA works on a variety of issues related to intellectual property rights. The group says “strong patent and other intellectual property rights are vital incentives and protection for innovation, especially in the pharmaceutical sector” and that “claims that patents are a barrier to access to medicines are unfounded and inaccurate,” and that real barriers to access to health care in poor countries include poor health infrastructure and financing. IFPMA also works on matters of counterfeit medicines, which it says are an equal problem for both generic and branded drugs, and has a position on the use of genetic resources and related benefit sharing which is being discussed at the Montreal-based UN Convention on Biological Diversity.
Other biotechnology groups are also intensifying their presence in Geneva.
Housed within the IFPMA, the ICH brings drug regulators and pharmaceutical experts to try and achieve “greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.”
They have also taken a stance on access to vaccines in the context of potential influenza pandemics, where they argue for increasing the manufacturing capacity of pharmaceutical companies, including via technology transfer to improve manufacturing capability in developing countries, and emphasise that the development of new technologies to fight pandemics depends on the incentives of “robust intellectual property rights.”
The Medicines for Malaria Venture is a public-private partnership working to facilitate the development and delivery of antimalarial drugs. Since 2005, this has also included a focus on access to and delivery of developed drugs, which its site says is limited because of financial constraints, ineffective distribution systems, erratic supplies, and limited reach of public health services. Reduction of prices, including via health subsidies, and policy changes in endemic countries are key areas of MMV’s plan to improve access, its site says.
MMV does not do research in-house, but contracts with partners in order to do so. MMV provides financing to its partners, and the partners (generally pharmaceutical companies) provide “in kind” contributions in the form of facilities, pharmaceutical technologies and staff.
MMV’s policy on intellectual property rights [pdf] consists of three parts. First, MMV must be granted the IP to the drug resulting from the partnership or must be granted an exclusive, and global, licence to use the IP developed during its partnership as well as any necessary background IP. These licences “are preferably royalty-free,” at least in endemic countries, and must be transferable to other partners, as MMV does not do in-house R&D.
MSF is a humanitarian organisation providing emergency medical care to people in need of it, due to poor infrastructure and/or crisis situations. MSF also aims to raise awareness of the problems it seeks to alleviate, and bears witness to human rights abuses and to the plight of the people they are working with. The organisation has projects in over seventy countries throughout the world, but is headquartered in Geneva.
A critical part of MSF’s work involves procuring medicines and medical tools for the patients the organisation treats. The MSF Campaign for Access to Essential Medicines was set up in 1999 in an attempt to improve both access to existing medicine and fuel innovation of needed and not yet available treatments. The key challenges the Access Campaign addresses are: medicines are too expensive, new treatments take a long time to go through regulatory procedures necessary to reach patients, most new research and development is aimed at market potential not at the needs of poor people in poor countries, and lack of health staff and infrastructure. “Patent protection has increased in developing countries and this pushes prices up because patents provide a monopoly,” says the Access Campaign site. And alternative ways of funding and incentivising research is necessary to encourage a focus on “medical needs of people in developing countries, rather than market priorities.”
MVP is a partnership between PATH (see below) and the WHO aimed at eliminating meningitis in sub-Saharan Africa.
The NGO Forum for Health works to build “alliances in health among NGOs and with UN agencies, governments and others to strengthen the voice of health advocacy” and lists intellectual property as one of its current areas of concern. Meningitis is a potentially fatal disease affecting the spinal chord and the brain. PMV aims to develop vaccines against it that are appropriate for use in sub-Saharan Africa, and then to ensure access via licensing, production at an affordable price, finding creative ways to finance procurement of vaccines, and encourage routine immunisation programmes, according to its site.
PATH is a non-governmental organisation that intends to break “longstanding cycles of poor health” worldwide with public-private partnerships. They work on areas of emerging and epidemic disease, health technologies (including development of new diagnostics), reproductive and maternal health, and vaccines (including vaccines delivery and development). PATH’s “policies for responsible conduct include a policy on the protection of IP. The organisation “views managing intellectual property as an important means of advancing our mission” and acknowledges its importance to PATH’s partners, and tries on a case-by-case basis to come up with the best way of licensing technology. Often these cases include investing in partner’s IP (that is, making agreements on pricing and supply without licensing), licensing for specific places or parts of the market, or developing the IP itself or in collaboration with a partner.
Hosted at the WHO in Geneva, the 1998-launched RBM partnership now contains more than 500 partners working together to control the outbreak of malaria.
A Stop TB Initiative was also launched in 1998, later becoming in 2001 the Stop TB Partnership. It also is hosted at the WHO.
While headquartered in Malaysia, TWN’s Geneva office maintains a strong voice on public health issues as seen by the the developing world. In particular, the group has had strong representation in fighting the use of the term ‘counterfeit medicines’ at the WHO and in encouraging an examination of the paragraph 6 system at the WTO. (see above for details)
Drug purchasing mechanism UNITAID has been financing projects to fight HIV/AIDS, malaria and tuberculosis using an innovative ‘air tax’ financing mechanism. According to its site, UNITAID engages in “long-term funding commitments and the purchase of high volumes of medicines and diagnostics. This helps stimulate increased production, which creates economies of scale that drive prices down. In turn, this means that UNITAID and its partners can provide more medicines and treatments with the same budget.”
The organisation made a recent foray into IP rights with the launch of a Patent Pool Foundation, an independent legal entity that will work closely with the established UNITAID. The Medicines Patent Pool is in the process of negotiating licences with drug manufacturers, with the goal of creating a one-stop shop to reduce transaction costs associated with getting licences to produce drugs. Antiretroviral drugs, particularly fixed-dose combinations and paediatric formulas, are a first goal of the new patent pool.
Kaitlin Mara may be reached at firstname.lastname@example.org.