Intellectual Property Watch
6 May 2008
WHO IP And Health Group Concludes With Progress; Tough Issues Remain For Assembly
By Kaitlin Mara and William New
The World Health Organization (WHO) negotiations on public health, intellectual property and innovation ended Saturday with substantial progress toward consensus on a draft strategy but with a plan of action remaining and the most contentious articles in the strategy still under brackets – indicating lack of agreement – as the paper goes to the World Health Assembly.
The air in the room was cautiously optimistic as WHO Director General Margaret Chan’s closing comments praised the assembled delegates at the 28 April to 3 May Intergovernmental Working Group on Public Health, Innovation, and Intellectual Property (IGWG) for reaching consensus on 107 paragraphs (many through deletions) that had been unresolved at the meeting’s start Monday.
The group’s mandate from the 2006 Health Assembly was to agree on a strategy and plan of action to boost research and development of, and access to, treatments for diseases disproportionately affecting developing countries, in time for this year’s annual assembly. If sufficient agreement is reached on the remaining items and the plan of action, implementation of the strategy should follow.
But there was also a sense from many delegates that substantive work lies ahead, and some nongovernmental organisations expressed disappointment at the IGWG’s perceived lack of strong commitment to public health, and the potential lost opportunity to make a profound difference.
While the global strategy being drafted by the group is not legally binding, it is being taken seriously by governments and other stakeholders because it could have a significant impact on policy. “It is a political document,” said one official. “It can have a lot of weight.”
Both developing and developed countries representatives found positive things to highlight about the IGWG, though it is clear that outcomes are not yet guaranteed and large gaps remain between what different stakeholders want from the draft strategy. Much of the work was done in closed informal sessions, often into the night, participants said.
Some key outcomes or debates were the proposed creation of an expert group on financing and the coordination of R&D, a mention of prizes as a possible alternative incentive for research and development, and policies on human clinical trials, competition, counterfeit medicines, and the role of the WHO on international IP and innovation issues.
Also significant was the apparent removal of advance market commitments, which would have created a mechanism for ensuring a market for new drugs, sources said. One source also said there was now a separation of provisions relating to access from those relating to intellectual property rights.
Ambassador Tom Mboya Okeyo of Kenya said the outcome’s impact will take time to see but that it was a good step. He noted consensus on provisions on access to medicines, and on flexibilities in the international IP system to accommodate access. Also agreed were several provisions that could strengthen innovation on essential medicines and encourage sustainable financing mechanisms, and provisions that could help protect traditional medical knowledge, all of which are important to developing countries, he said. The next challenges are in ensuring the key actions outlined in the strategy are implemented quickly, he said, adding that he hoped the WHO director general could mobilise funds for that purpose.
Suriname delegate Miriam Naarendorp called the week’s outcome the “start of the battle,” with the plan of action and implementation issues still to come. However, it was an important start, as, Naarendorp said, the IGWG was able to identify issues important to developing countries, and that the developing nations “stood firm on things that mattered” and had created a document that the WHO could not ignore.
An official from a leading developing country praised the outcome as successful as “so many member states agreed on so many things.” And a third developing nation delegate added that “we’ve made tremendous progress here [and] I expect we will get it finished at the World Health Assembly.” The assembly meets from 19 to 24 May.
A key developed country source was more concerned that the IGWG seemed to have averted potential negative consequences, saying that “the possibility of impact on the IP system has been reduced” and that “there were a lot of proposals that could have undermined innovation.”
Nongovernmental groups had higher hopes going into the meeting, for an outcome with profound effects on health product development for the poor. Over one hundred civil society organisations and patients groups signed a “joint declaration” (pdf) stating that “health is a fundamental human right and a necessary condition for human dignity” and calling for the IGWG to find sustainable solutions to encourage both innovation in healthcare and access to the fruits of that innovation, and several eminent academics signed a similar statement asking for IGWG delegates to consider “the exploration of new and innovative mechanisms that seek to correct the deficiencies of the current system” of drug development and delivery.
Draft Strategy Text Advances
The latest available version of the draft strategy was from the start of the last day, 3 May. Click here to read the 3 May version [pdf].
Delegates were able to reach full consensus on five out of eight elements within the draft global strategy, which includes principles for using the intellectual property system to maximise public health impact, particularly in innovation related to developing country diseases. Full consensus sections were element 1, on prioritising research and development needs; element 2, on promoting research and development; and element 3, on building and improving innovative capacity.
Article 3.4 outlines ways to support “policies that will promote innovation based on traditional medicine,” as well as Article 3.5.b, which encourages “the establishment of award schemes for health-related innovation.”
Article 5.3.a, which also saw consensus, mentions prizes as an innovation incentive, an issue important to developing countries and some nongovernmental participants. Barbados and Bolivia submitted a document at the outset of the week’s meeting proposing alternative incentive schemes for drug innovation in the form of prize funds for inexpensive tuberculosis diagnostic testing, for a Chagas disease treatment, for priority medicines and vaccines, and for cancer treatments. The document also calls for a global agreement on funding clinical trials as public goods.
Element 4, on transfer of technology, was largely agreed upon, with the exception only of element 4.1.b, which reads “promote transfer of technology and production of health products in developing countries through investment and capacity building, including by providing guidance on appropriate technologies.” As of the end of 2 May, this article was listed “consensus pending USA.” One developing country official said that in general the United States was “a bit tough” in negotiation, referring to the fact that the country was often the sole voice blocking consensus (though there may have been others unspoken). The US delegation included an IP negotiator from the US Trade Representative’s office.
Element 7, on promoting sustainable financing mechanisms, also reached full consensus, as did element 8, on the establishment of monitoring and reporting systems. The agreement on element 7 was reached only after a lengthy debate, Barbados said during the IGWG’s closing plenary session. Article 7.3, which detailed several strategies for the establishment of a global R&D fund to address gaps in diseases affecting developing countries, including the use of prizes and rewards as well as earmarked funds for patent buyouts to ensure access to medicines, was deleted by consensus.
Barbados asked during the final plenary that it be officially noted that this consensus was predicated on an understanding by Barbados and the rest of the Caribbean group, as well as Bolivia, that these issues be addressed under 7.1.a. That article calls for the establishment of a “results-oriented and time-limited expert working group under the auspices of the WHO and linking up with other relevant groups to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of financing to stimulate research and development” relevant to developing countries.
Element 5, on the application and management of intellectual property to contribute to innovation and promote public health, and element 6, on improving delivery and access, proved the hardest on which to reach consensus.
Still remaining to be resolved are issues of data-sharing, specifically through the creation of easy-to-use global databases on the status health-related patents (under article 5.1.c); on the training of patent examiners in intellectual property application and management, and possibly on TRIPS flexibilities (under article 5.1.e); on promoting competition to increase availability of health products under article 6.3, and particularly on support for the production/introduction of generic medicines (under 6.3.a). Another issue under debate in the strategy related to agreements that impose stricter intellectual property standards than agreements in the multilateral system (so-called TRIPS-plus provisions).
On 5.1.h, which originally stated, “establish measures to avoid unethical experiments involving human beings as a requirement for registration of medicines and technologies,” sparked a lengthy discussion on 2 May on the nature of ethics in human testing. Points discussed included: the difference between clinical tests for new drugs, or the bioequivalence tests done when generics are marketed, the ethics of testing new drugs against placebos when existing treatments are available for comparative testing (the Declaration of Helsinki, which lays out ethics of healthcare research, and says that new methods of treatment should be tested against the best existing treatments, where available, and not placebos), and the ethics of repeating a clinical test because the original tester has exclusive control over the results of first test and will not make the data public. Also of interest, especially to developing countries, was ensuring post-trial access to drugs by study participants, which the Declaration of Helsinki calls “necessary.”
The article eventually passed consensus on the condition it be moved from element 5.1 on information sharing and capacity building on health-related innovation to element 6.2, which covers ethical review and quality/safety regulation. The final text reads: “promote ethical principles for clinical trials involving human beings as a requirement of registration of medicines and health-related technologies, with reference to the Declaration of Helsinki, and other appropriate texts, on ethical principles for medical research involving human subjects, including good clinical practice guidelines.”
Other debates under element 5 included a provision on preventing anti-competitive practices related to IP rights, language on encouraging respect for flexibilities in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and a possible clause on counterfeit health products, including a definition. Some sources said an effort is being made to clarify the distinction between counterfeit products and generic products.
Also under element 5, a discussion was held on the role of the WHO on IP-related matters. Officials present from the World Intellectual Property Organization and the World Trade Organization signalled resistance to a proposal to create a formal coordinating body between agencies under Article 5.1.i. Creating a formal coordination effort would, a WIPO official said, just “add governance issues” to the already functioning informal collaboration that currently exists.
One participant said an informal relationship was seen as possibly minimising interagency turf battles. Still, some participants viewed the outcome as having strengthened the role of the WHO in IP issues. Consensus Article 5.1.f states, “strengthen efforts to effectively coordinate work relating to intellectual property and public health among the secretariats and governing bodies of relevant regional and international organizations (including WHO, WIPO and WTO) to facilitate dialogue and dissemination of information to countries.”
The traditional knowledge debate discussed earlier in the week (IPW, Public Health, 1 May 2008) was resolved after the Kenyan-led informal session came up with the text “facilitate, where feasible and appropriate, possible access to traditional medicinal knowledge for use a s prior art in examination of patents, including, where appropriate, the inclusion of traditional knowledge information in digital libraries.”
Lost Opportunities and Some Progress
Concerned entities and other nongovernmental organisations participating at the event were not entirely pleased with the outcome of the negotiating process.
Médecins Sans Frontières (MSF) sharply criticised the IGWG, saying it had “failed to take concrete action towards reforming a medical innovation system that largely disregards the health needs of millions of people in developing countries.” Tido von Schoen-Angerer, director of MSF’s access to medicines campaign said that negotiators had not “risen to the challenge” of “prescrib[ing] change to a broken system.” He called the working group a “lost opportunity,” particularly because there had been no consensus on the development of alternative research and development incentives.
Ethan Guillen, executive director of Universities Allied for Essential Medicines (UAEM) also expressed surprise at “the lack of bold commitment by most of the rich countries” and said “that there had to be stiff negotiations on the idea that the cost of medicines impedes access in the developing world makes you wonder if some negotiators hadn’t noticed that busloads of American retirees have to hop across the US border to Canada to get drugs they can afford.”
Sarah Rimmington, an attorney at public interest organisation Essential Action, said IGWG was meant to address how “the current corporate sector system of medical R&D, which is based on patent monopolies, has largely failed people in developing countries.” Rimmington said while the IGWG had taken an “important first step by agreeing to explore some common sense measures to address this failure,” such as innovation incentives not reliant on patent monopolies, consensus on actual implementation processes was not reached. This lack of agreement was, she added, largely due to “resistance from developed countries such as the United States, the EU, and Canada” and added that it “is hard not to wonder if pressure from the brand-name pharmaceutical industry – which is based in developed countries and remains ideologically committed to patent monopolies – influenced this disappointing outcome.”
Jamie Love of Knowledge Ecology International said the IGWG “did next to nothing on identifying R&D priorities, estimating funding needs, or creating a framework for sustainable funding for priority R&D, three tasks central to its mission.”
Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), when asked about whether this meeting represented progress toward the goal of addressing the problem of neglected diseases, said it “has lost focus on that,” but added that there was hope it could come back. He stressed the importance of advanced market commitments, or guarantees of a market in the event a medication or vaccine is developed (which were deleted from the draft strategy). He also stressed the importance of partnerships for development that link companies and the public sector in coordinated research efforts.
But there were also some positive views. Guillen said his group was “pleased to see the advancement… of important issues like technology transfer” in the draft strategy and said UAEM is “hopeful that consensus recommendations on open licensing and other technology transfer provisions agreed to during this round will send a strong message to universities… to adopt policies that will free up the tools of innovation and make medicines discovered on campuses available at low-cost in the developing world.”
Love was pleased to see that advanced market commitments had come out of the draft strategy and prizes had been included.
Nicoletta Dentico, policy and advocacy manager at the Drugs for Neglected Diseases Initiative (DNDi) said “the outcome of this intense week-long negotiation shows that some uncertain lights are looming, but still in a forest of thick shadows” that research on essential medicines still faces the “resistance of those who have set the direction of innovation so far” but that hopefully the “”spirit of Geneva” [would] clear, in the face of poor people’s needs, the shadows.”
MSF has said that, as the IGWG failed to arrive at strong conclusions, it is now up to the World Health Assembly “to translate bold ideas into concrete action.”