WHO Members Inch Toward Consensus On IP, Innovation And Public Health

By Kaitlin Mara and William New
Members of the World Health Organization (WHO) gathered this week to address innovation and intellectual property issues in public health saw hope for agreement on a strategy paper focused on the needs of developing countries, particularly on neglected diseases. But with two days remaining in the negotiations, difficult issues on intellectual property rights and the action plan remained unresolved.

The WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) is meeting from 28 April to 3 May, as a part of its resumed second session (the second session begin in November 2007)(IPW, WHO, 9 November 2007). The current round of negotiations is under mandate to create a consensus document for presentation at the World Health Assembly, which will take place later this month.

In her opening remarks to the IGWG, WHO Director-General Margaret Chan said that an “agreed framework can make the cycle of product discovery, development and delivery more efficient and more sensitive to health needs in the developing world” by giving the international community a “common tool” to leverage against health problems. She stressed the importance of the negotiations moving forward “as rapidly and efficiently as possible,” and urged a continuation of the “sense of urgency” seen in past months.

Further pressure for resolution has been placed on negotiators by some developed countries who would like to see the IGWG discussions end this week, and to pull the WHO back from involvement with IP issues, according to some participants. Others thought that the negotiations should not be rushed, and one developing country official said, “I hope we don’t do in haste what we will repent later.”

This week’s debate is the result of several years of intensive discussion at the WHO on policies to address the problem that the existing intellectual property system lacks economic incentives for the private sector to invest in research and development (R&D) for diseases primarily affecting those who cannot afford to pay the higher prices necessary to recover R&D costs.

But a larger issue of the role of the WHO in discussions relating to intellectual property is underlying the talks. Many feel the issues belong primarily in the World Trade Organization, World Intellectual Property Organization, or in national laws. But others see the WHO with the lead on public health issues as having been sidelined in global debates as they relate to IP and public health, even as those debates have resulted in rules that have possibly had a pejorative effect on public health.

“The IGWG is a historic opportunity and this should not become a historic failure for lack of response,” Médicins sans Frontières’ Tido von Schoen-Angerer told the plenary. “Governments, and the WHO, must not abdicate from their responsibilities, or pass the buck to others. We are asking you to strengthen WHO’s role in intellectual property and health, to change the way R&D is prioritised and financed so that paying for the research does not equal prohibitive prices, and to take measures to increase generic competition.”

Draft Text Taking Shape

While most negotiations have happened behind closed doors, on 1 May WHO members met as a whole in an attempt to hammer out consensus on the draft global strategy on public health. The talks were able to cover elements two, three and four out of the eight-element draft strategy – covering, respectively, promoting research and development, building and improving innovative capacity, and transfer of technology – and had begun to discuss element five, on the application and management of intellectual property to contribute to innovation and promote public health.

Remaining aspects of element five are expected to be contentious, according to some participants. In general, consensus is being achieved through a relative weakening of provisions, often, but not always, along north-south lines. Compromises involved the insertion of phrases like “possible” and “appropriate.”

The morning’s negotiations focussed on element two, promotion of research and development. Convergence was reached on accessibility to libraries and technical support to create compound libraries in developing countries (Article 2.2.b), and the related article (2.4.c) on the creation of open databases and compound libraries. The United States sought to delete the second article as it felt it was redundant, sparking discussion on the issue.

The dissemination of publicly or donor-funded medical inventions and know-how (Article 2.4.d), and the “incorporation of research exemptions in legislation of developing countries” for public health purposes (Article 2.4.e) were both contested by the United States. Korea agreed with the US on 2.4.d, as one of the suggested ways to disseminate medical know-how was through open licensing and the Korean delegate was unsure if his country had a policy allowing for such licensing. Brazil and India felt that open licensing was a useful addition to the paragraph, and India mentioned that the use of open source technologies in India was very effective. Jamaica supported India and Brazil. A distinction also was made between proprietary and non-proprietary databases. A compromise was reached with the language “including but not limited to open licensing.”

On 2.4.e, which reads “consider the incorporation of research exemptions in legislation of developing countries to address public health needs, consistent with the TRIPS and the Doha declaration on TRIPS and Public Health,” the United States asked for the paragraph to be deleted, as such issues would be dealt with in the IP chapter (element 5). Delegations pointedly asked the US delegation to explain its problem with research exemptions, as they are covered in both the TRIPS agreement and in US legislation. Japan supported the United States, which argued that the term ‘research exemptions’ was not well-defined, and it was unclear as to its actual scope.

The encouragement and promotion of traditional knowledge (and traditional medicines) was another key debate. Suriname wanted to ensure that traditional medicine is protected from being carried away from its nations of origin and brought back as patented matter. The traditional knowledge clause in element 5, Article 5.1.f, on the creation of digital libraries of traditional knowledge in order to prevent misappropriation, caused much disagreement. Some delegates were uncertain if discussions on traditional knowledge even belonged in the WHO negotiation. Others could not see how a digital database could prevent misappropriation, as it would offer greater access to the knowledge. Several new suggestions were offered, but after lengthy discussion no convergence was forthcoming so the chair suggested interested parties meet outside the plenary. Kenya is chairing this side session.

Another discussion in element 5 reflected a debate that has arisen at other institutions in Geneva that the training on IP in developing countries, such as of patent examiners, should fully reflect public health priorities.

Element 5 seems likely to be difficult to negotiate, with upcoming discussions on provisions such as how to address research involving humans. Delegates on 1 May discussed Article 5.1 and several of its subsections, but had trouble reaching consensus on several topics. In addition to traditional knowledge, a clause on strengthening “education and training in the granting, application and management of intellectual property from a public health perspective” also presented a problem. The US wanted to strike the word “granting” from the paragraph, and other members proposed adding specific references to flexibilities contained in the TRIPS agreement and other instruments. Consensus was unable to be reached.

Under Article 5.1, on the management of intellectual property in a manner that maximises health-related innovation, Suriname was concerned about the ethics of clinical trials, citing examples in which such trials have been conducted in developing countries, aiding medical innovation on drugs that were subsequently out of the price range of individuals who had participated in trials. Suriname wishes to add “maximises health related innovation and access” to the clause; consensus is pending agreement on that addition.

Civil Society Views

The hottest points of disagreement have tended to arise over practical solutions for solving this problem, reflected in the wide variation in proposals from civil society groups addressing negotiators. Public interest advocacy group Knowledge Ecology International’s Jamie Love has suggested prizes and prize funds replace [correction: his position is that they would coexist, see comment below] patents for neglected diseases, and expressed disappointment that most references to such systems in the strategy paper appeared to be surrounded by brackets indicating lack of consensus on their presence in the text. Love suggested that if the governments are not ready at this point in time to achieve real improvements, then perhaps the process should wait for another time.

International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Director General Harvey Bale said the industry group wants to preserve strong intellectual property protection, which it says promotes innovation, and instead focus on market incentives outside of IP, such as advanced market commitments (AMC) and “fast track” approval for drugs targeting developing country diseases. An AMC is a guarantee of a market in the event a medication or vaccine is developed in order to incentivise the development of health solutions in diseases or for areas where the existence of a market is uncertain or too small to compensate for R&D costs.

Health Action international also said that WHO must have a clear mandate to work in IP and health, and that the final draft strategy should not dilute flexibilities in IP enforcement already guaranteed under the WTO’s Trade-Related Aspects of Intellectual Property Rights Agreement. The European Generic Medicines Association and the International Generic Pharmaceutical Alliance, represented by Greg Perry, said data exclusivity must not be used to create market exclusivity beyond patent protection.

“IGWG must systematically address innovation and access to medicines” and should “delink the cost of research and development from the price of developed products,” said Sarah Rimmington of Churches’ Action for Health. The role of WHO should be strengthened on IP and issues in health, and the organisation should “provide active guidance, specifically on TRIPS flexibilities.”

The International Alliance of Patients Organizations called for IGWG recognise patients and patient organisations as key stakeholders.

MSF’s von Schoen-Angerer urged that the medical R&D process be government-led, and said it appeared wealthy countries objected to a proposed R&D fund without offering alternatives.

Kaitlin Mara may be reached at kmara@ip-watch.ch. William New may be reached at wnew@ip-watch.ch.