Intellectual Property Issues Come To A Head At World Health Assembly

[Note: Monday midday update below]
By William New
Member governments of the World Health Organization will try this week to finalise a strategy and plan of action to stimulate innovation on diseases disproportionately affecting poor populations. The members also will discuss the WHO’s latest efforts on counterfeit medicines, the impact of intellectual property rights on pandemic influenza outbreaks, and may be asked to reconsider a proposed change in its publication policy.

[Monday midday update: intellectual property issues are expected to be moved up the agenda and come up early Tuesday, which would lead to the formation of a working group to report back possibly by late Wednesday or Thursday, according to sources. The Executive Board report, which includes the publication policy issue, is expected to come up today. The publication issue also could arise with the agenda approval shortly.]

Official documents for the Health Assembly are here: http://www.who.int/gb/e/e_wha61.html. However, the IGWG documents are not yet available (see below for latest text).

But IP issues are likely to be contentious at the annual World Health Assembly, and appear to be headed for continued discussion in the coming year, according to official sources. The assembly will be held from 19 to 24 May, followed by a meeting of the WHO Executive Board.

Health ministers at the assembly will review the two years of work of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), whose mandate was to deliver this week a recommended global strategy and plan of action for neglected diseases. At its latest session earlier this month (IPW, WHO, 6 May 2008), the IGWG resolved over 100 provisions that had been bracketed (meaning not agreed), earning the praise of WHO Director General Margaret Chan.

But IGWG participants left at least about a dozen brackets, and these are among the most critical for the strategy. Bill Kean of the WHO secretariat told reporters last week that he expected some brackets would be “sorted out” but probably not all the IP provisions in the global strategy, especially relating to financing and costs. The plan of action also could be unfinished by the end of the week as well, sources said.

Kean said a working group is likely to be formed quickly in the week to work alongside the assembly during the week, doing the best possible that it can to resolve matters. The assembly then could give the right to the WHO secretariat to take the work forward, he said. It is possible that non-governmental groups and the media could be excluded from the working group if it operates in the same way as the IGWG, which involved closed subgroups with very few outside stakeholders present.

Draft Resolution: Another Year for Action Plan, Experts’ Group

The draft resolution on the draft global strategy [pdf] envisions the adoption of the global strategy pending discussion at the assembly and with language on the plan of action to be developed. The draft resolution also urges members to adopt and implement the strategy, and would extend discussion of the plan of action until the 62nd Health Assembly in May 2009.

The draft resolution also includes a mandate for a budgeted “Quick Start Programme” to guide implementation of the strategy. This would include mapping global research and development activities; supporting R&D and standard-setting for traditional medicines in developing countries; strengthening regulatory capacity, and supporting information-sharing and capacity building on management of IP for health innovation and public health; and urgently establish an expert working group to look at financing and coordination of R&D, to report to the 2009 assembly.

The draft resolution foresees the strategy and action plan reflected in the WHO programme budget, and the monitoring of implementation reporting next year and then every two years – through the Executive Board. The resolution appears to reflect the draft report by the IGWG to the Health Assembly.

Michel Lotrowska of non-governmental Médecins sans Frontières told an NGO gathering on 18 May that the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which sets the standard for IP and public health among other things, has brought no gain for public health, only high prices for pharmaceuticals.

He warned that the outcome of the IGWG negotiation could lead to language more restrictive than the TRIPS agreement, usually referred to as TRIPS-plus measures. He noted the already significantly weakened language in the draft global strategy on alternative methods for stimulating and finding funding for research and development for neglected diseases.

Expanding Efforts against Counterfeiting?

The WHO has stepped up its involvement in the fight against counterfeit medicines, and the Health Assembly draft agenda item on counterfeit likely will be discussed next to the IGWG, Kean said.

The assembly is expected to hear an update on the work of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), a global coalition it established in 2006. The IMPACT team within WHO has recently added an official from international police force Interpol who is now situated within WHO.

The WHO has been working to help clarify that counterfeit medicine does not equate to generic medicine, and has focussed on counterfeits from a public health standpoint rather than, say, an IP standpoint, according to sources. It will try to work more with governments on their efforts.

The report by the secretariat on Counterfeit medical products, A61/16, includes a description of IMPACT’s activities to date, as well as its plan for the future. For 2008, it said it would disseminate documents to convince decision-makers to strengthen national capacity to fight counterfeit products, finalise documents on issues such as packaging materials, sampling and testing, information-gathering and expanding the WHO alert system. In addition, it plans to design a comprehensive approach to preventing the online sale of counterfeit medical products, including targeting legislative and regulatory measures, investigation and enforcement, collaboration with internet service providers and electronic trade platforms, and warnings to internet users.

Another topic that may come up in the week is a possible new definition of counterfeit under the IMPACT programme that sources said could represent a significant expansion of the term.

According to an informal document circulated at the recent IGWG meeting, the current WHO definition is: “A medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.”

The proposed IMPACT definition is said to be: “A medical product is counterfeit when there is a false representation in relation to its identity, history, or source. This applies to the product, its container, packaging or other labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging.”

Avian Flu Pandemic and Patents

Yet another key issue with IP elements on the draft WHA agenda is A61/4 on the sharing of viruses and access to the vaccines and other benefits in relation to pandemic influenza preparedness. The main issue is that there would not be enough treatments for everyone in the world should a pandemic break out, and developing countries, including those sharing their strains of the flu, do not appear to be assured sufficient treatments. Part of the access issue relates to patenting of vaccines developed from the shared viruses.

WHO members held a meeting (IPW, WHO, 14 December 2007) on the pandemic flu issue last November, but did not resolve differences, planning another meeting for later this year. Kean said it was “unrealistic” to think they could resolve the issue in one meeting, and the group has made “frustratingly slow progress.” There is a “huge amount” of work to go, he said, and the Health Assembly will receive a progress report. In the meantime, the WHO has an internal tracking system for viruses shared into its programme for vaccine development, and the director general is developing an advisory mechanism for avian flu.

A key concern of developing countries has been that they may not have access to the vaccines developed from viruses they share into the WHO system, which is based primarily in developed countries. Patents related to avian flu research are on the rise, according to studies (including by the World Intellectual Property Organization).

Developing countries have offered several proposals on improving the system to ensure equitable benefit-sharing, such as using standard material transfer agreements, and point to international rules under the UN Convention on Biological Diversity. A key effort is to ensure developing countries get their right to access and benefits rather than receive a sort of charity, said Sangeeta Shashikant of the Third World Network.

The sustainability of the WHO sharing system relies on the sharing of virus strains, which relies on equitable sharing of benefits, Shashikant told the 18 May event. She also said the WHO tracking website showing which country shared a virus and who is using it is a “very good first start” toward transparency, but that it also should show what they are doing with it and how much they are profiting.

Shashikant called the pandemic flu issue an opportunity to explore new ideas on how research can be done collaboratively with the results being shared with all countries and with the aim to build capacity in developing countries.

Tighter Central Control Of WHO Publication Policy

Another controversy at the WHO is a proposed change by the director general to channel all WHO publications through her office for approval. This change arose after the United States complained about a study that reflected unfavourably on the effect of its trade policy on public health (IPW, Public Health, 26 September 2006). It is unclear whether there were other members who had complaints as well, but the director general’s office is proceeding with the plan and it is not on the Health Assembly draft agenda. Rather it will be addressed by the Executive Board next week, according to the WHO.

Kean said at the briefing that the intent of the secretariat is to ensure quality and accuracy in its publications, which are widely used and relied upon by a variety of stakeholders. “It’s important that we get it right,” he said. It also is to watch for duplication in publications.

But some have asked how the director general’s office will determine quality and accuracy as well as identify publications considered possibly controversial. Martin Khor of the Third World Network said at an 18 May event that this could lead to all sides of the issues to cast publications into doubt.

A group of more than 40 civil society members sent a letter dated 15 May to WHO Director General Margaret Chan raising concern about the publication policy that may amount to “self-censorship.” The letter cites possible differential treatment of some publications, as those describing the activities of a particular government or with policy implications for the WHO in controversial areas would be subject to additional clearance by Chan’s office. Chan urged the Executive Board earlier this year to trust her office not to be unduly influenced by any particular side. Civil society says her office should only look at technical issues in publications.

Another concern of civil society is subjecting publications by regional offices to scrutiny by Chan’s office. Other concerns are a proposal for a master list of planned publications subject to influence by the director’s office, and the possibility that the new policy might “de-motivate” staff from preparing the best publications possible.

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