Counterfeit Medication, R&D Financing Key IP Issues At WHO Board Meeting

By Kaitlin Mara
The Executive Board of the World Health Organization meets next week with significant discussion expected on a new secretariat report on counterfeit medical products as well as on the implementation of the WHO’s mandated global strategy on public health, innovation, and intellectual property. There has been significant interest from a variety of sources in an expert working group formed as a part of the global strategy, which met for the first time this week.

Avian influenza, also an agenda item at the 19-27 January Executive Board meeting (EB), is less likely to generate discussion, several sources said, as a consensus text could not be finished during the intergovernmental meeting on pandemic influenza preparedness in December (IPW, WHO, 15 December 2008), and the gathering was suspended with plans to reconvene in May.

A list of documents publicised for the board meeting is available here.

R&D Financing Experts Meet

The expert working group on financing and coordination of research and development for neglected diseases, seen as a key innovative outcome of the global strategy on public health innovation and intellectual property, had its first meeting from 12-14 January. Creating and implementing a global strategy aimed at under-researched diseases predominantly afflicting poorer populations was mandated by WHO member governments at the May 2008 World Health Assembly.

The 24-member group of experts (primarily drawn from governmental and intergovernmental agencies), formally announced in November (IPW, WHO, 19 November 2008), heard two days of presentations from stakeholders. These presenters were from both inside and outside the WHO, and included at least some think tanks and industry groups, and provided information on the current state of research and development, including where gaps remain.

Group Chair Sir George Alleyne of Barbados, said that while the informational presentations were heard, it would be “premature” to make any conclusions about substance at this point in the process.

The major focus of the final half-day meeting on 14 January – where the experts met in private – was on procedure, Alleyne told Intellectual Property Watch. This included confirming the terms of reference for the group that are contained in paragraph seven of the global strategy document [pdf].

The global strategy tasks the WHO, member states, and other stakeholders with assessing priority needs of developing countries in medical research and development, improving developing country capacity for R&D, implementing alternative funding strategies and incentive schemes to stimulate R&D, boosting technology transfer, and generally improving access to health products.

The strategy was the result of a process begun with the Commission on Intellectual Property Rights, Innovation and Public Health, established at the annual WHO World Health Assembly in 2003. The work of the Commission gave rise in 2006 to the Intergovernmental Working Group on Public Health, Innovation, and Intellectual Property (IGWG), which eventually succeeded in drafting a global strategy and plan of action on public health, adopted at the World Health Assembly in May of 2008 (IPW, WHO, 29 May 2008).

This paragraph mandates the working group to “examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific research and development needs of developing countries in relation to Type I diseases, and open to consideration of proposals from Member States, and to submit a progress report to the Sixty-second World Health Assembly and the final report to the sixty-third World Health Assembly through the Executive Board.”

Type I diseases are found in large numbers in both developing and developed countries; Type II diseases are found in both developing and developed countries, though the primary instance is in developing countries; and Type III diseases are found either overwhelmingly or exclusively in developing countries. The sixty-second World Health Assembly will be held in May 2009, and the final report of the expert working group is expected to be submitted for the Assembly in 2010.

The group this week asked the WHO secretariat to find documents and data related to the areas it is meant to examine, Alleyne told Intellectual Property Watch. The group does not expect to submit a progress report to the EB next week, he added, other than to say that they met. The EB consists of 34 individuals nominated by member states from the WHO’s seven regions; its purpose is to advise and facilitate the work of the World Health Assembly.

General Progress on Global Strategy Unclear

What other progress has been made on the implementation of the global strategy is unclear, and the WHO secretariat has refused to answer questions in that vein. The plan of action for implementing the global strategy still had outstanding components that were expected to be finalised by next week’s EB, and many watchers are asking questions about a “quick start programme” calling for any elements of the global strategy and plan of action falling under the WHO’s responsibility to receive “immediate” attention after the strategy’s approval in May 2008.

One diplomat characterised the progress as “slow,” and another noted that there was clearly work being done but that it was as yet unclear how much had been accomplished.

The Pan-American Health Organization has made notable efforts to find ways to implement the global strategy on a regional level [pdf].

A progress report released by the secretariat on 20 November [pdf] claims the plan of action has been finalised, though the only publicly released document from this work is a series of progress indicators made public on 18 December [pdf]. However, the indicators are non-specific, including neither dates nor numbers that would be considered progressive success.

One non-governmental source called it a “weak document” and “lacking in detail.” For example, an indication of progress in promoting research and development is said to be the “number of countries whose national strategic plans for the health workforce and related professionals include a research and development component.”

But several member-state sources expressed confidence that the plan of action would be finalised this week. An informal meeting hosted by Norway and Canada is meant to take place this Sunday to help this process along, according to one. One of the most controversial items is expected to be that related to a research and development treaty, which makes several developing countries uncomfortable.

On the quick start programme, the 20 November document says the WHO has initiated these activities: “(i) mapping of global research and development activities, identification of research gaps and research priority setting; (ii) supporting research and development and promoting standard setting for traditional medicines in developing countries; (iii) developing and strengthening regulatory capacity in developing countries; and (iv) development of a monitoring and reporting framework,” though the organisation has not provided specific details as of yet.

A delegate from a developing country said it would be good to see more information on where the WHO stands in regards to building its own capacity to implement the global strategy, a task contained in article 15 of the original WHA document.

Counterfeit Medication

The new report on counterfeit drugs released on 18 December also is likely to generate discussion, as some sources are concerned about what they see as contradictions between this report and earlier WHO statements on counterfeit drugs, and others are concerned about what they see as internal contradictions in this report.

A meeting of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) — a taskforce of anti-counterfeiting stakeholders, including pharmaceutical industry associations and drug regulatory authorities, international agencies and non-governmental agencies, and enforcement bodies, launched by the WHO in 2006 – in Tunisia in December 2008, for instance, defined counterfeits in such a way that “disputes about patents” would not be accidentally equated with counterfeits. However, the new report contains the broader statement “recognising that disputes about IP rights are not to be confused with counterfeiting.” A developed nation delegate said that the patent definition is preferable, but expected disagreement on the issue. [Editor’s note: the secretariat issued a correction on 19 January, changing the the WHO report wording to “disputes about patents” rather than “IP.”]

The definition IMPACT agreed on is: “a product with a false representation of its identity and/or source. This applies to the product, its container or other packaging or 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.”

The definition by IMPACT adds that “violations or disputes concerning patents must not be confused with counterfeiting of medical products,” yet there is much concern — particularly on the part of developing countries and non-governmental agencies – that disputes concerning trademarks could still be conflated with counterfeiting.

The counterfeit drugs report will be the “big IP item” on the agenda next week, a developed country source predicted. A developing country source predicted a “very difficult discussion” on the document.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)’s director general Alicia Greenidge approved of the report, saying it “touches on some key issues concerning the fight against counterfeits, including the appropriate definition of a counterfeit medicine,” and endorsed the IMPACT definition. She added that “generic medicines play an important role in ensuring global health and are unfortunately themselves widely counterfeited, [therefore] it is important to have a definition which provides guidance that authorized generic medicines are not counterfeits and which also assures that patent actions are not confused with counterfeit actions … this will help authorities in both developing and developed countries to identify and address counterfeits of trademarked products, including the many authorized branded generics.”

But several non-governmental sources have expressed concern over the use of the term “counterfeit” in general – saying that legally speaking it is associated with violations of trademark law, a legal association which is confirmed in international law by its definition in the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement relating it specifically to trademark violations. They also say that even statements within the report itself that “legal instruments related to intellectual property rights have a broad scope and are not focused on the protection of public health,” cannot take away the fact that the terminology is focussed on IP and not on healthcare.

There was also concern, one non-governmental source said, that the WHO was simply “endorsing in total the work of IMPACT,” and that that work did not give priority to the real public health threat of substandard drugs.

A Brazilian delegate agreed with this assessment, saying “we do not want to see WHO as an agency of enforcement related to trademark,” and the use of the word “counterfeit” automatically brings in discussion of IP, especially given its presence in TRIPS. Further, the delegate added, the work of IMPACT was done outside the WHO and therefore “and we cannot simply import IMPACT recommendations without discussion.” It should not be legitimised as though it were an intergovernmental process, the delegate explained.

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