Slow Going On Intellectual Property, Innovation Strategy At Health Assembly

[Note: new 23 May draft text of strategy and plan of action posted to IP-Watch Subscriber section]
By William New
Negotiators of a global strategy to boost innovation in and access to treatments for under-researched diseases largely afflicting the poor this week are working behind closed doors in increasingly smaller groups and have a few breakthroughs to report so far, according to some participants.

Still to be agreed at the World Health Assembly as of press time were tough provisions on competition, test data, data exclusivity, training of patent examiners, a right to public health, counterfeiting and pricing policies. Officials did reach tenuous agreement on global patent databases, measures beyond existing international trade rules, types of diseases covered, and boosting the role of the World Health Organization in international intellectual property policy, the participants said. No new text on any provision is available. The text from the start of the week is available here.

The 61st annual Health Assembly is taking place from 19 to 24 May. IP issues are being address under an agenda item of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). The group was mandated two years ago to draft a global strategy and action plan on neglected diseases, Assembly document A61/9. Also being discussed this week is a draft resolution aimed at strengthening WHO involvement in anti-counterfeiting issues.

Since the second day of the assembly, IP and public health officials have been working in a closed-door drafting group sometimes till midnight to reach consensus on a small number of intellectual property-related provisions in the global strategy, and to begin work on the action plan. All of the other provisions in the draft global strategy were previously agreed.

On Thursday, the negotiating group on the strategy got even smaller, with interested parties in the room working in an informal status. A separate informal group was set up to work on the action plan, according to participants.

Officials remained relatively hopeful they would complete the week with a consensus document. But several ideas began to circulate on how to take the discussion forward if it does not finish by Saturday, sources said.

Stepped-Up IP Role for WHO; Human Rights Showdown

A breakthrough on Thursday was on Article 15 in the principles of the global strategy, on the WHO Constitution, which was agreed after some changes to the language. According to government sources, it calls for the WHO to play a “central” role in policies on public health, innovation and intellectual property, within its mandate, and in order to achieve this, it shall strengthen institutional competencies and programmes to implement the global strategy and plan of action.

There also appeared to be consensus on a sticky provision on which classifications of diseases the strategy would relate to, which was found in a footnote to Article 14.b. The changed language removed the specificity and made the strategy more flexible, broader and more inclusive, according to negotiators. The article also retains a reference not only to Type II (found in both developing and developed countries, but mostly developing) and III diseases (found overwhelmingly or exclusively in developing countries), but also Type I diseases, which are found in large numbers in both developing and developed countries. The strategy will apply to Type I diseases only as they relate to developing countries.

At press time, the debate had turned to a different provision, Article 18, which states, “The objectives of public health and the interests of trade should be appropriately [coordinated and mutually supportive]/[balanced and coordinated.]]” The United States objected to the reference to “right to health takes precedence over commercial interests,” as it might create a new human right that would be taken as an obligation by member states, and could lead to new entitlements, an official said. Some developing countries were pressing for the provision.

During the week, Article 17 of the principles, which also dealt with human rights and health, was dropped by consensus, according to sources.

On the patent database, a provision (Article 5.1.c) mandating WHO to compile, maintain and update global patent databases was watered down out of concern by some developed countries such as Switzerland that the health agency not reproduce existing databases at significant expense and effort unless necessary.

A developing country official said the WHO will provide compiling, maintaining and updating on patent databases and that the provision as redrafted does not prejudge what will be in the database. But a new database does not have to be rebuilt from the start, a source said.

A non-governmental source told Intellectual Property Watch that the WHO has published compilations and updates in the past and that it can be used for procurement purposes. The source also said what is important is what is included in the database. Governments and NGO purchasers need to know where they can buy health products, so it is important to know where a patent has been revoked at the national level, or follow leads on where certain products are in the pipeline for development.

The language on “TRIPS-plus” issues (Art. 5.2.b) appeared to be reworked for governments to consider health aspects of new measures that are stronger than the 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which many smaller economies are already struggling to adopt.

Discussion on a provision in the global strategy mentioning counterfeiting (Art. 6.2.e) was delayed apparently until another Health Assembly committee can address a draft resolution setting out the work plan for the WHO on counterfeiting, which is expected on Friday.

Other provisions that have changed but still are not agreed are on the impact of data exclusivity on access to medicines (Art. 5.3.b), policies promoting competition in health products (Art. 5.3.c), and pricing (Arts. 6.3.d and 6.3.e, both pending United States approval). On an additional provision (Art. 5.3.d) relating to patent examiners taking a public health perspective into account, references to guidelines and patentability criteria were removed by developed countries, one participant said.

US biotechnology, pharmaceutical and medical device industry representatives received informal briefings from a member of the US delegation before this evening’s activities. Groups representing consumers did not appear to receive a similar briefing. On hand at the meeting are a number of representatives of medical devices industry, who are concerned about the inclusion of their products in the strategy, sources said.

Pandemic Flu

Earlier in the week the assembly completed the agenda item on pandemic influenza, taking note of the progress report from the November 2007 meeting. A number of member states made statements generally accentuating the importance of equitable access to treatments, and ensuring the WHO virus sharing system is working as well as possible.

Canada, according to sources, proposed an informal session in early autumn to iron out issues as much as possible before the next full meeting on the issue, in November.

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