By William New
The member governments of the World Health Organization finished an intensive week of negotiations on ways to improve access to healthcare for poorer populations with significant progress on a framework. But difficult work remains for the next session, participants said.

“I’ve been very much impressed by the level of engagement,” WHO Director General Margaret Chan told the closing session. At the secretariat, she added, “We are gearing ourselves to do more.”

The Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) is mandated to come up with a strategy and plan of action before the May 2008 World Health Assembly. The aim is to address insufficient research and development on diseases disproportionately afflicting the poor [Clarification: the overall aim is broader than R&D.]

The next meeting of this IGWG was agreed tentatively for 28 April to 3 May. A secretariat document will be prepared on work so far. It will include language that is agreed, bracketed (discussed but not agreed), and that which was not yet discussed. Members can comment on the undiscussed section until January, and the secretariat will issue a document on these comments. Meanwhile, on the subgroup work on a plan of action, a separate note will be prepared, and a two to three-day meeting is planned immediately after the January Executive Board meeting.

Chan reaffirmed the WHO secretariat’s commitment, and her personal commitment, to the work of the group, and promised more to come.

At the closing session on Saturday, Ahmed Ogwell, head of international health relations at Kenya’s health ministry, set a serious tone for the continuation of the meeting.

“Let me remind us that the reason why we are meeting and exchanging ideas is precisely because the current systems have failed to respond to the health needs of the poor,” Ogwell said. “Existing health products are too expensive for the poor and the so-called Types II and III diseases are not being given attention in research and development. I hope, chair, no one will put square brackets around that phrase.” That refers to brackets placed on negotiating text that is not yet agreed.

“The health sector is the final common pathway of human endeavour,” Ogwell continued. “If any sector fails, it becomes a health problem, be it in transport, environment, trade or even politics.”

“It is also clear to us,” he added in prepared remarks, “that current proprietary regimes have also resulted in major health problems for Africa and the world. Avoiding facing the real issues will not address the original problems that led to the establishment of the IGWG.” Ogwell further cited the importance of finding sustainable funding models for R&D.

Members both publicly and privately stressed the good spirit of the meeting. Some questions arose over whether there were delay tactics by debating semantics in order to extend the momentum in a process that could lead to significant change in the existing R&D system.

A developed country participant said they are seeking a substantive action plan, and while they hoped for completion this week, the highest priority for those countries is a good outcome.

But a developing country official asserted to Intellectual Property Watch, “The fact is, it takes a great amount of time and effort to remove the huge square brackets that the industry has placed around the word “health” and around the World Health Organization as the UN body in charge of promoting it to the benefit of humanity, above and beyond considerations to do with trade interests or the interest of intellectual property rights holders.”

Industry groups say they share the concern about achieving substantive improvements to health in poor populations. But a central issue is the “overall maintenance of the incentive model” based on patents, and building on it rather than replacing it, said Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

“I am fairly confident that the IGWG, at the end of the day, will look at special means and not undermine the system” by instituting measures that are less stringent than the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Bale said in an interview.

As an example of complementary thinking, Bale cited section 11.02 of the renewal of the Food and Drug Administration mandate passed in September, which allows expedited treatment of drugs developed for tropical diseases. Shorter time to market can help companies recover costs sooner, he said.

But some participants said the meeting showed that support is growing for more substantial change, though none said there is push to dismantle the patent system.

While industry and developed country governments seek additions to the existing system, such as more public-private partnerships, a consensus portion of the text states that the initiatives taken in recent years are “not sufficient to surmount the challenges of meeting the goal of ensuring access and innovation for needed health products and medical devices.”

This could be interpreted as “members have agreed that more of the same is not sufficient,” one participant said.

Sisule Musungu, who participated in the meeting as a WHO-invited expert, said it was a good conference and that the IP section appeared to be the most difficult. But the lengthy discussions that were held have led a better understanding of issues and positions, which may lead members to make a change in the system, he said.

“I think they’re moving in a direction where it could have a serious impact on the type of research that this group is supposed to work on, and serious consideration of new ideas that are proposals on the table,” Musungu said afterward.

Nicoletta Dentico of the Drugs for Neglected Diseases Initiative, who sat in on the negotiations, said afterward that “the political culture around these issues is changing,” and noted that the highest level within the WHO has given it attention. Dentico said efforts would be made to keep the momentum going on the issue until the next meeting.

Drafting group B adopted plan of action report with brackets to be worked on again in January. The 9 November version showed progress on plans to map global R&D to identify gaps of neglected diseases, developing prioritised strategies – including traditional medicine, increase funding, improve health research programmes, improving cooperation, and promoting greater access to knowledge and technology.

In the closing session, the United States raised concern, seconded by Europe, that some introductory text does not accurately reflect discussion precisely. It appeared to be generally understood that technical changes may be necessary to the text.

NGO Reaction Positive

“This week the whole world joined the i+a [innovation+access] movement,” James Love, director of Knowledge Ecology International, said afterward. “This is a very serious and important discussion on the need to reconcile innovation and access.”

“The progress was slow, but the issues are very tough,” Love added. “The language is good. What I found impressive was the very serious way that each delegation engaged the substance. They are trying to find the right tone, and the right direction, and they are working on the most difficult and important issues.”

“What is most encouraging is that governments have decided that business as usual won’t do anymore,” Michel Lotrowska, a campaigner at Médecins sans Frontières’ Access to Essential Medicines Campaign, said in a statement. “They are open to exploring entirely new ways of financing essential health research, in such a way that the fruits of innovation are accessible to those who need it the most. One example is the decision to pursue discussions on an essential health and biomedical R&D treaty.”

“We are getting a sense that countries are pushing WHO to be more active in resolving the access to medicines crisis, and take a pro-health approach to intellectual property,” Lotrowska said. “And governments are taking steps to address the fundamental reasons why investment into innovation for diseases of the poor is lacking.”

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