The United States today made clear its opposition to a World Health Organization (WHO) resolution that aims to promote research and development into neglected diseases, and which is scheduled to be discussed at this week’s WHO annual meeting. Meanwhile proponents of the resolution are finding it difficult to operate, according to sources.

The draft resolution, entitled, “[Global framework on] essential health research and development (EB117 R13),” was first proposed by Brazil and Kenya and was forwarded by the WHO Executive Board meeting in January to the World Health Assembly (IPW, Public Health, 28 January 2006). The assembly is being held from 22 to 27 May.

The draft resolution requests the director general to establish a working group of interested member states to “consider proposals to [establish a global framework for supporting] [strengthen incentives and mechanisms for] needs-driven research, consistent with appropriate public interest issues.” The resolution also requests the director general to “[suggest alternative simplified systems for protection of intellectual property, with a view to enhancing accessibility to health innovations and building capacity for product development, uptake and delivery in developed and developing countries.]”

The brackets show areas of remaining disagreement. A health attaché at the US mission in Geneva told Intellectual Property Watch that some of the brackets in the resolution, including those in the headline, have been suggested by the United States.

He said the United States opposes the suggestion that R&D in this area should be subject to intergovernmental procedures and a binding treaty, adding that the US wants “a different approach” to the same problem. He said the US acknowledges that there is a problem but said how the framework suggested in the resolution would work is “utterly beyond us.” He was not able to clarify exactly what approach the United States would suggest, however.

At a press conference of the US mission in Geneva on 22 May it also became clear that the main focus of the US government during the assembly is international mobilisation to fight a possible avian influenza pandemic outbreak, as this is the objective of US Health and Human Services Secretary Mike Leavitt.

In his remarks to the briefing, Leavitt did not mention the R&D resolution specifically, but said that the US would continue to advocate the position that intellectual property creates incentives.

But William Steiger, special assistant to the secretary for international affairs, when asked about the resolution, said that the United States is “still studying a number of aspects” in the resolution and is engaged in discussions. He said that a treaty is not the best answer, and the United States would “prefer not to see such a rigid structure.”

A related resolution based on a recent report from the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), which was forwarded at a representative Executive Board meeting on 28 April, has also not been posted on the website together with a report as was scheduled, sources have pointed out (IPW, Public Health, 28 April 2006).

The resolution from the CIPIH report suggests establishment of an intergovernmental working group to develop a global strategy and plan of action based on the recommendations of the commission. It would particularly address “ways of addressing diseases that disproportionately affect developing countries.”

R&D Resolution Supporters Watchful for Fair Treatment

Meanwhile, supporters of the Kenya and Brazil resolution were working before the assembly’s start to ensure fair consideration by the assembly of the R&D resolutions.

Some non-governmental organisations questioned the fact that the R&D resolutions are not easily located on the WHO website under documents for the assembly.

Questions also were circulating about the fact that CIPIH Chair Ruth Dreifuss will not present the CIPIH report to the assembly.

In addition, Consumers International and the Consumer Project on Technology were concerned when told that no space could be found at the United Nations for their 24 May meeting on the R&D framework, and it had been offered instead to hold its event at the end of the assembly. But now the event will be held on 23 May at 6pm, with another, broader look at the issues on 25 May. Kenya will hold a briefing on its resolution on 23 May at 12:30 to 2pm, a source said.

A WHO spokesperson told Intellectual Property Watch that the R&D resolution is listed under the “Executive Board” documents and not the WHA. The spokesperson also said there is nothing unusual in the fact that Dreifuss will not be presenting the CIPIH report as presentations are never given at the assembly unless an issue is being presented for the first time, the spokesperson said, adding that this is “normal procedure.”

Separately, five members of the US Congress also called for a fair debate on the resolution in a 19 May letter to Leavitt. They are: Tom Allen (D-Maine), Dan Burton (R-Indiana), Lloyd Doggett (D-Texas), Bernard Sanders (I-Vermont) and Dennis Kucinich (D-Ohio).

In the letter they state that, “The WHA proposal to discuss new ways to addressing the global sharing of R&D costs is timely and important, and should be supported by the United States government.” It further states that if the United States wants to be taken seriously by its trading partners regarding its concerns about the global R&D burden, it should allow for “a full and fair debate” on the resolution.

Industry Event Echoes US Message

The United State’s resistance to the R&D resolution was echoed by panellists at an industry-sponsored event on 21 May on the impact of intellectual property on healthcare in developing countries. But a number of people in the audience expressed disappointment that the presentations were not balanced.

The event was held by the International Policy Network (IPN), and the message was that the main problem for access to medicines is poor infrastructure in developing countries, and that organised pharmacists may drive up the prices of drugs. IPN is seen as supportive to the pharmaceutical industry.

The moderator of the panel and executive director of the IPN, Julian Morris, directly stated his opposition to the R&D resolution, questioning why new mechanisms for innovative medicines should be developed when generics available today do not reach patients due to distribution problems. “What is the point of developing drugs when they cannot be distributed?” he said.

Barun Mitra of the Liberty Institute in India agreed and said he does not support government-funded R&D. He said the resolution was “unlikely to fly” and would “not be implemented in any case.”

Mitra said that even if these medicines were to be given for free, not many people would receive them because if the “extremely poor infrastructure.” He also said it was “extremely important to understand the importance of IP for development as such,” referring to the introduction of the Indian patent law for pharmaceuticals in 2005.

Jasson Urbach of Africa Fighting Malaria in South Africa said the private healthcare sector in his country was the “superior sector” and it is no need for the government to dominate health. He said that because of a recently decided regulation, 44 community pharmacies have now closed down in the poorest areas of the country. A person in the audience said that these had been community-owned pharmacies and that new players would open new pharmacies.

Urbach also said that if the South African government is serious about access to medicines it should remove the tax on the medicines. Also, regulatory affairs is a problem with 25 months approval time on average for generic medicines and 36 months for new medicines, he said.

Bibek Debroy of the Chamber of Commerce and Industry in India also advocated the private healthcare sector. He said that in terms of patents India had thought of short-term objectives and not ensured that innovation takes place. He also said that while there used to be 25,000 pharmaceutical companies in India, now there are some 6,000 and they have not closed down because of patents.

But many in the audience took issue with the presentations such as a woman from South Africa. She said Urbach’s talk was not balanced and only painted a bright picture of the private healthcare sector. “The public sector may have problems but it provides free health services,” she said.

Another South African asked rhetorically how many people living with AIDS would be able to afford drugs if everything were in the private sector. A person in the audience echoed this, saying that in the United Kingdom there was a price issue between private and public care.

A WHO representative said that price controls are not the problem but taxes and mark-ups are, mentioning countries in which the price of a generics medicine is set down from the top price instead of being calculated up from the base. Mark ups are the price hikes pharmacies add to medicine prices.

Dr Lee Passes Away

Separately, the WHO Director General for the past three years, Lee Jong-wook, passed away on 22 May after having been hospitalised on 20 May for a blood clot in his brain, the WHO says. “The sudden loss of our leader, colleague and friend, is devastating,” the WHO said in a statement.

Anders Nordström, currently assistant director general for general management, will serve as acting director general, the WHO said. The WHO said the assembly will proceed more or less as scheduled but the opening reception has been cancelled.