Health Assembly Officials Watch For Last-Minute Amendments

At the U.N. World Health Assembly negotiations in Geneva, officials have been watching carefully for the last-minute introduction of any amendments they view as unfavourable. This is true for all of the texts being developed, only some of which have a direct relation to intellectual property issues.

The assembly, which runs from 16 to 25 May, is the top annual event for the Geneva-based World Health Organisation. The halls outside the negotiating rooms are populated with industry representatives and non-governmental groups catching the ear of officials.

Intellectual property issues appear to varying degrees in assembly resolutions on malaria, tuberculosis, immunizations, influenza, and the ministerial summit on health research, according to one government source. With some, such as immunizations and influenza, shortages of manufacturers may be linked with the patent system, he said.

With some diseases, such as malaria, tuberculosis and HIV/AIDS, critics argue that the global system for patenting pharmaceuticals has led to those diseases being neglected. The argument is that a small market in wealthy countries makes those diseases less commercially interesting to industry, which then puts fewer resources into research and development in addressing them.

The United States as of Thursday afternoon was satisfied with the wording of the resolutions being developed at the assembly. “The U.S. can accept the language as drafted now,” an official said Thursday. Officials are watching for amendments and to see that they agree with the way each item is drafted. With 192 WHO member states, the possibility for amendments is significant, he said.

The U.S. position is to support regulations that “will ensure that intellectual property rights are respected,” the official said.

One U.S. concern is that bodies such as the WHO develop policies seen as consistent with other international bodies. “We don’t want the WHO to accidentally stray” into the responsible areas of other bodies such as the World Intellectual Property Organisation or the World Trade Organization, the official said.

The U.S. view also is that it is trying domestically and internationally to encourage greater protection of safe antiretrovirals against HIV/AIDS, he added, citing the U.S. drug approval process.

Moreover, the U.S. position is that patents are not the problem when it comes to global health crises. “We don’t believe intellectual property is a barrier to access,” he said. The bigger barriers are lack of infrastructure, production capacity and trained professionals, he said.

This message echoed one put forward by Michael Leavitt, U.S. Secretary of Health and Human Services (HHS), at a Tuesday press briefing.

Leavitt called intellectual property “a really important and constant concern to the United States” and “a fundamental of our economic principles.” Leavitt was asked about criticism of the Bush administration for limiting the supply of critical drugs in Africa by not allowing generic drugs but only brand-names. He replied that his office is working with the U.S. Food and Drug Administration and manufacturers from other nations to accelerate the approval of their drugs so they can be used as part of the Bush administration initiative.

William Steiger, an HHS official, said the department approved two manufacturers of non-branded medications that are providing drugs to the administration’s US$15 billion emergency plan, one of which is a South African company. He said many others are “in the pipeline,” and said, “We expect to see many other approvals during the course of the year.”

But a reporter noted criticism from the WHO and Médecins Sans Frontières that more effort is needed to approve generic companies. Steiger replied that even with approvals it is necessary for the regulatory authorities of the countries in need to license the product for marketing there. This has been “difficult” in some places, he said, so missions from the FDA have gone all over the world to expedite their approvals.

Leavitt, who took office in late January, was also asked for an opinion on Brazil’s decision last month to refuse $40 million from the United States for the HIV/AIDS program in Brazil because of the conditions placed on the assistance. Leavitt did not directly address the question of Brazil, which is currently under public pressure to issue compulsory licenses for drugs to fight HIV/AIDS, but said he met with the ministers of 15 nations who received U.S. aid and they expressed “optimism” and “gratitude.”

That, he said, is “a message I will carry back to the president, who I am sure will be pleased to know of their appreciation.”