World Health Assembly To Consider IP Resolutions Amid Flurry Of Side Events

By Tove Iren S. Gerhardsen and William New

The World Health Organization’s annual meeting on 22-27 May will consider at least three resolutions related to health and intellectual property rights. There is some overlap among them, and it remains to be seen how the meeting chooses to approach them.

This will be the 59th World Health Assembly (WHA) of the 192 member states of the WHO.

The first IP resolution on the agenda falls under the headline, “International trade and health” (agenda item 11.10). This refers to Resolution EB117.R5, which calls for “greater understanding of and response to the interplay between international trade and health and for work towards policy coherence between the trade and health sectors,” the WHO said.

This would mean that health and trade ministers in various countries would work more closely and be familiar with issues in areas where their work overlaps.

This resolution was adopted by the WHO Executive Board meeting in January and reflects amendments proposed by member states, according to the WHO. This was adopted easily at the Executive Board meeting, which may indicate that this will not be among the most controversial IP resolutions.

The second IP resolution on the WHA agenda (item 11.11: intellectual property rights), however, was subject to “extensive debate and informal consultations,” as the WHO notes in the agenda – but was also recommended by the board for consideration by the WHA.

This is resolution EB.117.R13 on a new global framework on essential health research and development, originally proposed by Brazil and Kenya. (IPW, 28 January 2006, Public Health).

“Despite positive discussions, agreement could not be reached on all proposed amendments and the text of the resolution recommended to the Health Assembly for consideration contained wording in square brackets that was open to discussion,” the WHO said.

The EB117.R13 resolution was debated under the “intellectual property rights, innovation and public health” agenda item of the board meeting, but at that time in January, a report from the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) had not yet finalised its report.

This report was published on 3 April and a “mini-Executive Board” meeting was held shortly afterward at which two representatives from each of the WHO’s six regions were present. They agreed on another resolution based on the report, which contains elements similar to the EB117.R13 resolution.

A report on the “mini-EB” meeting, including the resolution, will be discussed at the Health Assembly, also under agenda item 11.11, according to the programme.

Under agenda item 11.13, the “WHO’s role and responsibilities in health research” will be discussed, but this time under another resolution (EB117.R6).

Side Events Around the Assembly

A number of side events have been held or are scheduled to be held leading up to and during the assembly.

On 16 May the Drugs for Neglected Diseases Initiative (DNDi) held a meeting at the UN called, “Appeal to WHA: Waking up governments for research on neglected diseases.” DNDi highlighted the two draft resolutions on R&D to be addressed by the assembly.

Guilherme Patriota of the Brazilian Ministry of External Relations spoke at the DNDi event. He said, “In the next few days, world governments have an opportunity to support essential health R&D through really innovative and modern non-proprietary mechanisms,” according to a DNDi release. “We have begun to move in the right direction but it is essential that we develop better and new health tools to improve the long-term health both of the patients and of the developing countries.”

DNDi also raised the “R&D Appeal” for more investment in neglected diseases that it launched in June 2005. “In just over 10 months, more than 5,400 scientists, policymakers, industry and NGO members have signed onto the appeal,” it said.

On 19 May, Médicins Sans Frontières (MSF) hosts a discussion in Geneva on the CIPIH report in which the commission chair Ruth Dreifuss will take part. In a release, MSF said it is “calling on governments to overhaul the way medical research and development is prioritised and financed,” and to support the Kenya and Brazil resolution. MSF said the WHO secretariat has consistently obstructed the resolution despite growing support from governments.

The Consumer Project on Technology is also scheduled to hold two side events during the assembly, both at 6pm, it said. On 24 May, a panel will address the proposed R&D resolutions, and on 25 May, a panel will address more broadly new ways to stimulate research and development.

Industry is also gearing up for the WHO gathering. The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) invited a small number of UN-based journalists to a “media briefing” on 18 May. IFPMA used the event to register its opposition to the R&D resolutions and to push for problems to be addressed through more public-private partnerships, participants said. A representative of the group also denied that industry had seen the CIPIH report unfairly before other non-governmental sectors, despite evidence that the representative did see the report or a portion of it early.

On 21 May, Les Entreprises du Médicament (Leem), a French pharmaceutical industry association, will host an event in French featuring speakers such as the ministers of health of Mali and Lebanon, followed by a dinner at the Intercontinental Hotel.

Also in the evening of 21 May at the Intercontinental, the International Policy Network, a London-based think tank generally seen as favourable to the pharmaceutical industry, will hold a panel on the impact of intellectual property protection on health care in less-developed countries. Panelists include: Bibek Debroy of the Indian Chamber of Commerce, Barun Mitra of the Liberty Institute (India), Jasson Urbach of Africa Fighting Malaria (South Africa), and Philip Stevens of the International Policy Network.

Does the WHO ‘Have the Stomach’ to Lead on R&D?

Separately, but also in the lead-up to the assembly, the WHO held a discussion on 9 May on the CIPIH report and published a special issue of the WHO monthly bulletin focusing on intellectual property and public health.

At the WHO panel, Ellen ‘t Hoen of MSF said that governments are “waking up” to the lack of research into neglected diseases, of which the WHO resolutions were proof. But ‘t Hoen said WHO leadership is lacking on the Brazil and Kenya resolution. “I do not see a great sense of leadership coming out of the WHO in this field,” she said, adding that it was probably “a danger” to say this “in this building, but it needs to be said.”

A WHO official took issue with the comment, saying that, for example, an international clinical trials register is being developed at the WHO.

‘t Hoen replied that there is a lot happening in the WHO but still there is an absence of leadership and it is not enough to call for public-private partnerships or more funding alone.

Another WHO official pointed out that one had to be more specific on what the WHO was doing wrong, as the WHO could be both the secretariat and its member states, and that the WHO was being “attacked on both sides.”

Adrian Towse, director of the Oxford University Office of Health Economics, said that for the development of products such as vaccines for neglected diseases, “IP is necessary but not sufficient,” and he said purchasers such as the Global Fund to Fight AIDS, Tuberculosis and Malaria are needed.

But he said that while only 20 dugs for such disease were developed during the 25 years up to 2000, 63 drugs have been registered or are in development since 2000. Towse argued that public-private partnerships have generated a “pipeline that did not exist five years ago.”

David Winters of the Global Fund talked about philanthropy. He said he was surprised to see the number of times the Gates Foundation was mentioned in the CIPIH report, and said it raised concern to rely on one donor. Winters warned against “drive-by grant-making” and said it is important to “go there, live there, stay there.”

He said the WHO should take the “intellectual and moral leadership” on medicine, but the question, he said, is whether the WHO “has the stomach for it?”