By Tove Iren S. Gerhardsen
The Indonesian government’s reluctance to share avian influenza virus samples to help develop a global vaccine for humans has revealed a weakness in the international flu research system related to developing countries’ concern with the impact of intellectual property rights on public health.

Developing countries are concerned that if they supply avian influenza virus samples for free to the international health community under the World Health Organization (WHO) system, the samples will be used to develop patented vaccines targeted to wealthy countries and too expensive for developing countries to purchase. The market for traditional influenza vaccines has been in industrialised countries, so it has been a “north-north process,” a WHO official told Intellectual Property Watch.

“We are very worried,” an Indonesian official told Intellectual Property Watch, adding that there is an “unfair mechanism” regarding the sharing of samples of viruses. Some manufacturers will use the samples to develop vaccines, but there is no guarantee that poor developing countries such as Indonesia would be provided with the vaccine, as manufacturers’ production capacity is only 40 million, he said, referring to the more than 6 billion people in the world. There is a “high gap in demand and supply,” he said.

Indonesia is the hardest-hit country in terms of human deaths from avian influenza, according to the WHO, which said there has been a total of 277 cases of avian flu in human beings worldwide.

The sharing of virus strains links into another current IP policy issue. The virus samples taken from people affected by H5N1, the most common avian flu virus, also may be considered genetic material to which, according to the Convention on Biological Diversity (CBD), countries have a sovereign right. If others want to use the genetic material to develop a medicine, for example, they would have to ask permission, disclose the source of the material, and share the possible benefit of the outcome with the owners of the genetic material.

But as the CBD is soft law and not legally binding, a number of developing countries are pushing to amend the legally binding World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to include this requirement in patent applications. The relationship between the CBD and TRIPS is one of the most important issues for developing countries in the current round of trade liberalisation negotiations at the WTO, referred to as the Doha Round.

Direct to Industry

As a result of the concern over sharing, Indonesia has been in talks with the US pharmaceutical company Baxter for several months regarding use of the samples for developing and producing a vaccine for the Indonesian domestic market, sources said.

A Baxter spokesperson told Intellectual Property Watch that no deal had been struck and no samples had been shared, but Indonesia and the company had been in talks for “quite some time” and had in February signed a memorandum of understanding as a framework for continuing discussions for possible development and production.

But the memorandum was not a contract and did not grant Baxter any exclusive rights to the virus strains nor did it exclude Baxter from working with anyone else, she said. Baxter has an avian flu vaccine in clinical trial development based on a virus strain from Vietnam that it got for free from the WHO collaboration system, the spokesperson said. It said the United Kingdom government has ordered two million stockpiles of Baxter’s candidate vaccine for avian flu.

Indonesia has also been in talks with WHO, and another high-level meeting has been scheduled for 27-28 March in Jakarta. But as of 7 March Indonesia had not shared samples with WHO, the WHO spokesperson told Intellectual Property Watch. “There will certainly be member states from the region and beyond, technical experts from WHO, maybe the vaccine manufacturers, and others,” another spokesperson said. “At this point it is a technical meeting to hear the concerns of member states and to see what options can be developed immediately as well as for the mid and long-term.”

The first WHO spokesperson said there have been “private discussions” between the Indonesian Minister of Health, Siti Fadillah Supari and David Heymann, WHO acting assistant director general for communicable diseases.

The spokesperson said the UN agency understands the need of Indonesia to ensure an adequate vaccine supply for its people, but said at the same time it is important for WHO to ensure that a vaccine will be developed and available to the public health community.

The Indonesia case also shows that a 50-year-old system under the WHO of sharing influenza virus samples that has been tailored mainly for the developed world needs to be updated for serious diseases mainly affecting poor countries, he said. WHO already is looking at updating the system through its Global Vaccine Action Plan.

WHO is working on transferring technology to developing countries for the production of vaccines under licenses, and a number of developing countries have expressed interest.

The Current System of Sharing

There is no legally binding requirement to share samples, but a voluntary system has been in place for common seasonal influenza for more than 50 years, the WHO spokesperson said.

Under this system, countries have submitted virus samples to the four centres for collaboration on research on influenza under WHO (located in Tokyo, Melbourne, London and Atlanta). These samples have been available free to any company interested in using them to develop vaccines, the spokesperson said, but there has only been a market for these vaccines in developed countries.

But now there are new issues as avian influenza affects developing countries, and changing the system may be a natural continuation of the current system, he said. Before Indonesia, no developing country had wanted to ensure access to an influenza vaccine before submitting samples. To date, countries that have been affected by avian influenza have shared their samples with WHO, he said.

The spokesperson said that it is “very important” to share virus samples as the viruses change quickly and mutate, and it is necessary to look at all samples to get the best risk assessment and produce an ever better vaccine.

Baxter has encouraged the Indonesian government to share its samples with WHO and possibly work in parallel with the company and WHO, the spokesperson said. The Baxter spokesperson said the company’s role is to develop a vaccine and not to have ownership of the strains, adding that it has been working very closely with WHO.

A joint statement from the Indonesian health ministry and WHO dated 16 February said: “Both WHO and the ministry of health of Indonesia agree that local capacity to produce vaccines is the long-term solution to ensuring availability and access to influenza pandemic vaccine.”

But it is also stated that Indonesia has committed to sharing the samples. “The minister agrees that the responsible, free and rapid sharing of influenza viruses with WHO, including H5N1, is necessary for global public health security and will resume sharing viruses for this purpose,” the statement said.

Separately, French pharmaceutical company Sanofi-Aventis, has submitted an avian influenza vaccine for registration at the US Food and Drug Administration. WHO said that 16 manufacturers from 10 countries are developing prototype influenza vaccines against H5N1 avian influenza virus, and more than 40 clinical trials have been completed or are ongoing.

Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.