Indonesia's move on bird flu samples highlights key access issues

The reluctance of Indonesia to freely provide bird flu samples to the World Health Organisation because of the fear that commercial companies would obtain them to develop patented products is understandable, since samples of other viruses given to WHO have previously been used by corporations to obtain patents.

The Indonesian government's announcement that it would stop sharing bird flu samples with the WHO unless the agency stopped providing the strains to commercial vaccine makers won the support from health officials in other Asian countries as well as sympathy from mainstream media such as the New York Times and New Scientist.

Earlier this month, Indonesia signed an agreement with the US drug company Baxter Healthcare to develop a human bird flu vaccine. Indonesia would provide H5N1 virus samples while the company would provide it with technology and expertise in vaccine production. The WHO and other organizations would have access to the samples only if they agreed not to distribute them to commercial companies.

Indonesian health officials explained that the move was to ensure that the people had access to the vaccine during a pandemic, as otherwise it would have to buy the vaccines from commercial drug manufacturers at high prices. They maintain that the WHO's virus-sharing mechanism has been misused for commercial purposes.

According to an Associated Press article: "Other countries, including China, Thailand and Vietnam, have previously stalled on sharing viruses. Like Indonesia, they fear [that] the vaccines and drugs produced from their viruses would ultimately be unaffordable for them, leaving their populations dangerously vulnerable - while rich countries add to their stockpiles."

Up to now, WHO Member States that experience bird flu outbreaks provide samples of the virus isolates to WHO collaborating centres. At these centres, the isolates are used in the process of creating vaccine seed stocks, frequently using patented techniques. WHO then provides the seed stocks to vaccine producers.

But the vaccine producers, say many developing countries, are charging too much for the vaccines. Several countries raised the issue at the World Health Assembly last May (See SUNS #6035 dated 29 May 2006).

However, the Indonesian withholding of its samples appears to be short-lived. On 16 February, the Indonesian Health Minister announced that the country would resume sharing influenza viruses with the WHO. A joint statement between Indonesia and the WHO said that in the short term, Indonesia will discuss with vaccine production companies to meet its vaccine needs and in the long term, Indonesia will work with WHO to develop its local vaccine production capacity.

The WHO will also work with Indonesia to develop Material Transfer Agreements and a meeting of Asian countries will be held to identify mechanisms for equitable access to influenza vaccine and production.

While Indonesia may resume sending its virus samples to the WHO centres, the issues it raised will continue to be hotly debated. The WHO and the corporations that hope to profit from making, patenting and marketing vaccines were outraged by what they saw as a defiant act, while officials in other developing countries were encouraged by the Indonesian action and even some mainstream media provided sympathetic editorials.

An IPS article quoted UNICEF East Asia regional immunization officer Basil Rodriques as saying that ''Indonesia has tossed the latest salvo into a debate that has been simmering under the surface for a long time. It is an issue of relevance that the world needs to come to grips with", adding that Indonesia's decision forces public health officials to ask what is best for the public good.

A health official in Thailand was also quoted as saying that the WHO system of sharing virus samples is positive if the benefits are evenly shared, but the reality is otherwise because developed countries gain more from the vaccines produced from virus samples collected from the developing world.

IPS also quotes Philippines' health secretary, Francois Duque: ''The US and Western countries are gobbling up the drug and denying access to developing countries that need it most. The poor countries once again have been excluded from the arena.''

Last May, the US-based NGO Sunshine Project revealed that patents had been granted for anti-viral drugs for the treatment of smallpox and that a smallpox vaccine had also been granted a European patent.

Many developing countries had handed over to the WHO their stocks of the smallpox (variola) virus, and the World Health Assembly had mandated that the remaining smallpox virus stocks would eventually be destroyed. Meanwhile, two laboratories (one in the US and the other in Russia) were authorized to maintain stocks of the virus, and to undertake research, including to develop smallpox vaccines and anti-viral drugs.

In an article in SUNS (No #6034 dated 24 May 2006), Edward Hammond of the Sunshine Project revealed that several of the drugs (or their components) that have been developed are under patent, or under patent application. This will affect the affordability or availability of the drugs in the event they are needed.

There are two principal compounds (cidofovir analogs and SIGA-246) under consideration in the US for use as smallpox anti-virals. Both could be covered by intellectual property claims that could hinder rapid and free access to the anti-viral drugs. The proprietary claims may conflict with resolutions passed by the World Health Assembly which requested that the WHO ensure that the benefits of the smallpox research be made available to all countries.

Cidofovir analogs for treatment of variola virus infection are covered by patents issued to the University of California, including two patents issued in April 2004 and April 2006. International patent applications have also been filed, including in China, South Africa, Brazil and Mexico. The university has stated that it intends to seek patents in many other developing countries, including most of Africa and many countries in Asia and Latin America.

The other smallpox anti-viral compound under consideration in the US is SIGA-246 (ST-246) that belongs to the US company SIGA Technologies.

The Danish company Bavarian Nordic also holds a European patent on a smallpox vaccine, and the company was suing the company Acambis for infringing its patent. Acambis was then planning to take part in a $1.9 billion contract to provide smallpox vaccines to the US government.

"With several patents granted or pending on smallpox anti-virals and legal fights taking place over a patent on a smallpox vaccine, it is clear that there is a range of issues on who owns the stocks of the smallpox virus, whether patents should be issued on drugs relating to the virus, and the cost to, and access of, people especially in developing countries in the event they require the drugs," said Hammond.

The high cost of vaccines for avian flu and the need to prevent commercial monopoly over the medicines that are developed from stocks of the virus provided by affected countries was also a key issue at the World Health Assembly last May (See SUNS #6035 dated 29 May 2006).

Thailand raised the issue of the high costs of vaccines against bird flu, and insisted that the price of vaccines be brought down.

It proposed an amendment to the WHA resolution on the Application of the International Health Regulations, suggesting the insertion of the language "for non-commercial purposes only" in relation to the dissemination to WHO collaborating centres of information and the biological materials related to avian influenza and other novel influenza strains. The amendment would restrict the commercial use of the vaccine seed stocks developed from the samples provided to the collaborating centres.

In response to the Thai proposal, the WHO Secretariat said that private sector collaboration was required to produce bird flu vaccines due to limited global production capacity. Thailand defended its proposed amendment by noting that under the current system of vaccine seed stock development and distribution, "the result will be a monopoly", and that "measures must be implemented" to address the problem. Thailand's comments drew applause from many delegates.

However, because of objections by other countries, Thailand had to compromise and the eventual resolution urged member states to develop domestic influenza vaccine production capacity or work with neighbouring States to establish regional vaccine; and requested the Director-General to immediately search for solutions to reduce the current global shortage and inequitable access to influenza vaccine and also to make them more affordable for both epidemic and global pandemic.

Thailand stressed that this "trade-off" was "very painful." It believed that this trade-off was a "win-lose" solution where the winner was the developed countries which can produce vaccines and the loser was the developing countries which cannot access the vaccine, whereas it is the developing countries that are submitting the flu strains to the WHO collaborating centres. Thailand however said that it did not want a lose-lose situation where no one has the vaccine and everyone dies.

In response to the Indonesian move, the New York Times in its editorial on 16 February said: "Indonesia has raised a valid point that needs to be addressed: if a pandemic should strike, poor countries would be left without protection." It said however that what may be good for Indonesia could be harmful to global health - especially if other countries follow. Unfortunately, the WHO has no good answer to the inequities that Indonesia has spotlighted.

"If a pandemic struck, the current vaccine makers could produce only 500 million doses of vaccine per year if they ran 24 hours a day. That is far short of what would be needed to vaccinate all 6.7 billion people in the world," said the Times editorial.

"Thus, there seems no doubt that in a crisis, the countries that are home to the vaccine makers would tend to their own citizens first - or those willing to pay the highest prices - leaving little or no vaccine for everyone else. The WHO needs to work much harder to encourage the transfer of vaccine production technology to countries like Indonesia, that have the technical ability to use it. That will increase the supply of vaccine and presumably bring prices down. Even then, we fear, there still won't be enough."

In its 17 February issue, The New Scientist published an editorial, "Self defence over bird flu is no crime." It said: "Good for Indonesia. There, it's been said. The country at the centre of the H5N1 bird flu storm has stopped sending virus samples to the WHO. Though this means that scientists cannot track H5N1's increasingly worrying evolution, which is bad, Indonesia is doing the only thing it can to protect its people.

"It has also brought an unpalatable truth out into the open. In a fair world, Indonesia would send its virus to the best labs and share in any vaccine made from it. In our world, Indonesia sends off its virus, companies make vaccine from it and sell it to countries that can pay. Indonesia is not one of them, and neither are the other countries suffering badly from H5N1.

"Indonesia is treating this as a case of biopiracy. Like other tropical countries, it is a hotspot of biodiversity. For decades, foreign companies have helped themselves to its plants, microbes or whatever, and made lucrative products from them. In response, it has passed laws to stop exports of genetic material without agreement. It is invoking such a law to control samples of H5N1 and asking developed countries to respect the sort of intellectual property rules that they themselves have imposed for decades..."

"By withholding the virus, Indonesia is leveraging the one resource it has to obtain flu vaccine, possibly even its own factory. As Lily Sulistyowati of Indonesia's health ministry put it: 'Indonesia's state-owned drug maker Bio Farma does not have the technology and expertise to create the vaccine. We can only offer foreign pharmaceutical companies our strain of the virus'."

"The country says it is will do this only under material transfer agreements that ban commercial use except by prior agreement...We need a system that works for everyone. In its absence, those material transfer agreements should be signed now. We need to see what H5N1 is up to in Indonesia."

However, the Indonesian move to stop sending its virus samples to the WHO may be short-lived as it announced that it would resume sharing these samples.

A joint statement was issued by Indonesia and the WHO following a meeting between the Indonesian Minister of Health Siti Fadillah Supari and Dr David Heymann, WHO Acting Assistant Director-General for Communicable Diseases.

The statement said that Indonesia's leadership alerted the international community to the needs of developing countries to benefit from sharing virus samples, including access to quality pandemic vaccines at affordable prices.

Indonesia recognized that short and long term solutions are needed. In the short term, Indonesia will pursue discussions with vaccine production companies to meet its vaccine needs, which WHO fully supports.

Said the statement: "In the long term, Indonesia is working with WHO to develop its local vaccine production capacity through technology transfer. 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.

"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.

"WHO will continue discussions and work with the Ministry of Health and other countries to assess and develop potential mechanisms, including Material Transfer Agreements, that could promote equitable distribution and availability of pandemic influenza vaccines developed and produced from these viruses."

To this end, WHO and the Health Ministry will convene a meeting of selected countries in the Asia and Pacific region to identify mechanisms for equitable access to influenza vaccine and production.