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ISIS Report 02/07/07

Whose Bird Flu Virus is It Anyways?

A battle over the rights to bird flu viruses at the recent World Health Assembly raises important issues on access to health and medicines for people in the world’s poorest countries and presents a strong case for banning patents on disease agents and their genes and genome sequences. Dr. Mae-Wan Ho

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Struggle for possession of the virus

Indonesia was in the headlines at the beginning of 2007 for refusing to share the deadly H5N1 avian flu viruses with the World Health Organisation (WHO) and its collaborating centres in the WHO Global Influenza Programme. But after an acrimonious debate at the 60th World Health Assembly, Indonesian Health Minister Siti Fadillah Supari announced the country would share the viruses again.

“In doing so, we hope that we can trust the WHO and its collaborating centres to share this sense of responsibility, to prevent any misuse of the samples by Indonesia and other countries, and to ensuring a mechanism for the responsible sharing of these viruses from originating countries,” Supari said [1].

In a bid for equitable access to affordable H5N1 vaccines for developing countries, Indonesia had placed a motion calling for a new system of virus sharing that accords more rights to countries that provide virus samples to the WHO system. Countries like Thailand, Indonesia and Vietnam worst hit by the bird flu virus have been providing virus samples freely to the WHO and its collaborating centres. But drug companies have patented the viruses and gene sequences without their knowledge or consent and created vaccines to sell back to the countries at prices they could not afford. Supari called that “an unfair mechanism” that “violates the spirit in which the virus is given.”

The USA and many countries in Europe that can afford to pay are stockpiling H5N1 vaccines and the antiviral drug Tamiflu, leaving little for the poor countries. Though that may be a blessing in disguise, as the efficacy and safety of both vaccines and Tamiflu are open to question [2], and there are better ways to prevent the bird flu pandemic (How to Stop Bird Flu Instead, SiS 35).

Indonesia’s motion was supported by 20 developing countries including India, Malaysia, Vietnam, Bangladesh, East Timor, and Iran, and strenuously opposed by the United States [3].

In the course of the debate, WHO admitted that patents have been taken out on the avian flu virus (see Box 1), and WHO collaborating centres have also entered into Material Transfer Agreements (MTAs) with vaccine manufacturers without informing the countries from which the viruses originated. That was against WHO’s own 2005 Guidance for sharing viruses, which states that the consent of countries sharing the viruses had to be obtained first, if the centres wanted to pass on the viruses to other parties. But when challenged, WHO’s Assistant Director-General for Communicable Diseases Dr. David Heymann stated that the 2005 Guidance had been removed and replaced with a document of  “best practices”, which now states that the WHO centres receiving viruses should provide vaccine strains to any requesting vaccine producer, and does not mention that the WHO centres have to seek permission from the countries of origin.

This aroused great consternation among delegates from the developing nations, as Martin Khor, director of the Third World Network explained: “This in effect prevents countries providing the virus samples from having benefit-sharing arrangements. So, while those countries are obliged to share their viruses freely and the WHO centres are obliged to give vaccine strains freely, the companies which obtain these free materials are not placed under any obligations whatsoever.”

Heymann and other senior WHO officials had been quoted in the media as opposing MTAs between the country of origin of the virus and the WHO centres or the drug companies, a stance adopted by the US. And yet, WHO collaborating centres such as the Centers for Disease Control in the US have entered into MTAs with companies involving viruses collected from Indonesia, Vietnam and China.

Box 1

Patent claims on vaccines and gene sequences of H5N1

The Third World Network has identified at least 5 patent applications for vaccines as of May 2007 [4]

Influenza Recombinant Subunit Vaccine

US Patent Application 20070042002AI, 22 February 2007

Hawaii Biotech Inc. (USA)

Claims: the vaccine and gene sequences from influenza virus isolated in Indonesia in 2005 (A/Indonesia/5/05) and another from China in 1997 (A/Hong Kong/156/97)

Modified Influenza for Monitoring and Improving Vaccine Efficiency

US Patent Application 20070031453AI, 8 February 2007

St. Jude’s Children Hospital (USA)

Claims: small changes to influenza HA genes intended to strengthen host immune reaction, and any HA gene modified, also the modified HA gene from an influenza virus isolated in Vietnam (A/Vietnam/1203/04)

Vaccines for the Rapid Response to Pandemic Avian Influenza

US Patent Application 20070003576AI, 4 January 2007

University of Pittsburgh (USA)

Claims: human and animal vaccines based on theoretically replication-deficient adenoviruses incorporating gene sequences from H5N1, pieces of any influenza HA gene used, and specifically the HA gene from an influenza virus isolated in Vietnam (A/Vietnam/1203/04)

Influenza Hemagglutinin and Neuraminidase Variants

US Patent Application 20060008473AI,

EU EP1766059, CA2568015, AU2005248377, PCT WO2005116258

Claims: method of producing H5N1 vaccines wherein HA and NA genes are removed from circulating wild human and/or animal viruses, genetically engineered and placed into a backbone of a laboratory-adapted strain, any influenza HA and NA gene modified and used in this way, and specific H5N1 isolates in Vietnam and China (A/Vietnam/1203/2004, A/Hong Kong/40/97, and A/Hong Kong/213/2003).

Functional Influenza Virus-like Particles (VLPs)

US Patent Application 20060263804AI

Novavax, Inc. (USA)

Claims: methods of producing virus-like particles from influenza viruses – proteins that replicate structures of actual viruses prompting much the same reaction in the human body as the virus itself and can be used as vaccine - and the Indonesia-derived virus (A/Indonesia/5/2005) used to generate the VLP.

Intellectual property rights versus health for all

At stake in the World Health Assembly debate was the twin struggle over intellectual property rights for commercial exploitation on the one hand, and on the other, the humanitarian goal of providing health for all, rich and poor alike, which conflicts with maximising profits from patented vaccines.

The WHO’s Alma Ata ideal of “health for all by 2000” declared in 1978 has been severely compromised, if not totally eclipsed by the neo-liberal wealth creation agenda of the World Trade Organisation, aided and abetted by the international financial institutions like the World Bank and the International Monetary Fund. There has been a great deal of dissatisfaction within the ranks of the WHO over what they see as the agency’s “neo-liberal approach to health” [5] (“Let Us Live and Let Them Die”, SiS 34). Much hope has been pinned on the appointment of Dr. Margaret Chan as the new Director General of WHO in November 2006; and her pledge for a renewed emphasis on primary health care was seen by all delegates to the World Health Assembly as a step in the right direction towards restoring health for all.

When asked if Indonesia was after a share of intellectual property rights and royalties over vaccines made from virus samples, Mr. Makaim Wibisono, Ambassador of Indonesia to Switzerland, said emphatically that Indonesia was not after royalties, but equitable access to vaccines, for all developing countries, not just Indonesia.

Why not ban patenting of viruses?

There is an easy solution to the dilemma faced by poor Third World countries as far as access to vaccines are concerned, and that is to ban all patents on viruses and gene sequences under the Trade Related Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation, so that at least cheap affordable vaccines can be made in Third World countries themselves. These “patents on life” associated with biotechnology are indefensible for scientific and other reasons, as I have argued in detail [6] (Why Biotech Patents Are Patently Absurd) (see Box 2). The African Group successfully challenged the WTO on this very issue in 1999 [7], resulting in a still ongoing review of the relevant Article 27.3B of the TRIPS Agreement [8].

It is entirely feasible to ban the patenting of genes and sequences of viruses and bacteria that cause diseases on ethical grounds of ensuring that poor countries should have access to affordable vaccines and treatments, and as a defence against pandemics. Diagnosis as well as access to cheap generic medicines are being hampered by patents, so why not cut the Gordian knot by banning these patents once and for all. An amendment to the TRIPS Agreement already allows countries to impose ‘compulsory licensing of drug patents’, so the drugs can be reasonably priced for export to countries that lack the capacity to manufacture the products

Why biotech patents should be revoked and banned

Biotech patents or “patents on life” are covered under Article 27.3B of the Intellectual Property Rights (TRIPS) Agreement of the World Trade Organisation, currently under review. Such patents should be revoked and banned for the following reasons [6].

All involve biological processes not under the direct control of the scientist. They cannot be regarded as inventions, but expropriations from life

The hit or miss technologies do not qualify as ‘inventions’, and are inherently hazardous to health and biodiversity as recent evidence indicates [9] (No to GMOs, No to GM Science, ISIS Report)

There is no scientific basis to support the patenting of genes, genomes, cells and micro-organisms, which are discoveries at best

Many patents are unethical; they destroy livelihoods, contravene basic human rights including the right to health and access to medicine, create unnecessary suffering in animals, or are otherwise contrary to public order and morality

Many patents involve acts of plagiarism of indigenous knowledge and biopiracy of genetic resources, including plants, animals and micro-organisms, gene and genome sequences.

At The TRIPS Council meeting on 5 June 2007, a proposal put forward by 11 developing countries to amend the TRIPS Agreement to require disclosure on the countries of the genetic resources and traditional knowledge and their informed consent received a big boost when the 41-member African Group decided to co-sponsor it, and the 31-member Least Developed Nations Group also spoke in support of it [10]. There is broad agreement in the TRIPS Council on national sovereignty over biological resources, and concern over “misappropriation of genetic resources and traditional knowledge” and “the erroneous granting of patents.”


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