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| A question of ownership |
26-Apr-2007 |
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Questions over the ownership of the H5N1 influenza strain raise wider issues about medical research, individual rights and company profits.
By Bianca Nogrady
WHEN CSL proudly announced in January that it was applying to register its pandemic influenza vaccine, the company could not have foreseen that its supporting dossier would spark a global storm with far-reaching implications for vaccine research.
Within 24 hours the Indonesian Government made headlines by declaring it was seeking intellectual property rights over the Indonesian strain of the H5N1 influenza virus, and that CSL had not been given “permission” to use the virus for research.
The move threw a spanner in the global system of virus sample sharing that has been successfully administered by the WHO for decades. Indonesian Health Minister Siti Fadillah Supari said her country would withhold virus samples from the WHO and, instead, take the unprecedented step of entering into a private commercial agreement with health care company Baxter International.
CSL public affairs director Dr Rachel David says the company was extremely concerned about the long-term implications of Indonesia’s claims to ownership of the H5N1 influenza strain.
“From our perspective, if the 40-year-old system that the WHO has had for equally sharing viral strains was to collapse, that would be a disaster for public health across the world,” she says. “We would have difficulty making our seasonal flu vaccine if that was to cease.”
Under the current system, WHO collaborating centres around the world obtain viral strains and provide them freely to researchers, including vaccine manufacturers. No money changes hands, despite the fact manufacturers can potentially make billions of dollars in profit from the vaccines they develop from these freely obtained strains.
Indonesia’s claim marks the first time a country has challenged this system, and it has Dr Ian Barr worried. As deputy director of Melbourne’s WHO Collaborating Centre for Reference and Research on Influenza, Dr Barr is concerned about the precedent Indonesia’s move could set.
“If one country was successful in negotiating a royalty rate with a particular company directly, it would jeopardise the whole system because other countries would see it as an opportunity to recoup some money,” he says.
Dr David believes there is little merit to Indonesia’s claim. “It just happened to be where the virus was isolated. It would be a very hard thing to prove from an intellectual property perspective,” she says.
If Indonesia’s claim has implications at nation-state level, imagine a similar scenario played out on a rather smaller stage: a single human body. Most people would assume that a person owns their own tissue. But they would be wrong.
When Mr John Moore was diagnosed with hairy cell leukaemia in 1976, his doctor recommended his spleen be removed to slow progress of the disease. The doctor and co-researchers went on to develop a cell line using T-lymphocytes extracted from Mr Moore’s spleen and other tissues. They were granted a patent on the cell line and became wealthy from commercial agreements they entered into with two biotechnology firms.
Mr Moore sued for a share of the profits and also accused his doctor of breaching professional obligations. In rejecting Mr Moore’s financial claim, the US Supreme Court concluded a patient could not exercise property rights over discarded body tissues. Several court cases since then have reinforced that decision.
Dr Linda Barclay, from the Centre for Human Bioethics at Melbourne’s Monash University, says the main reason for the legal decision was that it would be a major impediment to medical research if patients’ removed tissues weren’t freely available. “How are we going to conceive of a situation where we have to bargain with patients about access to their diseased liver or spleen that has been taken out?” she says. “As long as people give proper informed consent for the procedure, that’s where their rights end.”
Informed consent was an issue in the Moore case, because the court found the doctor’s failure to inform Mr Moore of his financial interest in the patient’s tissues constituted a breach of duty. But even when informed consent has been given, cases can still end up in court.
Daniel and Debbie Greenberg’s two children died from Canavan disease — a rare degenerative brain disorder affecting Ashkenazi Jews. After the children died, the Greenbergs and other affected members of the community offered blood and tissue samples to Miami Children’s Hospital, hoping they could help researchers learn more about the disease and how to prevent it. The community also raised funds to support the research, which resulted in the isolation of the gene for Canavan disease.
And that’s where things started to go wrong. The hospital patented the gene and began to charge royalties to laboratories wanting to test for the disease. They also imposed limits on the number of tests that could be carried out each year. As a result, many members of the Ashkenazi community who wanted to find out if they were carriers of the gene were unable to access the test.
The Greenbergs sued the hospital in an attempt to gain some control over how the patent was used and force an easing of restrictions on the test. The case was settled in 2003, although the only concession to the Greenbergs’ demands appears to have been that the gene was to be available royalty-free for research, but not for testing.
The case has some similarities to Indonesia’s claim over the bird flu virus. In both cases, the law has been used in an attempt to leverage access to the health benefits of research. Indonesia has now said it will resume sharing H5N1 virus samples on the proviso it is given equitable access to any pandemic vaccine developed from them. Dr Dianne Nicol, associate professor of law at the University of Tasmania, believes this is only reasonable.
“It is a bit incongruous to think that Indonesia does this out of altruism, that then the place that’s most in dire need doesn’t get any benefit from it,” Dr Nicol says. “They are pushed into this position because they feel they really don’t get the benefits flowing back to them.”
Such situations highlight one of the more unfortunate aspects of the patent system — that the results of patents are often not accessible to those who need them most — according to Professor Paul Komesaroff, director of the Monash Centre for Ethics in Medicine. He cites the example of HIV medications being out of reach for most patients in the developing world, despite the fact that much of the research is conducted in those countries where the virus is wreaking its worst.
Professor Komesaroff believes there is a case for a national or international regime that would ensure the results of publicly funded research are made available to the public. “These kinds of products should be freely available to the community, rather than [having] a discussion about who ought to be entitled to enjoy substantial profits to the exclusion of the community,” he says.
Dr Rosanna Capolingua, chairwoman of the AMA’s ethics and medicolegal committee, agrees there needs to be debate at a community and global level about access to the benefits of patents.
“It is a problem if the information from their [patients’] material has been used, or could be used, to treat that problem but then they are unable to access that,” she says. “Wouldn’t it be nice if we could break beyond the barriers of industry and profit margins and go directly to the core of need?”
One patient advocacy group in the US has taken matters into its own hands, negotiating with researchers in advance to ensure it receives a share of the benefit. After Sharon and Patrick Terry’s two children were diagnosed with the rare genetic disease pseudoxanthoma elasticum, the Terrys formed an advocacy group and set up a patient registry, as well as creating a central repository for blood and tissue samples. Researchers wanting to access the samples had to sign a contract ensuring the advocacy group would be recognised as a co-inventor on any future patent.
In 2004 Mrs Terry, who is executive director of the advocacy group, became perhaps the first lay leader of such a group to be listed on a patent. “We are the stewards of this gene,” she said at the time. “We are responsible for using it to develop diagnostics and therapeutics that are accessible and affordable.”
Dr Barclay believes such scenarios pose a challenge to the patent system. “We need medical research and, if patients are going to start holding back and bargaining, it’s going to make medical research very difficult.” It also raises the unpleasant prospect of commodification of the human body, where patients may try to auction their tissues off to the highest bidder, she says. “It might be naïve to think that if we give John Moore property rights, we protect his interests — we might be turning bodies into commercial products.”
The difficulty is that, while the patent system is far from ideal, it does have a noble purpose — that of encouraging scientific research.
“We still need some way of rewarding investment in scientific research or people won’t do it,” Dr Barclay says. “But is patenting the best system or are there possible alternatives?”
There is debate about more equitable alternatives, but Dr Barclay says it is mostly taking place at the academic, rather than policy, level.
In the meantime, Indonesia’s stand has forced the WHO to re-examine its virus-sharing policies. It is holding a meeting of selected countries in the Asia-Pacific region this month “to identify mechanisms for equitable access to influenza vaccine and production”. Until that happens, Indonesia continues to withhold samples from the WHO and pursue its own agreements with vaccine manufacturers.
Dr Barr agrees there must be a better way. “In terms of countries leveraging their positions, and getting some access to either seasonal or pandemic vaccines or both, I think that there is sympathy for that sort of outcome,” he says. “Everybody would like to see developing countries better prepared for pandemic flu, if it ever comes.”
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