The Genome Swindle:
16 May 2009
How can it be that the fundamentally defining data that makes every cell in life unique, should be treated as property to be owned. And if it is owned, why is it not owned by all of humanity?
The USA patent code was never meant to cover naturally occurring gene sequences. As a matter of constitutional law, all of this is highly suspect. There's never been a vote by Congress to approve the patenting of human or animal life, there's never been an executive order by any president, and there's never been a decision by the USA Supreme Court on the patenting of any animal larger than a microorganism.
In fact, just twenty five years ago, you couldn't patent any of it. Back then, the USA patent code looked a lot more like the code Thomas Jefferson wrote, the code that was designed to protect inventions. But that hasn't slowed down the patent code, which not only applies to USA soil but now lays claim to ninety foreign countries, and even to any object made, used, or sold in outer space.
It's not just genes, either. There's a patent on the blood inside every human umbilical cord. So if, by chance, your newborn baby needs that blood, don't expect to get it for free. There's also a Swiss company called Novartis that has a patent on the stem cells in your bone marrow. Don't expect to access those cells if you ever need a transplant, either, unless you're prepared to pay.
Some companies have patents on entire species of animals, like the species of mice and pigs that belong to DuPont. You can patent people as well. These days, you can get a patent on just about anybody. A patent issued in 1995 to the USA Department of Health covered the cell line of an unsuspecting member of the Hagahai tribe in Papua New Guinea, whose resistance to certain diseases made him valuable to researchers. Other patents filed by the USA government at around the same time covered indigenous people from the Solomon Islands and from the Guaymi tribe in Panama.
By now you should be starting to get the impression that the USA patent laws have gotten out of hand. And why did they get that way so quickly without any public debate or government approval. The answer, most likely, is that we didn't know. We didn't know because nobody knew. Nobody knew because nobody cared.
It is just over 50 years since James Watson and Francis Crick published the news of their discovery of the structure of DNA the molecule that encodes the genetic information present in all living organisms. Their letter, published on 25 April 1953, signified the beginning of the modern age of biology. In 2001, as a result of the activities of public and private sector bodies working on the Human Genome Project, a draft map of the human genome was published. It was found that the total number of genes in the human species was just over 30 000. The search is now underway to discover the operation of each of the genes so isolated.
When knowledge of DNA and the genome emerged, Watson and Crick sought no intellectual property rights with respect to it or its applications. However, instead of devising a new, specialized and specifically appropriate legal regime peculiar to the new knowledge, as with the software used in informatics, lawyers reached for the old law of intellectual property pressing it into new service. At times, this has produced less than perfect results.
With the assistance of the International Bioethics Committee (IBC) of the United Nations Educational, Scientific and Cultural Organization (UNESCO), the first international response to the ethical dilemmas presented by the advance of the human genome project was developed. Thus, the Universal Declaration on the Human Genome and Human Rights was adopted by the General Conference of UNESCO in 1997. It was later endorsed by the General Assembly of the United Nations. While it is not a binding treaty, it is a broad statement of principles designed to uphold human rights in the context of the developments affecting the human genome. Significantly, in relation to the issue of patenting.
(1) The Human Genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.
(2) The Human Genome in its natural state shall not give rise to financial gain.
(3) [a] Benefits from advances in biology, genetics and medicine, concerning the human genome, should be made available to all, with due regard to the dignity and human rights of each individual. [b] Freedom of research, which is necessary for the progress of knowledge, is part of freedom of thought. The applications of research, including applications of biology, genetics and medicine, concerning the human genome, shall seek to offer relief from suffering and improve the health of individuals and human kind as a whole.
It is important to recognize the very useful purposes that intellectual property laws serve. They have their own foundation in ethical principles and the right of scientists to protect their intellectual property was acknowledged in the Universal Declaration of Human Rights. However, the same instrument also recognizes competing human rights such as the right to life, to health, to knowledge and to share in the benefits of scientific advances.
Converting discoveries about the human genome from raw scientific data to beneficial therapies and useful tests is potentially problematic and expensive. This problem demonstrates the principal social argument for protecting intellectual property, in the form of new technological inventions and novel techniques. The argument is that they lead to the development of short term legal monopolies that encourage and facilitate the investments necessary for large and expensive steps in scientific and technological research.
Intellectual property protection can provide an incentive for scientific and technological research and ensure that the outcomes of such research are disclosed to the world at large. These considerations encouraged the IBC and the wider global community to recognize that patents and their legal protections play an important role in advancing the frontiers and application of genomic science. Without such laws, it is unlikely that advances would occur as quickly and efficiently.
Notwithstanding these beneficial features of patents, there are a number of problems which the IBC and other bodies have discerned in the interaction of research and development concerning human genetics and national, regional and international laws governing patents.
Drawing on the debates that emerged in a Paris symposium in 2001, an IBC working group was formed. The group listed a number of sources of concern that explain why many people, in a wide variety of countries and disciplines, are expressing anxiety about the suggested over-reach of patent law in the context of expanding genomic knowledge.
(1) There has been a significant change in recent years in what was formerly a global tradition and culture of open science. Until very recently, almost universally, pure scientific research was substantially funded publicly. It operated in a culture in which individual scientists, universities and foundations did not seek or obtain financial benefits from primary scientific advances. This explains how, between 1920 and 1970, great progress was made in pharmaceutical developments (e.g. penicillin and other antibiotics and vaccines) with little demand for patent protection.
This contributed greatly to improvements in public health. However, during the 1970s and 1980s the situation began to change. In part, this was the result of laws enacted by the Congress of the United States during Mr. Reagan’s term as President. These laws were designed to enforce amongst universities and public institutions the duty to obtain patent protection for their scientific and technological innovations. Failure to comply with this duty would lead to the withdrawal of federal funding.
An illustration of the change has recently come to light in the development of HIV therapeutic drugs. Although essential to the right to life and health of millions, the intellectual property protections effectively made such drugs mostly unavailable, except in developed countries. This led to a public outcry, development of generic drugs, abandonment of court action taken to enforce intellectual property rights in South Africa and widespread public demand for removal of some intellectual property protections in respect of these therapies.
Although not specifically related to genomic therapies, the IBC saw the debates over HIV drugs as a predictor of what was likely to come in the field of genetic tests and therapies.
(2) Coinciding and connected with the change in the tradition and culture of open science has been a shift in the balance of private and public investment in research in science and technology. Public funding for general research has declined in many countries while the proportion of research funded by the private sector has increased. This has a potential to shift the priority of research and, in consequence, tests and therapies to those diseases of major significance in developed countries that can afford to pay high prices for pharmaceuticals.
The medical requirements of poorer, developing countries would consequently become of lesser priority. Maximizing financial rewards rather than satisfying the greatest human needs might determine the future of scientific research on genes and their operation.
(3) The foregoing developments have happened at a time when, as evident in the Declaration, international bodies such as the IBC, perceived the character of the genome as something specially intimate and particular to the human species.
Never before in science have individual human participants and groups been so closely involved in, and necessary to, scientific and technological advances. The genomic sequence, out of which tests and therapies are developed, begins in every case with a sample provided by an individual human being or samples provided by a group of the population concerned. There was a controversy about the meaning of the promise, set out in the Declaration, that the human genome, ‘in its natural state’, would not give rise to financial gains.
This controversy is not yet settled. There is no doubt that huge financial gains are being sought, and obtained, through patent protection and licensing arrangements. This occurs as laboratories continuously identify more genes that are useful in the short term for developing tests to identify the presence of inherited conditions and, in the long term, for therapies to treat, exclude or monitor such conditions.
(4) The implications of patent law, and especially of international regulations concerning patents, have emerged as major issues for human rights and biotechnology. To the extent that, in practice, intellectual property law restricts access to tests, therapies and knowledge developed from the scientific research on the genome, it affects the human rights of millions: most notably the right to health and to life.
(5) In addition to the foregoing concerns of a general kind, the IBC group expressed anxiety about various features of the way in which patent law operates. Of specific concern have been patents over genetic sequences claimed by applicants who seek and secure patent rights over genomic sequences of uncertain future utility, leading to premature accumulation of intellectual property rights which may have a consequence of discouraging unimpeded research in respect of particular genes or in the proteins which they express, because of awareness of a prior intellectual property right with respect thereto.
Many observers have concluded that the duration of typical patent protections (in most countries 20 years) is excessive, having regard to the context of genomic sequences and the rapid advance of knowledge about them.
A number of scientists from developing countries have expressed outrage about the way in which samples of source materials are being collected from subjects in developing countries for the production of tests and therapies, which would then only be available to those countries under licensing arrangements, which impose prohibitive costs. The scientists concerned pointed to the rich diversity of genetic material in many developing countries.
They insisted that there must be a genomic dividend for those countries and their people, lest intellectual property law enforces a new form of imperialism on the developing world. The ultimate insult, they suggest, would be for the countries from which the material is sourced be required to pay exorbitant fees for tests and therapies produced from those materials.
The human genome is already raising vexing policy questions about our rights to confidentiality for our genetic health information and protection against genetic discrimination by insurance companies and in the workplace. Just like gene patenting, these kinds of emerging issues will require new solutions and proactive public policy.
The time to start is now. As we begin the process of balancing commercial interests and public health, we need to be guided by our sense of fairness, by our democratic values and by established methods of transparency and reporting that will insure our ability to publicly regulate the situation in the future.
Ultimately, the most important thing is to remember the overriding public health mission of human genome research public or private. While it is tempting to try to speed development with patent incentives to private firms and universities, the impulse must be balanced against longer term concerns for how the ownership rights to genes will ultimately affect the equitable dissemination of health related products.
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