From: Rural Advancement Foundation Intl [rafi@rafi.org] Sent: Friday, January 21, 2000 1:08 PM Subject: RAFI News Release - Phase II for Human Genome Research RAFI Rural Advancement Foundation International www.rafi.org | rafi@rafi.org News Release –21 January 2000 Phase II for Human Genome Research: Human Genetic Diversity Enters the Commercial Mainstream A new report from RAFI reveals that the massive financial stakes involved in the frantic race to find and commercialize human genetic variation is taking place in the absence of public debate and government action. "The Human Rights abuse of research subjects has worsened and governments and intergovernmental institutions have fallen all over themselves trying to sidestep responsibility for this complex ethical and medical conundrum," notes the report. "In 1993, we first warned that the collection and management of human diversity research was taking place in an almost total policy and regulatory vacuum," says RAFI Executive Director, Pat Mooney. "That the vacuum still exists is cause for outrage." With computer-assisted DNA sequencing machines running faster and more cheaply than its originators ever imagined, researchers are now turning from the crude "generic" map of the Human Genome Project (HGP) to its inevitable Phase II – the drive to plunder, patent, and privatize the commercially-important bits of variation found in individuals, indigenous peoples, disease and disability groups, and ethnically-distinct communities. "What has changed since RAFI first reported on the subject, is the intensification of research on human genetic diversity and its commercialization," notes RAFI's Director of Research, Hope Shand. "The genomics companies are working hand-in-hand with the Gene Giants, and the rush is on to claim exclusive monopoly patents on even the tiniest bits and pieces of the human genome." The real money in human diversity mapping lies in identifying and patenting single nucleotide polymorphisms (SNPs or "snips") that code for specific traits including diseases. The Gene Giants are hoping to patent SNPs in order to develop diagnostic kits, monitoring instruments, and even "designer" drugs tagged to the specific DNA of wealthy customers. "Hundreds of millions of dollars are being spent in the effort to find and control SNPs but the long-term profits will be in the billions and could ultimately restructure the entire health care industry," warns the report. Were the commercial value of human genetic diversity research ever in doubt, those misgivings were unambiguously laid to rest when Iceland sold its genetic heritage to the genomics company deCODE, who, in turn, hawked the human data to Hoffman LaRoche of Switzerland for US $200 million. The spectacular and controversial deal turned genomics research overnight from an obscure biotech niche industry into a mainstream commercial venture. Suddenly, almost unheard of genomics companies like Millennium (US), Genset (France), and Axys (US), are patenting diversity studies into a multi-billion-dollar commercial product strategy aided and abetted by researchers at universities and even some governments. The extension of patentability by the US Patent and Trademark Office to single nucleotide polymorphisms (SNPs- the smallest unit of genetic variability) has further galvanized commercial pharmaceutical enthusiasm for the new industry. SNPs are the genetic basis upon which diversity re! searchers define their investigations and distinguish individuals and human populations from one another. Given this full-scale commercial foray into diversity research in combination with the new methods of sampling and sequencing, the pressing question for ethnically unique populations and particularly for indigenous peoples is no longer "Will we be sampled?" but rather "Who will have access to human genetic diversity, and will it be subject to exclusive monopoly control?" notes RAFI Researcher Julie Delahanty. "The financial stakes are so high in this research, that some of the actors involved are ignoring some of the basic ethical standards which should prevail in the collection of human material." This new RAFI Communique, focuses on some of the thorny issues involved in human genetic diversity research. Serious concerns have been raised by the expansion of patentability to SNPs and by the numerous corporate initiatives to privatize human genetic diversity, especially through large-scale sequencing programs and proprietary databases. The current status of the Human Genome Diversity Project (HGDP), the problem-plagued global initiative to collect and sequence human genetic diversity, is discussed; so is its commercial value. The report urges action at various levels. At the international level, action must be expected from the UN Human Rights Commission, from the World Health Organization, and from UNESCO’s International Bioethics Committee (which has woefully neglected the intellectual property and commercial issues arising from human DNA collection). Nationally, governments could review their medical ethics and research protocols to guarantee the rights and dignity of! their citizens. In particular, governments might consider legislation that would criminalize the collection or removal of human germplasm without the prior informed consent of the individual, their community, and the national government. RAFI s new report, Phase II for Human Genome Research - Human Genetic Diversity Enters the Commercial, is available on RAFI s web site, http://www.rafi.org For more information, contact: Hope Shand, RAFI, Tel: 919 960-5223, hope@rafi.org Julie Delahanty, RAFI Tel: 819 827 4494, julie@rafi.org Pat Mooney, RAFI, rafi@rafi.org RAFI, the Rural Advancement Foundation International, is an international civil society organization headquartered in Canada. RAFI is dedicated to the conservation and sustainable use of biodiversity, and to the socially responsible development of technologies useful to rural societies. RAFI is concerned about the loss of agricultural biodiversity, and the impact of intellectual property on farmers and food security.