Gene patents and the standard of care.

© 2002 Canadian Medical Association or its licensors Although many have debated the ethics of patenting human genes over the past 2 decades, recent controversies surrounding the effect of gene patents on genetic tests for breast and ovarian cancer have brought that debate to a head. In the absence of changes in Canada’s patent laws, physicians will face a variety of legal and ethical dilemmas regarding the ordering of appropriate genetic tests for their patients. A DNA sequence patent provides its holder with a great deal of power to control how anyone — including a physician and his or her patient — uses the “patented” sequence. Since all genetic tests require the reproduction of the patient’s target gene, gene patents can create a number of access problems. First, the patent permits patent holders to charge a premium for access to the service. Second, patent holders can require that physicians wishing to order genetic tests for their patients have the test done by the patent holder or one of its licensees. The patent holder may impose additional conditions, such as the requirement that the test be conducted at a specific location. In the case of the BRCA1 and BRCA2 genes, a mutation of which increases a woman’s predisposition to breast and ovarian cancer, Myriad Genetics, the patent holder, requires anyone wishing genetic testing to send their sample to Myriad in Salt Lake City to be analyzed by a method determined by Myriad at a cost of about US$2500. A comparable test provided by Genetic Diagnostic Laboratories in Ontario, licensed by the Ontario Ministry of Health and Long-Term Care, costs Can$1150. These limitations pose several problems for physicians. First, the implied or real threats of patent infringement may delay or block the development, validation and implementation of diagnostic tests by Canadian laboratories. Second, the method mandated by the patent holder for conducting the test may not be the most appropriate for the patient. Third, the high price charged by patent holders for genetic tests may cause provincial health care systems to refuse to insure these tests. A recent report issued by the Ontario Ministry of Health and Long-Term Care concluded that genetic tests will increase the cost burden on the health care system, at least in the short term. Fourth, the high costs of tests not covered by provincial health insurance plans may render these tests unaffordable and thus unavailable to many patients. Fifth, sending patient samples out of Canada to a company not subject to Canadian laws and regulations may cause ethical concerns over quality control and confidentiality. It is the availability of tests that perhaps is of greatest conGene patents and the standard of care