Biomedical patents and ethics: a Canadian solution.

World Trade Organization member states are preparing for the upcoming renegotiation of the Agreement on Trade-Related Aspects of Intellectual Property Rights. One of the important elements of that renegotiation is the ethical considerations regarding the patenting of higher life forms and their component parts (e.g. DNA and cell-lines). The interface between the genetic revolution, patentability, and ethical considerations is the subject of this article. The author identifies, explores, and critiques four possible positions Canada may adopt in respect of patentability of biomedical material. First, Canada could do nothing. This approach would mean keeping biomedical materials outside the patent system and outside the stream of commerce. Canada would simply wait for an international consensus to develop before adopting a position of its own. Second, Canada could go it alone. It could implement a policy that balances the incentive effects of patents with the need to incorporate ethical and social values into the decision-making process regarding the use of biomedical materials. In respect of this option, the author proposes a model whereby non-profit bodies would hold the exclusive rights to research, use, and exploit biomedical materials. Third, Canada could follow the United States, Europe, and Japan by providing for almost unrestricted patenting of biomedical materials. This would be the most industry-friendly alternative. The fourth and final option is to use the medicare system to promote discussion of ethical considerations involved in the use of biomedical materials. The power of provincial health agencies may be used as a lever to ensure the discussion of ethical considerations concerning the use of biomedical materials. The author concludes that the fourth and final option is the best alternative for Canada while waiting for an international consensus to emerge.