Genetic technologies, health care policy and the patent bargain.

The idea of granting patents on human genetic material continues to cause controversy. The debate is largely focussed on the moral acceptability of human gene patents, the impact of gene patents on the research environment and the value of patents to stimulate innovation and the commercialization and dissemination of genetic discoveries. As highlighted by a recent controversy in Canada, patents can also have a profound effect on health policy and access to genetic services. Creative and bold patent reform initiatives are necessary to ensure that society will, to the highest degree possible, reap the health care benefits of the genetic revolution.

Genetic testing, ethical concerns, and the role of patent law.

This article examines the changing debate over gene patenting and the possible connection between patent law and the ethical and policy concerns associated with the use of genetic testing technologies (e.g. the premature implementation and inappropriate marketing of genetic tests). Arguably, patent law helps to form the market forces that lead to these concerns. It is suggested that existing safeguards fail to control these concerns because of, for example, a lack of provider knowledge and an absence of an adequate regulatory framework. While patent law can be associated with a number of ethical and policy concerns, the article also suggests that patent law may have a positive role in reducing them. Patent law provides policy makers and the public with a focal point - the patent holder - upon which to attach accountability for ethical and legal conduct. The article concludes by inviting policy makers to consider the ways in which patent law could be modified in order to optimize its constructive influence.

Patenting human genetic material: refocusing the debate.

The biotechnology industry has become firmly established over the past twenty years and gene patents have played an important part in this phenomenon. However, concerns have been raised over the patentability of human genetic material, through public protests and international statements, but to little effect. Here we discuss some of these concerns, the patent authorities' response to them, and ways in which to address these issues and to move the debate forward using current legal structures.

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.

Short communication structure of 'natural antibodies' in lower vertebrates.

'Natural' antibodies are generally believed to possess solely 2H-2L immunoglobulin structure. They have many disulphide bonds, the structural importance of which is not yet understood. However, some natural heterohaemagglutinins in the sera of some lower vertebrates (eel, shark, perhaps also trout and toad) are subunit proteins; the subunits are held together not by disulphide bonds but solely by non-covalent interactions like animal lectins. The relevance of these findings for immunophylogeny is discussed.

The natural heterohaemagglutinin in the serum of the toad Bufo regularis, and its relationship to lower vertebrate immunoglobulins.

The serum of the toad Bufo regularis contains a natural heterohaemagglutinin for human erythrocytes, Which appears to have anti-(B + HP) specificity. Results of inhibition and absorption experiments indicate that only one agglutinin is present. The biochemical specificity of the agglutinin may be provisionally described as involving alpha-D-galactose residues linked (1-3) in the B determinant, of red cells possessing the H ANTIGEN. Unlike amphibian IgM, the agglutinin was insensitive to 2-mercaptoethanol treatment; moreover, it could be eluted from the alpha1 globulin region on cellulose acetate electrophoresis. These results suggest that this naturally occurring heterohaemagglutinin has a structure similar to that of plant and animal lectins. The relationship of this observation to the phylogenetic evolution of immunity is discussed.