Human Tissue Legislation and a New Medical Paradigm: Governing Tissue Engineering in Canada

Abstract

Tissue engineering is a promising biotechnology that uses advances in cell science, surgery, and engineering to create products that can be implanted into human patients to replace organs and tissues or to help restore or improve their function. Tissue engineered products contain living cells, scaffolds made from natural or synthetic materials, and chemical signals that help to guide the cells' development. An engineered skin substitute is already approved and on the market, and engineered tracheas, corneas, and blood vessels are entering clinical trials. Tissue engineering raises a number of legal and ethical issues, one of which is considered in this article: to what extent would existing human tissue legislation in Canada apply to the activities and products of this new technology, and what implications would this have? The key terms defining the scope of application of human tissue statutes are examined to see whether and when tissue engineering materials (cells, tissues, and organs donated for use in tissue engineering) and tissue engineered products, along with the processes of procuring material and implanting the final products, will fall within the statutes' scope. The article then considers how the applicability of human tissue legislation in this context might affect the law governing these products and processes, focusing on provisions involving consent to donation and prohibitions on compensation and sale. The analysis reveals that there is considerable uncertainty and variability in the law, which could have a chilling effect on the development of this technology and leave those involved unprepared to deal with legal issues that arise. As human tissue statutes are revisited and reformed across the country, and as larger debates continue about the use of human tissue in biotechnology, it would be useful to work toward greater consistency in key definitions and to consider and clarify how the legislation will apply to tissue engineering and other new technologies.