Responding to These Addressable Concerns

Despite the few direct refutations of the legitimacy of the concerns associated with the premature implementation of genetic services and with the potential impact that commercialization will have on the nature and climate of university of research, to date the dominant tone in many of the government policies in the area of biotechnology is one not of caution but of encouragement (Alberta Science and Research Authority, British House of Commons Science and Technology Committee, Ernst and Young). This position is understandable. Genetic research is extremely expensive and a government which is perceived as "anti-biotech" may discourage much needed private sector investment or drive research funds to another region or country (Novarro, 55, Burk and Boczar, 791). Similarly, if we wish to reap the benefits of the advances in human genetics, we must recognize that the vast majority of genetic services will ultimately be refined and delivered by industry. A regulatory environment hostile to biotech may impede this process.

Also, and perhaps most importantly, governments have probably had little reason to consider the concerns associated with the mix of genetics and the biotechnology industry, as the concerns are seldom articulated in connection with the broader commercialization policy. In other words, although there exists a great deal of commentary on legal, ethical and social issues, this commentary has not penetrated much of the industry's policy analysis. Indeed, it is possible for a government to have, on the one hand, a policy which addresses the concerns associated with the commodification of human genetics (e.g., Canada's failed Bill C-47, The Human Reproductive and Genetic Technology Act) (Caul-field, Hirtle and Le Bris, 3) and, on the other hand, blindly encourage the expansion of genetech and the collaboration of academia and industry (Prouty, 955, Alberta Science and Research Authority, Science and Technology Committee). However, given the increase in the commentary focusing on these issues, and given the fact that we are just now entering the era of practical application, it seems unlikely that this policy paradox can be sustained. A comprehensive commercialization policy, one that integrates the ethical and legal concerns, is essential.

In fact, despite the presence of numerous conflicting positions, I believe that many—but not all—of the commercialization issues, such as the fear of premature implementation, can be resolved in a manner which is advantageous to both industry and the general public. Indeed, resolving the legal and ethical concerns surrounding the implementation of genetic technologies by establishing sufficient safeguards will enhance consumer confidence which, in turn, may increase the uptake of genetic services (Marshall, 782, Bekker, et al., 1584). Some issues, such as the impact of commercialization on university research, will require a careful weighing of potential benefits (e.g., the attraction of research capital) and adverse side-effects (e.g., restricting the academic community's ability to collaborate). Nevertheless, if there exists the necessary political will, there is no reason to believe that these issues cannot be addressed.

There is a broad array of existing regulatory mechanisms which need to be considered and integrated in any comprehensive commercialization policy, including: research ethics boards; the common and civil law (e.g., negligence and fiduciary law); professional practice guidelines and accreditation mechanisms; university conflict of interest provi sions; and drug and device legislation (e.g., Canada's Food and Drug Act). In addition, as has been done in some jurisdictions, a specific regulatory framework could be developed to meet the issues which arise in connection to genetic technologies (Caulfield, Hirtle and Le Bris, 3).

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