The Challenge of Biotechnology and Public Policy

5. Policy Framework

Over the last two decades, whether it be organ transplants, reproductive technologies, or human genetics, four approaches are emerging. Briefly introduced, the broad ambit of a constitutional, human rights approach serves to circumscribe the applications of new technologies that otherwise might encourage discriminatory or stigmatizing practices. In contrast, a “statutory-specific” approach crafts laws issue by issue to address the implications of scientific advances through prohibitions, constraints or moratoria. A third possibility is an administrative, regulatory approach concentrating on quality assurance, standardization and monitoring either through governmental or professional bodies. Finally, a liberal, market-driven approach maintains that proper, professional practices will ultimately “win-out” and in any event, all new technologies are subject to the restraining impact of litigation.

Over the last two decades, whether it be organ transplants, reproductive technologies, or human genetics, four approaches are emerging... Put concisely, there are advantages and disadvantages to all four approaches.

Put concisely, there are advantages and disadvantages to all four approaches. The constitutional approach relies on already existing human rights instruments to interpret the applications of new technologies. These policy-oriented decisions of high ranking courts are strengthened by the intervenor status often afforded to public interest groups, and so serve to express public values, clarify the issues and set far-reaching precedents. Yet, ad hoc in nature and achieved after a given technology has already been integrated into research and health care, the process is a costly and lengthy one and if the court is timorous and refuses to go beyond the facts or issues, a limited recourse.

A statutory-specific method has the advantage of immediate certainty, clarification and precision as well as being an expression of political consensus. The danger remains however, of limited scope and impact beyond the immediate issues, of the closing of public debate and so of encouraging complacency. Finally, if such statutes are adopted in rapid succession, there is a risk of contradictory positions and definitions.

In contrast, a regulatory-standardization approach allows for the gradual development of professional codes of conduct and where necessary, licensing, monitoring and quality assurance through regulation pursuant to already existing broad health legislation. Professionally and procedurally oriented, it ensures a “buy-in” by those involved resulting in greater effectiveness and integration into practice. This incremental approach however has its own drawbacks. It “administers” technologies and fails to explicitly enunciate the value-choices underlying their acceptance or, explain why certain constraints are placed on access, use, or of certain forms of research in the codes or standards themselves.

Finally, the liberal, market place approach has been called the most flexible and promoting of scientific research. Technological development is dependent on investment and support is either public or private. Investment is subject however to lobbying by narrow interest groups, including those who stand to gain financially from public investment and/or lack of public control, and those who, for a variety of reasons, see certain technologies as potentially harmful or in conflict with their particular values. The inability of these groups to achieve compromise in the broader public arena inhibits the consensus necessary for successful government initiated oversight, thus leaving development of any given technology to the vagaries of the market, the chilling effect of litigation and consumer choice.

The choice between these approaches, or a mix thereof, depends not only on the degree of public trust in the credibility and effectiveness of such tools, but on the state of the debate.

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