Regulation options

Policy development in this area is challenging because the desire to enhance the regulation of genetic tests to improve patient safety and ensure public confidence must be balanced against the need to promote innovation and provide timely access to tests. These conflicting principles are not the only concern as there is also the practical matter of resources. Any increase in regulation will place burdens on both test developers/providers and on regulatory agencies. This final section discusses some options for dealing with these challenges.

This analysis will draw on current trends in regulatory theory, in particular the concept of 'responsive regulation' developed by Ayres and Braithwaite (1992). Responsive regulation aspires to transcend traditional approaches to regulation based on a top-down system of regulation by the state, advocating instead a more de-centered and diffuse approach, which assumes that the state is not the only effective regulatory agent and that other actors can fulfill many key regulatory functions. A balance between the two approaches can be struck by creating systems where the state delegates core regulatory functions to other parties, acting as a 'meta-regulator' with standard-setting authority and ultimate powers of enforcement.

Similarly, traditional reliance on statutory controls enforced by draconian sanctions, often including use of the criminal law (Black, 2002; Scott, 2003) are rejected in the responsive regulation model, which favors an approach premised on minimum statutory regulation required to achieve desired outcomes. This is achieved by creating regulatory systems that are risk-based, i.e. proportionate to the dangers posed, and responsive, i.e. rewarding good conduct with more minimal intervention, but punishing bad practice with increasingly tough sanctions. This approach is captured in the concept of an enforcement pyramid.

The concept of regulation by information disclosure, an approach to regulation which focuses on addressing 'the asymmetries of information between consumers and traders' (Howells, 2005) is also drawn on. This strategy is now very popular in consumer protection fields because it is seen as a way of balancing the need to protect the public with a desire to encourage freedom of choice.

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