Challenges to the economic evaluation of new biotechnological interventions in healthcare.

The next century is likely to bring unforeseen genetic and biotechnological discoveries, with new benefits, risks and costs. This paper explores some of the problem areas that healthcare biotechnologies are likely to encounter. Biotechnological interventions may present particular difficulties when they promise a major breakthrough in therapy, since economic evaluation early in the development of such technologies is inherently uncertain. Given the structure of the biotechnology industry, the perception of the high cost of new products and unknown uncertainties, governments may need to be proactive to ensure that meaningful clinical and economic data are generated in the product research phase and to manage the introduction and diffusion stages with further evaluation and surveillance. Progress usually comes at a price: both governments and the industry should prepare for this rather than offering bland reassurances about safety.