A good process would be politically acceptable. It would have appropriate accountability and would achieve legislative goals in obvious ways.

In addition, leadership must listen and hear the articulated needs of the constituency. The constituency for many of these problems is the public. One of the needs of the public is their concern about the safety of the blood supply, and so a good process must in an irreducible way respond to that as well.

Could there be, however, a regulatory process that not only responds to the public's concerns about safety but that itself promotes the public's appreciation of the safety of the blood supply? People respond to risks in ways different from the ways in which medical science responds to risk; it is a challenge for us to take that into account. How can the public be brought to recognize the realities of safety so that in fact the decisions that are partly science-based, partly value-based, and partly economics-based can be the right decisions to be reached at the end of the day, not distorted by the politics of misperception and misinformation? This is the regulatory challenge.

What combination of private and public systems will accomplish these things? That is as difficult a question for those who dwell in the law side of the house as the medical issues about antigen testing and Creutzfeldt-Jakob disease are for those who live in the medical side. We do not have unambiguous answers either. Our knowledge about alternative procedures is itself indeterminate. For that reason, among others, the notion of a pilot project makes good sense.

It seems clear that some investment of time, energy, and thoughtfulness about these regulatory issues will pay a considerable dividend. After all, the regulatory process is the infrastructure within which all of these other problems come to rest. Government is art, and if the metaphor may be expanded, it is difficult to create a free sculpture with a mean tool. Without an investment in the quality of the decision-making process itself, the odds of sculpting good decisions are not nearly as good as they might be.

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