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Blood Banking and Regulation: Procedures, Problems, and Alternatives V Postscript

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Blood Banking and Regulation: Procedures, Problems, and Alternatives This page in the original is blank.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives Investing in Regulatory Quality Edward A. Dauer What we have been exploring in our analysis of blood services regulation and its alternatives may be nothing less than good manufacturing practices for the law itself. What are the specifications of a good process for creating regulation and the procedures for ensuring compliance? REQUISITES OF REGULATORY PROCEDURES Predictability is certainly one of the requisites. There is also the challenge of matching the process to the problem in each of two dimensions. One is the dimension of effectiveness; the other is the dimension of efficiency. The procedure itself not only must work but it also must work better than any alternative in terms of its benefits and its costs. On the one hand it has been argued that any good process must maintain science-based decision-making. On the other hand, it is stubbornly true that some of the necessary science will always be missing. It is not always possible to determine causation unambiguously, to ''prove" that something is or is not in fact transmissible by blood. Under those circumstances, a good process may be one that is not frozen in place by the uncertainties and that does not allow uncertainty always to play the trump suit over other values such as public perception, morality, ethics, and economic welfare and the fact that every cost incurred in one endeavor inflicts additional risks somewhere else. In addition, a good process would be one that minimizes disincentives and other adverse effects. It would not, for example, discourage innovation. It would not require that attention be paid to the method of compliance, as much as to the objectives of compliance.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives PUBLIC PERCEPTIONS 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.