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The importance of the precautionary principle in public health was highlighted in France after the HIV contamination of blood products used for transfusion. However, the definition of this principle, its objectives, the way in which it should be applied, and its consequences had not been considered previously. The question as to whether the application of the precautionary principle is appropriate remains unanswered. The aim of this study was to analyze the interpretations of the application of the precautionary principle to determine its consequences in terms of risk management and patient rights. This was accomplished by interviewing persons involved in transfusion medicine. We conducted 33 interviews and describe the issues enunciated for and against the application of the precautionary principle. The precautionary principle concept was confusing to the respondents. A major issue emerging from the interviews was that the precautionary principle was perceived more as a means of protecting the decision maker than as a means of protecting the patient. Taken to its extreme, the use of the precautionary principle could prejudice sound medical decision making. However, it was felt that it also can lead to the introduction of measures that update and gradually reduce risks associated with transfusion.

TRUE RISKS AND THEORETICAL RISKS: The texts ruling the obligation of the physician to inform the patient appears not to include theoretical risks in their application. In France however, the field of blood transfusions extends this obligation to the theoretical risk of potential transmission through the blood of the infectious agent responsible for Creutzfeldt-Jakob's disease., Unanswered Questions: From an ethical point of view, is information on the theoretical risk of transmission founded? From a formal point of view, the means used for such an extension (i.e.,a bulletin) is debatable; was this an adequate measure? THE RETURN OF COMMON SENSE: If we look at the earlier texts, the principle of an obligation to inform the patient of the theoretical risks does not appear widespread or even confirmed. Do these text simply the return of "common sense"? And if so, to what extent does it encourage the illusion of a zero risk...?

The concept of risk cannot be limited to simply knowing the probability of occurrence and the seriousness of the damages caused. It's a matter of social construction and numerous elements contribute towards its perception and acceptability. These elements have been studied for 20 years or so. Some of these elements influence risk perception such as awfulness, unfamiliarity, the number of people exposed to it, other elements influence its acceptance such as individual perceptions, social factors, ethics and equity. Their knowledge allows a better understanding of the evolution of perception and of the risk acceptability in general and transfusion risk in particular.

The precautionary principle has boomed in the French public health sector through blood transfusion. There has been, however, no perambulatory reflection on the definition, objectives, methods of application or consequences of this principle. The question of the pertinence of its application remains unanswered. This study, based on interviews with blood transfusion practitioners, aims to establish their perceptions of the precautionary principle's application in this specific field and of its consequences in terms of risk management and patients' rights. The pros and cons of this application are analysed based on these perceptions. According to our analysis, the precautionary principle seems to be born of confusion. It is seen more as a way to protect decision makers than patients and, if taken to extremes, could prejudice medical logic. Nevertheless, it also brings measures which renew and encourage evolution in transfusion risk management.

Abstract: The precautionary principle first appeared in France during the health crisis following the contamination of patients with HIV via blood transfusion. This study analyses whether the risk associated with blood transfusion was taken into account early enough considering the context of scientific uncertainty between 1982 and 1985. The aim was to evaluate whether a precautionary principle was applied and whether it was relevant. First, we investigated the context of scientific uncertainty and controversies prevailing between 1982 and 1985. Then we analysed the attitude and decisions of the French authorities in this situation to determine whether a principle of precaution was applied. Finally, we explored the reasons at the origin of the delay in controlling the risk. Despite the scientific uncertainties associated with the potential risk of HIV contamination by transfusion in 1983, we found that a list of recommendations aiming to reduce this risk was published in June of that year. In the prevailing climate of uncertainty, these measures could be seen as precautionary. However, the recommended measures were not widely applied. Cultural, structural and economic factors hindered their implementation. Our analysis provides insight into the use of precautionary principle in the domain of blood transfusion and, more generally, medicine. It also sheds light on the expectations that health professionals should have of this principle. The aim of the precautionary principle is to manage rather than to reduce scientific uncertainty. The principle is not a futile search for zero risk. Rather, it is a principle for action allowing precautionary measures to be taken. However, we show that these measures must appear legitimate to be applied. This legitimacy requires an adapted decision–making process, involving all those concerned in the management of collective risks. [Copyright &y& Elsevier]