THE PRECAUTIONARY PRINCIPLE: HISTORICAL AND CONCEPTUAL BACKGROUND
THE PRECAUTIONARY PRINCIPLE: HISTORICAL AND CONCEPTUAL BACKGROUND

Summary/Abstract: Pharmaceutical decisions are affected by several forms of uncertainty which are sharpened both by the high stakes at play, and by the complexity of the epistemological procedures needed to provide the necessary information. The precautionary principle as applied to pharmaceutical decisions through the notion of “well-founded suspicion” takes into account one special sort of these uncertainties: the uncertainty concerning the causal connection between observed adverse reactions and suspected drug. The introduction of the precautionary principle has meant the shift from a legal system based on danger avoidance – where causality must be certain before any countermeasure is allowed/enforced – to a risk prevention system, where the hypothesis of causal connection may be as weakly supported by evidence as the expected harm is high. In this sense, the notion of well founded suspicion is equivalent to that of “hypothesis of causal connection” and it is measured probabilistically. Thus we have in principle two probabilities: one attached to the hypothesis that there is indeed a causal connection between expected harm and drug; the other measuring the expectation that the harm indeed occurs (possibly as a function of its incidence in the “population”). The higher the former, the more confident are we about the harm-drug connection, the higher the latter, the higher is the expected harm. The precautionary principle has been criticized for its inhibitory action against innovation and research, for its unjustified unbalance towards the risk produced by human agency vs. natural risks; and, from a formal point of view, for its vagueness and unsystematic application. Most criticisms are generally grounded on the supposed risk aversive nature of the precautionary principle. The purpose of this paper is to examine whether the precautionary principle really is a risk aversive norm, thus I will consider the notion of well-founded suspicion as the pharmaceutical version of the precautionary principle and compare it to the technical notion of risk aversion.

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