Mad Cows and Variant Creutzfeldt-Jakob Disease - The New Stature of the Precautionary Principle in European Law and Health Practice

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© April 2001 Peter Free

Precautionary Principle can also leave question of competing goods unanswered

            The Precautionary Principle, as policy, also runs into difficulty even when both sides to a controversy accept its precautionary bias as legitimate.  BSE demonstrated this difficulty in the controversy surrounding blood and vaccine safety.  Once vCJD was seen in humans, questions arose on two fronts.  Without a screening test for the disease, how sure could one be that blood donations from potentially infected donors would not contaminate the blood supply?  And, given that bovine products were used to manufacture some vaccines, how sure could one be that the resulting vaccine would be safe?  On the one hand, precaution questioned the wisdom of permitting the possibility of contamination.  On the other, precaution opposed the harm inherent in cutting off life-saving supplies, simply because there existed a small risk of adverse outcomes if current practice were continued or gradually modified. [209]

            Uncertainty continues to plague analysis of blood safety in regard to BSE.  The Spongiform Encephalopathy Advisory Committee recommended in October 1997 that government consider removing white blood cells from the blood supply to lower whatever risk existed of transmitting vCJD through transfusions. [210]  A few months later, the Department of Health ordered universal leukodepletion of cellular blood components. [211]  A risk assessment study commissioned by the Department concluded that leukodepletion would be only partially effective, because animal experimental evidence appeared to indicate that about half the potential infectivity resided in blood plasma. [212]  An editorial in the medical journal Lancet concluded that the government had ordered leukodepletion on the premise that safety concerns were paramount when evidence was uncertain. [213]  The editorial posited an aggressive formulation of the Precautionary Principle as it appeared to be operating in the United Kingdom blood-safety context:

(1) Less evidence is needed to justify intervention as risk of harm increases.

(2) Worst-case transfusion scenarios should be used to justify intervention.

(3) Action should be quick, even in the absence of conclusive proof of harm.

(4) Partial solutions should be introduced, if they will cause no harm. [214]

            Here, the critical insight is that worst-case scenarios (the transmission of vCJD), even though rare, might justify an expensive, partial measure.  Decreased safety might also result, because the expense of leukodepletion could shunt funding away from other transfusion services. [215]  Consequently, precaution in this context argues both ways. [216]

            When precaution pulls in opposite ways, transparently proportional decision-making must justify the agreed-upon result.  Decision-makers on both sides of a conundrum start with the same goal.  Letting the public in on the uncertainty, and listening to its myriad voices, governments can make more educated value judgments as to which risks are tolerable and which are not.

            Using blood supply as an example, obvious questions arise.  How abhorrent is the risk of vCJD transmission to even a very small group of potential blood recipients?  Does it outweigh the costs and risk diversions of uncertain interventions?  Might one sit tight (as the United States has), or is it better to adopt an interventionist stance (as the United Kingdom has)?  An open society may more legitimately claim to have mutually participated in the error of action or inaction than a closed one.  In its pursuit of overarching goals within contexts of uncertainty, the Precautionary Principle has an inescapably democratic tone.

Conclusion

            Bovine spongiform encephalopathy solidified the place of the Precautionary Principle in European case law.  The Principle will probably have wide-ranging impact on European political culture.  It requires a more conscious approach to social evolution.  It requires conscious selection for preservation of that which is most precious to people within the general domains of health and environment.  In this, the Principle may temper the individualistic bent of western democracy by developing a consensus more cognizant of the community values that lie at the heart of the social compact.

Indirectly, this result will come from the health and environmental workings of a poorly understood infectious protein.  The prion becomes an example of how physical reality, and the medicine based on it, affects culture.  In a spiritual/existential sense, the BSE experience may force us to recognize that what we do alters the planet and our individual and social places on it. [217]

 

(This is page 7)  Page 1 ─ Page 2 ─ Page3 ─ Page 4

Page 5 ─ Page 6 ─ Appendix ─ Footnotes