Wednesday, June 27, 2012

The EU Pfizer decision: Still provoking thought on risk regulation in the EU

This week I had an opportunity to discuss risk regulation with a group of American and French students. We reviewed Jonathan Weiner's article, Whose Precaution After All? A Comment on the Comparison and Evolution of RisK Regulatory Systems, 13 Duke J. Comp. & Int'l L. 207 (2003). I also had an opportunity read a summary of a 2002 case referred in Weiner's article, Pfizer Animal Health SA v. Council of the European Union (European Court of First Instance, 2002). The case addressed the issue of the authority of European Community institutions in regulating the marketing of antibiotics for use as an additive in "feedingstuffs." While the case is old, it remains unchallenged and provides food for thought. I was particularly struck by the following parts of the decision and their divergence from the U.S jurisprudence:

1. While EC institutions must seek the advice of scientific experts, their opinion is not binding on the public authority. It may choose to regulate a risk even when there is contrary finding (in fact, in exceptional circumstances it can circumvent the general requirement that scientific advice must be sought before deciding to regulate a risk).

2. The principle of proportionality, which is akin to a cost-benefit analysis, should guide the decision of public authorities. While this principle is generally understood to mean that an EC institution should not "exceed the limits of what is appropriate and necessary" to legitimatey pursue the objectives of a legislation, in the case of common agricultural policy, discretionary power is recognized unless a decision is "manifestly inappropriate."

3. "The protection of public health, which the regulation is intended to guarantee, must take precedence over economic considerations."

4. An economic actor (in this case Pfizer) has no "right to be heard" in legislative procedures, even when a measure may affect such an actor. (Apparently, a matter pending before courts under the Aarhuus Convention may affect this decision, but it unclear whether and to what extent).

To my knowledge, comparable standards are not applied by U.S. courts. In this post, I raise the questions that we discussed in class, albiet without any concrete conclusion: Why are the standards regarding risk regulations different? Which is a better approach? How can we learn from each jurisdiction?


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