The logic, methodological and practical flaws of the Harm-Benefit-Analysis (HBA) in Directive 2010/63/EU

Abstract

Directive 2010/63/EU regulates the use of animals for scientific purposes in EU member states and mandates that every project proposal involving procedures on living non-human vertebrates and cephalopods has to be approved in a review process that includes a Harm-Benefit-Analysis, to assess “whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical consideration and may ultimately benefit human beings, animals or the environment (EU Directive 2010/63, Art 38d).
The aim of this paper is 1) to summarize recent criticism on the epistemic and practical limitations of the prospective benefit assessment in the HBA in its current form and on the focus on tangible societal benefits in project evaluation and 2) as a proof of principle, demonstrate the argumentation of these papers on 2 concrete examples, namely the insulin inhalator Exubera and the cancer drug Ipilimumab.
First, we show that the HBA suffers from a logical and methodological flaw. The outcome of an experiment is per definition uncertain. If it wasn’t, the experiment would not generate new knowledge and would therefore be illegal. Moreover, as long as animals are used as models for humans there will always be uncertainty regarding the translatability of knowledge from model to target species. Second, we show that practical flaws further complicate prospective benefit assessment. There are non-scientific factors, such as market potential, lobbying, patient compliance, etc., that are impossible to predict and yet, are important parameters in prospective benefit assessment. Together, these uncertainties make a prospective benefit assessment implausible.
Also, the requirement to demonstrate societal benefits might incentivize researchers to overstate the tangible benefits of their research in project proposals, thereby making prospective benefit assessment in project evaluation more difficult for committees. Overstating potential societal benefits that are eventually not realized might also be detrimental to the credibility of science. In light of these flaws we think it necessary to develop an alternative model for project evaluation that focuses on potential knowledge gains as outcome of a project rather than prospective assessment of potential societal benefits.