The Harm-Benefit-Analysis in Directive 2010/63/EU - Should ethics review be public deliberation or an expert evaluation mechanism?

Date: 13th June 2018

Time: 1:00-3:00 pm

Venue: Banquet Hall (Kleines Sitzungszimmer), University of Veterinary Medicine, Vienna


Matthias Eggel, Institute for Biomedical Ethics and History of Medicine, University of Zurich, Switzerland

Peter Sandøe, Department of Food and Ressource Economics, University of Copenhagen, Denmark

Herwig Grimm, Messerli Research Institute, University of Veterinary Medicine Vienna, Medical University Vienna, and University of Vienna, Austria

Anna Olsson, Laboratory Animal Science, Institute for Research and Innovation in Health, University of Porto, Portugal

Corresponding Organizer:

Matthias Eggel (matthias.eggel(at)

Context and Aims:

Directive 2010/63/EU regulates the use of animals for scientific purposes through its implementation into the legislation of EU member states. It mandates that every project proposal involving procedures on living non-human vertebrates and cephalopods has to be approved in a review process including a "Harm-Benefit-Analysis“ (HBA), 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 humans, animals or the environment“ (1, article 38d). From this it follows that a project is only ethically and legally justified if the benefit can be expected to outweigh the harms inflicted on animals. Whereas the national competent authorities are responsible for the authorization, the underlying evaluation is often carried out with the help of advising experts and committees. To assess harm to animals, potential benefits to humans, animals and the environment and evaluate whether the requirement for ethical consideration of animals is met, requires evaluating the scientific justification of a proposal (strength of hypothesis, experimental design, etc) as well as the ethical implications (moral status of animal, weighing of benefit against harms,etc).  

Efforts have been made to systematize the assessment through the development of methods and scoring systems. Systematic assessment methods are useful for the aspects of evaluation where there is a well developed field of knowledge and experts can agree on a method. Of these components, This is the case for assessment of the scientific standard, strength and scientific importance of a proposal (matters which are part of the usual peer-review process for funding or publication) and for assessing animal harm (for which animal welfare science and veterinary medicine have expertise). But other components seem to have more to do with values and perspectives. Defining systematic methods for assessing ethical considerations seems to defy the purpose of assessing something which is arguably a matter of public deliberation.  

As the review of projects with animals is mandated through Directive 2010/63/EU, it seems to combine elements for expert assessment and elements for public deliberation. This raises questions about the composition of committees and about the appropriate level of assessment.

As a starting point for this workshop, we will ask if the ethics review of animal research is a matter of expert assessment or public deliberation. We aim for a critical discussion of how to best integrate or separate the evaluation of projects for authorization and the public deliberation over overarching matters of animal research ethics.

Target Group:

We welcome a wide participation in the workshop, including persons with an interest and / or activity in policy-making, animal research and animal protection.  

If you are interested to join, please contact in order to receive literature which will be debated.

Key Words:

Harm-Benefit-Analysis (HBA), ethics review, Project evaluation, Directive 2010/63/EU