Mission impossible accomplished? A European cross-national comparative study on the integration of the harm-benefit analysis into law and policy documents

The harm-benefit analysis (HBA) is a cornerstone of the European Directive 2010/63/EU (the Directive). The Directive regulates the care and handling of animals used for scientific purposes in the European Union (EU). Since its implementation, there has been ongoing debate around the practical applic...

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Bibliographic Details
Published in:PloS one 2024-02, Vol.19 (2), p.e0297375-e0297375
Main Authors: Hajosi, Dominik, Grimm, Herwig
Format: Article
Language:English
Subjects:
Animal experimentation
Europe
European Union
Laws, regulations and rules
Longitudinal Studies
Medicine and Health Sciences
People and places
Policy
Research and Analysis Methods
Science Policy
Social Sciences
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Summary:The harm-benefit analysis (HBA) is a cornerstone of the European Directive 2010/63/EU (the Directive). The Directive regulates the care and handling of animals used for scientific purposes in the European Union (EU). Since its implementation, there has been ongoing debate around the practical applicability of the HBA for research project review processes. The objectives of this study are to analyze the operationalization of HBA in EU member states and investigate the consistency of HBA's implementation in terms of national legislation and available policy documents. To meet these objectives, we evaluated the transposition of the HBA requirement into national legislation. We also conducted a comprehensive comparative cross-national analysis of all guidance documents pertinent to HBA. The results of our study show that there are (1) deficits in the transposition of the HBA requirement into national laws, (2) significant discrepancies in available policy documents relating to HBA, and (3) insufficiently consistent implementations of HBA in European countries.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0297375