THE IMPACT OF A NEW REGULATORY FRAMEWORK FOR THE SCIENTIFIC USE OF ANIMALS ON RESEARCH AND INNOVATION. 01.October March.

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1 ANIMPACT - AN ETHICAL, LEGAL AND PRACTICAL PERSPECTIVE ON THE IMPACT OF A NEW REGULATORY FRAMEWORK FOR THE SCIENTIFIC USE OF ANIMALS ON RESEARCH AND INNOVATION 1 st Period Report 01.October March.2015 Publishable Summary PROJECT FUNDED BY THE SEVENTH FRAMEWORK PROGRAMME OF THE EUROPEAN UNION UNDER GRANT AGREEMENT NUMBER Page 1 of 5

2 3.1 Publishable Summary European legislation regulating animal experimentation is based on the need to balance the two important interests at stake: advancing research and protecting animal welfare. Both aspects of this balance were important for the revision resulting in Directive 2010/63/EU. By analyzing how ethics review and project authorization operate and are perceived by stakeholders in animal research, as well as mapping the mechanisms which scientists operate themselves when deciding over animal research, ANIMPACT is providing information about major and previously uncharted aspects of regulation and decision making mechanisms in animal experimentation and about the interactions between Directive 2010/63/EU and health research. The work is organized into seven WPs across three main types of activities. The WPs are divided into coordination (WP1), information synthesis (WP 2-6) and dissemination (WP7): Coordinating the project - WP1 Coordination Synthesizing knowledge - WP2 The Directive, the Broader Legal Landscape and the Licensing Process - WP3 The Directive, the Ethical Landscape and the Practice of Ethical Review - WP4 Internal regulation in research: Safeguarding animal welfare through the 3Rs - WP5 Fish, mice or monkeys? The influence of different factors on the choice of model species - WP6 External regulation and competitiveness: practice and perception of key stakeholders in animal research Disseminating knowledge - WP7 Development and dissemination of supporting material for use in approval and decisionmaking processes over animal research This summary presents the work of the information synthesis and dissemination work packages. In the work package The Directive, the Broader Legal Landscape and the Licensing Process, the implementation of Directive 2010/63/EU in selected Member States is being mapped and regulatory and policy best practice and codes of guidance are being studied in each jurisdiction. This is necessary as the Directive has to be implemented in each Member State s Law, but has, within its requirements, a number of explicit discretionary options. Further, a lot of the terminology and to some extent the concepts used in the Directive are open to interpretation. Therefore, as a harmonizing initiative, building on the previous Law but taking into account developments in scientific practice and expectations, the Directive gives scope for a degree of difference between the Page 2 of 5

3 Member States. In terms of the effectiveness of the Directive, it is necessary to make this detailed study of both the European and the implementation on paper and in practice made by individual Member States. To date, an internal report has been produced to offer an analysis of the potential for express and implementation differences that could impede harmonisation of Law in the area. The report addresses points that are legal and others that are scientific (particularly relating to the way that scientific methodologies and the 3Rs are implemented, and how the licensing structure works). It maps a systematic commentary on the Directive onto the various Recitals and Articles of the Directive. This detailed analysis is then used as the basis of the analysis of the Member State Laws. Through webinars, other consortium members are contributing to the development of this work, bringing in experience and expertise which is complementary to the legal expertise in the work package. In the work package The Directive, the Ethical Landscape and the Practice of Ethical Review, the aim is to understand the diversity of approaches to ethics review of animal research and how differences influence the operation of Directive 2010/63/EU. An overall map of ethics review in EU-27 has been produced, showing that there is considerable diversity between countries in how the review process is organized. In most countries, projects are reviewed by a committee with some degree of multidisciplinarity. Scientific and veterinary / animal care expertise is present in nearly all committees, whereas other forms of technical expertise include legal professionals, ethicists, statisticians and experts on alternatives. Whether project review takes place on a national, regional/local or institutional level varies greatly, and some countries also combine different levels. Case countries for the in-depth analysis of ethics review have been selected based on an extensive mapping of the animal research situation across the countries. Selected countries are Italy, UK, Hungary and Sweden. An interview guide for the in-depth analysis has been developed and interviews have started. In the work package Internal regulation in research: Safeguarding animal welfare through the 3Rs, the aim is to explore how internal norms may influence the ethical treatment of animals in research through researchers decisions when planning and reporting their research, and when engaging in the peer review process (as reviewers, journal editors or panel members of funding agencies). The first task of the work package is a case study to examine an area of research in which the field has made efforts to self-regulate, offering an opportunity to examine both the aspects of animal welfare considered relevant to self-regulation and also whether such regulation has had an effect on animal welfare. This was done through a survey of the extent to which welfare concerns are reflected in the design and reporting of biomedical research has been conducted focussing specifically on research into Amyotrophic Lateral Sclerosis (ALS). This area was chosen because this field has made specific efforts in the recent past to improve and standardise research methodology through the publications of guidelines for animal study, allowing us to assess the effect of such guidelines on the conduct and reporting of research. This field has also been the focus of studies on the reliability and reproducibility of pre-clinical research, allowing us the opportunity to comment on the extent to which experimental design affects both welfare practice and research reliability critical for effective research translation. Page 3 of 5

4 In the work package Fish, mice or monkeys? The influence of different factors on the choice of model species the aim is to map the use of different animal species as experimental models in the EU, identifying possible differences among Member States and analyzing the possible effect of the Directive and other factors on the described scenario. An overall map on the use of animals as experimental models in the EU has been produced, with details on the use of different species, for different scientific purposes. According to the last report, mice and rats still represent the large majority of the animals used for experimental and other scientific purposes in the EU, although rats underwent a relative decrease in number between the years 2005 and 2011 (whereas the number of mice used increased). Almost half of the animals are used in biological studies of fundamental nature and their number has increased since 2005, while animals utilized for research and development (and for production and quality control of products and devices) for human and veterinary medicine has decreased. There are relevant differences among MS in terms of number of animals used, proportion of species used, and proportion of animals used for different purposes. In 2011, France, Germany and United Kingdom together utilised more than the half of the animals used in Europe. However, when analyzing the number of animals used in relation to countries economies (GDP and expenditure on R&D) these three countries did not result to be the major users, whereas Hungary, Estonia and Czech Republic occupied the first three positions. Among the MS using more than animals in 2011, countries with atypical distribution in the use of particular species were identified, as well as countries with atypical distribution of species utilized for different purposes. Based on this analysis, 10 MS has been selected as case studies: Czech Republic, Finland, Germany, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, and United Kingdom. These were chosen among the ones which make the most use of experimental animals and to represent the spectrum of different uses of animals in research, as well as differences in public attitudes towards animal research. In the work package External regulation and competitiveness: practice and perception of key stakeholders in animal research, the aim is to study how perceptions and practice of key stakeholders frame and influence the implementation of Directive 2010/63/EU. More specifically biomedical science s perception of good regulatory regimes will be identified; and it will be studied which roles private and public biomedical research institutions and companies play in the implementation of the Directive. So far, relevant scientific literature has been reviewed. Given the scarcity of specific literature of norms and practice in relation to EU legislation of animal research, selected case countries in relation to directive 2010/63/EU, it was decided to broaden the scope and include literature on stakeholder perspectives on animal research regulation in general and on Directive 2001/20/EU on clinical trials. The review pointed to two interesting observations and results: - Towards the end of the transposition period of directive 2010/63/EU, researchers present opposing views on the outcome of the revised legislation. Some are positive stressing the fact that it will be a better framework for scientists; others are, however, concerned about the increasing bureaucratic requirements. Page 4 of 5

5 - Literature on the clinical trials directive demonstrated the concern that it has proven more difficult to carry out clinical trials following the implementation of the directive. This was partly ascribed to the increasing bureaucratic burden. In the work package Development and dissemination of supporting material for use in approval and decision-making processes over animal research, the aim is to inform all interested researchers, stakeholders etc. about the work progress and the results of the ANIMPACT project. The ANIMPACT logo was created during the first months of the project so that it can be used by all consortium members in communications over the project. The ANIMPACT website was made available in the beginning of 2014 and the first results are currently being published and prepared for publication on the website. In addition, this work package has produced a virtual office for the internal management of the project and for interaction between consortium members. Presentations Fernandes JF, Franco NH, Grierson A, Olsson IAS Refinement and experimental design in publications: a longitudinal case study of ALS research. Oral presentation. 9 th World Congress on Alternatives and Animals in the Life Sciences. Prague, Czech Republic August Franco NH, Martins AR, Olsson IAS 2014 Classifying editorial policies on animal use in science: the EXEMPLAR scale. Oral presentation. 9 th World Congress on Alternatives and Animals in the Life Sciences. Prague, Czech Republic August Olsson IAS, Silva S, Lassen J and Sandøe P 2014 Ethics review of animal experiments in Europe under Directive 2010/63/EU. Scand-LAS (Scandinavian Society for Laboratory Animal Science) Congress, Stockholm. 25 April Page 5 of 5