Legislation in the Lab
(August 15th, 2017) The multidisciplinary project, ANIMPACT, was established in 2013 to address how legislation, regulating animal research, impacts upon biomedical research in Europe. Now, the first results are in.
Animal models play an important role in life science research. Rodents, insects and fish have immensely contributed to knowledge about our own species, in health and disease. In Europe, animal research has been regulated since 1986, when the first Directive, protecting animals, used for scientific and other experimental purposes, came into effect. This regulation was revised during the first decade of the 21st century, resulting in Directive 2010/63/EU. This Directive is often described as the most advanced legislation in the world for the regulation of animal research. It was created not to substitute the national legislation of each member state but to complement it and aid in setting up a standardised platform for animal research. In 2012, the European Commission made available funding for studying the interaction between research and the legislation regulating it. As a result, the ANIMPACT project was launched in October 2013.
ANIMPACT wants to understand how the Directive impacts animal welfare and research in both academia and industry. A team of ethicists, lawyers, sociologists, veterinarians and life scientists screened the literature, sent out questionnaires, conducted interviews and formed focus groups. The concluding conference, attended by experts from various European universities, the European Commission and animal welfare organisations, took place in Brussels, on December 8th, 2016.
Mapping the organisation of review and authorisation of animal research, the ANIMPACT team found that there is significant variation between EU member states. Interviews with researchers and industry stakeholders showed that they “overall agree with the need for regulation of animal research and, in general, they agree with the intentions of the Directive” but that many bench researchers are “concerned with the functioning of the actual regulation, especially with regards to paperwork, bureaucracy and delays in the project authorisation process”.
In addition, a survey among journal editors, who publish animal research, showed that more than 80% consider measures to improve animal welfare important and that over 25% reject papers when such measures are poorly implemented. “Interestingly, however, editors are split on whether they consider journals to be responsible for ensuring good animal welfare in research,” shares Anna Olsson, the project's coordinator and researcher in animal welfare and animal research ethics at the Institute for Molecular and Cell Biology, Porto, Portugal.
“What is already very clear is that there is an EU-wide engagement with this legislation. In my opinion, there is a clear sense of sharing a legislative framework. A very important factor in this is the unprecedented effort from the European Commission in assuring a good implementation and in engaging with the different stakeholders. There is also a huge interest from stakeholders in engaging with this implementation. Self-regulation plays an important role but its implementation is variable. Wider discussion among stakeholders of where responsibility lies could improve this,” concludes Anna Olsson.