The European Commission has launched a new website to track the progress of alternative test methods that replace, reduce and refine (the 3Rs) the use of animals in research.
Managed by the Institute for Health and Consumer Protection, one of the seven scientific institutes of the Commission’s Joint Research Centre, the Tracking System for Alternative test methods Review, Validation and Approval (TSAR) at http://ihcp.jrc.ec.europa.eu/tsar is designed to enhance transparency in the review, validation and approval of alternative test methods.
The ultimate aim is to cover “each and every” step in the validation process, from submission of a new method for pre-validation through to final adoption by means of inclusion in European Union legislation and/or related guidance documents, the Commission noted. The website will also explain the decisions that have been taken at every stage of the process, including the reasons for any negative final decisions on proposed test methods.
TSAR will be updated whenever a phase in the validation process has been completed. To ensure a rapid launch for the site, though, the initial version covers only the regulatory approval phase of alternative test methods for chemicals, the Commission pointed out.
Website users can check whether an alternative test exists in a particular area (e.g., skin irritation and corrosion) and whether that method is already accepted in EU legislation or for some other regulatory use. TSAR will also indicate which domain of the 3Rs a method belongs to and which legislation refers to that method if it is already adopted for regulatory use.
The launch of the website “proves that we are serious about our commitment to develop alternative methods to animal testing and to be transparent about progress being made”, commented European Science and Research Commissioner Janez Poto_nik.
Addressing a conference held in Brussels by the European Partnership for Alternative Approaches to Animal Testing (EPAA) earlier this month, Poto_nik noted the “impressive” advances made in this field over the last year, while also stressing that the goal of replacing fully the use of animals in safety testing is still some distance away.
One encouraging trend has been new models for research co-operation between Europe, the EU member states, industry and academia, he said. For example, the Innovative Medicines Initiative – the public-private partnership between the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission that was launched earlier this year – promotes the inclusion of the 3Rs principle in numerous work topics and “did so specifically in its first call”.
Among other advances, Poto_nik mentioned a new Joint Research Initiative between the Commission and the cosmetics industry (as represented by the European trade association COLIPA) that will look at alternatives to use of animals in repeat-dose systemic toxicity testing. A call for proposals under the Initiative, to which the Commission and COLIPA are each contributing funds of €25 million, will go out next year.
In addition, Poto_nik noted, a special memorandum of co-operation will shortly be signed by the Commission’s validating body, the European Centre for the Validation of Alternative Methods (ECVAM), with the US Interagency Coordinating Committee, The Japanese Centre, and the Environmental Health Science and Research Bureau of Health Canada.
Launched in November 2005, the EPAA brings together ECVAM, five Directorates General of the European Commission, industry associations and 40 member companies.
The 3Rs principle is also central to the Commission’s proposal on revising the animal testing Directive, 86/609/EEC, which emerged earlier this month following a long series of delays. The biotechnology industry has voiced concerns about what it regards as unnecessary regulatory and bureaucratic burdens in the proposal, particularly around ethical advice on the housing and care of laboratory animals.
EFPIA has expressed similar sentiments, insisting that any new provisions in the legislation “should be based on sound scientific evidence, and should not unnecessarily increase red tape”. The review of Directive 86/609/EEC “needs to balance animal welfare, research realities and patient needs”, the association stated.
