Potocnik calls for more dialogue to facilitate regulatory approval of alternatives to animal testing

EU Science and Research Commissioner Janez Potocnik has urged both industry and academia to do more to facilitate the regulatory acceptance of alternatives to animal testing, while promising
ongoing Commission support.

From a total of 30 methods validated by the European Centre for the Validation of Alternative Methods (ECVAM), part of the Commission’s Joint Research Centre, only eight have so far gained
regulatory acceptance. He suggested that at least some of this bottleneck is due to a lack of communication between researchers and regulators.

‘If the needs of regulators for information are an obstacle, then we must engage more fully with them to identify and meet those needs. Closer relationships, clearer channels of communications
and an ongoing dialogue are required,’ said the Commissioner, speaking at the annual conference of the European Partnership for Alternative Approaches to Animal Testing.

He went on to suggest that the best results will be obtained if this dialogue is applied to the entire research, development and validation process, rather than just the results. What Europe
needs is ‘a means by which regulators, the research community and industry can engage in a systematic and sustained exchange’, said Mr Potocnik.

More engagement between regulators and the research community will also have the added benefit of encouraging applied as well as basic studies on the specific needs of the 3Rs (replacement,
reduction, refinement) approach, said the Commissioner.

The Commissioner had a ‘to do’ list for both academia and industry, but also promised action on the part of the European Commission.

He noted the existence of only four professorships in alternative testing in the whole of the EU, and said that greater recognition of the domain as an academic discipline within the research
community would help.

For its part, industry should make its requirements better known to scientists in universities and research institutions. It can do this by supporting external research and linking with their
in-house projects, Mr Potocnik suggested.

Another step, which could be taken immediately, is to ‘be bolder in sharing information from industrial research and testing’, Mr Potocnik suggested, explaining that the same or similar tests
are often replicated by industrial competitors across sectors.

Once again, the Commissioner explained how taking this one, small step would bring additional benefits for companies: ‘The sharing of animal and substance data and methods will bring gains in
safety through validated methods, as well as efficiency. The likely reductions in cost and creation of new alternative products will be commercially rewarding.’

The Commission, meanwhile, will continue to provide political momentum while ensuring coordination across the relevant policy areas (industry, health, consumer protection, environment,
research), pledged Mr Potocnik. The Commission will also draw up proposals and legislation that are ‘ambitious, but also fair and realistic’, and will encourage dialogue across industry

Research projects looking into non-animal testing methods will receive support under the Seventh Framework Programme (FP7). Two large projects, expected to share ?24 million, will investigate
novel, alternative testing strategies in pharmaceutical research. In addition, 12 small and medium-sized enterprises (SMEs) will work with major pharmaceutical companies and public research
institutes in studies intended to significantly cut the number of animals used in laboratory experiments.

The Commissioner closed by underlining the urgency of developing alternative methods to animal tested, and to getting them onto the market. Some 2,000 cosmetics companies in Europe are counting
upon alternative methods to enable them to meet legal obligations from 2009. An additional 27,000 companies will also need to comply with the requirements of the REACH chemical directive.

‘Can we do better?’ the Commissioner asked. ‘I hope I speak for all here when I say that we can, and we will,’ he said.

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