Alternatives to animal testing become more urgent as new chemicals legislation draws nearer

Brussels, 08 May 2003

On the day the Commission published its draft of new chemicals legislation for consultation, representatives of the industry, the European institutions and animal welfare groups gathered in the European Parliament to discuss the likely impact of these new laws on animal testing.

Professor Coenraad Hendriksen from Utrecht University in the Netherlands, animal welfare officer at the country's vaccine institute (NVI) and head of the Netherlands centre for alternatives to animal use (NCA), gave a presentation outlining how animals are currently used for research, explaining the 'three Rs' - replacement, reduction and refinement, and calling for the search for alternatives to be moved higher up the political agenda.

The new chemicals legislation will require companies to assess the risks arising form their use of chemicals, the aim being to protect human health and the environment through a new EU-wide regulatory system. But these new requirements will lead to a huge rise in research into chemicals, much of this involving animals.

'The subject of alternatives to animal testing needs much more attention than it has now. Increased consciousness of the three Rs must lead to new European legislation through which national procedures will be improved. The white paper on chemicals makes this extremely urgent,' said Dutch MEP Bob van den Bos, who hosted the seminar.

In 1999, over nine million animals were used in experiments across the EU, a drop of around two million from 1996. The majority are used for fundamental research, followed by the development of medicines and then quality control. Mice constitute over 50 per cent of animals used. A high number of rats are also used, and smaller numbers of invertebrates, primates, birds and carnivores.

Regulatory testing, the type of research required by the proposed chemicals legislation, is performed routinely, using a high number of animals per test, often between 120 and 150, according to Professor Hendriksen. Around 10 per cent of regulatory tests for toxicity lead to high levels of pain and distress for the animals involved, while 17 per cent of tests for biological products are equally agonizing, he explained.

Although Simon Webb from the European chemical industry council (CEFIC) stated the organisation's openness to cooperating with other stakeholders to reduce the number of animals 'consumed', Emily McIvor from the European coalition to end animal experiments, called upon CEFIC to provide funding, laboratory space and personnel for research into alternatives to animal experiments. 'Initiatives are welcome, but there have always been initiatives. What is really needed is funds. We would like to see fewer empty promises,' she said.

Although Professor Hendriksen is eager to develop alternatives to animal experiments, he admitted that 'life would be less safe than it is at the moment if we stopped testing now' and highlighted the contribution that animal testing made to the eradication of certain diseases from industrialised countries, including typhoid, tuberculosis, cholera and yellow fever.

Professor Hendriksen emphasised, however, that there are also drawbacks to testing on animals. The experiments are extremely costly and time consuming and results often vary when experiments are performed on different strains of the same animal. There is also the question of whether these results would be the same in humans.

The presentation also drew attention to the ethical aspects of animal testing. 'What right do we have? Do [animals] only have instrumental value or also intrinsic value?' asked Professor Hendriksen.

The three Rs can be achieved through the use of tissue culture, computer models, human volunteers and invertebrate organisms (replacement); test optimisation and better statistics methods (reduction); and anaesthesia, analgesia and better housing (refinement).

There are obstacles to developing replacement experiments, particularly for regulatory testing. Each new method needs to be pre-validated, validated and accepted before it can be implemented. The whole process can take as long as 18 years, as has been the case for an alternative method for testing tetanus vaccines, developed by Professor Hendriksen and his team.

Professor Hendriksen blames the lack of progress in the development of alternatives to animal experiments on a lack of scientific tools, a lack of funding, the low priority that the issue is awarded by research institutes and the negative cost-benefit balance incurred by the high risks that such research involves.

His recommendations therefore include moving the matter higher up the political agenda, including in the European Commission's Sixth Framework Programme for research; removing financial barriers to new research; harmonising guidelines and promoting the exchange of data.

Indeed, John Williams from COST, the European cooperation in the field of scientific and technical research, revealed that his organisation is currently in negotiation with the European centre for the validation of alternative methods (ECVAM) on the establishment of a network to obtain data. Such a network is necessary because all the data needed to develop alternatives to animal experiments is currently held by pharmaceutical companies. 'If we don't get the data, we need to do the experiments all over again,' said Mr Williams.

Concluding the seminar, Professor Hendriksen called on researchers to implement reduction and refinement when no replacement for animal experiments has been found.

On 12 May, EU Research Commissioner Philippe Busquin will present new alternative methods to animal testing developed by an EU funded project.

For further information on the chemicals White Paper, please visit:
http://europa.eu.int/comm/enterprise/che micals/index.htm

For further information on ECVAM, please visit:
http://ecvam.jrc.it/index.htm

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