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The development of alternatives
Many politicians and government officials within Europe accept that a ban on animal experimentation would produce disastrous results in many areas of medical research and pharmaceutical development and testing. However, they have to deal with the considerable pressure from animal protection groups and members of the public who want to see animal experimentation reduced or ended. The idea of developing non-animal alternative methods of research and testing has been very influential on those trying to resolve this problem. It is seen as a practical and reasonable way forward to meet the desires of all those taking part in the debate.
The Directive 86/609/EEC on the Approximation of Laws, Regulations and Administrative Provisions of the Member States Regarding the Protection of Animals Used for Experimental and Other Scientific Purposes sets out the way in which countries within the EU are required to regulate animal research and testing. This Directive specifically states that the Commission and Member States should "... encourage research into the development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals..." 1. This eventually lead to the establishment of the European Centre for the Validation of Alternative Methods (ECVAM) to co-ordinate the development and validation of alternative methods at the EU level. Professor Michael Balls, the Chairman and Director of the UK organisation FRAME (Fund for the Replacement of Animals in Medical Experiments) was appointed the first Director of ECVAM in 1993.
The most pressing aspect of this issue is the use of animals in the testing of cosmetics and cosmetic ingredients. This has been one of the main campaigning issues for animal rights and animal welfare groups for over twenty years. In the UK, the British Union for the Abolition of Vivisection began to campaign very strongly on this issue from 19872. The BUAV achieved a significant level of support for a ban on the use of animals for cosmetic testing amongst UK Members of Parliament, but the UK government made it clear that unilateral action was not possible since the safety testing of cosmetics and cosmetic ingredients was required by a number of European Directives and the requirement to use animals in those safety tests was also decided at a European level.
In 1990 BUAV joined forces with a number of other animal rights groups across Europe and lobbied hard against the animal testing of cosmetics3. The Eurogroup for Animal Welfare, representing more moderate animal welfare groups, also supported this campaign. Faced with this pressure and a growing volume of letters from their constituents, a large number of MEPs soon began backing the call for a ban on the sale of animal-tested cosmetics. There was pressure against such a ban from some sections of industry and from within the European Commission.
The development of alternative, non-animal testing methods is regarded as the perfect way to resolve this issue and ECVAM is viewed by some MEPs as the answer to the problem of cosmetic testing. However, there is a danger that the MEPs most concerned about this issue have unrealistic expectations of what can be achieved. Considerable scientific and industrial effort has been devoted to the hunt for alternative methods over the last decade with very little progress so far.
The campaigning against the testing of cosmetics on animals focused on the Sixth Amendment to the Cosmetics Directive, which was debated during 1993. Eventually, a clause was inserted in this amendment which would ban, within the EU after 1st January 1998, the marketing of cosmetics containing ingredients or mixtures of ingredients which had been tested on animals. However, the Sixth Amendment also required that the 1998 deadline should be postponed if the required alternative methods had not been developed and validated. The specific wording of this section is "If there has been insufficient progress in developing satisfactory methods to replace animal testing, and in particular in those cases where alternative methods of testing, despite all reasonable endeavours, have not been scientifically validated as offering an equivalent level of protection, for the consumer, taking into account OECD toxicity test guidelines, the Commission shall, by 1st January 1997, submit draft measures to postpone the date of implementation of this provision, for a sufficient period, and in any case for no less than two years ..." 4.
There appears to be no realistic prospect of alternatives being developed, by the end of 1997, to the full range of animal tests required by OECD, since these include tests for acute toxicity, percutaneous absorption, skin irritation, eye irritation, skin sensitisation, sub-chronic toxicity, mutagenicity, cutaneous photosensitivity, toxicokinetics, teratogenesis, two-generation reproductive toxicity, carcinogenicity and genetic toxicity. Indeed, many toxicologists consider that it will take many decades to develop and validate all the alternative methods required. Pessimistic assessments of how long it will take to develop alternatives should not be taken as any criticism of the objective of developing such alternatives. That clearly remains the best way forward in this issue. If the problem is more difficult than originally appreciated, there is an argument for increasing the resources devoted to developing alternatives methods of testing.
There is clearly a growing pressure from the European Parliament and in particular the Environment Committee, for a reduction in the number of animal experiments across Europe (as shown by their adoption of a target for a 50% reduction in the number of animals used in Experiments within the EU by the year 2000) and for an end to the use of animals in cosmetic testing. There is a danger that many MEPs may believe that these targets can be achieved with relatively short timescales by the development of alternative methods. They are investing their hope in a technology which is not capable of meeting these expectations. When they realise that alternatives cannot achieve the unrealistic goals which they created, these MEPs are likely to become disappointed and frustrated. If this should occur, there is a great danger that they may abandon their support for the development of alternatives and seek some other method to restrict animal experimentation. Even if they remain supportive of the idea of alternatives, the slow rate of advance may make politicians dissatisfied and lead to unproductive debates about who is to blame for the lack of progress.
Another clause included in the Sixth Amendment to the Cosmetics Directive requires the European Commission to produce an annual report on the progress in developing alternatives4. This report has to be presented to the European Parliament, who get the opportunity to comment upon it. The most recent of these reports available is for 19945. It was drafted by the influential Consumer Policy Service within the Commission, which manages the Cosmetics Directive. The report examines the progress towards the development of a validated alternative for each of the tests required by OECD guidelines. Their principal conclusion was "Up to now, no conclusions can be drawn from the numerous validation studies conducted in 1993 which would have an immediate influence on the implementation of the sixth amendment to Directive 76/768/EEC." (ie on the implementation of the ban on the marketing of animal-tested cosmetics in 1998). The report also stated "The interesting but limited findings to date mean that animal models cannot be replaced,...". Presented with such a frank and negative report, the Environment Committee of the European Parliament issued a strongly-worded response condemning "the fact that little progress has been made in replacing experiments on animals with alternative methods" and pointing out again that the European Parliament "insists on 1st January 1998 as the deadline for the banning of experiments on animals..." 6. The use of the phrase "experiments on animals" in this context is inaccurate, since the report only considers those animal tests used to assess the safety of cosmetic ingredients. However, this confusion is an indication of the way these two can become confused in the statements and thoughts of the MEP's concerned.
Over the next two years it will be very interesting to watch the progress of this issue. During 1996, the Consumer Policy Service of the Commission will have to prepare a report indicating whether or not validated alternatives to all the animal tests for cosmetics are likely to be developed by 1st January 1998. This report will have to conclude that there is no real prospect for alternatives to any of these tests being developed or validated by then. How the European Parliament will react to such a report will be interesting to observe. The best possible outcome will be for the MEP's to realise they were being over-optimistic, to agree a more realistic target date and to urge a substantial increase in financial support for ECVAM. Past experience on this issue within Europe does not suggest that this is a likely out-come.
- Article 23 of Council Directive 86/609/EEC (1986) Official Journal of the European Communities, L 358, 1-28
- BUAV launches biggest campaign ever, Liberator (April/May 1987) 1-3
- International action, Liberator (Autumn 1990) 8-10
- Council Directive 93/35/EEC (1993) Official Journal of the European Communities, L 151, 32
- Development, Validation and Legal acceptance of Alternative Methods to Animal Experimentation. Annual Report 1994, Commission of the European Communities (1994) COM(94) 606 final
- Report: 1994 Annual Report of the Commission on the Development, Validation and Legal acceptance of Alternative Methods to Animal Experimentation. European Parliament Session Documents A4-0165/95