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Animal experimentation legislations in The Netherlands
New legislation in the Netherlands
On 5 February 1997 a revised Experiments on Animals Act came into force in the Netherlands. Under the 1977 legislation, the Ministry of Welfare, Public Health and Cultural Affairs could grant a licence to the head of a scientific institution on the basis of an application describing the type of animal experimentation to be performed. However, there was no external control of individual research projects. Each institution had to appoint an animal welfare officer to supervise the well-being of the animals. In addition, the person responsible for determining the way in which an animal experiment was performed had to hold a doctoral degree in a relevant subject. The law also contained other provisions based on the EU Directive 86/609.
The main change introduced by the revised Act is to require that research plans must be approved by an ethical review committee, which has to consider the benefit to come from the experiments and whether this justifies the distress caused to the animals to be used. No maximum duration for a research plan is stipulated. Committees are required to give a decision on an application within three months and, if they do not approve the research plan, the applicant can appeal to the central animal review committee established under the previous legislation.
Although it is not stipulated in the revised Act, it appears likely these would be local ethical review committees, specific to larger establishments. Smaller research establishments might need to use the committees set up at larger establishments. The structure of these committees is defined in the new Act which requires that they have at least seven members made up from equal numbers of experts in i) animal experiments, ii) alternative methods, iii) animal welfare, and iv) ethical assessment. At least two members must not be conducting animal experiments and at least three members, including the chairperson, must not be employed by a scientific institution applying to the committee.
The ethical review committees must be recognised by the Minister, who will be advised by the central animal review committee. This mechanism is to ensure they operate properly and, for the same purpose, all committees are required to submit an annual report to the Minister. An obligation of confidentiality is placed upon members of these committees with respect to information provided to them.
One addition to the legislation which has been discussed by many observers is the requirement to recognise the intrinsic value of animal life. However, the Act only states that "Any right accorded by or pursuant to this Act shall be exercised in recognition of the intrinsic value of animal life." It is noticeable that the ethical review committees are not required to take this point into account when assessing research plans.
Additional provisions introduced by the revised Act ban the LD50 and LC50 tests, but permit an exemption to be granted if it can be shown that the experiment cannot be performed by any other method. The testing of cosmetics and cosmetic ingredients is completely banned. Licensing for animal breeders and suppliers is required, applying similar provisions to those for animal use establishments.
The fact that the previous Act did not require the licensing of breeders and suppliers would mean that the Netherlands was not properly implementing the Directive 86/609 which requires such registration. It was obviously important for this to be corrected. The introduction of a system of research plan review based on the cost-benefit principle was also a positive move, bringing the Dutch system closer to that operating in the UK and Germany. However, with the introduction of a ban on the LD50 and an absolute ban on cosmetic testing, the Netherlands system has now gone significantly further than any other EU country. Naturally, much will depend on how the new Act is implemented but, on the basis of the written legislation, this appears to introduce a significantly tighter system of regulation in the Netherlands.