EU proposes tighter rules on animal testing

The Science Media Centre in Britain has done a round-up of scientists’ views on the a new European Commission proposal that aims to strengthen the protection of animals still used in scientific procedures and enhance the quality of research conducted in the EU.

From the SMC UK

The SMC UK wraps up reaction to EU animal testing provisions

The new provisions will also contribute to minimising as far as possible the number of animals used in experiments.

European Environment Commissioner Stavros Dimas said: “It is absolutely important to steer away from testing on animals. Scientific research must focus on finding alternative methods to animal testing, but where alternatives are not available the situation of animals still used in experiments must be improved”

A much needed revision

The objective of the Commission’s proposal is to strengthen the EU legislation in force on the protection of animals used for experimental purposes, notably by requiring ethical evaluations to be carried out before projects using animals are authorised and by laying down minimum requirements on housing and animal care.

The proposed directive includes within its scope animals used in basic research, education and training. It covers all live non-human vertebrate animals plus certain other species likely to experience pain. The use of non-human primates is subject to restrictions, and the proposal also introduces a ban on the use of great apes – chimpanzees, bonobos, gorillas and orangutans – in scientific procedures. Only when survival of the species itself is at stake, or in the case of an unexpected outbreak of a life-threatening or debilitating disease in human beings, can a Member State exceptionally be granted permission for their use.

Improving the conditions of millions of experimental animals

At present it is not possible to ban outright the use of animals for safety testing or biomedical research. The proposed revision thus seeks to ensure that animals are used only where no other means are available. Their use must be fully justifiable and the expected benefits must outweigh the harm caused to the animals. The proposal would also ensure that animals receive suitable care and treatment such as appropriately sized cages and an environment adapted to each species. These provisions would be continually monitored.

The proposed revision would also require projects involving animals to be authorised by a competent authority before they can go ahead. Organisations wishing to breed, supply or use animals would be obliged to seek authorisation for their activities and for the personnel working with the animals.

Finding alternatives

The “Three Rs” principle of replacing, reducing, and refining animal testing is firmly anchored in the Commission’s proposal. The Commission believes strongly in the need to find alternative methods to testing on animals. Where this is not possible the number of animals used must be reduced or the testing methods refined so as to cause less harm to the animals.

Some 12 million animals are used in experiments throughout the Union each year.

Further information:

Commission webpage on lab animals

The Scientific Steering Committee

“The need for non-human primates in biomedical research”, 4-5 April 2002

Experts respond

Professor Max Headley, Department of Physiology & Pharmacology, University of Bristol, said:

“All factions in the UK bioscience sector are clear that high welfare standards should be applied to the use of animals, whether for research or other purposes.  It is also important, wherever appropriate, to continue developing alternative techniques that promote the refinement, reduction or replacement of the use of animals.

“The advances in biomedical research that are desperately needed to understand and address major human diseases will for the foreseeable future require the use of animals – alternative non-animal techniques can and do replace some, but far from all, animal tests.  Advances in veterinary medicine, the study of animal behaviour, and the impact on animals of environmental change all inevitably require the use of animal subjects.

“The issue with any such legislation is to encourage vital research while ensuring that animals are used responsibly and under the best appropriate welfare conditions.  The UK academic sector is concerned to ensure that any further restrictions on UK research resulting from the revised Directive are based on firm evidence that better welfare will result for animals used in research.  Overly restrictive or expensive regulation will not achieve that since it will cause research to be moved from the EU to other countries (as is entirely possible in a global economy).  Instead it will serve only to impede the ability of the world class UK bioscience sector to make the advances that are needed to benefit both humans and animals.”

Dr Sophie Petit-Zeman, Head of External Relations, Association of Medical Research Charities (AMRC), said:

“Our priority is that the Directive makes an absolute commitment to the highest standards of animal welfare while enabling research for patient benefit to flourish. While we are pleased to see the “Three Rs” principle of replacing, reducing, and refining animal use anchored in the Commission’s proposal, there must now be concerted action across the medical research sector to ensure that policymakers understand the complexities of achieving the right balance.

“For example, while animals must never be used where there are alternatives, aiming for blanket reductions in numbers may be an over-simplistic approach that enables our sector to be seen to be acting, while in some cases incompatible with progress in medical research. Similarly, a ban on the use of great apes, when none have been used for experimental research in the EU for over 6 years, could jeopardise rapid reactive work to a serious health challenge. This Directive needs to proceed in ways that are good for animals and good for patients.”

Aisling Burnand, Chief Executive of the BIA, said:

“One would expect that the proposed Directive would take into account the most up to date scientific and ethical practices, however this does not seem to be the case.

“The research community will feel that their core concerns have not been respected and indeed in some areas it could even have a negative impact on animal welfare.”

To speak to local experts on this subject, contact the Science Media Centre (NZ) on 04 499 5476 or smc@sciencemediacentre.co.nz

The proposed directive includes within its scope animals used in basic research, education and training. It covers all live non-human vertebrate animals plus certain other species likely to experience pain. The use of non-human primates is subject to restrictions, and the proposal also introduces a ban on the use of great apes – chimpanzees, bonobos, gorillas and orangutans – in scientific procedures. Only when survival of the species itself is at stake, or in the case of an unexpected outbreak of a life-threatening or debilitating disease in human beings, can a Member State exceptionally be granted permission for their use.

Improving the conditions of millions of experimental animals

At present it is not possible to ban outright the use of animals for safety testing or biomedical research. The proposed revision thus seeks to ensure that animals are used only where no other means are available. Their use must be fully justifiable and the expected benefits must outweigh the harm caused to the animals. The proposal would also ensure that animals receive suitable care and treatment such as appropriately sized cages and an environment adapted to each species. These provisions would be continually monitored.

The proposed revision would also require projects involving animals to be authorised by a competent authority before they can go ahead. Organisations wishing to breed, supply or use animals would be obliged to seek authorisation for their activities and for the personnel working with the animals.

Finding alternatives

The “Three Rs” principle of replacing, reducing, and refining animal testing is firmly anchored in the Commission’s proposal. The Commission believes strongly in the need to find alternative methods to testing on animals. Where this is not possible the number of animals used must be reduced or the testing methods refined so as to cause less harm to the animals.

Some 12 million animals are used in experiments throughout the Union each year.

Further information:

Commission webpage on lab animals

The Scientific Steering Committee

“The need for non-human primates in biomedical research”, 4-5 April 2002

Experts respond

Professor Max Headley, Department of Physiology & Pharmacology, University of Bristol, said:

“All factions in the UK bioscience sector are clear that high welfare standards should be applied to the use of animals, whether for research or other purposes.  It is also important, wherever appropriate, to continue developing alternative techniques that promote the refinement, reduction or replacement of the use of animals.

“The advances in biomedical research that are desperately needed to understand and address major human diseases will for the foreseeable future require the use of animals – alternative non-animal techniques can and do replace some, but far from all, animal tests.  Advances in veterinary medicine, the study of animal behaviour, and the impact on animals of environmental change all inevitably require the use of animal subjects.

“The issue with any such legislation is to encourage vital research while ensuring that animals are used responsibly and under the best appropriate welfare conditions.  The UK academic sector is concerned to ensure that any further restrictions on UK research resulting from the revised Directive are based on firm evidence that better welfare will result for animals used in research.  Overly restrictive or expensive regulation will not achieve that since it will cause research to be moved from the EU to other countries (as is entirely possible in a global economy).  Instead it will serve only to impede the ability of the world class UK bioscience sector to make the advances that are needed to benefit both humans and animals.”

Dr Sophie Petit-Zeman, Head of External Relations, Association of Medical Research Charities (AMRC), said:

“Our priority is that the Directive makes an absolute commitment to the highest standards of animal welfare while enabling research for patient benefit to flourish. While we are pleased to see the “Three Rs” principle of replacing, reducing, and refining animal use anchored in the Commission’s proposal, there must now be concerted action across the medical research sector to ensure that policymakers understand the complexities of achieving the right balance.

“For example, while animals must never be used where there are alternatives, aiming for blanket reductions in numbers may be an over-simplistic approach that enables our sector to be seen to be acting, while in some cases incompatible with progress in medical research. Similarly, a ban on the use of great apes, when none have been used for experimental research in the EU for over 6 years, could jeopardise rapid reactive work to a serious health challenge. This Directive needs to proceed in ways that are good for animals and good for patients.”

Aisling Burnand, Chief Executive of the BIA, said:

“One would expect that the proposed Directive would take into account the most up to date scientific and ethical practices, however this does not seem to be the case.

“The research community will feel that their core concerns have not been respected and indeed in some areas it could even have a negative impact on animal welfare.”

To speak to local experts on this subject, contact the Science Media Centre (NZ) on 04 499 5476 or smc@sciencemediacentre.co.nz<-->