Pul Littlefir* ，Mggy Jennings，Brney Reed

(a．RSPCA International，Wilberforce Way，Southwater，Horsham RH13 9RS，West Sussex，UK;b．Research Animals Department，RSPCA，Wilberforce Way，Southwater，Horsham RH13 9RS，West Sussex，UK)

1 REGULATION

The United Kingdom was the world's first country to pass legislation to regulate scientific experiments on animals．Following an era of increasing use of animals in experimentation，the Cruelty to Animals Act emerged in 1876．Although the Act was limited in scope it was the first to place controls on‘painful experiments’，requiring animals undergoing scientific procedures to be anaes the tised．

The law was criticised as weak and coincided with a rising movement against animal experimentation in the UK，but eventually proved flexible enough to serve the evolving needs of science for more than 100 years．

During the 1980s the momentum grew-particularly in Europe-for reform of standards relating to the use of animals in experiments．The 1986 Council of Europe's Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Procedures，and European Directive 86/609/EEC both set new requirements for the regulation ofanimaluse for scientific purpose in any procedure that may cause‘pain，suffering，distress or lasting harm’(European Commission，1986)．This language also appears in the the UK Animals(Scientific Procedures)Act 1986(‘ASPA’)which itself also saw the introduction of a three-pronged licensing system requiring authorisation of the person using animals(‘personal licence’，the programme of work or research(‘project licence’)and the institution where animal experiments can take place(‘certificate of designation’)(UK Government，1986)．

2 PUBLIC OPINION

An important factor in the development of legislation covering animals has been public opinion．The more that people become aware of the potential animals have to suffer，the more they begin to show concern．Over the last fifty years we have seen the rise of a collection of disciplines known as‘a(chǎn)nimal welfare science’，and in particular research has led to an increased understanding of the behavioural needs of animals．In the UK and elsewhere this science has gradually made its way into the public arena．For example，awareness of the impact on farm animals of closely confining livestock production systems has led to a series of EU directives aimed at phasing out those most detrimental to animal welfare in favour of systems which essentially provide more space and more opportunities for animals to express normal behaviours．The realities of intensive livestock production were formerly an industry largely hidden from public view，but in recent decades we have seen consumers growing increasingly knowledgeable about farming systems，and often able to use thatknowledge to make food purchasing choices．

Animalexper imentation， in contrast， remains largely out of sight of the public．In the UK polling frequently demonstrates，however，that this issue can arouse serious and legitimate concern among the general population．Overall most ordinary citizens may accept some use of animals in scientific research，but usually only under some very specific circumstances．The public is concerned about the purpose of the research (for example，it should be aimed at understanding or treating serious disease rather than developing non-essential products such as cosmetics)and also the species being used．A recent study in the UK indicated that 66%of respondents accept the use of animals in research as long as it is for medical research purposes，while 46% accept their use only when such research is into life-threatening diseases(I psos MORI，2012)．

Most important， however， is the level of any animalsuffering caused．The public has further concerns about the speed of development of alternative methods and whether these are always used when available，along with the strength and enforcement of regulatory controls．

There is sometimes a higher degree of public concern for those species of animal for which we have most affinity， particularly non-human primates，but also companion animal species such as cats，dogs and also horses．British legislation takes account of this by only allowing the use of these species where the regulator(in this case，the Home Office)is‘satisfied that animals of no other species are suitable for the purposes of the programme［of research］’(ASPA Art．5.6)(UK Government，1986)．

3 ETHICAL CONSIDERATIONS

The moral and scientific questions which underpin discussion on the use of animals in experiments reflect the concerns of both the scientific community and the general public．These include:How important is the research?What are the scientific objectives of the research?Why is the use of animals deemed necessary to meet these objectives?Are there any humane alternatives that can replace the use of animals in all or part of the work?How will the results of the work be used?Can the data from animal studies be successfully extrapolated to humans?Have similar experiments been undertaken before?How much will animals suffer?Is every opportunity being taken to reduce the impact of the experiment and other factors such as transport and housing on animals?Dothe potentialbenefitsto humans of the research outweigh the likely harms to animals?This harm-benefit consideration is central to the work of animal ethics committees(IACUCs)，which，in the UK are now called the local‘Animal Welfare and Ethical Review Body’．

Ethical review should include consideration of the validity and justification for using animals and other related practical is suessuch asst afftraining and whether the 3Rs (replacement，reduction and refinement)have been implemented as fully as possible．

Ethical review requires decisions to be made that impact on whether，and how，animals are used．These involve value judgements that are likely to change with time and with the perspectives，priorities，interests and expertise of those making them-and with the context in which they are made．The judgements are influenced by prevailing societal attitudes，which in turn are affected by concern generated by particular research directions，rapid developments in technology(e．g．genetic engineering and stem cell technology)and increasing understanding of animals and their ability to suffer．

4 LOOKING AHEAD

Current laws regulating animal experiments in the UK(and all other European Union Member States，28 countries from 2013)are being updated．As a result of agreement on a new European Directive［2010/63/EU］，revised new regulations came into effect on 1 Jan 2013．The new legislation represents a significant advance for many EU Member States and should lead to improvements for hundreds of thousands of animals．For example，all scientific uses of animals will now be legally controlled and all Member States will have a basic system of licensing of research establishments and projects．Very importantly，there is a requirement to implement the 3Rs and each project will have to undergo a harm-benefit assessment to determine whether the use of animals is necessary and justified．Every establishment will also have to set up an Animal Welfare Body to advise on the 3Rs throughout each project(European Commission，2010)．

The UK's current laboratory animal regulations are widely considered to be among the strongest in the world and already meet most of the requirements in the new Directive．There is also flexibility within the Directive(under Article 2)for the UK(and any other Member State)to maintain those provisions it already had in place which offer higher levels of protection for animals．

Reference:

European Commission， 1986． COUNCIL DIRECTIVE of24 November1986 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(86/609/EEC)．(accessed 28 Nov 2102 at http://ec．europa．eu/food/fs/aw/aw_legislation/scientific/86-609-eec_en．pdf)

UK Government，1986．Animals(Scientific Purposes)Act 1986．(accessed 28 Nov 2102 at http://www．legislation．gov．uk/ukpga/1986/14)

Ipsos MORI，2012．Current views on the use of animals in scientific research(for the Department for Business Innovation＆Skills)

European Commission，2010．DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the protection of animals used for scientific purposes．Official Journal of the European Union L 276/33