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The ethics of research involving animals - Nuffield Council on ...

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T h e e t h i c s o f r e s e a r c h i n v o l v i n g a n i m a l s<br />

<str<strong>on</strong>g>The</str<strong>on</strong>g> Netherlands there are three inspectors for the 600,000 <str<strong>on</strong>g>animals</str<strong>on</strong>g> used annually (see<br />

paragraph 13.20). In the USA, <strong>on</strong>ly instituti<strong>on</strong>s that c<strong>on</strong>duct <str<strong>on</strong>g>research</str<strong>on</strong>g> <str<strong>on</strong>g>involving</str<strong>on</strong>g> certain classes<br />

<str<strong>on</strong>g>of</str<strong>on</strong>g> animal covered by the Animal Welfare Act are subject to inspecti<strong>on</strong>s from the US<br />

Department <str<strong>on</strong>g>of</str<strong>on</strong>g> Agriculture. Additi<strong>on</strong>al levels <str<strong>on</strong>g>of</str<strong>on</strong>g> inspecti<strong>on</strong> operate for instituti<strong>on</strong>s that receive<br />

federal funds. <str<strong>on</strong>g>The</str<strong>on</strong>g> n<strong>on</strong>-governmental Associati<strong>on</strong> for Assessment and Accreditati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g><br />

Laboratory Animal Care (AAALAC) also carries out inspecti<strong>on</strong>s <str<strong>on</strong>g>of</str<strong>on</strong>g> accredited instituti<strong>on</strong>s.<br />

Accreditati<strong>on</strong> is voluntary but includes most large companies and major universities as<br />

accreditati<strong>on</strong> is an important factor for securing c<strong>on</strong>tracts and funding. 39<br />

13.45 Since the Directive was adopted in 1986, there has been a trend towards increased and more<br />

detailed regulati<strong>on</strong> in many Member States.<br />

■ France, <str<strong>on</strong>g>The</str<strong>on</strong>g> Netherlands and some parts <str<strong>on</strong>g>of</str<strong>on</strong>g> Spain have added a system <str<strong>on</strong>g>of</str<strong>on</strong>g> local animal<br />

<str<strong>on</strong>g>ethics</str<strong>on</strong>g> committees to their previously existing systems <str<strong>on</strong>g>of</str<strong>on</strong>g> c<strong>on</strong>trol.<br />

■ Austria, <str<strong>on</strong>g>The</str<strong>on</strong>g> Netherlands, Sweden and the UK have aband<strong>on</strong>ed the use <str<strong>on</strong>g>of</str<strong>on</strong>g> great apes in<br />

scientific procedures, although they had not been used in the UK and Sweden for some<br />

years. 40 With the voluntary retirement <str<strong>on</strong>g>of</str<strong>on</strong>g> a col<strong>on</strong>y used in vaccine development in Austria,<br />

no great apes were used in the EU in 2002, the last year for which statistics are available. 41<br />

■ <str<strong>on</strong>g>The</str<strong>on</strong>g> Netherlands and the UK have ceased using <str<strong>on</strong>g>animals</str<strong>on</strong>g> for testing cosmetics or cosmetic<br />

ingredients. Germany and Austria have introduced partial bans, permitted testing under<br />

some circumstances. More recently, a ban <strong>on</strong> the use <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> within the EU for the<br />

testing <str<strong>on</strong>g>of</str<strong>on</strong>g> cosmetics has been passed and is due to come into force in 2009 (and sales<br />

within the EU will not be allowed after 2013). However, there are certain excepti<strong>on</strong>s for<br />

particular types <str<strong>on</strong>g>of</str<strong>on</strong>g> test and the EU Directive <strong>on</strong> cosmetics testing <strong>on</strong> <str<strong>on</strong>g>animals</str<strong>on</strong>g> is currently<br />

under legal challenge from the French Government. 42<br />

■ <str<strong>on</strong>g>The</str<strong>on</strong>g> Netherlands and the UK have banned the acute oral LD 50 test (see paragraph 9.14<br />

and Box 11.2), with very limited exempti<strong>on</strong>s.<br />

13.46 Under the <str<strong>on</strong>g>Council</str<strong>on</strong>g> <str<strong>on</strong>g>of</str<strong>on</strong>g> Europe’s C<strong>on</strong>venti<strong>on</strong> ETS 123 there are periodic meetings <str<strong>on</strong>g>of</str<strong>on</strong>g><br />

representatives <str<strong>on</strong>g>of</str<strong>on</strong>g> the Member States and relevant n<strong>on</strong>-governmental organisati<strong>on</strong>s to<br />

‘examine the applicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> this C<strong>on</strong>venti<strong>on</strong>, and the advisability <str<strong>on</strong>g>of</str<strong>on</strong>g> revising it or extending<br />

any <str<strong>on</strong>g>of</str<strong>on</strong>g> its provisi<strong>on</strong>s’. In 1997, the revisi<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Appendix A to the C<strong>on</strong>venti<strong>on</strong>, which gives<br />

guidelines for the accommodati<strong>on</strong> and care <str<strong>on</strong>g>of</str<strong>on</strong>g> laboratory <str<strong>on</strong>g>animals</str<strong>on</strong>g>, was agreed. <str<strong>on</strong>g>The</str<strong>on</strong>g> revised<br />

Appendix A will include details about the husbandry and housing <str<strong>on</strong>g>of</str<strong>on</strong>g> all the principal<br />

laboratory animal species. It is expected that the <str<strong>on</strong>g>Council</str<strong>on</strong>g> <str<strong>on</strong>g>of</str<strong>on</strong>g> Europe will adopt the new<br />

Appendix in 2005. Since the EU ratified the C<strong>on</strong>venti<strong>on</strong>, Appendix A will be adopted as a<br />

revised Annex II to Directive EEC 86/609.<br />

13.47 In 2001 the European Commissi<strong>on</strong> proposed that Directive EEC 86/609 should itself be<br />

revised. This process started in 2003 when the Commissi<strong>on</strong> formed four Technical Expert<br />

Working Groups (TEWGs) to <str<strong>on</strong>g>of</str<strong>on</strong>g>fer advice <strong>on</strong> how the existing Directive could be improved.<br />

Discussi<strong>on</strong>s are currently in progress but it is likely that a revised Directive will not be<br />

adopted for several years. <str<strong>on</strong>g>The</str<strong>on</strong>g> provisi<strong>on</strong>s <str<strong>on</strong>g>of</str<strong>on</strong>g> the new Directive will be transposed into<br />

nati<strong>on</strong>al legislati<strong>on</strong> <strong>on</strong>ce the revisi<strong>on</strong>s have been agreed.<br />

39 Ibid. Chapter 1.<br />

40 Great apes have not been used for <str<strong>on</strong>g>research</str<strong>on</strong>g> in the UK since the passing <str<strong>on</strong>g>of</str<strong>on</strong>g> the A(SP)A in 1986. See House <str<strong>on</strong>g>of</str<strong>on</strong>g> Lords Select<br />

Committee <strong>on</strong> Animals in Scientific Procedures (2002) Animals in Scientific Procedures (Norwich: TSO), Chapter 1.<br />

41 European Commissi<strong>on</strong> (2005) Fourth Report <strong>on</strong> the Statistics <strong>on</strong> the number <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> used for experimental and other<br />

scientific purposes in the Member States <str<strong>on</strong>g>of</str<strong>on</strong>g> the European Uni<strong>on</strong> (Brussels: EC).<br />

42 Directive EC 2003/15 amending <str<strong>on</strong>g>Council</str<strong>on</strong>g> Directive EEC 76/768 <strong>on</strong> the approximati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> the laws <str<strong>on</strong>g>of</str<strong>on</strong>g> the Member States<br />

relating to cosmetic products.<br />

CHAPTER 13 LEGISLATION, REGULATION AND POLICY RELATING TO SCIENTIFIC PROCEDURES<br />

235

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