HOUSE OF LORDS SESSION 2001–02 SELECT COMMITTEE ON ANIMALS IN SCIENTIFIC PROCEDURES VOLUME I—REPORT Ordered to be printed 16 July 2002 PUBLISHED BY AUTHORITY OF THE HOUSE OF LORDS LONDON – THE STATIONERY OFFICE LIMITED [price] HL Paper 150—I CONTENTS Paragraph Page PREFACE ................................................................................................................................... 4 SUMMARY OF CONCLUSIONS AND RECOMMENDATIONS .......................................... 6 CONCLUSIONS............................................................................................................ 6 RECOMMENDATIONS ............................................................................................... 6 CHAPTER 1: INTRODUCTION ...........................................................................................1.1 4 Legislation in the United Kingdom ..............................................................................1.1 4 Trends in animal use.....................................................................................................1.6 4 The Three Rs ................................................................................................................1.12 4 Comparison to other regulatory systems ......................................................................1.14 4 Regulation in the United States ....................................................................................1.17 4 Regulation in France ....................................................................................................1.23 4 Regulation in Japan ......................................................................................................1.28 4 Issues raised..................................................................................................................1.29 4 CHAPTER 2: ETHICS............................................................................................................2.1 4 CHAPTER 3: THE PURPOSE AND NATURE OF ANIMAL EXPERIMENTS .................3.1 4 Types of animal experiments........................................................................................3.4 4 Non-laboratory animal research ...................................................................................3.11 4 Defence research ..........................................................................................................3.18 4 Government funded research abroad............................................................................3.25 4 CHAPTER 4: THE EFFICACY OF ANIMAL EXPERIMENTS ..........................................4.1 4 Fundamental and applied research ...............................................................................4.2 4 Toxicological research .................................................................................................4.16 4 The development of non-animal toxicological tests.....................................................4.26 4 Toxicology and the law ................................................................................................4.34 4 Potential of developing technologies............................................................................4.46 4 CHAPTER 5: REGULATION AND THE ANIMALS (SCIENTIFIC PROCEDURES) ACT 1986 ......................................................5.1 4 The Inspectorate ...........................................................................................................5.5 4 Weighing of harms and benefits...................................................................................5.19 4 Licence applications and bureaucracy..........................................................................5.28 4 Training modules..........................................................................................................5.42 4 The Animal Procedures Committee .............................................................................5.48 4 CHAPTER 6: THE ETHICAL REVIEW PROCESS .............................................................6.1 4 Role of the ERP............................................................................................................6.6 4 Membership of the ERP ...............................................................................................6.17 4 CHAPTER 7: THE THREE RS: ALTERNATIVES TO ANIMAL EXPERIMENTS...........7.1 4 Use and development of the Three Rs..........................................................................7.10 4 Centre for the Three Rs ................................................................................................7.17 4 Other ways to promote the Three Rs............................................................................7.27 4 CHAPTER 8: GENETICALLY MODIFIED ANIMALS ......................................................8.1 4 CHAPTER 9: PUBLIC INFORMATION...............................................................................9.1 4 Section 24.....................................................................................................................9.11 4 A new discussion forum...............................................................................................9.19 4 Product labelling ..........................................................................................................9.23 4 Statistics of Scientific Procedures on Living Animals, Great Britain ..........................9.26 4 Appendix 1: Membership and Declarations of Interest............................................................... 4 Appendix 2: Terms of Reference ................................................................................................ 4 Appendix 3: Committee Visits.................................................................................................... 4 Appendix 4: Conference Proceedings, 21 May 2002.................................................................. 4 Appendix 5: List of Witnesses .................................................................................................... 4 Appendix 6: Glossary.................................................................................................................. 4 Table: Project licences in force on 31/12/2000 ........................................................................... 4 4 REPORT FROM THE Note The evidence received by the Committee is published in two separate volumes—Volume II: Oral Evidence (HL 150-II) and Volume III: Written Evidence (HL 150-III). In the text of the report: Q. refers to a question in the oral evidence; p. refers to a page in the written evidence; and para. refers to a paragraph number in this report. REPORT 16 JULY 2002 By the Select Committee on Animals in Scientific Procedures ORDERED TO REPORT ANIMALS IN SCIENTIFIC PROCEDURES PREFACE The Select Committee on Animals in Scientific Procedures was appointed by the House of Lords in March 2001 to conduct an inquiry into the use of animals in scientific procedures in the United Kingdom. Following the dissolution of Parliament, the Committee was reappointed in June 2001. The membership of the Committee, together with their declarations of interest, is given in Appendix 1. The Committee’s terms of reference are given in Appendix 2. The Committee issued a call for evidence in April 2001, to which over 100 organisations and over 350 individuals responded with written submissions.1 The Committee also took oral evidence from nearly 40 organisations and individuals between May 2001 and May 2002.2 In addition, the Committee visited universities, pharmaceutical and testing companies and research laboratories in England, Scotland, France and the USA.3 Towards the end of its deliberations, the Committee convened a one- day conference of interested parties concerned with animal experiments. These included participants from the science community, industry, regulators and animal welfare and animal rights organisations.4 We are grateful to all those who presented written or oral evidence, and to those who hosted Committee visits in the USA, France, and here in the UK. We are also grateful to our Specialist Adviser, the Reverend Professor Michael Reiss. Animal experimentation is a subject under almost constant review. During the course of the Inquiry, reports relevant to animal experimentation have appeared from the Home Office, the Animal Procedures Committee, the Boyd Group, the European Union Committee of the House of Lords, the Royal Society, the British Union for the Abolition of Vivisection and many others. Further reports are expected shortly from the Agriculture and Environment Biotechnology Commission and from the Animal Procedures Committee. Developments have also taken place in Europe, from the granting of legal rights to animals in Germany, to the progress of legislation on animal testing and cosmetics in the European Parliament. In this context, and particularly in areas of rapid technological change such as the genetic modification of animals, we expect that further reports will become necessary over the next few years. On the basis of our review of the evidence and of the public debate about animal experiments, we have come to a number of conclusions about the current relationship between human beings and other animals in the context of the Animals (Scientific Procedures) Act 1986. The evidence shows that this relationship is not fixed, but has evolved under the influence of modern technological and scientific developments and our growing understanding of animal