ANIMAL PROCEDURES COMMITTEE REPORT ON OPENNESS AUGUST 2001 MIA 22501876967 CONTENTS Report Pages 2 - 11 Annex A Consultation exercise, and statistical analysis of responses (Summary of Tables and Figures of Responses) Pages 12 - 25 Annex B Commentaries on selected responses on the various options Pages 26- 33 Annex C Home Office circular (1 April 1998) introducing the Ethical Review Process; and Parliamentary Question of 1 November 2000 about a review of ERP. Pages 34 - 42 WELLCOWwe L'PRARY | INFORMATION SERVICE 01 OCT 2001 neya e Ba ae if, ma wax ae Ailes anne reg gl ka, See aa ASSt w YEARS LS OMS) | CrkAMeOrEN 700s 790 to REPORT BY THE ANIMAL PROCEDURES COMMITTEE ON OPENNESS Introduction 1s The Government made a commitment in its 1997 election manifesto to legislate to ensure that the public would have a clear and statutory night of access to information held by the public sector. Freedom of Information is seen as an essential component of the Government’s programme of constitutional reform. That programme aims to involve people more closely in the decisions which affect their lives. Giving people greater access to information is essential to that aim. The Freedom of Information Act 2000 provides for the first time, that everyone will have the right of access to information held by bodies across the public sector. That Act recognises that openness cannot be completely unlimited. It therefore sets out a framework within which the right of access to information is balanced against the equally important rights to privacy and to confidentiality, and the Government’s need for time and space in which to think and plan. . The Act achieves that by setting out a right of access and how it can be exercised, and then setting a number of conditions and exemptions from that right. The underlying principle is that information will be disclosed unless it is exempt information, and information is exempt if its disclosure would, or would be likely to, prejudice an interest, such as personal safety or commercial confidentiality. In most cases it will not be enough simply to say that there is an exemption. The Act also provides that for most exemptions the public authority holding requested information will also have to look at the balance of the public interest in maintaining that exemption or disclosing the information. If the authority concludes that there is no overriding public interest in withholding the information, it must disclose it. The Act provides for the right of access to publicly held information to be enforceable. It establishes an Information Commissioner and an Information Tribunal with wide powers. The Commissioner will be able to require that information is provided in order to assess any complaints, and to require the disclosure of information where she considers the authority has depended inappropriately on an exemption or has wrongly assessed the test of the balance of public interest. Authorities and complainants will have a night of appeal to the Information Tribunal and government departments and some other public authorities will also be able to ask the Secretary of State to override the Commissioner’s decision in respect of public interest disclosure. The Freedom of Information Act will be introduced in stages but must be in effect for all public authorities by no later than 30 November 2005. The Government has said that it intends to bring it into effect for central Government departments and most Non-Departmental Public Bodies as early as possible. This is likely to be during 2002, although a firm date has not yet been announced. The provisions of the Act will then be applied to further tranches of the public sector by agreement with the Information Commissioner, but probably at 6-month intervals. The Animals (Scientific Procedures) Act 1986 (the 1986 Act), requires the licensing of any experiment or other scientific procedure carried out on living, protected animals whith may cause them pain, suffering, distress or lasting harm. Licences under the Act are issued by the Home Office on behalf of the Home Secretary. They may only be issued if the benefits outweigh the likely adverse effects to the animals "4 concerned. The Home Office's Animals (Scientific Procedures) Inspectorate examines all applications and provides professional advice on them. The Animal Procedures Committee (APC) provides the Home Secretary with advice, independent from the Home Office and its Inspectorate, about the legislation and his functions under it. The Committee consists of experts from a wide variety of backgrounds. There are currently 20 members. . Some relevant background information about UK animal experimentation can be obtained from the statistics for 1999. At the end of 1999 there were a total of 3,481 project licences in force. The severity levels were as follows : sie|w i«|ii * (Unclassified = all procedures carried out under general anaesthesia from which the animal does not recover). There were 21 Inspectors who undertook 2,730 inspections. 2,656,800 experiments were undertaken and the number of animals used was 2,570,000. (The discrepancy is because some animals are used in more than one procedure). . Section 24 of the 1986 Act relates specifically to the release of confidential information about animal procedures. It makes it an offence for anybody ‘atheruise than for the purpose ofd ischarging his functions under the Act' to disclose information about animal procedures which the person who provided it has given in confidence. The future of this section of the Act is a key consideration in the debate on openness in animal procedures. If it continues in place without amendment, such information would be exempt from disclosure under the provisions of the Freedom of Information Act, which specifically exempts information disclosure of which is prohibited by or under any other enactment (section 44). . Much public concern has been expressed about what is perceived as the secrecy of the procedures for the licensing and conduct of animal procedures. Ten years after the implementation of the 1986 Act, the APC conducted a review of the operation of the Act, which was published in 1998 in the APC’s Annual Report for 1997. In the course of that review the Committee recognised that it would be considering the practical implications of a balanced application of "the principle ofo permess conceming the use of animals in scientific procedures" and said that it would be investigating the subject more thoroughly. Some specific areas to be explored were identified. e Should details of licence applications be made available? e Should the annually published statistics provide additional information, such as data on the severity banding of projects and the level of adverse effects actually caused? Should more information about the benefits which accrue from research involving animals be published, and linked to animal usage and suffering? Should the annual statistics be revised to provide more information on the use of genetically-modified animals and harmful mutants? (The last area has been taken up as a separate task by the APC’s Biotechnology Working Group). The Committee decided to establish a working group to take forward an investigation of openness. 10. The APC Openness Working Group was formed in 1999. It recognised that in addition to the issues identified by the review it would need to carefully consider what advice, if any, it might put forward in relation to the retention, variation or repeal of section 24 of the 1986 Act. It decided as a first step to seek the views of interested individuals and bodies on the issues. A copy of the consultation letter which was sent out on 13 January 2000, is at Annex A (i). The members of the working group took account of their own knowledge and expertise, and that of the representatives who met with them, in the consideration of the large number of responses received (2,320). A statistical analysis of the responses is at Annex A (ii). BE To inform the continuing discussions of the working group each member prepared commentaries based on the responses from five different groups of respondents: individual members of the public; animal welfare organisations; commercial institutions; individuals working in commercial institutions; and academics and academic institutions. These are recorded in Annex B. By recording those views the APC does not necessarily endorse them. |Wa r The working group also took account of the views of the Home Office Minister then responsible for animal procedures, Mr Mike O’Brien. Methodology 13. The working group met for the first time on 17 November 1999. Its initial membership was three members of the APC: Professor Christopher Atterwill (Director of Biosciences, Huntingdon Life Sciences Ltd) (chair), Mr Mike Baker (UK Director, International Fund for Animal Welfare) and Mr Robert McCracken (a barrister). The consultation period ended on 10 March 2000 (Annex A). Because of the large number of responses which were received it was decided to increase the membership of the working group by two further members of the APC: Professor Grahame Bulfield (Director and Chief Executive, Roslin Institute) and Professor David Clark (Honorary Semior Research Fellow, University of Kent) joined the working group on 17 March. 14. Each member of the working group was provided with copies of all the written responses which were received. In addition, they were provided with several statistical breakdowns of the responses (see Annex A (u)). Meetings of the Working Group took place on 17 November 1999, and in 2000 on 30 May, 13 June, 26 July, 25 September, 23 October and 20 and 27 November. At some of these meetings the working group was assisted by visiting specialists: representatives from Glaxo-Wellcome, the Police National Public Order Intelligence Unit and the Home Office Freedom of Information Unit attended our meeting on 26 July. Two other Home Office officials attended the working group’s meeting of 25 September: a superintending inspector of the Animals 4 Scientific Procedures Inspectorate and the head of the Animals Licensing Section of the Animals, Bye Laws and Coroners Unit. The Chief Inspector of the Animals Scientific Procedures Inspectorate attended the working group’s meeting of 20 November. The working group was grateful to all of them for their helpful contributions to the understanding of the issues. Discussion 15: After assessing all the responses to the consultation exercise the working group realised that there were large bodies of opinion which were at either end of the spectrum of thinking about openness in relation to the 1986 Act. The first of these, comprising animal welfare organisations and many individual members of the public, saw the only way forward as one of total openness, with full retrospective disclosure and the repeal, rather than adaptation of section 24. At the other end of the spectrum were those - from the private and public sectors - using animals in regulated procedures. They were very concerned about any increase in openness. This was for a variety of reasons, the predominant one being personal security. Others included commercial confidentiality; the erosion of the UK research base; and the concern that increased availability of information might delay the preparation and processing of applications. 16. It is recognised that institutions have already been required to provide an increased degree of openness through the Ethical Review Process (ERP), introduced from 1 April 1999. Additional openness is provided by the mandatory presence in the ERP of independent lay members. It is felt by some that the integration of the ERP within the licensing framework has already placed an increased burden on the institutions operating the process, which should be noted. Te The working group noted that the Home Office and the APC itself have made some progress towards openness by setting up pages on the web. The web addresses are www.apc.gov.uk; www.homeoffice.gov.uk/dob/abcu; www.homeoffice.gov.uk/dob/aspi . 18. Annex C contains the Home Office Circular letter of 1 April 1998 introducing the Ethical Review Process and the text of a reply to a Parliamentary Question announcing a review. LD From the results of the consultation exercise the Working Group tried to come to a pragmatic balance between the undoubted sincere and deeply held concerns of the public about animal welfare and openness and the equally deeply held concerns of industry and academia. The responses from the public and from welfare organisations saw wider openness as a means to increase the accountability of this controversial aspect of life making it more open to public scrutiny. But the working group also took into account the concerns of industry and academia: concerns about personal security; commercial confidentiality; an increase in the regulatory administrative burden; and the fear that work involving animals would move abroad to the detriment both of animal welfare and the UK’s commercial advantage. That might be caused both by enhanced openness and by increased regulation. Statutory implications 20. The Working Group considered an analysis of the Freedom of Information regimes in other countries - Australia, New Zealand, Eire, the Netherlands, the United States and Canada - prepared by the then Home Office Freedom of Information Unit as part of the consultation on the FOI Bill in 1999. Since none of these countries has a similar system of licensing of animal experiments to that of the UK the conclusions that can be drawn from this analysis are limited. 21. The Working Group noted that Part II of the Freedom of Information Act 2000 sets out the principal exemptions from the duty to disclose requested information. That Act can be viewed at www.hmso.gov.uk/acts/acts2000/20000036 . The most relevant sections include: = section 41 (Information provided in confidence). This exemption relates to information which a public authority has received under the common law duty of confidentiality and whose disclosure would constitute an actionable breach of confidence; and = section 43 (Commercial interests). Information is exempt if it constitutes a trade secret or its disclosure would, or would be likely to, prejudice the commercial interest of any person; IR The Committee noted that other parts of the 2000 Act qualify the way in which the exemptions operate, and in particular that each of the exemptions identified above is subject to a public interest duty of disclosure, except in respect of the exemptions for information received under a common law duty of confidence (section 41). Such a test is already inherent in the determination of the duty of confidentiality. 22: As already noted, section 24 of the 1986 Act prohibits the disclosure of any information received in confidence. The Freedom of Information Act 2000 makes provision for such statutory bars to be repealed or amended by Order for the purpose of removing or relaxing the prohibition (section 75). The working group noted from its consultations with the Animal (Scientific Procedures) Inspectorate and with the Animal Procedures Section of ABCU that appreciable extra demands would be placed on them if any change to section 24 of the 1986 Act were to be made retrospective. The working group was also very aware that all information contained in Project Licence Applications has been given up to now on the understanding by the applicants that all such information was given in confidence. 24. A key feature of the Freedom of Information Act 2000 is the requirement on each public authority to adopt and maintain a publication scheme. A scheme must set out the information which the authority proposes to publish pro-actively and must be approved by the Information Commissioner. Such a scheme provides an opportunity for the Home Office to actively place in the public domain that information in relation to experimentation on animals which it believes should be readily available and will assist in minimising the disruption to the Animals (Scientific Procedures) Inspectorate and ABCU which might otherwise arise from their obligations under the Freedom of Information Act. 20: The Committee concluded that it is likely that there will be a need to vary section 24 of the 1986 Act; that there should be no blanket exemptions on the duty to disclose information; and that any publication scheme which the Home Office might develop would need to reflect the spirit of openness. Other considerations 26. The Working Group considered the recommendations proposed in some of the responses to the consultation exercise for improving the openness of licensing procedures. The research and development process for new chemicals and medicines within life sciences ‘is a complex one, and one that is generally poorly understood by the public. Within that process, however, there are points besides the licensing process where we considered that increased openness could be applied. Is Apart from the issue of openness in regard to licensing procedures, we also considered the wider issue of openness in the public and private sectors. Openness might be furthered by: e an increase in the publication of data derived from animal experimentation, whether positive or negative; e an increased transparency of the Inspectorate’s activities in the form of enhanced publication of statistics and reports; e educating the public about the research and development process within the Life Science industries; e increasing the public’s knowledge about the Life Science industries by encouraging visits to establishments by responsible members of the public and by a programme of attendance by industry representatives to local groups and schools etc. 28. Some actions which could be taken by the industries themselves include: e an increase in the visibility of industry to the general public; and e a clarification of the research and development process to welfare organisations and the wider public by a process of education. Actions that could be taken by the Home Office include : e an increase in transparency in the APC and the Inspectorate. We go into further detail about this below. Recommendations Introduction ' Life Sciences are those areas of science covering biological research involving animal or human health. They have traditionally been referred to as the pharmaceutical and toxicology industries. 7