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Animals in Science Regulation Unit Annual Report 2015

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Animals in Science Regulation Unit Annual Report 2015 Animals in Science Regulation Unit Annual Report 2017 © Crown copyright 2018 This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit http://nationalarchives.gov.uk/doc/open-government- licence/version/3/ or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected]. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. ISBN: 978-1-78655-740-7 © Crown copyright 2018 This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit http://nationalarchives.gov.uk/doc/open-government- licence/version/3/ or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected]. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. ISBN: 978-1-78655-757-5 Contents Ministerial foreword 4 Section 6: Inspection 19 Inspection 19 Foreword 5 Baseline setting 19 Risk management 20 Section 1: What the Animals in Science Regulation Inspector training and continuous professional Unit does 7 development 20 The Policy and Administration Group 7 Inspection reporting 21 Investigating allegations made to the Animals in Science Regulation Unit 21 Section 2: The regulatory framework 9 Judicial Reviews 9 Section 7: Compliance 22 Publications 10 Non-compliance 22 Working with the EU Commission 10 Compliance in 2017, self-reporting and a culture of Working with the Animals in Science Committee 11 care 24 Key compliance messages 25 Section 3: Licensing 13 Transparency of major investigations 27 The framework 13 Performance 13 Section 8: Financial report 28 Licensing Team stakeholder engagement 13 2017/18 Expenditure 28 Animals Scientific Procedures e-Licensing 14 2017/18 Income 29 Section 4: Promoting the principles of replacement, Annex 1: Non-compliance cases 30 reduction and refinement of animals in research 15 Work with the National Centre for the 3Rs 15 Annex 2: Tables and figures 42 Section 5: Engaging with stakeholders 16 Annex 3: Household products ban update 46 Communications 16 Correspondence 16 Stakeholder communication 17 Licensee engagement 18 External representation 18 3 Ministerial foreword The use of animals in scientific research As we plan a future of the UK outside of the helps us to ensure that medicines are safe European Union we mark the start of a new to use and to find treatments for cancer beginning. The transposition of European and other diseases, among a range of other Directive 2010/63/EU has given us a strong benefits. This work must continue to be platform for the delivery of the use of animals authorised within a rigorous regulatory system. in science in the UK. In the near term we This ensures that animal research and testing seek to provide seamless continuation of is carried out only where no practicable the rigorous regulatory framework. We look alternative exists and under controls that forward to working together with the EU keep suffering to an absolute minimum. to deliver the best outcomes for science Central to this UK commitment is our and animal welfare as we build a new continuing full application of the 3Rs (the comprehensive partnership that sees replacement, reduction and refinement of us stay the closest of friends and allies. the use of animals in science). The UK’s life science strategy is based on a vision of how the UK may exploit its current strengths to support strong economic growth in this sector. As a regulator, the Home Office has an important role in balancing the need to enable innovation and research in the life Baroness Williams of Trafford sciences whilst maintaining public trust through a strong framework that has the necessary checks and balances. The Animals (Scientific Procedures) Act 1986 provides this underpin of assurance, thus promoting high standards of animal welfare and also opportunities to deliver high quality science of international standing. 4 Animals in Science Regulation Unit: Annual Report 2017 Foreword The Animals in Science Regulation Unit (ASRU) increased efficiencies for the processing has continued to focus efforts on high quality, • of licences; effective and efficient regulation. This is framed a robust assessment process and application in our three overarching aims of becoming a • of the 3Rs (replacement, reduction and ‘modern, consistent and responsive regulator’. refinement of the use of animals in science); and At the heart of regulation is our e-licensing the protection of confidential information. system (ASPeL). At the beginning of 2014 • we first rolled out an e-licensing system that The system will undergo an iterative roll-out placed our paper-based licences into an for full delivery in 2019. electronic format. This has been particularly effective in delivering more rapid personal Whilst the new ASPeL system is being licence authorisations. Now, in 2017, developed we have listened to licence we have embarked upon the next phase applicants for whom the process has been of the e-licensing project that will improve frustrating. Although we have met legislative functionality for users and be located on the targets (99.9% and 99.8% on personal and Government website. The project is being project licences respectively) this does not delivered through a process that places reflect the lead-in period for project licences. the system user – establishments, inspectors After listening to applicants’ concerns we and licensing officers – at the centre of the responded and developed an annotated design. Our plans are for extensive consultation licence form. The annotated form sets during the build; a process of agile delivery. out our expectations for a ‘complete and Through agile delivery we will pilot the system correct’ application and clearly presents with users as we build it. The new system how to implement the 3Rs and produce will deliver: a non-technical summary that supports openness and transparency. 5 Developing and maintaining a culture of Our planning for a seamless exit from the compliance is a key part of the effective delivery European Union continues apace. The aim of the Animals (Scientific Procedures) Act 1986 is to maintain substantially similar regulations (ASPA). During 2016 we undertook a review of with the EU, thus preserving a level of our compliance operations and policy. Our aims parity that will support the UK to retain were to have a new policy that: competitiveness in global markets. ASPA already enjoys that parity through the relatively embedded the principles of good regulation; recent transposition that we undertook in • continued to improve the efficiency and 2012. Through 2016 and 2017 we have • effectiveness of enforcement processes; and continued with our legislative plans that worked with the research community to uphold the integrity of the Act from March • improve the openness and transparency 2019 onwards and assure licensees of the of ASRU’s operations and decision making. continuation of the framework currently in place. Thus, we will not make any substantive We used the lessons learned from complex changes to ASPA, other than those required cases and focus groups of licence holders to to move from working under an EU Directive support the production of a new compliance to working under UK law only. policy. In 2017 we published our new compliance policy that we believe will better achieve our aims through positive support and effective enforcement. During 2017 there were significant changes to the Government estate as departmental buildings in central London were closed in Will Reynolds a drive for better value for money. In late Head of the Animals in Science Regulation Unit 2017 ASRU relocated part of its operation to government offices in Croydon, along with many other parts of the Home Office family. At the end of 2017, the Operations Team (Licensing, IT and Finance) and the Compliance Team were entirely based in Croydon. The Policy Team has remained in 2 Marsham Street. The inspectors are mainly home working so as to be located near establishments for inspection. We also maintain one-hub site and a few desks within touch-down offices around the UK. The fact that many of our stakeholders were unaware that a move had even taken place is testament to the hard work of the ASRU team that made it so smooth. 6 Animals in Science Regulation Unit: Annual Report 2017 Section 1: What the Animals in Science Regulation Unit does “We regulate the use of animals in scientific research for the benefit of people, animals and the environment through the provision of impartial licensing procedures and evidence-based advice, and by encouraging the development and use of the 3Rs (replacement, reduction and refinement).” The Animals in Science Regulation Unit (ASRU) responding to the EU Commission’s requests is a part of Home Office Security, Science and • regarding the transposition of the EU Directive Innovation. ASRU is responsible for regulating 2010/63/EU; the operation of the Animals (Scientific advising on matters related to the UK’s exit Procedures) Act 1986 (ASPA). • from the EU; supporting the requirements of the Judicial The Unit is led by the ASRU Leadership Team • Review process; (ALT), comprising the Head of Unit, Chief Inspector, Head of Policy, Head of Operations • the development of central government and Strategy and three principal inspectors. and operational policy; • the production of various Advice Notes; and • the publication of statistics. The Policy and The Policy Team also responds to Administration Group Parliamentary Questions, Freedom of Information requests and all correspondence The Policy and Administration Group is based (Ministerial and official). at the Home Office in Westminster, Croydon and Swindon.
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