Directive 2010/63/EU A National Government Perspective The views expressed are those of the author – who was at various times responsible for the interpretation, policy, and implementation of Directive 86/609/EEC: and played an active role in the development of the revision of Appendix II of Council of Europe Convention ETS 123 that provides the basis for Appendix III, requirements for establishments and for the care and accommodation of animals, of Directive 2010/63/EU. Dr Jon Richmond dr.jonrichmond@gmail.com dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

WC6: Does regulation drive, manage or monitor change? “Regulatory frameworks...should provide a sufficiently flexible approach to anticipate, promote and make provision for technical progress in science and welfare...The focus needs to be on what must be achieved and why, and less on how it is to be achieved...inflexible regulatory frameworks have the potential to delay progress with the 3Rs.” dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop UK lessons learned Set out sound principles. Apply them case by case. Flexibility to incorporate technical progress Peer pressure important The value of case studies dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop EU considerations dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Why was the Directive revised? (Taken from EU sources) Disparities between Member States, some applying only the minimum requirements. This constituted barriers to trade. Animal welfare a value of the Union which has signed and ratified Council of Europe Convention ETS123. New knowledge/technical progress. Transparency. A number of reasons have been advanced for why Directive 86/609/EEC was revised – those set out in the Recitals of 2010/63/EU can be summarised as... These are not discussed further – but if these were the problems, it raises the question as to whether 2010/63/EU is the solution. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop “Regulation” Regulation: delivering required/preventing unwanted behaviours and outcomes. It involves balancing different interests and values. It tends to produce costs for some, and benefits for others. Do nothing – Legislation ****** Self-regulation Co-regulation Information/education Codes of Practice Quasi-regulation Incentives Standards Quality marks Service Charters Professional Bodies Exclusions Societal norms Market forces Mix and match Prohibitions/sanctions Regulation is a politically contentious activity that presents a host of technical and intellectual challenges: it must involve practical people concerned with outcomes. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

EU Instruments The Commission had a choice Regulations. Directives are binding on member states as to the results to be achieved, but leave it to the member states to choose the necessary form and methods. Decisions. Recommendations. Opinions Deregulation dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop An EU Directive Must be transposed into national legislation and implemented. Thus many of the options previously shown are not in play. In some cases this Directive goes beyond what has to be achieved, and prescribes how in must be achieved. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Considering National Provisions dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

When regulating seek to avoid... Taking decision making away from regulators with specific expertise: in this case a number of the provisions require expert judgement. Multi-level decision making: a cause of delay, duplication, inconsistency and conflict. Undue influence: the agenda being set by one interest group. One form of this is Regulatory Capture: the regulator acting in the interests of the regulated rather than the public. A “captured” regulator acting in the interests of those it was established to regulate is often worse than no regulation at all. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Risk based regulation takes account of... The risks to be managed/risk appetite. Behaviours, attitudes and culture of those regulated. Regulators’ institutional environment. Interaction with other regulatory controls. Regulatory performance – what is the objective and how are outcomes measured? Progress and change. You have to reckon with the fact that in terms of public and political confidence the “harm” done by those who behave or perform below the required standards will be proportionately greater than the “good” done by those who perform or behave “better” than the norm. Regulatory failures are more newsworthy than regulatory successes. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Regulation will have several elements Legislation and administrative controls. A process of registration or licensing. A process of inspection or other form of ensuring compliance, including reporting and managing non-compliance. A process of exclusion/de-licensing whereby organisations or persons judged to be operating unsafely are required to stop. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Really Responsive Regulation Baldwin and Black Regulatory framework Monitor Detect Respond Enforce Assess performance and outcomes Modify and improve dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Communication is key - UK Liaison Other Government Departments Animal Welfare Funding Bodies Animal Protection Industry Users and Breeders IDG3Rs 3Rs/Alternatives Academia Other EU Competent Authorities dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Communications - purposes Raising awareness Gathering information and opinion Formal and informal consultation Reaching consensus/Ensuring buy-in/managing expectations Promoting compliance dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Key Questions for National Regulators What is required? What will compliance/success look like? How can progress and outcomes be measured and reported? dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Policy Development Define the policy outcome Understand the current situation Define preferred option Implement and monitor Evaluate impact and outcomes dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Policy Options - Key Consideration #1: What Implement the Directive text Work to the text Simple transposition Minimum requirements Focus on process, not outcomes What will transposition and implementation deliver? Deliver the underlying policy objectives Identify specific policy objectives Determine what you want to achieve Focus on outcomes, not process Consider with text ‘compliant’ EU Member States are required to transpose and implement EU legislation. Directives traditionally set out what has to be achieved, and provide a degree of flexibility as to how this is done at national level. Directive 2010/63/EU does not strictly follow this pattern – as I will demonstrate later in some instances the policy and operational objectives are not clear, and in others what has to be done (the process) is specified in detail but the purpose (the required outcome) is not clear. The Directive sets national regulators another challenge: regulators (and those regulated) do not like ambiguities. They favour certainty – requirements where it is clear to both the regulator and the regulated what is permissible and what is not. Directive 2010/63/EU in places uses subjective rather than objective terms which allow flexibility, but introduce uncertainties as to what constitutes compliance when the Directive as transposed and implemented – uncertainties that might be a matter for the courts rather than the scientist of national regulator to resolve. For example 47 occurrences of “appropriate”. Add examples. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Policy Options - Key Consideration #2: How Adjust existing provisions. Build on existing provisions and framework. Some options not available. UK – European Communities Act = Secondary Legislation. “Clean sheet”. Design system based on current best practice and policy objectives. Risks, time and resources. Primary legislation. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

What is the starting point? Provision 2010/63/EU 86/609/EEC Current UK ASPA Scope Article 1 3Rs Article 4 Permissible purposes Article 5 Methods of killing Article 6 Endangered species Article 7 Non-human primates Article 8 Animals from the wild Article 9 Purpose bred animals Article 10 Stray and feral animals Article 11 Procedures Article 12 Choice of methods Article 13 And so on dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Directive 86/609/EEC – the 3Rs Article 7... 2. An experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available. 3. ...In a choice between experiments, those which use the minimum number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress or lasting harm and which are most likely to provide satisfactory results shall be selected... 4. All experiments shall be designed to avoid distress and unnecessary pain and suffering to the experimental animals... Article 8... 1. All experiments shall be carried out under general or local anaesthesia. 2. Paragraph 1 above does not apply when: (a) anaesthesia is judged to be more traumatic to the animal than the experiment itself; (b) anaesthesia is incompatible with the object of the experiment. In such cases appropriate legislative and/or administrative measures shall be taken to ensure that no such experiment is carried out unnecessarily. Anaesthesia should be used in the case of serious injuries which may cause severe pain. 3. If anaesthesia is not possible, analgesics or other appropriate methods should be used in order to ensure as far as possible that pain, suffering, distress or harm are limited and that in any event the animal is not subject to severe pain, distress or suffering. 4. Provided such action is compatible with the object of the experiment, an anaesthetized animal, which suffers considerable pain once anaesthesia has worn off, shall be treated in good time with pain-relieving means or, if this is not possible, shall be immediately killed by a humane method. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Directive 2010/63/EU Article 47 Alternative approaches 47.1 The Commission and the Member States shall contribute to the development and validation of alternative approaches which could provide the same or higher levels of information as those obtained in procedures using animals, but which do not involve the use of animals or use fewer animals or which entail less painful procedures, and they shall take such other steps as they consider appropriate to encourage research in this field. 47.2 Member States shall assist the Commission in identifying and nominating suitable specialised and qualified laboratories to carry out such validation studies. Recital 10... the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so. To that end, it seeks to facilitate and promote the advancement of alternative approaches. Recital 46... In order to increase competitiveness of research and industry in the Union and to replace, reduce and refine the use of animals in procedures, the Commission and the Member States should contribute through research and by other means to the development and validation of alternative approaches. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Directive 86/609/EEC Alternative Methods Article 23 1. The Commission and Member States should encourage research into the development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals but which involve fewer animals or which entail less painful procedures, and shall take such other steps as they consider appropriate to encourage research in this field. The Commission and Member States shall monitor trends in experimental methods. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

The current position in the UK 1. UK Government pledge “...to work to reduce the use of animals...” 2. National Centre for the 3Rs. 3. Interdepartmental Group on the 3Rs “...to improve the application of the 3Rs and promote research into alternatives, reducing the need for toxicity testing through better sharing of data, and encouraging the validation and acceptance of alternatives.“ 4. Previously: National representation on the ECVAM Scientific Advisory Committee 5. No national reference laboratory dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

UK National Centre for the 3Rs “...to advance and promote the 3Rs in research and testing using animals. Developing a UK strategy for the implementation of the 3Rs; Supporting high-quality research that advances the 3Rs; Promoting a co-ordinated approach to 3Rs research; Providing advice and guidance on the 3Rs and animal welfare to the scientific community; Supporting the UK scientific community's commitment to best practice in all aspects of laboratory animal science and welfare; Working with regulators on the acceptance of alternative methods for regulatory toxicology..." dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Articles relevant to this meeting Local animal welfare bodies National Committees National competent authorities Alternative approaches Sharing organs and tissues Avoidance of duplication of procedures dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Directive 2010/63/EU (Advisory, “Local”) Animal Welfare Body Article 26 Animal-welfare body Member States shall ensure that each breeder, supplier and user sets up an animal-welfare body. 2. ...include at least the person or persons responsible for the welfare and care of the animals and, in the case of a user, a scientific member... 3. Member States may allow small breeders, suppliers and users to fulfil the tasks laid down in Article 27(1) by other means. Article 27 Tasks of the animal-welfare body (a) advise..on matters related to the welfare of animals...acquisition, accommodation, care and use; (b) advise...on the application of the requirement of replacement, reduction and refinement...informed of technical and scientific developments ...; (c) establish and review internal operational processes ...; (d) follow the development and outcome of projects...identify and advise as regards elements that further contribute to replacement, reduction and refinement; and (e) advise on rehoming schemes... Recital 31 Animal-welfare considerations should be given the highest priority in the context of animal keeping, breeding and use. Breeders, suppliers and users should therefore have an animal-welfare body in place with the primary task of focusing on giving advice on animal-welfare issues. The body should also follow the development and outcome of projects at establishment level, foster a climate of care and provide tools for the practical application and timely implementation of recent technical and scientific developments in relation to the principles of replacement, reduction and refinement, in order to enhance the life-time experience of the animals. The advice given by the animal-welfare body should be properly documented and open to scrutiny during inspections. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

The current position in the UK Local (institutional) ethical review processes: The aims of the process are: independent ethical advice to the certificate holder, particularly with respect to project licence applications, and standards of animal care and welfare; to provide support to named persons and advice to licensees regarding animal welfare and ethical issues arising from their work; and to promote the use of ethical analysis to increase awareness of animal welfare issues, and develop initiatives leading to the widest possible application of the 3Rs (replacement, reduction and refinement). dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop ...some UK detail... ...the process should allow... promoting the development and uptake of reduction, replacement and refinement alternatives in animal use, where they exist, and ensuring the availability of relevant sources of information; examining proposed applications for new project licences and amendments to existing licences, with reference to the likely costs to the animals, the expected benefits of the work and how these considerations balance; providing a forum for discussion of issues relating to the use of animals and considering how staff can be kept up to date with relevant ethical advice, best practice, and relevant legislation; undertaking retrospective project reviews and continuing to apply the 3Rs to all projects, throughout their duration; considering the care and accommodation standards applied to all animals in the establishment, including breeding stock, and the humane killing of protected animals; regularly reviewing the establishment's managerial systems, procedures and protocols where these bear on the proper use of animals; advising on how all staff involved with the animals can be appropriately trained and how competence can be ensured. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop ...and there’s more... UK ERPS implemented by administrative controls – not legislation. ...ensure as wide an involvement of establishment staff as possible in a local framework acting to ensure that all use of animals in the establishment...considered and justified; that proper account is taken of...the 3Rs); and that high standards of accommodation and care are achieved. ...Veterinary Surgeon and representatives from among the Named Animal Care & Welfare Officers should be involved...project licensees and personal licensees should also be represented...Where possible, the views of those who do not have responsibilities under the Act should be taken into account. One or more lay persons, independent of the establishment, should also be considered. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Directive 2010/63/EU Article 49 National Committee Article 49 National committees for the protection of animals used for scientific purposes 1. Each Member State shall establish a national committee for the protection of animals used for scientific purposes. It shall advise the competent authorities and animal-welfare bodies on matters dealing with the acquisition, breeding, accommodation, care and use of animals in procedures and ensure sharing of best practice. 2. The national committees referred to in paragraph 1 shall exchange information on the operation of animal-welfare bodies and project evaluation and share best practice within the Union. Recital 48 There is a need to ensure a coherent approach to project evaluation and review strategies at national level. Member States should establish national committees for the protection of animals used for scientific purposes to give advice to the competent authorities and animal- welfare bodies in order to promote the principles of replacement, reduction and refinement. A network of national committees should play a role in the exchange of best practice at the level of the Union. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

The current position in the UK Animal Procedures Committee Advice in relation to the operation of the legislation National Centre for the 3Rs A focal point for 3R related activities Interdepartmental Group on the 3Rs/HO Funding Bodies Group Embedding the 3Rs in Government policy dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Directive 2010/63/EU Article 59 National Competent Authority Article 59 Competent authorities 1. Each Member State shall designate...competent authorities responsible for the implementation of this Directive...may designate bodies other than public authorities for the implementation of specific tasks laid down in this Directive only if there is proof that the body: (a) has the expertise and infrastructure required to carry out the tasks; and (b) is free of any conflict of interests as regards the performance of the tasks... 2. Each Member State shall communicate details of a national authority serving as contact point for the purposes of this Directive to the Commission by 10 February 2011, as well as any update to such data. The Commission shall make publicly available the list of those contact points. The current UK provision:- A single Government Department (the Home Office) is the national competent authority. Structure/function: policy, assessment, authorisation, inspection, enforcement, advisory . No conflict of interest: UK competent authority does not... ...own or operate animal facilities... ...directly fund animal research... ...require animal test data for any statutory function... ...does not determine animal test requirements... dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Directive 2010/63/EU Article 47 – Alternative Approaches 1. The Commission and the Member States shall contribute to the development and validation of alternative approaches...take such other steps as they consider appropriate to encourage research in this field. 2. Member States shall assist the Commission in identifying and nominating suitable specialised and qualified laboratories to carry out such validation studies... 5. Member States shall nominate a single point of contact to provide advice on the regulatory relevance and suitability of alternative approaches proposed for validation. Recital 46 In order to increase competitiveness of research and industry in the Union and to replace, reduce and refine the use of animals in procedures, the Commission and the Member States should contribute through research and by other means to the development and validation of alternative approaches. Recital 47 ...It is necessary for the Commission to cooperate with the Member States when setting priorities for validation studies. The Member States should assist the Commission in identifying and nominating suitable laboratories to carry out such validation studies... dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop Possible UK position Policy decision not to establish national reference laboratory. Interdepartmental Group on the 3Rs possible national contact point for regulatory testing. Points to consider: What is meant by “contribute”? What is meant by “nominate”? What is a “qualified” laboratory? dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Directive 2010/63/EU Article 18 Sharing organs and tissues Article 18 Sharing organs and tissues Member States shall facilitate, where appropriate, the establishment of programmes for the sharing of organs and tissues of animals killed. Recital 27 Animal tissue and organs are used for the development of in vitro methods. To promote the principle of reduction, Member States should, where appropriate, facilitate the establishment of programmes for sharing the organs and tissue of animals that are killed. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop Current UK practice This is common practice at establishment level – encouraged/facilitated by the local ethical review processes. Breeders/suppliers who have a “biological surplus” offer this as a service. Encouraged by funding bodies. HOWEVER – there are issues relating to logistics, availability, biosecurity and cost. Point to consider: does “facilitate” mean more than “encourage”? dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Directive 2010/63/EU Article 46 Article 46 Avoidance of duplication of procedures Each Member State shall accept data from other Member States that are generated by procedures recognised by the legislation of the Union, unless further procedures need to be carried out regarding that data for the protection of public health, safety or the environment. Recital 42 To manage risks to human and animal health and the environment, the legislation of the Union provides that substances and products can be marketed only after appropriate safety and efficacy data have been submitted. Some of those requirements can be fulfilled only by resorting to animal testing, hereinafter referred to as ‘regulatory testing’. It is necessary to introduce specific measures in order to increase the use of alternative approaches and to eliminate unnecessary duplication of regulatory testing. For that purpose Member States should recognise the validity of test data produced using test methods provided for under the legislation of the Union. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop Comment Does this go further than existing mutual acceptance of data provisions: Testing to recognised internationally agreed protocols. In laboratories with appropriate QA/QC procedures. Relevant only for regulatory testing (<20% of animal use). Only data generated in other Member States. Provision is made for exceptions. Difficult to see how to put this into a single piece of domestic legislation. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Loose ends...UK Authorisation/Enforcement UK currently authorises places (breeders, supplies, users - 200), projects (4,000 – assessed and authorised), and those who actually perform procedures (14,000). Nominated veterinary surgeons and animal care and welfare officers. Enforcement: Inspection (>2,000 year, >50% unannounced). A range of administrative and criminal sanctions. 50% of non-compliance self-reported. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop Points to consider Can existing “competent people” be grand-fathered-in? Risk-based inspection programme – what are the risks to be managed, and how effectively must they be managed? Can the existing UK inspection programme be resourced and justified? Is it compliant? No qualification/ training standards set for inspectors. Commission oversight (Article 35) is of inspection side only. Who will do this, what training is required? Should more use be made of financial penalties and fees? Might this distort the internal market? dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Education and training Objective 1 – competent persons. Objective 2 – free movement of skilled labour. Points to consider: What is the significance of Commission “non-binding” training requirements? What about non-EU scientists? What about language skills and knowledge of national systems? Is this within the scope of the Services Directive? dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

Concluding remarks National perspective/challenges Proportionate approach to achieve high welfare standards and maintain the success, sustainability and competitiveness of the science base. Flexible enough to adapt to technical progress. National policy informed by impact assessments and consultations – and by measures being taken by other Member States. At national level key there are choices to be made: Amend current systems, or start again? Do the minimum required – or justify, finance and keep additional provisions? There is pressure to minimise regulatory burdens. “Copy-out”, or look beyond the text of the Articles? Funded through general taxation or fees – would the latter distort the internal market? Transpose/implement – early or at the deadlines? Primary or secondary legislation. dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop

dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop Thank you. dr.jonrichmond@gmail.com dr.jonrichmond February 2010 CAAT Europe/ECOPA Workshop