Better Regulation
Reducing costs to business
The Government is committed to efficient and effective regulation. In December 2006, the Prime Minister announced a government-wide action plan aimed at reducing costs to business through better regulation. This comprises separate ‘Simplification Plans’ for each central Government Department, including the Home Office.
The Home Office Simplification Plan, includes a target to reduce the compliance costs arising from the regulation of animal experiments.
Work towards the target will be taken forward in a dedicated ASPD better regulation programme which will look at
- issues identified in recent reviews – such as the Davidson Review of the transposition of EU legislation in the UK
- specific proposals already put forward by stakeholders and will benchmark current best practice
The programme also provides an opportunity to identify additional areas in which improvements can be made.
The overall objective of the programme is to simplify dministrative processes and reduce compliance costs by 25% by 2010, whilst maintaining proper provision for animal welfare.
Programme Management
The programme will be overseen and managed within the framework for implementation of the Home Office Simplification Plan.
Steering Group
A steering group, chaired by Cabinet Office officials, will provide advice on strategic issues relating to the programme and ensure that any changes to the regulatory system arising from the programme do not compromise animal welfare.
The group should also promote:
- stakeholder engagement in the programme
- stakeholder implementation of agreed measures intended to minimise or reduce compliance costs
The steering group has representation from ASPD and the Home Office Better Regulation Team, other Government Departments, industry, academia and organisations focused on animal protection and the reduction, refinement and replacement of animal procedures.
Practitioner group
In our June 2007 better regulation circular, we reported on a number of initiatives implemented since January 2007 and explained that the next stages of the programme would involve consultation with a cross-section of operational-level practitioners on wider options for change. We followed this up in August, when we carried out an e-mail consultation with a group of practitioners nominated by the joint inter-departmental and stakeholder steering group. The consultation looked at issues relating to personal and project licences, certificates of designation and the annual statistics and was followed up with a practitioners’ meeting on 5 October, which considered a number of options for licences and certificates and also looked at local ethical review processes.The main conclusions of the practitioner discussions were as follows:
Certificates of Designation
The revised form was generally well-received, but practitioners did not support making its use mandatory. Instead, they envisaged a long transition period during which its wider adoption and use would be encouraged. To support this, they identified the need for clear guidance, including worked examples and clarification of key terms. They also concluded that the revised form and guidance should be reviewed jointly by stakeholders and the Home Office to identify problem areas and refinements. We plan to do this in October 2008.
Project Licences
Practitioners strongly favoured the development of a new, shorter project licence application form, with Plain English prompts and word limits to encourage brevity. We will be presenting proposals at the February steering group meeting for further consultation and piloting of a revised application form. Practitioners also strongly supported the provision of licence templates and worked examples for suitable categories of work to and from which applicants could cut and paste to suit their particular needs. In addition, they identified a need for feedback from Home Office Inspectors where excess detail is provided in applications and for Module 5 training to include the principles of writing project licences.
Personal Licences
Practitioners strongly supported the development and implementation of standard wordings for use by applicants and licensees as a source list from which to choose those required for their particular work. They did not favour a more radical option involving a new style personal licence authorising the application of complete sets of techniques from the standard wordings list at two levels. This option would dispense with the need for applicants to specify the actual techniques required for their particular work. Amongst other things, practitioners thought that this might reduce personal responsibility and would highlight the need for project licence holders to monitor competencies. They also thought that it might be perceived by the public as less stringent than the current system. However it was seen as potentially a quick and flexible system which would simplify electronic submissions as well as the transfer of licences between establishments. We would welcome further feedback on this idea.
In the meantime, we have gone ahead with refining the standard wordings for techniques for personal licences. The list, incorporating comments received wherever possible, is now available with the licence application. We would encourage applicants to use these wordings in all new applications though they are not mandatory. We plan to begin a review of their uptake and impact in June 2008.
Ethical review processes
Practitioners saw no pressing need for fundamental change to the role and functions of ethical review processes (ERPs) but favoured measures to refocus their activities and improve their effectiveness and efficiency. They supported the provision of additional written guidance and workshops to disseminate good practice. The APC is currently reviewing ERPs and we will await their advice before drafting guidelines.
Annual statistics
There was wide practitioner support for the simplification of the annual statistics to bring them more closely into line with EU requirements. A further consultation with animal welfare and protection stakeholders has just been concluded and the results are being considered. We plan to report the findings and submit advice on options to Meg Hillier after the February steering group meeting.
Personal Licences: fast-tracking applications for short-term authorities
Whenever possible an application for a personal licence should be made well in advance of the actual need.
However, applications can be fast-tracked where there is a clear need. This can include applications from undergraduate students, industrial placement students and overseas visitors requiring personal licence authority for three months or less.
Where an application needs to be fast-tracked, the local Home Office inspector and/or staff at your local office should be alerted as soon as the need becomes apparent. A covering letter requesting and giving reasons for fast-tracking should also accompany the application.
All applications suitable for fast tracking will be dealt with within a time frame agreed with the applicant.
Please note that an application for a personal licence may be submitted before the relevant training modules are undertaken. However, the original training certificates will be needed before the licence can be issued.
They should be sent to the Home Office as soon as they are received. In exceptional circumstances, if there is urgent need for a short term licence and a delay in the issue of these certificates, a statement by the course provider of satisfactory completion of the course may be considered acceptable.
Personal licences: revised arrangements for periodic review Under Section 4(5) of the Animals (Scientific Procedures) Act 1986
Personal licences are reviewed at intervals not exceeding five years. Previously the Home Office wrote to personal licence holders at the time of the review date requesting that the licence be returned for review.
To reduce the administrative burden on licensees, personal licences submitted for amendment to sections 14 and 15 will now be reviewed at the same time and a new review date set, as appropriate. This change has already taken effect and should reduce the need to send in licences separately for review.
Advice on re-use of animals
We have reviewed and consolidated the current guidelines on the re-use of animals. To assist project licence applicants and holders this information will be republished in a single consolidated document and accompanied by a set of examples of specific scenarios, along with a simple flow chart, to help drafting and decision making. These will be posted on our website shortly.
Streamlined arrangements for moving genetically altered animals between projects
Many project licences already have suitable wording which allows for the transfer of genetically altered animals between projects, eliminating the need for technical amendments and formal transfer of animals requests.
Those currently preparing project licences should consider incorporating the following text in appropriate protocols, or in section 18, if use of genetically altered animals may be part of the programme of work.
[In 19b(iv)] “Genetically altered animals for use in this project may be obtained from projects with authority to breed genetically altered animals of that type and to provide them for use on other projects.”
[In 19b(v)] “Following any identification of genetic status, genetically altered animals produced under the authority of this project and not used in other regulated procedures may be supplied to other projects with authority to use genetically altered animals of this type.”
Those holding licences that do not have such wording may wish to request amendment to include it.
Reducing the need for transfer forms
We expect to issue advice on this issue shortly.
