Max Headley
University of Bristol, UK

https://doi.org/10.36866/pn.91.10

I last wrote an update for Physiology News nearly two years ago. At that stage the new Directive had been passed by the EU parliament and work was under way to ‘transpose’ the Directive into UK legislation. That process, with its various consultations with the public, learned societies and within government, took longer than expected, such that the final version of the revised legislation was only laid before Parliament in November 2012. There were concerns that there might be a last-minute push by the antivivisection lobby to get additional restrictions added in at the parliamentary stage. To help deflect any such move, Members of The Society were encouraged to write to their MPs supporting the legislation as laid. A gratifying number of Members obliged (130 letters sent to over 75 MPs) and, while we can’t say that that made the difference, we can say that the debates in both Houses went smoothly – perhaps surprisingly so. As a result, the new legislation was signed off on 16 December 2012 and became law on 1 January 2013.

For various quite complex reasons, the legislation was adopted by amending the old ‘ASPA’ (the Animals (Scientific Procedures) Act 1986). As a result, and somewhat confusingly, the new Act has the same name, including the 1986 date, as the old one.

Some of the changes of significance to physiologists

The licences
The Certificate of Designation (PCD) has now become an Establishment Licence (PEL), but the essence remains little changed. The Project Licence (PPL) is so far minimally changed. However, as Personal Licence (PIL) holders should already know, the new PIL has lost the list of techniques (s15); instead applicants apply for one of (almost always) four categories of technique, within which (and subject to competence) they may use whatever technique is appropriate to their study (see Research and testing using animals, URL below). However, the transition to the new categories has not happened automatically, so that users with pre-existing PILs remain limited by their s15 techniques list until their licence is updated. The Home Office (HO) will complete the conversion as soon as it can, but in the meantime users who need extra techniques will still need to apply for an amendment. But to avoid swamping the system, please only apply for amendments if/when necessary.

Emphasis on 3Rs
The 3Rs have a high profile in the new legislation and that will inevitably find its way into all corners. Licence holders should recognise the need to embed 3Rs thinking into all relevant paperwork.

Developmental forms
Mammals, birds and reptiles will be protected from 2/3 gestation/development, rather than half way, as at present. That should remove a significant amount of developmental work from the controls.

Breeding
There are more overt controls now over breeding, even where it is for tissue harvesting rather than for use in licensed procedures.

Humane killing
The HO readily admits that some of the humane killing arrangements in the Directive are not ideal. Offsetting this, however, is a new ability to apply to get extra methods of humane killing (outwith Schedule 1) attached to the Establishment Licence (PEL). This means that a PPL would not be required for individual users. This facility is being taken up by various establishments and could apply, for instance, for techniques that require added equipment or skills that may not be generally available. Under the Directive, the UK also has the right to make extra techniques available on a national basis, but at present the HO is not going that far. One other distinct benefit of the new rules is that where it is in the animal’s interests, sedatives can be used prior to Schedule 1 killing.

Competence
Institutions are more responsiblethan before for ensuring the competence of staff. There is flexibility over how this is achieved, but in many institutions it will require additional planning and monitoring. PPL holders will have to assume more responsibility for ensuring that those working on their project are assessed formally as being competent to do so.

Wildlife studies
Licensees doing this sort of work will have to tread rather carefully. Despite many requests to the HO, there are several regulations limiting/precluding such work without explicit exemptions.

Education and training
Education and training are now allowable purposes, although the HO has said it will pay such applications particular attention.

Sharing tissues
Sharing tissues is now an explicit expectation. That should facilitate appropriate provisions in PPL applications.

Statistics reporting
Statistics reporting will not change materially for 2013, but will for 2014 to match EU-wide data. An important (and ultimately beneficial) change is the requirement to assess severity retrospectively for every animal undergoing a procedure. Although those data will be collected formally only from January 2014, the HO has stated that they should be being collected from January 2013; the sector has queried the practicality and feasibility of this, but so far without confirmation from the HO. Various EU groups are working up examples that should help us all to apply this in a reasonably consistent manner.

Ongoing issues

Government guidelines for the implementation of EU Directives indicate that the formal guidance documents (which must be laid before Parliament and therefore carry some legal weight) should be published at least three months before the legislation comes into force. With the late adoption of ASPA by Parliament, this did not happen. The HO did produce some interim guidance in December, but the definitive guidance documents are still far from complete. Rather, in January/February the HO released draft documents for the sector’s comments. For several years the sector (industry, funders, charities, etc., as well as academia) has cooperated under the banner of the UK Biosciences Coalition (UKBSC) over the many issues involved in the Directive and ASPA. under the banner of the UK Biosciences Coalition (UKBSC). So UKSBC has been working on these HO drafts.

A response to the draft Guidance was submitted by UKBSC in mid-March and your Society (together with others) submitted a further detailed list of comments. We now understand that the next version of this detailed Guidance document should be released for further comment in June 2013.

At the time of writing there are consultations open on the Code of Practice (on how animals are kept) and on statistics. UKBSC is formulating its responses with input from The Society’s reps.

A major issue that is far from resolved concerns ASPA section 24 – on confidentiality of the material submitted to the HO. This was one topic raised in the House of Lords that the Government pledged to address. Universities are receiving ever more Freedom of Information requests and the situation is far from satisfactory from all parties’ perspectives. UKBSC has submitted its views and continues to liaise with the HO on this issue. We anticipate hearing more over the summer about government moves on both the Freedom of Information Act and s24 ASPA, and UKBSC will certainly be keeping a close eye on such moves.

So although we thought a year ago that all would be resolved by now, in practice we are still very much in transition, with many regulatory issues still far from resolved. Your reps will continue to feed into the discussions with a view to promoting research and animal welfare while minimising unhelpful regulation.

References

Directive 2010/63/EU of the European Parliament and of the Council. Available at: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0 079:EN:PDF [accessed 14 May 2013]

Animals (Scientific Procedures) Act 1986 Amendment Regulations. Available at: www.gov.uk/government/publications/animals-scientific-procedures-act-1986-amendment-regulations [accessed 14 May 2013]

Research and testing using animals: Details of the law on scientific research and testing involving animals, and guidance on applying for licences. Available at: www. gov.uk/research-and-testing-using-animals [accessed 14 May 2013]