[your name
Your address]
Animals Scientific Procedures Division
Home Office
4th Floor SW,
Seacole Building
2 Marsham Street
London
SW1P 4DF
Email: aspd-brp@homeoffice.gsi.gov.uk
[date]
Dear Home Office
CONSULTATION ON EU PROPOSALS FOR A NEW DIRECTIVE ON THE PROTECTION OF
ANIMALS USED FOR SCIENTIFIC PURPOSES
Please consider my individual response as part of this consultation process.
The overall Home Office approach
I am deeply concerned that the Government (Foreword and paragraph 26) has failed to explicitly
endorse and support the most important of the Commission’s high-level policy objectives: ‘the
ultimate goal should be to replace the use of animal experiments altogether’ (Commission
Proposal, Explanatory Memorandum, page 3).
As the Nuffield Council on Bioethics has made clear, inflicting pain and suffering on animals, at the
very least, poses serious ethical costs. Therefore, a world where animals are not subjected to pain
and harm in the course of research – i.e. a world without laboratory experiments on animals - must
be the ultimate ethical goal. The Animal Procedures Committee gave similar advice – advocating
related targets – to a previous Minister in 2005.
The Government refusal to acknowledge and promote the desirability of an end to animal
experiments is related to its policy objective of supporting the interests and autonomy of animal
researchers. Downplaying the ethical problems with animal experimentation appears to be part of
the Government’s strategy here. As the Government well knows, one cannot ‘ensure the welfare of
animals’ used in experiments, as the British Physiological Society has acknowledged. All it is
possible to do is to mitigate suffering to the extent that it does not interfere with the objectives of
the experiment. Given that the housing and husbandry conditions alone can cause harm to
animals, it is clear that animal suffering is inherent in their use in experiments.
I am therefore disturbed that the Government’s Consultation document peddles the lie that it is
possible to ensure animals’ welfare or attain good standards of animal welfare in experiments
(Foreword; para 29). The Government’s tendency to conceal the true adverse effects suffered by
animals in laboratories hinders informed public debate and betrays a rather extreme and one-sided
stance on this issue. Instead of aligning itself with mainstream values - that seek a world without
animal experimentation - the Government seems to have aligned itself with the extreme position
espoused by vested interests who aim to entrench this practice and encourage indifference to the
suffering of animals (see http://www.understandinganimalresearch.org.uk/about_us/). The same
former Minister conceded that few could disagree that such indifference is acceptable in a civilised
society, yet the settled policy of the Government embodies such indifference.
I therefore urge the Government to adopt the goal of ending animal experimentation as a high-level
policy objective, and promote positive, pro-active policies that reflect ethical and scientific
advances to achieve that goal, in its negotiations with other EU member states.
At paragraph 34 the Government sets out areas of concern it has with the draft Directive. Once
again, these are very similar to complaints made by industry. It appears that the Government’s
priority is to defend vested interests. It cannot form coherent, informed and legitimate policy while it
adopts such bias.
On the positive side, I am glad that the Government appreciates that harmonised comprehensive
ethical evaluation of animal experimentation proposals must be compulsory. To this end, I urge the
Government to oppose Amendments 125-129 and 167 to the Commission proposal passed by the
European Parliament on 5th May.
Purposes
Q9: I believe that experiments aimed at ‘advancing knowledge’ should not be permitted as the
alleged benefits are intrinsically uncertain, so they cannot be justified on harm-benefit grounds.
Furthermore, such a restriction is vital in order to direct research towards the aim of replacing the
use of animal in experiments. At the very least, any such experiments should have a maximum
severity limit of ‘mild’. Similarly, experiments for the purposes of species preservation, education
and forensics should be banned on harm-benefit grounds.
Primates
Q12: I believe that the Commission’s proposed approach of defining in advance, based on
democratic process of stakeholder consultation, the circumstances where primates can be used in
experiments offers major advantages in terms of public legitimacy, openness, animal welfare,
harmonisation and scientific advancement compared to the stated Government intention of
delegating power to the discretion of researchers and inspectors. The current UK approach means
the goals of animals researchers are always allowed to trump the most essential interests of
animals in not suffering pain and distress.
However, I believe that the Commission’s restrictions did not go far enough. Fundamental research
on primates should also be banned as an essential measure to reflect public opinion on what types
of experiment are and are not acceptable, and to promote the development and application of
alternatives: the more data is generated from primate experiments, the greater the temptation for
future researchers to build on that data with further experiments on primates.
The widespread support for WD40 in the European Parliament and public opinion polls indicate
widespread support for a rapid phase-out of primate experimentation. The Government should, for
once, listen to public opinion rather than act as agents for animal research interests and support a
targetted phase-out of primate use.
The additional paragraph added by the European Parliament (AM 59) provides a very valuable
mechanism for reviewing primate use and I urge the Government to support this as part of a policy
aimed at saving primates from experiments.
Severe pain and distress
Q23: I believe that the Government’s proposal to allow the infliction of prolonged, severe pain and
distress is deeply unethical. I note that such procedures are analogous to the US Government’s
definition of torture. The YouGov poll commissioned by ECEAE demonstrates clear, overwhelming
support for a ban on such extreme cruelty. Furthermore, that level of pain and distress will further
undermine the validity of any results. The Government’s belief that it will stop ‘important areas of
research’ is incorrect and signifies the blind support the Government gives to animal research
interests. In any case, the public clearly believes that the moral imperative not to inflict severe pain
and distress on animals is of greater weight than any impact on research paths.
Requirements for establishments
Q32: A new paragraph should be added to Article 24 requiring that establishments designate a
person responsible for receiving information on developments in alternative methods from
European and national centres for alternative methods, and disseminating that within the
establishment. I believe this is necessary to ensure best practice, maximise use of alternative
methods and to minimise the use of animals in experiments.
Q33: Reporting non-compliance solely to the establishment’s permanent ethical review body
trivialises animal welfare, is insufficient to maintain independence and accountability in animal
research, and falls short of current UK measures. Instead, non-compliance must also be reported
to the Inspectorate and the member state’s competent authority.
Q34: The absence of a stipulation for lay, ethical or independent membership of the
establishment’s ethical review body means that the remit of such bodies as set out at Article 26,
para 1 could not be satisfied in an independent and accountable manner. The composition and
structure of an establishment’s ethical review body should reflect human research ethics
committees. There is also a need for an independent body to monitor and inspect the performance
of permanent ethical review bodies.
Q41: There can and should be no get-out clause to reduce standards of veterinary oversight and
housing for the sake of any alleged scientific considerations. The UK should maintain any higher
standards than found in the final Directive. All experiments should be subject to 24 hour veterinary
supervision.
Inspections
Q42: To ensure independence, it is necessary to add a requirement for Inspectorates to have a
majority of independent members. I define independent as not being involved in animal research,
not being a member of the same professional, public or political body as an applicant, and having
no financial interest in entities engaged in animal research. Members of the Inspectorate should
include scientists in relevant fields of research, scientists and clinicians independent of animal
research, veterinarians and ethicists (especially if the Inspectorate, as it does now in the UK, also
performs the role of the competent authority and undertakes ethical evaluation of projects).
Requirements for projects
Q44: It is essential for the sake of accountability, welfare and science that all proposed
experiments require independent ethical evaluation rather than self-authorisation (‘notification’).
The Parliament’s amendments to reduce ethical evaluation requirements make a bad situation
worse.
Q45: Paragraph 2 of Article 36 undermines accountability, scientific quality and animal welfare. All
procedures with the potential to cause harm must be amenable and subject to proper ethical
evaluation.
Q46: An additional area of expertise that would assist the assessment of proposed projects would
be clinical experts independent of the institutions, bodies and companies to whom applicants is
affiliated.
Alternatives
Q54: While any reduction in animal suffering, both in terms of intensity and number of animals
harmed, is to be welcomed, the focus of alternatives research should be n replacement, due to the
inherent pain and suffering caused by laboratory procedures and the unreliability of animal-based
methods. The Commission’s original text for Article 45 was correct to highlight that non-animal
methods can yield superior data to animal methods by overcoming problems caused by species
differences. The Government should acknowledge this. Furthermore, in order to support progress
with alternatives, it is essential for the Government to provide leadership by acknowledging the
ethical and scientific problems with animal experiments and set targets as an effective way of
motivating progress.
Amendment 138 and 139 provide positive clarification regarding the contribution from the
Commission and Member States. I hope the Government supports these measures as they can
help overcome the marginalised status of alternatives research and foster a more progressive
culture with biomedical research. It is important that the EU Centre, possibly a reconstituted
ECVAM with a wider remit has a strategic role in guiding the promoting the replacement of animal
experiments.
However, another oft-overlooked factor that frustrates the achievement of the Commission goal of
eliminating procedures on animals is animal research aimed at the development of new animal
methods and models. Such research perpetuates the use of animals in experiments. Therefore, I
propose that a new clause should be inserted at Article 45 prohibiting the use of animals in
experiments whose purpose is to develop new animal methods and research models, including
models of disease.
Q55: Amendment 140 is also welcome as it requires research into alternatives to all types of
animal experiment, not just toxicity tests. Amendments 140-145 and 193 provide useful clarification
of the objectives and roles of national alternatives centres. Such centres should work in similar
ways to the German centre ZEBET, which not only funds alternatives research but additionally
assesses and recommends alternatives for recognition, both nationally and internationally.
Thematic Reviews
Q62: I agree with the principle behind AM 194, and believe that another factor for prioritising the
types of procedures to be reviewed should be evidence of scientific weakness and the
potential/availability to replace such procedures. Thematic reviews should contribute to the
activities of the EU and national centres for alternative methods, as well as informing all other
aspects of policy.
Competent authorities
Q63: I am strongly opposed to the proposal in the 2nd paragraph of this clause to allow non-public
bodies to implement the Directive. It would institutionalise self-regulation, contradict the aims of
public accountability and strip legitimacy from the decisions of the designated ‘competent
authority’.
Yours faithfully
[sign]