Background Memorandum by Huntingdon Life
Sciences
Introduction:
Huntingdon Life Sciences was established in
1952 and provides research and development services to the pharmaceutical,
biotechnology, agrochemical and chemical industries worldwide.
In conducting our operations and animal studies we
work under the Animals [Scientific Procedures] Act 1986, (A[SP]A).
Compliance with the Act and authority to conduct work under it,
is demonstrated by the Certificate of Designation issued by the
Secretary of State.
HLS constantly strives to implement the 3R's
(Refinement, Replacement and Reduction) in its R&D programmes.
We believe that we comprehensively recognise animal welfare as
being important to us for three reasons:
— Our fundamental personal and corporate
obligations to the animals that we must use in our R&D programmes;
— In order to comply with the Animals
[Scientific Procedures] Act, which effectively is our licence
to operate;
— To support and secure the delivery
of good science and valid results which are the corner stone of
the business.
We are based on two sites within the United
Kingdom separated by a distance of some 70 miles. About half of
the Company revenues are sales based on in-vivo studies, the remaining
half being made up of in-vitro bio-test systems and chemistries.
Whilst a limited amount of in-vivo research
and efficacy studies are performed on behalf of third party clients,
the vast majority of our animal studies are for regulatory safety
assessment submissions (compound development). Again all of our
work is for third party clients and as such we are bound by confidentiality
clauses to protect intellectual property.
In 2000 our animal use was: 71,507 (circa 2.75
per cent of the national total for 1999):
— Dogs/primates/cats = 2.9 per cent
of the total;
— Rodents/birds and fish = 92 per cent
of the total;
— Rabbits/farm animals/ferrets/other
= 5.1 per cent of the total.
Why are "in-vitro" safety evaluation
studies conducted at HLS?
Most of the animal experiments conducted at
Huntingdon Life Sciences and a substantial proportion of the procedures
undertaken within the UK are dedicated to satisfying regulatory
requirements for chemical and biological product development.
An International framework of regulations has been enacted to
control the introduction and usage of chemicals in order to ensure
consistent quality and to protect human and environmental health.
These regulations require that an adequate evaluation
of both the efficacy of the product and its potential to cause
adverse effects is performed. This provides the basis for a risk/benefit
assessment to be made for each chemical before authorisation to
market is granted. With such an approach, it is implicit that
a greater degree of adverse effects may be tolerated given a greater
degree of benefit to mankind in use of the product.
In order to accommodate this principle, regulations
have been developed for particular types of chemical including
pharmaceuticals, industrial chemicals, agrochemicals etc, so that
the testing requirements can be designed to meet the particular
conditions of use, or exposure. Whilst national regulations pertain,
they have been reasonably harmonised, especially for pharmaceuticals,
in order to optimise testing procedures for international products
and reduce animal use.
The burden of responsibility rests with the
developer/manufacturer of the chemical to ensure that adequate
data are available for the Regulatory Authorities to complete
the risk/benefit assessment. However, to facilitate this, the
regulatory framework clearly defines minimum testing standards.
In order to achieve a consistent approach and maintain rigorous
standards, a hierarchy of testing procedures is prescribed including
numbers of animals, choice of species, route of administration,
test duration and the range of investigations conducted. In this
way, the safety assessment process is able to identify hazard
and in the context of exposure, predict the risk for man and/or
the environment.
How does this Translate into our Day to Day Activities?
Referring only to our animal studies, the majority
of our day to day activities are limited to performing safety
assessment studies for compounds under development. A typical
study will consist of a control group (not receiving test material)
and three (dose) groups receiving test material in increasing
(but controlled) amounts.
Test substance administration may be by a variety
of routes including oral, inhalation or by injection. The number
of animals will vary depending upon the type of study and the
species used in the study. This will vary from as few as four
for a metabolism study, up to 700 for a two year (life-span) rodent
oncogenicity study.
At the end of the in-life phase the animals
are euthanased and are the subject of full necropsy and histopathological
examinations to determine any compound induced effects. In addition,
during the in-life phase, the animals will receive daily health
checks, periodic blood tests and various clinical examinations
to monitor animal welfare and to detect signs of compound toxicity.
These clinical examinations may include behavioural, ophthalmological,
neurological and electrocardiographic (ECG) tests.
In addition to safety assessment studies we
also undertake safety pharmacology, and metabolism studies.
Who Oversees, Conducts and Controls this Work?
The scientific aspects of the studies are overseen
by graduate and post graduate scientists.
Conduct of the scientific procedures is performed
in the main by animal technicians holding a personal licence under
the A[SP]A. The welfare of all animals is supervised on a daily
basis by a Named Animal Care and Welfare Officer (NACWO) and the
health of the animals is under the overall supervision of the
Named Veterinary Surgeon (NVS). HLS has an NVS at both of its
sites and they are supported by three full time veterinary clinicians.
The Certificate Holder of both sites is accountable
to the Home Office for the conduct of the NACWO's and NVS's.
HLS has some 16 NACWO's, all of whom have successfully
attended and passed the Institute of Animal Technology (IAT) training
course for new NACWO's. We believe this may be unique for the
size of establishment and number of NACWO's.
Both NVS's have undergone the RCVS registered
training for NVS's and the Certificate Holder is both a veterinary
surgeon and holder of the Diploma in Laboratory Animal Science
from the RCVS.
HLS has some 48 IAT, Registered Animal Technicians
(RanTechs) within its animal technology group and runs annual
courses on site for various IAT qualifications. These courses
are open to technicians from other establishments as well as our
own staff.
HLS has operated an ERP from April 1999 with
the Committee meeting on a monthly basis. In addition to having
three lay members of staff on the ERP, we have two external experts
who attend on a quarterly basis to provide independent guidance
and advice on matters of animal welfare and ethics. The ERP meetings
are chaired by the Certificate Holder.
Both sites receive regular unannounced visits
from the Home Office Inspectorate in addition to visits by appointment
when the inspector wishes to specifically meet with named individuals
such as project and personal licence holders.
We are the subject of extensive "peer review"
in the form of client inspections and study audits.
How Do We Perceive A[SP]A?
HLS believes the Act (A[SP]A) provides a "privilege"
by allowing experiments to be performed on animals, which may
cause pain, suffering, distress or lasting harm to them for the
benefit of mankind, animals under our care and the environment.
Along with this privilege come obligations and we believe it is
the provisions of the Act, which set out these obligations that
we must fulfil if we are to retain the privilege. It is this guiding
principle, which we follow in complying with the provisions of
the Act.
We have already stated our observations on the
strengths and weaknesses of the Act in our written submission
to the Inquiry and would not seek to repeat them here. We would
however, make the observation that there seems to be too great
a "disconnect" between the Home Office Inspectorate
and the functioning of the APC leading often to concurrent and
parallel initiatives, especially on matters of consultation.
In our mind the Act provides for some of the
best welfare standards in laboratory animal science in the world.
The Inspectorate implement the Act with firmness,
professional integrity and with due regard for scientific progress.
The APC is well positioned and appointed to
advise the government on strategic developments under the Act.
This concludes are background memorandum supplied
in connection with our impending visit to the House of Lords to
give verbal evidence to the Inquiry.
David Whittaker
Certificate Holder
June 2001
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