BRIEFING:
THE NEED FOR AN INDEPENDENT JUDICIAL INQUIRY
Contents
- Introduction
- Suffering in transportation
- Regulation of experimental procedures on animals
- "Severe" suffering
- The cost/benefit assessment
- Huntingdon Life Sciences
- ASPI: policy, composition and workload
- Home Office response to Diaries of Despair
- The Chief Inspector's report
- Home Office response to breaches and public concerns
This report is also available in PDF
format.
1. Introduction
This briefing has been produced in order to explain why there is
an urgent necessity for an independent judicial inquiry to investigate
Imutran's xenotransplantation research at Huntingdon Life Sciences
and the Government's failure to apply relevant laws and regulations,
to the benefit of the companies and resulting in severe suffering
for hundreds of higher primates.
The grounds for such an inquiry are to be found mainly in thousands
of pages of documents relating to this research programme which
were leaked from Imutran to Uncaged Campaigns in spring 2000. The
call for an independent judicial inquiry stems mainly from the evidence
of deliberate and systematic Home Office maladministration of animal
research regulations, prioritising the demands of industry and resulting
in extreme suffering endured by higher primates. The Home Office
has consistently sacrificed animal welfare and the rule of law for
the sake of commercial interests.
The Report, Diaries of Despair, was produced after analysis of
the documents and already-published information, and was aided by
professional scientific advice. Diaries of Despair meticulously
related the evidence contained in the documents to the regualtory
framework. A major exclusive article appeared in the Daily Express
on the same day as the publication of Diaries of Despair (21st September
2000).
The Imutran primate research programme was probably the most severe
research project that animals were subjected to during the 1990's,
taking into account the hugely traumatic nature of the procedures
and the use of higher primates, including wild-caught animals, as
well as thousands of pigs - acknowledged to be highly intelligent
and sensitive animals. The experiments involved the transplantation
of kidneys and hearts from genetically-engineered pigs into hundreds
of macaque monkeys and wild-caught baboons. After the transplants,
the primates were administered toxic cocktails of powerful drugs
in an attempt to prevent rejection of the foreign organs. Every
single one of the primates died in these experiments from causes
such as organ failure, infections and drug poisoning/side effects.
The report was entitled 'Diaries of Despair' in reference to the
suffering and death as described in the laboratory technicians'
own detailed records of the animals' post-transplant lives. One
monkey which had a pig heart attached to the blood vessels in its
neck was seen holding the transplant which was "swollen red"
and "seeping yellow fluid" for most of the last days of
its life. Animals are described as quiet, huddled, shivering, unsteady
and in spasm. Some had swellings, bruising or were observed with
blood or pus seeping from wounds. Others vomited repeatedly, or
suffered constant diarrhoea.
Not only have the animals suffered greatly - they have suffered
in vain. In order to try to maintain investor and public support,
over the past five years Imutran has claimed to have been on the
verge of solving the mountainous biological obstacles to cross-species
organ transplants. However, internal company reports admit that
they have failed to make any significant progress in the last seven
years.
It is the evidence about regulatory failures in particular which
gives rise to the necessity for an independent judicial inquiry:
those failures fall into three general categories:
- The collusive relationship between the Home Office Animals (Scientific
Procedures) Inspectorate (ASPI) and animal researchers in the
licensing process and other aspects of the enforcement of animal
research regulations.
- Serious concerns about the manner in which the cost-benefit
assessment and severity limits are executed by the Inspectorate,
which fail to take due consideration either of the level of suffering
of the animals subjected to xenotransplantation research or of
factors which undermine the likelihood of any benefits accruing.
- Other conduct by the Home Office in relation to this programme
of research, such as the legitimacy of the decision to re-issue
HLS with a Certificate of Designation in autumn 1997 and misleading
Written Answers.
This briefing is necessarily deeply critical of the conduct of
the Home Office. These criticisms, particularly those regarding
the lack of good faith on the part of the Home Office, are not made
lightly. However, the evidence clearly justifies - and demands -
a critical attitude. We stand by our criticisms. If the reader is
in doubt about any aspect of the briefing, then we urge them to
contact Uncaged Campaigns for clarification. They may also wish
to submit questions to the Home Office - we wish them luck in trying
to obtain an answer that is not economical with the truth.
The documents and the Diaries of Despair report based upon them
are currently banned from publication due to an interim injunction
on grounds of breach of confidentiality. Despite being unrepresented
(at time of going to press), Uncaged Campaigns and Dan Lyons (Director
and author of Diaries of Despair) are continuing to contest the
case because of the overwhelming public interest (such as the need
to expose Governmental failures) in the publication of the documents.
However, the reports in the Daily Express concerning this issue
that were published in late September 2000 are in the public domain,
and they give a useful overview of some of the relevant issues.
This briefing is quite severely constricted by the injunction.
The RSPCA downloaded the documents from a dedicated website before
Imutran forced its closure. In October 2000, the RSPCA won permission
to compile its own report, stating: "We welcome the opportunity
to access information on this subject of wide public interest..."
In August 2001, the RSPCA followed Uncaged Campaigns' lead and wrote
to the Home Secretary to urge him to establish an independent judicial
inquiry. In June 2002, the RSPCA finally published its own report
which echoed the principle concerns highlighted in the Diaries of
Despair report (available on the RSPCA
website).
^
2. Suffering in transportation
Almost 500 higher primates (captive-bred cynomolgus monkeys and
wild-caught baboons) were transported from holding camps in Kenya,
Philippines and Mauritius to the UK. Many aspects of these journeys,
from the suitability of the foreign facilities through to the size
of the transportation crates and the journey times demonstrate an
unwillingness on the part of the Home Office to (i) enforce regulations
and punish offenders, (ii) minimise animal suffering, (iii) be open
and honest with Parliament and the public when lethal mistakes happen.
The Express reports :
"In one shipment three animals died - probably
from suffocation - in a 35-hour trip from the Philippines."
These deaths were referred to by Mike O'Brien MP, then Parliamentary
Under-Secretary of State at the Home Office, in a Written Answer
on 28 June 2000. One of his statements was this: "International
Air Transport Association [IATA] minimum dimensions were not breached."
This was misleading. Mr O'Brien also mentioned that "all the
dead animals had been in central compartments, which were less well
ventilated." Once again, this reference is economical with
the truth. The IATA stipulates minimum ventilation requirements.
Frustratingly, we cannot be more explicit yet because of the current
injunction.
^
3. Regulation of experimental procedures on animals
At HLS, Imutran transplanted genetically-modified pig hearts and
kidneys into the monkeys and baboons. The two central regulatory
tools in place to control animal experimentation are:
- A ban on "severe suffering". Current guidance
claims that the Secretary of State will not licence procedures
that cause "severe" suffering. The guidance in operation
at the time includes a de facto ban on severe suffering in the
conditions attached to personal licences (#14). Article 8 of the
European Directive 86/609 stipulates: "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."
(emphasis added)
- The cost-benefit assessment, aspects of which include
(according to a Note by the Chief Inspector of the ASPI): "Judgement
on the likely severity of the adverse effects on animals";
"Technical competence of the people and establishments to
be involved in the project"; "Likelihood of 'success'";
""How the data generated will be used"; "Utility
of the product or substance being tested".
The Diaries of Despair report exposes deliberate failures in the
application of this regulatory system, and raises questions about
the ability of the current legal framework to give due consideration,
in practice, to the welfare implications of animal experiments.
^
4. Potentially illegal severe suffering
The impact of the experiments as related by the documents strongly
suggests that the primates experienced severe suffering. One set
of experiments involved the implantation of transgenic piglet hearts
into the necks of wild-caught baboons. (Incredibly, the Home Office
and Imutran decided that these experiments were only of "moderate"
severity.) As the Express reports:
"A baboon which had a pig heart attached to
the blood vessels in its neck was seen holding the transplant
which was 'swollen red' and 'seeping yellow fluid' [both of these
descriptions are verbatim quotes from the Imutran documents] for
most of the last days of its life."
The research involved the use of experimental, high-dose cocktails
of immune-suppressing drugs in an ultimately futile effort to stop
the foreign organ being rejected. When the porcine kidneys started
to fail, the primates' blood became loaded with toxins which are
normally excreted. With their immune systems ravaged by chemicals
and the removal of their spleens, the primates became highly vulnerable
to infections. The documents record how the drugs were implicated
in cancer and internal bleeding in some of the primates. Technicians
observed the animals "quiet", "huddled", "shivering",
"unsteady", "in spasm", "vomiting",
"severe diarrhoea"... This evidence represents the tip
of the iceberg.
An examination of the published papers describing the research
reveals further evidence of horrific suffering:
- "... severe anaemia...",
- "...cervical abscess eroding the internal jugular vein
leading to haemorrhage and collapse of the animal...",
- "...collapsed and died because of bronchopneumonia...",
- "Five animals had to be killed because of gastrointestinal
toxicity, resulting in severe diarrhoea."
The issue here is not only whether the animals experienced severe
pain and distress, but also that such severity was predictable given
the nature of the procedures, and therefore the research should
never even have qualified for a licence under British and European
law.
^
5. The cost/benefit assessment
Apart from the severe suffering caused by the procedures, a great
deal of evidence relating to other factors relevant to the cost-benefit
assessment has come to light in the report, leaked documentation
and other publications. This evidence further undermines the legitimacy
of the research programme on cost/benefit grounds:
- The high technical failure (TF) rates. According to Imutran's
own statements, 25% of the primates died purely as a result of
the trauma of surgery, before the experiment proper could commence.
In one experiment, TF's accounted for 62% of lives. In another
study, 13 out of 22 primates were killed by surgery.
- Failures in the performance of the experiments: At Huntingdon
Life Sciences, hundreds of stipulated readings were not recorded
in error and medicines were left uncapped and unlabelled. A monkey
died because the pig kidney it was about to be transplanted with
was accidentally frozen. Another died after a swab had been left
inside his wound during a transplant procedure. Imutran acknowledged
that it had "severe problems" with the data.
- The lack of success of the research. Despite claiming
in 1995 that human trials of pig hearts were only a year away,
Imutran made very little progress in overcoming the profound immunological
obstacles to xenotransplantation. The documents reveal (as reported
in the Express) that the crisis came to a head at a recent meeting
between Imutran and senior managers at Novartis. An eighteen month
deadline was set for the research to show "substantial"
increases in survival rates. The UK regulator, the UKXIRA, summed
up the progress of xenotransplantation at its public meeting earlier
this year. Transplant surgeon Mr John Dark described the Imutran
research as "leading up a blind alley". Professor of
Immunology Herb Sewell said that he could not foresee clinical
trials of pig organs "within ten years, if at all."
The UKXIRA Annual Report concluded in an understated fashion:
"It seems, therefore, that the likelihood of whole-organ
xenotransplantation (particularly for heart transplantation) being
available within a clinically worthwhile time frame may be starting
to recede." The wording of this significant statement alludes
to progress in the development of safer, more effective and more
ethical treatments for organ failure that either expand the pool
of human donors or treat organ failure with surgical techniques
or artificial/bioengineered organs.
- Public health dangers. Even in the unlikely event that
pig organs could evade rejection and function adequately in the
human body, the danger of transferring novel viruses, such as
porcine endogenous retroviruses, into the human population remains
a real concern. A number of studies have indicated this potential
and, ironically, the attempts to alter the pig organs to avoid
elements of the rejection may also enable viruses contained within
the pig tissue to be similarly shielded. In addition, the experiments
themselves may represent a public health hazard. Transplants appear
to have been mistakenly performed by Papworth surgeons on primates
who were positive for Herpes B, which is classified as a potentially
dangerous pathogen. Imutran received warnings from MAFF and Porton
Down regarding the possible risks to immune-compromised patients
posed by transplant surgeons involved in invasive experiments
on infected monkeys. This incident demands a full investigation.
Not only does it appear that the Inspectorate failed to conduct
an adequate cost/benefit assessment at the outset of the project,
but it also failed to take account of how this speculative research
failed to fulfil the promise initially advertised by Imutran in
1995 (i.e. clinical trials of pig organs within one year): part
of the Inspectorate's role is to make an ongoing assessment of the
costs and benefits of the programme in the light of changing scientific
and ethical thinking.
^
6. Huntingdon Life Sciences (HLS)
The documents also reveal failures at HLS and inadequate Government
regulation of the research centre, culminating in misleading statements
made to Parliament made by Ministers. The 'It's a Dog's Life' scandal,
which resulted in the suspension of HLS' Certificate of Designation,
occurred in the midst of the xenotransplantation research programme.
On hundreds of occasions throughout this programme scientists failed
to take readings and measurements from animals following operations.
The Home Office claimed in September 1997 that HLS had satisfied
16 conditions designed to prevent a recurrence of the brutality
and failures revealed by It's a Dog's Life. This was simply untrue.
To take just a few examples, the documents show that primates were
illegally re-used at Huntingdon Life Sciences. In another serious
incident, a female monkey had to be euthanased the day after she
was given a dose of a drug four times higher than recommended. The
records note that she was shaking and grinding her teeth. Imutran
later wrote to HLS, saying the mistake was 'unacceptable'.
^
7. ASPI: policy, composition and workload
The documents also raise serious concern about the appropriateness
of the relationship between the Home Office Animals (Scientific
Procedures) Inspectorate (ASPI) and those supposedly subject to
regulatory control. One of the most startling aspects of the documents
is the ASPI's cavalier attitude to the regulatory system as a whole
and the Home Office's systematic inaction when licence conditions,
statutory requirements and commitments are breached. Unfortunately,
these aspects were not reported directly in the Daily Express and
thus remain hidden from public scrutiny. However, our ongoing Defence
in Imutran's claim for breach of confidentiality relies on the public
interest in the exposure of these iniquities contained in the documents.
We would not have continued to contest this case if we did not genuinely
believe (a belief backed by legal opinion) that we were both morally
and legally justified in publishing Diaries of Despair and the leaked
documents.
The Diaries of Despair report and primary documentation were made
publicly available because of the improper conduct of the Home Office
that the documents show, and the track record of Home Office bias
and concerns about the impartiality of the ASPI. Clearly, we could
not rely on the Home Office to investigate properly concerns about
its own conduct. Therefore, having taken legal advice and in view
of the public interest in this matter and the evidence of deliberate
Home Office misdemeanours, we perceived the necessity to encourage
informed public debate by publishing the documents, in the expectation
that we could build a wide consensus for the need to investigate
and reform Government policy. Naturally we also submitted the Diaries
of Despair report and documents to both the Home Office and the
Animal Procedures Committee (APC).
The concerns about the Home Office's conduct raised by the documents
have been outlined above, within the constraints of the injunction.
There have been other incidents, however, that have shocked the
animal protection community. Recently, following evidence of breaches
of animal welfare regulations at the Harlan-Hillcrest beagle breeding
establishment, the ASPI conducted a report into the allegations.
In April 2000, the APC discussed the incident and report at its
meeting. The minutes record:
"...it was felt by a majority of members that
the Inspectorate's report left a number of outstanding questions.
Many members felt that that the report sought to exonerate Harlan-Hillcrest,
with the risk of creating the impression that the conditions which
prevailed there were deemed acceptable by the Inspectorate."
This is no surprise to seasoned animal welfare campaigners. It
is significant, however, when a committee where the vast majority
of members are not opposed to animal experimentation makes what
amounts to a direct attack on the integrity of the ASPI.
Concerns regarding impartiality are intensified when one examines
the composition of the ASPI. A Written Answer reveals that 17 out
of the 21 members of the ASPI have been licensed under the 1986
Act - in other words they have been directly involved in animal
experimentation. This does not engender faith in the impartiality
of the ASPI.
There is an inherent problem relating to the conduct of the Inspectorate's
work - apart, that is, from the affinities and mind-set that arise
from the majority of members having previously worked as vivisectors.
It is this: Any breaches or failings identified through undercover
work by campaign groups or by the media frequently amount to de
facto criticisms of the Inspectorate itself for not preventing or
otherwise acting to deal with the problems so identified. Such a
situation creates a clear conflict of interest.
Even if the ASPI was impartial, it would be impossible for it to
regulate animal experimentation effectively. The official workload
assigned of the ASPI is unfeasibly huge. Each year twenty-one
Inspectors (1)
are charged with:
- overseeing over two and a half million "procedures"
at approximately three hundred establishments
- assessing carefully nearly one thousand new project licence
applications, each of which may run to three drafts
as the Inspectorate works to facilitate the approval of a licence
application
- monitoring a further three thousand ongoing projects.
Each of these ongoing projects lasts an average of approximately
four years, and involves a mean of some 690 animals. The monitoring
process must include the crucial cost-benefit assessment, features
of which are:
- Judgement on the likely severity of the adverse effects on animals;
- Standards of care and accommodation;
- Technical competence of the people and establishments to be
involved in the project;
- Relevance of the animal "model" to human condition;
- Likelihood of "success";
- Soundness of experimental design;
- How the data generated will be used;
- Utility of the product or substance being tested;
Even with the best will in the world and a truly impartial approach,
it would be impossible for 21 individuals to carry out these duties
properly. Working from the figures above, it can be calculated that
every year, each Inspector is charged with monitoring and/or assessing
180 project licences. That pans out to about one and a quarter
days per year per project, or about 50 seconds per animal.
No wonder the notion of "stringent legislation" is viewed
as a cynical myth by informed observers. As part of its onerous
duties, the Inspectorate is expected to make visits - some unannounced
- to the Designated Research Establishments where project licences
take place, as well as to Designated Breeding and Supplying Establishments.
Facilities in which experiments take place are often large institutions
with several departments conducting several projects. On average,
each Designated Establishment hosts twelve project licences involving
almost 9,000 animals. Any infringements discovered by the Inspectorate
must be investigated.
No wonder the APC has stated:
"The successful operation of the 1986 Act
depends upon self-regulation by the scientific community, assisted
by the Home Office."
This cannot be consistent with the harmonious line promulgated
by the Government and the animal research industry that claims that
animal experimentation is "strictly regulated". Such a
claim is a deliberate deceit specifically designed to mislead the
public. Whatever one's position on the justifiability of animal
experiments, we should all agree that honesty is necessary for informed
debate. The lack of honesty on the part of the Government is indicative
of the weakness of its policy.
^
8. Home Office response to Diaries of Despair
On 29 September 2000, a week after we had sent the Diaries of Despair
report to the Home Office, we received a response from Mike O'Brien
MP, Home Office Minister. He stated in connection with Huntingdon
Life Sciences:
"... a number of issues are raised in relation
to the establishment's compliance with the conditions of issue
attached to the Certificate of Designation which merit further
consideration and I will ensure that this happens."
But with regard to the central recommendation for the setting up
of an independent judicial inquiry, Mr O'Brien claimed:
"They [the allegations regarding the Home
Office] all relate to administrative or regulatory issues and
my immediate thoughts are that it would be entirely proper for
the Home Office to investigate them subject to certain conditions."
Quite what Mr O'Brien precisely meant by this sentence remains
a mystery 16 months later.
On 2 November 2000, a meeting took place between Mr O'Brien and
Home Office officials, and Uncaged Campaigns together with representatives
from the British Union for the Abolition of Vivisection and Animal
Aid. However, Mr O'Brien had not read the Diaries of Despair report
in preparation and was not keen (or in a position) to discuss the
substantive issues, the meeting was therefore virtually pointless.
Following the meeting with Mr O'Brien, we received a letter from
the Minister on 29 November 2000, timed to coincide with a Written
Answer from the then Home Secretary Jack Straw. Once again, Mr O'Brien
- having apparently discussed the matter with the Home Secretary,
dismissed our recommendation for an independent judicial inquiry
without explanation. Most extraordinarily, Straw and O'Brien retreated
from the position stated in the Written Answer of 2nd November 2000.
Instead of an investigation overseen by the Animal Procedures Committee,
the Ministers revealed that they had:
"asked the Chief Inspector of the Animals
(Scientific Procedures) Inspectorate to carry out a routine assessment
of compliance with the relevant authorities but this will not
amount to a special investigation."
Despite Mr O'Brien's earlier assurance that the concerns regarding
HLS's regulatory compliance would be considered, the Chief Inspector's
review focussed solely on Imutran's compliance. Most importantly,
the review was conducted by - and failed to consider the conduct
of - the Inspectorate itself.
The Home Office's dismissal of legitimate concern in this area
extends even to its own advisory committee, the APC. The Chair of
the APC has been forced to write three times to the Minister in
order to try to extract a justification for the Home Office's refusal
to initiate any form of special investigation. The Committee has
expressed its "surprise" at the Home Office's inadequate
response, particularly given the especially "serious"
nature of the concerns that arise from the leaked documents (see
the annex to the minutes of the APC's February 2001 meeting).
We are also concerned that the Home Office may have sought to obstruct
the APC's deliberations on this matter. The Secretariat to the APC
is supplied by and located in the Home Office. Until April 2001,
the APC Secretariat had informed both ourselves and concerned members
of the public that APC members had seen the full Diaries of Despair
report. Following a direct question on this matter from myself,
it transpired that this had not in fact happened and that the Committee
had not been given access to the most important material - the primary
documentation. Had this situation not been rectified, this would
have severely hindered the APC's ability to scrutinise the matter
properly. The Secretariat has since apologised to me for the "confusion".
It may have been an innocent mistake, but when set in the context
of the Home Office's general approach to such matters, one cannot
help but be suspicious about this incident.
^
9. The Chief Inspector's Report
These are the general conclusions of our response to the Chief
Inspector's report into Imutran's compliance with regulations:
- The Home Secretary's decision to request a report from the Chief
Inspector (henceforth abbreviated to 'CI') with a narrow remit
was unjustifiable. The CI's report intrinsically lacks independence
and thoroughness. Our central criticism in the Diaries of Despair
report (henceforth abbreviated to 'DoD') came about because of
the strong evidence of inadequacies in the Home Office's regulation
of Imutran's research at Huntingdon Life Sciences. This has not
been investigated.
- An investigation must be both independent and powerful enough
to order witnesses to appear and obtain all necessary evidence.
This is why we concluded that an independent judicial inquiry
would be the most appropriate form of inquiry.
- The CI's report itself is unfair and stretches credulity in
several respects. Through its language and its selective and distorted
presentation of information, it seeks to exonerate Imutran, hide
HLS from criticism (by surreptitiously including errors and regulatory
breaches that were the responsibility of HLS in this report) and
unfairly discredit myself and Uncaged Campaigns. The report also
downplays the suffering experienced by the primates. On occasions,
the CI blatantly misrepresents positions and statements in DoD.
- Ironically, the main conclusion that can be confidently drawn
from the CI's report is that the Home Office continues to act
in bad faith and show disregard both for animal welfare and the
regulatory framework it is charged with executing.
A public copy of our response (i.e. with injuncted information
removed) can be located at www.xenodiaries.org/responsetoaspi.htm,
or as a hard copy on request.
We have, however, forced the Chief Inspector to admit that certain
breaches/discrepancies did take place:
- Imutran underestimated journey times (and therefore the likelihood
of animal suffering) when applying for permission to import primates
from Africa and the Far East. This is very significant: in one
particularly lengthy shipment three monkeys died in transit.
- A pig kidney was damaged before transplantation into a primate
due to human error. Despite this, the kidney was transplanted
and, when it failed to function, the surgeons continued with the
procedure - the monkey died on the table. Imutran did not reveal
the problems during the operation to the Home Office. The Chief
Inspector reluctantly admits that the decision to proceed with
the experiment despite the malfunctioning of the kidney was "an
error of judgement."
- Two drug-dosing errors occurred: in one case an animal was given
a quadruple overdose of an immunosuppressant - she died the following
day (the Chief Inspector tries to mitigate this incident by claiming
that evidence "strongly suggests" that the death of
the animal was not due to drug toxicity). In the other incident
a blood sample was taken at the wrong time, thereby hindering
attempts to calculate accurately the correct doses of immunosuppressants.
These mistakes were the responsibility of HLS, yet this fact goes
unreported in the Chief Inspector's review, which supposedly was
restricted to Imutran's compliance with regulations.
- Procedures were undertaken without a relevant personal licence.
- Three monkeys were illegally re-used without permission.
- A required humane endpoint (when monkeys should have been euthanased
as they were dying following pig kidney transplants) was not implemented
in 'several instances', resulting in a further intensification
of primate suffering for "up to 24 hours" according
to the Chief Inspector.
- A swab was left inside a primate during a transplant procedure
that was conducted without adequate staff. The Chief Inspector
claims that neither the mistake nor the lack of proper staffing
were subsequently reported to the Home Office in Imutran's submitted
progress report. (The Express revealed that this had fatal consequences
for the monkey: he died because the swab caused his spleen to
go septic. Typically, the Chief Inspector's report attempts to
conceal the disastrous welfare consequences of this mistake, despite
the fact that some of the information was already in the public
domain (therefore the omission cannot be justified by reference
to confidentiality and the current injunction.)
^
10. Home Office response to breaches and public concerns
In response to representations from concerned MPs and members of
the public, the Home Office has issued a standard letter.
The first point made by the Home Office refers to general objections
to the use of animals in research. However, in the context of Diaries
of Despair, this is irrelevant because the central concern has been
about the implementation of the regulatory framework, rather than
the entire issue of animal experimentation per se - though we hope
that by publishing Diaries of Despair we can contribute to an informed
debate about animal experimentation in general. Thus the Home Office
is deliberately misrepresenting the concerns central to the Diaries
of Despair report.
The Home Office refers to "two newly identified infringements"
that it deems are not worthy of prosecution. The Home Office omits
to mention the nature of these infringements in its communication
with members of the public and MPs. 'One' of those infringements
is, in fact, the failure on "several" (the words of the
Chief Inspector) occasions to put dying primates out of their misery
at the time ordered by the Home Office - in other words additional,
unlicensed suffering of a deeply traumatic nature caused by irreversible
kidney failure. Furthermore, one would imagine that the infliction
of unlicensed severe suffering would attract severe punishment in
a "strict" regulatory system. Instead, the Home Office
claims that the gravest breach of the law possible in this area
does not merit prosecution: instead, they have been "dealt
with by issuing letters of admonition to those responsible".
This astonishingly weak response cannot be consistent with Ministers'
claims that they "are working to ensure that the highest standards
of animal welfare are being implemented."
The Home Office's deceitful and evasive response to the Diaries
of Despair report merely serves to confirm the necessity of an independent
judicial inquiry to examine the Home Office's regulation of Imutran's
xenotransplantation research and its implementation of the Animals
(Scientific Procedures) Act 1986.
(1) The Home Office has recently appointed
a small number of additional Inspectors in response to industry
complaints regarding the time taken to "approve" licence
applications (such comments from the pharmaceutical industry always
use the term "approve" rather than "assess"
which, we think, betrays the "rubber-stamp" practice of
the regulatory system). These additional Inspectors will have the
task of helping industry rather than reducing animal suffering.
In any case, a handful of additional Inspectors comes nowhere near
to fulfilling the basic requirements to enable proper scrutiny and
enforcement of the 1986 Act.
Further reading and information
"Cost/benefit Assessment - a note by the Chief Inspector",
Report of the Animal Procedures Committee 1997, pp. 50-59.
"Animal Tissue into Humans" (aka "The Kennedy Report"),
Department of Health, 1996.
Minutes of Animal Procedures Committee meetings, available via
the APC Secretariat, or at www.apc.gov.uk/reference/minutes.htm
UKXIRA
Third Annual Report - September 1999 - November 2000, Department
of Health.
Guidance on the Operation of the Animals (Scientific Procedures)
Act 1986, Home Office.
About the author
This briefing has been prepared by Dan Lyons, Director of Uncaged
Campaigns and author of the Diaries of Despair report. Mr Lyons
has an honours degree in Politics and Philosophy from the University
of Sheffield, and is currently working towards a PhD on the subject
of the ethical and political theory implications of xenotransplantation.
His speciality is bioethics, and his work has been published in
the Bulletin of Medical Ethics and Medical Law textbooks.
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