Establishing Legal Restrictions and
the Need for Acquiring Actual
Situations
in Japan
6th World Congress on Alternatives & Animal Use
in the Life Sciences
Special Symposium - Dialogue with Citizens - 25 Aug. 2007
Asako Araki
ALIVE
1. For the Advancement of Alternatives to Animal Experiments
2. Alternatives : Researchers and Citizens
We are not scientists or experts on science. We are just ordinary
citizens whose wish is to end the suffering of animals.
We see two standpoints when we say “alternatives to animal
experiments”.
One is from the scientific research point of view. In scientific
research animals are merely subject of research, a “thing”,
where a part of it is taken out and data is gathered, analyzed,
put into statistics, have some kind of conclusion drawn, written
in a paper and published. In this process, researchers can try to
reduce the number of animals used in their experiments. Or they
can try to reduce the stress, pain, and suffering of the animals.
They may also think of replacing vertebrates with other subjects.
This is the idea of alternatives, or 3R, from the scientific research
point of view.
On the other hand, the alternatives that we citizens can practice
differ from those of the researchers. For example, when we hear
that animals are being poisoned to check the toxicity of a certain
chemical substance, we try to choose products that don’t require
these tests. This means using natural products whose safety have
been proven by years of long use. When we find out that a tremendous
number of animals are experimented on pharmaceuticals, we change
our views on health and sickness. We try to get treatment in alternative
medicine, that is, medicine not dependent on animal experiments.
Furthermore, we look for ways to stay healthy and fit, focusing
on preventive medicine. These changes in our lifestyle are all alternatives
that we citizens can choose and practice.
Today the theme of this symposium is for us citizens to ask researchers
and scientists for further advancement in the use of alternatives.
We therefore would like to make a few suggestions on how this could
be done.
3. 3R and Social Consensus
People conducting animal experiments insist that animal experiments
are necessary in medical and scientific research, while citizens
feel sorry for the animals and ask for dignified respect for life.
These two standpoints often come into conflict with each other,
sometimes leading to serious arguments. We can say that the 3R in
animal experiments are a result of both parties trying to settle
the matter.
4. 3R in Animal Welfare Law
The Japanese had been using traditional medicine before modern
western medicine took over 100 years ago. Along with modern medicine,
the method of animal experimenting was also introduced. Since then,
without any grasp of the actual situation or legal restrictions,
and without ever being debated whether or not the method was right
or wrong, animal experimenting has been conducted to date.
In present Japan there is no knowing who is conducting what kind
of animal experiment using how many and what kind of animals and
where it is being conducted. There is no system to grasp the actual
situation.
For years, we have been taking action towards the Japanese government
for legal restrictions on animal experiments and finally, Animal
Welfare Law was revised in 2005, incorporating the principles of
the 3R.
Although it states in the law that it is obligatory for those performing
animal experiments the refinement, or reduction of pain and distress,
unfortunately, there is no system to supervise this. As for the
reduction of animals and replacement to other non-animal methods,
they are merely stated as an “effort”.
Ministry of the Environment has set standards for animals used
in experiments in Standards Relating to the Care and Management
of Laboratory Animals and Relief of Pain, but with no tools enforce
them. Ministry Of Education, Culture, Sports, Science and Technology
and Ministry of Health, Labor and Welfare both have set relevant
guidelines, but with no practical effect.
ALIVE is in the process of making disclosure claims to state run
research institutions conducting animal experiments. Surprisingly,
many of the institutions were not even aware of the guidelines.
5. Articles Necessary in the Revision of the Current Standards
Although there are standards and guidelines for animal experiments,
there are no ways or systems to see that they are being followed.
This is the current situation in Japan.
That is why we are asking for a registration system of all institutions
conducting animal experiments. Furthermore, we think that it is
necessary for on-the-spot inspection by the authorities to check
that the law and standards are being followed.
And then there is the problem of pet shops and animal breeders
selling the animals on the “black market” for use in
animal experiments.
There is also the fear of wild monkeys being illegally used in
animal experiments. In order to assure worried citizens that these
acts will not be the case, we believe that breeders of laboratory
animals should be registered as well.
In Animal Welfare Law, it is stated that it is the obligation
of those performing animal experiments to reduce pain and distress
of the animals, but there are no ways in which to check that this
is being followed and we think that this is a big problem. It should
be at least documented and submitted for review.
6. What 3R Can Achieve
The 3R cannot do away with all animal experiments in the present
situation, but there are places where it can make a difference.
First of all, in the field of education. Animals should not be
hurt or killed in order to convey facts already known. This goes
for learning techniques in medicine as well. Animal experiments
for the sole purpose of writing graduation thesis should also not
be performed.
Avoiding redundancies in experiments is another. Regardless of
the outcome, all experiments should be made public and accumulated
onto a data base. By doing this, unnecessary experiments can be
avoided.
At this World Congress various active measures are being taken in
the field of toxicology. This is not just animal friendly but has
proven to be extremely efficient.
7. Advancement of 3R
To actually further advance the 3R there is a need for a new system.
But researchers and scientists and those others conducting animal
experiments claim that instead of a new system, the traditional
“voluntary effort” is enough. “Voluntary effort”
here, meaning self-inspection and self-review. But we all know that
buildup and fanfare do not move forward a plan. There needs to be
some kind of external pressure to guarantee real results.
Setting numerical targets can be an incentive in getting results.
We can say, ”Compared to he traditional method of experimenting
where * number of animals have been used, the method employing alternatives
enables a reduction of *% in the number of animals being used.”
In other words, setting a realistic goal and carrying it out.
And it is also necessary to review whether or not the target has
been reached, and how effective the alternatives had been.
In order to materialize this plan there is a need for an alternative
validation system. There will be a strong public support for a system
of this kind. Public support means a “yes” for using
the taxpayers’ money. A highly supported project will receive
larger financial aid from the government.
And of course, giving legal base for this system is more than
desirable.
8. Reviewing Animal Welfare
In the Animal Welfare Law it states that all animals bred, pets
and laboratory animals and farm factory animals included, should
be handled appropriately. To ensure conditions are in accordance
with this law and for the advancement of the welfare of animals,
there needs to be in place a reviewing system by a third party.
The following items should be included in the Animal Experiment
Protocol.
- Selection of laboratory animals – Why a certain breed
of animal was selected and why a certain number of animals are
used should be closely examined by a reviewing committee including
a well-informed outsider.
- Acquirement of the laboratory animals and maintenance condition
– Confirmation of legal acquirement of the animals, not
by an illegal breeder, and confirmation that the animals’
living conditions are in accordance with the welfare of the animals
should be verified by a third party committee.
- A close examination on how pain and distress of the laboratory
animals can be reduced or avoided.
- The disposal method of the dead animals should be documented
from the environmental pollution point of view, not to mention
euthanasia.
Most importantly, the Animal Experiment Protocol should be reviewed
not only by insiders and not just as a formality, but by a third
party and by the public. Finally, the Animal Experiment Protocol
should be disclosed to the public.
9. Setting Numerical Target
Setting a numerical target is undoubtedly one certain way of advancing
the 3R. We are asking for concrete results, not just words.
As for “Reduction of Pain and Distress” there are
currently 4 levels of evaluating the animals’ pain and distress,
but there should be a more detailed evaluation specifying the pain
and distress a certain action towards the animal would cause.
Maintenance of the animals, or living conditions, should also
be a subject to evaluation on the basis of the five principles of
animal welfare(five freedoms), that is, sufficient supply of food
and water, comfortable and sanitary living space, treatment for
diseases and injuries, no infliction of unnecessary fear, agony
or anguish, and adequate space in consideration of the animals’
natural behavior.
In regard to “Reduction of Number of Animals” a concrete
number of the actual reduction in the number of animals used should
be shown, as in the case of LD50 tests where we saw a great decrease
in the number of animals used by employing alternative methods.
Concerning “Replacement of Animal Experiments”, unmistakably
the core for alternatives, there is much room for research and development.
The potentials of alternatives in the different areas and potential
alternatives should be explored. Active funding for the research
is crucial on the side of the policy-makers.
10. 3R Assessment Committee
In the current research system once an experiment is performed,
it is difficult to trace which experiment was presented with what
specific results, let alone in what form the experiment was returned
to society.
We therefore propose for the advancement of the 3R the setting of
numerical target and forming a third party organization to assess
the achievement of the target. The organization should be composed
of members with knowledgeable people from a wide variety of fields,
including members representing the citizens.
This assessment committee should not only disclose results of
the assessment but also contribute opinions to scientific journals
and have the authority to comment on funding applications. The committee
shall play an important role in the advancement of the 3R.
11. Funding System for Alternatives
One reason for the slow progress in alternatives research in Japan
is that alternatives are not acknowledged and the importance not
sufficiently understood by the people. We must explain to the public
in clear form that the use of alternatives can reduce the animals’
suffering and at the same time, cut costs.
It is difficult to imagine anyone disagreeing to this.
With the public assent we can expect more funding from the government
for alternatives research, and contribution from private institutions
and individuals.
12. 3R Advancement Plan
In order for the 3R to be put into practice without fail, we must
establish a concrete action plan. EU’s restrictions on chemical
substance, or REACH, which came into effect this June are a set
of regulations concerning registration, evaluation, licensing, and
restriction of chemical substances. It is said that it was originally
drafted to reduce the use of animals in experiments by actively
employing alternative methods. It is predicted that for the first
eleven years after REACH takes into effect, we will see an estimated
3% increase in animal experimentation in the EU, but after that
period, having sufficiently covered all problems concerning the
30,000 chemical substances used today, the number of experiments
conducted will decrease dramatically, with only a few new substances
to be tested yearly.
Ministry
of the Environment information on REACH
http://www.env.go.jp/chemi/reach/reach.html
In order to make a valid prediction as mentioned above, there
needs to be a clear understanding of the present level.
But unfortunately in Japan, there is no knowing at which institution,
what kind of animal experiments are being conducted using what kind
of animals, and how many. We do not have a clue to even the most
basic facts about these experiments. In this current situation,
even if the 3R were to be advanced, there are no ways to compare
or evaluate their effectiveness.
If animal experiments must be conducted, and if the lives of these
animals are precious and noble as scientists and researchers claim
them to be, then they should be treated accordingly, by taking accurate
record of the animal experiments performed and having them assessed
by a third party. Not a single life should be wasted. An animal
experiment not returned to the people in any form should immediately
be put a stop to.
In Japan now, a new system of evaluating achievements are being
introduced to administrative agencies, research institutions, and
private corporations. Animal experimentation shouldn’t be
an exception. We must not let insiders continue to evaluate each
other out of formality. As with the rest of the society, the traditional
system should be changed to a system where citizens and residents
can participate.
13. Legal Restrictions and Promotion of Public Interest
In Japan we do not have any laws or regulations to restrict animal
experiments and now is the time for one.
We must first grasp the actual situation by registering those conducting
animal experiments and facilities and institutions where they are
being performed.
We have many large-scale earthquakes every year here in Japan.
There is always the possibility of an animal experiment facility
being damaged or destroyed. From the crisis management point of
view, a better understanding of the current situation is crucial.
Without this information speedy measures cannot be taken
Having legal restrictions can also ensure procedural efficiency
and transparency of the whole process. The effectiveness to research
cost would become visible and assessable. Having a legal basis for
saving animal lives and cutting cost will be the driving force for
the advancement of the 3R.
Furthermore, a larger social recognition towards animal sacrifice
will lead to enrichment in financial aid and support in manpower
for alternative research.
14. Many people are saddened by animal experiments.
We believe that a social consciousness towards animal experiments
will lead to a better understanding of and support for alternatives.
We hope for researchers and scientists and citizens to all get
together and have a thorough discussion on what we can and should
do.
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