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If you were a laboratory rat, and could live anywhere in Europe, you
would do well to choose Switzerland. It enforces strict animal welfare laws
and makes efforts to minimise animal experiments – many Swiss would like
to ban them altogether. But the wise rat should avoid Spain and Greece,
where animal rights are hardly represented in law, to say nothing of much
of Eastern Europe.

The wild variation in conditions and requirements covering experimental
animals and animal testing across Europe is supposed to disappear once the
European Community, and its economic allies, have completed the formation
of the single market. But will the overall scenario for our Euro-rat be
closer to the Spanish or the Swiss version? The European Parliament, European
Commission and member states are currently battling over this question.

At one level, the diversity of Europe’s attitudes to animal welfare
is cultural, and unlikely ever to disappear. Whatever its critics may claim,
the Community cannot legislate moral standards or cultural preferences,
whether they apply to a British sausage or to the animal that died to produce
it.

But the Community can effect change where it is needed to bring about
the single European market, which is meant to ensure that companies in different
member countries compete on equal terms. If one member state’s law limits
imports from elsewhere in the Community, and the member state cannot prove
that this is based on permitted concerns for health or the environment,
then the law has to be changed. In theory, such barriers to trade can include
requirements for animals to be used in the testing of a product, nonrecognition
of another country’s tests, or a set of specific conditions under which
animal tests must be carried out before a product can be sold. Laws on animal
experiments are therefore among those to be ‘harmonised’ by the single market.

Harmonisation is achieved by means of directives written by the Commission
and approved by the Council of Ministers. These must become law in member
states. Legislators in Brussels have paid particular attention to safety
testing, especially for chemicals. Common standards for testing and licensing
products within the Community, the world’s largest and richest trading bloc,
will have an impact beyond it. All European countries, even those who have
not yet applied to join the Community outright, want at least to be able
to trade freely with it. The elimination of duplication in animal testing,
and the abolition of numerous, slightly different tests now required by
separate, national licensing authorities, could drastically reduce the number
of animal tests required across Europe. Moreover, the Community has pledged
to eliminate animal testing whenever alternatives become available. In 1986,
a directive on ‘the protection of animals used for experimental and other
scientific purposes’ called for the smallest possible numbers of animals
to be used for testing, for experiments to cause minimum pain and to be
carried out with species with the ‘lowest degree of neurophysiological sensitivity’,
and for the use of nonanimal methods where possible. The directive also
calls for government regulation of breeding establishments, approval of
experiments and researchers by national authorities, and special authorisation
for experiments involving severe pain. The directive applies to the development
and testing of drugs, foods and other ‘products related to disease or abnormality’,
as well as experiments in environmental protection.

The directive was supposed to have been enacted into national law in
member states by 1988. But this has happened only in Germany, Britain and
the Netherlands. France and Italy are said to be preparing the required
legislation. Spain, Portugal and Greece remain opposed to it, as they are
to numerous regulations that would require them to meet the standards set
by their wealthier northern neighbours. There is little the Commission can
do to enforce such nonenactment of directives.

Meanwhile, the drugs market within the Community remains fragmented,
largely as a result of pressure from the pharmaceuticals industries in Britain,
Germany and France, which have lobbied hardest against the setting up of
a Central European drugs agency. Plans for an agency, and the phased transfer
of licensing responsibilities from national to European authorities, have
been on the Commission’s agenda for several years. They look unlikely to
get any further. As a result, there is much duplication and unnecessary
repetition of animal tests across Europe. Testing is expensive, so the pharmaceuticals
industry has an interest in minimising it to an extent.

But it has more to gain from keeping the European drugs market divided.
Suppose, for example, that regulatory authorities in Italy approve a drug
while Germany does not. As a result, the company sells some of the drug
– and creates a demand for it elsewhere, putting pressure on the more cautious
authorities. A Community authority which included Germans and Italians,
on the other hand, would be more likely to take the approach of the most
cautious of its members, and the company would end up selling nothing in
Europe. For example, since 1990, the French government has permitted the
marketing of the abortion drug RU486, while other European countries have
remained opposed. Sale of RU486 in any European country would probably have
been impossible if approval was at European level.

More pressure for tests?

In some areas, the Community’s efforts to harmonise and centralise procedures
for testing chemicals could lead to more testing. The proliferation of directives,
says Michael Balls of Britain’s Fund for the Replacement of Animals in
Medical Experiments, has increased the pressure for animal tests. One factor
is the growing demand for products that present few risks to people or wildlife.
Another is the need to ensure that European requirements appear stringent
in order to get the approval of all member states. An easy way to do this
is to specify extensive animal testing.

The animal welfare community panicked briefly in 1990, when the European
Commission proposed common regulations for testing ingredients in cosmetics
that would have required the testing or retesting of hundreds of chemicals
that are already in use. Their protests prompted a second proposal last
year which, according to some lobbyists, goes too far in the other direction
and bans animal tests for cosmetic ingredients altogether.

Balls says the proposed cosmetics directive would force manufacturers
of soaps, shampoos and other widely used chemical preparations to use only
older, probably less medically or environmentally safe chemicals, approved
before the ban on animal tests came into force. A new chemical tested on
animals for another purpose would be banned for use in cosmetics simply
because it had been tested – even if it was a safer chemical. This would
also make it pointless for cosmetics manufacturers to continue investing
the considerable amounts they now spend on alternatives to animal tests.

A ban on just cosmetics testing would also save few animals used for
tests, Balls says. Only 4365 animals were used in Europe to test cosmetics
ingredients in 1990, out of the total of 276 674 animals used to test products
other than pharmaceuticals. About 10 times as many animals were used for
pharmaceuticals, bringing the total to 3.2 million.

Balls says that what the Community really needs is a directive aimed
at the prohibition, limiting and phasing out of animal tests, regardless
of what value society places on the product involved. Instead, the European
Parliament has approved the proposed ban on animal tests for cosmetics –
then withdrawn its approval. It is now negotiating with the European Commission
to find a compromise, which might then be further altered by member states.
Amid the politicking by different European institutions, the overall goal
of limiting animal testing might be lost.

Much therefore depends on another Community initiative, the setting
up of a European Centre for the Validation of Alternative Methods to animal
testing, or CEVMA. The Commission will fund and run the centre, and wants
it to primarily tackle the difficult progression from the development of
an alternative test to its ‘acceptance as part of the regulatory testing
system’. But CEVMA has been delayed by France’s refusal to approve any site
for a new European institution until the Community makes Strasbourg the
official home of the European Parliament. Late last year, the Commission
decided to set up CEVMA in the laboratory of the Community’s Joint Research
Centre at Ispra, near Milan in Italy.

The Centre’s effectiveness has been much criticised in recent years.
But Anita Pollack, a British Labour MEP, says the Community desperately
needs to set up the new centre, regardless of where it has to go. ‘We need
a data bank on what experiments are being done where, by whom,’ she says.
Only Britain keeps reliable statistics on how many experimental animals
it uses, although this was one of the requirements of the 1986 directive.
The lack of a central database is one problem which should be solved by
CEVMA.

Europe’s leaders at their summit in Maastricht last December decided
to ‘call upon the European Parliament, the Council and the Commission, as
well as member states, when drafting and implementing Community legislation
on the common agricultural policy, transport, the internal market and research,
to pay full regard to the welfare requirements of animals.’ The declaration,
which was a British initiative, may end up without any practical effect.
So far, there have been no proposals to regulate and limit animal testing
in the Community, apart from the limited measures on cosmetics tests. Such
a proposal will be needed soon, before a plethora of Community directives
and regulations makes any attempt to address animal experimentation on its
own impossible.

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Perilous prospects in the Wild East

As market economies replace Communism in the states of Eastern and Central
Europe, Western companies are starting to take an interest in the opportunities
offered by their well-trained but cheap labour forces. Among the bargains
companies are looking for are less expensive ways of performing the animal
experiments required for safety testing of products in the West.

Countries in Eastern Europe have few rules governing the care of experimental
animals. Poland is now drafting its first law to protect experimental animals,
the World Society for the Protection of Animals reports.

According to Janice Cox of the WSPA, Hungary is the Eastern European
country that has the best conditions for experimental animals. It has no
laws governing animal experiments, but the University of Veterinary Science
in Budapest is trying to ensure that its ethical guidelines are included
in legislation now being drafted. Cox says scientific standards in Hungary
are comparable to those in the West.

Because of these relatively high standards, Western countries and Japan
are already commissioning animal tests in Hungary, to cut costs. This will
mean lower and therefore cheaper standards for housing and feeding the animals,
as the prices charged for the test themselves are comparable to those in
the West. Cox says the Hungarian Toxicological Institute sets its prices,
and its tests, according to norms laid down by the OECD, the club of industrialised
nations based in Paris.

Czechoslovakia has drafted a new animal protection law, based on ethical
guidelines developed by the Academy of Sciences. The Academy has also set
up an ethical committee to vet research proposals and ensure that tests
are not being duplicated. Cox says that this has led to 2 out of 15 proposals
being stopped so far.

The real problem in Czechoslovakia, according to Cox, is that the poor
quality of test animals has led to the need to repeat tests, or to use larger
numbers of animals in each test. Velaz, the country’s largest supplier of
laboratory animals, has been censured for buying in animals from unknown
sources.

The Czech republic, meanwhile, has set up a society for the protection
of laboratory animals, under the Institute of Physiology.

Bulgaria has a large, well-run experimental animal facility in Sofia.
But there is no legal control on animal welfare, even in draft form. Meanwhile
in Romania, the new National League for the Protection of Animals has
vowed to end cruelty to laboratory animals. But ‘it is difficult to see
how they will accomplish this aim,’ says Cox.