Radiol Oncol 2001; 35(4): 303-8. 

Legislation on the protection of experimental animals 

Dragica Ornik and Milan Pogačnik 

1Ministry of Agriculture, Forestry and Food, Veterinary Administration of the Republic of 
Slovenia, Maribor, 2Veterinary Faculty of the University of Ljubljana, Institute of Pathological 
Morphology, Forensic and Administrative Veterinary Medicine, Ljubljana, Slovenia 

The aim of this paper is to establish the current situation in the field of legislation on the protection of experimental 
animals in Slovenia. The protection of experimental animals has been regulated by the provisions 
of the Protection of Animals Act.1 On the basis of this act, the Instructions on Conditions for the Issuing of 
Authorisations for Experiments on Animals for Scientific and Research Purposes2 and the Rules on the 
Ethics Commission for Experiments on Animals 3 have been used. 
The basic protection of experimental animals is provided for by a system of permits for experiments on animals. 
Permits for experiments on animals are granted by the administrative authorities responsible for veterinary 
medicine in cases where experiments are urgently required for medical, veterinary medical, or scientific 
and research purposes and the results are expected to produce important new knowledge, or when 
the suffering of animals is ethically acceptable in comparison with what the experiment is expected to 
achieve; where, in cases of basic research, experimental aims cannot be achieved by any other method or 
procedure, the experiment is performed on the minimum possible number of animals of the lowest neurophysiological 
sensitivity and a method is used that causes the minimum level of suffering, pain or lasting 
harm. Staff involved in the execution of experiments or in the care and nursing of animals, the premises for 
the accommodation or rearing and provision of animals, and the installations and devices used must all comply 
with the set conditions. 
With the adoption of the Act, which has been harmonised with EU regulations, legislation on the protection 
of experimental animals has been put into effect. As laid down by the act1, the implementing regulations will 
lay down the conditions for the issuing of permits for experiments on animals, the procedure, documentation, 
records, reports and responsibilities of experts on the protection of animals, and staff and other conditions 
relating to the execution of experiments and procedures involving animals. 

Key words: animals, laboratory; animal husbandry; animal rights; legislation 

Received 19 October 2001 
Accepted 25 October 2001 

Correspondence to: Dr Dragica Ornik, Dr vet. med., 
Ministry of Agriculture, Forestry and Food, Veterinary 
Administration of the Republic of Slovenia, Maribor 
Unit, Ulica heroja Tomšiča 2, 2000 Maribor, Tel: + 386 
2 22 01 673, Fax: + 386 2 25 26 758, E-mail: 
Dragica.Ornik@gov.si 

This paper was presented at the “Laboratory Animals 
in Biomedical Research” seminar, Ljubljana, 27 
October 2001. 


Ornik D and Pogačnik M / Legislation on the protection of experimental animals 

Introduction 

The above cited parts of the legislation on the 
protection of experimental animals in 
Slovenia have been reviewed. The protection 
of animals used for experimental purposes is 
an increasingly important area. In most developed 
European countries, extensive legislative 
activities in this area began back in 
1986. With the adoption of the Protection of 
Animals Act1 (which came into effect on 18 
December 1999), legislation regulating the 
protection of experimental animals finally entered 
into force in Slovenia. 

The act not only provides protection for 
animals against cruelty but also lays down 
the principles of animal welfare. In the general 
provisions section, the act defines public 
responsibility for the protection of animals 
and their life, health and welfare by stressing 
the following basic principle: “No man shall 
be allowed to cause suffering, illness or death 
to an animal without a well-substantiated 
reason.” 

Data from the legislation in force 
in Slovenia 

The field of protection of experimental animals 
in Slovenia is regulated by the 
Protection of Animals Act1, the Instructions 
on Conditions for the Issuing of Authorisations 
for Experiments on Animals for 
Scientific and Research Purposes2, and the 
Rules on the Ethics Commission for 
Experiments on Animals.3 All animals with a 
developed nerve system that enables them to 
feel painful external influences must be dealt 
with under the terms of this act. The provisions 
of the act must always be taken into 
consideration when working with vertebrate 
animals and, depending on their level of sensitivity, 
with all other animals. There is a special 
chapter in the act: Experiments on 
Animals (Articles 21-24). Basic protection for 

experimental animals is provided for by a system 
of permits for experiments on animals 
which are issued by the administrative authorities, 
competent for veterinary medicine. 

Experiments on animals may only be carried 
out by organisations registered to perform 
experiments on animals and granted 
permission by the Veterinary Administration 
of the Republic of Slovenia (VARS). Any organisation 
performing experiments on vertebrate 
animals must appoint an animal protection 
expert with the appropriate qualifications. 
The expert provides the explanations 
needed in order to obtain approval for 
the experiment and is responsible for ensuring 
that experiments are carried out in compliance 
with the law. 

Permission for an experiment is granted only 
if the experiment is truly necessary, and if: 

• 
the experiment is required for medical, 
veterinary or general, scientific and research 
purposes, it is expected that the results 
will yield new and important findings, 
and it is expected that animal 
suffering will be ethically acceptable in 
comparison with what the experiment is 
expected to achieve; 
• 
it is basic research; 
• 
the goal of the experiment cannot be 
achieved by any other methods and procedures; 
• 
the lowest possible number of animals 
with minimal neuro-physiological sensitivity 
and methods that cause the lowest 
amount of suffering, pain or permanent injury 
are used in the experiment; 
• 
the animal is anaesthetised before the start 
of the experiment, unless the pain caused 
by the experiment is lower than the pain 
caused by anaesthesia or the anaesthetisation 
of the animal is against the purposes 
of the experiment; 
• 
the animal will be properly treated or 
killed after the experiment is completed, if 
suffering cannot be prevented; 
Radiol Oncol 2001; 35(4): 303-8. 


Ornik D and Pogačnik M / Legislation on the protection of experimental animals 

• 
the persons who carry out experiments or 
take part in them and the persons who 
take care of the animals, including duties 
of a supervisory nature, have attained the 
appropriate level of education; 
• 
the animals used in the experiment come 
from well-organised and registered breeding 
establishments; in exceptional cases, 
when the experiment is necessary for the 
preservation of an animal species and the 
animal is the only one suitable for the experiment 
or when it cannot be bred, the 
competent authority may issue permission 
for the experiment in compliance with the 
Regulation on the Protection of Endangered 
Animal Species.4 Experiments on 
equine animals, bi-ungulates, dogs or cats 
may only be performed when it is not possible 
to achieve the envisaged aim by experimenting 
on other animals.2 
A special permit from VARS is required 
for each individual experiment. The person 
who will conduct the experiment must have 
the proper qualifications.1 Only persons with 
adequate qualifications in veterinary and human 
medicine, biology and animal husbandry 
may perform experiments on animals.2 An 
authorisation is not necessary for experiments 
that have been prescribed by a legal act 
or ordered by a court of law or a competent 
inspector on the basis of a legal act, or in the 
execution of vaccinations or diagnostic investigations, 
the collection of blood or other material, 
or the detection of injuries and diseases.
1 The performance of experiments on 
animals in order to test chemical agents used 
in war, cosmetic preparations, alcohol or tobacco 
products, or of experiments in which 
muscle-paralysing agents are used and performed 
without the use of anaesthesia are 
prohibited.1 Surgical operations for educational 
purposes which cause suffering and 
harm to or even the death of the animal are also 
prohibited. These can be performed only 
exceptionally by university or scientific and 

research institutions in cases where they are 
necessary in the course of the regular training 
of doctors of human or veterinary medicine, 
biologists or pharmacists, and where their objective 
cannot be achieved by any other 
means of training (films, photographs, models, 
etc).1,2 

The Rules on the Ethics Commission for 
Experiments on Animals lay down the procedure 
of examining and processing opinions 
on the necessity of a certain experiment in order 
to grant permission to carry it out on an 
animal.3 The rules lay down in detail the 
composition, tasks, competence and method 
of work of the ethics commission for experiments 
on animals. 

Immediate inspection and control of the 
implementation of the law and other regulations 
and international agreements on the 
protection of animals against suffering is carried 
out by veterinary inspection and control 
services. The Veterinary Practice Act5 and 
the Protection of Animals Act1 define the 
competence of the veterinary inspection and 
control service to order measures to protect 
animals against suffering, and the penalties 
for violations of the legislation. A veterinary 
inspector has the right and duty to prohibit 
the performance of any procedures on animals 
which are not permitted or which violate 
the provisions of the Protection of 
Animals Act, order such experiments to be 
discontinued, or prohibit the carrying-out of 
experiments on animals which are carried 
out in violation of the provisions of the act, 
or when any existing deficiencies have not 
been eliminated by the prescribed deadline. 
The performance of experiments on animals 
in violation of the regulations is punishable 
by a fine under the Protection of Animals 
Act1 and, when premeditated, is considered 
as having caused suffering to the animal in 
question, which as such is punishable under 
the Penal Code.6 The penalty envisaged for 
such an offence is a prison sentence of up to 
three months. 

Radiol Oncol 2001; 35(4): 303-8. 


Ornik D and Pogačnik M / Legislation on the protection of experimental animals 

A fine of between SIT 100,000 and 150,000 
under the act1 is imposed on an individual 
carrying out an experiment on animals in violation 
of Article 21 of the Act (without permission 
and in an organisation that has not 
been registered for such an activity) or when 
experimenting on animals in violation of 
Article 22 of the act (procedures for educational 
purposes without an approval). A fine 
of between SIT 150,000 and 10 million is imposed 
on a legal entity for the same violation. 

A fine of between SIT 150,000 and 10 million 
is imposed on an individual who conducts 
painful procedures on vertebrate animals 
without the use of appropriate 
anaesthesia or when conducting experiments 
on vertebrate animals in violation of Article 
23 of the Act (when the organisation in question 
fails to appoint an expert on the protection 
of animals). A fine of between SIT 25,000 
and 500,000 is imposed on the responsible 
person of the legal entity which committed 
such a violation. 

Discussion 

There is direct and indirect links between animals 
and human beings – they are of vital 
importance to us. We should never forget 
that animals are living creatures with senses 
and are capable of expressing their feelings. 
We should handle them in a humane manner 
and with a due level of responsibility. Well-
regulated legislation is of great importance 
for animal protection. Major progress at the 
international level in the legal regulation of 
the protection of experimental animals was 
made in the 1980s. An important turning 
point was the 1986 Convention of the Council 
of Europe on the Protection of Animals Used 
for Experimental and Other Scientific 
Purposes.7 A contribution towards increased 
protection for experimental animals was also 
made by the European Union (then the 
European Economic Community) with the 

adoption of Directive 86/609/EEC8, which is 
essence does not differ from the European 
Convention. The objective of the Directive 
and of the European Convention is to ensure 
that the provisions on the protection of experimental 
animals are harmonised in the national 
legislation of the member states. The 
European Convention7 and the European 
Union Directive8 define in different chapters 
the essential principles of use of animals in 
experiments and the conditions for rearing 
and accommodating the animals, with the 
minimum recommended housing areas for 
individual animal species and the micro-climatic 
conditions. By incorporating the proposed 
standards, any departures from the 
norm will be eliminated; by prescribing conditions 
for the rearing, accommodation and 
use of animals in experiments, measures for 
the protection of experimental animals will 
be made uniform. Most importantly, by 
granting mutual recognition to the test results 
of experiments performed on animals, the 
unnecessary duplication of experiments will 
be prevented. 

Slovenia is undergoing accelerated legislative 
activities to protect experimental animals. 
Experiments on animals carried out for 
scientific and research purposes have been 
regulated and subject to restrictions in 
Slovenia since 1985, when the Instructions on 
Conditions for Granting Authorisations for 
Experiments on Animals for Scientific and 
Research Purposes were issued.2 These instructions 
include certain provisions that 
were laid down later on by the European 
Convention 7 and EU Directive.8 According to 
the instructions, any organisation intending 
to use animals in experiments that cause 
pain, suffering or lasting harm must obtain 
the approval of the competent administrative 
authority, provide conditions in which such 
experiments may be carried out, restrict the 
use of domestic animals in experiments and 
for educational purposes, and keep a protocol 
of the experiment and a report on the experi-

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Ornik D and Pogačnik M / Legislation on the protection of experimental animals 

ment by the person in charge of it. A drawback 
to these instructions was that the penalties 
they prescribed were low and the execution 
of inspection and control ineffective. 

By adopting the Protection of Animals 
Act1, progress has been made in regulation of 
the protection of experimental animals. The 
act includes some of the basic provisions of 
EU Directive 86/609/EEC8 as follows: 

• 
Experiments on vertebrate animals may be 
performed only when it is anticipated that 
the suffering of the animal will be ethically 
acceptable in the light of the envisaged 
results. 
• 
Experiments on animals may only be performed 
by organisations registered to carry 
out experiments on animals and duly 
authorised by the competent administrative 
authority. 
• 
Experimental animals may only originate 
from an organised and registered rearing 
establishment for the rearing of experimental 
animals; 
• 
The person carrying out the experiments 
shall have appropriate professional qualifications. 
• 
The person carrying out the experiments 
shall keep records on the number and 
species of animals used and the type of experiment, 
and notify the competent administrative 
authority thereof. 
Slovenia has the Rules on the Protection of 
Experimental Animals, which transpose all 
other provisions of the EU Directive.8 The 
rules lay down the detailed conditions for 
granting permits to carry out experiments on 
animals, the procedure, documentation, 
records, reports and obligations of professionals 
relating to the protection of animals, 
staff and other conditions for the execution of 
experiments, and the procedures relating to 
the use of animals in experiments. The rules 
lay down detailed conditions regarding the 
establishments involved in the rearing, supply 
and use of animals in experiments, and 
the premises, equipment and staffing thereof. 

The rules include provisions concerning the 
planning of experiments under consideration 
of the 3R concept (1R – replacement, or replacement 
of a planned method with another; 
2R – reduction, or selection of an experiment 
that requires fewer animals; 3R – refinement, 
or the conducting of an experiment to perfection 
so as to guarantee its success) and the 
use of alternative methods. The EU Directive8 
and the draft rules include the 3R concept in 
the following provisions: 

• 
An experiment may not be repeated when 
any other scientifically satisfactory method 
is available that enables attainment of 
the envisaged result and does not require 
the use of animals. 
• 
When an experiment is urgently necessary, 
the selection of animal species must 
be carefully studied. An experiment must 
be chosen which requires the minimum 
number of animals, and animals with the 
minimum neuro-physiological sensitivity, 
which causes the minimum pain, suffering, 
stress and lasting harm, and which in 
all probability will give satisfactory results. 
• 
All experiments must be planned so as to 
avoid stress, avoidable pain and suffering 
on the part of experimental animals. 
• 
Experiments causing lasting pain to animals 
are subject to a special application to 
the competent authority and their use 
must be justified. 
Efforts have been made in Slovenia to ratify 
the European Convention for the Protection 
of Vertebrate Animals Used for Experimental 
and Other Scientific Purposes (ETS 
123).7 

Data on the use of experimental animals in 
European countries (including Slovenia) 
shows a decline in the use of animals in experiments. 
The annual number of experimental 
animals used in Slovenia in the past three 
years has totalled approximately 22,000 (in 
1996 it was still 30,000, and between 1993 
and 1995 it was 33,000). Most of the experi-

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Ornik D and Pogačnik M / Legislation on the protection of experimental animals 

ments are carried out on laboratory rodents 
by the chemical and pharmaceutical industries 
for substance testing in compliance with 
applicable legislation, regulations and international 
agreements. Institutes and laboratories 
of the faculties of medicine, veterinary 
medicine, biology, zootechnics and physiology 
use animals for basic research or scientific 
and research activities; these account for 
nearly one fifth of all experimental animals 
used. To a lesser extent, animals are also used 
in the diagnosis of disease and for education 
and training purposes. An important role in 
reducing the number of experimental animals 
is played by the applicable legislation, the replacement 
of animals with alternative methods 
(and a legal requirement to do so), the required 
permits for conducting experiments, 
ongoing staff training, successful co-operation 
between research institutions and researchers 
at national and international levels, 
active associations and societies, and increased 
responsibilities of the commissions 
for the protection of animals. 

References 

1. 
Zakon o zaščiti živali (Protection of Animals Act); 
(ZZZiv). Uradni List RS (Official Gazette of the 
Republic of Slovenia) 1999; 98 (9):14645-53. 
2. 
Navodilo o pogojih za izdajo dovoljenja za 
poskuse na živalih v znanstveno-raziskovalne 
namene (Instructions on Conditions for the 
Issuing of Authorisations for Experiments on 
Animals for Scientific and Research Purposes). 
Uradni List RS 1985; 41 (40): 2030-1. 
3. 
Pravilnik o etični komisiji za poskuse na živalih 
(Rules on the Ethics Commission for Experiments 
on Animals). Uradni List RS 2000; 10 (84): 9958-9 
4. 
Uredba o zavarovanju ogroženih živalskih vrst 
(Regulation on the Protection of Endangered 
Animal Species). Uradni List RS 1993; 3 (57): 28514. 
5. 
Zakon o veterinarstvu (Veterinary Practice Act). 
Uradni List RS 2001; 11(33): 3673-93. 
6. 
Kazenski zakonik (Penal Code). Uradni List RS 
1994; 4(63): 3455-503. 
7. 
European Convention for the Protection of 
Vertebrate Animals Used for Experimental and 
Other Scientific Purposes (ETS 123). Strasbourg: 
Council of Europe, 1986. 
8. 
EEC. Council Directive 86/609/EEC of 24 
November 1986 on the approximation of laws, 
regulations and administrative provisions of the 
Member States regarding the protection of animals 
used for experimental and other scientific 
purposes. Off J EEC 1986; 29(L 358): 1-28. 
Radiol Oncol 2001; 35(4): 303-8.