Survey of European legislation

Jorgos Sbokos, Dr iuris, private lecturer UoC

Constitutional Balancing between rights

EU Treaties

ethical

pragmatic

legal

Lab animals Directive

Cosmetics Directive

National constitutions & legislations

VICE Interview March 25, 2013 (http://www.vice.com/en_dk/read/talking-animal-testing)

Animal research at the University of Sydney

Journalist Pharmacologist

So what have you been working on recently?

The last study used 16 rats. We were working with venom peptides … investigating how their individual neurotoxins can cut off certain pain. To do this we induced pain in rats by surgically attaching a ligature to … a big nerve that runs down their legs. The rats then developed mild pain, … and we administered the venom peptides to see if we could divert that pain.

Why use rats instead of computers?

Because you can’t study pain without animals. When you’re in pain there are several changes occurring to your nervous system and we don’t fully know what those change are. We just can’t use computer modelling because it won’t even come close to the complexity of what we’ll see in the animal model.

Do you think animals perceive pain in the same way humans

do?

I think some animals do. I think primates perceive pain

in a more psycho-social sense where they actually feel depressed and want to

be alone. I think other animals don’t.

And just to be clear on this, after each experiment you euthanise all the

animals?Yes, we euthanise, or sacrifice the animals at the end of each experiment. In the experiments that I do we need to use their tissue so I can’t pull bits of an

animal’s central nervous system and then sew it back up. It’s not

going to live after that.

Public law – experiments

The use of laboratory animals sets a new field of application for public law

Questions application of constitutional rights (intrinsic animal rights, life, health, scientific freedom, protection against biomedical interventions

Tests the effectiveness of administrative law enforcement.

Constitutional protection

Swiss Constitution

Article 80: established the mandate for federal legislation on animal welfare to cover :

animal keeping animal care animal experimentation

German Constitution

Article 20a: The state takes responsibility for protecting the natural foundations of life and animals in the interest of future generations.

Legal protection

Swedish Laws

Animal Protection: exempted all great apes and nine species of Gibbons from research procedures

Finnish laws

Animal Welfare Act of Ministry of Agriculture and Forestry (247/1996)

Decree on Animal Experimentation of 20 December 1985 (1076/1985)

Finnish constitution

Section 20 Responsibility for the environment

(1) Nature and its biodiversity, the environment and the national heritage are the responsibility of everyone.

(2) The public authorities shall endeavour to guarantee for everyone the right to a healthy environment and for everyone the possibility to influence the decisions that concern their own living environment.

Dutch laws

The Dutch Animals Act from 19 May 2011 protect animal welfare and prohibit cruelty towards animals.

Dutch constitution

Article 21 This article imposes a duty on

government to ensure the habitability of the land — including the general infrastructure and especially the vital sea-defences — and the protection and improvement of the environment.

Greek Laws

Art. 6 of the Greek Ministerial Desicion (ΥΑ 132979/2005), bans the marketing of cosmetics (end products) and cosmetic ingredients used animals for testing.

Law1197/1981 (animal experiments allowed only to graduates of the Medicine Faculty or the Faculties of Biological Sciences)

PD 160/1991 (Directive 86/609/EEC)

Greek Constitution

Art 24: The State is bound to adopt special preventive or repressive measures for the preservation of the environment in the context of the principle of sustainable development.

1948 OEEC

1949 COUNCIL

OF EUROPE

1951 EUROPEAN

COAL & STEEL

COMMUNITY

1957 EUROPEANECONOMIC

COMMUNITY

1986 TREATY OF

ROME REVISION

Economic and social cohesion

Research and technological development

Environment

1986 TREATY OF

ROME REVISION

1986 TREATY OF

ROME REVISION

1992 MAASTRICHT

TREATY

1997 AMSTERDAM

TREATY

2001 NICE TREATY

2009 LISBON TREATY

2009 LISBON TREATY

Article 13

"In formulating and implementing the Union's agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage."

"In formulating and implementing the Union's agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage."

"In formulating and implementing the Union's agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage."

Article 3 EU Treaty:

protecting and improving the quality of the environment.

2009 LISBON TREATY

Article 3 EU Treaty:

protecting and improving the quality of the environment.

2009 LISBON TREATY

2009 LISBON TREATY

Article 114 Treaty on the Functioning of the EU:

par 3. The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective.

2009 LISBON TREATY

Article 114 Treaty on the Functioning of the EU:

par 3. The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective.

2009 LISBON TREATY

Article 191 Treaty on the Functioning of the EU:

- preserving, protecting and improving the quality of the environment

- protecting human health

- rational utilization of natural resources,

- promotion at international level, measures to deal with regional or worldwide environmental problems, and in particular combating climate change.

Article 191 Treaty on the Functioning of EU:

- preserving, protecting and improving the quality of the environment

- protecting human health

- rational utilization of natural resources,

- promotion at international level, measures to deal with regional or worldwide environmental problems, and in particular combating climate change. 2009

LISBON TREATY

- protecting the environment

- protecting human health

2009 LISBON TREATY

- protecting the environment

- protecting human health

environment

human health

Welfare of animals

fauna

embiotic

environment

human health

Welfare of animals

fauna

embiotic

environment

development or production of new medicines

physiological studies

studying environmental effects

testing of chemicals or new food additives

human health

Welfare of animals

development or production of new medicines

physiological studies studying

environmental effects testing of chemicals

or new food additives

Conflict:

Animal rights conflict with fundamental laws, such as scientific and educational

freedom

Constitutionally permissible intervention

Constitutionally permissible intervention

Personal suitability of the breeder, supplier, user (scientific/moral way)

Interventions may be justified if they are necessary to safeguard an important good

Interventions are only permitted to prevent serious and provable dangers for a supremely important good (e.g. Public Health, Right to Life).

Welfare

development or production of new

use for

scientific or

educational purposes

additives

Welfare

development or production of new

cosmeticsadditives

excursus

Cosmetics Directive

76/768/EEC

On the approximation of the laws of the Member States relating to

cosmetic products

Corrected by 11

Commission regulations

Ammendedby 69

Commission Directives

Cosmetics Directive

In early 2003 the Directive provided an immediate end to animal testing in the EU for cosmetic products and a complete ban of animal testing for cosmetic ingredients by the 11th of March 2009.

The only exception related to animal testing for the more complex toxicological endpoints such as repeated dose toxicity, reproductive toxicity and oxicokinetics, for which the deadline was set to 11 March 2013.

Cosmetics Directive

Between 2003 and 2010 the European Commission funded research programmes in the area of alternatives in the region of 150 million €.

In 2011, the Commission called the stakeholders to review the situation regarding the technical difficulties in complying with the 2013 ban. It has being decided that another 4–8 years need to be realistically added to the time estimates for the research and development efforts before regulatory risk assessment would become feasible without any animal

experiments.

EURL

EVCAM

European Union Reference Laboratory (2011)

increasing need for new methods to be developed and proposed for validation

each breeder, supplier and user should maintain accurate records reports

objective information concerning projects using live animals should be publicly available

excursusend

Welfare

development or production of new

cosmeticsadditives

Article 4a of Directive 76/768/EC bans the marketing of cosmetics (end products) and cosmetic ingredients used animals for testing.

Article 4a of Directive 76/768/EC bans the marketing of cosmetics (end products) and cosmetic ingredients used animals for testing.

the production of cosmetics?

Directive 2010/63/EU on the protection of animals used

for scientific purposes

Apermissible intervention

use of animals

Three R’s

use of animals

Replace

Reduce

Refine

Three R’s

Replace

Principally try to use an alternative method for experimenting

Replace

= a scientifically satisfactory method or testing strategy, not entailing the use of live animals

ReduceWhere no alternative method is recognised by the legislation of the Union, the numbers of animals used may be reduced

Reduce= the number of animals used in projects is reduced to a minimum

Refine

Ensure refinement of breeding, accommodation and care, and of methods used in procedures

Refine

= perform experiments with tissues, cells or biological molecules outside their normal biological context (test tube experiments)

In vitro

Refine

= eliminate or reduce to the minimum any possible pain, suffering, distress or lasting harm to the animals

In vivo

In vitro In vivo

Refine

In vitro In vivo

Refine

Bintervention conditions

Art. 1 par. 6 of the 2010/63/EU Directive This Directive shall apply without

prejudice to Council Directive 76/768/EEC of 27 July 1976

Experimental Procedure ‘procedure’ means any use, invasive or

non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.

Experimental Procedure ‘procedure’ means any use, invasive or

non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.

Research Drug safety Food safety Human welfare Animal welfare Vocational skills (praktika) Forensic inquieries (criminal investigations)

Purposes for invasive uses on animals

Prohibitions

Prohibition for endangered species Exceptional use of non-human primates Prohibition for captured animals Prohibition for stray and feral animals of

domestic species

Special provisions

Three R’s Anaesthesia End of procedure (veterinarian advice) Authorisation – Registration (breeders,

suppliers, users) Animal records

Reuse

Reuse requirements

(a)

the actual severity of the previous procedures was ‘mild’ or ‘moderate’;

(b)

it is demonstrated that the animal’s general state of health and well-being has been fully restored;

(c)

the further procedure is classified as ‘mild’, ‘moderate’ or ‘non-recovery ’

Non recovery

Mild

Moderate

Severe

Classification of severity of procedures

Classification of severity of procedures Non-recovery: Procedures which are performed entirely

under general anaesthesia from which the animal shall not recover consciousness shall be classified as ‘non-recovery’.

Classification of severity of procedures Non-recovery: Procedures which are performed entirely

under general anaesthesia from which the animal shall not recover consciousness shall be classified as ‘non-recovery’.

Classification of severity of procedures

Mild: Procedures on animals as a result of which

the animals are likely to experience short-term mild pain, suffering or distress, as well as procedures with no significant impairment of the well-being or general condition of the animals shall be classified as ‘mild’.

Classification of severity of procedures

Mild: Procedures on animals as a result of which

the animals are likely to experience short-term mild pain, suffering or distress, as well as procedures with no significant impairment of the well-being or general condition of the animals shall be classified as ‘mild’.

Classification of severity of procedures

Moderate: Procedures on animals as a result of which

the animals are likely to experience short-term moderate pain, suffering or distress, or long-lasting mild pain, suffering or distress as well as procedures that are likely to cause moderate impairment of the well-being or general condition of the animals shall be classified as ‘moderate’.

Classification of severity of procedures

Moderate: Procedures on animals as a result of which

the animals are likely to experience short-term moderate pain, suffering or distress, or long-lasting mild pain, suffering or distress as well as procedures that are likely to cause moderate impairment of the well-being or general condition of the animals shall be classified as ‘moderate’.

Classification of severity of procedures Severe: Procedures on animals as a result of which

the animals are likely to experience severe pain, suffering or distress, or long-lasting moderate pain, suffering or distress as well as procedures, that are likely to cause severe impairment of the well-being or general condition of the animals shall be classified as ‘severe’.

Classification of severity of procedures Severe: Procedures on animals as a result of which

the animals are likely to experience severe pain, suffering or distress, or long-lasting moderate pain, suffering or distress as well as procedures, that are likely to cause severe impairment of the well-being or general condition of the animals shall be classified as ‘severe’.

Authorisation requirements for breeders, suppliers and users

Requirements for installations and equipment

Competence of personnel

Specific requirements for personnel (e.g. scientific member)

Designated veterinarian (with expertise in laboratory animal medicine)

Animal-welfare body (responsible for the welfare)

Documentation of procedure Project evaluation (scientific/ educational

standards) Harm-benefit analysis Competent authority (as designated from

Member States) Transparency Retrospective assessment Summary of compliance with the

requirement of replacement, reduction and refinement

http://ec.europa.eu/environment/chemicals/lab_animals/ms_en.htm Project evaluation (scientific/ educational

standards) harm-benefit analysis Competent authority (as designated from

Member States) Transparency Retrospective assessment Summary of compliance with the

requirement of replacement, reduction and refinement

Competent authority

Competent authority

Competent authority

Directive’s final provisions Each Member State shall establish a

national committee for the protection of animals used for scientific purposes.

The Commission may modify the technical Annexes of Directive 63/2010/EU until 2018.

The Commission will be assisted by a Committee.

The Parliament may reject the Commission Acts within a period of 2 months from notification.

Political outsourcing

on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein.

Annexes

List of animals List of non human primates Requierments for accomodation and

care of animals (feeding, watering, ventilation, cmᶟ, etc)

Killing methods Duties of Union Reference Laboratory Severity classification

Conclusions (ethical)

“Replace principle” … use an alternative method for experimenting

Do alternative methods get voluntarily registered?

European Union Reference Laboratory (2011)

increasing need for new methods to be developed and proposed for validation

each breeder, supplier and user should maintain accurate records reports

objective information concerning projects using live animals should be publicly available

remember

Conclusions (ethical)

“Reduce principle”

… the number of animals used in projects is reduced to a minimum

Who sets the minimum?

So what have you been working on recently?

The last study used 16 rats. We were working with venom peptides … investigating how their individual neurotoxins can cut off certain pain. To do this we induced pain in rats by surgically attaching a ligature to … a big nerve that runs down their legs. The rats then developed mild pain, … and we administered the venom peptides to see if we could divert that pain.

remember

Conclusions (ethical)

“Refine principle” … perform experiments with tissues

Can you remove tissues from an animal's nervous system without harming it ?

remember

And just to be clear on this, after each experiment you euthanise all the

animals?Yes, we euthanise, or sacrifice the animals at the end of each experiment. In the experiments that I do we need to use their tissue so I can’t pull bits of an

animal’s central nervous system and then sew it back up. It’s not

going to live after that.

Conclusions (pragmatic) Cooperation lack of the industry/ institutions Impact of cosmetic industry Lack of alternative methods Effectiveness lack of the “European Centre for

the Validation of Alternative Methods” (1991) Transparency lack/ stigma Proprietary rights, exposure of confidential

information, discourage alternative methods registration

Lack of political will (prohibition of marketing, not production)

Conclusions (legal) The magnitude of bureaucratic procedures do not

constitute a friendly environment for laboratories. Transparency lack and political tolerance will direct

laboratories to informal (illegal) practices. As long as the policies are decided from the EU

Commission there is a mediation pro private and contra public interest to expect.

Few Member States move to stricter regulations. Animal testing can be exceptionally allowed under

certain prerequisitions and for certain research fields (e.g. cancer drug research).

EU regulations have to fight “law tourism”.

Thank you!