Why we say No to Directive 2010/63/EU

Directive 2010/63/EU, passed by the European Parliament on September 8, 2010, consists of 56 recitals, 66 articles and 8 Annexes.

In contrast with the Directive it replaces, the new revision explicitly forbids Member States to pass national laws that would raise animal welfare standards beyond those set by the Directive itself. And it permits experiments on stray cats and dogs.

A safeguard clause opens the door to the use of Great Apes and ensures that Member States can “allow the use of a procedure involving severe pain, suffering or distress that is likely to be long lasting and cannot be ameliorated”.

Among the more humane methods of killing animals it lists the dislocation of the neck, the destruction of the brain, carbon dioxide, percussive blow to the head, decapitation, shooting with a free bullet, electrical stunning, exsanguination (Annex IV).

Last but not least, Directive 2010/63/EU doesn’t make alternative methods mandatory not even when and where they exist.

Here are the main reasons to say NO to Directive 2010/63/EU and to animal experimentation:

1 Business comes first (recital 1)

To outline the reasons why a new law on animal testing was needed, Recital 1 of the Directive highlights the crucial role of the economic and financial market, saying that

• A) Certain Member States had adopted national measures ensuring a high level of protection of animals used for scientific purposes while others only applied the minimum requirements laid down in Directive 86/609/EEC.
  And that:

• B) Such disparities had to be eliminated in order to ensure a proper functioning of the internal market.
  *in other words:

As animal testing is more expensive in European Countries with higher standards of animal welfare, the research labs of those richer countries badly needed to reduce their competitive disadvantages to hold their ground against other competitors in the EU. A new playing field had to be achieved at the lower and more convenient level for the scientific community.

2 No higher standards of animal welfare permitted (article 2)

On the operational level, to ensure the above mentioned “level playing field ”, article 2 of the Directive states that “Member States may maintain provisions in force on 9 November 2010 aimed at ensuring more extensive protection of animals” but cannot adopt new ones.

* in other words:
Member States will not be allowed to adopt new measures aimed at ensuring higher standards of animal welfare at the national level. They can only maintain provisions that were already in force in 2010. Moreover, when deciding to maintain stricter national rules on animal welfare, a Member State will not be able to prohibit the supply or use of animals bred or kept in another Member State.

This could be the case of stray cats and dogs, whose trade aimed at scientific experiments will be free across Europe.

3 Alternative methods won’t be mandatory (articles 4 and 13)

Alternative methods won’t be mandatory even when they exist (articles 4 and 13) and are reasonably available
The original text of the Directive, dated 2008, stated that:

• 1) “Where a method of testing not involving the use of animals exists and may be used in place of a procedure, Member States shall ensure that the alternative method is used (article 4);

• 2) Member States shall ensure that a procedure may not be carried out if a scientifically satisfactory method not entailing the use of an animal (including computer supported, in vitro and other methodologies not entailing the use of an animal), is reasonably and practicably available (article 13)

This sounds good, but unfortunately by September 2010, the Directive had got rid of those principles. The result was achieved by adding two words to article 4 expressing the view that alternative methods should be used just “wherever possible”, and stating, in article 13, that Member States should ensure that the preference be given to those methods not entailing the use of animals that are recognised under the legislation of the Union (whose number is conspicuously inferior to the methods scientifically satisfactory and reasonably available on the market mentioned in the previous text of the law).

* in other words:
methods not entailing the use of animals will not be mandatory (nor used) even if they exist and are scientifically satisfactory, which means that their development is verbally voiced but practically not supported as necessary to make vivisection history.

4 Stray cats and dogs (article 11)

Unlike the Directive that was passed in 1986, article 11 of Directive 2010/63/EU permits to experiment on stray cats and dogs. Indeed, procedures on “stray and feral animals of domestic species” will be possible whenever researchers will judge that:

• there is an essential need for studies on stray cats and dogs concerning the health and welfare of the animals;

• there is an essential need for studies concerning serious threats to the environment;

• there is essential need for studies concerning serious threats to human health;

• there is an essential need for studies on stray cats and dogs concerning serious threats to animal health.
  Last but not least, procedures on stray cats and dogs will be possible whenever “there is scientific justification to the effect that the purpose of the procedure can be achieved only by the use of a stray or a feral animal”.

*in other words:
procedures on stray animals will be freely available to experimenters, since in general terms they will be themselves in charge either to decide which procedures to carry on and to demonstrate that “the purpose of the procedure can be achieved only by the use of a stray animal”.

5 Re-use of animals (article 16)

Article 16 states that an animal already used in one or more procedures may be used in a new procedure provided that the actual severity of the previous procedures was “mild” or “moderate” (…) and that the further procedure is classified as “mild”, “moderate” or “non recovery”.
This means that there is no limit to the number of procedures an animal will be obliged to endure, provided these procedures are classified as mild or moderate.
Here are some examples of “moderate” procedures as listed in Annex VIII of the Directive:

• surgery associated with post surgical pain, suffering or impairment of general condition (examples: thoracotomy, craniotomy, laparotomy, orchidectomy, lymphadenectomy, orthopaedic surgery; organ transplantation, surgical implantation of catheters or biomedical devices)

• creation of genetically altered animals through surgical procedures;

• use of metabolic cages involving moderate restriction of movement up to five days;

• evoking escape and avoidance reactions where the animal is unable to escape or avoid the stimulus.

Regrettably, by way of derogation of the above stated, after a veterinary examination of the animal and gaining the approval of the “competent authority”, it will be possible to reuse an animal that has already undergone a procedure entailing severe pain, distress or equivalent suffering.
Here are some examples of “severe pain and distress”, as listed in Annex VIII. They are associated with:

• the use of metabolic cages involving severe restriction of movement over a prolonged period

• surgical and other interventions in animals which are expected to result in severe or persistent moderate postoperative pain, suffering or distress and persistent impairment of the general condition of the animals;

• the production of unstable fractures, thoracotomy without adequate analgesia, trauma to produce multiple organ failure;

• breeding animals with genetic disorders that are expected to experience severe and persistent impairment of general condition (relapsing neuritis models, muscular dystrophy, Huntington’s disease);

• inescapable electric shocks;

• immobilisation stress to induce gastric ulcers or cardiac failure in rats;

• complete isolation for prolonged periods of social species e.g. dogs and primates;

• forced swim or exercise tests with exhaustion of the animals as the end-point.

* in other words:
the re-use of animals that have undergone moderate pain and distress is admitted as current praxis whilst the re-use of animals that have undergone severe pain and distress is being submitted to the discretionary powers of judgment of the “competent authority” [They are bodies either public or not, designated to the purpose of implementing specific tasks of the Directive, see article 59).
Besides that, as the London Home Office states in its “Consultation on Options for the Transposition of European Directive 2010/63/EU” (June 2011, page 40), there is indeed a great potential for “inconsistent interpretation of the severity classification system”.

6 Multiple generic projects and simplified administrative procedures (articles 36 to 43) >>> secrecy as the norm

As the Parliament put a lot of emphasis on the reduction of administrative burden on laboratories using animals, no wonder that under articles 40/42, Member States may allow the authorization of multiple generic projects for a period up to five years and introduce a simplified administrative procedure if the projects contain procedures classified as “non-recovery”, “mild” or “moderate” - and are held to satisfy regulatory requirements or use animals for production or diagnostic purposes.
Besides the benefit of limiting “red tape” in order to apply for multiple generic projects lasting up to five years, under a simplified administrative procedure the requirement for a non-technical summary may be waived.

* in other words:
altogether, this is a focal point on transparency. As a matter of fact the non-technical summary – where experimenters provide anonymised information on the objectives of the project and the number and types of animals to be used – is a document that Member States are to make available to the public. But if experimenters can omit it, secrecy on the suffering of animals will be still the norm and the public will be kept in absolute darkness about what goes on in laboratories.

Moreover, as stated by the Commission itself, a three-way authorisation (authorisation of establishments, persons and projects) was the central pillar of the Commission proposal of Directive in 2008, “essential for enhancement of animal welfare, and ensuring compliance”. But the text passed in 2010 removes the requirement to authorise personnel working with animals and replaces it by a requirement to name a person who is responsible for the training of personnel dealing with animals. Who is going to secure the competence of personnel dealing with animals, and how?

7 Anaesthesia and neuro muscular blocking agents (article 14)

Article 14 allows that procedures be carried out without general or local anaesthesia if the researchers think they are “inappropriate” or “incompatible with the purpose of the procedure”.
Particularly horrendous, article 14 also states that neuro muscular blocking agents can be used with analgesics instead of general anaesthetics, and these would not mitigate the terror and distress of a totally paralysed but fully conscious animal.

* in other words:
The European Commission, in its “Communication to the European Parliament” dated 15.6.2010, states that “one of the main criticisms of the current Directive (Directive 86/609 has been the lack of compliance and enforcement”. To enforce article 14 won’t cost experimenters anything, (so they will) and too much to animals.

8 Experiments on primates (articles 5, 8 and 55)

First: experiments on primates will be possible in basic research as well as in procedures undertaken “with a view to the avoidance, prevention, diagnosis or treatment of debilitating conditions in human beings”

Second: experiments on primates taken from the wild - a practice that according to the European Commission was to be phased out in ten years - will be permitted for a longer period, possibly sine die.

* in other words:
considering that experimenting on primates for basic research (i.e. the research arising out of curiosity, not especially linked to medical objectives) is fully permitted and considering that even a cold or a flu are “debilitating conditions in human beings” – laboratory experiments on primates cannot and will not be challenged as long as this Directive will be in force.

9 Experiments on Great Apes (articles 5, 8 and 55)

At first sight, the use of Great Apes [chimpanzees, gorillas, orangutans and bonobos] in laboratory experiments is prohibited. Indeed, their “provisional and exceptional use” is allowed by article 55 (Safeguard clauses) in procedures aiming at:

• the avoidance, prevention, diagnosis or treatment of disease, ill-health or other abnormality or their effects in human beings, animals or plants;

• for any if the aims above mentioned in the development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feed-stuffs and other substances or products;

• research aimed at preservation of the species.

Useful links:

Directive 2010/63/EU
Full text

Directive 2010/63/EU
Basic information, Key players and events, Technical information, Documentation gateway

Communication from the Commission to the European Parliament, 15.6.2010

HOME OFFICE: Consultation on Options for the transposition of Europea Directive 2010/63/EU

Directive 86/609/EEC