Animal Aid

Please note: You can complete the whole of the consultation here. But we have made the job simpler by selecting what we believe to be the most relevant questions, offering background to each of them and proposed answers. Feel free to adjust our text and add your own thoughts.

Q1. What are your views on the proposed inclusion of animals bred for their tissues and organs within the scope of the proposal and our estimate of its impact?

Background

The Home Office has recently acknowledged that about one million animals are bred every year just so they can be killed and their tissues and organs used for research. Not only do these animals receive no protection under the meagre laws governing vivisection labs, but the government has always refused to publish statistics about this category of vivisection victims.

Answer

There must be full protection for – and appropriate reporting and publishing of data relating to the use of – animals bred and killed so that their tissues and organs can be used in experiments. There should additionally be reporting on and protection of animals bred for ‘procedures’ but who are ultimately regarded as surplus to needs. Their fate, typically, is to be killed.

Q2: What are your views on the provisions regarding the protection of immature forms?

Background

There is widespread resistance in animal research and political circles to recognising that animals growing in the womb are capable of suffering pain and distress when experimented upon. The political decision as to whether they should in future be afforded such protection is in the balance.

Answer

The scope of the Directive should be broadened to include immature forms of both mammalian and non-mammalian species, because there is sound scientific evidence of their potential to feel pain and be harmed.

Q3: What are your views on the inclusion of cyclostomes, cephalopods and crustacean decapods within the scope of the proposal?

Background

A similar position to that set out for the background of Q2 applies here except that the British government and others are even more reluctant to acknowledge that these invertebrate animals are sentient.

Answer

The scope of the Directive should be broadened to include cyclostomes, cephalopods and crustacean decapods, because there is sound scientific evidence of their potential to feel pain and be harmed.

Q8: Do you have any comments on the provisions of Article 4 relating to replacement, reduction and refinement?

Background

With few exceptions, governments across Europe pay lip service to the development and implementation of non-animal research methods. The application of non-animal methods inevitably becomes more difficult and less practicable as a consequence of this lack of commitment.

Answer

There needs to be a well-funded, well-coordinated and executed EU-wide programme directed at simplifying the replacement of animal tests with non-animal methods.

Q11: What are your views on the provisions protecting endangered species?

Background

The proposed directive will not usually permit endangered species to be used for research. But there is an important ‘let-out’ clause, which allows their use where it is claimed that no other ‘suitable’ species is available.

Answer

The use of endangered species should be prohibited without exemptions.

Q12: What are your views on the provisions limiting the use of non-human primates?

Background

The Commission’s proposal restricts primate use to those experiments that relate to ‘serious and debilitating’ human conditions. This is a very broad, inclusive category, given that a large number of ailments ‘debilitate’. However, the European Parliament subsequently passed an amendment that provides primates with no more protection than other species and allows them to be used for such purposes as ‘basic’ or curiosity-driven research.

Answer

An amendment passed by the European Parliament (Amendment 56) acknowledges that non-human primates have a ‘particularly high level of neurophysiological sensitivity and cognitive development’. Additionally, according to a recent opinion poll, 81 per cent of the public across Europe believes ‘that the new law should prohibit all experiments causing pain or suffering to primates’. All primate use should be opposed and there certainly should not be any weakening of the original Commission proposal.

Q13: What are your views on the provisions relating to Great Apes?

Background

The Home Office gave a formal commitment in 1997 that they would issue no more licences for the use of Great Apes, and no Great Apes have been used since that time. The proposed directive would extend this protection across the EU but with the inclusion of a so-called ‘safeguard clause’ – that Great Apes could be used ‘in relation to an unexpected outbreak of a life-threatening or debilitating clinical condition in human beings’.

Answer

There must be an outright ban on the use of Great Apes across the whole of the EU with no exemptions.

Q14: What are your views on the provisions limiting the use of animals taken from the wild? Would there ever be justification for the use of such animals on the grounds that suitable purpose-bred animals were not available?

Background

Researchers sometimes complain of a shortage of certain species for research or that captive breeding programmes are too complicated, time-consuming and costly. They use such reasoning to seek to justify the capture and use of wild animals.

Answer

The use of all wild-caught species should be opposed without exception.

Q23: Do you have any comments on the proposed limitation on the performance of ‘severe’ procedures?

Background

It was the Commission’s intention to outlaw prolonged and severe suffering but the European Parliament voted to overturn that prohibition and allow animals to experience both prolonged and severe suffering.

Answer

There can be no scientific or ethical justification for an animal being deliberately subjected to prolonged, severe pain. Monitoring such suffering, as suggested by the Parliament, cannot make it justifiable nor can reference to research into various chronic human conditions such as arthritis. Other, non-animal, research methods can and must be adopted.

Q26: Do you have any comments on the proposed requirement regarding sharing of organs and tissues and how it might be implemented in practice?

Background

There needs to be more sharing of organs and tissues to reduce the numbers of animals killed for research but the argument is offered that making such sharing mandatory could be costly and logistically complicated. However, these same arguments could be applied to the commercial trade in animals and biological products, which continues to flourish unabated.

Answer

There are no valid excuses for resisting mandatory sharing of organs and tissues in order to achieve a reduction in the total number of animals used. Driving down the numbers of animals used is a principal objective at the heart of the draft Directive. Aside from questions of ethics, the sharing of organs and tissues, if coordinated and managed strategically, will produce cost savings. In fact, donated tissues of human origin should be used instead of animal tissues. It is a more ethical material and would give better results.

Q27: Do you have any comments on the proposed requirement regarding the setting free or rehoming of animals?

Background

In the UK, aside from the occasional monkey, animals no longer useful for experimental purposes are rarely rehomed. The Directive proposes that, where appropriate, animals should be set free or, in the case of ‘domesticated’ animals such as cats and dogs, they should be rehomed.

Answer

The proposal to rehome or set free animals should be supported. The draft Directive at present is specific only about cats and dogs. It is important that less favoured species such as rats and rabbits are given a chance of a new beginning. The Home Office, in its consultation commentary, is suggesting rehoming is difficult because sanctuaries are full but the authorities should provide funding and other resources so that proper provision is made for victims of animal research.

Q30: What are your views on the proposed provisions for the mandatory suspension and withdrawal of authorisation for non-compliance with the provisions of the directive and on our preference for a more proportionate approach?

Background

The Commission proposes that there should be automatic suspension of licences in cases where the terms of such licences have been breached. The Home Office, in its consultation commentary, argues that this is too severe an approach and that any response to breaches should be ‘proportionate’. The record shows that the Home Office has been anything but proportionate in response to neglect, cruelty and incompetence revealed by undercover footage shot in laboratories. In response to such evidence, it has been essentially inactive.

Answer

Any breach, which results in the suffering, neglect or harm of animals, should lead to mandatory automatic suspension.

Q34: Do you have any comments on the proposed requirement for permanent ethical review bodies (PERBs)? What are your views on their proposed membership? Is there a need to involve lay or external members?

Background

Under the draft Directive, every establishment will have a ‘permanent ethical review body’ whose primary function is focusing on: ‘ethical debate at establishment level, fostering a climate of care and providing tools for practical application and timely implementation of the recent technical and scientific developments in relation to the principles of replacement, reduction and refinement to enhance the life-time experience of the animals.’ The original draft called for these bodies to be ‘independent’ of the establishment. That requirement is now being removed.

Answer

Permanent Ethical Review Bodies (PERBs) in reality have little power to refuse or significantly change proposed research. Their inclination to attempt to do so will be much reduced without a genuinely independent component, with members unconnected with the establishment concerned. PERBs should have as members people who are genuinely independent of the establishment concerned.

Q44: What are your views on the proposal for authorisation of projects and on possible provision for notification of projects?

Background

Under the draft Directive, only ‘procedures’ classified as ‘moderate’ or ‘severe’ or those involving primates would need prior authorisation from a so-called ‘competent authority’. (In the UK, that ‘competent authority’ is the Home Office.) It is proposed that all other experiments could take place simply by the establishments concerned ‘notifying’ the competent authority that they intend to proceed. This would mean that approximately 4.3 million animal experiments could take place without any meaningful external scrutiny.

As worded, even if the permanent ethical review body objected to what was proposed, it would be unable to stop the experiment. The amendment would have a devastating impact on efforts to ensure accurate central record keeping, data sharing, and the drive to improve animal welfare and implement non-animal methods. It would also make it easier to underestimate pain levels.

Answer

All projects should require authorisation from a competent authority rather than being approved through a ‘notification’ process.

Q47: Do you have any comments on the provisions for retrospective assessments of projects? Or our belief that further clarification is required?

Background

The draft Directive proposes that certain procedures are looked at – in a so-called ‘retrospective assessment’ – once they have been completed to see what lessons can be learned about, for instance, how animals were used, whether they should have been used, the harm inflicted on them and if the objectives of the experiment were achieved. The Commission wanted retrospective assessment for all projects except those classified as ‘up to mild’. But the Parliament reduced the number it wants assessed by excluding all experiments classified as ‘moderate’. In the UK, so-called ‘moderate’ experiments can involve animals being subjected to deliberate brain damage after which they suffer symptoms such as seizures and bloody diarrhoea.

Both the Commission and the Parliament wanted retrospective assessments for all projects involving primates.

Answer

Retrospective reviews should be carried out for all experiments because they would contribute important information that would drive down the total number of experiments and reduce the harm inflicted.

Q50: Do you have any comments on the provisions for granting of project authorisations?

Background

The draft Directive proposes that establishments be authorised to carry out numerous experiments under a ‘multiple project’ licence. The argument is that such licences would relate to groups of experiments that are significantly similar to each other and that time and money could be saved.

Answer

All projects should be licensed on an individual basis. Providing multiple authorisations reduces scrutiny and potentially damages animal welfare. Conducting lethal experiments on animals is an extremely serious matter. In each and every case, ‘justification’ should be offered and permission sought.

Q53: Do you have comments on the provisions relating to the sharing of data?

Background

The draft Directive sets out an obligation to share data derived from both regulatory tests (safety testing required under law) and non-regulatory tests. It does so while protecting confidential information and ensuring that those who generate the data are fairly compensated by others who make use of such information. Just such a data-sharing scheme – with compensation element built in – is prescribed under REACH (The European chemical safety testing Directive).

Answer

Data generated in the course of animal experiments must be shared across the EU. This is a solid, practical and achievable measure by which animal use can be driven down.

Q54: Do you have any comments on the provisions to encourage the development of alternative approaches?

Background

The draft Directive sets out a requirement for both the Commission and Member States to ‘contribute financially and otherwise’ to the development and validation of non-animal research and testing methods. There is also a call for a centrally located establishment (such as the European Centre for the Validation for Alternative Methods) to perform a powerful coordinating, training, project development and validation role. It is envisaged that each Member State helps fund and provide expertise for this proposed initiative. The Home Office in its commentary shows signs of wanting to resist making a concrete commitment.

Answer

For too long, lip service has been paid to the development and implementation of validated non-animal methods. There has been a reluctance to translate such rhetoric into reality, not least to commit adequate financial and other resources. The UK government is urged to press hard for the establishment of a proper resource centre for non-animal research methods that would serve the whole of the EU and work in collaboration with suitable research establishments within the Member States.

Q55: What are your views on the proposed requirements for the designation and functions of national reference laboratories?

Background

This question relates directly to the one above. The draft Directive calls for national centres to be established whose function, in cooperation with the Commission, will be to develop an active programme of validation and promotion of alternatives to animal tests, as well as to provide training and advice in the use of such methods. The Home Office in its consultation commentary makes plain that it does not wish to see a new national centre set up. It prefers to see work on alternatives handled by existing research establishments across the country.

Answer

In whichever fashion the Commission-directed programme into non-animal research methods is carried out in Britain and other Member States, it is essential that it is properly resourced and energetically pursued – both at the centre and at Member State level.

Q59: Do you have any views on the safeguard clause?

Background

The safeguard clause relates to circumstances under which a ban on the use of Great Apes might be breached. In that sense, it is researchers and not Great Apes that are safeguarded. Under this clause, Great Apes could be used ‘in relation to an unexpected outbreak of a life-threatening or debilitating clinical condition in human beings’. In so far as Britain is concerned, the Home Office gave a formal commitment in 1997 that they would issue no more licences for the use of Great Apes, and no Great Apes have been used since that time. The fear is that the safeguard clause punches a hole in this ban.

Answer

There must be an outright ban on the use of Great Apes across the whole of the EU with no exemptions.

Q63: What are your views on the provisions for competent authorities and the best option for the UK?

Background

Under the new Directive, each Member State will have at least one ‘competent authority’ whose function will be to authorise and monitor animal experiments and to promote methods that lead to the reduction and replacement of such tests. In the UK, the current competent authority under the existing Directive is the Home Office. In its consultation commentary, it asks the question as to whether it or another government department should continue in that role; whether there should be, perhaps, more than one regional competent authority; if the function should be deregulated – i.e. go to a non-governmental agency; or, most worrying of all, whether ‘some form of self-regulation’ should be introduced.

Answer

Whichever body(ies) is (are) assigned the role of competent authority, it is vital that it operates in a transparent and accountable manner. There is a far better chance of accomplishing this outcome if the body concerned is a public entity that has a minister at its head who is directly answerable to Parliament and the electorate. A deregulated or self-regulating competent authority could not provide such accountability.

Q66: Do you have views on Annex 1?

Background

The Commission wants the Directive to extend protection to a number of invertebrate species that currently can be used with impunity. The additional animals that it wants to come under the law are cyclostomes (e.g. lamprey), cephalopods (octopus and squid) and decapod crustaceans (crabs, lobsters and shrimps).

Answer

The scope of the Directive should be broadened to include cyclostomes, cephalopods and crustacean decapods, because there is sound scientific evidence of their potential to feel pain and be harmed.