President. – The next item is the report (A6-0240/2009) by Mr Parish, on behalf of the Committee on Agriculture and Rural Development, on the proposal for a directive of the European Parliament and of the Council on the protection of animals used for scientific purposes (COM(2008)0543 – C6-0391/2008 – 2008/0211(COD)).

  Neil Parish, rapporteur. − Madam President, firstly I would like to thank all the shadow rapporteurs who have been very willing to work with me on what is an incredibly technical and difficult dossier. By working together we have been able to come up with what I believe is a good compromise. I would also like to thank the Commission for their cooperation, and we look forward to working with them on this dossier in the future. I would also like to thank Patrick Baragiola from the AGRI secretariat and my adviser Dan Dalton.

Animal testing is a highly controversial area and involves a moral dilemma. Is it ever right to test on animals in order to potentially save the lives of humans? I believe that, as long as tests are properly justified from both the scientific and ethical perspective, then it is.

However, we must do everything we can to minimise both the number of tests and the amount of suffering imposed upon animals. The Commission report was a good start. It showed that the Commission is keen on moving towards an end to animal experimentation whenever possible. However, in many areas the Commission proposal was ambiguous and may have the opposite effect to that which the Commission is seeking.

The omission of definitions of a severity classification was a glaring hole in the whole proposal. The Commission was in effect asking Parliament to make a judgement on the rules surrounding the classifications without knowing what they actually were. In addition, some provisions, particularly the recommendations on the reuse of animals and on the proposed use of only F2 primates (second-generation primates) are likely to mean that many more animals will have to be used.

In the case of F2 primates, no feasibility study has been done to see whether it is possible to do what the Commission is proposing. Their impact assessment only looks at numbers; it does not look into the welfare implications. For this reason, Parliament urgently needed to amend the proposal: not to weaken it but to make it clear exactly when testing on animals should be allowed and under what circumstances.

I believe that the AGRI Committee report strikes a compromise between ensuring that research can continue in the EU and improving animal welfare. From an animal welfare perspective it is a step forward. It is all about promoting alternatives to animal experimentation through a financial commitment, more emphasis on the three ‘R’s and the strengthening of the role of ECVAM.

In addition I have also proposed regular thematic reviews of primate experiments to identify and phase out those experiments which are not necessary.

It is also a step forward for medical research. It will update the current outdated legislation and will allow medical research to continue as and when that research is scientifically and ethically justified. I believe that this is fundamentally important. We also want to see animal tests reduced. However, European citizens quite rightly demand that the best and more effective medicines are available.

Reliable European research and development is essential. Vaccines for polio, German measles, hepatitis B, diphtheria, measles, mumps, rubella and meningitis, along with combined therapy drugs for HIV, medicines to control asthma, life support systems for premature babies and deep brain stimulation for Parkinson’s disease, have all been developed through experimentation on animals, and specifically primates. Many millions of lives have been saved or improved as a result.

Until we have alternatives in place, I believe that it would be unwise to outlaw these types of experiments, either directly or indirectly through poorly worded legislation. This directive will set out the framework to ensure that we can phase out animal testing as soon as alternative methods are available. It significantly improves the search for alternatives and puts us firmly on the path to one day phasing out animal testing altogether. We have a good compromise in the AGRI Committee. However, the Liberal group appears to be trying to drive a coach and horses through this agreement. I would urge them not to vote against this report, because it will set back animal welfare by several years and it would be completely wrong for them to take this action.

  Stavros Dimas, Member of the Commission. − (EL) Madam President, I welcome the opportunity that we have this evening of debating the proposal to revise the directive on the protection of animals used for scientific purposes. I should like to thank the rapporteur, Mr Parish, and the three parliamentary committees that examined the report for their efforts and their comments. I am certain that the dialogue which ensues will be constructive.

Numerous Member States have long since adopted their own national legislation on the protection of animals used for scientific purposes. As a result, there are different levels of protection in Europe. The review will achieve a harmonised level of protection within the Community and will safeguard the smooth operation of the internal market. The Commission’s aim is to improve the legislation of the European Union governing animal experiments. On the one hand, this will both limit the number of experimental animals and, on the other hand, it will provide suitable care and treatment of animals subjected to experiments, as required under the Protocol on protection and welfare of animals added to the Treaty establishing the European Community.

Our aim is for this review to considerably improve the welfare of experimental animals within the European Union. The welfare requirements of animals are now officially included in the Treaty on European Union and must be taken into account when laying down policies in sectors such as the internal market. Experts and specialists in the animal testing sector, the research community, the industry directly interested and citizens were involved in formulating the proposal with transparent procedures and without exclusions. The proposal is also based on a carefully substantiated impact assessment. Moreover, numerous scientific agencies made a significant contribution to this procedure. A comparative analysis of the possible benefits and the costs of taking action against not taking action was carried out in order to draw up the proposal. This proposal strikes the necessary balance; on the one hand, it promotes competitiveness and research in Europe and, on the other hand, it takes full account of the welfare requirements of animals. The Commission has carefully examined the concerns expressed by various sides that the proposal would expel European research from Europe, due to the supposed administrative burden or the cost involved in specific animal welfare requirements. However, there is no evidence that there will be any such drain to non-EU countries. Several of the welfare standards contained in our proposal and many of the stricter licensing procedures are already being applied by Member States who lead the way in research globally. Furthermore, our proposal makes provision for measures to minimise the administrative burden. There is, in fact, no contradiction between the adoption of strict animal welfare standards and the promotion of a high level of scientific research. On the contrary, the two concepts are interconnected.

Under the Commission proposal, the licensing of research on animals who are still conscious will be accompanied by systematic independent ethical evaluation. This will put the principles of restoring, restricting and improving the use of animals into practice. These provisions are the fundamental objectives of the review. We shall be unable to achieve our objectives if we replace licensing by tacit agreement to every type of research or if we allow the ethical evaluation to be carried out by those with a direct interest in the research project.

Finally, the Commission wishes to avoid any possible interruption to scientific projects under way and to minimise the administrative burden. That is why it allows for flexible application and encourages the use of existing infrastructures in the Member States wherever possible.

Ladies and gentlemen, the recast proposal will restore the smooth operation of the internal market, improve animal welfare standards and promote research. The current legislation urgently needs to be strengthened and improved in a properly balanced manner and that is precisely what the Commission proposal achieves.

  Marios Matsakis, rapporteur for the opinion of the Committee on the Environment, Public Health and Food Safety. − Madam President, it is a necessary evil of our times that, unfortunately, human and animal health research requires, as a must, animal experimentation. It is my firm belief that no true scientist enjoys experimenting on animals or does so when alternative means of research are available. Such research must of course at all times be as humane as possible to the animals involved.

To this end the directive under debate seeks – correctly, in my view – to improve matters significantly and decidedly. Important areas of note are the safeguarding of the principles of ethical review and authorisation as well as the concepts of enhanced national inspections and increased transparency throughout. It must be emphasised that the aim of the scientific and political world should always be to phase out the use of animals in research if and when alternative and effective methods not using animals are made available.

  Esko Seppänen, draftsman of the opinion of the Committee on Industry, Research and Energy. − (FI) Madam President, Commissioner, the report by the Committee on Agriculture and Rural Development is a compromise that takes account of the views of the parties in a balanced way. The Commission proposal has been amended in a way that the Committee on Industry, Research and Energy is also proposing.

As there are no alternative procedures for developing all drugs and vaccines, animal experiments have to be conducted. We are responsible to the citizens of the EU for ensuring that our fellow citizens, when ill, are comforted by the hope that the drugs needed to cure them are also developed in Europe.

At the same time, those who conduct animal tests are under an obligation to treat experimental animals well and cause them as little pain as possible. The directive is a clear improvement for animal welfare, and many of the amendments tabled by the Committee on Agriculture are the same or similar to what we, the Committee on Industry, proposed. Accordingly, the Committee on Agriculture’s report should be adopted with as few changes as possible.

  Elisabeth Jeggle, on behalf of the PPE-DE Group. – (DE) Madam President, Commissioner, ladies and gentlemen, the Animal Testing Directive is based on the 3Rs principle. Our objective is the replacement, reduction and refinement of animal testing. In order to achieve this, we need to develop and promote alternative methods. Thirdly, we must find a compromise between animal welfare and research, while placing the emphasis on human health. Commissioner, you have also emphasised that we need to have the same standards in all Member States.

The current legislative proposal is based on the Community Action Plan on the Protection and Welfare of Animals and on the animal health strategy. We want to ensure a high level of protection and high standards in the European Union and throughout the world. However, the complete abolition of animal testing without other methods being available as an adequate replacement would make the majority of the research based on animal experimentation in the European Union almost impossible. Research projects would move abroad, we would lose the huge amount of knowledge that we currently have and we would make ourselves completely dependent on other countries. Therefore, it is important to find a compromise and the Committee on Agriculture and Rural Development has presented a good compromise. Admittedly it is not an easy balancing act, but for people who are ill it may be a matter of survival.

The result of the vote in the Committee on Agriculture and Rural Development on 31 March meets these requirements. We must support this compromise which was accepted by 72% of the committee. Therefore, I call on all Members of this House to reject all the more far-reaching amendments that have been submitted and to vote in favour of the amendments from the Group of the European People’s Party (Christian Democrats) and European Democrats and the Socialist Group in the European Parliament.

My warm thanks go not only to the rapporteur, but also to many of my fellow Members throughout Parliament.

IN THE CHAIR: Edward McMILLAN-SCOTT
Vice-President

  Roselyne Lefrançois, on behalf of the PSE Group. – (FR) Mr President, Commissioner, ladies and gentlemen, I must firstly congratulate the rapporteur, Mr Parish, on the quality of his work and the importance that he placed on cooperation with the shadow rapporteurs.

Before we vote tomorrow at first reading, I want to go over the main lines of this report. Nowadays, the negative image that animal experimentation can have among the general public confirms the indisputable importance of this issue. Like me, you will have also received, over the last few weeks, a large number of letters from worried citizens.

However, while we have a duty to propose a text that takes account of the public’s fears, we must not, for all that, neglect the demands of researchers. I must underline the fact that we cannot forget that researchers are not only legitimate representatives of this public opinion, but primarily people whose role is absolutely fundamental within our society.

You must be aware that, in the last 20 years, the number of animals used for scientific purposes has not increased, despite the fact that the number of scientific publications in the area of biomedical research has doubled every two years. In order to understand the challenges involved in revising this directive, I myself have met with many stakeholders representing the various opinions on this issue.

To my mind, the initial text proposed by the European Commission was really moving away from the fundamental aim in using animals, namely to make advances in research. It was therefore essential to put the issue of human health back at the heart of the discussions.

Clearly, the provisions on animal experimentation must be amended, but European research must not, however, suffer negative consequences from this new legislation. The strategy that I adopted, and which has been taken up by the rapporteur, therefore involved rebalancing this proposal to ensure that researchers are not harmed.

Based on the report adopted in the Committee on Agriculture and Rural Development, I believe that we can arrive at a coherent and reasonable text, which I hope will be broadly supported by Parliament.

  Jorgo Chatzimarkakis, on behalf of the ALDE Group. – (DE) Mr President, Mahatma Gandhi said ‘The greatness of a nation and its moral progress can be judged by the way it treats its animals.’ The welfare of laboratory animals is an important and delicate subject that many people would like to ignore. However, it is a very sensitive issue, in particular when it comes to research using monkeys and especially great apes. We know that this is the case from the public reaction.

The Commission was subjected to great pressure. I would like specifically to thank Commissioner Dimas. You have done some very good preparatory work and you have introduced important improvements in the welfare of laboratory animals, such as prior authorisation and follow-up checks for all tests. You have extended the directive to cover all animal species, not just mammals. The Commission has also effectively resolved the highly controversial issue of tests on non-human primates. These tests have been restricted to life-threatening illnesses and brain diseases.

Unfortunately, many details of the Commission proposal have been amended by the votes in the committees. For instance, the standards that I have just referred to have been turned on their heads by the vote in the Committee on Agriculture and Rural Development. To give just one example, following the vote in the Committee on Agriculture and Rural Development, tests will be automatically authorised if they have not received official authorisation after 60 days. This is an indefensible situation for us in Europe.

This is why I am calling on my fellow Members to read through what you are voting on tomorrow and not just to follow your voting guidelines. I am grateful to the rapporteur for being prepared to make some compromises at the last minute. I am pleased that Mr Parish plans to introduce an oral amendment tomorrow to ensure that the rules on the authorisation period for projects are made clearer.

However, it is a pity that Article 15 has not got through. Article 15 gives some Member States the option of retaining stricter standards, as is the case, for example, in the Netherlands. Why do we want to lower the standards which are currently very high in the Netherlands? Our joint aim must be to find a balance between high levels of animal welfare and intensive research. I have had enough of the knock-out argument, which is always trotted out, that research will move abroad. This is not necessarily always true.

Schopenhauer said ‘Any stupid boy can crush a beetle, but all the professors in the world cannot create a new beetle.’ We must provide a set of values, because that is our job.

  Kartika Tamara Liotard, on behalf of the GUE/NGL Group. – (NL) I am pleased that the Commission has taken the initiative to revise the Directive on the protection of animals used for scientific purposes. Both the use and the suffering of laboratory animals must be substantially reduced, and this can be done by encouraging the development of scientific methods that are equivalent or more efficient, but without unduly hindering the development of medicinal products.

Something I have difficulty with, however, is the fact that several amendments have been tabled that could considerably weaken the proposal. We must not lose sight of the objective of the proposal. This is about protecting laboratory animals and not about business profits. The most important thing is to ban procedures categorised as ‘severe’ in which laboratory animals may suffer prolonged pain. These procedures are unethical and barbaric.

Finally, the use of non-human primates in experiments must be phased out completely – and rapidly. Parliament adopted a written declaration on this back in 2007, and I think that it is now time to match words with deeds.

  Bastiaan Belder, on behalf of the IND/DEM Group. – (NL) Mr President, high animal welfare standards are an expression of civilisation and of respect for one’s fellow creatures. Where good alternatives to animal testing are available, these must be used, as we want less animal testing. This also goes for good procedures that reduce animal suffering or require fewer laboratory animals, as we want less animal suffering.

I think that the proposed compulsory ethical review is progress. Naturally, the objective of this directive cannot be to compel Member States to accept testing on human embryos as an alternative. Member States must take their own ethical decision on this.

The Commission’s ultimate aim is to abolish animal testing completely. Although we share this aim, it is an unfortunate fact that we cannot yet do without animal testing, nor are we yet in a position to say definitively when this will be the case. Already giving a final deadline for banning animal testing would be ill-advised and perhaps even hazardous to human health; I agree with the rapporteur on this.

  Françoise Grossetête (PPE-DE). – (FR) Mr President, our fellow citizens are calling for more research, particularly in the biomedical area, in order to find new treatments for diseases for which we do not yet have a cure. This is the case, among others, with all the neurodegenerative diseases, such as Parkinson’s and Alzheimer’s. We also know that we need animal experimentation and that this animal experimentation has fortunately reduced in recent years because we have set ourselves the goal of finding alternative solutions.

However, unfortunately, we know that, in some cases, these solutions do not exist and we still need to use animal experimentation, particularly on non-human primates. In this case, we must do absolutely everything we can to ensure that European research remains in the territory of Europe so that we can offer maximum protection. Taking into account an animal’s pain during an experiment offers every guarantee that this experimentation will produce good results.

Therefore, let us keep our research and, in particular, let us also keep animal experimentation. Let us particularly make sure that this research is not relocated outside Europe.

  Luis Manuel Capoulas Santos (PSE). – (PT) Mr President, Commissioner, ladies and gentlemen, using animals for scientific purposes is a very sensitive matter that gives rise to controversial and irreconcilable emotions, if viewed from one side only. It is impossible to discuss this issue solely from the perspective of protecting the interests and rights of animals. It is also impossible to discuss this issue looking solely at the interests of science or using a logic of obtaining results at the lowest possible cost.

No one can be indifferent to the suffering of other living beings, even less so in the case of animals as close to us as primates. However, our sensitivity is even further heightened when we are faced with the suffering of human beings caused by accidents, war or disease. In order to combat pain, we cannot refuse science the instruments that it needs, including the use of guinea pigs.

This report sets out a possible balance between the contradiction of values and emotions with which we are faced, and it reveals an effort to compromise which can only ennoble this Parliament and its most committed Members. I therefore congratulate those with whom I dealt most in this discussion – the rapporteur, Neil Parish, and the shadow rapporteur of the Socialist Group in the European Parliament, Roselyne Lefrançois – on their excellent work and the consensus that they managed to achieve on such a difficult and controversial issue.

My political group, the PSE Group, will therefore vote for this report and the amendments with which we tried to further improve it, in the belief that we will therefore help to reduce the suffering of animals, without compromising scientific progress for the benefit of human health and the viability of European research.

  Zuzana Roithová (PPE-DE). – (CS) Mr President, Commissioner, ladies and gentlemen, I am concerned about the suffering of laboratory animals as well, but at the same time I know, as a physician, that we must do everything we can to make vaccines and medicines available to our patients as soon as possible, for the treatment of new and old diseases. I would like to thank our fellow Members, who have succeeded in finding a truly balanced compromise which respects and honours ethical principles applying to the treatment of animals while at the same time making it possible to carry on with research projects. First and foremost this directive sends a clear political signal that we want our scientists to look for alternative methods of verifying research into new medicines, in order to minimise the number of animals and the number of tests, while naturally complying with all of the possible ethical principles so as to avoid the suffering of animals. I would like to thank you all for this outcome.

  Caroline Lucas (Verts/ALE). - Mr President, I cannot hide the fact that this report has been a serious disappointment to those of us who thought that a rapporteur who was also the president of the animal welfare intergroup might have reflected that concern for animals rather more diligently in his report.

It is therefore essential that some crucial amendments are adopted when we vote on this. In particular, the scope of authorisation must apply to all projects, not just to severe and moderate ones. If we fail to ensure that, it will mean that many procedures causing pain, distress or suffering would no longer be subject to a centrally monitored ethical review and that in turn would effectively undermine the enforcement of many of the measures set out in the proposal as a whole.

But, if our amendments are passed, it will mean that there will be renewed effort going into research and the alternatives to animal testing, which is particularly critical in basic and medical research. Current efforts are concentrated on regulatory testing, which accounts for only 10% of animal use. For the sake of both the animals and human health, it is essential that more modern, effective non-animal tests come into use as soon as possible.

  Stavros Dimas, Member of the Commission. − (EL) Mr President, I should like to thank all the speakers for their very constructive contributions to this evening’s debate. Allow me to formulate some brief comments on certain amendments. The Commission can accept numerous amendments in full, in part or in principle. These amendments include proposals to improve the confidentiality of data relating to installations and staff working with animals. They also include proposals for regular review of the use of non-human primates at European Union level.

Concern was also expressed about the criteria for severity bands. I am in a position to announce to you that, before the summer recess, the Commission will convene a working party of experts to examine the definition of appropriate criteria for use in the European Union. Without doubt, we will need to maintain the balance struck, as a result of detailed consultation with those directly involved, between the needs of industry and the promotion of research, on the one hand, and animal welfare, on the other. Consequently, the restrictions on the use of non-human primates must be retained, as must the principle of licensing and independent ethical evaluation of all forms of research, which are basic elements in this proposal. To recapitulate, the Commission is able to accept 83 of the 202 proposed amendments in full, in part or in principle. I shall send Parliament’s secretariat a list with the Commission’s detailed positions on the amendments.

Finally, I should like to say that, over and above this proposal, which is very important and for which we must maintain the balance between the needs of scientific research and improving human health, while at the same time using methods which are not hard on animals, I must say that the Commission, all the while I have been Commissioner, has taken numerous measures to protect animals. I would remind you of our previous debate on seals, of the very drastic measures and reaction in connection with whale hunting, of the issues relating to unsustainable hunting, especially in spring, and of the measures which we took for the first time as the Commission, with safety measures to prevent precisely such cases.

I truly cannot understand how practices such as fox-hunting or bullfights or cockfighting can be compatible with today’s culture.

  Neil Parish, rapporteur. − Mr President, I should like to thank Members very much for their views and the Commissioner for his views.

We are right to have this review of this legislation. It is right to refine, reduce and replace animal testing wherever possible. We are right to keep the momentum going. Both industry and animal welfare organisations believe this is necessary.

This is an issue which I believe goes well beyond politics and is very much a moral issue that we must get right. I for one am very disappointed – if he were here I would say it to him clearly – that Graham Watson has made a personal attack on me in my own region, making this a highly political issue. This is regrettable because we need to come forward with a sensible proposal in the end.

A lot of technical expertise and work has been put into this report. We do not deliver this report lightly. We have put serious work into it and we have good compromises. I have sought to bring all sides together to deliver a report which is right for Parliament, right for research and industry, and right for animal welfare. I would urge all to support it because, if we do not get it through, we face delaying the report for a couple of years, and this would be detrimental to the industry and to animal welfare. So I would urge all Members to support it.

If there are groups here that decide to vote against it, I think in the long run all it will do is delay what is a good proposal, one which will help to make sure there is research available in the European Union to help with disease control and new medicine while at the same time reducing the number of animals we need to use and actually strengthening ECVAM in looking for alternatives. So I would urge all Members to vote for it because we want a really resounding result in the morning.

  President. − The debate is closed.

The vote will take place tomorrow (Tuesday, 5 May 2009).

Written statements (Rule 142)

  Šarūnas Birutis (ALDE), in writing. – (LT) The draft Commission report strongly supports the development of a more animal welfare friendly approach to the issue of the use of animals in scientific experimentation. This demonstrates the Commission’s commitment towards the end goal of the abolition of animal experimentation.

The European Union should be working towards this goal. The European Parliament has made its belief clear that more should be done towards the final objective of removing animals from scientific experiments altogether.

However, whilst this remains the end goal, we are not yet in a position to end animal experimentation altogether. There remains a huge gap in the development of alternative, non-animal testing methods. Whilst this remains the case, it would be unwise and potentially disastrous for human health to mandate a date beyond which animal testing or testing on certain categories of animals, such as non-human primates, can no longer be carried out. Public opinion polls tend to support this approach and they cannot be ignored.

  Daciana Octavia Sârbu (PSE), in writing. – (RO) I would first of all like to congratulate the European Commission for its proposal to revise Directive 86/609/EEC, but I am sorry that the rapporteur did not put forward more ambitious objectives.

I think that we must invest more in carrying out research into finding alternatives to using animals for scientific purposes. We must oblige laboratories to resort to the use of animals for scientific experiments as little as possible, especially those taken from the wild.

I strongly oppose the use of non-human primates for biomedical research, except only where there is a need to use them exclusively in experiments involving life-threatening or debilitating conditions.

From an ethical standpoint, there must be an upper limit of pain, suffering and distress above which animals must never be subjected in scientific procedures. With this in mind, carrying out experiments which result in severe pain, suffering or stress, and which are likely to be prolonged, must be banned.

I am aware that public health is of paramount importance, but we must not allow animals to be subjected to extreme suffering in order to test treatments.

I also support the amendment stipulating that the directive must not restrict Member States from applying or adopting more stringent national measures, aimed at improving the welfare and protection of animals used for scientific purposes.