Debates

Wednesday, 8 September 2010 - Strasbourg

4. Protection of animals used for scientific purposes (debate)

  President. – The next item is the recommendation for second reading by the Committee on Agriculture and Rural Development on the Council position at first reading with a view to the adoption of a directive of the European Parliament and of the Council on the protection of animals used for scientific purposes (06106/1/2010 – C7-0147/2010 – 2008/0211(COD)) (Rapporteur: Mrs Jeggle) (A7-0230/2010).

  Elisabeth Jeggle, rapporteur. – (DE) Madam President, Mr Dalli, ladies and gentlemen, after almost two years of intensive discussions, we have come to an agreement with the Council and the Commission on a directive on the protection of animals used for scientific purposes. We have achieved a noteworthy balance between the interests of animal welfare and those of research.

For this reason, I would like to express my gratitude to everyone involved for their excellent cooperation in this area. I would also like to thank our former colleague, Neil Parish, who was able to establish a good starting position for Parliament during the first reading in May of last year. I would like to thank all the shadow rapporteurs and the representatives of the Commission and of the Swedish and Spanish Presidencies. Not least, I also want to thank the staff of the political groups and of the committee secretariat. We have all done everything in our power to achieve this compromise.

Compared with the existing directive, which dates back to 1986, this new animal experiments directive represents a quantum leap in animal welfare. Medical research using animals will still be possible if there are no alternatives, but it will be subject to very strict regulations. The principles behind the new directive are to replace and reduce animal testing and to refine animal welfare. The directive lays down comprehensive protection regulations and control criteria for the purpose of improving welfare. By introducing the obligation to carry out an ethical evaluation, which includes a harm-benefit analysis, and the authorisation process for projects, and by standardising and guaranteeing the competence of the people who work with animals, we are putting in place new and fundamental cornerstones.

Experiments in which animals are used may not be carried out without advance authorisation. This includes an assessment of the project on the basis of ethical considerations. Detailed evaluations must be carried out to determine whether a specific animal experiment is needed, whether it can be replaced by an alternative procedure and whether all the animal welfare requirements concerning the severity of the test have been taken into consideration. Wherever possible, researchers must avoid causing distress, suffering and pain to animals.

In addition, at the insistence of the delegation from Parliament, we have been successful in calling for a very strict control and inspection system. The competent authority will adjust the frequency of the inspections, which include unannounced on-site checks, to match the expected level of risk. I am certain that we have managed to find a balance between high levels of animal welfare and the possibility of continuing to carry out research in Europe. This balance takes into account the requirements of research in relation to human dignity and health, does not ignore the legitimate interests of sick people, and introduces a quantum improvement in animal welfare, compared with the standard set in 1986.

In the trialogue negotiations, we reached a compromise which was accepted on 3 June 2010. Ladies and gentlemen, I would ask you to support this compromise and to reject all the proposed amendments.

  John Dalli, Member of the Commission. – Madam President, firstly, I would like to express Commissioner Potočnik’s disappointment at not being able to be here today. He is presently in Ghent, participating at the informal ministerial meeting on the EU position for the 10th meeting of the Conference of the Parties to the Convention on Biological Diversity, which is to take place this October in Nagoya.

I wish to thank Parliament and, in particular, the rapporteurs, Ms Elisabeth Jeggle and former MEP, Mr Neil Parish, the shadows and all those who have worked equally hard in the preparation of this very important piece of legislation. I am delighted to be able to note the excellent collaboration between Parliament, the Council and the Commission.

The negotiation between the institutions and the consultations before and during the codecision procedure proved to be challenging, as the diverse and often sharply divergent views and needs of Member States, industry, academia and animal welfare advocates had to be taken into account and reflected as far as possible in the text. I believe that the result constitutes a fair and workable piece of legislation which successfully strikes a balance between promoting European research and competitiveness and also ensuring that full regard is paid to animal welfare.

The revision was much needed as it was vital to significantly improve conditions for experimental animals, clarify the legal obligations and ensure a level playing field within the EU. Once the new legislation is implemented, the European Union will be able to lay claim to having the highest standards of experimental animal welfare in the world, lifting the bar throughout the 27 Member States of the European Union in a manner that will not compromise, but foster, the competitiveness of our research and industry.

We consider that the text put to your vote today retains all the key elements of the Commission’s original proposal. I therefore believe that if your vote is positive, then the Commission’s ambitious objectives for this revision will have been achieved.

  Herbert Dorfmann, on behalf of the PPE Group. – (DE) Madam President, ladies and gentlemen, all animals need our protection, regardless of whether they are used in animal experiments or for agricultural purposes, are kept as pets or live in the wild.

However, as far as my value system is concerned, an animal is an animal and a person is a person. There is a clear hierarchy of values. For example, over the last few days, we have discussed the fact that it would now apparently be possible to carry out experiments on animals without anaesthetising them first. It is true to say that you can take a blood sample from an animal without sedating it. However, the same applies to people. I do not believe that any of us has ever been sedated before giving a blood sample. The advances made in the field of medicine are of great benefit to mankind and, therefore, animal experiments are unfortunately necessary. In the case of many illnesses, some of which occur very seldom, we are longing for progress to be made in the fields of medicine, science and research. Animal experiments will continue to be needed in these areas.

I am in favour of animal experiments not being used when other equivalent methods are available. The proposal that we have in front of us guarantees this, with one exception, which is that neither people nor human reproductive cells should be used in these alternative methods.

We have reached a good compromise which provides protection for research, for Europe as a research location and, above all, for animals. We should vote in favour of this compromise today to ensure that there is greater protection for animals and for valuable research in Europe.

  Daciana Octavia Sârbu (S&D). – (RO) I would like to begin by thanking both Mrs Jeggle and our other fellow Members, the shadow rapporteurs, for the good cooperation we have enjoyed during the negotiations conducted with the Council in order to reach this compromise.

Approximately 12 million animals are used in scientific experiments every year in the European Union. The need to provide them with better protection has been frequently raised as an issue by the general public.

If it were possible, we would all like to stop animal testing. However, we still need to use them to protect the health of humans and animals, and the environment.

The new provisions added to this directive include the obligation for much more frequent inspections than in the past, without the need to give any prior notice for a large number of them. Prior authorisation is also required for procedures using animals, especially non-human primates.

In fact, a limit has been set on the suffering which an animal involved in scientific procedures can be subjected to and a restriction has been proposed on the use of non-human primates. This means that they can now only be used in procedures aimed at avoiding, preventing, diagnosing and treating illnesses which are potentially fatal to man.

I am pleased that the final text retained the obligation to carry out a regular review of the directive, taking into account the scientific advances made. I wish to emphasise the importance of promoting alternative methods to animal testing, specified in this draft directive.

We are all aware that the current legislative proposal has been on the cards for a very long time. I believe that, following the negotiations conducted with the Council during the Swedish and Spanish Presidencies, we have achieved a balanced common position which meets both the need to protect animals used in scientific procedures and the needs of the scientific community.

  Marit Paulsen, on behalf of the ALDE Group. – (SV) Madam President, I shall try to give you a little of the historical background. Firstly, I would like to thank Mrs Jeggle for her exceptional leadership in this very difficult matter.

We took over the work on a matter in which, to put it briefly, the Commission’s proposal could almost be described as extremely animal friendly and Parliament’s first reading could, to the same extent, be described as extremely industry friendly. Over recent years, with excellent support from the Swedish and Spanish Presidencies, Parliament, under the leadership of Mrs Jeggle, the Commission, the Council, our party groups and the committee officials, have worked our way through it, bit by bit, word by word, to what is now a reasonably balanced directive.

If it is, first and foremost, the animals that we want to protect, then personally I would like to direct attention to the structures that we are currently constructing for the animals that we are eating. In this regard, we have an enormous amount of work to do. As things stand, these animals have a poorer level of protection than animals used in experiments. Look at the long transport routes to slaughter in Europe. Do you not see them when you are on the motorway?

I have been involved with difficult reports and in difficult negotiations before, but I have never actually seen Parliament shift its opinions and decisions according to the position of the particular lobby groups present. I would not have expected that of this Parliament.

  Jill Evans, on behalf of the Verts/ALE Group. – Madam President, I would also like to thank Mrs Jeggle for her hard work on this report. There are significant improvements in the compromise text, particularly on inspections, on the new authorisation process for experiments and on a proper classification system, which we welcome. However, we have been waiting several years for the update of this law, and my group still has three major areas of concern, which is why we submitted the amendments.

We believe Member States should keep the right to introduce stricter rules on animal protection, as they have at the moment and as we agreed at first reading. We believe that alternatives to animals must be used wherever that is possible. The current wording limits the mandatory alternative requirement to a minority of tests carried out, which weakens existing laws and, again, is not what we voted for in the first reading.

On non-human primates, we believe that, without the word ‘substantial’ to define it, a debilitating condition could be interpreted as almost any human ailment rather than as a serious reduction in human health, which is what the intention is here.

We know from experience with legislation in this field that implementation and enforcement are key to achieving effective legislation, and these issues are crucial ones. With the aim of achieving clarity through further discussion, my group will be calling for a referral back to committee.

  Janusz Wojciechowski, on behalf of the ECR Group. – (PL) Madam President, I am pleased that this directive has come into being. I would like to congratulate Mrs Jeggle, because the work needed to achieve this compromise was very difficult. It is good that the European Union is regulating another important area concerning the treatment of animals and that we are adopting solutions which are intended to prevent cruelty towards them. In the previous system of essential experiments conducted on animals, there was much cruelty. This can be reduced, and this directive moves in this direction. Cruelty to animals harms animals and causes their suffering, but most of all, it strikes at man. It is an affront to human dignity. Those who are cruel to animals act against their own humanity and their own dignity. It is good that the resolution adopted by Parliament today is a step in this direction. It does contain one provision about which I have some reservations, but I will talk about this in my statement after the vote.

  Marisa Matias, on behalf of the GUE/NGL Group. – (PT) Madam President, Europe has an obligation to promote the protection of animals, but what is under discussion here goes far beyond this premise and poses us some difficult questions. No belief should be viewed as having an absolute value in itself. We are, however, in the midst of choices and contradictions, and these can only be resolved by balanced legislation.

On a scale of values, should animal well-being be ranked below the value of human health or not? What is the actual European research strategy where human health and basic research are at stake, for example? How can we prevent the abolition of European medical research, as this could ultimately lead to its destruction?

By eliminating these issues, we might salve our European conscience, but we are transferring research into medicine, for example, to other countries where there may be no monitoring of animal welfare. We must have the ability to develop and promote alternative methods for using animals for scientific purposes, but there remains much to discuss, and I very much hope this matter will be examined more closely.

  Giancarlo Scottà, on behalf of the EFD Group. – (IT) Madam President, ladies and gentlemen, it is both important and necessary to achieve a balance between the need to advance scientific research and the need to protect animal welfare.

Protection for animals used in scientific procedures is currently inadequate. New scientific knowledge means that alternatives can be promoted to replace or reduce the use of animals. Methods or procedures must be used that cause as little pain and suffering as possible, but without impeding scientific research designed to fight diseases.

It is therefore right to review Europe’s animal protection legislation in order to achieve satisfactory results that both meet the demands of the research industry, given the need to pursue scientific research that benefits human health, and, at the same time, look after the welfare of those animals still needed for scientific purposes.

IN THE CHAIR: Stavros LAMBRINIDIS
Vice-President

  Mike Nattrass (NI). – Mr President, the Commission proposed this directive in 2008 and there were concerns about placing excessive burdens on the scientific research industry. The proposal will dilute certain restrictions and I note that the requirement for sharing animal research data has been removed.

Some 12 million animals are being used in experiments in the EU each year and this proposal could increase their suffering. We must reduce the need for experimentation on animals.

Civilised human beings will try to strike a balance between the need for research and the obligation to respect the lives of other creatures on this planet. These decisions require the wisdom of Solomon. I regret, I have to say, I have to ask the question: does the EU Parliament have such wisdom?

  Martin Kastler (PPE). – (DE) Mr President, ladies and gentlemen, we are taking a new and important step forward in the field of animal welfare by providing more protection for animals used in scientific research.

We have heard a great deal about animal welfare. We have also heard that Europe is an important location for industrial research and innovation. However, there is one issue which we have not talked about enough. This concerns a fundamental value of the European Union, namely human dignity, and the question of how we handle it. I believe that we must not, on the one hand, improve animal welfare and, on the other, expose ourselves to risks in an area which, at least in part, runs counter to our European values.

Why am I saying this? The European Commission has referred to alternative methods in its documents. These include five methods relating to research into and use of embryonic stem cells and, in particular, human stem cells. In my opinion, this is immoral. It is something which I cannot ignore when it comes to voting today on the proposed compromise between Parliament, the Council and the Commission. Therefore, I would like to call on you and, in particular, on the Council, the Member States and the Commission, in the form of the so-called Regulatory Committee, to take a highly sensitive approach. When we show concern for human dignity, this does not mean that we are opposed to animal welfare. On the contrary, we want both of these things. We want to cooperate to protect the dignity of living creatures, whether they are animals or humans, in a way that corresponds to our European concept of dignity, so that we can work together to defend and support it.

One of Europe’s trademarks is that we are prepared to fight for human freedom and dignity. For this reason, I will not be able to take part in today’s vote, because in moral terms, it is not possible for me to do one thing and ignore another. Discussing this subject today was the right thing to do, but the third dimension of human dignity has come off rather badly.

  Paolo De Castro (S&D). – (IT) Mr President, Commissioner, ladies and gentlemen, after a year and a half of difficult negotiations between Parliament, the Council and the Commission, we have at last arrived at a compromise text in the sensitive dossier on animal experimentation. It has been difficult work and I should like to thank our rapporteur, Mrs Jeggle, and our shadow rapporteurs, for having carried out such intense negotiations.

The text was adopted unopposed, with only 4 abstentions, by the Committee on Agriculture and Rural Development, which it is my honour to chair. It achieves a good balance between the need to improve the welfare of animals used in experiments and the need to allow for progress in medical research. The proposal aims to examine and improve the 1986 directive, which is now obsolete, and harmonise European regulations on the subject.

Animal experimentation is a particularly sensitive topic for all of us as well as for the general public, but I can say with conviction, ladies and gentlemen, that the text on which we are about to vote is reasonable and the outcome of serious, meticulous work. It is a definite improvement on the existing legislation in terms of animal protection while, at the same time, it does not lose sight of our moral responsibility to advance medical research.

  George Lyon (ALDE). – Mr President, there are clearly strong views on both sides of this argument. The argument is quite clear. It is about those who believe that the rights of animals should take precedence and those of us who believe in the rights of society to see progress in the development of medicines, treatments and cures for the infirm, the ill and those who are suffering. We need to get that balance right. Yes, we need to protect animals, but we need to make sure that our scientists have the tools to be able to develop the new medicines that will provide cures in the future for some of the most desperate diseases that we face as a society.

I think that in this argument, the text in front of us gets the balance right between these two points of view. I believe that the protection of animals and the rights of society are dealt with properly, and we have the balance right here in the text before us. I would like to pay tribute to Mrs Jeggle and all the shadow rapporteurs for the work they have done.

I would ask at this late stage in the day for the Greens to think twice about the amendments they are putting forward. This has already been covered in the debate. We have had a negotiation. I believe the text actually takes their concerns into account and deals with them. This is a subject that is too important to play politics with and I would ask, at this late stage, that they think about withdrawing before we get to the vote.

  Carl Schlyter (Verts/ALE). – (SV) Mr President, the fight on behalf of animals goes hand in hand with the fight for better research. Anyone who defends animal experiments weakens research. There is a tradition, a false belief in the effectiveness of animal experiments. More and more medicines involve human-specific reactions and, for this, animal experiments are completely worthless. The alternatives, however, are effective, as well as quicker and cheaper. The amendments tabled by the Group of the Greens/European Free Alliance aim to help the animals and research, so I recommend that you vote for them instead.

Moreover, there is a loophole that allows the use of monkeys. We should close this loophole with the amendments proposed by the Greens. Monkeys can only be accepted in the worst case scenario for serious human disease symptoms – there are no loopholes there.

Finally, countries must have an opportunity to lead the way when it comes to protecting animals and testing new methods. Only then can Europe become a world leader in this area with regard to animal protection and medical research.

  John Stuart Agnew (EFD). – Mr President, as a farmer, I have always wanted to see animals properly treated and it is my belief that in the UK they are, at least by our scientific community.

I have visited Huntingdon Life Sciences in my constituency and I know that dedicated people are doing only what is necessary for scientific progress. This institution carries out essential tests on drugs that, in a few years’ time, may protect the life of somebody in this Chamber. Every employee there has an obligation to be a whistleblower if they have evidence of the maltreatment of animals.

We cannot and must not impose unnecessary controls which arbitrarily restrict certain approaches. These three amendments will not enhance animal welfare, but their imposition will impede research. They are, inter alia, a recipe for legalistic conflict which does nothing to advance medicine but may line lawyers’ pockets.

Frankly, the EU needs to apply rather more the concept of ‘if it isn’t broken, don’t fix it’. In the UK, we have a sensible regime, a responsible scientific community – including, in my own constituency, that powerhouse of global scientific progress, Cambridge University – and balanced laws which sensibly address the needs of both science and animal welfare. That careful balance needs to be preserved. My message to the EU on this is straightforward: just for once, leave well alone.

  Miroslav Mikolášik (PPE). – Mr President, the directive that we are discussing aims to limit animal tests and improve the conditions of animals used for research.

In Europe, we already have the highest animal welfare standards in the world and this directive will raise those standards even further. That is very commendable. Nonetheless, we must bear in mind that human beings and their prosperity mean more than the well-being of animals, and that there is a fundamental difference in dignity between animals and human beings.

I appreciate the balance between stricter rules on animal welfare and the use of animals, while still allowing research under strict conditions. I support the ‘three Rs’ principle: replace animal tests whenever possible with other methods; reduce the number of animals used to a minimum; and refine standards for breeding, accommodation and care.

Animal tests will only be allowed when no alternative method is available. At the same time, medical research will still be possible. That will provide a balance between the ethical necessity of the reduction of animal testing and the requirements of modern medical research.

Here, I would like to strongly oppose alternative methods to animal testing that might include tests based on the use of human embryonic stem cells. I am concerned about those Member States whose domestic laws do not explicitly exclude from compulsory alternative testing those methods which involve the use of human embryos. When this directive comes into force, Member States might be obliged to ensure that these alternative methods are applied, whether or not they are based on stem cells from embryos.

I will therefore abstain in the final vote, and call on Member States to provide for alternatives other than those involving the destruction of human life.

  Luis Manuel Capoulas Santos (S&D). – (PT) Mr President, Commissioner, ladies and gentlemen, I would also like to begin by congratulating Mrs Jeggle on the excellent work that she has done on behalf of Parliament and the Committee on Agriculture and Rural Development, in conjunction with the Commission and the Council. Following a year and a half of successive negotiations under the Swedish, Spanish and Belgian Presidencies, it was possible to reach a balanced compromise between the demands of the scientific community and what we might call ‘animal welfare’ in these circumstances.

The majority required to achieve this result was reached during a very emotional and intense debate in which all parties made concessions. There was also broad involvement from the public, as is to be expected in a matter as sensitive as this. Yet policy makers must make decisions, and while we should not be devoid of sensitivity towards animal suffering, we must make choices and rank values. The position represented by Mrs Jeggle today centres upon of a ranking of values that seems well balanced between the benefits for human health and the suffering of animals. The Group of the Progressive Alliance of Socialists and Democrats in the European Parliament will therefore vote in favour of the report and reject any amendments.

  Jorgo Chatzimarkakis (ALDE). – (DE) Mr President, firstly, I would like to express my gratitude to and respect for Mrs Jeggle, who has been working on this report for years. However, Mrs Jeggle, there is one thing that I must say. As Europeans, we cannot take pride in this report. It is too vague and it permits too many things which a country or a continent that plays a leading role in animal welfare throughout the world should not allow.

I foresee a worsening of the situation, in particular, as far as the reuse of experimental animals is concerned. Previously, this was more difficult, but I believe that the regulations have now been watered down. You are shaking your head, but it is true that when you look at this carefully, the small print and the nuances in the wording are the things that make the difference. The severity of the tests is also an area where, in many Member States, things are likely to get worse. Some Member States, such as Germany, the United Kingdom and Sweden, had already gone further than this. We have introduced a pain threshold and the Council has watered it down by permitting exceptions. In addition, the power of the Commission has been reduced with regard to inspections.

Nevertheless, I will be voting in favour of this report, Mrs Jeggle, because it represents an improvement on the 1986 directive, which is now 24 years old. The authorisation mechanisms are in place. A licence is needed in advance for three stages of testing, which is a good thing. The procedures have been simplified, which is also a positive step. Personally, I am proud of the fact that we have been able to rescue the subject of alternative test methods from the last parliamentary term. However, we will need to provide more funding for this.

This directive will have to be revised within the next seven years. It represents quite a good foundation, but in seven years, we will need to improve it so that we can live up to our reputation here in Europe for having the highest levels of animal welfare in the world.

  Maria do Céu Patrão Neves (PPE). – (PT) Mr President, the report being presented in this Chamber today comes from our fellow Member, Mrs Jeggle. It is aimed at finalising a process that has been as long as it has complicated, and has only been possible through hard work and skilled dialogue, and so we would like to thank her for it.

Whenever the matter under consideration involves not only multiple interests but also moral values, it triggers not only solid, rational arguments but also an emotional response. This does not help to achieve the consensus that we are hoping for here, in order to serve the European public while respecting the views of the various political groups and Member States. This would allow us to contribute to European integration through the preparation and presentation of common standards. It is precisely this hoped-for standardisation of criteria that is at issue in this report, in an approach that assumes a higher level of protection for animal life.

This has meant that over the two years following the decision to revise Council Directive 86/609/EEC on the protection of animals used for scientific purposes, and acknowledging the disparities between Member States in this regard, there has been an attempt to establish more detailed rules on this matter, with the aim of reducing procedural disparities. In doing so, it was important to balance a greater level of protection for animals used for scientific purposes with the need to safeguard the necessary conditions for biomedical research, which allow it to develop within the European Union. This balance has been achieved in the text which we are to vote upon shortly.

This will benefit the animals under our protection, and it fulfils our human responsibilities towards animals without compromising the quality and progress of biomedical research which helps us all, every day.

  Ulrike Rodust (S&D). – (DE) Mr President, ladies and gentlemen, we should vote in favour of this report on the animal experiments directive. In its negotiations with the Commission and the Council, Parliament has achieved a great deal: namely replacement, reduction and refinement.

It is true that from an animal welfare perspective, we are still doing too little. However, the Council was not prepared to do more and has made it clear that there would be no new directive if we did not accept these results. This does not mean that we cannot continue to make progress in this area in future. Animal welfare and research must be given high priority in our policies. I would be very happy if we were able to stop animal experiments completely today. Unfortunately, we are a long way from achieving this goal and, therefore, we must ensure that we provide animals with as much protection as possible.

The compromise that has been negotiated offers a far better foundation for doing this. The only important thing is to make sure that all the Member States implement the new directive consistently. I would like to thank the rapporteur and all the shadow rapporteurs warmly for their hard work.

  Cristiana Muscardini (PPE). – (IT) Mr President, ladies and gentlemen, the rapporteur and those who have worked with her have certainly done a difficult job, for which we thank them.

Personally, however, I cannot hide the fact that along with several members of the Italian Government, which I support, I am puzzled about an issue that, even after 24 years, still does not appear to have been sorted out as we would have liked it to be.

Some Members have pointed out that animal sensitivities are different to those of human beings. Indeed, no animal would ever do what is happening, what has already happened and what is yet to happen in Iran. In general, animals do not torture, stone to death or tell those lies that are so typical of our own political world.

We must rightly call for these animals to be useful to us in advancing scientific research and improving human health, but we do not have the right to call for them to continue to be subject to useless, repetitive experiments that only serve to line the pockets of some so-called researcher.

We are very well aware that in vitro experiments or computer simulations of human metabolism make it possible to achieve more accurate results today than can be achieved by animal experiments, because the results of an experiment often cannot be extrapolated from one species to another, either between animals or from an animal to human beings.

For these reasons, we hope that this directive will be revised to be more in tune with current trends and mutual respect.

  Elisabetta Gardini (PPE). – (IT) Mr President, ladies and gentlemen, I should like to thank the rapporteur and the shadow rapporteurs for the result they have achieved. I think we have obtained the best possible compromise between the needs of research and ensuring the welfare of animals used for scientific purposes.

Unfortunately, animal-based research is still essential since no alternatives exist. Computer simulations and cell cultures are not enough, and it is not politicians that say this, but researchers. I should like to remind the House that cures for some very serious diseases have been developed precisely because of tests carried out on live animals. Ninety-eight per cent of these animals are rodents, which means that larger species are used only to a very minor extent. I must also point out that it is thanks to these tests that today we have cures for leukaemia, diabetes and some kinds of tumour. Lastly, I would point out that researchers are the first to want to avoid unnecessary suffering, and I think one just has to see them at work to realise that.

It is true that there are still some sections that cause concern. I should like to refer to one that has not yet been mentioned: in Article 49, all reference to ethics committees has disappeared and has been replaced with the more generic national committees for the protection of animals. That has rung some alarm bells among those working in the area, because ethics committees already exist in many laboratories and others are being set up. There is a fear, therefore, that these committees may somehow have their role diminished, and they may even be replaced by more general committees that are less well prepared both ethically and scientifically.

  Rareş-Lucian Niculescu (PPE). – (RO) I would first like to thank the rapporteur, Mrs Jeggle, on the fine job she has done. I also support my fellow Members who have spoken today against the three amendments to the common position.

This is not a perfect compromise, although it is the best possible wording at the moment.

The content of the draft has been produced after consulting with eminent scientists who know what they need to be able to continue their research.

Any amendment to the compromise will lead to a resumption of the usual procedure, which, in my view, is not in anyone’s interest. This is why I am calling on all fellow Members taking part in today’s vote to reject the three amendments and allow European research to perform at its best.

  Anna Záborská (PPE). – (FR) Mr President, Commissioner, I call on the Council and the Commission to guarantee the ban on the use of embryonic or adult cells from human beings to protect animals.

The current situation in fact allows for human material to be used to protect animals during necessary experimentation. We always talk about compromise, and the result of this culture of compromise is that we no longer know what is ethically acceptable and what is not. However, there are some ethical issues for which no compromise is possible. If the Commission and the Council cannot guarantee this ban, it will be factual evidence of how the EU treats human beings.

I am sorry, but without this guarantee, I cannot support the text of the proposed directive.

  Karin Kadenbach (S&D). – (DE) Mr President, Mr Dalli, we are very much agreed that we need to provide the best healthcare for the citizens of Europe. This includes reliable medicines with as few side effects as possible and the latest modern treatment methods. Unfortunately, given the current state of scientific progress, we cannot do this without animal experiments.

Therefore, I see this report as a highly successful attempt to bring about a balance between animal welfare and human healthcare provision. The three Rs, replacement, reduction and refinement, are the basic requirements for actually achieving this, given that we have spoken so often today about human dignity, which for me also includes respect for animals.

We need advance authorisation, strict controls and effective inspection systems. Legislation on its own is not enough. We must remain vigilant and ensure that the contents of the reports are actually put into practice.

  Frédérique Ries (ALDE). – (FR) Mr President, I think that we are all agreed on this issue: in an ideal world, there would be no need for research on animals. However, the reality is that we live in a suffering world, one in which sick men, women and children are waiting for treatment and hence for the results of this research, which is vital and crucial. This is why we must support the excellent compromise reached by Mrs Jeggle, from the Committee on Agriculture and Rural Development, and the Council.

As has been stated, the agreement minimises animal suffering but does not restrict this research, which is vital for millions of patients in Europe and throughout the world. Did you know that 70% of the Nobel Prizes in Medicine have been won for work based on animal experimentation?

This text does not ask us to choose between mice and men; this directive protects both patients and animals. This directive protects our future.

  Martin Häusling (Verts/ALE). – (DE) Mr President, ladies and gentlemen, these regulations are better than those which we had previously. I think we all agree on that. However, I think it is very rash of you, Mrs Jeggle, to say that there is no alternative to the compromise. I think we could have got more out of the situation.

Of course, it is true that the research lobby exerted a great deal of pressure. We were all aware of that. However, have we achieved our main objective, which is a reduction in the number of animal experiments? There is still a big question mark over this. The other problem is, of course, that the use of non-human primates has not actually been reduced.

We in the Group of the Greens/European Free Alliance find it most disturbing, and we also believe it is a serious violation of European principles, that the Member States will not be permitted to put in place regulations which are stricter than those in the existing legislation. This situation must change. It needs serious reconsideration. That is the first point in the amendments submitted by the Greens and that is why we will not be withdrawing these amendments. We are calling for the proposal to go back to the committee.

  João Ferreira (GUE/NGL). – (PT) Mr President, the development of techniques and methods which dispense with the need for experimenting on animals and which minimise the suffering inflicted on animals, in cases where this is necessary, should be an important objective of scientific research, and the experimental and technological development that it is important to stimulate. Apart from such development, the need to disseminate these techniques and methods should be taken into account, along with their uptake by research and development institutions, and national scientific and technological systems with various levels of development.

The European Union must take on an important role in this field by promoting cooperation between the scientific and technological institutions and systems in different countries, including third countries. We believe – in this field as in others, naturally – that the establishment of common minimum levels of protection in legislation should not prevent an individual Member State from adopting higher levels of protection if it so wishes.

  Anna Rosbach (EFD). – (DA) Mr President, improvement of the directive on the protection of animals used for scientific purposes is something I can only support. However, it is a little paradoxical, as I am in fact opposed to animal experiments. Alternative test methods do exist, and fortunately, the revision of the directive includes this area. I am very grateful for that. I hope that greater momentum is given to the development of more alternative test methods. Right here and now, however, the EU must introduce humane and secure rules for animals used in experiments. It is finally being recognised that animals are sentient beings and so we will now introduce pain limits. Why, however, are we not introducing a section prohibiting the use of the same animals again and again? Why are we not prohibiting the use of monkeys in brain research? It makes me angry that we take so much more account of the interests of interested organisations than we do of animal welfare. I also find it frustrating that we are only able to legislate for the EU in this House, because how are animal experiments dealt with outside the EU?

  Laima Liucija Andrikienė (PPE). – Mr President, I welcome the Commission’s initiative. I think it is an important achievement that we have managed to agree on the harmonisation of practices in the area of animal experimentation in the EU.

This directive marks an important step in ensuring that experiments on live animals for scientific purposes will be replaced as soon as it is scientifically feasible to do so. This directive will first oblige the Member States to promote the advancement of alternative methods. I strongly urge the Member States to ensure that adequate funding is provided for training, research, development and the implementation of scientifically satisfactory methods or testing strategies that do not entail the use of animals.

  Paul Rübig (PPE). – (DE) Mr President, as a member of the Committee on Industry, Research and Energy, I naturally welcome these regulations and the agreement that has been reached here. I know that it is always difficult to come to a compromise, but we need suitable ethical standards both for animal experiments and for human trials, and we can only implement the highest standards that are currently available.

Of course, it is also important for us to develop alternatives. The Eighth Framework Programme for Research and Technical Development must focus heavily on alternative test methods. In addition, we also need simpler procedures and this is what is laid down in these regulations. An evaluation after seven years will be of major benefit to the industry, because the safety of the processes and the clear, standardised European regulations will also bring legal certainty for the industry.

  Elisabeth Köstinger (PPE). – (DE) Mr President, I would like to state clearly that Europe has the highest animal welfare standards in the world. This report represents another important step towards improving animal welfare even further. Our joint objective is to restrict animal experiments and to improve the living conditions for animals used for research purposes. I welcome the fact that animal experiments will be replaced by other methods wherever possible and that the standards for breeding, housing and caring for these animals will be improved. However, I would like to look back to some of the experiences of the agricultural sector and to express my criticism of some of the points in the report.

We should not assume that more red tape in the field of research will improve animal welfare. Research and the related downstream economic sectors in Europe must not be put at a disadvantage internationally and when compared with other industries. It is true that both here and in the agricultural industry, when society calls for higher standards of animal welfare, we need to consider the standards which apply to imported products. The high European quality and animal welfare standards must receive adequate recognition with regard to fair competition. The rapporteur, Mrs Jeggle, has done an excellent job with this highly sensitive report and deserves our support.

  John Dalli, Member of the Commission. – Mr President, first of all, I would like to thank you for your comments and the general support for the provisions included in this directive.

We have before us an ambitious directive that, if adopted, will significantly improve animal welfare in the EU. I agree with Ms Sârbu that full and faithful implementation will be key for the directive to fulfil its potential. That challenge is just beginning. Today, we can be satisfied that a good compromise has been reached on a difficult but important file, and that a big step forward can be made on improving the lives of animals still needed in scientific procedures.

I will now give my reactions to some of the comments that were made this morning. Regarding the comments made by Ms Evans, it has to be realised that this directive provides further legal clarity to today’s situation. In addition, in basic and applied research for which no EU methods are prescribed, Article 4 is very clear in requiring the use of alternative methods wherever possible. Therefore, the requirement to use alternative methods is not weakened; on the contrary, it is further strengthened.

As for the comments made by Mr Kastler and Mr Mikolášik about human embryonic stem cells, this matter was not disregarded in the discussions. It was discussed at length during the negotiations, and the solutions found reflect the fact that there is no consensus in the EU as to whether human embryonic stem cells should be used. The Commission therefore believes this is best regulated at national level.

The agreed text answers these concerns by leaving the decision on whether to allow their use to each individual Member State. It must be added that, in Member States where there is no explicit legislation prohibiting the use of embryonic stem cells, the use of such a testing method would only be obligatory under the revised directive if this testing method were recognised by EU legislation. No legislation of this kind exists at EU level, and any such legislation would require Member States to agree to its being passed.

As for the ethical evaluation mentioned by Ms Gardini, the concept of ethical evaluation and the committee carrying it out remain firmly in Article 38. However, the word ‘ethical’ had to be removed during the Council discussions. The full requirement remains.

I hope that, with your vote, you will send a strong signal that the European Parliament stands behind the outcome negotiated by the institutions under the skilful leadership of Ms Jeggle and the Swedish Presidency. Today, we have the chance to bring the EU to the forefront in combining a high level of animal welfare with quality science. Let us live up to our slogan: ‘The EU – caring for animals, aiming for better science’.

  Elisabeth Jeggle, rapporteur. – (DE) Mr President, Mr Dalli, ladies and gentlemen, I would like to extend my sincere thanks to you, Mr Dalli, for your remarks, which have clarified certain issues and which I do not need to repeat. I would also genuinely like to thank all my fellow Members for their comments.

It is clear that this is a highly sensitive subject which involves a number of different interests that we have had to bring together. I am calling on everyone to vote in favour of the report that is now in front of us, which I admit is a balancing act.

Mr Häusling, if we reject this report now, the directive from 1986 will continue to apply for a long time, which will not improve the situation of laboratory animals. We will not be able to introduce any new legislation in the near future. The amendments which you have once again submitted were rejected by the Committee on Agriculture and Rural Development. There was no support for your amendments. You have now tabled them again. It is your right to do so and I respect that right.

What use is the highest standard of animal welfare in the European Union if we cannot implement the same standard throughout the world? The important thing for us all to do now is to ensure that the legislation which we will hopefully be adopting later today is implemented in the Member States over the next few years. That is a challenge for us. Firstly, we must make sure that all the Member States reach the same high standard in this area. That is our first task and we should not already be calling for individual Member States to implement higher standards.

Where there are already higher standards, and I am speaking here as a German about Germany, these standards will remain in place. We are not asking some states to take a step backwards. On the contrary, we respect the sovereignty of the Member States, in the same way as we do in the case of research using embryonic stem cells. This is the right thing for us to do and it is an important point.

If you really want higher standards of animal welfare, then please vote in favour of this report and reject all the amendments.

  President. – The debate is closed.

The vote will take place on Wednesday, 8 September 2010.

Written statements (Rule 149)

  Pavel Poc (S&D), in writing. – (CS) I welcome and support the Directive of the European Parliament and of the Council on the protection of animals used for scientific purposes from the rapporteur Mrs Jeggle, because the compromise achieved represents progress compared to the current situation. However, I am at the same time unhappy about the fact that it was not possible to include all invertebrates within the scope of the directive in the final draft. The European Parliament requested that the scope of the directive at least include those species of invertebrates that have been scientifically shown to have the potential for registering pain, distress, fear and lasting harm. The draft does not even mention this request. Although I acknowledge the need to use animals for scientific research, I firmly believe that the directive should have gone further and included within its scope all creatures without exception. Let us not forget that our understanding is still expanding the range of creatures in respect of which official scientific bodies acknowledge the ability to feel pain, distress and fear and to suffer lasting harm. We can therefore deduce that the ability to feel fear, distress and pain is distributed throughout the animal kingdom. The acknowledgement of this fact is a matter more of morality than science. We have unfortunately demonstrated through the adopted compromise that European culture has yet to rid itself of the Cartesian concept of an animal as a thing, and that we still have a long way to go in this respect.

  Konrad Szymański (ECR), in writing. – (PL) In relation to the procedure for second reading, Members were not able to express their opinions on the final form of the Directive on the protection of animals used for scientific purposes (the Jeggle report). I would now like to use this opportunity to make clear my fundamental opposition to the consent given in the directive to the use of embryonic stem cells as an alternative to experiments on animals for scientific purposes. This is the outworking of an erroneous anthropology, which allows the possibility of destroying human life in the earliest phase of its development in order to improve the welfare of animals. The guarantees proposed by the European Parliament at first reading were much more explicit in this respect. The ambiguous provisions of the directive constitute a real threat to existing law in countries such as Germany, where embryos enjoy a degree of protection. The fact that these research methods have not been ruled out is an outright imposition of their legality in countries such as Poland, Ireland and Malta.