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I. INTRODUCTION
The Rapporteur, Mr Neil PARISH (EPP/ED - UK), presented a report on behalf of the Committee
on Agriculture and Rural Development consisting of 161 amendments (amendments 1-161). In
addition, the PES political group tabled five amendments (amendments 162-166), the EPP/ED
political group tabled four amendments (amendments 167-170), the Greens/EFA political group
tabled fifteen amendments (amendments 171-181 and 191-194), the ALDE political group tabled
eight amendments (amendments 183-190) and the EUL/NGL political group tabled eight
amendments (amendments 195-202). Amendment 182 was cancelled.
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II. DEBATE
The Rapporteur opened the debate, which took place on 4 May 2009, and:
· welcomed the Commission proposal as a good start, but stated that the omission of definitions of a severity classification was a great gap because the Commission was in effect asking the
Parliament to make a judgement on the rules surrounding the classifications without knowing
what they actually were;
· stated that the recommendations on the re-use of animals and on the proposed use of only F2 primates (second-generation primates) were likely to result in more animals being used;
· noted that in the case of F2 primates no feasibility study had been performed to determine whether the Commission's proposal was possible. The impact assessment only looked at the
numbers; it did not look into the welfare implications. The Commission's proposal in this
respect had to be amended, not to weaken it but to make it clear exactly when testing on animals
should be allowed and under what conditions;
· argued that the amendments contained in the report of the Committee on Agriculture and Rural Development struck a compromise between ensuring that research could continue in the EU and
improving animal welfare. From the animal welfare perspective, they constitute progress. The
amendments are intended to promote alternatives to animal experimentation through a financial
commitment, more emphasis on the `Three Rs' and the strengthening of the role of ECVAM;
· noted that he had proposed regular thematic reviews of primate experiments in order to identify and phase out those experiments which are not necessary;
· argued that the Committee's amendments constitute progress for medical research. They will update the current, outdated, legislation and will allow medical research to continue as and
when that research is scientifically and ethically justified;
· recognised that everyone would like to see a reduction in animal testing, but also recognised that European citizens demand that the best and most effective medicines should be made available;
· argued that, unless and until adequate alternatives become available, it would be unwise to outlaw animal experimentation, either directly or indirectly through badly drafted legislation.
The proposed Directive would establish a framework to ensure that animal testing can be phased
out as soon as alternative methods become available. It also significantly improves research for
alternatives and thus paves for the way for the eventual phasing out of all animal testing;
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· stated that the ALDE political group appeared to be trying to wreck the compromise agreement reached in the Committee, but called on it not to vote against the Committee's amendments
because that would set animal welfare back by several years.
Commissioner DIMAS:
· noted the different standards that are in force across the various Member States. The proposed Directive would harmonise the different regimes and boost the internal market;
· argued that the proposed Directive would reduce animal testing and lead to more humane treatment of animals; and
· stated that there was no reason to believe that the Directive would lead to a mass exodus of scientists from the European Union. Some Member States already apply the proposed rules.
There was no conflict between the two objectives of promoting scientific research and
improving animal welfare.
Speaking on behalf of the Committee on the Environment, Public Health and Food Safety, Mr
Marios MATSAKIS (ALDE - CY):
· stated with regret that animal experimentation is necessary, but called for animals to be treated as humanely as possible;
· welcomed the safeguarding of the principles of ethical review and authorisation as well as the concepts of enhanced national inspections and increased transparency; and
· called for the use of animals in research to be phased out if and when alternative and effective methods beome available.
Speaking on behalf of the EPP/ED political group, Mrs Elisabeth JEGGLE (EPP/ED - DE):
· called for equal animal welfare standards in all Member States;
· opposed the banning of animal experimentation in the absence of adequate alternatives; and · gave her support to the compromise contained in the report of the Committee on Agriculture and Rural Development.
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Speaking on behalf of the PES political group, Mrs Roselyne LEFRANÇOIS (PES - FR):
· noted that, whilst the level of animal experimentation has remained constant over the last twenty years, the number of scientific publications in the biomedical research field has been doubling
every two years;
· called for the strengthening of the human health dimension in the Commission's proposal;
· welcomed the Rapporteur's support for her initiative to alter the balance of the Commission's proposal to make sure that research is not adversely affected; and
· supported the amendments tabled by the Committee on Agriculture and Rural Development.
Speaking on behalf of the ALDE political group, Mr Jorgo CHATZIMARKAKIS (ALDE - DE):
· welcomed the Commission's proposals for: o preliminary authorisation and subsequent controls;
o the extension of the current scope from mammals to all animals; and
o the limitation of experimentation on primates to research on certain specified medical
conditions.
· opposed the amendment tabled by the Committee on Agriculture and Rural Development that would allow for tests which have not been approved within sixty days to receive automatic
approval by default;
· called for Article 15 to be ultimately worded in such a manner that it did not require Member States with high animal welfare standards, such as the Netherlands, to lower their standards; and
· rejected warnings that raising standards too high would drive research out of Europe.
Speaking on behalf of the EUL/NGL political group, Mrs Kartika LIOTARD (EUL/NGL - NL):
· stated that the main purpose of the Directive should be to improve animal welfare rather than to increase corporate profits; and
· emphasised the importance of animals not suffering long-term pain as a result of experimentation.
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Speaking on behalf of the IND/DEM political group, Mr Bastiaan BELDER (IND/DEM - NL)
agreed with the Rapporteur that it is not yet possible to set a date for prohibiting all animal
experimentation. To do so would be to jeopardise human health.
Mrs Françoise GROSSETÊTE (EPP/ED - FR) stressed the need to avoid driving research out of the
European Union.
Dr Caroline LUCAS (Greens/EFA - UK) called for the scope of authorisation to apply to all
projects. Otherwise, many procedures causing pain, distress or suffering would no longer be subject
to a centrally monitored ethical return. This in turn would effectively undermine the enforcement of
many of the measures set out in the Directive.
Commissioner DIMAS once more took the floor and:
· welcomed those tabled amendments concerning the improvement of data confidentiality, of installations, and of personnel standards. He also welcomed the proposal for regular reviews;
and
· stated that the the Commission would convene before the summer recess an expert group to determine which critieria should be applicable throughout the European Union. A balance needs
to be struck on the basis of consultation of all interested parties.
III. VOTE
The parliament adopted 167 amendments when it voted in plenary on 5 May 2009. The text of the
amendments adopted and the European Parliament's legislative resolution are annexed to this note.
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ANNEX
(5/5/2009)
Protection of animals used for scientific purposes ***I
European Parliament legislative resolution of 5 May 2009 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))
(Codecision procedure: first reading)
The European Parliament,
having regard to the Commission proposal to the European Parliament and the Council
having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the
Commission submitted the proposal to Parliament (C6-0391/2008),
having regard to Rule 51 of its Rules of Procedure,
having regard to the report of the Committee on Agriculture and Rural Development and the
opinions of the Committee on the Environment, Public Health and Food Safety and the Committee on Industry, Research and Energy (A6-0240/2009),
-
1.Approves the Commission proposal as amended;
-
2.Calls on the Commission to refer the matter to Parliament again if it intends to amend the
proposal substantially or replace it with another text;
-
3.Instructs its President to forward its position to the Council and the Commission.
Amendment 1
Recital 6
Text proposed by the Commission Amendment
(6) It is necessary to include specific invertebrate species within the scope of this Directive, as there is scientific evidence of the potential ability of such species to experience pain, suffering, distress and lasting harm. (6) It is desirable to include specific invertebrate species within the scope of this Directive, where there is scientific evidence of the potential ability of such species to experience pain, suffering, distress and lasting harm.
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Amendment 2
Recital 7
Text proposed by the Commission Amendment
(7) This Directive should also cover embryonic and foetal forms of vertebrate animals, as there is scientific evidence showing that such forms in the last third of their development have an increased risk of experiencing pain, suffering and distress, which may also affect negatively their subsequent development. Scientific evidence has also shown that procedures on embryonic and foetal forms at an earlier stage of development could result in pain, suffering, distress or lasting harm, should the developmental forms be allowed to live beyond the first two thirds of their development. (7) This Directive should also cover embryonic and foetal forms of vertebrate animals, in cases where there is scientific evidence showing that such forms in the last third of their development have an increased risk of experiencing pain, suffering and distress, which may also affect negatively their subsequent development. Scientific evidence has also shown that procedures on embryonic and foetal forms of species of mammals at an earlier stage of development could result in pain, suffering, distress or lasting harm, should the developmental forms be allowed to live beyond the first two thirds of their development. Amendment 3
Recital 8
Text proposed by the Commission Amendment
(8) While it is desirable to replace the use of live animals in procedures by other methods not entailing the use of live animals, the use of live animals continues to be necessary to protect human and animal health and the environment. (8) The use of live animals continues to be necessary to protect human health, animal health and the environment, within current scientific limitations. However this directive represents an important step towards achieving the goal of the full replacement of procedures on live animals for scientific purposes as soon as it is scientifically possible to do so. To that end, this directive seeks to facilitate and promote the advancement of alternative methods and to ensure a high level of protection for animals used in procedures. This directive should be reviewed regularly in light of evolving scientific and animal protection measures.
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Amendment 4
Recital 8 a (new)
Text proposed by the Commission Amendment
(8a) In light of scientific progress, the use of animal experiments remains an important means of ensuring a very high standard of research into public health.
Amendment 5
Recital 9
Text proposed by the Commission Amendment
(9) The care and use of live animals for scientific purposes is governed by internationally established principles of replacement, reduction and refinement. To ensure that the way in which animals are bred, cared for and used in procedures in the Community is in line with that of the other international and national standards outside the Community, the replacement, reduction and refinement should be considered systematically when implementing this Directive. (9) The care and use of live animals for scientific purposes is governed by internationally established principles of replacement, reduction and refinement. To ensure that the way in which animals are bred, cared for and used in procedures in the Community is in line with that of the other international and national standards outside the Community, the replacement, reduction and refinement should be considered systematically when implementing this Directive. The Commission shall ensure a high level of transparency in relation to the use of animals and in terms of reporting to the public on the implementation of animal protection measures and progress made towards replacing animal methods.
Amendment 6
Recital 10
Text proposed by the Commission Amendment
(10) Animals have an intrinsic value in themselves which must be respected. There are also ethical concerns of the general public as regards the use of animals in procedures. Therefore, the animals should always be treated as sentient creatures and (10) Animals have an intrinsic value in themselves which must be respected. There are also ethical concerns of the general public as regards the use of animals in procedures. Therefore, the animals should always be treated as sentient creatures and 9312/09
their use in scientific procedures should be restricted to areas which advance science and ultimately benefit human or animal health, or the environment. Use of animals for scientific procedures in other areas under Community competence should be prohibited. their use in scientific procedures should be restricted to areas which advance science and fundamental knowledge, since this may ultimately have benefits for e.g. human or animal health, or the environment. The use of animals in scientific procedures should therefore only be considered where a non-animal alternative is not available. Use of animals for scientific procedures in other areas under Community competence should be prohibited.
Amendment 7
Recital 11 a (new)
Text proposed by the Commission Amendment
(11a) In accordance with the objectives of the Community Action Plan on the Protection and Welfare of Animals 2006 2010 (COM(2006)0013) the Commission should endeavour to promote the welfare of animals used for scientific purposes internationally, and in particular to seek promotion of the replacement, reduction and refinement of animal procedures through the World Organisation for Animal Health (OIE), and by seeking to add animal welfare standards to the criteria assessed in order to establish compliance with Good Laboratory Practice (GLP). Amendment 8
Recital 12
Text proposed by the Commission Amendment
(12) The choice of methods and the species to be used have a direct impact on both the numbers of animals used and their welfare. The choice of methods should therefore ensure the selection of the method that is able to provide most adequate results and likely to cause the minimum pain, suffering or distress. Such selected methods should use the minimum number of animals that (12) The choice of methods and the species to be used have a direct impact on both the numbers of animals used and their welfare. The choice of methods should therefore ensure the selection of the method that is able to provide most adequate results and likely to cause the minimum pain, suffering or distress. Such selected methods should use the minimum number of animals that 9312/09
would provide statistically reliable results and choose the species with the lowest degree of neurophysiological sensitivity that are optimal for the extrapolation into target species. would provide reliable results and choose the species with the lowest degree of neurophysiological sensitivity that are optimal for the extrapolation into target species. Amendment 9
Recital 14
Text proposed by the Commission Amendment
(14) The use of inappropriate methods for killing an animal can cause significant pain, distress and suffering to the animal. The level of competence of the person carrying out this operation is equally important. Animals should therefore be killed only by an authorised person with a humane method that is considered appropriate to the species. (14) The use of inappropriate methods for killing an animal can cause significant pain, distress and suffering to the animal. The level of competence of the person carrying out this operation is equally important. Animals should therefore be killed only by a trained and authorised person with a humane method that is considered appropriate to the species.
Amendment 10
Recital 16
Text proposed by the Commission Amendment
(16) With current scientific knowledge the use of non-human primates in scientific procedures is still necessary in biomedical research. Due to their genetic proximity to human beings and to their highly developed social skills, the use of nonhuman primates in scientific procedures raises specific ethical and practical problems in terms of meeting their behavioural, environmental and social needs in a laboratory environment. Furthermore, the use of non-human primates is of the highest concern to the public. Therefore the use of non-human primates should only be allowed in those essential biomedical areas for the benefit of human beings for which no other replacement alternative methods are yet available and only in cases where the procedures are carried out in relation to clinical conditions having a substantial impact on patients' day-today functioning (16) With current scientific knowledge the use of non-human primates in scientific procedures is still necessary in biomedical research. Due to their genetic proximity to human beings and to their highly developed social skills, the use of nonhuman primates in scientific procedures raises specific ethical and practical problems in terms of meeting their behavioural, environmental and social needs in a laboratory environment. Furthermore, the use of non-human primates is of the highest concern to the public. Therefore the use of non-human primates should only be allowed in those essential biomedical areas for the benefit of human beings for which no other replacement alternative methods are yet available, or for the preservation of the respective non-human primate species. Fundamental research in some areas of the biomedical sciences can provide important 9312/09
as being either life-threatening or debilitating, or for the preservation of the respective non-human primate species. Fundamental research in some areas of the biomedical sciences can provide important new information relevant to many lifethreatening and debilitating human conditions. The reference to lifethreatening or debilitating clinical conditions is established terminology in EC legislation as reflected in Regulation 141/2000/EC, in Directive 2001/20/EC, Regulation 726/2004/EC and Commission Regulation 507/2006/EC. new information relevant, at some future stage, to many life-threatening and debilitating human conditions. Amendment 11
Recital 18
Text proposed by the Commission Amendment
(18) The capture of non-human primates from the wild is highly stressful for the animals and increases the risk of injury and suffering during capture and transport. In order to gradually end the capturing of animals from the wild for breeding purposes, only animals that are the offspring of an animal which has been bred in captivity should be made available for use in scientific procedures as soon as possible. Establishments breeding and supplying non-human primates should therefore have a strategy in place to support and facilitate the progressive move towards that goal. (18) In order to gradually end the capturing of animals from the wild for breeding purposes, a thorough scientific study should be conducted as soon as possible on the feasibility of limiting the animals used to those from self-sustaining colonies. Establishments breeding and supplying non-human primates should therefore have a strategy in place to support and facilitate the progressive move towards that goal.
Amendment 12
Recital 21
Text proposed by the Commission Amendment
(21) To enhance transparency, facilitate the project authorisation and provide tools for monitoring compliance, a severity classification of procedures should be introduced on the basis of estimated level of pain, suffering, distress and lasting harm that is inflicted on the animals. To give (21) To enhance transparency, facilitate the project authorisation and provide tools for monitoring compliance, a severity classification of procedures should be introduced on the basis of estimated level of pain, suffering, distress and lasting harm that is inflicted on the animals. 9312/09
precision how severity classes should be assigned, the Commission should develop criteria with stakeholder input using existing severity classification schemes in place in Member States as well as those promoted by international organisations as basis.
Amendment 13
Recital 22
Text proposed by the Commission Amendment
(22) From the ethical standpoint, there should be an upper limit of pain, suffering and distress, above which animals should never be subjected in scientific procedures. To that effect, the performance of procedures that result in severe pain, suffering or distress and which is likely to be prolonged, should be prohibited. When developing a common format for reporting purposes, instead of the predicted severity at the time of the ethical evaluation, the actual severity experienced by the animal should be taken into account. (22) From the ethical standpoint, there should be an upper limit of pain, suffering and distress, above which animals should not be subjected in scientific procedures. To that effect, the performance of procedures that result in severe pain, suffering or distress and which is likely to be prolonged, should not ordinarily be permitted. When developing a common format for reporting purposes, instead of the predicted severity at the time of the ethical evaluation, the actual severity experienced by the animal should be taken into account.
Amendment 14
Recital 23
Text proposed by the Commission Amendment
(23) The number of animals used in procedures could be reduced by performing procedures on animals more than once, where this does not detract from the scientific objective or result in poor animal welfare. However, the re-use of animals should be judged against minimising any adverse affects on their welfare, taking into account the lifetime experience of the individual animal. As a result of this potential conflict, the re-use of animals should be considered on a case-by-case basis and limited only to those procedures where pain, distress and suffering are significantly reduced. (23) The number of animals used in procedures could be reduced by performing procedures on animals more than once, where this does not detract from the scientific objective or result in poor animal welfare. However, the re-use of animals should be judged against minimising any adverse affects on their welfare, taking into account the lifetime experience of the individual animal. As a result of this potential conflict, the re-use of animals should be considered on a case-by-case basis and limited to only those procedures where the cumulative pain, distress and suffering are ethically justified. 9312/09
Amendment 15
Proposal for a directive
Recital 24
Text proposed by the Commission Amendment
(24) At the end of the procedure, the most appropriate decision should be taken as regards the future of the animal on the basis of animal welfare and potential risks to the environment. The animals whose welfare would be compromised should be killed using a humane method. In some cases, animals should be set free or animals such as dogs and cats should be allowed to be re-homed in families as there is a high public concern as to the fate of those animals. Should establishments allow rehoming, it is essential that there is a scheme in place to provide the appropriate socialisation to those animals in order to ensure successful re-homing as well as to avoid unnecessary distress to the animals and to guarantee public safety. (24) At the end of an authorised procedure, the most appropriate decision should be taken as regards the future of the animal on the basis of animal welfare and potential risks to the environment. The animals whose welfare would be compromised should be killed using a humane method. In some cases, animals should be set free or animals such as dogs and cats should be allowed to be re-homed in families as there is a high public concern as to the fate of those animals. Should establishments allow re-homing, it is essential that there is a scheme in place to provide the appropriate socialisation of those animals in order to promote successful re-homing as well as to avoid unnecessary distress to the animals and to guarantee public safety.
Amendment 16
Recital 25
Text proposed by the Commission Amendment
(25) Animal tissue and organs are used for the development of in vitro methods. To implement the principle of reduction, Member States should establish programmes for sharing the organs and tissue of animals that are killed using humane methods. (25) Animal tissue and organs are used for the development of in vitro methods. To implement the principle of reduction, it is desirable for Member States to establish
programmes for sharing the organs and tissue of animals that are killed using humane methods.
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Amendment 17
Recital 26
Text proposed by the Commission Amendment
(26) The welfare of the animals used in procedures is highly dependent on the quality and professional competence of the personnel supervising procedures, as well as of those performing procedures or supervising those taking care of the animals on a daily basis. In order to secure an adequate degree of competence of the persons dealing with animals and with procedures involving animals, those activities should only be performed by persons authorised by the competent authorities. The main focus should be on obtaining and maintaining an adequate level of competence which should be demonstrated before authorising those persons or renewing their authorisation. (26) The welfare of the animals used in procedures is highly dependent on the quality and professional competence of the personnel supervising procedures, as well as of those performing procedures or supervising those taking care of the animals on a daily basis. In order to secure an adequate degree of competence of the persons dealing with animals and with procedures involving animals, those activities should only be performed in establishments, and by persons, authorised by the competent authorities. The main focus should be on obtaining and maintaining an adequate level of competence which should be demonstrated before authorising those persons or renewing their authorisation. Authorisation by a competent authority and proof of the successful completion of relevant training courses should be mutually recognised by all Member States.
Amendment 18
Recital 27
Text proposed by the Commission Amendment
(27) Establishments should have adequate installations and equipment in place to meet the accommodation requirements of the animal species concerned and to allow the procedures to be performed efficiently and with the least distress to the animals. The establishments should operate only if they are authorised by the competent authorities. (27) Establishments should have adequate installations and equipment in place to meet the accommodation requirements of the animal species concerned and to allow the procedures to be performed efficiently and with the least distress both to the animals directly concerned and their animal companions. The establishments should operate only if they are authorised by the competent authorities. 9312/09
Amendment 19
Recital 29
Text proposed by the Commission Amendment
(29) Animal welfare considerations should be given the highest priority in the context of animal keeping, breeding and use. Each establishment should therefore have an independent permanent ethical review body in place with the primary task of 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 decisions of the permanent ethical review body should be properly documented and open to scrutiny during inspections. (29) Animal welfare considerations should be given the highest priority in the context of animal keeping, breeding and use. Each establishment should therefore have a permanent ethical review body in place with the primary task of 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 decisions of the permanent ethical review body should be properly documented and open to scrutiny during inspections.
Amendment 20
Recital 30
Text proposed by the Commission Amendment
(30) In order to enable the competent authorities to monitor compliance with this Directive, each establishment should maintain accurate records on the numbers of animals, their origins and fate. (30) In order to enable the competent authorities to monitor compliance with this Directive, each establishment should, where possible, maintain accurate records on the numbers of animals, their origins and fate.
Amendment 21
Recital 31
Text proposed by the Commission Amendment
(31) Non-human primates with highly developed social skills should have a personal history file from birth covering their lifetimes in order to be able to receive the care, accommodation and treatment that meet their individual needs and characteristics. (31) Non-human primates with highly developed social skills, as well as dogs and cats, should have a personal history file from birth covering their lifetimes in order to be able to receive the care, accommodation and treatment that meet their individual needs and characteristics. 9312/09
Amendment 22
Recital 34
Text proposed by the Commission Amendment
(34) There are differences in the requirements for the accommodation and care of animals between Member States, which contribute to the distortion of the internal market. Furthermore, some of those requirements no longer reflect the most recent knowledge on the impacts of accommodation and care conditions on both the animal welfare and the scientific results of procedures. It is therefore necessary to establish in this Directive the minimum requirements on accommodation and care. (34) There are differences in the requirements for the accommodation and care of animals between Member States, which contribute to the distortion of the internal market. Furthermore, some of those requirements no longer reflect the most recent knowledge on the impacts of accommodation and care conditions on both the animal welfare and the scientific results of procedures. It is therefore necessary to establish in this Directive the minimum requirements on accommodation and care subject always to developments based on new scientific evidence.
Amendment 23
Recital 38
Text proposed by the Commission Amendment
(38) It is also essential to ensure both on moral and scientific grounds that each use of animals is carefully evaluated on the scientific validity, usefulness and relevance of the expected result of that use. The likely harm to the animals should be balanced against the expected benefits of the project. Therefore, an independent ethical evaluation should be carried out as part of the authorisation process of projects involving the use of live animals. Effective implementation of an ethical evaluation should also allow for an appropriate assessment of the use of any new scientific experimental techniques as they emerge. (38) It is also essential to ensure both on moral and scientific grounds that each use of animals is carefully evaluated on the scientific validity, usefulness and relevance of that use. The likely harm to the animals should be balanced against the expected benefits of the project. Therefore, an ethical evaluation independent of those in charge of the study should be carried out as part of the authorisation process of projects involving the use of live animals. Effective implementation of an ethical evaluation should also allow for an appropriate assessment of the use of any new scientific experimental techniques as they emerge.
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Amendment 24
Recital 39
Text proposed by the Commission Amendment
(39) In certain cases, due to the nature of the project, the type of species used and the likelihood of achieving the desired objectives of the project, it is necessary to carry out a retrospective assessment. Since projects may vary significantly in terms of complexity, length, as well as the delay for obtaining the results, it is necessary that the decision as to whether retrospective assessment should be carried out takes those aspects fully into account. (39) In certain cases, due to the nature of the project, the type of species used and the likelihood of achieving the desired objectives of the project, it might be necessary to carry out a retrospective assessment. Since projects may vary significantly in terms of complexity, length, as well as the delay for obtaining the results, it is necessary that the decision as to whether retrospective assessment should be carried out takes those aspects fully into account.
Amendment 25
Recital 40
Text proposed by the Commission Amendment
(40) To ensure that the public is informed, it is important that objective information on the projects using live animals is made publicly available. The format of that information should not violate proprietary rights or expose confidential information. Therefore, user establishments should provide anonymous non-technical summaries of those projects, including the results of any retrospective assessments, and make those summaries publicly available. (40) To ensure that the public is informed, it is important that objective information on the projects using live animals is made publicly available. The format of that information should not violate proprietary rights or expose confidential information. Therefore, user establishments should provide the competent authority with data, which may be qualitative and/or quantitative, concerning the use of live animals and make such data publicly available.
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Amendment 26
Recital 45
Text proposed by the Commission Amendment
(45) The European Centre for the Validation of Alternative Methods is established within the Joint Research Centre of the Commission and coordinates the validation of alternative approaches in the Community. However, there is an increasing need for new methods to be developed and proposed for validation. To provide the necessary mechanisms at Member State level, a reference laboratory for the validation of alternative methods should be designated by each Member State. Member States should designate reference laboratories which are accredited in accordance with Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances in order to ensure coherent and comparable quality of the results. (45) The European Centre for the Validation of Alternative Methods is established within the Joint Research Centre of the Commission and coordinates the validation of alternative approaches in the Community. However, there is an increasing need for new methods to be developed and proposed for validation. To provide the necessary mechanisms at Member State level, a reference laboratory for the validation of alternative methods should be designated by each Member State. Member States should designate reference laboratories which are accredited in accordance with Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances in order to ensure coherent and comparable quality of the results. In addition, the remit of the European Centre for the Validation of Alternative Methods should be extended to include the co-ordination and promotion of the development and use of alternatives to animal experiments. Amendment 27
Recital 47
Text proposed by the Commission Amendment
(47) The technical and scientific advancements in biomedical research can be rapid as can the increase in knowledge of factors influencing animal welfare. It is therefore necessary to provide for review of this Directive. Such a review should examine possible replacement of the use of animals, and in particular non-human (47) The technical and scientific advancements in biomedical research can be rapid as can the increase in knowledge of factors influencing animal welfare. It is therefore necessary to provide for review of this Directive. Such a review, based on the results of peer-assessed scientific studies, should examine possible 9312/09
primates, as a matter of priority where it is possible, taking into account the advancement of science. replacement of the use of animals, and in particular non-human primates, as a matter of priority where it is possible, taking into account the advancement of science.
Amendment 28
Article 2 paragraph 1 subparagraph 1
Text proposed by the Commission Amendment
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1.This Directive shall apply where animals are used or intended to be used in procedures, or where they are bred specifically so that their organs or tissues may be used for scientific purposes. 1. This Directive shall apply to the accommodation and husbandry of animals used or intended to be used in procedures or where they are bred specifically so that their organs or tissues may be used for scientific purposes, and shall cover all uses of animals in procedures that are likely to cause them pain, suffering, distress or lasting harm.
Amendment 29
Article 2 paragraph 1 - subparagraph 2
Text proposed by the Commission Amendment
The elimination of pain, suffering, distress or lasting harm by the successful use of anaesthesia, analgesia or other methods shall not exclude the use of an animal in procedures from the scope of this Directive. Where there is any pain, suffering, distress or lasting harm, its elimination by the successful use of anaesthesia, analgesia or other methods shall not exclude the use of an animal in procedures from the scope of this Directive.
Amendment 30
Article 2 paragraph 2 point a
Text proposed by the Commission Amendment
(a) live non-human vertebrate animals, including independently feeding larval forms and embryonic or foetal forms as from the last third of their normal development; (a) live non-human vertebrate animals, including independently feeding larval forms and embryonic or foetal forms of species of mammals as from the last third of their normal development; 9312/09
Amendment 31
Article 2 paragraph 2 point b
Text proposed by the Commission Amendment
(b) live invertebrate animals, including independently feeding larval forms, of those species listed in Annex I. (b) live invertebrate animals of those species of orders listed in Annex I.
Amendment 32
Article 2 paragraph 4 introductory part
Text proposed by the Commission Amendment
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4.This Directive shall not apply to the following : 4. Other than the general checks on breeding facilities, this Directive shall not apply to the following :
Amendment 33
Article 2 paragraph 4 point d
Text proposed by the Commission Amendment
(d) practices that are not invasive (d) practices that do not cause pain, suffering, distress or lasting harm.
Amendment 34
Article 3 point 1
Text proposed by the Commission Amendment
(1) 'procedure' means any use of an animal for experimental or other scientific purposes, with known or unknown outcome, which may cause the animal pain, suffering distress or lasting harm, including any course of action intended, or liable, to result in the birth of an animal in any such condition or in the creation of a new genetically modified animal line; (1) 'procedure' means any use of an animal for experimental or other scientific purposes, with known or unknown outcome, which may or may not cause the animal pain, suffering distress or lasting harm and includes any course of action intended, or liable, to result in the birth of an animal in any such condition or in the creation of a new genetically modified animal line; 9312/09
Amendment 35
Article 3 point 6 a (new)
Text proposed by the Commission Amendment
6a. 'competent authority' means the authority or authorities designated by each Member State as being responsible for supervising the enforcement of this Directive;
Amendment 36
Article 3 point 6 b (new)
Text proposed by the Commission Amendment
(6b) 'ethical approach' means the approach which precedes experimentation and consists of assessing the scientific and societal grounds for using animals, with reference to humankind's duty to respect animals as living, sentient beings;
Amendment 37
Article 3 point 6c (new)
Text proposed by the Commission Amendment
(6c) 'competent person' means any person who is considered by a Member State to be competent to perform the relevant function described in this Directive; Amendment 38
Article 3 point 6d (new)
Text proposed by the Commission Amendment
(6d) 'husbandry' means all those activities required to breed and maintain phenotypically normal animals, whether for scientific or other purposes, but which do not themselves constitute experiments; 9312/09
Amendment 39
Article 3 point 6e (new)
Text proposed by the Commission Amendment
(6e) 'practice' means any nonexperimental activity or any scientific activity which does not constitute an experiment;
Amendment 40
Article 3 point 6f (new)
Text proposed by the Commission Amendment
(6f) 'properly anaesthetised' means deprived of sensation by means of anaesthesia, whether local or general, which is as effective as those used in good veterinary practice;
Amendment 41
Article 3 point 6g (new)
Text proposed by the Commission Amendment
(6g) 'protocol' means a series of procedures that constitute an experiment with a defined objective;
Amendment 42
Article 3 point 6h (new)
Text proposed by the Commission Amendment
(6h) 'regulated procedure' means any experimental or other scientific procedure, which is likely to have the effect of causing a protected animal pain, suffering, distress or lasting harm;
9312/09
Amendment 43
Article 3 point 6i (new)
Text proposed by the Commission Amendment
(6i) ) `re-use' means the use of an animal already used in a procedure, when a different animal on which no procedure has previously been carried out could also be used;
Amendment 44
Article 3 point 6j (new)
Text proposed by the Commission Amendment
(6j) 'confidential information' means information, the non-consensual release of which could prejudice the legitimate commercial or other interests of its owner or a third party.
Amendment 170
Article 4 paragraph 1
Text proposed by the Commission Amendment
-
1.Where a method of testing not involving the use of animals exists and may be used in place of a procedure, Member States shall ensure that the alternative method is used. 1. Where a method of testing, experimentation or other scientific activity not involving the use of living animals exists which, from a scientific point of view, is a satisfactory method or testing strategy for obtaining the result sought and which may be used in place of a procedure, Member States shall ensure that the alternative method is used, provided it is not prohibited in the Member State concerned. Pursuant to this Directive, testing methods which involve the use of human embryonic and foetal cells shall not be regarded as alternatives, in other words the Member States may take their own ethical decisions concerning the use of these methods of testing.
9312/09
Amendment 46
Article 4 paragraph 3 a (new)
Text proposed by the Commission Amendment
3a. Member States shall ensure that funding is provided for training and research on, and development and implementation of, scientifically satisfactory methods or testing strategies that do not entail the use of animals.
Amendment 47
Article 4 paragraph 3 b (new)
Text proposed by the Commission Amendment
3b. Member States shall ensure that the aim of paragraph 1 is pursued by the competent authority when considering the authorisation of projects.
Amendment 48
Article 4 paragraph 3 c (new)
Text proposed by the Commission Amendment
3c. Member States shall ensure that training is provided on the use of scientifically satisfactory methods or testing strategies that do not entail the use of animals, to appropriate persons and establishments, and promote such methods or testing strategies.
9312/09
Amendment 49
Article 5 point 2 point b a (new)
Text proposed by the Commission Amendment
(ba) the improvement of the production conditions and welfare of animals reared for agricultural purposes;
Amendment 50
Article 5 point 4 a (new)
Text proposed by the Commission Amendment
4a. the protection of human health in the context of workers' or consumers' exposure to chemicals;
Amendment 51
Article 5 point 5
Text proposed by the Commission Amendment
(5) research aimed at preservation of the species; (5) research aimed at preservation, health and welfare of the species;
Amendment 52
Article 6 paragraph 1 subparagraph 1
Text proposed by the Commission Amendment
-
1.Member States shall ensure that animals are killed in an authorised establishment, by an authorised person and with a minimum of pain, suffering and distress and, in relation to the species included in Annex V, using the appropriate humane method of killing as set out in that Annex. 1. Member States shall ensure that animals are killed in an authorised establishment, by an authorised person and with a minimum of pain, suffering and distress and, in relation to the species included in Annex V, using an appropriate humane method of killing as set out in that Annex or by such other methods as are 9312/09
scientifically demonstrated to be at least as humane. Where a more humane method of killing is possible and readily available, it may be used even if it is not included in Annex V.
Amendment 53
Article 6 paragraph 2
Text proposed by the Commission Amendment
-
2.Competent authorities may grant exemptions from paragraph 1 on the basis of scientific justification that the purpose of the procedure cannot be achieved by the use of a humane method of killing. 2. Competent authorities may grant exemptions from paragraph 1 on the basis of scientific justification that the purpose of the procedure cannot be achieved by the use of a humane method of killing or that other methods providing better animal protection have been developed. otwithstanding any exemption, animals
shall be killed with a minimum of pain, suffering and distress.
Amendment 54
Article 6 a (new)
Text proposed by the Commission Amendment Article 6a
ational measures
This Directive shall not prevent Member States from applying or adopting stricter national measures seeking to improve the well-being and protection of animals used for scientific purposes. Amendment 55
Article 7 paragraph 1 point b a (new)
Text proposed by the Commission Amendment
(ba) as far as possible, the animals used should be bred specifically for testing purposes;
9312/09
Amendment 56
Article 8 paragraph 1 introductory phrase
Text proposed by the Commission Amendment
-
1.Non-human primates shall not be used in procedures, with the exception of those procedures meeting the following conditions: 1. Given their particularly high level of neurophysiological sensitivity and cognitive development, non-human primates shall not be used in procedures, with the exception of those procedures meeting the following conditions:
Amendment 57
Article 8 paragraph 1 point a
Text proposed by the Commission Amendment
(a) the procedure has one of the purposes referred to in points (1), (2)(a), (3) and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of lifethreatening or debilitating clinical conditions in human beings or the purpose referred to in point (5) of Article 5; (a) the procedure has one of the purposes referred to in points (1), (2)(a), (3) or (5) of Article 5; Amendment 58
Article 8 paragraph 1 point b
Text proposed by the Commission Amendment
(b) there is a scientific justification that the purpose of the procedure cannot be achieved by the use of other species than non-human primates. (b) the applicant provides a scientific and ethical justification that the purpose of the procedure cannot be achieved by the use of other species than non-human primates. Amendment 59
Article 8 paragraph 2 a (new)
Text proposed by the Commission Amendment
2a. Every two years, and for the first time two years after the entry into force of this Directive, the Commission shall, in consultation with Member States, conduct a review of the use of non-human 9312/09
primates in procedures and publish the results thereof. The review shall examine the impact of developments in technological, scientific and animalwelfare knowledge, and set targets for the implementation of validated replacement methods.
Amendment 60
Article 10 paragraph 1 subparagraph -1 (new)
Text proposed by the Commission Amendment
The Commission shall carry out an animal welfare assessment and a feasibility evaluation of implementation of the requirements set out in subparagraphs 1 and 2, five years after the entry into force of this Directive.
Amendment 61
Article 10 paragraph 1 subparagraph 2
Text proposed by the Commission Amendment
However, as from the dates set out in Annex III, Member States shall ensure that non-human primates listed in that Annex may only be used in procedures where they are the offspring of non-human primates which have been bred in captivity. Where feasibility is established, as from the dates to be set in Annex III in light of the evaluation referred to in subparagraph -1, Member States shall ensure that non-human primates listed in that Annex may only be used in procedures where they are sourced from selfsustaining colonies. Amendment 62
Article 10 paragraph 2
Text proposed by the Commission Amendment
-
2.Competent authorities may grant exemptions from paragraph 1 on the basis of a scientific justification. 2. Competent authorities may grant exemptions from paragraph 1 on the basis of a veterinary justification for reasons of animal welfare or on the basis of a scientific justification. 9312/09
Amendment 63
Article 11 a (new)
Text proposed by the Commission Amendment Article 11a
Use of cadavers, tissue and organs of animals for training purposes
For higher education and training purposes, the cadavers, tissue and organs of animals may be used only if they come from animals slaughtered in accordance with the provisions of Council Regulation (EC) o .../2009 [on the protection of animals at the time of killing] 1
.
1 OJ L .... [COM(2008)0553].
Amendment 64
Article 12 paragraph 1 subparagraph 1
Text proposed by the Commission Amendment
-
1.Member States shall ensure that procedures are always carried out in user establishments. 1. Member States shall ensure that procedures are always carried out in establishments as defined in Article 3.
Amendment 65
Article 14 paragraph 1
Text proposed by the Commission Amendment
-
1.Member States shall ensure that all procedures are carried out under general or local anaesthesia. 1. Member States shall ensure that, where appropriate, all procedures are carried out under general or local anaesthesia or using other methods that may alleviate pain or minimise suffering. Amendment 66 Article 14 paragraph 2 point ca (new)
Text proposed by the Commission Amendment
(ca) where analgesics are used to prevent or control potentially severe pain. 9312/09
Amendment 67
Article 14 paragraph 3
Text proposed by the Commission Amendment
-
3.If the procedure is carried out without anaesthesia, analgesics or other appropriate methods shall be used to ensure that unavoidable pain, suffering and distress are kept to a minimum. 3. If the procedure is carried out without anaesthesia, analgesics or other appropriate methods shall be used wherever this would be beneficial to the animal to ensure that unavoidable pain, suffering and distress are kept to a minimum.
Amendment 68
Article 14 paragraph 5
Text proposed by the Commission Amendment
-
5.An animal, which may suffer considerable pain once anaesthesia has worn off, shall be treated with pre-emptive and post-operative analgesics or other appropriate pain-relieving methods, provided that it is compatible with the purpose of the procedure. Where the treatment with analgesics is not possible, the animal shall be immediately killed by a humane method. 5. An animal, which may suffer pain once anaesthesia has worn off, shall be treated with pre-emptive and post-operative analgesics or other appropriate painrelieving methods, provided that it is compatible with the purpose of the procedure. Where the treatment with analgesics is not possible, the animal shall be immediately killed by a humane method.
Amendment 69
Article 15 paragraph 1
Text proposed by the Commission Amendment
-
1.Member States shall ensure that all procedures are classified as 'up to mild', 'moderate', 'severe' or 'non-recovery' on the basis of the duration and intensity of potential pain, suffering, distress and lasting harm, the frequency of intervention, the deprivation of ethological needs and the use of anaesthesia or analgesia or both. 1. Member States shall ensure that all procedures are classified as 'up to mild', 'moderate' or 'severe' in conformity with Annex VIIa. 9312/09
Amendments 70 and 175 Article 15 paragraph 2
Text proposed by the Commission Amendment
-
2.Member States shall ensure that the procedures classified as "severe" are not performed if the pain, suffering or distress is likely to be prolonged. 2. Member States shall ensure that the procedures classified as "severe" are scientifically justified, and ethically monitored if the pain, suffering or distress is likely to be more than transient. Such procedures must be exceptional and shall be subject to particular harm/benefit analysis and scrutiny by the competent authority.
Amendments 71 and 185
Article 15 paragraph 4 subparagraph 1
Text proposed by the Commission Amendment
-
4.The Commission shall establish the criteria for classification of procedures. 4. The Commission shall, within 12 months from the date of entry into force of this Directive, complete the criteria for classification of procedures as referred to in Annex VIIa on the basis of international classifications and in line with best practices developed within the European Union. Such criteria shall include an upper limit of severity beyond which procedures on animals will be prohibited.
Amendment 72
Article 16 paragraph 1 introductory part
Text proposed by the Commission Amendment
Member States shall ensure that an animal already used in a procedure, when a different animal on which no procedure has previously been carried out could also be used, may be re-used in a new procedure only when all of the following conditions are met: Member States shall ensure that an animal on which a procedure has already been carried out, when a different animal on which no preparatory or other procedure has previously been carried out could instead be used, may be re-used in subsequent unrelated new procedures only when all of the following conditions are met: 9312/09
Amendment 73
Article 16 paragraph 1 point a
Text proposed by the Commission Amendment
(a) the previous procedure was classified as 'up to mild'; (a) the previous procedure was classified as 'up to moderate';
Amendment 74
Article 16 paragraph 1 point c
Text proposed by the Commission Amendment
(c) the further procedure is classified as 'up to mild' or 'non-recovery'. (c) the further procedure is classified as 'up to moderate' or 'non-recovery'. The re-use of animals shall be accompanied by veterinary examinations.
Amendment 75
Article 16 paragraph 2
Text proposed by the Commission Amendment
-
2.By way of derogation from paragraph 1, the competent authority, on the basis of scientific justification, may allow re-use of an animal as long as the animal is not used more than once after having undergone a procedure entailing severe pain, distress or equivalent suffering and the further procedure is classified as 'up to mild' or as 'non-recovery'. 2. By way of derogation from paragraph 1, the competent authority, on the basis of scientific justification, may allow re-use of an animal where the previous procedure performed on the animal is classified as'up to moderate' and the further procedure is classified as 'up to moderate' or as 'non-recovery'.
Amendment 76
Article 17 paragraph 3
Text proposed by the Commission Amendment
-
3.An animal shall be killed by a humane method when it is likely to remain in lasting pain or distress. 3. At the end of a procedure an animal shall be killed by a humane method when it is likely to remain in lasting pain or distress.
9312/09
Amendment 77
Article 18
Text proposed by the Commission Amendment
Member States shall establish programmes for the sharing of organs and tissues of animals killed by a humane method. Member States shall encourage the establishment of programmes for the sharing of organs and tissues of animals killed by a humane method.
Amendment 78
Article 19 introductory phrase
Text proposed by the Commission Amendment
Member States may allow animals used or intended to be used in procedures to be set free or rehomed provided that the following conditions are met: Member States may allow animals used or intended to be used in procedures to be released into their original habitat, returned to a husbandry system appropriate to the species, or rehomed provided that the following conditions are met:
Amendment 79
Article 19 point c
Text proposed by the Commission Amendment
(c) the maximum possible care has been taken to safeguard the well-being of the animal. (c) the maximum possible care has been taken to safeguard the well-being of the animal, including an assessment of the animal's behaviour and its ability to adapt to highly variable environmental conditions. Amendment 80
Article 19 point c a (new)
Text proposed by the Commission Amendment
(ca) the animals concerned are not genetically modified experimental animals or non-human primates. 9312/09
Amendment 81
Article 20 paragraph 1 introductory part
Text proposed by the Commission Amendment
-
1.Member States shall ensure that persons are authorised by the competent authority before they carry out any of the following functions: 1. Member States shall ensure that persons are authorised by the competent authority or the delegated authority before they carry out any of the following functions:
Amendment 82
Article 20 paragraph 2 subparagraph 1
Text proposed by the Commission Amendment
-
2.Member States shall ensure that, for the purposes of the authorisation, the persons referred to in paragraph 1 have the appropriate education and training and have demonstrated the requisite competence. 2. Member States shall ensure that, for the purposes of the authorisation, the persons referred to in paragraph 1 have the appropriate veterinary or scientific education and training and have evidence of the requisite competence
Amendment 83
Article 20 paragraph 3
Text proposed by the Commission Amendment
-
3.All authorisations of persons shall be granted for a limited period of time, not exceeding five years. Member States shall ensure that the renewal of an authorisation of persons is only granted on the basis of demonstration of the requisite competence. 3. All authorisations of persons shall be granted for a limited period, not exceeding five years. Member States shall ensure that the renewal of an authorisation of persons is only granted on the basis of evidence of the requisite competence. Member States shall ensure the mutual recognition of education and training qualifications and authorisation to conduct designated procedures.
9312/09
Amendment 84
Article 22 paragraph 1
Text proposed by the Commission Amendment
-
1.Where an establishment no longer complies with requirements set out in this Directive, the competent authority shall suspend or withdraw its authorisation. 1. Where an establishment no longer complies with requirements set out in this Directive, the competent authority shall have the power to suspend or withdraw its authorisation, or take appropriate remedial action or require such action to be taken. There shall be appropriate procedures for the license-holders to appeal against any such decision.
Amendment 85
Article 23 paragraph 2
Text proposed by the Commission Amendment
-
2.The design, construction and method of functioning of the installations and equipment referred to in paragraph 1 shall ensure that the procedures are carried out as effectively as possible, obtaining consistent results with the minimum number of animals and the minimum degree of pain, suffering, distress or lasting harm. 2. The design, construction and method of functioning of the installations and equipment referred to in paragraph 1 shall ensure that the procedures are carried out as effectively as possible, with the minimum number of animals and the minimum degree of pain, suffering, distress or lasting harm.
Amendment 86
Article 24 point 2a (new)
Text proposed by the Commission Amendment
2a. Without prejudice to the generality of point 1, each breeding, supplying and user establishment shall ensure that there is at least one trained person available at all times to look after the animals' welfare.
9312/09
Amendment 87
Article 25 paragraph 2
Text proposed by the Commission Amendment
-
2.The permanent ethical review body shall include the designated veterinarian, the person(s) responsible for the welfare and care of the animals in the establishment and, in the case of a user establishment, a scientific member. 2. The permanent ethical review body shall include as a minimum the designated veterinarian, the person(s) responsible for the welfare and care of the animals in the establishment and, in the case of a user establishment, a scientific member and a person with expertise in the application of the principles of replacement, reduction and refinement.
Amendment 88
Article 26 paragraph 1 introductory phrase
Text proposed by the Commission Amendment
-
1.The permanent ethical review body shall fulfil the following tasks: 1. Having regard to the objectives of this Directive, and in particular Article 4, the permanent ethical review body shall fulfil the following tasks :
Amendment 89
Article 26 paragraph 1 point d introductory part
Text proposed by the Commission Amendment
(d) review annually all projects which are of more than 12 months duration, focusing in particular on: (d) review annually all projects classified as "severe" or those on non-human primates, and every 3 years all other projects which are of more than 12 months duration, focusing in particular on:
9312/09
Amendment 90
Article 26 paragraph 1 point d indent 2 a (new)
Text proposed by the Commission Amendment
-
-the scientific progress of the project;
Amendment 91
Article 26 paragraph 2 subparagraph 2
Text proposed by the Commission Amendment
The records shall be submitted to the The records shall be made available to the competent authority upon request. Member States shall pay particular attention to the collection, collation and publication of records relating to projects classified as "severe" or those on non-human primates in order to provide information which can improve animal welfare and further the principles of replacement, reduction and refinement. competent authority upon request.
Amendment 92
Article 27 paragraph 1
Text proposed by the Commission Amendment
-
1.Member States shall ensure that breeding and supplying establishments of non-human primates have a strategy in place for increasing the proportion of animals that are the offspring of nonhuman primates that have been bred in captivity. 1. Member States shall ensure that EU breeding and supplying establishments of non-human primates have a strategy in place for increasing the proportion of animals that are the offspring of nonhuman primates that have been bred in captivity. Where the use of non-human primates is authorised, the Commission and the Member States shall take all necessary measures to ensure appropriate transport conditions. 9312/09
Amendment 93
Article 27 paragraph 2
Text proposed by the Commission Amendment
-
2.Establishments acquiring non-human primates shall supply proof to the competent authority, on request, that the establishment from which animals have been acquired have a breeding strategy in place. 2. EU establishments acquiring non-human primates shall supply proof to the competent authority, on request, that the establishment from which animals have been acquired have a breeding strategy in place.
Amendment 94
Article 29 paragraph 1 introductory part
Text proposed by the Commission Amendment
-
1.Member States shall ensure that all breeding, supplying and user establishments keep records of the following: 1. Member States shall, where possible, ensure that all breeding, supplying and user establishments keep records of the following: Amendment 95
Article 29 paragraph 1 point a
Text proposed by the Commission Amendment
(a) the number and the species of animals bred, acquired, supplied, released or rehomed; (a) the number and the species of vertebrate animals bred, acquired, supplied, released or re-homed;
Amendment 96
Article 29 paragraph 1 point e
Text proposed by the Commission Amendment
(e) the name and address of the recipient of animals; (e) the name and address of the the establishment receiving the animals; 9312/09
Amendment 97
Article 30 paragraph 2 subparagraph 1
Text proposed by the Commission Amendment
Each non-human primate shall have an individual history file, which follows the animal throughout its life. Each dog, cat and non-human primate shall have an individual history file, which follows the animal throughout its life. Member States shall ensure the adequate and consistent implementation of this Directive. Amendment 98
Article 30 paragraph 2 subparagraph 2
Text proposed by the Commission Amendment The file shall be established at birth and
The file shall be established at birth and shall cover any relevant reproductive, medical and social information on the individual animal.
shall cover detailed reproductive, medical
and social information on the individual
animal.
Amendment 99
Article 32 paragraph 1 point a
Text proposed by the Commission Amendment
(a) all animals are provided with accommodation, an environment, at least some freedom of movement, food, water and care which are appropriate to their health and well-being; (a) all animals are provided with accommodation, an environment, freedom of movement, food, water and care which are appropriate to their health and wellbeing and which allow them to satisfy their ethological as well as physical needs; Amendment 100
Article 32 paragraph 1 point d
Text proposed by the Commission Amendment
(d) the well-being and state of health of animals are observed by a competent person to prevent pain or avoidable suffering, distress or lasting harm; (d) the well-being and state of health of animals are observed by a competent person at least once a day to prevent pain or avoidable suffering, distress or lasting harm; 9312/09
Amendment 101
Article 32 paragraph 1 point e
Text proposed by the Commission Amendment
(e) arrangements are made to ensure that any defect or suffering discovered is eliminated as quickly as possible. (e) arrangements are made to ensure that any avoidable defect or suffering discovered is eliminated as quickly as possible.
Amendment 102
Article 32 paragraph 3
Text proposed by the Commission Amendment
-
3.Member States may allow exemptions to paragraph 2 for animal welfare reasons. 3. Member States may allow exemptions to paragraph 2 for justified scientific reasons, veterinary reasons or animal welfare reasons.
Amendment 168
Article 32 paragraph 3 a (new)
Text proposed by the Commission Amendment
3a. In those procedures whose purpose is described in Article 5(2)(ba), the animal species of agricultural interest listed in Annex IVa may be housed in normal breeding conditions as defined by the current agricultural practices of the Member States and the applicable rules.
Amendment 103
Article 33 paragraph 2 subparagraph 1
Text proposed by the Commission Amendment
-
2.National inspections shall be carried out by the competent authority at least twice a year. 2. National inspections shall be carried out by the competent authority on average once a year, with the competent authority adapting the frequency of inspection on the basis of a risk analysis for each establishment. 9312/09
Amendment 104
Article 33 paragraph 3
Text proposed by the Commission Amendment
-
3.Member States shall ensure that the frequency and the extent of inspections are adequate to the number and species of animals housed, to the compliance record of the establishment with this Directive and, in the case of user establishments, to the number and types of projects carried out in those establishments. 3. Member States shall ensure that the frequency and the extent of inspections are adequate to the number and species of animals housed, to the compliance record of the establishment with this Directive and, in the case of user establishments, to the number and types of projects carried out in those establishments. Member States shall take the necessary measures to ensure that the inspections do not jeopardise the scientific quality of the projects and the welfare of the animals, and do not take place under conditions that fail to comply with the other regulations in force.
Amendment 105
Article 33 paragraph 4
Text proposed by the Commission Amendment
-
4.Records of all inspections shall be kept for at least five years. 4. Records of all inspections, including details of any failure to meet the requirements of this Directive, shall be kept by each Member State's competent authority for at least five years.
Amendments 186 and 176
Article 34 paragraph 1
Text proposed by the Commission Amendment
-
1.The Commission may undertake controls of the infrastructure and operation of national inspections in Member States. 1. The Commission shall undertake controls of the infrastructure and operation of national inspections as well as of the correct application of severity classifications in Member States. To that end, the Commission shall set up a system to monitor each Member State's inspections and enforcement of this Directive on average once every three 9312/09
years, ensuring harmonised practices for the use and the care of animals used or intended to be used in scientific procedures.
Amendment 167
Article 35 paragraph 1
Text proposed by the Commission Amendment
-
1.Member States shall ensure that projects are not carried out without a prior authorisation by the competent authority. 1. Member States shall ensure that projects classified as "moderate" or "severe" or any projects involving non-human primates are not carried out without a prior authorisation by the competent authority. All other projects shall be notified in advance to the competent authority following ethical review by the institution's permanent ethical review body.
Amendment 108
Article 35 paragraph 2
Text proposed by the Commission Amendment
-
2.Granting of authorisation shall be subject to favourable ethical evaluation by the competent authority. 2. Granting of authorisation shall be subject to favourable independent ethical and scientific evaluation by the competent authority.
Amendment 109
Article 36 paragraph 1 introductory part
Text proposed by the Commission Amendment
-
1.The user establishment shall submit an application for the project authorisation, which shall include the following: 1. When required, the user establishment or the person scientifically responsible for the project shall submit an application for the project authorisation, which shall include the following:
9312/09
Amendment 110
Article 36 paragraph 1 point ca (new)
Text proposed by the Commission Amendment
(ca) a scientifically justified statement that the research project is indispensable and ethically defensible and that the purposes of the project cannot be achieved using other methods or procedures.
Amendment 111
Article 37 paragraph 1 point a
Text proposed by the Commission Amendment
(a) the project is scientifically justified or required by law; (a) the project is scientifically justified, indispensable and ethically defensible ;
Amendment 112
Article 37 paragraph 1 point b
Text proposed by the Commission Amendment
(b) the purposes of the project justify the use of animals; (b) the purposes of the project justify the use of animals and cannot be achieved through other methods or procedures;
Amendment 113
Article 37 paragraph 1 point c
Text proposed by the Commission Amendment
(g) the project is designed so as to enable procedures to be carried out in the most humane and environmentally sensitive manner. (c) the project is designed so as to enable procedures to be carried out with maximum respect for animal welfare and in the most environmentally sensitive manner. 9312/09
Amendment 114
Article 37 paragraph 2 point d
Text proposed by the Commission Amendment
(d) a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress, and to the environment, where appropriate, is justified by the expected advancement of science that ultimately benefits human beings, animals or the environment; (d) a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress, and to the environment, where appropriate, is ethically defensible in light of the expected advancement of science that may ultimately benefit human beings, animals or the environment;
Amendment 115
Article 37 paragraph 3 introductory sentence
Text proposed by the Commission Amendment
-
3.The competent authority carrying out the ethical evaluation shall consider experts in particular in the following areas: 3. The competent authority carrying out the ethical evaluation shall consider corresponding expertise in particular in the following areas:
Amendment 116
Article 37 paragraph 4
Text proposed by the Commission Amendment
-
4.Ethical evaluation shall be performed in a transparent manner, by integrating the opinion of independent parties. 4. Ethical evaluation shall be performed in a transparent manner by integrating independent expertise whilst safeguarding intellectual property and confidential information as well as the safety of goods and persons.
9312/09
Amendment 117
Article 38 paragraph 1 subparagraph 1
Text proposed by the Commission Amendment
-
1.The ethical evaluation shall determine, on the basis of the harm-benefit analysis referred to in point (d) of Article 37(2), whether the project should, once it has been completed, be assessed retrospectively by the competent authority. 1. The competent authority carrying out the ethical evaluation shall determine, on the basis of the harm-benefit analysis referred to in point (d) of Article 37(2), whether the project should, once it has been completed, be assessed retrospectively.
Amendment 118
Article 38 paragraph 2 introductory sentence
Text proposed by the Commission Amendment
-
2.Retrospective assessment shall evaluate the following: 2. Retrospective assessment shall establish the following:
Amendment 119
Article 38 paragraph 2 point c
Text proposed by the Commission Amendment
(c) elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement. (c) whether there are elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.
Amendment 120
Article 38 paragraph 4
Text proposed by the Commission Amendment
-
4.Without prejudice to paragraph 3, all projects involving only procedures classified as "up to mild" shall be exempted from the requirement for a retrospective assessment. 4. All projects involving only procedures classified as "up to moderate" shall be exempted from the requirement for a retrospective assessment.
9312/09
Amendment 121
Article 40 paragraph 1 introductory phrase
Text proposed by the Commission Amendment
Subject to safeguarding confidential information, the non-technical project summary shall provide the following Subject to safeguarding confidential information, establishment and personnel details, the non-technical project summary shall provide the following:
Amendment 122
Article 40 paragraph 1 point b
Text proposed by the Commission Amendment
(b) a demonstration of compliance with the requirement (b) a demonstration that the principles of replacement, reduction and refinement have been observed where practicable. of replacement, reduction and
refinement.
Amendment 123
Article 40 paragraph 4
Text proposed by the Commission Amendment
-
4.Member States shall make publicly available the non-technical project summaries of authorised projects and any updates to them. 4. Member States shall make publicly available anonymous versions of the nontechnical project summaries of authorised projects and any updates to them.
Amendment 178
Article 40 paragraph 4 a (new)
Text proposed by the Commission Amendment
4a. Subject to the safeguarding of confidential and personal information, Member States shall make publicly available non-personal information regarding infringements of this Directive, national laws and authorisations.
9312/09
Amendment 124
Article 41 paragraph 3
Text proposed by the Commission Amendment
-
3.Project authorisations shall be granted for a period not exceeding four years. 3. Project authorisations shall be granted for a period not exceeding five years.
Amendment 125
Article 41 paragraph 4
Text proposed by the Commission Amendment
-
4.Member States may allow the authorisation of multiple projects when those projects are required by law. 4. Member States may allow the authorisation of multiple projects when those projects are required by law, or when standardised procedures are applied, the ethical evaluation of which has already produced a positive result.
Amendment 126
Article 42 paragraph 1
Text proposed by the Commission Amendment
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1.The competent authority may amend or renew the project authorisation on the request of the user establishment. 1. The competent authority may amend or renew the project authorisation on the request of the user establishment or the person in charge of the project.
Amendment 127
Article 42 paragraph 2
Text proposed by the Commission Amendment
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2.Any amendment or renewal of a project authorisation shall be subject to a further favourable ethical evaluation. 2. Any amendment or renewal of a project authorisation shall be subject to a further ethical evaluation. 9312/09
Amendment 128
Article 42 paragraph 2a (new)
Text proposed by the Commission Amendment
2a. Amendments to mild or moderate procedures that do not increase the severity of the procedure may be made by the permanent ethical review body but must be communicated to the competent authority within one week of such change.
Amendment 129
Article 42 paragraph 3
Text proposed by the Commission Amendment
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3.The competent authority may withdraw the project authorisation where the project is not carried out in accordance with the project authorisation. 3. The competent authority may withdraw the project authorisation where the project is not carried out in accordance with the project authorisation and may cause a deterioration in animal welfare standards.
Amendments 131 and 187
Article 43 paragraph 2
Text proposed by the Commission Amendment
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2.otwithstanding paragraph 1, in exceptional circumstances and where the project is non-routine, multi-disciplinary and innovative, the decision to grant an authorisation shall be taken and communicated to the user establishment within 60 days from the submission of the application. deleted
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Amendment 132
Article 44 paragraph 1
Text proposed by the Commission Amendment
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1.Each Member State shall accept data that are required by law and generated by procedures recognised by Community legislation from another Member State, unless further procedures need to be carried out regarding that data for the protection of public health, safety or the environment. 1. Each Member State shall accept from another Member State data that are generated by procedures recognised by, or which take place under, Community legislation.
Amendment 180
Article 44 paragraph 2
Text proposed by the Commission Amendment
-
2.Outside the area of testing required by law, subject to safeguarding confidential information, the Member States shall ensure the sharing of data generated by procedures.
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2.Member States shall ensure the sharing of data generated by procedures, including those which have taken place in the European Union prior to the coming into force of this Directive. Anyone seeking to rely on data owned by another shall, where appropriate, contribute towards the cost of producing such data.
Amendment 134
Article 44 paragraph 2 a (new)
Text proposed by the Commission Amendment
2a. Subject to the safeguarding of confidential information, Member States shall ensure the sharing of data generated by procedures, including those which have taken place in the European Union prior to the coming into force of the Directive. A person seeking to rely on data owned by another shall where appropriate contribute towards the intrinsic cost of such data. 9312/09
Amendment 135
Article 44 paragraph 2 b (new)
Text proposed by the Commission Amendment
2b. Before applying for a project authorisation, a person intending to carry out a procedure must take all reasonable steps to ascertain whether data relevant to the proposed project already exists and, if so, to access such data (including contributing towards the cost thereof), and Member States shall similarly verify whether such data exists before granting an authorisation.
Amendment 136
Article 44 paragraph 2 c (new)
Text proposed by the Commission Amendment
2c. Member States shall not authorise a procedure where a person has not taken reasonable steps to comply with paragraph 2b.
Amendment 137
Article 44 paragraph 2 d (new)
Text proposed by the Commission Amendment
2d. Where relevant data is reasonably available, Member States shall only grant authorisation for a project where this is necessary for the protection of the public.
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Amendment 138
Article 45
Text proposed by the Commission Amendment
The Commission and Member States shall contribute to the development and validation of alternative approaches that could provide the same or higher level of information as that obtained in procedures using animals but that do not involve the use of animals or use fewer animals or that entail less painful procedures and shall take such other steps as they consider appropriate to encourage research in this field. The Commission and Member States shall contribute financially and otherwise to the development and, where appropriate, the scientific validation of alternative approaches intended to provide a comparable level of information as that obtained in procedures using animals but that do not involve the use of animals or use fewer animals or that entail less painful procedures and shall take such other steps as they consider appropriate to encourage research in this field. It is appropriate to establish large-scale veterinary biobanks to support the principles of replacement, reduction and refinement using surplus tissue taken as part of clinical procedures. Amendment 139
Article 45a (new)
Text proposed by the Commission Amendment Article 45a
European Centre for the Validation of Alternative Methods
The remit of the European Centre for the Validation of Alternative Methods shall be extended so that it includes the coordination and promotion of the development and use of alternatives to animal procedures including applied and basic biomedical research and veterinary research and regulatory testing by performing the following functions: a) coordinate research undertaken to facilitate the development of alternatives to animal procedures by the ational Centres for Alternative Methods described in Article 46; b) conduct research to facilitate the development of alternatives to animal procedures; 9312/09
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c)commission research in fields likely to yield information that will facilitate the replacement, reduction or refinement of animal procedures; d) in consultation with relevant stakeholders, create and implement strategies to replace, reduce and refine animal procedures;
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e)make available information on alternatives to animal procedures through regular reporting to the public, to stakeholders and to Member State authorities;
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f)provide databases to facilitate the exchange of relevant information including information on available alternative methods and information contributed voluntarily by researchers which would otherwise remain unpublished, but which could prevent duplication of unsuccessful animal studies; (g) coordinate pre-validation and validation studies undertaken by the ational Centres for Alternative Methods
in accordance with Article 46 of this Directive;
(h) conduct validation and pre-validation studies where appropriate;
(i) in consultation with relevant regulatory bodies and stakeholders, create and implement strategies to replace, reduce and refine animal tests used for regulatory purposes; (j) facilitate the scientific endorsement and regulatory acceptance of alternatives to animal tests used for regulatory purposes;
(k) inform relevant regulatory authorities when pre-validation and validation studies begin, and when alternative test methods achieve scientific endorsement and regulatory acceptance, and make this information available to the public and stakeholders through dedicated websites.
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Amendment 140
Article 46 paragraph 1
Text proposed by the Commission Amendment
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1.Each Member State shall, by [one year after entry into force of this Directive], designate a national reference laboratory for the validation of alternative methods replacing, reducing and refining the use of animals. 1. Each Member State shall, by [one year after entry into force of this Directive], nominate a centre responsible for supporting the development, validation and promotion of alternatives to animal tests used for regulatory purposes, and facilities to develop and promote the use of alternatives to animal procedures undertaken for other purposes, such as basic and applied biomedical and veterinary research.
Amendment 141
Article 46 paragraph 4 point a
Text proposed by the Commission Amendment
(a) cooperate with the Commission in their area of competence; (a) cooperate with the Commission in their area of competence and perform tasks to advance strategies for replacing animal procedures;
Amendment 142
Article 46 paragraph 4 point b
Text proposed by the Commission Amendment
(b) participate in pre-validation and validation of alternative methods under the co-ordination of the Commission; (b) participate in pre-validation and validation of alternative methods, where appropriate, under the co-ordination of the Commission;
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Amendment 143
Article 46 paragraph 4 point d
Text proposed by the Commission Amendment
(d) provide scientific and technical assistance to the relevant authorities of the Member States for the acceptance and implementation of alternative methods; (d) provide scientific and technical assistance to the relevant authorities and to user establishments, within and between the Member States, for the acceptance and implementation of alternative methods;
Amendment 144
Article 46 paragraph 4 point e
Text proposed by the Commission Amendment
(e) provide training on the use of alternative methods to persons referred to in Article 20(1). (e) provide training on the use of alternative methods to persons referred to in Article 20(1) and, if required, to user establishments .
Amendment 145
Article 46 paragraph 4 point e a (new)
Text proposed by the Commission Amendment
ea) communicate developments on alternative methods and inform the public of positive and negative outcomes.
Amendment 193
Article 46 paragraph 4 a (new)
Text proposed by the Commission Amendment
4a. The national centres shall work with all relevant stakeholders to further the aim of replacing all animal procedures.
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Amendment 147
Article 49 paragraph 2 subparagraph 2
Text proposed by the Commission Amendment
Member States shall submit that statistical information to the Commission by [three years from transposition date] and every year thereafter. Member States shall make that statistical information publicly available and submit it to the Commission by [three years from transposition date] and thereafter at intervals not exceeding two years.
Amendment 148
Article 53
Text proposed by the Commission Amendment
The Commission shall review this Directive by [10 years after the date of entry into force] taking into account advancement in development of alternative methods not entailing the use of animals, and in particular of non-human primates, and propose any amendments, where appropriate. The Commission shall review this Directive by [5 years after the date of entry into force] taking into account advancement in development of alternative methods not entailing the use of animals, and in particular of non-human primates, and propose any amendments, where appropriate.
Amendment 194
Article 53 a (new)
Text proposed by the Commission Amendment
Article 53a
Thematic review
The Commission shall, in consultation with Member States and any relevant stakeholders, conduct a thematic review of the use of animals in procedures every two years commencing two years after the entry into force of this Directive. The review shall examine the impact of developments in technological, scientific and animal welfare knowledge, and set targets for the implementation of 9312/09
validated replacement methods.
In the periodic reviews, the Commission shall give priority to the reduction and elimination of procedures causing the greatest permissible pain, suffering, distress or lasting harm and those which are not designed to alleviate lifethreatening or debilitating clinical conditions in human beings, with a view to the elimination of all procedures. The Commission shall take into account evolving public opinion about the use of animals in procedures in the periodic reviews.
Amendment 150
Annex I - Title
Text proposed by the Commission Amendment
Invertebrate Species referred to in Article 2 (2) Invertebrate Orders referred to in Article 2 (2)
Amendment 151
Annex I line 1
Text proposed by the Commission Amendment Cyclostomes deleted
Amendment 152 Annexe I line 3
Text proposed by the Commission Amendment
Decapod crustaceans Decapod crustaceans of the infraorders Brachyura and Astacidea
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Amendment 153
Annex II point 8
Text proposed by the Commission Amendment Rabbit (Oryctolagus cuniculus) deleted
Amendment 154
Annex II point 11 a (new)
Text proposed by the Commission Amendment 11a. Zebrafish (danio danio)
Amendment 155
Annex III line 3 - column 2
Text proposed by the Commission Amendment
7 years after transposition of Directive 10 years after transposition of Directive
Amendment 156
Annex III line 4 - column 2
Text proposed by the Commission Amendment
7 years after transposition of Directive 10 years after transposition of Directive
Amendment 157
Annex IV subtitle (new)
Text proposed by the Commission Amendment
The care and accommodation conditions shall be tailored to the scientific objective
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Amendment 158
Annex IV point 1 introductory part
Text proposed by the Commission Amendment
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1.THE PHYSICAL FACILITIES 1. THE PHYSICAL FACILITIES
The accommodation conditions shall be tailored to the scientific objective.
Amendment 159
Annex IV point 3 introductory part
Text proposed by the Commission Amendment 3. CARE 3. CARE
The care shall be tailored to the scientific objective.
Amendment 169
Annex IV a (new)
Text proposed by the Commission Amendment
A EX IVa List of animals referred to in Article 32(3a)
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1)Cattle (Bos taurus and Bos indicus);
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2)Sheep and goats (Ovis aries and
Capra hircus);
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3)Swine (Sus scrofa);
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4)Equine animals (Equus asinus);
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5)Domestic fowl (Gallus gallus
domesticus);
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6)Domestic turkey (Meleagris
gallopavo);
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7)Ducks and geese (Anas
platyrhynchos, Anser anser domesticus, Cairina moschata);
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8)Domestic quail (Coturnix spp);
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9)Pigeons (Colombia livia);
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10)Rabbits (Oryctolagus cuniculus).
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Amendment 160
Annex V table 5 `Overall rating' column Carbon dioxide
Text proposed by the Commission Amendment 1 - if sole agent 5
5 - if animal unconscious
Amendment 161
Annex VIIa (new)
Text proposed by the Commission Amendment
A EX VIIa General Definitions of Degrees of Severity referred to in Article 15(1)
In general:
Unless the contrary is known or established, it should be assumed that procedures that cause pain in humans also cause pain in animals. o pain or mild pain: Severity Grade 1
Interventions and manipulations in animals for experimental purposes as a result of which the animals experience no pain or short term mild pain, suffering, injury, or mild distress with no significant impairment of their general condition. Examples:
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-studies with differing feed compositions or with unphysiological diet, with minor clinical signs or symptoms. - withdrawal of blood samples or injection (s.c., i.m., i.p., i.v.) of a drug. - superficial tissue biopsy under anaesthesia - non-invasive scanning techniques, with or without sedation or anaesthesia of the
animals
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-tolerability studies which give cause to expect short term, minor, local or systemic reactions - Electrocardiogram (ECG) recordings in conscious animals
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-observational studies such as open-field test, labyrinth tests, or staircase test - experiments under general anaesthesia without recovery Moderate: Severity Grade 2
Interventions and manipulations in animals for experimental purposes which subject the animals to short term moderate distress, or a moderately long to long-lasting episode of mild distress, pain, suffering, or injury, or significant impairment of general condition. Examples:
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-surgery under anaesthesia and appropriate analgesia
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-implantation of devices such as catheters, telemetry transmitters, minipumps under general anaesthesia - studies with unphysiological diet, with clinical signs or symptoms of untreated diabetes mellitus - frequent repeated blood sampling or administration of substances - induction of anxiety in animal models
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-acute toxicity tests, acute tolerability studies, range-finding studies, chronic toxicity/carcinogenicity tests with nonlethal endpoints - seizure models e.g. epilepsy studies
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-non-lethal animal models of cancer e.g. xenograft studies Severe: Severity Grade 3
Interventions and manipulations in animals for experimental purposes which cause the animals severe to very severe distress, or subject them to a moderately long to long-lasting episode of moderate distress, severe pain, prolonged suffering or severe injury, or significant and 9312/09
persistent impairment of general condition.
Examples:
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-bacterial or viral lethal infections
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-chronic models of rheumatoid arthritis
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-genetically modified animals with lethal phenotypes (e.g. oncogenes), without early termination of the experiment - organ transplantation (e.g. kidney, pancreas)
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-chronic models of severe neurological diseases, e.g. Parkinsons disease
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- 5 nov '08COM(2008)543 - Bescherming van dieren die voor wetenschappelijke doeleinden worden gebruikt
- 18 sep '08COM(2008)553 - Bescherming van dieren bij het doden
- 23 jan '06COM(2006)13 - Gemeenschappelijk actieplan inzake de bescherming en het welzijn van dieren 2006-2010
- 26 sep '02COM(2002)530 - Voorstel voor een Richtkijn van het Europees Parlement en de Raad betreffende de harmonisatie van nationale wetgevinginzake de toepassing van de beginselen van goede laboratoriumpraktijken en het toezicht op de toepassing ervan voor tests op chemische stoffen
- 26 nov '01COM(2001)404 - Gemeenschappelijke procedures voor het verlenen van vergunningen, het toezicht en de geneesmiddelenbewaking met betrekking tot geneesmiddelen voor menselijk en diergeneeskundig gebruik en tot oprichting van een Europees Bureau voor de geneesmiddelenbeoordeling
- 27 jul '98COM(1998)450; - Weesgeneesmiddelen
- 3 sep '97COM(1997)369 - Harmonisatie van nationale wetgevinginzake de invoering van goede klinische praktijk bij de uitvoering van klinische proeven op geneesmiddelen voor gebruik bij de mens
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Voorwaardelijke vergunningen voor het in de handel brengen van geneesmiddelen voor menselijk gebruik die binnen het toepassingsgebied van Verordening 726/2004 vallen
