Activities of Roselyne LEFRANÇOIS related to 2008/0211(COD)
Plenary speeches (1)
Protection of animals used for scientific purposes (debate)
Amendments (43)
Amendment 134 #
Proposal for a directive
Recital 3
Recital 3
(3) On 24 November 1986 the Council adopted Directive 86/609/EEC in order to eliminate disparities betweenharmonise laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Since the adoption ofAccordingly, thatis Directive, further disparities between Member States have emerged. Certain Member States have adopted national implementing measures that ensure a high level of protection of animals used for scientific purposes while others only apply the minimum requirements laid down in Directive 86/609/EEC. Accordingly, this Directive should provide for more detailed rules in order to reduce such disparities and to ensure a proper functioning of the internal market should guarantee the application of harmonised objectives and minimum standards throughout the European Union.
Amendment 136 #
Proposal for a directive
Recital 6
Recital 6
(6) It is necessarymay be desirable 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.
Amendment 141 #
Proposal for a directive
Recital 13
Recital 13
(13) The methods selected should avoid, as far as possible, death as an end-point due to severe suffering caused by the approaching death. Where possible, it should be substituted by more humane end-pointethical methods using clinical signs that determine the impending death thereby allowing the animal to be killed by a humann appropriate method without any further suffering.
Amendment 143 #
Proposal for a directive
Recital 16
Recital 16
(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 non- human 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 as being either life-threatening or debilitating, or for the preservation of the respective non-human primate species. Fundamental research in someall areas of the biomedical sciences can provide important new information relevant to many life- threatening and debilitating human conditions. The reference to life- threatening or debilitating clicontributing to knowledge of humans, animals or the environment. However, the high sensitivity of non-human primates and their advanced social needs mean that fundamental research projects using such anicmal 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/ECs should be subjected to strict scientific peer review and a strict ethical evaluation taking account of the specific characteristics of these species.
Amendment 150 #
Proposal for a directive
Recital 24
Recital 24
(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-homused in families as there is a high public concern as to the fate of those animals. Should establishments allow re-homing,specialist centres, but in such cases it is essential that there is a scheme in place to provide the appropriate socialisation to those animals in order to ensure successful re-homingintegration as well as to avoid unnecessary distress to the animals and to guarantee public safety.
Amendment 151 #
Proposal for a directive
Recital 25
Recital 25
(25) Animal tissue and organs are used for the development of in vitro methods. To implement the principle of reduction, it would be desirable for Member States shouldto establish programmes for sharing the organs and tissue of animals that are killed using humane methods.
Amendment 153 #
Proposal for a directive
Recital 35
Recital 35
(35) To monitor compliance with this Directive, Member States should carry out at least two inspections annually in each establishment. To ensure public confidence and promote transparency at least one inspection a year must be unannounced. Programmes for joint inspections by Member States should be established to foster an environment of sharing good practice and expertisen average of one inspection per year.
Amendment 156 #
Proposal for a directive
Recital 40
Recital 40
(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 summariesthe competent authority with data, which may be qualitative and/or quantitative, concerning the use of live animals and make such data publicly available.
Amendment 159 #
Proposal for a directive
Recital 47
Recital 47
(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 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 161 #
Proposal for a directive
Recital 52
Recital 52
Amendment 167 #
Proposal for a directive
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) live non-human vertebrate animals, including independently feeding larval forms and embryonic or foetal forms of mammals as from the last third of their normal development;
Amendment 184 #
Proposal for a directive
Article 5 – paragraph 2 – point b a (new)
Article 5 – paragraph 2 – point b a (new)
(ba) the improvement of the production conditions and welfare of animals reared for agricultural purposes.
Amendment 191 #
Proposal for a directive
Article 6 – title
Article 6 – title
Amendment 193 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
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.
Amendment 194 #
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
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 humann appropriate method of killing or that other methods providing better animal protection have been developed.
Amendment 195 #
Proposal for a directive
Article 6 a (new)
Article 6 a (new)
Article 6a National measures This Directive shall be a reference framework for the Member States in the field of the protection of animals used for scientific purposes. However, the adoption or application of additional national measures aimed at improving animal welfare may be envisaged.
Amendment 206 #
Proposal for a directive
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(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 life- threatening or debilitating clinical conditions in human beings or the purpose referred to in point (5) of Article 5;
Amendment 215 #
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1
Article 10 – paragraph 1 – subparagraph 1
1. Member States shall ensure that animals belonging to the species listed in Annex II may only be used in procedures where those animals have been bred for use in procedures or for agronomic purposes.
Amendment 219 #
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Competent authorities may grant exemptions from paragraph 1 on the basis of a veterinary justification for reasons of animal welfare or of a scientific justification.
Amendment 230 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Member States shall ensure that a procedure is not carried out if another internationally recognised and scientifically satisfactory method or testing strategy of obtaining the result sought, not entailing the use of an live animal, is recognised by Community legislation. In the absence of such a method, a procedure may not be carried out if a scientifically satisfactory method or testing strategy for obtaining the result sought, including computer supported, in vitro and other methodologies, not entailing the use of an animal, is reasonably and practicably available.
Amendment 246 #
Proposal for a directive
Article 15 – paragraph 4 – subparagraph 1
Article 15 – paragraph 4 – subparagraph 1
4. The Commission shall establish the criteria for classification of procedures, on the basis of international classifications and in line with best practices developed within the European Union.
Amendment 266 #
Proposal for a directive
Article 18
Article 18
Member States shall encourage the establishment of programmes for the sharing of organs and tissues of animals killed by a humane method.
Amendment 268 #
Proposal for a directive
Article 20 – paragraph 1 – introductory part
Article 20 – paragraph 1 – introductory part
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 274 #
Proposal for a directive
Article 22 – paragraph 2 a (new)
Article 22 – paragraph 2 a (new)
2a. Where the authorisation is suspended or withdrawn, Member States shall establish a mechanism for appeals against the decision.
Amendment 279 #
Proposal for a directive
Article 26 – paragraph 1 – introductory part
Article 26 – paragraph 1 – introductory part
1. The permanent ethical review body that reviews protocols and procedures shall fulfil the following tasks:
Amendment 287 #
Proposal for a directive
Article 32 – paragraph 2
Article 32 – paragraph 2
2. For the purposes of points (a) and (b) of paragraph 1, Member States shall apply the care and accommodation standardsguidelines, tailored to the scientific objective, set out in Annex IV as from the dates provided for in that Annex.
Amendment 289 #
Proposal for a directive
Article 33 – paragraph 2 – subparagraph 1
Article 33 – paragraph 2 – subparagraph 1
2. National inspections shall be carried out by the competent authority at least twice a yearon average once a year, with the competent authority adapting the frequency of inspection on the basis of a risk analysis for each establishment.
Amendment 290 #
Proposal for a directive
Article 33 – paragraph 2 – subparagraph 2
Article 33 – paragraph 2 – subparagraph 2
Amendment 291 #
Proposal for a directive
Article 33 – paragraph 3
Article 33 – paragraph 3
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 308 #
Proposal for a directive
Article 36 – paragraph 2
Article 36 – paragraph 2
2. Member States may waive the requirement in paragraph 1(b) and permit the user establishment to submit a reduced project proposal covering only the information necessary for the ethical evaluation and elements listed in Article 41(2), provided that the project involves only procedures classified as "up to mildoderate" and does not use non-human primates.
Amendment 329 #
Proposal for a directive
Article 38 – paragraph 1 – subparagraph 1
Article 38 – paragraph 1 – subparagraph 1
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 by the competent authority.
Amendment 333 #
Proposal for a directive
Article 38 – paragraph 3
Article 38 – paragraph 3
Amendment 334 #
Proposal for a directive
Article 38 – paragraph 4
Article 38 – paragraph 4
4. Without prejudice to paragraph 3, aAll projects involving only procedures classified as "up to mildoderate" shall be exempted from the requirement for a retrospective assessment.
Amendment 342 #
Proposal for a directive
Article 41 – paragraph 2 – point d
Article 41 – paragraph 2 – point d
d) at least one person demonstrating species specific knowledge.eleted
Amendment 351 #
Proposal for a directive
Article 42 – paragraph 2
Article 42 – paragraph 2
2. Any amendment or renewal of a project authorisation shall be subject to a further favourable ethical evaluation.
Amendment 358 #
Proposal for a directive
Article 43 – paragraph 1
Article 43 – paragraph 1
1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within 30 days from the submission of the application. Should the Member State fail to take a decision within that period, or in the case of a minor amendment, the authorisation shall be deemed to have been granted, where the project concerned involves only procedures classified as "up to mildoderate" and non-human primates are not used. In all other cases, no such presumption shall apply.
Amendment 367 #
Proposal for a directive
Article 45
Article 45
The Commission and Member States shall contribute financially to the development and, where appropriate, scientific 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.
Amendment 383 #
Proposal for a directive
Annex I
Annex I
Invertebrate Species referred to in Article • Cyclostomes2(2) 2(2) • Cephalopods • Decapod crustaceans
Amendment 386 #
Proposal for a directive
Annex II – point 8
Annex II – point 8
Amendment 389 #
Proposal for a directive
Annex II – point 11 a (new)
Annex II – point 11 a (new)
11a. Zebrafish (danio danio)
Amendment 394 #
Proposal for a directive
Annex V – title
Annex V – title
Amendment 395 #
Proposal for a directive
Annex V – table 1 – title
Annex V – table 1 – title
Table 1 - HumanAppropriate methods of killing fish, including gnathostomes and cyclostomes/slaughter of fish
Amendment 396 #
Proposal for a directive
Annex V – table 5 – ‘Overall rating’ column – Carbon dioxide
Annex V – table 5 – ‘Overall rating’ column – Carbon dioxide