Activities of Françoise GROSSETÊTE related to 2008/0211(COD)
Plenary speeches (2)
Protection of animals used for scientific purposes (debate)
Explanations of vote
Amendments (28)
Amendment 13 #
Proposal for a directive
Recital 7
Recital 7
(7) This Directive should also cover embryonic and foetal forms of vertebrate animals which are intended to be born, when it has been scientifically shown that their nervous system is capable of registering pain signals, 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.
Amendment 15 #
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8a) In the light of scientific progress, the use of animal experiments is still one important approach to ensuring a very high quality of public health research.
Amendment 21 #
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 problemsissues and justifies practice 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 research and 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 some 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 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, 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 human conditions.
Amendment 23 #
Proposal for a directive
Recital 18
Recital 18
(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 orderWith a view to gradually ending the capturing of animals from the wild for breeding purposes, only animals that are the offspring of an aaccount should be taken of the technimcal which has been bred in captivity should be made available for use in scientific proceduand scientific feasibility of this process, studies should be carried out on its economic viability and its effects – both positive and negative – on animal welfares, 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 goalnd possible solutions should be considered to the problem of supplying the European Union in the long term. The Commission and the Member States should also take the necessary measures to support appropriate transport conditions for non- human primates on the territory of the European Union.
Amendment 26 #
Proposal for a directive
Recital 22
Recital 22
(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 prohibitedrestricted as far as possible taking account of their scientific and public health benefits. 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 27 #
Proposal for a directive
Recital 23
Recital 23
(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 reducedhave been justified by an ethical review.
Amendment 31 #
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 availabcollected and compiled. The format of that information should not violate proprietary rights or expose confidential information or information relating to the safety of persons and installations. Therefore, user establishments should providedraw up anonymous non-technical summaries of those projects, including the results of any retrospective assessments, and make those summaries publicly available to the relevant authorities.
Amendment 41 #
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 as from the last third of their normal developmentwhich are intended to be born and have been scientifically shown to possess a nervous system capable of registering pain signals;
Amendment 44 #
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
3. This Directive shall apply to animals used in procedures, which are at an earlier stage of development than that referred to in point (a) of paragraph 2, if the animal is to be allowed to live beyond that stage of development and is likely to experience pain, suffering, distress or lasting harm after it has reached that stage of development which are intended to be born and have been scientifically shown to possess a nervous system capable of registering pain signals.
Amendment 47 #
Proposal for a directive
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Where a method of testing not involving the use of animals exists, provides equally relevant information and may be used in place of a procedure, Member States shall ensure that the alternative method is used.
Amendment 55 #
Proposal for a directive
Article 6 – title
Article 6 – title
Amendment 68 #
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) and, (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 83 #
Proposal for a directive
Article 10
Article 10
1. Member States shall ensure that aNo later than [5 years from the entry into force of this directive], the Commission shall submit a technimcals belonging to the species listed in Annex II may only be used in procedures where those animals have been bred for use in procedures. However feasibility study of the requirements set out in paragraph 1a, detailing the consequences for animal welfare 1a. In the light of the results of the study referred to in paragraph 1, and if justified on scientific, economic and ethical grounds, 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. 2. Competent authorities may grant exemptions from paragraph 1 on the basis of a scientific justification or linked to animal welfare.
Amendment 102 #
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. 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 totally different from the previous procedure from a scientific point of view only when all of the following conditions are met: (a) the previous procedure was classified as 'up to mildmoderate'; (b) it is demonstrated that its general state of health and well-being has been fully restored; (c) the further procedure is classified as 'up to mildmoderate' or 'non-recovery'; (ca) a prior veterinary inspection is made before the possible re-use.
Amendment 127 #
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 128 #
Proposal for a directive
Article 26 – paragraph 1 – point d – introductory part
Article 26 – paragraph 1 – point d – introductory part
(d) review annuallyevery three years all projects which are of more than 12 months duration, focusing in particular on:
Amendment 131 #
Proposal for a directive
Article 27 – paragraph 1
Article 27 – paragraph 1
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 non- human primates that have been bred in captivity. The Commission and the Member States shall take the necessary measures to support appropriate conditions of transport and shall draw up a common strategy to sustain the indispensable presence of non-human primates on Community territory.
Amendment 144 #
Proposal for a directive
Article 32 – paragraph 3
Article 32 – paragraph 3
3. Member States may allow exemptions to paragraph 2 for justified scientific reasons, veterinary reasons or animal welfare reasons.
Amendment 149 #
Proposal for a directive
Article 35 – paragraph 1
Article 35 – paragraph 1
1. Member States shall ensure that projects are not carried out without a prior authorisation by the competent authority or, by delegation, by the permanent ethical review body that reviews protocols and procedures.
Amendment 151 #
Proposal for a directive
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Granting of authorisation shall be subject to favourable ethical evaluation by the competent authority or, by delegation, by the permanent ethical review body that reviews protocols and procedures.
Amendment 165 #
Proposal for a directive
Article 37 – paragraph 2 – point d
Article 37 – paragraph 2 – point d
(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 could ultimately be benefitscial to human beings, animals or the environment;
Amendment 170 #
Proposal for a directive
Article 37 – paragraph 4
Article 37 – paragraph 4
4. Ethical evaluation shall be performed in a transparent manner, by integrating the opinion of independent parties, and by preserving confidentiality and protecting intellectual property and the safety of goods and persons.
Amendment 177 #
Proposal for a directive
Article 40 – paragraph 1
Article 40 – paragraph 1
1. Subject to safeguarding confidential information, including those of the establishment and its staff, the non- technical project summary shall provide the following: (a) information on the objectives of the project, including the likelihood of achieving them, the potential harm, and details of the number and types of animals to be used; (b) a demonstration ofthat there has been compliance with the requirement of replacement, reduction and refinement.
Amendment 178 #
Proposal for a directive
Article 40 – paragraph 4
Article 40 – paragraph 4
4. Member States shall make publicly available tThe non-technical project summaries of authorised projects and any updates to them shall be sent, on request, to the competent authorities, which shall make them publicly available.
Amendment 180 #
Proposal for a directive
Article 41 – paragraph 2 – point d
Article 41 – paragraph 2 – point d
Amendment 208 #
Proposal for a directive
Annex I
Annex I
• Cyclostomes • Cephalopods • Decapod crustaceanephalopods
Amendment 212 #
Proposal for a directive
Annex III – table – column 2 – line 2 to 4
Annex III – table – column 2 – line 2 to 4
[715 years after transposition of Directiveconfirmation of interest by the Commission] [715 years after transposition of Directiveconfirmation of interest by the Commission] [120 years after transposition of Directiveconfirmation of interest by the Commission]
Amendment 219 #
Proposal for a directive
Annex V
Annex V
Annex deleted.