36 Amendments of Philippe BUSQUIN related to 2008/0211(COD)
Amendment 10 #
Proposal for a directive
Recital 6
Recital 6
(6) It iswill be necessary to include specific invertebrate species within the scope of this Directive, as there is once scientific evidence is available of the potential ability of such species to experience pain, suffering, distress and lasting harm.
Amendment 14 #
Proposal for a directive
Recital 7
Recital 7
(7) This Directive should also cover embryonic and foetal forms of vertebrate animals, asonce 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 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 19 #
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 scientific peer review and a strict ethical evaluation taking account of the specific characteristics of these species.
Amendment 36 #
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 39 #
Proposal for a directive
Article 2 – paragraph 2
Article 2 – paragraph 2
2. This Directive shall apply to the following animals: (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; (b) live invertebrate animals, including independently feeding larval forms, of those species listed in Annex I.
Amendment 51 #
Proposal for a directive
Article 5 – point 2 – point b a (new)
Article 5 – point 2 – point b a (new)
(ba) the improvement of the production conditions and welfare of animals reared for agricultural purposes.
Amendment 58 #
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 humane method of killing or that other methods providing better animal protection have been developed.
Amendment 60 #
Proposal for a directive
Article 6 a (new)
Article 6 a (new)
Article 6a National 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 67 #
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 79 #
Proposal for a directive
Article 8 – paragraph 2 a (new)
Article 8 – paragraph 2 a (new)
2a. The Commission shall develop a strategy to establish a high-level group to review annually the use of non-human primates in procedures.
Amendment 85 #
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 2
Article 10 – paragraph 1 – subparagraph 2
Amendment 92 #
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
Amendment 94 #
Proposal for a directive
Article 14 – paragraph 2 – introductory part
Article 14 – paragraph 2 – introductory part
2. By way of derogation from paragraph 1, pProcedures may be carried out without anaesthesia in the following conditions:
Amendment 99 #
Proposal for a directive
Article 15 – paragraph 2
Article 15 – paragraph 2
2. Member States shall ensure that the procedures classified as "severe" are not performedsubject to an enhanced scientific and ethical evaluation procedure involving the putting in place of clearly established limit points if the pain, suffering or distress is likely to be prolonged.
Amendment 104 #
Proposal for a directive
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
(a) the previous procedure was classified as 'up to mildoderate';
Amendment 106 #
Proposal for a directive
Article 16 – paragraph 1 – point c
Article 16 – paragraph 1 – point c
(c) the further procedure is classified as 'up to mildoderate' or 'non-recovery'.
Amendment 107 #
Proposal for a directive
Article 16 – paragraph 1 – point c a (new)
Article 16 – paragraph 1 – point c a (new)
(ca) the repeated use of the animal is accompanied by veterinary inspections. Repeated interventions under the same protocol may be necessary in the context of longitudinal projects.
Amendment 110 #
Proposal for a directive
Article 19 – introductory part
Article 19 – introductory part
Member States may allow animals used or intended to be used in procedures to be set freeplaced in normal breeding conditions or re-homed provided that the following conditions are met:
Amendment 113 #
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 115 #
Proposal for a directive
Article 20 – paragraph 3
Article 20 – paragraph 3
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. Member States shall guarantee the mutual recognition of this competence and of the authorisation.
Amendment 119 #
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 124 #
Proposal for a directive
Article 25 – paragraph 2
Article 25 – paragraph 2
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 and a person with expertise in the application of the principles of replacement, reduction and refinement.
Amendment 134 #
Proposal for a directive
Article 27 – paragraph 1
Article 27 – paragraph 1
1. Member States shall ensure that breeding establishments of non-human primates in the Community 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.
Amendment 143 #
Proposal for a directive
Article 32 – paragraph 3
Article 32 – paragraph 3
3. Member States may allow exemptions to paragraph 2 for animal welfare reasons or for experimental protocol requirements.
Amendment 145 #
Proposal for a directive
Article 33 – paragraph 3 – subparagraph 1 a (new)
Article 33 – paragraph 3 – subparagraph 1 a (new)
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 152 #
Proposal for a directive
Article 35 – paragraph 2 a (new)
Article 35 – paragraph 2 a (new)
2a. No formal authorisation shall be necessary for projects required by law, but these should be subject to favourable ethical evaluation.
Amendment 157 #
Proposal for a directive
Article 36 – paragraph 1 – introductory part
Article 36 – paragraph 1 – introductory part
1. The user establishmenscientific director or the person in charge of the establishment where the project is to be carried out shall submit an application for the project authorisation, which shall include the following:
Amendment 163 #
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 ultimately benefitscould be beneficial to human beings, animals or the environment;
Amendment 174 #
Proposal for a directive
Article 38 – paragraph 2 – point b
Article 38 – paragraph 2 – point b
(b) harm inflicted on animals including the numbers and species of animals used and the severity ofnature, level and duration of the harm inflicted on animals during the procedures;
Amendment 182 #
Proposal for a directive
Article 41 – paragraph 3
Article 41 – paragraph 3
3. Project authorisations shall be granted for a period not exceeding fourive years.
Amendment 184 #
Proposal for a directive
Article 42 – paragraph 1
Article 42 – paragraph 1
1. The competent authority may amend or renew the project authorisation on the request of the user establishment or the scientific director of the project.
Amendment 190 #
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, the authorisation shall be deemed to have been granted, where the project concerned involves only procedures classified as "up to mild" and non-human primates are not used. In all other cases, no such presumption shall apply.
Amendment 197 #
Proposal for a directive
Article 45
Article 45
The Commission and Member States shall contribute by various means, particularly financial, to the development and 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 201 #
Proposal for a directive
Article 49 – paragraph 2
Article 49 – paragraph 2
2. Member States shall collect and make publicly available, on an annual basis, statistical information on the use of animals in procedures, including information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures. Member States shall submitmake that statistical information publicly available and submit it to the Commission by [three years from transposition date] and every year thereafterthereafter at intervals not exceeding two years.
Amendment 215 #
Proposal for a directive
Annex IV – point 1 – introductory part
Annex IV – point 1 – introductory part
1. THE PHYSICAL FACILITIES The accommodation conditions should be tailored to the scientific objective.
Amendment 216 #
Proposal for a directive
Annex IV – point 3 – introductory part
Annex IV – point 3 – introductory part
3. CARE The care should be tailored to the scientific objective.