BETA

33 Amendments of David HAMMERSTEIN related to 2008/0211(COD)

Amendment 46 #
Proposal for a directive
Article 4 – paragraph 1
1. Where a method of testing not involving the use of living animals exists and may be used in place of a procedure, Member States shall ensure that the alternative method is usednot authorise the use of animals.
2009/02/23
Committee: ITRE
Amendment 52 #
Proposal for a directive
Article 5 – point 3
(3) the development, manufacture or testing of the quality, effectiveness and safety of drugs, food- and feed-stuffs and other substances or productsmedicinal or veterinary products and devices, having either of the aims referred to in point (2);
2009/02/23
Committee: ITRE
Amendment 53 #
Proposal for a directive
Article 5 – point 3 a (new)
(3a) the development, manufacture or testing of the quality, effectiveness and safety of substances or products, other than those referred to in point (3) having either of the aims referred to in point (2);
2009/02/23
Committee: ITRE
Amendment 59 #
Proposal for a directive
Article 6 a (new)
Article 6a 1. Procedures for the purpose of basic research may be carried out only if the following criteria are met: (a) the suffering experienced by the animal does not exceed the moderate level; (b) there is compelling justification that there is a realistic prospect that the results of the research will contribute to achieving the aims referred to in point (2) of Article 5.
2009/02/23
Committee: ITRE
Amendment 62 #
Proposal for a directive
Article 6 b (new)
Article 6b This Directive shall not prevent Member States from applying or adopting stricter national measures aimed at improving the welfare and protection of animals used in experiments.
2009/02/23
Committee: ITRE
Amendment 76 #
Proposal for a directive
Article 8 – paragraph 2
2. Notwithstanding paragraph 1, great apes shall not be used in procedures, subject to the use of the safeguard clause in Article 50.
2009/02/23
Committee: ITRE
Amendment 77 #
Proposal for a directive
Article 8 – paragraph 2 a (new)
2a. The Commission shall, in consultation with Member States, conduct a review of the use of non-human primates in procedures. The review shall be conducted every two years, commencing two years after the entry into force of this Directive. The review shall consider the impact of developments in technological, scientific and animal welfare knowledge and set targets for the implementation of validated replacement methods.
2009/02/23
Committee: ITRE
Amendment 80 #
Proposal for a directive
Article 8 – paragraph 2 b (new)
2b. The Commission shall develop a strategy to establish a high level group to review annually the regulatory use of non-human primates with a view to ending this practice within five years of the date specified in Article 59.
2009/02/23
Committee: ITRE
Amendment 81 #
Proposal for a directive
Article 9 – 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 an animal which has been bred for use in procedures.deleted
2009/02/23
Committee: ITRE
Amendment 86 #
Proposal for a directive
Article 10 – paragraph 2
2. Competent authorities may grant exemptions from paragraph 1 on the basis of a scientific justification.deleted
2009/02/23
Committee: ITRE
Amendment 88 #
Proposal for a directive
Article 13 – paragraph 1
1. Member States shall ensure that a procedure is not carried out if another scientifically satisfactory method or testing strategy of obtaining the result sought, not entailing the use of an 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.
2009/02/23
Committee: ITRE
Amendment 90 #
Proposal for a directive
Article 13 – paragraph 3
3. Death as the end-point in a procedure shall be avoided as far as possible and replaced by early and humane end- points. If death as the end-point is unavoidable, the procedure shall be designed so as to result in the deaths of as few animals as possible.
2009/02/23
Committee: ITRE
Amendment 97 #
Proposal for a directive
Article 15 – paragraph 2
2. Member States shall ensure that the procedures classified as "severe" are not perfscientifically justified, and ethically monitormed if the pain, suffering or distress is likely to be prolonged. These procedures must be exceptional and shall be subject to particular harm/benefit analysis and scrutiny by the competent authority.
2009/02/23
Committee: ITRE
Amendment 123 #
Proposal for a directive
Article 25 – paragraph 2
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, persons with expertise in the "3Rs" (Replacement, Reduction, Refinement), and an independent lay person.
2009/02/23
Committee: ITRE
Amendment 132 #
Proposal for a directive
Article 27 – paragraph 1
1. Without prejudice to the principle of replacement, reduction and refinement, 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.
2009/02/23
Committee: ITRE
Amendment 136 #
Proposal for a directive
Article 27 – paragraph 2 a (new)
2a. Member States shall take all steps necessary to ensure that as soon as practicable the use of non-human primates in procedures is discontinued.
2009/02/23
Committee: ITRE
Amendment 139 #
Proposal for a directive
Article 32 – paragraph 1
1. Member States shall, as far as the care and accommodation of animals is concerned, ensure the following: (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 and which allow them to satisfy their ethological as well as physical needs; (b) any restrictions on the extent to which an animal can satisfy its physiological and ethological needs are limited to a minimum; (c) the environmental conditions in which animals are bred, kept or used are checked daily; (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; (e) arrangements are made to ensure that any defect orin equipment causing suffering is discovered isand eliminated as quickly as possible.
2009/02/23
Committee: ITRE
Amendment 140 #
Proposal for a directive
Article 32 – paragraph 2
2. For the purposes of points (a) and (b) of paragraph 1, Member States shall apply the care and accommodation standards set out in Annex IV as from the dates provided for in that Annex18 months after the date referred to in Article 59.
2009/02/23
Committee: ITRE
Amendment 142 #
Proposal for a directive
Article 32 – paragraph 3
3. Member States may allow exemptions to paragraph 2 for animal welfare reasonpply or adopt stricter measures for the protection of animals used in experiments.
2009/02/23
Committee: ITRE
Amendment 147 #
Proposal for a directive
Article 34 – paragraph 1
1. The Commission mayshall undertake controls of the infrastructure and operation of national inspections in Member States. The Commission shall set up a system to monitor inspections and enforcement of this Directive in each Member State, on average every three years, ensuring harmonised practices for the use and the care of animals used or intended to be used in scientific procedures.
2009/02/23
Committee: ITRE
Amendment 154 #
Proposal for a directive
Article 35 – paragraph 2 a (new)
2a. Ethical evaluation for all projects using non-human primates shall be conducted by a panel of independent experts appointed by the competent authority.
2009/02/23
Committee: ITRE
Amendment 155 #
Proposal for a directive
Article 35 – paragraph 2 b (new)
2b. Authorisation shall not be granted for any project using non-human primates unless the application has been subject to public consultation.
2009/02/23
Committee: ITRE
Amendment 156 #
Proposal for a directive
Article 35 – paragraph 2 c (new)
2c. The minimum period between publication of a notice of intention to consult pursuant to paragraph 2b and the deadline for receipt of responses shall not be less than 42 days.
2009/02/23
Committee: ITRE
Amendment 173 #
Proposal for a directive
Article 38 – paragraph 2
2. Retrospective assessment shall evaluate the following: (a) whether the objectives of the project were achieved and how they contribute to achieving the stated potential benefits; (b) the harms inflicted on animals including the numbers and species of animals used and the severity of the procedurenature, level and duration of the harms experienced by the animals; (c) elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.
2009/02/23
Committee: ITRE
Amendment 191 #
Proposal for a directive
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 or the end of the consultation period specified in Article 35(2c), whichever is the later date. 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.
2009/02/23
Committee: ITRE
Amendment 194 #
Proposal for a directive
Article 43 a (new)
Article 43a Public register The competent authority shall publish a register of all applications for project authorisation which shall include the following: (a) details of the applications for project authorisation; (b) details of any public consultation conducted; (c) the ethical evaluation; (d) the retrospective assessment, if conducted; (e) details of the project authorisation; and (f) details of any amendment, renewal and withdrawal of a project authorisation.
2009/02/23
Committee: ITRE
Amendment 196 #
Proposal for a directive
Article 45
The Commission and Member States shall contribute to the development andfinancially and by other appropriate means, to the development and, where appropriate, scientific validation of alternative approaches that couldintended to 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.
2009/02/23
Committee: ITRE
Amendment 198 #
Proposal for a directive
Article 45 a (new)
Article 45a The Commission shall, by [one year after entry into force of this Directive], review and strengthen the role of the European Centre for the Validation of Alternative Methods to facilitate the development and use of alternatives to animal procedures. The European Centre for the Validation of Alternative Methods shall coordinate with the national reference laboratories referred to in Article 46 in order to: (a) develop a strategy on the implementation of the 3Rs approach (replacing, reducing and refining); (b) identify the need for research into alternative procedures; (c) provide advice and guidance and information on the 3Rs to competent authorities, the scientific community, the public and relevant stakeholders; (d) coordinate pre-validation and validation studies; (e) identify new alternative methods suitable for validation and specific requirements for their validation, in consultation with relevant national and international regulatory bodies; (f) facilitate the scientific endorsement and regulatory acceptance of alternatives to animal tests used for regulatory purposes.
2009/02/23
Committee: ITRE
Amendment 202 #
Proposal for a directive
Article 50
1. Where a Member State has justifiable grounds for believing that action is essential for the preservation of the species or in relation to an unexpected outbreak of a life-threatening or debilitating clinical condition in human beings, it may authorise the use of great apes in procedures having one of the purposes referred to in Article 5(2)(a), (3) or 5; provided that the purpose of the procedure cannot be achieved by the use of other species than great apes or by the use of alternative methods. However, the reference to Article 5(2)(a) shall not be taken to include the reference to animals or plants. 2. The Member State shall immediately inform the Commission and the other Member States thereof, giving reasons for its decision and submitting evidence of the situation as described in paragraph 1 on which the provisional measure is based. 3. The Commission shall take a decision in accordance with the procedure referred to in Article 51(2) within 60 days of receipt of the information from the Member State. This decision shall either: (a) authorise the provisional measure for a time period defined in the decision; or (b) require the Member State to revoke the provisional measure.Article 50 deleted Safeguard clause
2009/02/23
Committee: ITRE
Amendment 204 #
Proposal for a directive
Article 53
The Commission shall review this Directive by [10five 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.
2009/02/23
Committee: ITRE
Amendment 206 #
Proposal for a directive
Article 53 a (new)
Article 53a Regular review of the use of animals in procedures The Commission shall, in consultation with Member States, conduct a thematic review of the use of animals in procedures. The review shall be conducted every two years commencing two years after the entry into force of this Directive. The review shall consider the impact of developments in technological, scientific and animal welfare knowledge and set targets for the implementation of validated replacement methods.
2009/02/23
Committee: ITRE
Amendment 207 #
Proposal for a directive
Article 54 – paragraph 1 - subparagraph 2
Member States mayshall not designate bodies other than public authorities for the implementation of this Directive. Bodies thus designated shall be considered competent authorities for the purposes of this Directive.
2009/02/23
Committee: ITRE
Amendment 213 #
Proposal for a directive
Annex III – table – column 2 – line 2 to 4
[7five years after transposition of Directive] [7five years after transposition of Directive] [10five years after transposition of Directive]
2009/02/23
Committee: ITRE