34 Amendments of Sergio BERLATO related to 2008/0211(COD)
Amendment 139 #
Proposal for a directive
Recital 7
Recital 7
(7) This Directive should also cover embryonic and foetal forms of vertebrate animals, asin 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 mammal 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 145 #
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-to-day 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/ECabout human beings.
Amendment 148 #
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 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 in the European Union should therefore have a strategy in place to support and facilitate the progressive move towards that goaldevelopment of self- sufficient colonies.
Amendment 157 #
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 summaries publicly available.
Amendment 165 #
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 development except for hens' eggs used for vaccine production and quality control;
Amendment 183 #
Proposal for a directive
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
(a) the avoidance, prevention, diagnosis or treatment (including the development of medical devices) of disease, ill-health or other abnormality or their effects in human beings, animals or plants;
Amendment 207 #
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 209 #
Proposal for a directive
Article 8 – paragraph 2
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. iven their particularly high level of neurophysiological sensitivity and cognitive development, procedures may be carried out on great apes only with a view to the avoidance, prevention, diagnosis or treatment of clinical conditions that are life-threatening for human beings or these animal species or which cause serious suffering and impairment or which threaten the survival of the species. In order to ensure that procedures are carried out on great apes only in exceptional cases, every corresponding project proposal must comply with the strictest possible conditions and undergo the most stringent possible scrutiny.
Amendment 218 #
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 2
Article 10 – paragraph 1 – subparagraph 2
Amendment 221 #
Proposal for a directive
Article 10 – paragraph 2 a (new)
Article 10 – paragraph 2 a (new)
2a. The Commission shall assess the welfare of the animals and the appropriateness of implementing the measures called for in paragraph 1 five years from the entry into force of this directive.
Amendment 243 #
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 performed if the pain, suffering or distress is likely to be prolonged unless there are any factors justifying the use of such procedures.
Amendment 251 #
Proposal for a directive
Article 16 – paragraph 1 – introductory phrase
Article 16 – paragraph 1 – introductory phrase
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 subsequently re-used in a new unrelated procedure only when all of the following conditions are met:
Amendment 254 #
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 259 #
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'. The repeated use of animals shall be accompanied by veterinary examinations.
Amendment 260 #
Proposal for a directive
Article 16 – paragraph 1 – point c a (new)
Article 16 – paragraph 1 – point c a (new)
(ca) a prior veterinary inspection is made before the possible re-use.
Amendment 263 #
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
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 furtherif the previous procedures used on the same animal are classified as 'moderate' and the subsequent procedure iss are classified as 'up to mildoderate' or as 'non-recovery'.
Amendment 280 #
Proposal for a directive
Article 27 – paragraph 1
Article 27 – paragraph 1
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 non- human primates that have been bred in captivity.
Amendment 281 #
Proposal for a directive
Article 27 – paragraph 2
Article 27 – paragraph 2
Amendment 283 #
Proposal for a directive
Article 30 – paragraph 1 – introductory sentence
Article 30 – paragraph 1 – introductory sentence
1. Member States shall ensure that all breeding, supplying and user establishments keep, where possible, the following information on each dog, cat and non- human primate:
Amendment 297 #
Proposal for a directive
Article 35 – paragraph 1
Article 35 – paragraph 1
1. Member States shall ensure that projects classified as '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 to the competent authority.
Amendment 301 #
Proposal for a directive
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Granting of authorisationThe commencement of the project shall be subject to favourable ethical evaluation by the competent authority.
Amendment 302 #
Proposal for a directive
Article 35 – paragraph 2 a (new)
Article 35 – paragraph 2 a (new)
2a. Projects required by law shall not need formal approval, provided that they do not involve 'severe' procedures or the use of non-human primates but are subject to favourable ethical evaluation. Or. it
Amendment 310 #
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 required for the ethical evaluation and elements listed in Article 41(2), provided that the project involves only procedures classified as "'up to mild"' or 'moderate' and does not use non-human primates.
Amendment 325 #
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 whilst respecting information confidentiality and intellectual property rights.
Amendment 336 #
Proposal for a directive
Article 38 – paragraph 4
Article 38 – paragraph 4
4. Without prejudice to paragraph 3, all projects involving only procedures classified as "'up to mild"' or 'moderate' shall be exempted from the requirement for a retrospective assessment.
Amendment 338 #
Proposal for a directive
Article 40 – paragraph 1 – introductory sentence
Article 40 – paragraph 1 – introductory sentence
1. Subject to safeguarding confidential information, company and personnel details, the non-technical project summary shall provide the following:
Amendment 340 #
Proposal for a directive
Article 40 – paragraph 1 – point b
Article 40 – paragraph 1 – point b
b) a demonstration of compliance with the requirementthat the principles of replacement, reduction and refinement have been considered.
Amendment 345 #
Proposal for a directive
Article 41 – paragraph 4
Article 41 – paragraph 4
4. 4. Member States mayshall allow the authorisation of multiple projects when those projects are required by lawinvolve standardised procedures which have been approved further to an ethical opinion.
Amendment 347 #
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. Amendments which do not affect animal welfare may be adopted by means of the ethical opinion procedure.
Amendment 350 #
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 353 #
Proposal for a directive
Article 42, paragraph 2 a (new)
Article 42, paragraph 2 a (new)
2a. Amendments to 'mild or moderate' procedures which do not determine an increase in severity of those procedures shall be notified to the competent authority further to approval by the Ethics Committee.
Amendment 354 #
Proposal for a directive
Article 42 – paragraph 5 a (new)
Article 42 – paragraph 5 a (new)
5a. Each amendment to 'severe' procedures, or to procedures which determine an increase in severity, is subject to a further favourable ethical evaluation and approval by the competent authority.
Amendment 357 #
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 363 #
Proposal for a directive
Article 43 – paragraph 2
Article 43 – paragraph 2
2. NotwithstandingSubject to the provisions of 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.