16 Amendments of John PURVIS related to 2008/0211(COD)
Amendment 22 #
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. F, or for the purposes of fundamental research in some areas of the biomedical sciences canwhich potentially will provide important new information relevant to manybasic scientific knowledge and in due course to 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.
Amendment 25 #
Proposal for a directive
Recital 21
Recital 21
(21) To enhance transparency, facilitate the project authorisation and provide tools for monitoring compliance, a severity classification of procedures should be introduced on the basis of estimated level of pain, suffering, distress and lasting harm that is inflicted on the animals. To give greater precision as to how severity classes should be assigned, the Commission should develop criteria with stakeholder input using existing severity classification schemes in place in Member States and third countries as well as those promoted by international organisations as basis. In order to ensure greater clarity in the classification system, the number of gradations should be expanded by dividing the existing "moderate" grade into "low moderate" and "high moderate".
Amendment 28 #
Proposal for a directive
Recital 23 a (new)
Recital 23 a (new)
(23a) In that it would reduce the number of animals required for experiments and greatly assist research, the extended re- use of animals should be permitted where a tracking, recording or transmitting device has been introduced by means of a surgical intervention under anaesthetic and where such intervention involves pain not exceeding the "low moderate" gradation.
Amendment 29 #
Proposal for a directive
Recital 26
Recital 26
(26) The welfare of the animals used in procedures is highly dependent on the quality and professional competence of the personnel supervising procedures, as well as of those performing procedures or supervising those taking care of the animals on a daily basis. In order to secure an adequate degree of competence of the persons dealing with animals and with procedures involving animals, those activities should only be performed in establishments and by persons authorised by the competent authorities. The main focus should be on obtaining and maintaining an adequate level of competence which should be demonstrated before authorising those persons or renewing their authorisation.
Amendment 30 #
Proposal for a directive
Recital 27
Recital 27
(27) Establishments should have adequate installations and equipment in place to meet the accommodation requirements of the animal species concerned and to allow the procedures to be performed efficiently and with the least distress both to the animals directly concerned and their animal companions. The establishments should operate only if they are authorised by the competent authorities.
Amendment 32 #
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, with due consideration for security risks, user establishments should provide authorised access to anonymous non-technical summaries of those projects, including the results of any retrospective assessments, and make those summaries publicly available.
Amendment 69 #
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, or is justified by the expected advancement of science that ultimately benefits human beings;
Amendment 72 #
Proposal for a directive
Article 8 – paragraph 1 – point b a (new)
Article 8 – paragraph 1 – point b a (new)
(ba) the procedure is necessary for significant fundamental research justified by its potential for improved human health and quality of the human condition.
Amendment 84 #
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 2
Article 10 – paragraph 1 – subparagraph 2
Amendment 96 #
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Member States shall ensure that all procedures are classified as 'up to mild', 'low moderate', 'high moderate', 'severe' or 'non-recovery' on the basis of the duration and intensity of potential pain, suffering, distress and lasting harm, the frequency of intervention, the deprivation of ethological needs and the use of anaesthesia or analgesia or both.
Amendment 103 #
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 mildnot higher than 'low moderate';
Amendment 105 #
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 mildnot higher than 'low moderate' or 'non- recovery'.
Amendment 117 #
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 fiseven 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.
Amendment 160 #
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 ethical evaluation and elements listed in Article 41(2), provided that the project involves only procedures classified as "up to mild" and does not use non-human primlow moderates".
Amendment 175 #
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"low moderate" shall be exempted from the requirement for a retrospective assessment.
Amendment 200 #
Proposal for a directive
Article 46 – paragraph 1
Article 46 – paragraph 1
1. Each Member State shall, by [one year after entry into force of this Directive], designate a nationalensure access to one or more accredited European reference laboratorycentre(s) for the validation of alternative methods replacing, reducing and refining the use of animals.