18 Amendments of Erika MANN related to 2008/0211(COD)
Amendment 63 #
Proposal for a directive
Article 8 – paragraph 1 – introductory part
Article 8 – paragraph 1 – introductory part
1. NOwing to their high level of neurophysiological sensitivity and cognitive development, non-human primates shall not be used in procedures, with the exception of those procedures meeting the following conditions:
Amendment 65 #
Proposal for a directive
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(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 pointor (5) of Article 5;
Amendment 70 #
Proposal for a directive
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) there is a scientific justification by the applicant to the competent national authority that the purpose of the procedure cannot be achieved by the use of other species than non-human primates.
Amendment 73 #
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 50iven 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.
Amendment 98 #
Proposal for a directive
Article 15 – paragraph 2
Article 15 – paragraph 2
Amendment 100 #
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 only if the pain, suffering or distress is likely to be prolongedir relevance is scientifically apparent.
Amendment 101 #
Proposal for a directive
Article 16
Article 16
Amendment 148 #
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, unless they are subject only to obligatory notification.
Amendment 150 #
Proposal for a directive
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Granting of authorisation shall be subject to favourable ethical evaluation byon the competent authoritybasis of information provided by the applicant.
Amendment 159 #
Proposal for a directive
Article 36 – paragraph 1 – point c a (new)
Article 36 – paragraph 1 – point c a (new)
(ca) a scientifically justified statement that the research project is indispensable and ethically defensible and that the purposes of the project cannot be achieved using other methods or procedures.
Amendment 161 #
Proposal for a directive
Article 37 – paragraph 1
Article 37 – paragraph 1
1. The ethical evaluationBefore authorisation is granted, it shall be verifyied that the project as described and scientifically justified by the applicant meets the following criteria: (a) the project is scientifically justified or required by law, indispensable and ethically defensible; (b) the purposes of the project justify the use of animals and cannot be achieved through other methods or procedures; (c) the project is designed so as to enable procedures to be carried out in the most humaneanimal-welfare oriented and environmentally sensitive manner.
Amendment 162 #
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 byethically defensible in the light of the expected advancement of science that ultimately benefits human beings, animals or the environment;
Amendment 166 #
Proposal for a directive
Article 37 – paragraph 3 – introductory part
Article 37 – paragraph 3 – introductory part
3. The competent authority carrying out the ethical evaluation shall consider corresponding expertsise in particular in the following areas:
Amendment 168 #
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 partiesby integrating independent expertise whilst safeguarding intellectual property and confidential information.
Amendment 172 #
Proposal for a directive
Article 38
Article 38
Amendment 189 #
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 390 days from the submission of the application. Should the Member Statecompetent authority 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 192 #
Proposal for a directive
Article 43 – paragraph 2
Article 43 – paragraph 2
Amendment 217 #
Proposal for a directive
Annex IV – point 3 – point 3.5 – point a
Annex IV – point 3 – point 3.5 – point a
(a) USufficient uncontaminated drinking water shall always be available to all animals.