Activities of Esko SEPPÄNEN related to 2008/0211(COD)
Plenary speeches (1)
Protection of animals used for scientific purposes (debate)
Amendments (27)
Amendment 12 #
Proposal for a directive
Recital 7
Recital 7
Amendment 17 #
Proposal for a directive
Recital 10
Recital 10
(10) Animals have an intrinsic value in themselves which must be respected. There are also ethical concerns of the general public as regards the use of animals in procedures. Therefore, the animals should always be treated as sentient creatures and their use in scientific procedures should be restricted to areas which advance science andfundamental knowledge in science, since this may ultimately have benefits, for example, to human or animal health, or the environment. Use of animals for scientific procedures in other areas under Community competence should be prohibited.
Amendment 20 #
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 some areas of the biomedical sciences can provide important new information relevant to many life- threatening and debilitating human conditions. The reference toat some future stage to many life- threatening orand 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/EChuman conditions.
Amendment 24 #
Proposal for a directive
Recital 18
Recital 18
(18) TIn order to gradually end the captureing of anon-human primatels 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 possiblefor breeding purposes, a thorough scientific evaluation should be conducted as soon as possible on the feasibility of restricting the use of animals that are the offspring of an animal which has been bred in captivity. Establishments breeding and supplying non-human primates should therefore have a strategy in place to support and facilitate the progressive move towards that goal.
Amendment 34 #
Proposal for a directive
Recital 45
Recital 45
(45) The European Centre for the Validation of Alternative Methods is established within the Joint Research Centre of the Commission and coordinates the validation of alternative approaches in the Community. However, there is an increasing need for new methods to be developed and proposed for validation. To provide the necessary mechanisms at Member State level, a reference laboratory for the validation of alternative methods should be designated by each Member State. Member States should designate reference laboratories which are accredited in accordance with Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances in order to ensure coherent and comparable quality of the results. In addition, the remit of the European Centre for the Validation of Alternative Methods should be extended to include the coordination and promotion of the development and use of alternatives to animal experiments.
Amendment 42 #
Proposal for a directive
Article 2 – paragraph 2 – point b a (new)
Article 2 – paragraph 2 – point b a (new)
(ba) animals covered by point (a) or (b) which have been genetically manipulated, cloned or are the offspring of, the subsequent generation of or are from the line of an animal covered by point (a) or (b) which has been genetically manipulated or cloned.
Amendment 43 #
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
Amendment 45 #
Proposal for a directive
Article 3 – paragraph 6 a (new)
Article 3 – paragraph 6 a (new)
6a. 'competent authority' means the authority or authorities designated by each Member State as being responsible for supervising the enforcement of this Directive.
Amendment 57 #
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. Notwithstanding any exemption, animals shall be killed with a minimum of pain, suffering and distress.
Amendment 61 #
Proposal for a directive
Article 6 a (new)
Article 6 a (new)
Article 6a Adoption of stricter measures 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.
Amendment 82 #
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Competent authorities may grant exemptions from paragraph 1 on the basis of scientificcompelling scientific and societal justification that the purpose of the procedure cannot be achieved by the use of an animal which has been bred for use in procedures.
Amendment 87 #
Proposal for a directive
Article 10 – paragraph 2 a (new)
Article 10 – paragraph 2 a (new)
Amendment 95 #
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', '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 or 'severe' in accordance with Annex VIIa.
Amendment 108 #
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 sufferingwhere the previous procedure performed on the animal is classified as ‘moderate’ or 'up to mild' and the further procedure is classified as 'moderate', 'up to mild' or as 'non-recovery'.
Amendment 118 #
Proposal for a directive
Article 22 – paragraph 1
Article 22 – paragraph 1
1. Where an establishment no longer complies with requirements set out in this Directive, the competent authority shall suspend or withdraw its authorisation. Member States shall establish an appropriate mechanism for appeals against suspension or withdrawal of authorisation.
Amendment 121 #
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The design, construction and method of functioning of the installations and equipment referred to in paragraph 1 shall ensure that the procedures are carried out as effectively as possible, obtaining consistent results with the minimum number of animals and the minimum degree of pain, suffering, distress or lasting harm.
Amendment 122 #
Proposal for a directive
Article 25 – paragraph 2
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, as the scientific member a person with expertise in the "3Rs" (Replacement, Reduction, Refinement), and an independent lay person.
Amendment 129 #
Proposal for a directive
Article 26 – paragraph 1 – point d – introductory part
Article 26 – paragraph 1 – point d – introductory part
(d) review annually all projects classified as "severe" or on non-human primates and every three years the other projects which are of more than 12 months duration, focusing in particular on:
Amendment 130 #
Proposal for a directive
Article 26 – paragraph 2 – subparagraph 2
Article 26 – paragraph 2 – subparagraph 2
The records shall be submittedmade available to the competent authority upon request. Member States shall pay particular attention to the collection, collation and publication of records relating to projects classified as severe or on non-human primates in order to provide information which can improve animal welfare and further the 3Rs.
Amendment 137 #
Proposal for a directive
Article 29 – paragraph 1 – introductory part
Article 29 – paragraph 1 – introductory part
1. Member States shall wherever possible ensure that all breeding, supplying and user establishments keep records of the following:
Amendment 138 #
Proposal for a directive
Article 29 – paragraph 1 – point a
Article 29 – paragraph 1 – point a
(a) the number and the species of vertebrate animals bred, acquired, supplied, released or re- homed;
Amendment 146 #
Proposal for a directive
Article 34 – paragraph 1
Article 34 – paragraph 1
1. The Commission may undertake controls of the infrastructure and operation of national inspections in Member States to ensure that severity classifications are applied correctly and uniformly in the EU territory.
Amendment 158 #
Proposal for a directive
Article 36 – paragraph 1 – introductory part
Article 36 – paragraph 1 – introductory part
1. TWhen required, the user establishment or the person scientifically responsible for the project shall submit an application for the project authorisation, which shall include the following:
Amendment 171 #
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. For intellectual property and security reasons, confidentiality should be ensured.
Amendment 186 #
Proposal for a directive
Article 42 – paragraph 2
Article 42 – paragraph 2
2. Any amendment or renewal of a project authorisation that involves severe procedures or non- human primates, or a moderate or greater increase in animal harm shall be subject to a further favourable ethical evaluation and authorisation by the competent authority.
Amendment 187 #
Proposal for a directive
Article 42 – paragraph 3
Article 42 – paragraph 3
3. The competent authority may withdraw the project authorisation where the project is not carried out in accordance with the project authorisation and may cause a deterioration in animal welfare.
Amendment 222 #
Proposal for a directive
Annex VII a (new)
Annex VII a (new)