53 Amendments of Joseph DAUL related to 2008/0211(COD)
Amendment 135 #
Proposal for a directive
Recital 6
Recital 6
(6) It iswill be necessary to include specific invertebrate species within the scope of this Directive, as there isoon as scientific evidence is available of the potential ability of such species to experience pain, suffering, distress and lasting harm.
Amendment 137 #
Proposal for a directive
Recital 7
Recital 7
(7) This Directive should also cover embryonic and foetal forms of vertebrate animals which are intended to come to term, when it has been scientifically shown that their nervous system is capable of registering pain signals, as 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 embryonic and foetal forms of mammals 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 142 #
Proposal for a directive
Recital 13
Recital 13
(13) The methods selected should avoid, as far as possible, death as an end-point due to severe suffering caused by the approaching death. Where possible, it should be substituted by more humane end-points using clinical signs that determine the impending death thereby allowing the animal to be killed by a humann appropriate method without any further suffering.
Amendment 144 #
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 someall 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 clicontributing to knowledge of humans, animals or the environment. However, the high sensitivity of non-human primates and their highly developed social skills mean that fundamental research projects using such anicmal 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/ECs should be subjected to a strict scientific review and ethical evaluation taking account of the specific characteristics of these species.
Amendment 146 #
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 orderWith a view to gradually ending 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 should therefore have a strategy in place to support and facilitate the progressive move towards that goala full study should be carried out into the technical, scientific and economic feasibility of this process. Investigations should also be made into its effects – both positive and negative – on animal welfare, and consideration should be given to the European Union’s potential long-term sources of supply. Concurrently with the study called for above, the Commission and the Member States should also take the necessary measures to support appropriate transport conditions for non-human primates in the territory of the European Union.
Amendment 149 #
Proposal for a directive
Recital 22
Recital 22
(22) From the ethical standpoint, there should be an upper limit of pain, suffering and distress, above which animals should never be subjected in scientific procedures. To that effect, the performance of procedures that result in severe pain, suffering or distress and which is likely to be prolonged, should be prohibitedrestricted as far as possible. When developing a common format for reporting purposes, instead of the predicted severity at the time of the ethical evaluation, the actual severity experienced by the animal should be taken into account.
Amendment 152 #
Proposal for a directive
Recital 29
Recital 29
(29) Animal welfare considerations should be given the highest priority in the context of animal keeping, breeding and use. Each head of an establishment should therefore have an independent permanent ethical review body in placeidentify an ethical assessment body with the primary task of focuscarrying out an ethical debate at establishment level, fostering a climate of care and providing tools for practical application and timely implementation of the recent technical and scientific developments in relation toassessment of the establishment’s projects, in accordance with the principles of replacement, reduction and refinement to enhance the life-time experience of the animals. The decisopinions of the permanent ethical reviewse ethical assessment bodyies should be properly documented and open to scrutiny during inspections by the competent authority.
Amendment 154 #
Proposal for a directive
Recital 38
Recital 38
(38) It is also essential to ensure both on moral and scientific grounds that each use of animals is carefully evaluated on the scientific validity, usefulness and relevance of the expected result of that use. The likely harm to the animals should be balanced against the expected benefits of the project. Therefore, an independent ethical evaluation independent of those in charge of the study should be carried out as part of the authorisation process of projects involving the use of live animals. Effective implementation of an ethical evaluation should also allow for an appropriate assessment of the use of any new scientific experimental techniques as they emerge.
Amendment 155 #
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 availabcollected and compiled. The format of that information should not violate proprietary rights or expose confidential information. Therefore, user establishments should provide or information relating to the safety of persons and installations, or impair the safety of persons or installations. Therefore, user establishments should have the option of making available to the competent authorities anonymous non- technical summaries of those projects, including the results of any retrospective assessments, and make those summaries publicly available.
Amendment 158 #
Proposal for a directive
Recital 46
Recital 46
(46) There is a need to ensure a coherent approach to ethical evaluation and ethical review strategies at national level. Member States should establish national animal welfare and ethics committees to give advice toset out principles for the competent authorities and permanent ethical review bodies of establishments in order to promote the principles of replacement, reduction and refinement. Therefore, the network of national animal welfare and ethics committees should play a role in the exchange of best practice at Community level.
Amendment 160 #
Proposal for a directive
Recital 47
Recital 47
(47) The technical and scientific advancements in biomedical research can be rapid as can the increase in knowledge of factors influencing animal welfare. It is therefore necessary to provide for review of this Directive. Such a review, based on the results of peer-assessed scientific studies, should examine possible replacement of the use of animals, and in particular non-human primates, as a matter of priority where it is possible, taking into account the advancement of science.
Amendment 164 #
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 frof mammals, intended to come the last third of their normal developmento term, which have been scientifically shown to possess a nervous system capable of registering pain signals;
Amendment 168 #
Proposal for a directive
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
Amendment 170 #
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
3. This Directive shall apply to animals used in procedures, which are at an earlier stage of development than that referred to in point (a) of paragraph 2, if the animal is to be allowed to live beyo which are intended to come to term and that stage of development and is likely to experience pain, suffering, distress or lasting harm after it has reached that stage of developmentve been scientifically shown to possess a nervous system capable of registering pain signals.
Amendment 173 #
Proposal for a directive
Article 3 – point 6 a (new)
Article 3 – point 6 a (new)
(6a) 'ethical approach' means the approach which precedes experimentation and consists of assessing the scientific and societal grounds for using animals, with reference to humankind's duty to respect animals as living, sentient beings;
Amendment 174 #
Proposal for a directive
Article 3 – paragraph 6 b (new)
Article 3 – paragraph 6 b (new)
(6b) 'ethical evaluation body' means a committee with the scientific, technical and civil competences required to deliver an enlightened ethical opinion on a project;
Amendment 189 #
Proposal for a directive
Article 6 – title
Article 6 – title
Amendment 192 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
1. Member States shall ensure that animals are killed in an authorised establishment, by an authorised person and with a minimum of pain, suffering and distress and, in relation to the species included in Annex V, using the appropriate humane method of killing as set out in that Annex. The Commission shall develop guidelines that it shall update as progress is made.
Amendment 205 #
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 213 #
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1
Article 10 – paragraph 1 – subparagraph 1
1. Member States shall ensure that animals belonging to the species listed in Annex II may only be used in procedures where those animals have been bred for use in proceduNo later than 5 years from the entry into force of this directive, the Commission shall submit a technical feasibility study of the requirements set out in paragraph 2, detailing the consequences for animal welfares.
Amendment 217 #
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 2
Article 10 – paragraph 1 – subparagraph 2
Amendment 220 #
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Competent authorities may grant exemptions from paragraph 1 on the basis of a scientific justification or reasons linked to animal welfare.
Amendment 249 #
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 re-used in a new procedure totally different from the previous procedure from a scientific point of view only when all of the following conditions are met:
Amendment 253 #
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 mildmoderate';
Amendment 258 #
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 mildmoderate' or 'non-recovery'.;
Amendment 265 #
Proposal for a directive
Article 18
Article 18
Member States shall encourage the establishment of programmes for the sharing of organs and tissues of animals killed by a humane method.
Amendment 269 #
Proposal for a directive
Article 20 – paragraph 1 – introductory part
Article 20 – paragraph 1 – introductory part
1. Member States shall ensure that persons are authorised by the competent authority or the delegated authority before they carry out any of the following functions:
Amendment 272 #
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 five 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. Member States shall guarantee the mutual recognition of this competence and of the authorisation.
Amendment 275 #
Proposal for a directive
Article 22 – paragraph 2 a (new)
Article 22 – paragraph 2 a (new)
2a. Where the authorisation is suspended or withdrawn, Member States shall establish a mechanism for appeals against the decision.
Amendment 286 #
Proposal for a directive
Article 32 – paragraph 2
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 Annexguidelines before 2017.
Amendment 288 #
Proposal for a directive
Article 32 – paragraph 3
Article 32 – paragraph 3
Amendment 292 #
Proposal for a directive
Article 33 – paragraph 3
Article 33 – paragraph 3
3. Member States shall ensure that the frequency and the extent of inspections are adequate to the number and species of animals housed, to the compliance record of the establishment with this Directive and, in the case of user establishments, to the number and types of projects carried out in those establishments. Member States shall take the necessary measures to ensure that the inspections do not jeopardise the scientific quality of the projects and the welfare of the animals.
Amendment 298 #
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 or, by delegation, by the permanent ethical review body that reviews protocols and procedures.
Amendment 300 #
Proposal for a directive
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Granting of authorisation shall be subject to favourable ethical evaluation by the competent authority or, by delegation, by the permanent ethical review body that reviews protocols and procedures.
Amendment 306 #
Proposal for a directive
Article 36 – paragraph 1 – point c
Article 36 – paragraph 1 – point c
(c) informthe declaration onthat the elements set out in Annex VIImatter has been referred to the competent authority responsible for ethics.
Amendment 309 #
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 necessary for the ethical evaluation and elements listed in Article 41(2), provided that the project involves only procedures classified as "up to mildoderate" and does not use non-human primates.
Amendment 335 #
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"moderate" or less shall be exempted from the requirement for a retrospective assessment.
Amendment 341 #
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 343 #
Proposal for a directive
Article 41 – paragraph 2 – point d
Article 41 – paragraph 2 – point d
d) at least one person demonstrating species specific knowledge.eleted
Amendment 349 #
Proposal for a directive
Article 42 – paragraph 2
Article 42 – paragraph 2
2. Any amendment or rRenewal of a project authorisation shall be subject to a further favourable ethical evaluation.
Amendment 352 #
Proposal for a directive
Article 42 – paragraph 2a (new)
Article 42 – paragraph 2a (new)
Amendment 359 #
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, or in the case of a minor amendment, the authorisation shall be deemed to have been granted, where the project concerned involves only procedures classified as "up to mild"moderate" or less and non-human primates are not used. In all other cases, no such presumption shall apply.
Amendment 374 #
Proposal for a directive
Article 47 – paragraph 1
Article 47 – paragraph 1
1. Each Member State shall establish a national animal welfare and ethics committee that shall advise the competent authorities and permanent ethical review bodieresponsible for ethics in matters dealing with the acquisition, breeding, accommodation, care and use of animals in procedures and ensure sharing of best practices.
Amendment 375 #
Proposal for a directive
Article 47 – paragraph 2
Article 47 – paragraph 2
2. The national animal welfare and ethics committees shall exchange information on the operation of permanent ethical reviewaluation bodies and ethical evaluation and share best practices within the Community.
Amendment 376 #
Proposal for a directive
Article 49 – paragraph 2 – subparagraph 1
Article 49 – paragraph 2 – subparagraph 1
2. Member States shall collect and make publicly available, on an annual basiat intervals not exceeding three years, statistical information on the use of animals in procedures, including information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures.
Amendment 377 #
Proposal for a directive
Article 49 – paragraph 2 – subparagraph 2
Article 49 – paragraph 2 – subparagraph 2
Amendment 384 #
Proposal for a directive
Annex I
Annex I
Invertebrate Species referred to in Article • • Cephalopods •2(2) 2(2) Cyclostomes • Cephalopods Decapod crustaceans
Amendment 387 #
Proposal for a directive
Annex II – point 8
Annex II – point 8
Amendment 388 #
Proposal for a directive
Annex II – point 11 a (new)
Annex II – point 11 a (new)
11a. Zebrafish (danio danio)
Amendment 390 #
Proposal for a directive
Annex III – dates – lines 2 to 4
Annex III – dates – lines 2 to 4
[715 years after transposition of Directiveconfirmation of interest by the Commission] [715 years after transposition of Directiveconfirmation of interest by the Commission] [105 years after transposition of Directiveconfirmation of interest by the Commission]
Amendment 391 #
Proposal for a directive
Annex IV – title
Annex IV – title
Care and accommodation standardguidelines referred to in Article 32
Amendment 392 #
Proposal for a directive
Annex IV – subtitle (new)
Annex IV – subtitle (new)
The care and accommodation conditions should be tailored to the scientific objective.
Amendment 393 #
Proposal for a directive
Annex V
Annex V
This annex is deleted.