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									Animal Welfare Highlights
Ad hoc information on developments with potential to shape EU debate                                               9 July 09

                                86/609: News from co-decision
                                The Council                                   Not all Member States have already
 Contents                                                                     developed their positions. Some of them
                                The adoption of the Parish report by an       are only consulting now with different
 Revision of Dir 86/609     1   overwhelming majority of MEPs (80%) in        stakeholders groups. In the UK, the
                                May 09 was only a very first step in the      House of Lords is conducting an inquiry
 OIE guidance on animals                                                      with a series of hearings. They
                                co-decision process. The Council is now
 used in research           2   looking into the text and would propose       expressed interest in meeting an EFPIA
                                its own amendments. Ultimately, the           delegation and this meeting will take
 EU qualitative survey on       Council will try and reconcile its proposed   place on 14 July 2009.
 image of research          3   amendments and those from the
                                European Parliament to allow for a            The Commission
 Events – mark you diary    3   smooth progress in further steps of the
                                procedure. But it may well be that the        Usually within a few weeks from an EP
                                two positions might not be completely         vote, the Commission prepares an
                                compatible.                                   amended proposal where their
                                                                              incorporate EP amendments which the
                                The Council working group on animal           Commission can support (as they are in
                                welfare will hold its next meetings on 22     the spirit of the text or improve the text).
                                and 23 July. The group will have a first      However, for this dossier, no amended
                                exchange of views on the draft common         proposal is planned and the Commission
                                position prepared by the Swedish              will most likely inform the Council on
                                Presidency. Further meetings will take        their opinion almost at last moment
                                place in September and in October. The        before the vote.
                                Swedish Presidency aims at adopting a
                                Council Common position at the 19             In the meantime, the Commission set up
                                November Agriculture Council.                 an expert working group on severity
                                                                              classification that will complement the EP
                                As far as we understand from the              amendment on Annex VIIa (proposed
                                contacts with different member states         definitions and examples of procedures
                                (based on feedback from PAT members           under each severity class). The meeting
                                and the Brussels coordination group) the      will take place in Brussels on 9 and 10
                                following questions have been raised to       July. The Commission invited all key
                                date in meetings under the Czech              stakeholders groups, including trade
                                Presidency:                                   associations representing different
                                     excessive bureaucratic burden, and       industry sectors, professional and
                                     possibilities to maintain existing       scientific organisations such as ESLAV or
                                     systems in place                         FELASA, animal protection groups, one
                                     severity classification to be            patient organisation and all member
                                     established asap                         states.
                                     need to clarify on the roles and tasks
                                     of different ethical review and          The Commission wants to maintain the
                                     authorisation bodies,                    four classes currently in the proposed
                                     reasons for including invertebrates;     revision: non-recovery, up to mild,
                                     animals used in training and for         moderate and severe. They also want to
                                     tissue collection                        establish upper limit of severity beyond
                                     the F2 requirement was questioned,       which no study should be conducted, as
                                     limitations of the use of primates to    well as lowest levels of severity where
                                     certain essential uses is supported,     the administrative procedure of the
                                     but not necessarily to extent            directive should not apply.
                                     proposed by the Commission
                                     concerns were raised about national      The European Parliament
                                     reference laboratories in particular
                                     on their funding remit                   What would happen with the revision of
                                     Reuse would be further looked at to      86/609 after election? Strictly following
                                     find adequate balance between            the rules, according to the new Rules of
                                     reduction and refinement (a case by      Procedures of the Parliament there are
                                     case approach was suggested)             several theoretical options for “renewed
                                     Annexes on euthanasia and on             referral to Parliament” of a text on which
                                     housing and care would be further        the EP has already given its opinion.

                          One of these is that “if the conference of    table amendments which have not been
                          presidents consider it desirable” – the       adopted in the first reading (which is the
                          Commission could be asked to refer            general rule).
                          again its proposal to the EP (to restart
                          the process again). This is highly            Co-decision for non specialists
                          unlikely. However the question remains
                          – how determined the new parliament           As recommended by PAT animal welfare
                          would be to defend a position taken by        in May 2009, EFPIA prepared a lay
                          the old parliament.                           language overview of the co-decision
                                                                        process focussing on key players and
                          Obviously, the bioscience sectors should      milestones for the revision of 86/609.
                          start again a targeted information            This document can be used to inform of
                          campaign to avoid leaving the field to our    academic organisations and third parties
                          opponents and take the risk of losing         not familiar with the EU procedures and
                          support for the key first reading             in particular raise awareness about the
                          achievements.                                 fact that the EP first reading vote in May
                                                                        is just one milestone in the overall co-
                          Even in case where the first reading          decision procedure.
                          position is not questioned by the new
                          parliament, the rules for admissibility of    Read more: DocShare
                          amendments can be changed – a new
                          political situation may make it possible to

                         OIE guidance on animals used in research
                          The World Organisation for Animal             Guidance is provided as to the oversight
                          Health is currently revising its Code for     framework, specifying that its key
                          Terrestrial Animals. At a meeting of          elements are: project proposal review,
                          dedicated committee on animal welfare,        facility inspection and animal care and
                          the issue of welfare of animals used in       use programme review. The components
                          research was discussed and as a result a      of each of these three key elements are
                          draft document on the Use of Animals in       defined, without specifying at what level
                          Research, Testing or Teaching was             and by which body it is to be conducted.
                          produced and released for comments            The necessary expertise is however
                          (the deadline for comments is just about      defined.
                          to expire). .
                                                                        The document contains a rather detailed
                          In the preamble, the OIE recognises the       description of what is meant by
                          vital role played by the use of live          assurance of training and competency.
                          animals in research and the contribution      Other chapters include: provision of
                          of such research to wellbeing of people       veterinary care; physical facility and
                          and animals. The OIE highlights the need      environmental conditions; source of
                          for humane treatment of sentient              animals; husbandry; occupational health
                          animals and that good quality of science      and safety; and post-approval
                          depends upon good animal welfare.             monitoring.
                          Finally the OIE emphasises the
                          importance of standards based on              This document could ultimately
                          outcomes for the animal.                      contribute to global convergence of
                                                                        standards. The approach focused on
                          While the document is supposed to set         outputs rather than processes, could be
                          guiding principle, the OIE considers that     used in advocacy on the revision of
                          the oversight of animal research should       Directive 86/609.
                          be implemented in each country,
                          recognising that the systems would vary       We will monitor further developments on
                          according to cultural, economic, religious    this guidance.
                          and social factors.
                                                                        The draft text is available at:
                          The document provides for a set of            http://www.aphis.usda.gov/import_expor
                          definitions. The scope covers all animals     t/animals/oie/downloads/tahc_mar09/tah
                          used in research, teaching or testing, as                               h     09 df
                          well as animals bred for tissue collection.

                             EU qualitative study on image of science
                             The Commission DG Research and DG                 impossibility of getting by without
                             Communication commissioned a survey               tests (unless they were to be
                             on the image of science and the research          performed on humans themselves)
                             policy of the European Union. The
                             outcomes of the study conducted among         Areas that give rise to interest include
                             the citizens of the 27 member states          the medico-pharmaceutical field,
                             were published in October 2008. The           amongst others. As to the channels and
                             commission surveyed EU citizens attitude      sources of information about science,
                             vis à vis stem cells research … and           television comes first followed by written
                             experiments on animals.                       press. Internet is often mentioned as
                                                                           source for finding more detailed
                             On this latter, quoting from the report:      information about something to which
                             -   “Attitude regarding experiments on        attention has already been drawn by
                                 animals show themselves to be             other channels.
                                 extremely homogenous in all the
                                 groups questioned”                        The full report is available at:
                             -   The survey identified “more or less       http://ec.europa.eu/research/science-
                                 strong emotive reactions of               society/document_library/pdf_06/qualitat
                                 compassion towards animals                ive-study-rapport08012009_en.pdf
                                 (amongst female respondents in
                                 particular) counterbalanced by the
                                 rational consideration of the practical

                             Events – mark your diary
                             VII World Congress on Alternatives            EPAA Annual Conference
                             30/08- 3/09, Rome                             6/11/2009, Brussels

Send information to be       The 7th World Congress on alternatives        The 2009 Annual Conference will take
                             and animal use in the life sciences will      place on 6 November in Brussels. This
included in Highlights to:
                             take place in Rome, Italy from 30 August      year event will be dedicated to
magdachlebus@efpia.org       to 3 September 2009. The congress was         dissemination of 3Rs information, the
                             given the motto "Calling on Science" in       mechanisms of dissemination and its role
                             order to emphasize that scientific            in enhancing regulatory acceptance;
                             progress today goes hand in hand with         speeding up uptake of 3Rs methods in
                             progress towards the reduction,               labs; and raising the profile and
                             refinement and replacement of                 legitimacy of 3Rs research
                             experimental animals (the 3-R's).             More information and on line registration
                             Programme, additional information and         would soon be available at
                             registration is available at:                 www.epaa.eu.com
                                                                           NB. Calendar of EU institution meetings
                             NC3Rs Primate Welfare Meeting                 and other events related to the revision
                             28/10/09, London                              of Directive 86/609 is available on
                             This event, which is combined with the
                             European Primate Veterinarians will be
                             held in London on 28 October 2009. The
                             theme of this joint NC3Rs/EPV joint
                             session is “Refining scientific
                             procedures”. The meeting is free and
                             open to laboratory personnel working
                             directly with primates used in research.
                             For more information and registration
                             (deadline 30 September) visit:

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