CELEX: 51991PC0340
Language: en
Date: 1991-09-27
Title: Amendment to the proposal for a COUNCIL DECISION designating and laying down the functions of a Community Coordinating Institute for foot-and-mouth disease vaccines

COMMISSION OF THE EUROPEAN CGAMUNITIES
                                          COM(91) 340 final
                                          Brussels, 27 September 1991
               Amendment to the proposal for a
                        COUNCIL DECISION
       designating and taying down the functions of a
             Community Coordinating Institute for
                foot-and-mouth disease vaccines
   (presented by the Commission pursuant to Article 149(3)
                       of the EEC Treaty)
 ---pagebreak---                                 EXPLANATORY MEMORANDUM
On 26 June 1990, the Council adopted Directive 90/423/EEC, amending,
amongst others, Directive 85/511/EEC introducing Community measures for
 the controi of foot and mouth disease. By this amendment, the Council,
acting on a proposal from the Commission, was required to designate a
specialized      institute for vaccine and cross-immunity                 checks, and to
determine its powers, by 1 April 1991.
 In fact, Article 14 of Directive 85/511/EEC, before its amendment, had
contained      a  similar   requirement        for   Council     to  designate    such   an
 institute. On the 8 April          1988, the Commission made a proposal              for a
Council     Decision    designating       and    laying    down    the   functions    of  a
Coordinating Institute for foot and mouth disease vaccines (C0M(87)537
final).     The   Institute    nominated      at    the   time   was   the   Animal   Virus
Research Institute, Pirbright, UK. This proposal has not been adopted.
Since     the    Commission's      original      proposal,       certain    changes    have
occurred.      Firstly, other     amendments       to Directive 85/511/EEC made by
Directive 90/423/EEC require that Member States should cease routine
vaccination against foot and mouth disease before 1 January 1992, and
that    the   Commission    should      make    proposals     for   the   setting    up  of
Community reserves of ant I-foot-and-mouth disease vaccines. This latter
proposal was sent to Council on 26 April 1991 (C0M(91)131 final). This
new development means that the functions of the Community Coordinating
Institute     (CCI) must now       include tests on the quality and safety of
vaccines      in   the  Community       reserves,     while     reducing    the   activity
relating     to   testing   of   nationally       produced     vaccines    as   previously
foreseen.
Secondly, following discussions in Council on the original proposal to
designate Pirbright as the CCI, the other two candidate                       laboratories
were reassessed, this also being done in the light of improvements made
in   those     laboratories. As       a   result,     it   is now    proposed    that   The
Central    Veterinary     Institute,      Lelystad,      the   Netherlands,     should   be
appointed as CCI, as the only alternative to Pirbright. Meanwhile, Lyon
has   been   proposed    as   the    site of      part   of   the   EC   vaccine   reserve
[C0l.'.(91)131 Final], thus       involving all candidate           laboratories    in the
final strategy.
 ---pagebreak--- This amendment to the Commission's proposal is, therefore, made to take
account of the new situation, and is made pursuant to Article 149(3) of
the EEC Treaty.
It should be noted that the CCI may receive Community     financial aid
according to and following the conditions provided for.in Article 28 of
Council  Decision 90/424/EEC of 26 June 1990, on expenditure     in the
veterinary field.
 ---pagebreak---                        Amendment to the proposal for a
                               COUNCIL DECISION
               designating and laying down the functions of a
                    Community Coordinating Institute for
                       foot-and-mouth disease vaccines
The Commission presented the above mentioned proposal to the Council on
8 ApriI 1988 ( 1 ). The initial proposal is amended as follows:
1.  The first recital is replaced by the following:
     "Whereas Article     14(1) of Directive 85/511/EEC authorizes Member
    States to retain reserves of antigens and to retain establishments
    for    the   packaging   and   storing   of  ready-to-use      vaccines  for
    emergency vaccination;
    Whereas Article 14(3) of that Directive requires the Commission to
    make    proposals   for  the   setting  up  of   at   least   two  Community
    reserves of anti-foot-and-mouth disease vaccines;
    Whereas Article 14(2) of that Directive requires the designation of
    a   specialized    institute   for  vaccine  and   cross-immunity    checks;
    whereas it is also necessary to lay down the functions and duties
    of such an institute, which should        include the standardization of
    control    of vaccines carried out by national         institutes prior   to
    authorization for use in Member States, and the necessary checks on
    antigen stored     in the Community reserves, to ensure the potency,
    safety    and   stability   of   the   antigens   and    vaccines   produced
    therefrom;"
2.  The final recital is deleted.
3.  Articles 1 and 2 are replaced by the following:
(1) COM (87) 537 final
 ---pagebreak---                                    "Article 1
Coordination of the control of foot and mouth disease vaccines used
within the Community shall be carried out by "The Central Veterinary
institute,    Lelystad,   Nether lands",   hereinafter    referred   to   as  the
Community Coordinating Institute.
                                   Article 2
The   functions   and  duties of     the Community     Coordinating     Institute
designated in Article 1 shall be:
1.  to coordinate the methods of control carried out by the national
     institutes on foot and mouth disease antigens and vaccines intended
    for use in accordance with Articles 13(3) and 14(1) of Directive
    85/511/EEC;
2.  to coordinate the control of foot and mouth disease vaccine by
    national institutes in each Member State specifically by:
    (a) at regular intervals or on the request of the Institute or the
         Commission, receiving representative samples of batches of foot
         and mouth disease vaccine       intended for use     in the Community
          including that produced     in third countries for use either in
         the Community, in Community supported vaccination campaigns or
         for use in animals intended for importation into the Community
         and testing such vaccines for safety and potency;
    (b) carrying out     comparative    studies  to ensure    that   safety   and
         potency   testing    in  each   Member   State    is  carried    out  by
         comparable methodology;
    (c) testing by means of cross immunity assays in live cattle the
         efficacy   of  existing    vaccines   against   important    new   field
         strains of foot and mouth disease virus and communicating the
         results of such assays without delay to the Commission and the
         Member States;
 ---pagebreak---                     :
    o r gzih^r        rg.  data ana     information on the control      procedures an;!
          ih?    -'âcch'e       tests    and   the  periodic   transmission    of  such
          UrV.*TT:it ion to the Commission and the Member Slatas;
3.  (a; tu i?>si'.s and        Implti-nent the necessary arrangements for further
          training of experts In vaccine verification and testing with a
          V"L>VJ 1i,- i ^nnoriz !ng such techniques;
    (b)  tc orgcMze            an annual     meeting where   representatives of     the
         nation»!          institutes may      review  vaccine   control   and  testing
         techniques and the progress of coordination;
4. u O tc check antigen submitted for the Community antigen reserves
         as provided for in Article 14 of Directive 85/511/EEC for the
         pol^ncy and safety and compliance with conditions of supply;
   (b) to       carry       out   routine    potency   testing   of   antigen   in  the
         Community antigen reserves;
   (c) to m e e k         the sterility of vaccine produced from the Community
         antigen reserves when needed, in accordance with the European
         Pharmacopoeia;
5.   '=) i«i cooperation with appropriate Community experts, to assist
         and advise          the Commission      in ensuring   that   institutes which
         produce foot and mouth disease vaccine are operating to the
         necessary minimum safety requirements;
   (b) to assist the Commission                in reviewing the    list of   institutes
         authorized          to  manipulate     virus   in connection     with  vaccine
         production, in accordance with the provisions of Article 13(2)
         of Directive 85/511/EEC;
o. in cooperation with              the suppliers of antigen and         the Community
   Reference Laboratory, to review strains stored                    in the Community
   reserves, and            to select     suitable   new strains    to be adapted    to
     icst'e culture for future vaccine production;
 ---pagebreak---                                                                           •?•
   7.  to store important seed virus strains other than those held In
       the bank;
   8.  to   carry   out   research    in  relevant    aspects   of    vaccine
       production,   especially   development   of   technology   for    virus
       production, cell culture and vaccine manufacture;
   9.  to collaborate with the Community Reference Laboratory           in all
       relevant   aspects of   foot   and  mouth   disease,   including    the
       publishing a regular     bulletin on the activities of       the two
        Institutes, and   the training of     field  veterinarians     in the
       clinical diagnosis and epidemiology of foot and mouth disease."
4. Articles 4 and 5 are deleted.
5. In Article 6, the first sentence is replaced by the following:
   "The Community   Coordinating    Institute shall    be appointed     for a
   period of 5 years, as from 1 November 1991."
 ---pagebreak---  ---pagebreak---                                                                                 6
                                                                     ISSN 0254-1475
                                                              COM (91) 340 final
                                                      DOCUMENTS
EN                                                                              03
                                 Catalogue number : CB-CO-91-402-EN-C
                                                             ISBN 92-77-75816-3
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