CELEX: 51990PC0251
Language: en
Date: 1990-06-11
Title: RE-EXAMINED PROPOSAL FOR A COUNCIL DECISION ADOPTING A SPECIFIC RESEARCH AND TECHNOLOGICAL DEVELOPMENT PROGRAMME IN THE FIELD OF HEALTH: HUMAN GENOME ANALYSIS ( 1990-1991 )

COMMISSION OF THE EUROPEAN COMMUNITIES
                                       COM(90) 251 final - SYN 146
                                       Brussels» 11 June 1990
                     Re-examined proposal for a
                           COUNCIL DECISION
     adopting a specific research and technological development
      programme in the field of health : Human Genome Analysis
                              (1990-1991)
      (presented by the Commission pursuant to Article 149.2(d)
                         of the EEC treaty)
 ---pagebreak---                        EXPLANATORY MEMORANDUM
On 16 May 1990 the European Parliament In Its second reading of the
"Human Genome Analysis" proposal (Initial proposal : COM(88)424,
modified proposal : COM(89)532) adopted eight amendments to the Common
Position.
The Com»I«sion, «hen defining its position, accepted six of these
amendMents.
Consequently, pursuant to Article 149.2(d) of the EEC Treaty, the
Commission establishes Its re-examined proposal by Integrating
accepted amendments into the Common Position of Council. Indeed, the
Commission takes as a basis the Common Position since, as stated in
its declaration to the European Parliament, the modifications Council
introduced in its modified proposal were accepted.
Amendments of Parliament accepted by the Commission
     Amendment no.1 : In conformity with the position taken at the
     first reading, the Commission accepts this amendment which
     mentions predictive medicine as an example of an area where
     caut ion Is needed.
     Amendments nos. 2 and 4 : the Commission accepts to adopt, in one
     recital, the substance of both these amendments which refer to
     positions of the E.P. regarding the ethical and legal aspects of
     genetic engineering. The Commission cannot, for legal coherence
     and institutional reasons, Introduce these amendments in the
     legal part of the text.
     Amendment no.10 : the Commission accepts. It acknowledges the
     Importance of the pre-normatIve nature of research of which the
     pre-competitIve nature is in any case obvious.
     Amendment no.6 : the Commission accepts this amendment which
     means that medical applications can bear upon all cells, tissues
     or organs, except for germ cells (spermatozoa, oocytes).
     Amendment no.14 : the Commission accepts this deletion amendment,
     thus avoiding any ambiguity concerning the meaning of the word
     "Industrial".
 ---pagebreak--- Comments of the Commission on amendments of Parliament not accepted by
the Commission
     Amendment no.3 : the Commission cannot accept this amendment, the
     substance of which Is already covered by part 3 of Annex 11 of
     the Common Position (Implementation).
     Amendment no.5 : the Commission cannot accept this amendment.
     Its objective is of a horizontal nature, and already amply
     covered by paragraphs 3.1, 3.3 and 4.4 of Annex II of the Common
     Position.
The text of the re-examined proposal of the Commission Is to be found
at Annex 1. The text of the amendments of Parliament which are not
accepted by the Commission, Is to be found at Annex 2.
 ---pagebreak---                                                                             y
                                                               Annex 1
The Commission modifies its proposal as follows
     Recital no. 12 :
     Whereas, In the absence of clear standards and provisions concerning
     possible developments in the field of genome analysis, there may be a
     risk on the one hand that attempts will be made to intervene in the
     human genome in order to make the modifications so obtained
     hereditary, and on the other hand that genetic analyses will be
     carried out for monitoring purposes, which may have a profound effect
     on social life; whereas there are, accordingly, good grounds for
     taking the necessary steps to preclude unacceptable developments,
     particularly in terms of predictive medicine:
     Recital no. 13 bis (new)
     Whereas, in the implementation of the programme, it is appropriate to
     take account, in relation to the ethical and legal aspects, of the
     recommendations expressed in the resolution of the European Parliament
     of 16 March 1989;(1>
     (1)  O.J. no. C96 of 17.04.1989, page 165
     Annex II, section 4, pargraph 4.1, second indent :
          the launching of a programme of pre-normat ive research aiming at
           improvement of the methods and basis of the study of the human
          genome ;
     Annex II, section 4, paragraph 4.4, point (5)
     (5)  That only somatIc actual or potential medical applications should
          be faciIitated.
     Annex II, section 4, paragraph 4.4, point (6)
     The fol lowing sentence :
     "(6) That potential opportunities for Industrial development should be
          obtained."
     is deleted.
 ---pagebreak---                                                           Annex 2
Amendment no. 3
ANNEX II, point 2.1
2.1   IMPROVEMENT OF THE GENETIC MAP OF MAN
      Financial support for a Europe-based world-wide network for the
      collection and mapping of the DNA of large families on the
      condition that the network and the members of the families
      studied bv It conclude clear legal agreements on the nature of
      the use and study of their DNA and the rights of those concerned
      In respect of the use of the research results, which are also
      binding on the research workers cooperating with the network.
Amendment no. 5
ANNEX II, point 4.1, indent 3a (new)
      contract for research into the reoutred legal, technical and
      health measures to prevent the misuse of scientific knowledge of
    . the human genome and Its possible applications.
 ---pagebreak---  ---pagebreak---                                                                                ISSN 0254-1475 *
                                                                COM(90) 251 final
                                                      DOCUMENTS
EN                                                                                         16
                                  Catalogue number : CB-CO-90-266-EN-C
                                                              ISBN 92-77-61031-X
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