Source: EURLEX
Language: en
Format: md

### **`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)

```

```
            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".

```

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Comments of the Commission on amendments of Parliament not accepted by

the Commission

```

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Amendment no.3 : the Commission cannot accept this
substance of which Is already covered by part 3 of
the Common Position (Implementation).

```

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amendment, the

Annex 11 of

```

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   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.

```

### **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.

```

##### **`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.

```

##### 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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