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". 
Comments of the Commission on amendments of Parliament not accepted by 
the Commission 
Amendment no.3 : the Commission cannot accept this 
substance of which Is already covered by part 3 of 
the Common Position (Implementation). amendment, the 
Annex 11 of 
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. 

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