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 )
Date: 1990-06-11
Institutions: European Commission
Subjects: action programme, genetic engineering, public health, research and development, scientific progress

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. 

ISSN 0254-1475 

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