Strasbourg, 2 December 2015                                                                DH-BIO/INF (2015) 13 FINAL






COMMITTEE ON BIOETHICS (DH-BIO)


8th meeting
1-4 December 2015 Strasbourg




Statement on genome editing technologies





adopted by the DH-BIO

•     The development of new genome editing technologies, such as CRISPR-Cas9, has given rise to important reaction in 
particular  within the scientific community.  Gene modification methods are not  new  and  have  been  used  for  
several  decades  playing  an  essential  role  in  biomedical research.  The  new  genome  editing  technologies  have 
 made  possible  simple  and  precise modifications in a wide variety of species.

•     There  is  strong  support  for  the  better  understanding  of  the  causes  of  diseases  and  for  future 
treatment  and  these  technologies  have  considerable  potential  for  research  in  this  field  and  to improve  
human  health.    However,  the  application  of  genome  editing  technologies  to  human gametes  or  embryos  raises 
 many  ethical,  social  and  safety  issues,  particularly  from  any modification of the human genome which could be 
passed on to future generations.

•     These developments have led eminent experts and institutions within and outside the biomedical field  worldwide  
to  call  for  an  in-depth  analysis  of  potential  risks  of  genome  editing  and  for international and regional 
debate on its implications for the human being.

•     In this context, the Committee on Bioethics (DH-BIO), representing 47 European states, wishes to  recall  the  
work  carried  out  at  the  level  of  the  Council  of  Europe  on  developments  in  the biomedical  field  and  its 
 implications  for  human  being,  and  to  underline  the  relevance  of  the framework provided by the Convention on 
Human Rights and Biomedicine (ETS N° 164, 1997), hereinafter  referred  to  as  “the  Oviedo  Convention”  –  the  only 
 international  legally  binding instrument addressing human rights in the biomedical field.

•     The  Convention  represents  the  outcome  of  an  in-depth  discussion  at  European  level,  on developments in 
the biomedical field, in particular in the field of genetics. This work was guided by   the   acknowledgement   of   
the   positive   perspectives   of   genetic   modification   with   the development of knowledge of the human genome; 
but also by the greater possibility to intervene on and control genetic characteristics of human beings, raising 
concern about possible misuse and  abuses,  in  particular  the  intentional  modification  of  human  genome  so  as  
to  produce individuals or groups endowed with particular characteristics and required qualities.

•     Article 131 of the Oviedo Convention addresses these concerns about genetic enhancement or germline genetic 
engineering by limiting the purposes of any intervention on the human genome, including in the field of research, to 
prevention, diagnosis or therapy.   Furthermore, it prohibits any intervention with the aim of introducing a 
modification in the genome of any descendants.

•     These  expectations  and  concerns  remain  both  very  relevant  today  with  regard  to  those  new genome 
editing technologies.

The Committee on Bioethics (DH-BIO):
•     is convinced that the Oviedo Convention provides principles that could be used as reference  for  the  debate  
called  for  at  international  level  on  the  fundamental questions raised by these recent technological 
developments; and recalls that the need for such debates was foreseen by the Convention in its Article 282;

•     agrees, as part of its mandate, to examine the ethical and legal challenges raised by these emerging genome 
editing technologies, in the light of the principles laid down in the Oviedo Convention.



1 Article 13 - Interventions on the human genome
An  intervention  seeking  to  modify  the  human  genome  may  only  be  undertaken  for  preventive,  diagnostic  or 
therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.
2 Article 28 – Public debate
Parties to this Convention shall see to it that the fundamental questions raised by the developments in biology and 
medicine are the subject of appropriate public discussion in the light, in particular, of relevant medical, social, 
economic, ethical and legal implications, and that their possible application is made the subject of appropriate 
consultation.

2