Draft Additional Protocol to the Convention on Human Rights and Biomedicine, on Genetic Testing for Health Purposes
- Author(s):
- Parliamentary Assembly
- Origin
- Assembly
debate on 24 January 2008 (8th Sitting) (see Doc.11466, report of the Committee on Culture, Science and Education,
rapporteur: Mr Wodarg; and Doc.
11506, opinion of the Committee on Legal Affairs and Human
Rights, rapporteur: Mr Haibach). Text adopted by the Assembly on
24 January 2008 (8th Sitting).
- Thesaurus
1. The draft additional protocol
to the Convention on Human Rights and Biomedicine (hereafter referred to
as the Bioethics Convention, ETS No. 164) on genetic testing for
health purposes is the fourth in the series of additional protocols
to the convention, after those on the Prohibition of Cloning Human
Beings (1997, ETS No. 168), on Transplantation of Organs and Tissues
of Human Origin (2001, ETS No. 186) and on Biomedical Research (2004,
CETS No. 195). The Parliamentary Assembly welcomes this further
enrichment of the convention.
2. The Assembly regrets that 26 out of the 47 member states of
the Council of Europe have not yet ratified or acceded to the Convention
on Bioethics and urges them to do so as soon as possible.
3. Remarkable progress has been made in the field of human health,
thanks to research in biology and medicine. Knowledge of the human
genome has been the source of considerable advances, in particular
the development of genetic tests. These tests make it possible to
identify genetic characteristics responsible for a disease or involved
in its development.
4. Several hundred genetic tests are currently in use and more
are being developed. Genetic testing is becoming more and more an
integral part of medical practice, but at the same time a direct
commercial offer for genetic tests outside any health system is
developing. This may pose ethical problems.
5. The present additional protocol to the Convention on Bioethics
builds on the principles embodied in the convention with a view
to defining and safeguarding the fundamental rights of the persons
concerned by genetic testing for health purposes.
6. The Assembly notes that this protocol has been agreed unanimously
by the Steering Committee on Bioethics following detailed examination.
7. It would point out that this is only the first in a series
of protocols regarding genetic testing and will follow carefully
the developing debate in this field.
8. The Assembly, while satisfied in general with the present
draft protocol, feels that it could be improved and, in consequence,
recommends that the Committee of Ministers consider the following
amendments:
8.1 in Article 6,
add the words “and medical indication” after the words “clinical
utility”;
8.2 in Article 7.1, add at the end the words “of appropriately
qualified physicians”;
8.3 in Article 8.2, add the words “or to exclude” after the
word “detect”;
8.4 in Article 8.2, add the words “or to exclude” after the
word “identify”;
8.5 change the first paragraph of Article 10 as follows: “Subject
to Article 13 of this Protocol, a genetic test on a person who does
not have the capacity to consent may only be carried out for his
or her direct benefit”.
