C Explanatory memorandum, by Mr Holger
Haibach
1. The rapporteur refers to Mr Wodarg’s explanatory
memorandum, which describes the background to the draft Additional
Protocol to the Convention on Human Rights and Biomedicine on Genetic
Testing for Health Purposes. Mr Wodarg also sets out the main principles
of the draft additional protocol.
2. So far, fewer than half of the Council of Europe’s member
states have ratified the Convention on Human Rights and Biomedicine.
NoteThe
rapporteur considers this extremely regrettable given the importance
of the subject matter and urges member states that have not yet
done so to sign and/or ratify the convention as soon as possible.
3. He agrees with the rapporteur of the Committee on Culture,
Science and Education that the draft additional protocol offers
balanced and appropriate protection for those who take part in genetic
testing, as well as legal safeguards that have hitherto not existed.
It will be the first legally binding international instrument in this
field.
4. The rapporteur notes that what might be termed a “thematic”
approach has been adopted. In this way several additional protocols
to the Convention on Human Rights and Biomedicine on various themes
have already been adopted.
NoteThe
latest draft additional protocol supplements existing protection
by tackling a new topic, that of genetic testing for health purposes.
5. Clearly, other areas need to be covered to offer the widest
possible protection and to respond to scientific progress in the
biomedical field, which by its nature is constantly evolving. The
rapporteur particularly wishes to encourage current work on the
use of genetic testing for insurance purposes.
6. Turning to the proposed amendments of the Committee on Culture,
Science and Education, the rapporteur fully supports the proposals
in paragraphs 8.4, 8.5 and 8.6 of the draft opinion.
7. However, he wishes to comment on the other proposed amendments.
8. He has a number of reservations about the one in paragraph
8.1 of the draft opinion presented by the Committee on Culture,
Science and Education, which reads: “in Article 2.1, add the word
‘only’ after the words ‘which are’”.
9. He is concerned that as currently worded the proposed amendment
could be misinterpreted and thus be incompatible with the protocol’s
intentions.
10. The draft additional protocol must always be read in parallel
with the Convention on Human Rights and Biomedicine, whose provisions
are still applicable. Yet, Article 12 of the convention specifically
bans predictive tests that are not performed for health purposes
or for scientific research linked to health purposes. Far from filling
a gap, therefore, adding the word “only” introduces an element of
redundancy.
11. Moreover, the addition of “only” in paragraph 2 presents another
risk, since the provisions of the protocol would only apply to tests
performed for medical purposes, and not to those with dual medical
and research purposes. The rapporteur considers that this aspect
could cause problems.
12. He also notes that Article 2.1 defines the scope of the additional
protocol and is very concerned that adding the word “only” could
be interpreted as a prohibition, which is not appropriate in the
scope.
13. The rapporteur cannot therefore support the proposed amendment
of the Committee on Culture, Science and Education to Article 2.1
of the draft additional protocol.
14. He also wishes to comment on the proposed amendment in paragraph
8.3 of the draft opinion presented by the Committee on Culture,
Science and Education, which reads: “in Article 7.1, add at the
end the words ‘of appropriately qualified physicians’”.
15. The rapporteur considers that the proposed addition is already
covered by Article 5 of the draft additional protocol. Article 5.c calls for measures to ensure that
“persons providing genetic services” – a category that certainly
includes physicians offering individualised medical supervision
– “have appropriate qualifications to enable them to perform their
role in accordance with professional obligations and standards”.
16. It therefore seems unnecessary to repeat in Article 7.1 of
the draft additional protocol that persons offering such supervision
must have appropriate qualifications.
17. The rapporteur thinks that it might be more appropriate to
change the proposed amendment to a clarification in the section
of the explanatory report of the draft additional protocol dealing
with Article 7.
18. Finally, the rapporteur wishes to return to the notion of
clinical utility in Article 6 of the draft additional protocol.
Clinical utility is a well-developed concept in genetics literature
and the authors of the draft additional protocol have paid very
close attention to the established terminology. They have drawn
on a number of sources, such as the Organisation for Economic Co-operation
and Development (OECD) guidelines for quality assurance in molecular
genetic testing,
Noteexpert
advice and the recommendations of the European Society of Human
Genetics.
19. The notion of clinical utility has two dimensions, in that
it is concerned not just with the state of the individual patients
but also with the clinical potential of the test results themselves,
in terms of both prevention and treatment. However, the notion of
medical indication, which the Committee on Culture, Science and Education
wishes to add to Article 6 of the draft additional protocol (see
its proposed amendment in paragraph 8.2 of the draft opinion), only
concerns the individual dimension and is already covered by the concept
of clinical utility. Paragraph 58 of the explanatory report on Article 6
of the draft additional protocol also includes the notion of medical
indication in the criteria for determining clinical utility.
20. The rapporteur therefore concludes that the proposed amendment
in paragraph 8.2 of the draft opinion presented by the Committee
on Culture, Science and Education, which reads “in Article 6, add
the words ‘and medical indication’ after the words ‘clinical utility’”,
serves no purpose.
Reporting committee: Committee on Culture, Science and Education.
Committee for opinion: Committee on Legal Affairs and Human
Rights.
Reference to committee: Doc. 11440 and
Reference No. 3376 of 1 October 2007.
Opinion approved by the committee on 22 January 2008. See
8th Sitting, 24 January 2008 (adoption of the draft opinion, as
amended); and Opinion
No. 267.
