Genetic testing for health care purposes, a council of europe protocol

European Journal of Health Law

Volumn 15, Issue 4, 2008, Pages 353-359

  Roscam Abbing, Henriette D C ^a  

^a Department of Health Law ^*  (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

EDITORIAL; GENETIC ANALYSIS; GENETIC SCREENING; HEALTH CARE; HUMAN; MEDICAL ETHICS; MEDICOLEGAL ASPECT; PATIENT RIGHT; PRACTICE GUIDELINE; CONFIDENTIALITY; EUROPEAN UNION; HEALTH CARE DELIVERY; INTERNATIONAL COOPERATION;

CONFIDENTIALITY; DELIVERY OF HEALTH CARE; EUROPEAN UNION; GENETIC SCREENING; HUMANS; INTERNATIONAL COOPERATION;

EID: 62449307935     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/157180908X379291     Document Type: Editorial

References (24)

1. Somatic genetic mutations take place in non-germinal cells and are not transmissible to off spring. T ey are not dealt with.
2. Screening involves a systematic off er to a seemingly healthy (target group) of the population for the purpose of early identifi cation of health risks (latent disease or risk factor for future occurrence of a disease) in order to facilitate prevention and early treatment. A positive outcome of a screening test requires confi rmation.
3. Employment related testing may have a health purpose as well.
4. STRATA expert group, report on Ethical, Legal and Social aspects of Genetic Testing: research, development and clinical applications, European Commission, Directorate-General for Research, Directorate C-Science and Society, Brussels, 2004, p. 26.
5. Sjef Gevers, "Population Screening: the Role of the Law" EJHL 5 (1998) 7-18.
6. Adequate is determined both by proven medical eff ect and ethical and legal acceptability. Council of Europe Recommendation R. 94 (11) on screening as a tool of preventive medicine.
7. STRATA, o.c., p. 41-47.
8. The Additional Protocol to the Convention on human rights and biomedicine, concerning Genetic Testing for health purposes was adopted by the Committee of Ministers (at deputy level) of the Council of Europe on 7 May 2008. Work on the Protocol started in 1997. See pp. 453-462 for the text.
9. A test that aims specifi cally to identify the genetic characteristics of a person, inherited or acquired during early prenatal development.
10. Chromosomal analysis, DNA or RNA analysis, analysis of any other element enabling equivalent information to be obtained.
11. Para. XV of the Appendix to the Protocol and its explanatory report (para. 57).
12. See para. 33 of the ER to the present Protocol.
13. H.D.C. Roscam Abbing, "Human Rights and Medicine, a Council of Europe Convention", EJHL 3 (3) (1996) 201-205.
14. Clearly, the drafters did not intend to include this kind of testing into the Protocol. Para 14 of the ER holds out the prospect of a separate instrument concerning genetic testing for employment and insurance purposes.
15. Pre-employment testing may be useful if the health status of the person holding the job is directly linked to the health of other persons (e.g. a pilot or truck driver). Screening at the workplace may be useful if applied for the purpose of adapting the workplace to the health status of the worker.
16. The Convention on Human Rights and Biomedicine also fails to address the issue.
17. At the time, the possibility of a protocol on genetics being drawn up was the main reason why the recommendation prepared by the Group responsible for that report was not passed on to the Committee of Ministers for approval.
18. Article 18.2: tests predictive of monogenic diseases, tests serving to detect a genetic predisposition or genetic susceptibility to a disease, carrier tests.
19. To be documented in case of predictive genetic testing.
20. They are the person's persistent refusal (to be informed or to share information), the absence of an alternative solution and provision of only strictly necessary information.
21. Herman Nijs, "Research on Human Biological Materials and the Council of Europe: Some Unanswered Questions, Overlaps and Empty Boxes", EJHL 1(2008) 1-6.
22. Somatic genetic mutations and changes in the human microbiome also can be associated with human health and disease. T ere too, legal and ethical issues arise.
23. H.D.C. Roscam Abbing, "T e Convention on Human Rights and Biomedicine", An Appraisal of the Council of Europe Convention, EJHL, 3(1998) 380.
24. Strata, o.c. p. 46.