Patients' rights in a technology and market driven-Europe

European Journal of Health Law

Volumn 17, Issue 1, 2010, Pages 11-22

  Abbing, Henriette D C Roscam ^a  

^a NONE

Author keywords

commercial screening; Convention on Human Rights and Biomedicine; cross border health care; cross border research; free choice; patients' rights; predictive medicine; technological developments

Indexed keywords

ARTICLE; ETHICS; EUROPE; HUMAN; INTERNATIONAL COOPERATION; INTERPERSONAL COMMUNICATION; LEGAL ASPECT; MASS COMMUNICATION; MEDICAL RESEARCH; MEDICAL TECHNOLOGY; PATIENT RIGHT; RESEARCH ETHICS;

BIOMEDICAL RESEARCH; COMMUNICATION; DIFFUSION OF INNOVATION; ETHICS, RESEARCH; EUROPE; HUMANS; INTERNATIONALITY; PATIENT RIGHTS; TECHNOLOGY, MEDICAL;

EID: 77957121038     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/157180909X12604572349566     Document Type: Article

References (38)

1. Keynote address at the second conference of the European Association of Health Law, 15-16 October 2009, Edinburgh, Scotland. The Conference was hosted by the AHRC/SCRIPT Research Centre, School of Law, University of Edinburgh, and generously supported by the British Academy.
2. Profiling that takes into account all relevant disease factors and their interaction (physical and mental, environmental factors, life style and socio-economic).
3. Stratification into clinically relevant sub-groups. Individualised medicine for single persons will not always be feasible for reasons of economy, practicality and usefulness.
4. Protocol concerning the prohibition of cloning human beings (1998), Protocol concerning transplantation of organs and tissues of human origin (2002), Protocol concerning biomedical research (2005), and Protocol concerning genetic testing for health purposes (2008).
5. The European Convention on Human Rights, Council of Europe (1950) the Revised European Social Charter, Council of Europe (1996) and the Charter of Fundamental Rights of the European Union (2002) also have impact on the rights of the patient, especially if a subject is not yet, or insuffi ciently covered by the sector specifi c instruments.
6. Health Consumer Powerhouse, the empowerment of the European patient 2009, options and implications, report. Health Consumer Powerhouse AB 2009. Brussels, Stockholm, Winnipeg.
7. H.J.J. Leenen, Health law in the twenty-first century, editorial, European Journal of Health law 5 (1998) p. 344.
8. H.D.C. Roscam Abbing, Human tissue research, individual rights and biobanks, in: Jennifer Gunning & Soren Holm (red.), Ashgate Ethics, Law and Society, vol II, Aldershot: Ashgate 2006, p. 14. See also the explanatory report to the Council of Europe Recommendation 2006/4 on research on biological materials of human origin, para. 27.
9. H.D.C. Roscam Abbing, Human rights and medicine, a Council of Europe Convention, European Journal of Health Law 3 (1996) 201-205.
10. In the meantime, the Proposal for a Directive of the European Parliament and of the Council on the application of patients' rights in cross border care. (COM(2008)4 final) was rejected by the Ministers of Health (EU) (1-12-2009).
11. Directive 95/46/EC on the protection of individuals with regard to the processing of data and on the free movement of such data, OJ L 281, 23.11.1995, p. 31.
12. Henriette D.C. Roscam Abbing, Problem doctors and patients right to good quality care in the European Union, European Journal of Health Law 16 (2009) 1-9.
13. Elisabeth Rynning, Public trust and privacy in shared electronic health records, editorial, European Journal of Health Law 14 (2007) 105-112.
14. Henriette D.C. Roscam Abbing, Public health insurance and freedom of movement within the European Union, European Journal of Health Law 6 (1999), p. 5.
15. Supra, footnote 10, Considerans, para. 34.
16. Directive EC 95/46/EC and Article 16 of Council of Europe Recommendation on research on biological materials of human origin (Rec(2006)4).
17. So far Directive 98/79/EC (IVD Directive) fails to off er the necessary protection when it comes to "do it your self " tests. J.K.M. Gevers, Health screening services supplied directly to the public, editorial, European Journal of health law 16 (2009) 1-6.
18. For the health of the persons concerned and for members of their family and when the genetic test has important implications concerning procreative choices.
19. Protocol concerning genetic testing for health purposes, Article 7, Oviedo Convention, Article 12.
20. Proposal for a Directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription. Directive 2001/83/EC on the Community code relating to medicinal products for human use. Brussels, 10 December 2008, COM (2008) 663.
21. Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. L 121/34 of 1.5.2001.
22. H.D.C. Roscam Abbing, Medical research involving incapacitated persons: What are the standards? European Journal of health Law 1 (1994) 147-160.
23. The EC Directive refers to the explicit wish of a person who is capable of forming an opinion and assessing the information received "to refuse participation or to be withdrawn". In relation to minors, the recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC refer to "assent". European Journal of Health Law 15 (2008) 223-250.
24. These conditions come in addition to overall requirements for the protection of research participants (e.g. risk-benefit proportionality, scientifi c and ethical acceptability and approval by the competent person or body).
25. No more risk than in routine daily medical practice, e.g. taking a single blood sample.
26. The risk cannot be increased beyond minimal, even if the research promises a high level of benefit.
27. According to the Directive, minors may be included in research that either relates directly to the clinical condition from which the minor concerned suff ers or is of such a nature that it can only be carried out on minors, provided some benefit for the group of patients is obtained (Article 4). According to the implementation guidelines a minor increase over minimal risk is considered to be in balance with the benefit of the trial for the paediatric population provided the benefit to risk balance is at least as favourable as that of alternative approaches. Ad hoc Group for the development of implementing guidelines for Directive 2001/20/EC, European Journal of Health Law 15 (2008) 223-250.
28. J.K.M. Gevers, Medical research involving children, Editorial, European Journal of Health Law 15 (2008) 103-108.
29. Convention, Article 6.2; Protocol Article 15.1. iv. The Directive acknowledges refusal by the minor, Article 4 c.
30. Roberto Andorno, et al., Advance health care directives: towards a coordinated European policy? European Journal of Health Law 16 (2009) 207-227.
31. Intermittent moments of capacity may give the opportunity for reconfi rming earlier decisions. Th is without prejudice to the necessity to take into account the actual situation, both in relation to progress in treatment possibilities, as in relation to the actual situation of the patient. Sjef Gevers, Dementia and the law, European Journal of Health Law 13 (2006) 209-217.
32. Salla Lötjönen, Medical research on patients with dementia, European Journal of Health Law 13 (2006) 235-261.
33. Edward W. Keyserlink E.A., Proposed guidelines for the participation of persons with dementia as research subjects, Perspectives in Biology and Medicine 38 (1995) 319-362.
34. The Council of Europe Steering Committee on Bioethics currently has the issue on its agenda for the purpose of preparing an instrument. Major principles for the use of sensitive personal information outside health care were identifi ed in 2000 in the Council of Europe report "Medical examinations preceding employment and/or private insurance, a proposal for European guidance." Th is report was published under the responsibility of the authors.
35. To be applicable, the doctrine of confl ict of duties must meet with several criteria. See H.J.J. Leenen, Genetics, confi dentiality and research, editorial, European Journal of Health Law 7 (2000) 363-366. Depending on the legislative approach of a country, this doctrine may be part of medical professional standards or else be part of formal legislation. The inclusion of the conditions to be met if tests on persons not able to consent are envisaged, in Article 13 of the Protocol concerning genetic testing for health purposes, is an example of formalising a particular situation of confl icting duties. Th is does not stand in the way of regulation in professional medical standards (see the Explanatory Report to the Convention, para. 174).
36. Human Genetics Commission, Profiling the newborn: a prospective technology? London. 2005. www.hgc.gov.uk
37. Bärbel Hüsing, Juliane Hartig, Bernhard Bührlen, Th omas Reiß and Sibylle Gaisser, individualisierte Medizin und Gesundheitssystem. TAB-report No. 126, Berlin. 2008. An English summary "Individualised medicine and health care system" is available on www.tab.fzk.de/en/projek/ zusammenfassung/ abl1126.htm.
38. H.J.J. Leenen, Genetic manipulation with human beings, Medicine and Law 7 (1988) 78-79.