Legal and ethical concerns in personalized medicine: a European perspective

被引：2

作者：

Regniault, Alexandre ^{[1
]}

Kupecz, Andras ^{[2
]}

Gavey, Michael ^{[4
]}

Mignolet, Olivier ^{[3
]}

De Carlo, Paolo ^{[5
]}

Meyer, Peter ^{[6
]}

Bailey, Sarah ^{[1
]}

机构：

[1] Simmons & Simmons, F-75001 Paris, France

[2] Simmons & Simmons, Amsterdam, Netherlands

[3] Simmons & Simmons, Brussels, Belgium

[4] Simmons & Simmons, London, England

[5] Simmons & Simmons, Milan, Italy

[6] Simmons & Simmons, Dusseldorf, Germany

来源：

PERSONALIZED MEDICINE | 2009年 / 6卷 / 05期

关键词：

biobanks; discrimination; ethical issues; framework conditions; European policy; gene diagnostics; legal issues; patents; patient stratification; personal data;

D O I：

10.2217/PME.09.42

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Expectations in the integration of pharmacogenomics into clinical practice remain high in a number of therapeutic areas. This review focuses on the key legal and ethical issues concerning personalized medicine that have given rise to debate, law-making and/or Court decisions in Europe, especially involving: trial subject stratification during clinical trials; the protection of innovation in pharmacogenomics through intellectual property rights; the regulation of access to genetic testing; the regulatory framework for genetic testing devices; gene-based discrimination; legal duties and liabilities resulting from 'tailored' medicine; and confidentiality issues with respect to family members. This article explains these issues and identifies some of the difficulties encountered in seeking to build a harmonized legal framework within Europe.

引用

页码：517 / 528

页数：12

共 50 条

[31] Personalized genomic medicine: Ethical considerations
Jonsson, J. J.
[J]. CLINICA CHIMICA ACTA, 2019, 493 : S734 - S734
[32] Regulatory and ethical challenges of personalized medicine
Torr-Brown, Sheryl R.
[J]. PERSONALIZED MEDICINE, 2010, 7 (05) : 465 - 468
[33] ETHICAL CONCERNS IN PSYCHOTHERAPY AND THEIR LEGAL RAMIFICATIONS - THOMPSON,A
MANN, T
[J]. CANADIAN JOURNAL OF PSYCHIATRY-REVUE CANADIENNE DE PSYCHIATRIE, 1985, 30 (03): : 233 - 233
[34] Personalized medicine: An introduction to the ethical challenges
Fleck, Leonard M.
[J]. UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS, 2014, 32 (02) : 186 - 186
[35] Workplace teams: Ethical and legal concerns and approaches
Levine, M
Sibary, S
[J]. ETHICS & BEHAVIOR, 2001, 11 (01) : 55 - 66
[36] ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS OF PERSONALIZED GENOMIC MEDICINE RESEARCH: CURRENT LITERATURE AND SUGGESTIONS FOR THE FUTURE
Callier, Shawneequa L.
Abudu, Rachel
Mehlman, Maxwell J.
Singer, Mendel E.
Neuhauser, Duncan
Caga-Anan, Charlisse
Wiesner, Georgia L.
[J]. BIOETHICS, 2016, 30 (09) : 698 - 705
[37] Ethical and Legal Concerns Associated With Withdrawing Mechanical Circulatory Support: A U.S. Perspective
Mueller, Paul S.
[J]. FRONTIERS IN CARDIOVASCULAR MEDICINE, 2022, 9
[38] Ethical and legal framework and regulation for off-label use: European perspective
Lenk, Christian
Duttge, Gunnar
[J]. THERAPEUTICS AND CLINICAL RISK MANAGEMENT, 2014, 10 : 537 - 546
[39] Legal pressures and incentives for personalized medicine
Marchant, Gary E.
Milligan, Robert J.
Wilhelmi, Brian
[J]. PERSONALIZED MEDICINE, 2006, 3 (04) : 391 - 397
[40] Personalized Medicine and Medicinal Chemistry: Towards a Legal Frame-work in the European Union
Duardo-Sanchez, Aliuska
De Miguel Beriain, Inigo
[J]. CURRENT TOPICS IN MEDICINAL CHEMISTRY, 2018, 18 (25) : 2165 - 2173

← 1 2 3 4 5 →