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

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