Classification and ethical issues regarding advanced therapy medicinal products

Research output: Contribution to journalArticle

Abstract

European Union’s (EU) Regulation No. 1394/2007 has introduced a new regulatory category of medicines – advanced therapy medicinal products, into the EU legal system. They are divided at present into three major groups: gene therapy, somatic cell therapy and tissue engineered medicinal products. The reasons for such classification are complex and vary in a broad spectrum comprised from political-legislative to scientific concerns. The aim of the paper is to discuss some classification issues that arise from the reluctance of the European legislator to address in a clearer way some important ethical issues with regard to those advanced therapies.

Fingerprint

European Union
Ethics
Group Psychotherapy
Cell- and Tissue-Based Therapy
Genetic Therapy
Therapeutics

Keywords

  • Advanced therapy medicinal products
  • Classification
  • Ethical issues

Cite this

@article{56ecd3e91d6c41969d3af210eb420e1b,
title = "Classification and ethical issues regarding advanced therapy medicinal products",
abstract = "European Union’s (EU) Regulation No. 1394/2007 has introduced a new regulatory category of medicines – advanced therapy medicinal products, into the EU legal system. They are divided at present into three major groups: gene therapy, somatic cell therapy and tissue engineered medicinal products. The reasons for such classification are complex and vary in a broad spectrum comprised from political-legislative to scientific concerns. The aim of the paper is to discuss some classification issues that arise from the reluctance of the European legislator to address in a clearer way some important ethical issues with regard to those advanced therapies.",
keywords = "Advanced therapy medicinal products, Classification, Ethical issues",
author = "Jonas Juskevicius",
year = "2013",
language = "English",
volume = "20",
pages = "2--7",
journal = "Medic{\'i}nska etika a bioetika : casopis {\'U}stavu medic{\'i}nskej etiky a bioetiky = Medical ethics & bioethics : journal of the Institute of Medical Ethics & Bioethics",
issn = "1335-0560",
number = "3/4",

}

TY - JOUR

T1 - Classification and ethical issues regarding advanced therapy medicinal products

AU - Juskevicius, Jonas

PY - 2013

Y1 - 2013

N2 - European Union’s (EU) Regulation No. 1394/2007 has introduced a new regulatory category of medicines – advanced therapy medicinal products, into the EU legal system. They are divided at present into three major groups: gene therapy, somatic cell therapy and tissue engineered medicinal products. The reasons for such classification are complex and vary in a broad spectrum comprised from political-legislative to scientific concerns. The aim of the paper is to discuss some classification issues that arise from the reluctance of the European legislator to address in a clearer way some important ethical issues with regard to those advanced therapies.

AB - European Union’s (EU) Regulation No. 1394/2007 has introduced a new regulatory category of medicines – advanced therapy medicinal products, into the EU legal system. They are divided at present into three major groups: gene therapy, somatic cell therapy and tissue engineered medicinal products. The reasons for such classification are complex and vary in a broad spectrum comprised from political-legislative to scientific concerns. The aim of the paper is to discuss some classification issues that arise from the reluctance of the European legislator to address in a clearer way some important ethical issues with regard to those advanced therapies.

KW - Advanced therapy medicinal products

KW - Classification

KW - Ethical issues

M3 - Article

VL - 20

SP - 2

EP - 7

JO - Medicínska etika a bioetika : casopis Ústavu medicínskej etiky a bioetiky = Medical ethics & bioethics : journal of the Institute of Medical Ethics & Bioethics

JF - Medicínska etika a bioetika : casopis Ústavu medicínskej etiky a bioetiky = Medical ethics & bioethics : journal of the Institute of Medical Ethics & Bioethics

SN - 1335-0560

IS - 3/4

ER -