Legal Governance in HTA: Environment, Health and Safety Issues / Ethical, Legal and Social Issues (EHSI/ELSI), the Ongoing Debate
This paper aims to provide a better understanding of the law circumscribing the social role of Health Technology Assessment (HTA) and gain insight into the reasons challenging the inclusion of ethics into HTA. We focused on a debate at the core of the perceived role of regulatory law in health tech...
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Programmes de bioéthique, École de santé publique de l'Université de Montréal
2020-04-01
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doaj-c5b25bba12f24f0f87f0049b382d11572021-04-02T11:13:07ZengProgrammes de bioéthique, École de santé publique de l'Université de MontréalCanadian Journal of Bioethics2561-46652020-04-0131Legal Governance in HTA: Environment, Health and Safety Issues / Ethical, Legal and Social Issues (EHSI/ELSI), the Ongoing DebateLouise Bernier0Georges Auguste Legault1Charles Étienne Daniel2Suzanne K.-Bédard3Jean Pierre Béland4Christian A. Bellemare5Pierre Dagenais6Hubert Gagnon7Monelle Parent8Johane Patenaude9Faculté de droit, Université de Sherbrooke, Sherbrooke, CanadaFaculté de droit; Institut interdisciplinaire d’innovation technologique (3IT) de l’Université de Sherbrooke, Sherbrooke, CanadaFaculté de droit; Institut interdisciplinaire d’innovation technologique (3IT) de l’Université de Sherbrooke, Sherbrooke, CanadaCentre intégré universitaire de santé et services sociaux (CIUSSS) de l'Estrie – Centre hospitalier de l'université de Sherbrooke (CHUS); Institut interdisciplinaire d’innovation technologique (3IT) de l’Université de Sherbrooke, Sherbrooke, CanadaUnité d’enseignement en éthique, Département des sciences humaines, Université du Québec à Chicoutimi (UQAC), Chicoutimi; Institut interdisciplinaire d’innovation technologique (3IT) de l’Université de Sherbrooke, Sherbrooke, CanadaCentre intégré universitaire de santé et services sociaux (CIUSSS) de l'Estrie – Centre hospitalier de l'université de Sherbrooke (CHUS); Institut interdisciplinaire d’innovation technologique (3IT) de l’Université de Sherbrooke, Sherbrooke, CanadaCentre intégré universitaire de santé et services sociaux (CIUSSS) de l'Estrie – Centre hospitalier de l'université de Sherbrooke (CHUS); Faculté de médecine et des sciences de la santé; Institut interdisciplinaire d’innovation technologique (3IT) de l’Université de Sherbrooke, Sherbrooke, CanadaInstitut interdisciplinaire d’innovation technologique (3IT) de l’Université de Sherbrooke, Sherbrooke, CanadaInstitut interdisciplinaire d’innovation technologique (3IT) de l’Université de Sherbrooke, Sherbrooke, CanadaFaculté de médecine et des sciences de la sant; Institut interdisciplinaire d’innovation technologique (3IT) de l’Université de Sherbrooke, Sherbrooke, Canada This paper aims to provide a better understanding of the law circumscribing the social role of Health Technology Assessment (HTA) and gain insight into the reasons challenging the inclusion of ethics into HTA. We focused on a debate at the core of the perceived role of regulatory law in health technology development, namely: Environment, Health and Safety Issues (EHSI) vs Ethical, Legal and Social Issues (ELSI) that arose in technology governance. Data collection was based on a literature review and a case study analysis. The former was founded on previous work. Three HTA agencies were selected for the latter using categories ranging from a greater to a lesser level of legal obligatory intensity. Our literature review revealed five different themes relating to the social role of HTA and a distinction between the role/use of “hard law” and “soft law” in regulatory law, thus providing an understanding of how agencies used law for handling ethics in HTA. Both approaches revealed that the debate, first observed in the EHSI/ELSI technology-governance and assessment, is reproduced in HTA. The main trend revealed by the literature review and the case study, is the presence of a pact between science and regulatory law. The social demand for integrating ELSI, and more precisely, ethical evaluation into HTA, is not the main preoccupation of the traditional legal frameworks governing HTA and remains to be considered primarily by alternative, soft law initiatives. The reported difficulties in integrating ethics into HTA demonstrate the need for rethinking legal governance in HTA. https://cjb-rcb.ca/index.php/cjb-rcb/article/view/199governancesocial rolehealth technology assessmentethics |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Louise Bernier Georges Auguste Legault Charles Étienne Daniel Suzanne K.-Bédard Jean Pierre Béland Christian A. Bellemare Pierre Dagenais Hubert Gagnon Monelle Parent Johane Patenaude |
spellingShingle |
Louise Bernier Georges Auguste Legault Charles Étienne Daniel Suzanne K.-Bédard Jean Pierre Béland Christian A. Bellemare Pierre Dagenais Hubert Gagnon Monelle Parent Johane Patenaude Legal Governance in HTA: Environment, Health and Safety Issues / Ethical, Legal and Social Issues (EHSI/ELSI), the Ongoing Debate Canadian Journal of Bioethics governance social role health technology assessment ethics |
author_facet |
Louise Bernier Georges Auguste Legault Charles Étienne Daniel Suzanne K.-Bédard Jean Pierre Béland Christian A. Bellemare Pierre Dagenais Hubert Gagnon Monelle Parent Johane Patenaude |
author_sort |
Louise Bernier |
title |
Legal Governance in HTA: Environment, Health and Safety Issues / Ethical, Legal and Social Issues (EHSI/ELSI), the Ongoing Debate |
title_short |
Legal Governance in HTA: Environment, Health and Safety Issues / Ethical, Legal and Social Issues (EHSI/ELSI), the Ongoing Debate |
title_full |
Legal Governance in HTA: Environment, Health and Safety Issues / Ethical, Legal and Social Issues (EHSI/ELSI), the Ongoing Debate |
title_fullStr |
Legal Governance in HTA: Environment, Health and Safety Issues / Ethical, Legal and Social Issues (EHSI/ELSI), the Ongoing Debate |
title_full_unstemmed |
Legal Governance in HTA: Environment, Health and Safety Issues / Ethical, Legal and Social Issues (EHSI/ELSI), the Ongoing Debate |
title_sort |
legal governance in hta: environment, health and safety issues / ethical, legal and social issues (ehsi/elsi), the ongoing debate |
publisher |
Programmes de bioéthique, École de santé publique de l'Université de Montréal |
series |
Canadian Journal of Bioethics |
issn |
2561-4665 |
publishDate |
2020-04-01 |
description |
This paper aims to provide a better understanding of the law circumscribing the social role of Health Technology Assessment (HTA) and gain insight into the reasons challenging the inclusion of ethics into HTA. We focused on a debate at the core of the perceived role of regulatory law in health technology development, namely: Environment, Health and Safety Issues (EHSI) vs Ethical, Legal and Social Issues (ELSI) that arose in technology governance. Data collection was based on a literature review and a case study analysis. The former was founded on previous work. Three HTA agencies were selected for the latter using categories ranging from a greater to a lesser level of legal obligatory intensity. Our literature review revealed five different themes relating to the social role of HTA and a distinction between the role/use of “hard law” and “soft law” in regulatory law, thus providing an understanding of how agencies used law for handling ethics in HTA. Both approaches revealed that the debate, first observed in the EHSI/ELSI technology-governance and assessment, is reproduced in HTA. The main trend revealed by the literature review and the case study, is the presence of a pact between science and regulatory law. The social demand for integrating ELSI, and more precisely, ethical evaluation into HTA, is not the main preoccupation of the traditional legal frameworks governing HTA and remains to be considered primarily by alternative, soft law initiatives. The reported difficulties in integrating ethics into HTA demonstrate the need for rethinking legal governance in HTA.
|
topic |
governance social role health technology assessment ethics |
url |
https://cjb-rcb.ca/index.php/cjb-rcb/article/view/199 |
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