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This paper aims to provide a better understanding of the law circumscribing thesocial role of Health Technology Assessment (HTA) and gain insight into the reasonschallenging the inclusion of ethics into HTA. We focused on a debate at the core of theperceived role of regulatory law in health technology development, namely: Environment,Health and Safety Issues (EHSI) vs Ethical, Legal and Social Issues (ELSI) that arose intechnology governance. Data collection was based on a literature review and a case studyanalysis. The former was founded on previous work. Three HTA agencies were selected for thelatter using categories ranging from a greater to a lesser level of legal obligatoryintensity. Our literature review revealed five different themes relating to the social roleof HTA and a distinction between the role/use of “hard law” and “soft law” in regulatorylaw, 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/ELSItechnology-governance and assessment, is reproduced in HTA. The main trend revealed by theliterature review and the case study, is the presence of a pact between science andregulatory law. The social demand for integrating ELSI, and more precisely, ethicalevaluation into HTA, is not the main preoccupation of the traditional legal frameworksgoverning HTA and remains to be considered primarily by alternative, soft law initiatives.The reported difficulties in integrating ethics into HTA demonstrate the need for rethinkinglegal governance in HTA.

Legal Governance in HTA: Environment, Health and Safety Issues / Ethical, Legal and Social Issues (EHSI/ELSI), the Ongoing Debate