Interaction initiatives between regulatory, health technology assessment and coverage bodies, and industry

Int J Technol Assess Health Care. 2012 Oct;28(4):374-81. doi: 10.1017/S0266462312000591.

Abstract

There has been an increased focus on the relationship between health technology assessment (HTA) and regulatory assessments and how regulatory, HTA and coverage bodies, and industry can work better together to improve efficiency and alignment of processes. There is increasingly agreement across sectors that improved communication and coordination could contribute to facilitating timely patient access to effective, affordable treatments that offer value to the health system. Discussions on aspects of this relationship are being held in different forums and various forms of coordination and collaboration are being developed or piloted within several jurisdictions. It is therefore both timely and of value to stakeholders to describe and reflect on current initiatives intended to improve interactions between regulatory, HTA and coverage bodies, and industry. Drawing on 2011 meetings of the HTAi Policy Forum and the Center for Innovation in Regulatory Science (CIRS), this study aims to describe and compare initiatives, and point to success factors and challenges that are likely to inform future work and collaboration.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Canada
  • Decision Making*
  • Drug Approval / legislation & jurisprudence*
  • Drug Approval / methods
  • Drug Approval / organization & administration
  • Drug Industry / legislation & jurisprudence*
  • Drug Industry / methods
  • Drug Industry / organization & administration
  • European Union
  • Government Regulation
  • Health Policy*
  • Humans
  • Insurance Coverage / organization & administration*
  • Internationality
  • Sweden
  • Technology Assessment, Biomedical / legislation & jurisprudence*
  • Technology Assessment, Biomedical / methods
  • Technology Assessment, Biomedical / organization & administration
  • United Kingdom
  • United States