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This chapter explores the evolution of the processes for patient involvement in European HTA from the European Network for Health Technology Assessment (EUnetHTA) through the application of Regulation (EU) 2021/2282 (HTAR) on January 12, 2025. This chapter presents high-level procedural details for patient involvement as noted in the HTAR and its Implementing Regulations. It further explores the evolution of patient involvement throughout EUnetHTA and discusses the envisioned process under the HTAR and the identification of challenges or gaps in the planned process. Finally, the chapter concludes with a discussion of the potential limitations of the patient involvement process under the HTAR. The HTAR recognises the importance of involving clinical experts and patients with relevant in-depth, specialised expertise to provide input on the Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC), while preserving the scientific integrity of the joint work by developing rules on conflict of interest management. More work remains to be done in developing the European procedures and templates for patient input in JSC and JCA and attention should be paid to already existing best practices.

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European Union: Patient Involvement Model in HTA Under the European HTA Regulation

  • 章节

  • 出版模式：

    开放获取

  • 发表日期：

    2026年

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  • Margaret Galbraith,
  • Valentina Strammiello,
  • Anne Willemsen

摘要

This chapter explores the evolution of the processes for patient involvement in European HTA from the European Network for Health Technology Assessment (EUnetHTA) through the application of Regulation (EU) 2021/2282 (HTAR) on January 12, 2025. This chapter presents high-level procedural details for patient involvement as noted in the HTAR and its Implementing Regulations. It further explores the evolution of patient involvement throughout EUnetHTA and discusses the envisioned process under the HTAR and the identification of challenges or gaps in the planned process. Finally, the chapter concludes with a discussion of the potential limitations of the patient involvement process under the HTAR. The HTAR recognises the importance of involving clinical experts and patients with relevant in-depth, specialised expertise to provide input on the Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC), while preserving the scientific integrity of the joint work by developing rules on conflict of interest management. More work remains to be done in developing the European procedures and templates for patient input in JSC and JCA and attention should be paid to already existing best practices.