engleski

Compromise on HTA Regulation: Facilitating or Hindering Development of High Quality New Health Technologies

The development of health technologies is crucial for fostering innovation and economic growth in the European Union, as well as for achieving the high quality level of health protection that Union and national health policies should ensure. Health Technology Assessment (HTA) is a scientific evidence-based process which allows competent authorities to determine the relative effectiveness of existing or new technologies, focusing on the added value of a certain health technology in comparison with other existing or new health technologies. A regulation aiming to offer the best outcomes for patients and society as a whole by creating permanent EU-level cooperation to simplify the process and avoid duplications and variations between different Member states, was proposed by the Commission in 2018. A final political agreement between the Parliament and the Council was reached in June 2021. The aim of the proposed presentation is to analyse the final compromise text of the HTA Regulation Proposal and determine whether these rules facilitate or hinder the development of high quality new health technologies-. The presentation first briefly explains the context of the HTA Regulation Proposal, especially in relation to the current EU legal framework on health technologies. This first part is followed by an analysis of the legislative process which led to the compromise text agreed upon by the Parliament and the Council. Next, the final text is analysed, with a focus on its legal strength, namely the rights and obligations imposed by it upon the Member States Finally, it is submitted that the agreement reached has fallen short of the objective to create a common European HTA system and avoid duplications and variations between different national procedures. It has, instead of substituting 27 different national procedures with one European, added the European procedure to the existing national ones, thereby further complicating the whole HTA process and hindering development of high quality new health technologies.

health technology assessment, quality, regulation

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