Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Implementation of the EU Regulation on health technology assessment (HTA) - Chances and challenges - ***

Dr. Tanja Marzluf (Abschlußjahr: 2022)

Summary
Language: English
After a process that took several years, the Regulation (EU) 2021/2282 of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU was adopted on December 15, 2021. This creates the legal basis for a European framework for the joint clinical assessment of medicinal products and selected medical devices and in vitro diagnostics. The initial proposal for EU HTA stated the following goals: (1) improve access to innovative healthcare technologies for EU patients; (2) allow efficient use of resources; (3) improve business predictability; (4) harmonize HTA methodologies, tools and procedures; and (5) reduce duplication of work for HTA bodies and industry; (6) ensure the use of joint work in EU Member States; and (7) ensure the long-term sustainability of EU HTA. The implementation follows a stepwise approach, with medicinal products for the treatment of cancer and ATMPs being the first to be assessed jointly in 2025, followed by orphan drugs in 2028 and then all products as of 2030. The HTA Regulation creates the basis, but many details regarding the procedure still have to be clarified in guidance documents developed by EUnetHTA21 and implementing acts by the European Commission. Additionally, key components of the future EU HTA system like the Coordination Group or the stakeholder network are currently in the process of being established. Ongoing discussions highlight the need for further clarification and detailed guidelines, e.g. for the selection of assessors, involvement of patient organizations and experts or how to align different treatment standards across the EU. From industry perspective, challenges remain particularly in the context of the targeted timeline for the joint clinical assessment, a sufficient supply of joint scientific consultations and the evidence requirements to enable a robust health technology assessment on Union level, that actually provides an added value for both industry and HTA authorities.
Pages: 73