Masterarbeit

The European Commission's Proposed Regulation on Health Technology Assessment–Background, Challenges, and Opportunities ***

Dr. Hamza Al-Tamari (2020)

Summary
Language: English
Health Technology Assessment (HTA) is a form of policy research that systemically that synthesizes and evaluates the medical, social, economic, legal, organizational, and ethical consequences/ impacts of the application of a health technology, a set of related technologies, or a technology related matter. HTA aims to provide decision makers with scientific evidence to inform decisions on health technology access and reimbursement and efficient allocation of healthcare funds.
Owing to rising healthcare expenditure, demand, and economic pressures, the last two decades have witnessed advances and increased collaborations in the field of HTA. This increase underlines the significant role of HTA in the sustainability of healthcare systems and the improvement in their performance.
The European Union (EU), is a political and economic coalition of 27 European countries, referred to as Member States In the European Union (EU), the HTA involves national and regional players. Since more than 20 years, the European Commission promotes HTA by funding and supporting a series of projects and joint actions aimed at strengthening HTA, fostering knowledge sharing, and promoting collaboration on HTA among EU countries. These projects and joint actions have produced significant achievements and results. However, the full benefits of the EU level cooperation on HTA have not yet been exploited because of several shortcomings, including the following: (i) the duplication of work by national/ regional HTA bodies and industry has remained high because of the limited uptake of joint work at the EU level into national decision making processes; (ii) there are still differences in HTA methodologies across EU countries, leading to divergent outcomes of the evaluations and thereby, to a lack of business predictability; and (iii) the current cooperation lacks long term sustainability due to the non sustainable financing model of those projects. In order to enhance EU-level cooperation on HTA and address the shortcomings of the current cooperation models, the European Commission has recently published a proposal for the Regulation of the European Parliament and of the Council on Health Technology Assessment and Amending Directive 2011/24/EU). The proposed regulation creates both significant challenges and a wealth of opportunities.
This master’s thesis outlines the EC’s proposed HTA regulation, and demonstrates the challenges and opportunities that the proposed regulation of HTA would bring, mainly for health technology developers (industry), patients, and Member States’ HTA bodies and decisions makers. This thesis also provides an overview of HTA in the EU Member States and presents past and current EU cooperation on HTA projects and initiatives.
Pages: 81:
Annexes: 3, 5 pages