GetReal Institute

EU Legislative Interests

GetReal activities are mainly focused on the following EU legislations: 1. The European Union (EU) legal framework for pharmaceuticals (Regulation (EC) No 726/2004) 2. Regulation on Health Technology Assessment – Regulation (EU) 2021/2282 3. Proposal for a regulation – The European Health Data Space (COM(2022) 197/2) 4. A pharmaceutical Strategy for Europe (COM(2020) 761 final) Potentially GetReal Institute will focus on the following legislations as well: 5. Legislation around the use of the AI act 6. Data Act The general focus of the GetReal Institute within these legislations is to look to examine the impact of this legislation on RWE decision making for the generation and use of RWE in order to support decision making by regulatory and HTA bodies. Furthermore, GetReal Institute is looking to assess how the legislations impact the abilities of commercial organisations (pharma and SME) and how patient interests are represented.

Communication Activities

Skills, Education, and Training: Through initiatives like the GetReal Academy, the institute has developed educational materials and training platforms to support the implementation of real-world evidence in healthcare. Shared Learning forum: A key component of this mission is the establishment of a multi-stakeholder Shared Learning Forum. This forum serves as a collaborative platform where diverse stakeholders—including decision-makers, researchers, patients, and clinicians—can share experiences, discuss challenges, and develop best practices related to the generation and application of RWE. By fostering open dialogue and knowledge exchange, the Shared Learning Forum aims to build trust and consensus on the use of RWE, thereby enhancing its integration into regulatory, health technology assessment (HTA), and clinical decision-making processes. GetReal Annual Conference: The annual GetReal Conference features in-depth debates and discussions with HTA representatives and regulators, focusing on preparedness for utilising RWE as the new HTA Regulation comes into effect. Moreover, practical experiences in applying RWE to real-world decision-making in medicine development are explored. Health and Long-Term Care: The institute has focused on enhancing healthcare systems by incorporating real-world evidence into drug development and decision-making processes. This approach aims to improve the quality and sustainability of healthcare within the EU. The GetReal Institute has been actively involved in the development of the European Health Data Space (EHDS), focusing on the integration of real-world evidence (RWE) into healthcare decision-making across Europe. As an independent, multi-stakeholder forum, the institute collaborates with various stakeholders to advance the adoption and implementation of RWE in regulatory, health technology assessment, and clinical decision-making. In this context, the GetReal Institute has joined other health stakeholders in expressing concerns over certain aspects of the EHDS regulation negotiations. Collaboration with the European Medicines Agency: The GetReal Institute contributed a multi-stakeholder response to the EMA’s consultation on the Data Quality Framework, reflecting its commitment to enhancing RWE use in regulatory decisions. Additionally, GetReal has invited the EMA to its Scientific Advisory Board. These activities demonstrate the GetReal Institute's commitment to promoting the integration of RWE in healthcare, complementing the EMA's efforts to enhance the use of real-world data in regulatory decision-making. The institute is focused on developing tangible outputs with our European partners in regulatory, HTA, industry, academia and patient advocacy to support our key objective of increasing the awareness and knowledge of RWE in healthcare decision making across Europe.

Interests Represented

Does not represent commercial interests

Member Of

N/A

Organisation Members

List of member organisations can be found on our website: https://www.getreal-institute.org/about-us/members/