Policy & advocacy
At the core of EHA’s advocacy efforts are four priority themes. For each of these themes, the main messages and recommendations directed at EU institutions and other stakeholders have been written down in a Position Paper.
Position papers
- EHA position paper on affordable access to OMPs
- EHA position paper on Fair pricing of innovative medicines
- EHA position paper on Precision Diagnostics
- EHA position paper on Personalized Medicine
Position papers are not static documents but flexible tools that are regularly adapted to reflect changing political or policy contexts, members’ feedback, or alignment with the positions of other stakeholders.
These position papers are the basis for EHA’s engagement with EU policymakers and regulators and for establishing partnerships with other stakeholders at the European level. They address different but closely interlinking aspects of EHA’s overarching advocacy goal: advancing affordable and equitable access to innovative therapies.
Research policies
Themes such as personalized medicine, rare diseases and affordability also play an important role in EHA’s advocacy aimed at EU research policies and funding programs, such as Horizon Europe and EU4Health. See ‘Support for Research’.
EU regulation
Ensuring that the voice of clinicians and researchers is heard in the design, implementation and evaluation of EU legislation is a key activity in the European Affairs realm. Recent examples:
- Implementation of the In Vitro Diagnostic medical devices Regulation (IVDR)
EHA has led the laboratory diagnostic medical community’s involvement in preparations for the implementation of this important new EU legislation. See IVDR page. - Implementation of the Clinical Trials Regulation (CTR)
EHA is leading the cross-disciplinary Coalition for Reducing Bureaucracy in Clinical Trials and will take part in ACT EU, the new collaborative platform for EU regulators and stakeholders aimed at improving and boosting clinical research in the European Union. - Revision of the Blood, Tissues and Cells legislation
As a member of the stakeholder pool for evaluation and revision of the outdated EU legislation on blood and blood components, EHA has advised the European Commission and the national competent authorities throughout the review process. - Revision of the EU pharmaceutical legislation (including the existing legislation on orphan medicines)
In light of its relevance for EHA’s advocacy objectives around affordable and equal access, EHA is actively following and engaging in discussions on the revision of the EU’s pharmaceutical legislation, which also replaces the current regulations on medicines for children and rare diseases. Find all the information on our advocacy priorities and efforts on our EU pharmaceutical legislation page. - EU Health Technology Assessment Regulation (HTAR)
Viewing collaborative, harmonized clinical effectiveness and cost-benefit assessments as an important step towards improving affordable access to innovative therapies, EHA was actively involved in the political negotiations leading up to the adoption of the HTA Regulation and as a member of the EU's official HTA Stakeholder Network continues to be advocate for timely and effective involvement of clinical experts in high-quality joint assessments.