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 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.
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’.
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As a member of the stakeholder pool for evaluation and revision of the outdated EU legislation on blood and blood components, EHA has advised the European Commission and the national competent authorities throughout the review process.
- Review of the EU Pharmaceutical Legislation and the Orphan Regulation
Highly relevant for EHA’s advocacy objectives around affordable and equal access, EHA is engaging in discussions on the EU’s Pharmaceutical Strategy and the revision of the multiple sets of EU directives and regulations that make up the EU pharmaceutical legislation, including the for hematology important Orphan Regulation.
- 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.
The Madrid Declaration - EHA and National Societies call for increased training requirements across the EU
Launched at EHA22 in Madrid (June 2017), the Madrid Declaration on enhanced training requirements for hematologists in the Professional Qualifications Directive has been co-signed by 26 out of 28 national hematology societies in EU Member States, and is supported by the Haematology Nurses & Healthcare Professionals Group (HNHCP) and nearly a dozen patient organizations. Read more.
EHA Roadmap for European Hematology Research
The European Hematology Association Roadmap for European Hematology Research: A Consensus Document (also called the Research Roadmap) summarizes the current status of basic, translational and clinical hematology research and identifies areas of unmet scientific and medical need in Europe. It provides guidance for European and national policy makers, funding agencies, charities, research institutes and researchers when they make decisions on initiating or funding research and developing research programs.
Authored by experts from all fields of hematology, the Research Roadmap was published in the February 2016 issue of Haematologica.
The Cost of Blood Disorders
Two studies funded by EHA and published in the medical journal Lancet Haematology by a team of researchers from Oxford University and King’s College found that the economic burden of blood disorders (malignant and non-malignant) across the European Union, Iceland, Norway and Switzerland amounts to €23 billion per year.
The need for more research funding, for speeding up the development of innovative treatments, and for increasing the availability and affordability of treatments is at the basis of much of EHA’s advocacy work.