EHA updates its position on the EU pharmaceutical legislation
The European Union is currently revising its outdated pharmaceutical framework, with a new proposed Directive and Regulation under scrutiny.
EHA ensures that the needs and concerns of the hematology community are heard in this process (see our dedicated webpage on the revision of EU pharmaceutical legislation). To that end, EHA has updated its position on the EU pharmaceutical legislation, reflecting the feedback from EHA members, committees, and key opinion leaders.
The EU’s pharmaceutical legislation is a particularly valuable avenue to improve the availability, accessibility, and affordability of medicines—a core advocacy priority for EHA. Our (updated) position therefore focuses on the following core topics:
- Hospital exemption
- Unmet medical needs (UMN)
- Drug repurposing
- Incentives
- Bolar exemption
- Conflict of interest
- Shortages
EHA has released both a long version and a summarized version.
- EHA's recommendations for the revision of the EU pharmaceutical legislation—full version
- EHA's recommendations for the revision of the EU pharmaceutical legislation—summary
Our key asks
Hospital exemption (HE)
EHA highlights its role as a complement rather than a threat to the commercial pathway, and advocates for a EU-wide harmonised framework. The HE is indispensable for patients with rare conditions and/or in need of personalixed treatment, and we support cross-border exchanges to meet patient needs.
Unmet medical needs (UMN)
EHA asks for a patient-centric and inclusive definition of UMN, encompassing parameters such as quality of life, disease severity and progression, the availability of alternative treatments, and burden of disease.
Funding transparency
EHA strongly supports transparency regarding funding to (1) ensure public investment is worthwhile, (2) improve insight into R&D costs and, consequently (3) improve fairness in pricing discussions.
Drug repurposing
EHA supports this strongly provision and its extension beyond UMN.
Shortages
EHA welcomes the measures proposed to mitigate and prevent shortages, placing more responsibility on marketing authorization holders (MAH). We emphasise that input from health professionals is particularly important.
Incentives
EHA supports a lower baseline protection with conditional increases. EHA also calls for a comprehensive set of measures to encourage pharmaceutical companies to conduct R&D in Europe. EHA warmly welcomes the new provisions on access reporting and the access to medicines notification system.
Bolar exemption
EHA states that this provision is of great importance and cannot be watered down, to ensure that generics and biosimilars can reach the market as soon as possible, creating competition and more affordable prices.
Conflict of interest (CoI)
Declarations regarding financial interests are necessary to enhance transparency and ensure impartiality. However, any implementation of CoI rules must take into account the small expert pool in rare diseases.
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