On October 20, the European Hematology Association (EHA) joined a group of 29 stakeholders in welcoming the European Commission’s proposal on the European Health Data Space.

The speakers of the HTA conference hosted by the European Commission.

On April 1, the European Commission approved funding for the TOLERATE training network, proposed by a KU Leuven-led consortium including EHA.

Drug repurposing (finding new indications for existing authorized medicines) is increasingly prominent in the debate about improving access to medicines.

Introduction Spurred by COVID-19 and rising challenges to the financial sustainability of Europe’s health systems, a flurry of new EU policies and programs in health has sprung up since last year.…

Spurred by COVID-19 and rising challenges to the financial sustainability of Europe’s health systems, a flurry of new EU policies and programs in health has sprung up since last year. Some of the most eye-catching initiatives are highly relevant for hematology: the Europe’s Beating Cancer Plan, the Pharmaceutical Strategy and the European Health Data Space.

The European Hematology Association (EHA) has joined the European Cancer Organisation, a not-for-profit federation of organizations working in cancer at the European level. EHA’s membership application was approved by the General Assembly of the European Cancer Organisation on November 18, 2020.

EPHA published a position paper on medicine shortages in Europe. EHA welcomes its  recommendations to address the increasing shortages crisis, which threatens patient outcomes and patient safety.

Advanced therapy medicinal products (ATMPs) are a game changer for improving the lives of patients with severe to life-threatening diseases. Yet, despite fast-paced innovation in the field, few ATMPs have reached the EU market and benefited patients. The challenges facing their adoption by health systems are complex. A test case is the uptake of CAR T-cell therapy; what are the hurdles and what action is needed from stakeholders?

While health policy remains the primary responsibility of Member States, in many areas the added value of EU-level collaboration and harmonization has increased. EU initiatives in health have shown a mixed record in terms of impact, but hopes are high for the latest one, the ambitious Europe’s Beating Cancer Plan.

Clinical trials and drug development have become more complex over the years. One complicating factor is the increased administrative burden, as was pointed out in the previous edition of HemAffairs. Doctors and clinical researchers are more and more bound to rules they deem neither necessary nor effective. At first sight, the requirements for clinical trials seem clear and thorough. Nonetheless, the interpretation and implementation of these rules leave room for improvement.

Blood, tissues and cells (BTC) are used in medicine and in hematology on a daily basis. EU legislation has been in place for over 15 years to regulate those practices, and to ensure safety and quality standards for substances of human origin (SoHO). For instance, through technical and traceability requirements for BTC, the reporting of serious adverse reactions (SARs), and verification procedures for imported BTC.

To solicit input from a wide range of non-ICH members about the revision of ICH E8(R1), ICH held a Public Meeting on ICH E8(R1) “General Considerations for Clinical Studies” (Silver Spring, USA, October 31, 2019).

On September 24, Prof Ulrich Jäger, former EHA President and current member of the EHA European Affairs Committee, was elected as co-chair of the Health Care Professionals Working Party (HCPWP) of the European Medicines Agency (EMA). He will lead the working party during its 2019-2022 mandate alongside Juan Garcia-Burgos, EMA’s head of Public Engagement.

There have been many developments on rare diseases since the EU Orphan Medicinal Products Regulation came into force in 2000. As the European Commission is evaluating its effectiveness, EHA discussed with Prof. Giampaolo Merlini, Director of the Amyloidosis Research and Treatment Center and researcher at the Department of Molecular Medicine of the University of Pavia, how far we have come and what still needs to be done to improve access to treatment for rare diseases.