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 new EU Regulation on in vitro diagnostic medical devices (IVDR) will come into full effect per May 26, 2022 and will have substantial consequences for diagnostic laboratories.

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.

Medical societies and patient advocates across disciplines have joined forces with EHA to call for urgent action to make clinical trials less bureaucratic and more patient-centered, efficient and cheaper.

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.

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.

EHA has recently brought key stakeholders around the table to discuss bureaucratic obstacles in clinical research. Regulators, patient organizations, the European Commission and industry representatives were invited for a day-long discussion at EHA offices, building on an informal dialogue with the European Medicines Agency (EMA) that had been initiated by a group of prominent clinical researchers.

In recent weeks, two Calls for proposals were published that offer relevant funding opportunities for hematologists: IMI2 – 18^th Call for proposals, a jointly funded partnership between the European Union, and Horizon 2020 – Call for cancer research proposals, call for research proposals in the category ‘Societal Challenge 1 (SC1): Health, demographic change and wellbeing’. . 

In 2014 the European Parliament approved the Clinical Trials Regulation (CTR) that is supposed to replace the Clinical Trials Directive (CTD) from 2001. Five years later, the regulation has not yet become applicable. What is the aim of the ‘new’ regulation, what issues does it address, and why was its application delayed?

2019 will see significant changes within the European institutions. The first already took place in late May, as 50% of EU citizens – the highest turnout since 1994 – went to the ballot box to elect their Members of the European Parliament (MEPs). The result: Confirmation that nationalism and Euroscepticism are on the rise, and a set-back of center political parties.

Patient-centric treatments such as gene and cell therapies have been a game-changer in tackling hematological disorders. Nonetheless, their development remains slow and erratic, limiting benefit for patients.

Learning how to recognize and treat a disease that is relatively new to many parts of Europe, and spreading, is crucial to limit, if not avoid, irreversible impact and provide proper care to patients.

Gathering clinical, genetic and molecular information into a single database: this is the challenge taken on by the HARMONY Alliance. By bringing together data currently scattered across different clinical trial databases and registries, the HARMONY Alliance is harnessing the enormous potential of Big Data and Big Data analytics to deliver insights that will help improve the care of blood cancer patients.

Joint Actions are projects designed and financed by Member State Authorities and the EU to address specific priorities under the EU Health Program.

EHA welcomes initiatives but calls for more focus on causes

Medicine shortages have a negative impact on the quality and cost of treatments and on patient access to the best possible care. EHA has helped flag the problem with policymakers and regulators, but lack of data and understanding of the causes make it notoriously difficult to tackle.