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Harmony - Innovative Medicines Initiative (IMI)

Between 2016–2019, the UNESCO Chair in Bioethics was developing an ethical and legal framework for large-scale European blood cancer project

The Medical University of Vienna was the lead partner in an international Big Data project for promoting the clinical investigation of haematological malignancies. The EU "HARMONY" project (2016–2019) involved 51 partner institutions from eleven countries. MedUni Wien –  the domicile of the UNESCO Chair in Bioethics at the Josephinum – developed ethical and legal guidelines for the handling of sensitive patient information.

The aim of the "HARMONY" project was to process large quantities of existing data from clinical research into haematological cancers (leukaemia, lymphoma, myeloma, etc.), make this data available for secondary use in the field of Big Data analysis and thereby find new approaches for treating blood cancer. The project was financed by the "Innovative Medicines Initiative" (IMI) to the tune of €40 million.

When handling patient data provided by numerous research institutions, it was essential to ensure that patients' rights were being protected and data protection was guaranteed. For example, data may have only been used anonymously or with the consent of the individuals concerned. The “HARMONY" project aimed to create a technical, ethical and legal infrastructure to enable this data to be correctly used in the context of Big Data analysis.

The Josephinum (History of Medicine, Collections and Ethics), home to the UNESCO Chair in Bioethics, was responsible for heading up the "Legal, Ethics and Governance" work package. "As a competence centre in the ethics of medical research, we have taken on the task of developing and shaping this sensitive aspect," explains Christiane Druml, Head of the UNESCO Chair in Bioethics and Director of the Josephinum. MedUni Vienna's industrial partners in the "HARMONY" project were the pharmaceutical companies Bayer and Amgen.

About the Innovative Medicines Initiative (IMI)
IMI is Europe's largest public-private initiative aimed at giving patients access to better and safer drugs more quickly. IMI supports community research projects and relies on networks of experts from industry and the academic world, in order to accelerate pharmaceutical innovation in Europe. IMI is a joint initiative of the European Union and the EFPIA, the "European Federation of Pharmaceutical Industries and Associations."

Workpackage 8 - Ethics, Law, Governance

Christiane Druml

Workpackage leader

Mag. Klaus Wassermann