DIGITALEUROPE contribution to EMA discussion paper on the Secondary Use of Data for Medicines and Public Health Purposes under the GDPR

DIGITALEUROPE represents a variety of industry actors actively involved in the development of medicines and related research.

The complementarity between data protection and innovation is an objective that a correct understanding of the GDPR principles, concepts and rules should always strive to achieve, including in medicine.

We welcome to opportunity to help to determine the upcoming Q&A of the EMA on the GDPR and the Secondary Use of Data for Medicines and Public Health Purposes”.

Clarifying the existing data processing regulatory framework is a key step to build a Common European Health Data Space.

General comments

• We urge the EMA to consider all sources for the secondary use of health data, besides clinical trials. Organisations derive data in scope also from clinical practice, such as from Electronic Health Records (EHRs), claims and registries (as per Figure 2 in the discussion paper). For example, researchers may wish to explore the data from patients admitted to hospitals across Europe with pneumonia symptoms in late 2019, to identify whether 2019-nCoV was present earlier than thought. This would require the secondary processing of patients’ data, in a way that was not foreseen when they were first admitted to the hospital. The EMA should expand on these other data sources in its upcoming Q&A, including by providing practical and industry-specific examples.

• The application of scientific research in accordance with Article 9(2)(j) of the GDPR is especially important for the secondary use of health data. It is a clear example of how to better unlock the potential of health data in the EU and should be given more recognition in upcoming EMA consultation papers.

• It is very important not to mix secondary use of data and compatibility, as this paper seems to suggest. They are two different aspects of the GDPR. Organisations can use data for secondary purposes without them being compatible purposes, provided there is an appropriate legal basis.

Please find our full recommendations in the complete policy paper. Our members stand ready to discuss and share our expertise and experiences.