"Data is the heart of our industry": pharmacists on the future with EHDS

The new EU regulation creating the European Health Data Shared Space (EHDS) could transform the pharmaceutical industry. According to Karen Crabbé, Economic and Health Data Advisor at pharma.be, this is a major shift: data that previously had to be collected manually or built in-house can now be made available in a centralised and structured way.

Until now, pharma companies have had to build their own data collection infrastructures: clinical trials, patient questionnaires, mobile apps, insurance registries. The EHDS will open up access to these sources and encourage doctors to structure their records - which in turn will create a richer and more reanalysable database.

Particular attention is paid to so-called real-world data - data obtained outside the clinical trial setting, in the ordinary lives of patients. These data are important both for improving existing treatments and for identifying differences between patient groups.

Pharmaceutical companies are already using artificial intelligence at R&D stages: from searching for new molecules to creating diagnostic assistants for doctors. With the introduction of EHDS, the volume of available data will increase many times over - and this will accelerate the development of AI tools. This is especially relevant for collaborations between large pharma brands and startups: the former provide resources and infrastructure for clinical trials, while the latter provide flexibility and know-how in analysing large data sets.

Will the industry, over time, collect less and analyse more? Perhaps, but not immediately. The introduction of fundamentally new drugs requires new types of data that do not yet exist. However, EHDS is creating a flexible framework that can adapt to these needs: pharma companies will only have to pay for the additional information they need and use what they already have.

The EHDS obliges 'data holders', including pharma companies, to share data for secondary use. This could raise questions about intellectual property protection. However, as Crabbe emphasises, companies will be able to specify which data is sensitive - such blocks of information will not be disclosed if the request is approved.