How the EHDS will improve access to EU health data for pharma

Representing the innovative biopharmaceutical industry in Belgium, pharma.be brings together 130 pharma companies. As part of our series of articles exploring the impact of the forthcoming European Health Data Space (EHDS), we spoke to economic and health data advisor Karen Crabbé about how the regulation will affect the pharma industry.

The access to health data is crucial for the pharma industry. What does the implementation of the European Health Data Space mean to pharma.be’s member companies? 

Karen Crabbé: Data is indeed at the very core of our industry and used at every stage of the development of new medicines and treatments. In addition to the results collected from clinical trials, real-world data from sources such as reimbursement claims, patient-reported outcomes, disease registers and mobile health applications provide crucial information for product development as well as for obtaining the necessary approvals for market launch.

Until now, pharma companies have often had to set up their own systems to collect this data as it was generally not already available. The EHDS could encourage physicians to register more structured data to gain their own insights, which we could then reuse.

What other opportunities will the EHDS bring to the pharma industry?

We anticipate that the EHDS will facilitate our access to the real-world data sources that I just mentioned. They can provide essential information on how treatments are performing in the real life of patients outside the clinical setting. If data from different sources can more easily be linked, we can better understand the health journey of individual patients and analyse why some groups of the population are suffering more from ill health than others. Artificial intelligence (AI)-enhanced tools can quickly spot anomalies and trigger further studies and treatment development.  

How important is the use of AI for this development?

It is essential. Pharma companies increasingly use AI, mainly in the discovery phase of the R&D process, but also to develop AI-powered clinical decision tools for example. By making much larger datasets available, the EHDS will drive the development of AI tools. These tools will become more accurate and useful for healthcare professionals once it becomes easier to use data from multiple sources rather than just a single hospital or company.

By making much larger datasets available, the EHDS will drive the development of AI tools.
Karen Crabbé, pharma.be

This is also a field where there are some interesting synergies between pharma groups and startups. Startups using AI to analyse pharma data can, for instance, discover new molecules targeting diseases that have yet to be treated, much faster than traditional research methods. They are the AI experts, but when it comes time to test these molecules through clinical trials, pharma companies bring their expertise in conducting those trials efficiently. For me, this is an example of collaboration where all partners do what they know best.

Do you think that over time, the pharma industry will focus less on data collection and more on data analysis?

That is possible – but we are not there yet. There will always be a need for collecting new data. Innovative medicines that disrupt healthcare will require the collection and analysis of data that there was no need for before. Nevertheless, the EHDS will hopefully allow the system to adapt more easily and include these new parameters as add-ons. The pharma industry would then just have to pay for the collection of the additional data and the re-use of existing data, needed to answer  specific questions from authorities.

According to the EHDS, data holders such as pharma companies must make a wide range of data available to other players for permitted secondary use. Do you see this requirement as a potential threat to competitiveness in the industry?

It can for sure be an issue, and many US or UK-headquartered pharma companies may not be fully aware of this development yet. However, data holders will be able to indicate which data is sensitive due to intellectual property rights or trade secrets. If their point of view is approved, health data access bodies will reject the parts concerned of access requests.

Do you think this obligation could discourage international pharma companies from conducting R&D in Europe?

I don’t think so. The situation today is more complicated and fragmented than what it will be after the introduction of the EHDS, which doesn’t prevent the pharma industry from being here today. With almost 450 million inhabitants, the EU is an attractive market and data on European patients is required for market entry. In my opinion, the EHDS will improve the situation for real world data-driven studies and treatments.