Finalizing the European Health Data Space

In May 2022, the European Commission (EC) proposed the introduction of a European Health Data Space (EHDS) to improve health democratization in Europe and develop a national infrastructure for health data management, exchange, and sharing (1). Creating a common EHDS was one of the priorities of the EC during 2019–2025, and the proposal builds on the European digital strategy for data, COM(2020) 66 (2), and enables the EC to meet its goals to improve public health, reduce health inequalities, and move towards a more social Europe (3).

EHDS seeks to streamline data access and sharing in the EU

On 13 Dec. 2023, the European Parliament (EP) adopted its position on creating EHDS with 516 votes in favour, 95 against, and 20 abstentions (4). Each country would establish national health data access services based on the MyHealth@EU platform. The law would also set out rules on the quality and security of data for providers of Electronic Health Records (EHR) systems in the European Union, to be monitored by national market surveillance authorities (4). Health data, including EHRs, electronic prescriptions, laboratory results, hospital discharge reports, and patient summaries, would be made available in a common format that could be shared with healthcare professionals and the patient both within and between European countries (5).

The EHDS seeks to address health-specific challenges regarding data access and sharing, which include:

• creating rules for making EHR systems available on the EU market
• empowering patients with new rights to control their electronic health data in the context of healthcare
• establishing mandatory cross-border infrastructure enabling the use of electronic health data across the EU for the primary use purpose of providing health services

• introducing obligations on ‘data holders’ to make electronic health data available to third parties, including public sector bodies, for ‘secondary use’, and set out rules and mechanisms to support this (5).

According to the EC, “Citizens should be empowered to make better decisions based on insights gleaned from non-personal data. And that data should be available to all—whether public or private, big or small, start-up or giant. This will help society to get the most out of innovation and competition and ensure that everyone benefits from a digital dividend” (2).

Implication of the EHDS on the pharma industry

The EHDS would enable pharma to gain access to a broader pool of quality data for R&D purposes (5). It should also help to standardize data and would mean that, within the EU, pharma companies would only have to comply with a single set of rules regarding data usage and privacy rather than dealing with multiple sets of regulations. This is important as the current General Data Protection Regulation (GDPR) is unevenly applied and open to interpretation within member states and has created uncertainty and challenges around access and resulted in barriers to the “secondary use of electronic health data” (6).

One key feature of the EHDS that could have a far-reaching impact on the pharmaceutical sector is the proposal to expand the availability of electronic health data for secondary use, such as R&D activities (6). “Data holders”, which include the pharmaceutical, healthcare, and MedTech sectors, may be compelled to allow access to certain categories of data (e.g., health registries and clinical trials). However, access to these data would only be granted where the intended purpose for processing satisfies Article 34(1) of the Proposal, which includes the following criteria:

• activities relating to public interest, development, and innovation activities in/contributing to the area of public and occupational health
• educational, teaching activities, and scientific research related to health or the care sector
• providing personalized healthcare consisting in assessing, maintaining, or restoring the state of health of individuals
• ensuring high levels of quality and safety of health care, medicinal products, or devices
• testing, training, and evaluating algorithms, including artificial intelligence (AI) systems, digital health applications, and medical devices, contributing to public health or social security (7).

Secondary use of health data would require the data “re-user” to submit an access application, which would then be assessed and permission granted by the competent Health Data Access Bodies (HDAB). Any fees charged by the data holder would have to be transparent, proportionate, and “must not restrict competition.” Where access to data is granted, it must be transferred in an anonymized format unless the applicant’s purpose cannot be achieved by processing anonymized data, in which case pseudonymized data may be provided (7).

The lack of clarity over the protection of data that pharma generates has caused significant uncertainty and is an area that will need to be addressed to ensure the EHDS does not stifle innovation and investment in medical research (6).

EFPIA’s stance on the EHDS proposal

In September 2023, the European Federation of Pharmaceutical Industries and Associations (EFPIA) participated in a multi-stakeholder group including patient organizations, industry associations, and EU officials, to discuss the EHDS (8). This followed from a previous meeting in June 2023 where they discussed concerns over an opt-out mechanism that could impact the secondary use of electronic data (9).

In December 2023, EFPIA responded to the EP’s adoption of the EHDS and stated that it “believes that sharing of health data can bring enormous benefits to patients, healthcare professionals, and health systems.” However, “it is concerned about the inclusion of opt-out and opt-in mechanisms or certain categories of data as this will reduce the amount of data ultimately available within the EHDS” (10).

EFPIA is particularly concerned about the impact of EHDS in rare disease R&D where data are scarce and it could further limit the development of personalized/precision medicines. EFPIA would like further clarification and clearer rulings on how the private sector’s intangible assets will be protected. Although the EP has amended the EDHS to include provisions on the protection of intellectual property (IP), it does not fully address how the EU IP framework will coexist with the future EHDS framework and it shifts the responsibility of HDAB to preserve the data holder’s trade secrets, which could cause bottlenecks in the system (10).

Next step

The EP is now ready to start negotiations with the governments of EU member states on the final form of the law (1). Meanwhile, EFPIA is keen to work with stakeholders to clearly define the respective rules around the protection of IP rights and Trade Secrets and what is meant by each data type and definitions currently listed for secondary access (10). Further negotiation will be essential to get the balance right and establish a fit-for-purpose, workable ecosystem for health data access and sharing for the future.

References

1. European Parliament News. EU Health Data Space: Access to Your Health Data Across the EU. Europarl.europa.eu, 13 Dec. 2023.
2. EC. COM/2020/66 A European Strategy for Data. Communication Document, 19 Jan. 2020.
3. European Parliament News. Improving Public Health: EU Measures Explained. Europarl.europa.eu, 10 Oct. 2022.
4. European Parliament News. EP Supports Creating EU Health Data Space to Boost Access to Data and Research. Europarl.europa.eu, 13 Dec. 2023.
5. Vettorazzi, S. Establishing the European Health Data Space. Initial Appraisal of a European Commission Impact Assessment. European Parliament Briefing, January 2023.
6. McFadyen, A. What the European Health Data Space Means for Pharmaceutical Companies. Pinsent Masons, Out-Law Analysis, 30 Sept. 2022.
7. EC. COM/2022/197 Proposal for a Regulation of the European Parliament and of the Council on the European Health Data Space. 3 May 2022.
8. EFPIA. EFPIA attends meeting to discuss opt-out requirements in EHDS. Press Release, 6 Sept. 2023.
9. EFPIA. Joint Statement: Health Organisations Define EHDS’ Opt-out Required for Life-Saving Research. Press Release, 6 June 2023.
10. EFPIA. EFPIA Response to EHDS Report Adopted by ENVI/LIBE Committee in the European Parliament. Press Release, 1 Dec. 2023.

About the author

Cheryl Barton is director at PharmaVision, Pharmavision.co.uk.

Article details

Pharmaceutical Technology Europe
Vol. 36, No. 1
January 2024
Pages: 8–9

Citation

When referring to this article, please cite it as Barton, C. Finalizing the European Health Data Space. Pharmaceutical Technology Europe, 2024, 36 (1), 8–9.