Amidst a wave of regulatory changes in the European Union (EU) that are underway, the new EU Health Data Space (EHDS) Regulation is anticipated to smoothen data transfer in the pharmaceutical industry starting this month.
The European Commission (EC) first proposed the EHDS regulation in March 2024, followed quickly by an approval from European parliament in April. The regulation was adopted on 5 March this year, and will be enforced by individual member states today, on 26 March. The new regulation should “generate €11 billion in savings over the next decade by enhancing data accessibility” and “healthcare service efficiency across EU member states”, says the European Commission on its website.
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In the last few years, the EC has worked to revamp its regulatory landscape introducing new policies like the European Pharmaceutical legislation, EU HTA harmonisation and the EU Critical Medicines Act. These regulations are part of a larger plan to “harmonise” healthcare regulations amongst EU member states to improve outcomes for businesses and individuals alike, says Gunnar Sachs, a partner at the British multinational law firm Clifford Chance, specialising in intellectual property law and the healthcare sector.
The different policy changes have garnered mixed reactions. In July 2024, the European Federation of Pharmaceutical Industries and Associations (EFPIA) raised concerns about the integrity of the industry’s intellectual property (IP) under the new EHDS and requested further information on opt-out clauses for the new regulation. However, following initial critique, the organisation affirmed its support for the regulation in January 2025, saying that the policy is “a significant step forward in leveraging health data to advance research, innovation, and healthcare delivery across the EU”. In an exclusive interview with Pharmaceutical Technology, Sachs discussed the implications of the new regulation and its potential impact on the pharmaceutical industry.
This interview has been edited for length and clarity.
Akosua Mireku [AM]: Why did European legislators feel the need to create this new legislation?
Gunnar Sachs [GS]: The biggest challenge with handling personal health data in Europe was that we had a very heterogeneous and diverse, non-harmonised, patchwork of European multinational and federal laws and regulations across all member states, which hindered innovative use of health data in the past… Whenever industry stakeholders, public policy makers, governments, authorities, R&D organisations, or contract manufacturers wanted to use personal health data there were only limited mechanisms to access it under the EU General Data Protection Regulation (GDPR), namely either through patient consent, or on the basis of a “research privilege”. The former meant that the relevant data processor had to acquire express and informed consent from the patient regarding the specific use of their personal health data. As to the second, the EU member states individually defined their regulations for “research privileges”. But, this meant that there was no complete harmonisation across the EU, so legislators thought it might be appropriate to set up a fully harmonised EU framework for the use of personal health data. Thus, EC came up with the first proposal for the EHDS in May 2022. This was inspired by some more historic EU approaches, such as a 2019 EC directive that proposed the sharing of personal data in the orphan drugs space.
AM: What are the most relevant objectives of the new regulation for pharma companies and how will they be enforced?
GS: The regulation sets up clear, harmonised rules for the primary and secondary use of health data. It also enhances a fully harmonised single market across all EU member states for digital health products and services. That is also the reason why this approach has been adopted via a regulation and not as a directive.
As per the EHDS “primary use” approach, all EU patients will be entitled to direct access to their personal health data, labelled as electronic health records (EHR), under the new regulation across the European Union. This system assumes that every patient has given consent to the related data processing and that consent can be withdrawn at any time through an opt-out mechanism, which depends on a member state implementing the opt-out solution.
As per the secondary use approach, once health data has been uploaded to the EHDS, selected industry stakeholders, contract manufacturing organisations (CMOs), governments, authorities, research and development organisations can apply for data access in one or more EU member states under secondary use. Once access is granted, they can look into this data in a secure data processing environment, and use key findings from it for their research purposes. If patients are not willing to make their data accessible for this purpose, they can apply to withdraw consent.
The EC has also set up a dedicated governance structure for the EHDS, laying down minimum standards for data quality and interoperability. Furthermore, newly developed EHR systems now need to go through a certification procedure and must be formally approved. For example, this applies to medical devices under the EU Medical Device Regulation (MDR). We already have dedicated electronic cross-border health services in place for two systems: e-prescription and e-dispensation of medicinal products, and electronic patient summaries.
AM: How has the industry reception been to this new regulation?
GS: The industry is very much looking forward to this new approach. Typically, you have to invest millions of dollars to bring a new active pharmaceutical ingredient (API) to the market, and a typical R&D lifecycle is extensive and risky. The EHDS will allow these companies to access more health data at earlier stages, potentially reducing investment costs. For example, artificial intelligence (AI) can be used on large EHR datasets to understand how certain APIs might work in specific patient populations. If the EHR system does not have data on one specific API yet, it may have data on some ingredients, or on side effects of specific ingredients, which is extremely helpful. Therefore, most of the industry stakeholders, are looking at it in a very positive way. Clinical results and trial findings can remain trade secrets, so intellectual property (IP) should remain safe.
AM: What impact could data sharing through the EHDS have on the EU pharmaceutical market and could this be something regulators in other geographies adopt?
GS: The EHDS is really a unique selling point for Europe. The EU has over 448 million citizens with personal EHRs. This is a huge asset, and it’s not only logical from the point of view of a legislator, but also from that of the healthcare industry and health insurers to the personal health data available and accessible to all relevant stakeholders. This advantage is only really available for geographies that have access to bigger populations of patients like in the EU, US, China or Russia.
The UK has discussed data sharing in the past, but this may be less advantageous due to the country’s limited dataset. It is better than nothing, but it is not comparable to the huge EU dataset at hand. Also, larger datasets will be better at training AI to predict different outcomes. The larger the relevant datasets, the better the outcome of R&D or AI training with such data.
