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The European Health Data Space (EHDS) will change how patients, doctors, researchers, and policymakers access and use health data, and also affect companies operating in – or about to enter – the EU, writes Leander Vranken, Digital Health Policy Officer at the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE).
On May 3, 2022, the European Commission released a proposal for a regulation introducing the European Health Data Space (EHDS).
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) welcomes the proposal and recognizes the importance of EU-level data collection standards and the promotion of data interoperability and exchange protocols.
However, given the lengthy history and importance of trans-Atlantic collaborations in the area of life sciences, it is important to review some of the challenges that small and mid-sized companies in both Europe and the United States could face with the current EHDS proposal.
The European Health Data Space (EHDS) and the international exchange of health data
First and foremost, for the EHDS to fully achieve its goal, it is imperative it enables the cross-border transfer and exchange of health care data for research purposes, both in the EU and US.
However, the EHDS does not prioritize or even address the need to ensure the global exchange of data. This may discourage greater US scientific R&D endeavors or investment in the EU.
In addition, limitations on the transfer of personal data for health research purposes from countries in the EU to countries outside the EU affect early-stage R&D efforts. Collectively, these restrictions may delay R&D.
Product development timeframes may frustrate the ability of treatments to effectively reach patients in need and create challenges to obtaining meaningful pharmacovigilance and patient safety data. This may compromise a company’s ability to meet global medical safety reporting requirements.
The relationship between EHDS and GDPR
The ability to access and transfer health data to optimize patient care and drive cutting-edge biomedical research is being crafted in an increasingly complex EU legislative landscape. The fragmented landscape is caused by different interpretations and implementation of the General Data Protection Regulation (GDPR) by member states, thus causing (legal) uncertainties that create barriers to the secondary use of electronic health data.
The major barriers for organizations when it comes to sharing health data are the additional conditions that apply under Article 9 of the GDPR Regulation.
Article 9 of GDPR must be satisfied in order to process special categories of personal data, such as health data. This is primarily delegated to individual member states to determine. As a result, we currently have a patchwork of implementing legislation on how health data can be lawfully processed and shared within these member states, with significant differences from country to country.
Without addressing this fundamental issue, the GDPR will potentially continue to create barriers to the secondary use of data for both EU and US companies.
This disharmony is hampering the cross-border exchange of data both within and outside the EU. Achieving greater harmonization across this interrelated legal and regulatory landscape would help the EHDS legislation realize its goal of a more interoperable, patient-centric framework committed to driving biomedical R&D.
Listen to EUCOPE’s recent Sounds of Science podcast episode on the EHDS legislation:
What EHDS means for international data transfers
The current EHDS proposal could impede the global exchange of data for R&D because of the risk of re-identification upon transfer to a third country, such as the United States.
For example, Article 61 creates uncertainty with respect to certain types of data deemed highly sensitive under Article 5(13) of the Data Governance Act. This non-personal data is regarded to be highly sensitive and critical to R&D efforts. The global scientific community requires additional clarity on the objective criteria defining the types of supplemental protection measures.
In addition, Article 63 could further exacerbate the challenges the global biomedical community faces with respect to the lack of a harmonized approach to the implementation of GDPR. This creates a wide policy space for member states to unilaterally—and without justification—block international transfers of personal data on an ad-hoc basis.
The impact of data flow restrictions
Small and mid-sized companies, as well as researchers in the EU, will be impacted by the lack of clear measures enabling global transfers of health data for life science research. Smaller European companies, lacking a harmonized approach in the EU with respect to international data transfers, may have significant expenditures as they assess transfers abroad on a case-by-case basis. This is a significant logistical undertaking, which puts European small and mid-sized biotech firms at a competitive disadvantage globally.
The uncertainties and complexities that come with restrictions on data flows could deter scientific investment in the EU and frustrate the EU’s ambitions to be a leading player in the life sciences.
Not only do uncertainties around the ability to transfer data abroad potentially harm smaller European-based biotech companies, but they also do a disservice to the increasingly globalized and interconnected world of science.
Global society depends on innovation in life sciences—especially the critical collaborations between European scientists and partners—to solve some of the most pressing concerns facing humanity. The COVID-19 pandemic is a good example.
Strengthening scientific cooperation between the EU and the global biotech community should be a priority. It can be incentivized appropriately through an EHDS framework without impinging on the legitimate protections of EU citizens’ privacy rights.
Quality data for R&D, digital standards, pseudonymization, and anonymization
It is still unclear how data in the context of international transfers is pseudonymized or anonymized. Currently, the EHDS framework does not clearly define how data is made identifiable, pseudonymized, or anonymized.
Clear guidance on rules and standards regarding this question would allow for data partners both in Europe and in the US to participate in the EHDS framework, collaborate, and innovate.
IP considerations and incentives for data curation
The highly collaborative and globalized nature of the biomedical research space is a hallmark of the innovative biotech sector.
A predictable and sound intellectual property (IP) framework is what underpins the ability of companies and research institutions to partner on shared objectives and cutting-edge research projects. Preserving a strong IP system should therefore be a priority of the EHDS.
However, the provisions on the compelled disclosure of proprietary information—in Paragraph 40 of the Whereas clauses, Article 33 (paragraph 4), Article 34 (paragraph 40), and Article 46 (paragraph 11)—still present significant concern about the potential to undermine private sector IP protections.
Research partners in both the EU and US need to be able to share confidential commercial information over the course of the R&D process in a reliable and secure fashion. For instance, confidential commercial information is often developed and used by real-world data providers to generate real-world evidence that supports regulatory decision-making is a highly technical process that takes many years. The EHDS framework should provide safeguards to protect the forced disclosure of proprietary information and confidential datasets, and should recognize and reinforce the crucial role IP protections play in driving biomedical innovation.
Recognizing and respecting the values of privacy, security, and safety, EUCOPE strongly encourages the Health Data Space to establish an enabling environment for global data flows, as well.
We encourage the creation of a research-friendly EHDS that enables innovation and strengthens scientific collaborations with researchers around the world.
Since 2008, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has been the voice of small to mid-sized health technology companies in Europe. Representing 2600+ innovative biopharmaceutical companies directly or through national associations, EUCOPE advocates for sound public policy that supports innovation, while fostering a community built on a shared purpose: improving and saving the lives of European patients through ground-breaking therapies and medical technology. Learn more at www.eucope.org.
Check out EUCOPE’s latest podcast episode exploring the European Health Data Space (EHDS):
