The EHDS won’t only change how patients, doctors, researchers and policymakers access and use health data; it’s also hoped that the plan will lead to billions in economic gains for European life sciences.
On 3 May 2022, the European Commission released a proposal for a Regulation introducing the European Health Data Space (EHDS). EUCOPE welcomes the proposal and it recognises the importance of EU-level data collection standards and the promotion of data interoperability and exchange protocols.
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 be facing by the current EHDS proposal.
International exchange of health data
First and foremost, for the EHDS to fully achieve its goal, it is imperative that it enables the cross-border transfer and exchange of healthcare data for research purposes, both in the EU and US. However, the EHDS does not prioritise or even address a need to ensure global exchange of data. This may discourage greater US scientific R&D endeavours 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 affect early-stage R&D efforts. Collectively these restrictions may delay R&D.
Product development timeframes may frustrate the ability for 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.
Relation between EHDS and GDPR Regulation
The ability to access and transfer of health data to optimise patient care and drive cutting-edge biomedical research is being formed in an increasingly complex EU legislative landscape. The fragmented landscape caused by different interpretations and implementation of General Data Protection Regulation (GDPR) by Member States is causing (legal) uncertainties that create barriers to the secondary use of electronic health data.
The major barriers for organisations in 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. It is an area that is primarily delegated to individual member states to determine. Thus, we currently have a patchwork of implementing legislation on how health data can be lawfully processed and shared within these member states which significantly diverges from country to country. Without addressing this fundamental issue, the GDPR will potentially continue to create barriers to 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 for a more interoperable, patient-centric framework that is committed to driving biomedical R&D.
International Data Transfers
The current EHDS proposal could impede the global exchange of data needed 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 that is 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 that the global biomedical community faces with respect to the lack of harmonised 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.
Impact of data flow restrictions
Small and mid-sized companies, and researchers in the EU will be impacted by the lack of clear measures that enable global transfers of health data to enable life science research. Smaller European companies that are lacking a harmonised approach in the EU, with respect to international data transfers, may have significant expenditures as they conduct assessment on 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 comes along with engaging with global R&D programs due to the restrictions on data flows could deter scientific investment in the EU and frustrate the EU’s ambitions to be a leading player in life sciences.
Global Society Depends on Life Science Innovation
Not only do uncertainties around the ability to transfer data abroad potentially harm smaller European-based biotech companies but, fundamentally, they do a disservice to the increasingly globalised and inter-connected world of science.
Global society depends on innovation in life sciences, especially the critical collaborations with European scientists and partners, to solve some of the most pressing concerns facing humanity – the current COVID-19 pandemic is a good example. Strengthening scientific cooperation between the EU and the global biotech community should be a priority and can be incentivised appropriately through an EHDS framework without impinging on the legitimate protections of EU citizens’ privacy rights.
Quality Data for R&D, Digital Standards, Pseudonymisation and Anonymisation
It is still unclear how data in the context of international transfers is pseudonymised or anonymised. The EHDS still has an unclear framework of standard-setting rule-based processes that clearly define how data is made identifiable, pseudonymised or anonymized. Clear guidance on rules and standards on this question would allow for data partners both in Europe and the US to efficiently collaborate and participate in the EHDS framework 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. Underpinning the ability for companies and research institutions to partner on shared objectives and cutting-edge research projects is a predictable and sound Intellectual Property (IP) framework. 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, Articles 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 that 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.