Sunday, February 9, 2025

EFPIA’s Position on the Regulation on the European Health Data Space

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The European Federation of Pharmaceutical Industries and Associations (EFPIA) acknowledges the final agreement on the European Health Data Space (EHDS) Regulation as a pivotal moment in health data sharing across Europe. This regulation promises long-term benefits for patients, healthcare professionals, public and private health researchers, and health systems as a whole. Health data is a crucial catalyst for driving the discovery of innovative therapies, particularly in areas where therapeutic options are currently non-existent or unsatisfactory. Therefore, access to health data is vital for facilitating research and improving patient outcomes.

The EHDS will necessitate unprecedented collaboration between the public and private sectors. EFPIA looks forward to working with EU institutions and Member States to address critical aspects requiring further clarification during the implementation phase. EFPIA is committed to resolving several key issues that need particular attention.

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Key Concerns and Recommendations

One of the primary concerns is the unclear definition of data sets in scope for secondary use. The broadly defined data sets could lead to confusion for data holders in assessing which sets are shareable and which are not. This confusion may be compounded by the fact that each data holder may interpret the definitions differently. There is an urgent need for agreed vocabulary and definitions for these data sets to prevent inconsistencies and ensure clarity.

Additionally, the absence of a provision on the territorial scope of the EHDS raises complex legal and operational issues for companies operating globally. It is crucial to clarify that the Regulation does not apply to sponsors or data controllers established outside of the EU and to delineate how it applies to entities in the EU processing data of subjects outside the EU.

Intellectual Property Protection

The terms for sharing IP-protected data under the EHDS may reduce Europe’s attractiveness for health research. Specific knowledge and expertise are necessary to assess the economic impact and serious economic risk of sharing a dataset containing IP rights, including trade secrets. Despite the expectation that Health Data Access Bodies (HDAB) will build the necessary knowledge over time, only the data holder can fully understand the economic impact on a case-by-case basis. Industry proposals included a final right of refusal to share data, similar to provisions in the Data Act, which should be considered to protect the economic interests of data holders.

The creation of an opt-out mechanism for patients could diminish data diversity for medical research. It is critical that patients understand the implications of opting out, including the risk of fragmentation in data availability and bias in future healthcare research. While the agreed text allows Member States to provide their own opt-out mechanisms, standardization and harmonization should be key considerations to prevent complications in navigating varying systems across different Member States.

Addressing International Data Transfers

Conditions for international transfer of data under the EHDS create ambiguity. Provisions allowing Member States to introduce further conditions for international access and transfer of personal health data may lead to fragmentation, contradicting the drive for harmonization of the European health data ecosystem. These provisions could create further ambiguity in an already complex data environment and hinder the free movement of electronic health data.

EFPIA members have extensive experience and knowledge in generating and sharing health data. They commit to contributing this expertise to the timely development and adoption of secondary legislation, providing greater legal certainty on key provisions, and guiding harmonized implementation. It will require the collaborative efforts of all stakeholders to realize the full potential of the EHDS.

EPFIA

Conclusion: A Collaborative Path Forward

EFPIA recognizes the importance of the EHDS and is eager to participate actively in the EHDS ecosystem. The research-based industry plays a crucial role in building a well-functioning data and digital ecosystem and should be included in pilot projects and the broader implementation phase. Clear and applicable measures are essential for ensuring the effectiveness and inclusivity of the EHDS, enabling the industry to contribute fully to its success and advancement.

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Looking ahead, EFPIA emphasizes the need for data holders to remain involved at all stages of the decision-making process. Data holders should retain control over their intellectual property and have the right to refuse access to data if it could jeopardize their IP rights or trade secrets. Furthermore, EFPIA calls for clarity on anonymization requirements and the need for standardized data formats to facilitate data sharing and research.

By working together with the European Commission, Member States, and responsible authorities, EFPIA aims to ensure that the EHDS achieves its objectives of making European health systems more efficient, contributing to better health outcomes, and strengthening public health, research, and innovation activities in the EU.

 

Resource: European Federation of Pharmaceutical Industries and Associations, July 24, 2024

 


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