EFPIA believes that sharing of health data can bring enormous benefits to patients, healthcare professionals, and health systems. Sharing a range of electronic health data types for secondary purposes through the EHDS can boost research and innovation, improve treatments and care for patients, and enhance public health decision-making.

After the adoption of the amended text by the European Parliament’s health and civil liberties committees, EFPIA is concerned about the inclusion of opt out and opt in mechanisms for certain categories of data as this will reduce the amount of data ultimately available within the EHDS.

This becomes even more critical in rare diseases and therefore the overall value to research and development, and decision making. It would undermine one of the primary objectives of EHDS and limit its ability to help advance more personalised and precise medicine.

In order to keep the right balance between the dual private sector role as data user and a holder, clear rules to protect companies’ intangible assets are essential to retaining healthcare innovation.

This is important where data holders have a more active role in the safeguards for the protection of Intellectual Property Rights and Trade Secrets and is similar to what the legislators agreed for the Data Act.

While the text amended by the EP includes provisions on the protection of IP and Trade Secrets, it does not fully address how the existing EU IP framework will coexist with the future EHDS framework and the specific types of data in scope.

It also shifts the responsibility to Health Data Access Bodies to preserve the data holder’s trade secrets.

This could create bottlenecks in the system as such an assessment requires technical, scientific, commercial, or economic expertise to evaluate whether data constitutes a Trade Secret. 

EFPIA would welcome continued collaboration with the Commission and national authorities to further define the respective rules based on already existing and well-functioning practices. 

With regards to data categories listed for secondary access and sharing, we believe further work is still needed to define very clearly what is meant by each data type and definition, and the intended scope.

We look forward to working with stakeholders to address this in future guidance to ensure all stakeholders have clarity.

We are pleased to  see greater effort to align with provisions of existing legalisation such as the GDPR.

We would encourage further discussion on providing more clarity on international data transfer and implication of data storage requirement in the context of scientific research, conduct of clinical trials and international cooperation.

We would also welcome the opportunity to participate in the EHDS Board and yet-to-be-created advisory forum to establish a fit for purpose, future proof and workable ecosystem for health data access and sharing.