On 31 January 2024 the European Federation of Pharmaceutical Industries and Associations (EFPIA) published its considerations for the ongoing trilogue discussions on the EHDS. The document follows an outline of recommendations for multiple aspects such as Data sharing and Intellectual property & trade secrets.
As trilogue negotiations move forward, it is essential, that a balanced compromise can be found. The compromise should aim at enhancing data-sharing mechanisms while preserving a competitive European innovation ecosystem and safeguarding individuals’ rights to control health-related data. Additionally, EFPIA lists several aspects that are fundamental to the success of the proposal, including some considerations to prevent unintended consequences and maintain the competitiveness of EU businesses globally.
In terms of “Data sharing obligations and secondary use”, the EFPIA welcomed the amendment aligning clinical trial data sharing with existing legislation for legal clarity. Nonetheless, they expressed concerns over the remaining uncertainty stemming from broadly defined concepts and terminologies related to other health data in scope for secondary use. Additionally, raised concerns about the broad disclosure requirements for non-clinical research data, potentially hindering investment in early research in Europe (Article 33 of the EHDS) were discussed. The EFPIA is calling for provisions in primary legislation or subsequent implementing acts that will clarify the specifics of data sharing for secondary use, to protect EU citizens from being left out of innovative healthcare research.
The current proposal raises concerns regarding “Intellectual property and trade secrets”. Assigning Health Data Access Bodies (HDAB) the role of gatekeeper for assessing commercially confidential information lacks the tangible protections seen in the already finalized Data Act. To address this, the EHDS should incorporate recognized principles, ensuring data holders retain a crucial role, including the right to refuse data sharing if economic harm to the company is imminent.
EFPIA strongly believes that introducing an opt-out mechanism in the EHDS is unnecessary, as the original European Commission proposal adequately addresses patients' control over their health data. The inclusion of opt-out or opt-in mechanisms may potentially hinder future innovations by reducing overall data availability in the EHDS. In case that EU lawmakers decide to include a general opt-out right, EFPIA suggests limiting it to the data categories in Article 33 of the proposal where offering, changing, managing, and respecting the general opt-out choice can be reasonably accommodated without imposing undue burdens on the healthcare system and data holders.
