The proposal for a regulation of the European Health Data Space (EHDS) introduces a common framework for the secondary use of health data within the EU. In defining the broad scope of ‘electronic data’, the proposal refers (amongst other categories of helath data) to ‘electronic health data from clinical trials’. This provision seems rather straightforward and leaves little room for interpretation. Accordingly, there are no other provisions or recitals for that matter to interpret what the legislator views as ‘electronic health data from clinical trials’. Couple this provision with the proposed Ar. 33 (4) which reads: ‘Electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use’.
Read together, these provisions are too self-explanatory to imagine them passing through the amendment process unchallenged and/or unchanged. There are conflicting interests at play not least because clinical trial sponsors (read ‘pharmaceutical companies’) will want to safeguard the confidentiality of their intellectual property (read ‘data collected during the different phases of the clinical trial). The interplay between confidentiality and the reuse of data from clinical trials is not new. What seems to be new, however, especially following the COVID-19 pandemic, is the European Union’s eager commitment to unleash the full potential of data and promote health research. With such a political commitment on the one hand and the sponsors’ financial interests on the other, we are left with the same old story: a battle between intellectual property rights and public interest not dissimilar to the one we witnessed during the COVID-19 vaccine patents saga.
Three aspects of this debate are likely to be at the centre of policy attention.
1. What categories of data will data holders/clinical trial sponsors share through the proposed Health Data Access bodies?
The wording of the EHDS proposal is quite straightforward. It wants to include to the definition of electronic data for secondary use, ‘electronic health data’ / ‘from clinical trials’. It is impossible to read this provision without understanding something along the lines of ‘data that have been collected as part of a clinical trial’. It is also impossible to read this without expecting strong opposition from clinical trial sponsors. Policymakers shall expect pressure for crossing out Ar. 33 (j) altogether or they shall expect (and indeed a circulated draft report by the LIBE-ENVI joint committee includes) amendments that afford clinical trial sponsors a form of control over the content of the data that they may be asked to share through the EHDS i.e. by committing to sharing what they are already obliged to share under the European Regulation on Clinical Trials (CTR), namely the final summary of the clinical trial with general information on the trial, the sponsor, the adopted methodology, any adverse effects and their frequency, and the general results of the trial. Perhaps of relevance here is Ar. 81 of the CTR which provides that commercially confidential information from a clinical trial shall not be publicly accessible ‘unless there is an overriding public interest in disclosure’. The question then becomes: Do the goals of the EHDS initiative provide an overriding public interest under certain circumstances?
2. Data Act and EHDS for clinical trial data
Many organisations have highlighted the need for legal certainty and coherence between the Data Act and the EHDS. According to Ar. 15 of the Data Act, public sector bodies can use data initially collected by other data holders should an exceptional need arises in order to: a) respond to a public emergency; b) prevent a public emergency, or assist the recovery from a public emergency (only if access to the data requested is limited in time and scope…); or c) fulfil a specific task in the public interest that has been explicitly provided by law. All other things being equal, allowing public sector bodies direct access to data from clinical trials in case the case of 15 (c) is not easy for clinical trial sponsors to accept as this will leave open the possibility of having legitimate reasons of public interest overriding the protection of their intellectual property. In a future pandemic, for example, allowing secondary use of clinical trial data by a public sector body based on the EHDS Ar. 33 (j) and the Data Act Ar. 15 (c) can spare us from discussing vaccine patent rights, which is of course an excellent thing if you are not the sponsor of the clinical trial.
3. When will data holders be obliged to share data with data applicants/users?
Last but certainly not least. Clinical trials have many phases and stages that can take many years before the respective authority issues (or objects to) a marketing authorisation. Additionally, following this decision, research teams and sponsors can take their time before publishing the end-of-trial summary. The question then becomes: when will public sector bodies or other healthcare entities that fulfil the requirements of the EHDS be allowed to request clinical trial data for secondary use? What will be the relevant time? The application for marketing authorisation? The decision on marketing authorisation? The declaration of the end of the clinical trial? Some other point in the process? Understandably, the stakes are different at each stage of a clinical trial.
These and other questions are likely to be asked during the negotiations. Overall, there are numerous aspects of the EHDS proposal that require rigorous policy attention. I have expanded on some of them here. It is likely that clinical trials will occupy a prominent position in the parliamentary debate. And rightfully so. However, by gravitating the lion' share of our policy resources and attention towards it, we risk having intellectual property monopolising the political energy and dialogue to the detriment of other important issues of the proposal (EHR systems interoperability, wellness applications, the potential role of Big Tech in the EHDS, and others). Clear policies and priorities are needed. Half-commitments and exceptions upon exceptions will not work for the public interest. They rarely do.
*Photo by Volodymyr Hryshchenko on Unsplash