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And, in equal measure, patients and doctors—as EU mulls new rules.
The announcement of a new EU plan for wider sharing of health data has won endorsement from across the health community—but this is sensitive territory, so unsurprisingly the detailed reactions vary widely, depending on whether it’s industry, patients, or healthcare professionals doing the talking.
Predictably, pharmaceutical companies in this familiar battle-ground are keen to get their hands on as much data as possible to further their own product development plans. Equally predictably, patients and doctors tend to focus on protecting privacy and ensuring data security. What is surprising this time round is that the proposal has prompted the expression of strong opinions on a previously unexplored area of health-data sharing: How far should drug firms share their own data with the wider world? The answer, to judge from industry comments, is “not very much.”
The debate has been triggered by a formal proposal for EU legislation, with the unexceptionable aim of bringing EU rules into line with the opportunities and challenges of the digital world. The so-called “European health data space” will, according to the EU, promote safe exchange of patients’ data and give citizens control over their health data, and will also “support research on treatments, medicines, medical devices, and outcomes.” The envisioned framework is intended to “encourage the access to and use of health data for research, policymaking, and regulation, with a trusted governance framework and upholding data-protection rules,” as well as supporting digital health services and clarifying the safety and liability of artificial intelligence in health. It is an agenda more remarkable for its scope than for its originality, in that it largely mirrors what has been obvious for a decade and more as the development of digital technology has accelerated. Consequently, the bulk of the reactions follow a similar pattern, welcoming the possibility of more standardized procedures and common specifications to overcome Europe’s current legal and technical fragmentation, opening the way to exploiting neglected treasure-houses of data that can lead to better care and faster innovation.
Industry bodies, avid for easier access for secondary use, are energetically enthusiastic about the prospect and urge streamlining of regulations to “stimulate innovation to the benefit of EU competitiveness,” as the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), representing smaller innovative drug firms, puts it. The major industry body, the European Federation of Pharmaceutical Industries and Associations (EFPIA), claims that 80% of data produced by health systems “is not put to work” and is offering its own solutions to “unlock its potential to bring the best medicines and healthcare to patients.”
The caution comes predominantly from the classic providers of data: “Patients are generally willing to share their data for research, policy, and public services, particularly if they feel that there is a public benefit in doing so and if they are able to control and monitor access to their data,” explains the European Patients’ Forum. “Data should only be made available when pseudonymized, and when the citizen is actively and clearly informed about it,” insists AIM, one of the main payers of healthcare in Europe. Other healthcare payers warn against giving away data too easily so that drug firms can exploit it commercially. European doctors insist on the supremacy of medical confidentiality and professional secrecy obligations “which the processing activity for secondary use must not overrule.”
What’s new to this legislative debate, however, is this: The new rules “must give clearer assurances on the conditions for sharing data, including around how intellectual property and trade secrets will be protected when data is requested” from pharmaceutical companies, says EFPIA. The industry body is deeply concerned that its members will be required to share clinical trial data and real-world data from registries, electronic health registries, and non-interventional clinical trials. Johnson & Johnson says the success of the legislation will depend on balancing data access and the responsibilities of sharing data “while protecting trade secrets and IP.” Therefore, there must be clear assurances around how its own data will be protected when requests are made of it. By no coincidence, GSK, Roche, and others have piled in with similar demands.
It is not hard to grasp the logic of this concerted industry position. But this debate is going to play out in a public arena—and it will be difficult for an industry seeking easier access to other people’s data to win hearts and minds with a demand for exceptional immunity of its own data.
Reflector is Pharmaceutical Executive’s correspondent in Brussels