This article is the product of a POLITICO Working Group, presented by Janssen.
Everyone wants a seat at the European Health Data Space table. But will there be space for industry?
That’s the question companies are faced with as they try to convince the Parliament, Council and Commission that they can be trusted to be a significant player in the creation and rollout of the Health Data Space.
As the Commission’s proposal, first presented in May, is reworked into what will comprise the final regulation, the looming question is how much access private companies will be given to some of the bloc’s most valuable data.
Industry wants in, but not without promises that its own research and intellectual property will be protected. On the other side of the table are privacy organizations like the European Data Protection Board and concerned academics who fear that the proposal may open the door to the abuse of health data or privacy infringements.
With companies being fined for health data breaches and increasing concern about Big Tech accessing health information about patients, convincing MEPs across the two parliamentary committees that have been allocated the file to allow industry the level of access they want may be difficult.
The file is being shared by the Environment, Public Health and Food Safety (ENVI) committee as well as the Civil Liberties, Justice and Home Affairs (LIBE) committee. Tomislav Sokol, an MEP from the European People’s Party group, will be ENVI’s rapporteur, while Annalisa Tardino, from the Identity and Democracy group, will be rapporteur for LIBE.
But there’s already one thing going for the private sector — an unusual show of solidarity from groups that are often not aligned. In a joint statement on October 20, more than two dozen research and medical professional organizations, patient groups, and industry associations put forward several key asks regarding the Health Data Space. That’s not to say the groups are aligned on all aspects of industry’s involvement, but it’s a promising sign of unity of purpose as the negotiations kick off.
Industry stands to benefit from the Health Data Space, with the Commission’s proposal stating that the use of health data for research should enable both public and private entities to use the data for research and innovation. The only clear no-go areas are if the use of the data would harm people, increase people’s insurance premiums, be used to advertise to people or develop harmful products.
The devil is, as always, in the details. Questions remain around contentious issues such as the use of pseudonymized data, the fees applicable to accessing the data and, importantly, whether industry will be involved in the governance of the Health Data Space.
For its part, industry — which includes organizations such as pharmaceutical companies and private health care providers — hopes that by demonstrating the value it can provide, Brussels bureaucrats, diplomats and MEPs will be convinced.
“Can the use of health data for R&D lead to increased profit margins? Sure and this is needed to overcome investment risk,” said Ray Pinto, director for digital transformation policy at tech industry group DIGITALEUROPE, speaking at a POLITICO working group on the Health Data Space in October. But Pinto notes that industry will also be able take these massive datasets and create quality data out of them, using it to beef up things like cybersecurity or to make a doctor’s life easier.
For Angel Martín, Janssen’s senior director of digital health advocacy for the EMEA region, the purposes for which data is used and the potential social benefits are key.
“If we think that industry, within those purposes, can bring benefit to society, I don’t see why we would exclude some of the innovation happening,” he said. What Martín underlines is that there will need to be principles about how data is shared and used by all players, which will be key to building trust.
It’s good to share
The idea that patients are always opposed to sharing data with industry also doesn’t ring true for those who have worked in the health sector for years.
“When you engage with patients or members of the public, and you really explain about the value of health data, they quite quickly understand … that it’s the purpose that matters, whether the body that undertakes the research …. is a public body or a private body is not the most important thing, provided they uphold good practices of trust,” said Dipak Kalra, president of the European Institute for Innovation through Health Data. “What matters most is the purpose.”
Where the challenge lies is getting the entire EU population to shift from the idea that “industry is not trustworthy,” said Kalra.
Even then, industry is sure to come up against tetchy privacy regulators.
Already, the European Data Protection Board, and the EU’s in-house privacy regulator, the European Data Protection Supervisor, have issued a response that seeks to throttle back some of the original proposal’s ambitions. The regulators say wellness and other digital health applications should be excluded from being made available for secondary use and that the storage of sensitive health data should only occur in Europe. They are both issues that the industry will likely push back against.
The private sector also isn’t only concerned about its ability to be part of the Health Data Space — it’s also worried about how the data it provides to the space will be used by others. The European Federation of Pharmaceutical Industries and Associations has already said that the Health Data Space “must give clearer assurances on the conditions for sharing data, including around how IP and trade secrets will be protected when data is requested” from a pharmaceutical company.
Getting on the guest list
One of industry’s first targets is to have a say on how the Health Data Space is run and to do that it needs to be part of the board that will be overseeing the effort. The sector is quick to press that they aren’t asking for a “free for all.” “We’re talking [about a] very specific interaction,” said Pinto.
That interaction will need to be very clearly delineated, Markus Kalliola, coordinator of the TEHDAS project — a joint initiative to ensure safe access to data in a way that serves the cause of public health. He warned against allowing the same people who set the rules to benefit from those edicts. In fact, ensuring that doesn’t happen would actually benefit industry, Kalliola said.
The joint consensus statement published October 20 doesn’t specifically mention the board, but it makes clear that the top of the wish list is for everyone — including industry — to be “strongly involved” in the Health Data Space. “Winning trust and broad engagement will be essential for the general acceptance, effectiveness, endorsement, and rapid adoption of the EHDS,” they write.
What remains to be seen is whether industry can first win the trust of the MEPs, Commission officials and diplomats negotiating the proposal.
This article is part of POLITICO’s Evolution of health care series which is presented by Janssen. It is the product of a Working Group and was produced with full editorial independence by POLITICO reporters and editors. Learn more about editorial content presented by outside advertisers.