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This column has commented previously—and occasionally scathingly—about the gap between words and action on personalized medicine in Europe, but a new straw has appeared in the wind that may mean something more substantial will emerge than the customary rhetoric.
It isn't the planned European Partnership on Personalized Medicine, reported on here last March. For all its fine aspirations, the latest update on its genesis is a disappointment. A "basic information" website for the project reports: "No network description provided." It lists participants as "0", countries involved as "0", joint calls as "0", funded projects as "N/A" and period as "N/A". According to the official EU website, the start is now scheduled for 2023/2024—adding merely "more details will be provided at a later stage".
Nor is it the EU-backed IC-Permed, whose next step is to hold—in early November—the first “ICPerMed family meeting”, which "aims to explore cooperation and synergies" in "different areas of personalized medicine" and "possibly other related projects." Besides establishing a forum for discussion, the aim—says an IC-Permed announcement—is "to harmonize future activities, to expand cooperation and to jointly develop strategies for fostering PM research and implementation of PM approaches in healthcare and health systems." So not exactly a fast-track operation there…
Not much either can be expected in the near future from the EU's new pharmaceutical strategy, currently stuck in a seemingly endless round of consultations and impact assessments. Although the outline is full of warm words about how "personalized therapies dramatically improved the prognosis of patients with some cancers", citing trastuzumab, or how "initiatives such as the ‘1+ million genome’ are exploring ways to access genetic data with the potential to improve disease prevention and allow for more personalized treatments". There is a promise of a legislative proposal in 2022 – which will no doubt take at least a year, and probably more, to turn into legislation - that would include "flagship initiatives on innovation", including personalized medicine. And there are plans for access to 10 million genomes across borders for personalized medicine by 2025. But that all remains for the present in the lap of the EU gods.
Even the European medicines agencies' strategy for 2025, while positive about the concept, is non-committal in its approach. Commenting on "innovations in patient-centered healthcare, and precision/personalized medicine", it says these "often do not fit properly into existing regulatory systems” and suggests only that "protecting public health while providing a regulatory environment that can support such steps towards precision medicine is key if EU patients’ needs are to be better addressed."
The clue in fact springs not from the familiar world of EU medicines policy, but from the more robust realm of EU data policy. It comes in the shape of an announcement at the beginning of October that the Council—that is, the ministers of the EU member states—has agreed its position on a draft law known as the Data Governance Act. The agreement means that the Council can now start negotiating the final shape of this critical piece of legislation with the European Parliament – the co-legislator in the EU. In short, this opens up the prospect of stronger European data-sharing mechanisms. As the Council said in its announcement, "The aim is to promote the availability of data that can be used to power applications and advanced solutions in artificial intelligence, personalized medicine, green mobility, smart manufacturing and numerous other areas."
The outcome should be easier access for the reuse of certain categories of protected public-sector data—including on health, and an increased trust in data intermediation services. This will give a much-needed boost to the EU efforts to bring digitalization and data use into practical operation—prizing open the door to the wealth of information that constitutes one of the fundamental resources of shifting personalized medicine from an idea into a reality. The fact that this announcement comes within the framework of the EU's data policy makes it all the more encouraging, since – with no disrespect to the many EU officials working in the health area – the EU's data policy is flying, because there is a strong legal base and plenty of budget and political momentum for it, while EU health policy remains hobbled by its absence of any real place in the EU treaties, reluctant member states, and piecemeal budgeting.
Now, of course, it will be necessary to follow up these—and other health- and medicine-related—developments in EU data policy, and that is yet another task for the clinical trial community already burdened with keeping up to speed with a constantly-changing evolution of regulatory and legislative challenges in Europe. This column can't promise to solve all those challenges—but it will, in its own modest way, do whatever it can.