The EHDS: a before and after in the use of health data in Europe
The legal implications of the European Health Data Space (EHDS) and how it will affect the pharmaceutical sector
by mercedes galán
The European Health Data Space (EHDS) is one of the most ambitious legislative initiatives in healthcare digitalization in the EU. To learn firsthand about the legal impact that this new regulation will have on the pharmaceutical industry, we spoke with Jorge Muñoz Fuentes, assistant general counsel Global MedTech, Global AI & Privacy at Telix Pharmaceuticals.
What would you say are currently the main legal challenges for the pharmaceutical industry in Europe, in a context of technological, regulatory and social transformation?
Clearly, ensuring the sustainability of the system. Together with public administrations, which are the main payers of treatments, the industry must seek creative solutions for the financing of drugs and for these to reach the patients who need them as soon as possible.
What does the arrival of the EHDS mean for a pharmaceutical company like yours? Do you see it as a challenge or an opportunity?
We see it as a tremendous implementation challenge, as it requires significant investment and coordination from all stakeholders. Likewise, as an opportunity. We are a company that researches precision radiopharmaceuticals for the diagnosis and precision treatment of cancer, carrying out research activities through agreements with hospitals and other centers that provide anonymized patient data. This allows us to analyze what is the best dosage of drugs for different types of patients. Regulated access to these data in the European Space will undoubtedly be an opportunity to improve our treatments so that they reach patients as soon as possible.
From your point of view, what are the main legal risks of the EHDS?
Undoubtedly, the most important thing is that there is a uniform and consolidated position throughout the European Union regarding the legitimate basis for the use of data, for secondary and tertiary use. The logistical challenges are enormous, because it will not be easy for all member states to use similar systems that provide the data in the same format. Even more so when, for example, currently, the regions in Spain have not been able to do so when talking, for example, about our health card.
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