Digitization, databases, Hta: EU challenges for more competitive healthcare. “EMA timeframe needs to be shortened”

Rome – Digitization, database, Hta. Acronyms and designations that seem far removed from citizens’ lives but represent tomorrow’s EU challenge. And whose outcomes will affect—no doubt—the everyday life of every European. These are some of the topics discussed at the conference “Europe in Health. Challenges and Opportunities for the Future“, organized on Wednesday, March 6, at Spazio Europa in Rome by Ely Lilly.

In particular, the focus was on two major regulatory challenges that will take centre stage after the European elections on June 8 and 9, because the regulation to establish the European Health Data Space put forward by the Commission in 2022 provides a framework for accessing and sharing health data among member countries and aims to improve health care delivery, research, innovation, and policymaking. In addition, the target is to enable citizens to take control of their own data. This sensitive and relevant topic is currently being negotiated among EU states to draft the final text. “Data today is our ‘oil,’ a source of energy and wealth,” says former Health Minister Beatrice Lorenzin, now a PD senator and the first signatory of a bill filed in Parliament. “Without data, there is no health planning,” she adds. Bringing a concrete example, “Agenas has to evaluate the new Essential Assistance Levels, but without those fundamental data, how do you organize programming?”

In this sense, the National Recovery and Resilience Plan can come to the rescue. Simona Loizzo, a Lega Deputy and Chair of the Parliamentary Intergroup for Digital Health, is convinced of this: “Digitization, as the NRRP conceives it, can be of great comfort and help because there are finally so many resources dedicated to the issue, to the concept of proximity medicine, of getting closer through these telehealth and telemedicine pathways.”

The second point of debate was implementing the Health Technology Assessment (HTA) regulation, which allows the evaluation of innovation as a clinical, economic, and social investment by overcoming the cost paradigm. This regulation, adopted in 2021, established standard evaluation criteria and processes that can be applied from 2025 onward.

The conference was also helpful in turning the spotlight on the urgency to promote a community-based and holistic approach to combating health inequalities, as already indicated by the European Commission. The discussion that developed looked at the European Cancer Plan, unveiled in 2021 and associated with a common strategy, and the “Healthier Together” initiative, launched by the European Commission to support EU countries in reducing the burden of non-communicable diseases through promotion and prevention, helping to improve diagnosis and treatment, as well as patients’ quality of life.

Another key aspect to be implemented in the EU, then, is the process of drug approval by the EMA. The topic dominated the Ely Lilly discussion because, among
advanced countries’ regulatory authorities, the European one continues to have
longer approval times for new drugs than other international partners (and
competitors) such as the United States, Japan, Canada, and Australia. According to data from the Centre for Innovation in Regulatory Science, the EMA reserves about 430 days for approval of a new active ingredient, compared with 322 in Japan, 334 in the US, 351 in Canada and 347 in Australia. So, another challenge for Europe in the near future.

Just as the next EU legislature will be called upon to implement the competitiveness of the Old Continent by introducing (this is the summary of the debate) a substantive, ambitious, and innovative reform, including a timely pathway to assessment and marketing authorization, aligning timelines with those of the Food & Drug Administration, to ensure timely access and a concrete response to medical needs that would otherwise go unmet.