Inside EU Health: Spain to propose alternative to SPC; clinical trials transparency; AI

Dear Readers,

This is the final ‘Inside EU Health’ newsletter before the summer break. Vital Signs will continue to publish articles should any major developments arise.

We'd like to take this opportunity to wish you all a restful and enjoyable summer. We'll be back on 1 September, fully recharged and ready to bring you the latest on EU health policy.

Spain to propose early procurement as an alternative to SPC Extension

Spain is preparing an alternative proposal to the 12-month extension of the Supplementary Protection Certificates (SPCs) included in the Biotech Act. Speaking at a biopharmaceutical forum, Spanish Secretary of State for Health Javier Padilla outlined an alternative approach that Spain intends to present to other EU member states from September.

Diario Farma reported that Padilla said the European Commission suffered from “lamppost bias,” in which it tends to look where the light shines rather than where it should be looking. As extending SPCs falls under EU jurisdiction, it is also a lever it can propose.

Padilla argued that this incentive arrives too late in a medicine's lifecycle. By the final years of exclusivity, products already face intense competition from newer therapies, limiting the value of an additional year of protection. As a result, he suggested that extending SPCs may do little to encourage manufacturing or investment in Europe, though he did not mention that the SPC was conditional on EU production.

Spain will propose an "early procurement" mechanism that would operate between European Medicines Agency (EMA) approval and national pricing and reimbursement decisions.

Under the proposal, the European Commission would establish a framework for purchasing innovative medicines during this pre-pricing phase, giving companies "preferential access to the entire European market from the moment of authorization" rather than rewarding them only at the end of patent protection. Padilla argued this would accelerate patient access while avoiding disruption to biosimilar competition once exclusivity expires.

Spanish Farmaindustria Director General Juan Yermo welcomed the debate but urged caution, saying that given the volatile situation, Europe cannot afford reforms that take two, three, or four years to materialize if it wants to remain globally competitive. The proposal sounds like the advanced purchasing agreements proposed in response to the COVID pandemic.

European health NGOs push for full publication of clinical trial results

A coalition of 20 European health, patient and transparency organisations urged the European Commission and the European Medicines Agency (EMA) to take stronger action to ensure that all clinical trial results are made public, warning that missing data could undermine patient safety and public trust in medicines.

The lead NGO TranspariMED’s analysis of the Clinical Trials Information System (CTIS) found that only 116 of the first 234 drug trials required to publish results had done so fully and on time. A further 20 trials reported results late, while 98 had not fully reported their findings, meaning that around half of eligible trials failed to comply with the law.

Under EU rules, pharmaceutical companies, universities and hospitals conducting drug trials must publish both scientific results and plain-language summaries, usually within a year of a trial ending. National medicines regulators are responsible for enforcing these requirements across the 30 countries using the CTIS system.

The campaign prompted a swift response from EMA. The agency has started sending reminders to trial sponsors when results are due and has introduced a monitoring system that enables national regulators to identify overdue studies. By the end of the year, it also plans to publish overall data on clinical trial reporting.

TranspariMED founder Till Bruckner welcomed the rapid action: "We have never before seen a regulator respond so positively, decisively and rapidly to a campaign," he said. He added that the response showed the EMA "deeply cares about clinical trial transparency" and wants the new system "to work as intended."

However, campaigners say further steps are needed. They are calling for a public dashboard showing which organisations comply with reporting rules and how national regulators perform in enforcing the law. They also want a quality assurance system to ensure that submitted trial results are complete and meaningful rather than containing vague narratives or heavily redacted documents.

WHO/Europe urges faster development of AI governance

WHO/Europe has found that nearly two-thirds of countries in the European Region are already using AI in diagnostics. Yet only 8% have a health-specific AI strategy, and just 8% have liability standards defining responsibility when AI systems fail.

"Every country in the world is wrestling with the same questions right now: how do we govern AI responsibly, how do we build the health workforce to use it safely, and how do we make sure it serves patients rather than just those who can afford the technology?" Dr Hans Henri P. Kluge, WHO Regional Director for Europe. 

“A biased algorithm can produce a wrong diagnosis, for a real patient, with real consequences. A health worker trained to trust an AI system they can’t interrogate is not empowered, leading to mistakes outside their control. And all of this erodes public trust in health systems more broadly,” he added.

WHO warns that the longer governance lags behind deployment, the greater the risks. At a conference WHO/Europe and the Government of Portugal brought together ministers and senior representatives from 37 countries in Lisbon to develop a shared approach to AI governance in health.

WHO says governance must keep pace with innovation. Kluge says every country deploying AI in healthcare needs a clear national strategy, robust accountability frameworks and training to ensure health professionals can use AI safely and responsibly.

"Regulating AI in health is hard," Dr Kluge said. "But not regulating it is harder - measured in patients harmed, trust lost and inequalities widened."