en.Wedoany.com Reported - Spain's new Royal Decree on Health Technology Assessment, passed in May 2026, is seen as a strategic turning point for the country's industry. The regulatory framework is considered an opportunity to optimize the National Health System, making it more predictable and accelerating patient access to advanced therapies and medical devices.
Three industry giants—Sanofi, Roche, and Philips—have expressed their expectations for the new framework. Although operating in different branches of health innovation, the three companies agree that the Royal Decree represents an opportunity to enhance transparency and evaluation quality.
Sanofi welcomes the introduction of a "more structured, participatory, and transparent model aligned with European Health Technology Assessment (HTA) regulations," viewing this European synergy as a way to avoid duplication of clinical evaluations and allow Spain to focus on specific non-clinical aspects. Inés Domingo, Director of Legal Consulting at Philips Iberica, positively assessed the "construction of a more unified, predictable, and evidence-based framework," which will optimize decisions regarding the introduction, funding, use, and reassessment of technologies within the National Health System, providing regulatory certainty for the industry.
One of the strong points of industry consensus is moving beyond old evaluation criteria. Companies welcome the shift from a purely budgetary impact perspective to a holistic one. Sanofi notes that the Royal Decree allows a transition from traditional criteria of efficacy, safety, and budgetary impact to a broader view that incorporates the overall value of medicines, including social, ethical, and environmental aspects, which can be supplemented with real-world data. Federico Plaza, Director of Corporate Relations and Public Affairs at Roche Farma, emphasized that the key is to evaluate innovative medicines based on their clinical and overall value, introducing the concept of "social value," which encompasses factors such as improved patient autonomy, reduced dependency needs, savings in hospitalization costs, and increased productivity. Philips clarified that this evolution does not necessarily mean higher prices, but rather better recognition of the value contributed.
Regarding regulatory requirements to disclose development costs, Roche reminded that drug development is a high-risk activity. Philips pointed out that in the medical technology field, development costs are complex and linked to platforms, software, services, maintenance, and interoperability. Philips believes this obligation should be applied with proportionality, legal certainty, and protection of commercially sensitive information to safeguard industrial know-how. No company plans to delay product launches as a result; Roche committed to bringing innovations to patients as quickly as possible.
The success of the Royal Decree will depend on its daily implementation. Roche Farma believes that if the stipulated 180-day evaluation period is met, the regulation will bring agility. Sanofi is optimistic that if the new rules are implemented agilely and coordinately, they will significantly reduce waiting times and ensure equitable access to medical innovation in a sustainable manner. The industry considers this reform to bring Spain closer to European standards, but its impact depends on actual execution, adherence to deadlines, and transparent, uniform criteria from the administration. If these conditions are met, the new model will promote faster and fairer access to health innovation.
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