Following the approval on February 10th by the Council of Ministers of the Royal Decree regulating the procedure for the selective funding of medical devices within the pharmaceutical benefits for non-hospitalized patients—pending its upcoming publication in the Official State Gazette (BOE)—the Federación Española de Empresas de Tecnología Sanitaria (Fenin) wishes to state the following:
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We welcome the Ministry of Health’s commitment to adopting regulatory changes that allow for the incorporation of technological innovation into pharmaceutical benefits. This ensures that patients have access to better treatments for their conditions, a situation that has been pending since 2006.
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We trust in the Ministry’s agility regarding the swift resolution of applications for the inclusion of new products, as well as the updating of conditions to guarantee the supply of essential products.
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It is essential to include new categories and product groups within the National Health System’s pharmaceutical benefits. This will allow users—many of whom are chronic patients, dependents, or elderly—to access new clinical solutions and medical devices aimed at disease prevention or managing their consequences. This brings significant cost savings for the health administration and improves patients’ quality of life. Given this sector’s innovative capacity, a streamlined mechanism should be established to incorporate new categories or product groups into public funding.
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However, it must be noted that the current regulation of pharmaceutical benefits is designed for the pharmaceutical sector, not for the Healthcare Technology sector. Therefore, we expect the new Law on Medicines and Medical Devices to provide our sector with a distinct regulatory framework that recognizes the unique characteristics and specificities of these products, as the Ministry of Health has informed us.