SPAIN Trends and Developments Contributed by: Joan Carles Bailach, Lluís Alcover, Laia Rull and Pablo Mansilla, Faus Moliner
Transparency One of the hottest topics at present is transpar- ency and confidentiality in relation to the price and reimbursement conditions of medicinal products in Spain. Following freedom of information requests from citizens, several court rulings were issued in 2023–24 obliging the MOH to provide access to the price and reimbursement conditions of cer- tain medicinal products. These rulings are not final and have been appealed. A Supreme Court ruling is expected in the coming years. So far, the MOH has maintained a firm stance in defending the confidentiality of this information, arguing that disclosure thereof would be detri- mental to its ability to negotiate with companies when setting prices for medicinal products, thus undermining the economic sustainability of the NHS. Despite some messages from the MOH at the beginning of 2024 that point to a potential change in criteria, in reality the MOH’s position remains unchanged. Indeed, the leaked draft of the new RDL 1/2015 reinforces the confidential- ity of the price and reimbursement conditions.
new regulation is intended to replace the cur- rent regulations, dating from 1996. The proposed draft is aimed at addressing digital advertising, the use of social media and audio- visual modalities, the distribution of competen- cies between the state and regions and obliga- tions for accessibility for individuals with sensory disabilities. Regarding medical devices, the MOH published a draft Royal Decree governing the advertising of medical devices in March 2024. This draft encompasses several elements, such as stream- lining the process for obtaining prior approval for the public promotion of medical devices, a new requirement for responsible advertising of specific devices and the prohibition of hospitality in relation to promotional meetings, except pro- fessional-scientific events. The draft also explic- itly bans off-label promotion and offers detailed guidelines on permissible and prohibited content in advertisements directed at the public. This Royal Decree is expected to be approved during 2025.
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