SPAIN Trends and Developments Contributed by: Lluís Alcover, Joan Carles Bailach and Claudia Gonzalo, Faus Moliner
The Supreme Court’s ruling thus represents a para- digm shift: it removes the absolute prohibition on promotion prior to the pricing/reimbursement deci- sion, conditioning it instead on compliance with legal advertising requirements. The sanction was confirmed solely because the promotional material failed to include the price, an essential element under the law. For pharmaceutical companies, this decision has a significant impact. It enables early communication about authorised products, particularly in hospital set- tings, provided the promotion includes the applicable price. Confidentiality of PVL and reimbursement conditions of medicinal products On a different matter, there has been an ongoing debate over whether pricing and reimbursement deci- sions for medicinal products – including the PVL and reimbursement conditions – should be publicly acces- sible. Since the LTAIBG came into force, requests for access to this information have increased, but posi- tions from authorities like the CTBG and lower courts have been inconsistent. The dispute stems from a request for access to a MOH decision on a medicinal product’s price and reimbursement. After the MOH refused to disclose the information, the CTBG ruled in favour of disclosure, but that decision was challenged in court, leading to conflicting outcomes in different judicial instances.
On appeal, the Spanish National High Court ( Audi- encia Nacional ) upheld the appeal brought by both the MOH and the MA holder. The court held that the specific confidentiality regime under Article 97.3 of the LGURMPS – which protects all technical, economic and financial information submitted during pricing and reimbursement procedures – should prevail over the LTAIBG. As such, the PVL and reimbursement condi- tions remain confidential. The court reasoned that disclosing the PVL and reim- bursement decision would allow inferences about a company’s technical, economic and financial data, potentially harming commercial interests. It also emphasised that any decision to grant access under the LTAIBG must balance public and private interests. In this case, the court found no overriding public inter- est that justified disclosure and concluded that con- fidentiality protects both company interests and the broader public interest in negotiating favourable terms for the NHS. This ruling is not yet final and has been appealed before the Spanish Supreme Court. The Supreme Court is expected to issue a ruling on this matter dur- ing 2026.
343 CHAMBERS.COM
Powered by FlippingBook