SPAIN Trends and Developments Contributed by: Lluís Alcover, Joan Carles Bailach and Claudia Gonzalo, Faus Moliner
effects, such as disincentivising innovation or increas- ing the risk of shortages. The Draft Law also provides, among other measures, that hospital-dispensed medicinal products be treated as independent groups, and that orphan medicinal products and plasma-derived products be excluded from the SPR. The exclusion of orphan medicinal products, de facto, has already been applied in recent years. These SPR modifications were incorporated as amendments to the current LGRUMPS through a law passed by the Spanish Parliament in July 2025. There- fore, these measures are now law and are currently in force. Information resulting from reimbursement agreements shall be considered confidential One of the most controversial issues in the pharma- ceutical sector in recent years has been the debate over the confidentiality of the PVL and the reimburse- ment conditions of medicinal products. The current LGURMPS establishes that the techni- cal, economic and financial information provided by pharmaceutical companies to the MOH during the reimbursement process is confidential. Both the companies and the MOH itself have argued that this confidentiality regime should extend to the PVL and the reimbursement conditions, as these are directly derived from information protected under that guar- antee. The current situation, however, remains unclear. On the one hand, following various freedom of informa- tion requests under Law 19/2013 of 9 December on Transparency, Access to Public Information, and Good Governance (LTAIBG), the Transparency and Good Governance Council ( Consejo de Transparencia y Buen Gobierno CTBG) has concluded that the PVL and reimbursement conditions must be made public. On the other hand, the National Court has ruled in favour of maintaining the confidentiality of the PVL and reimbursement conditions in three recent deci- sions (discussed in more detail below).
In this context, the Draft Law expressly recognises that information resulting from reimbursement agreements or their implementation (although it is not expressly stated, this is generally understood to also include the PVL) shall be considered confidential. Streamlining the negotiated procedure without prior public notice for medicines with market exclusivity Concerning the public procurement of medicinal products, the Draft Law does not adopt the indus- try’s request to completely exempt innovative and reimbursed medicines from the Public Procurement Act, which some critics see as a missed opportunity for clarity and efficiency, considering that the price of such medicinal products is already subject to regula- tory intervention by the authorities. Instead, the Draft Law focuses on streamlining the negotiated procedure without prior public notice for medicines with market exclusivity. Also, the Draft Law introduces greater flexibility in contract duration by allowing supply contracts for one-off gene therapy medicinal products with long- lasting effects to exceed the general five-year limit, up to a maximum of ten years, where justified by the recovery of relevant investments and the nature of the treatment. It also introduces provisions to encourage joint procurement at the national or EU level, prioritis- ing award criteria other than price, such as environ- mental performance and strategic autonomy. Change in the scope of the tax on sales regulated in LGURMPS A final relevant change introduced by the Draft Law concerns the scope of the tax on sales regulated in the LGURMPS. Currently, this contribution applies solely to retail products. However, the extension to hospital-use or hospital-dispensed products had already been envis- aged in the 2024–28 Pharmaceutical Industry Strate- gy, approved by the Council of Ministers in December 2024, as one of the measures to ensure the sustain- ability of the NHS.
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