SPAIN Trends and Developments Contributed by: Lluís Alcover, Joan Carles Bailach and Claudia Gonzalo, Faus Moliner
ble” pharmaceutical forms to be grouped together, provided they are substitutable. This system is linked to new dispensing regulations that shift a portion of the financial burden to the patient based on their choice. While the NHS cov- ers the lowest-priced options, patients who prefer a “non-selected” presentation must pay the standard co-payment plus the full price difference. Stakehold- ers including Farmaindustria, Aeseg and BioSim have voiced criticism. They argue that an excessive focus on the lowest price could be counterproductive, and such a system may attract unsustainable bids from actors lacking robust logistical guarantees, potentially leading to supply shortages and discouraging invest- ment in incremental innovations that provide genuine clinical value. As a result of the widespread opposition that this system generated, the MOH announced that it would work on an alternative mechanism, without further updates on this matter to date. General obligation for pharmaceutical companies to supply medicinal products for free before obtaining formal marketing authorisation (MA) This marks a major change from the current frame- work, where prices for non-authorised products used in special situations are typically negotiated individu- ally with hospitals based on international bench- marks. In the firm’s view, the practical impact may be limited, as many companies already provide early access products free of charge. However, making this a general obligation could distort the exceptional nature of compassionate use and generate artificial demand effects, while the budgetary impact could be addressed through less burdensome mechanisms, such as the obligation to reimburse the differential between the price invoiced during the compassion- ate use phase and the final list price ( precio de venta libre – PVL) (see “cost equalisation rule” in the follow- ing section). New accelerated, conditional and provisional reimbursement system for certain medicinal products This system is for products that address unmet medi- cal needs, provide a relevant clinical benefit and must be used in treatment without delay. These products may be provisionally included within public reimburse-
ment until a final decision is made. A “cost-equalisa- tion rule” has been proposed, ensuring that provisional reimbursement does not result in costs or budgetary impact for the NHS higher than those resulting from the final decision; it also applies to special access programmes. This mechanism represents a significant advance, enabling a binding national-level provisional decision for all regional health services. This reduces inequities and legal uncertainty while ensuring equitable access nationwide and facilitating rapid access to essential treatments in line with constitutional rights to life and health. Promotion of medicinal products prior to pricing and reimbursement decisions Health authorities have traditionally maintained that promotion is not permitted until reimbursement is granted, although a Supreme Court ruling in March 2025 introduced important developments. However, the Draft Law classifies as a serious infringe- ment the advertising of medicines authorised but not yet marketed in Spain, subject to fines ranging from EUR90,001 to EUR1 million. Following the publica- tion of the Draft Law, officials from the MOH have announced their intention to remove this infringement and clarify the rules governing the promotion of medi- cines once MA has been obtained – and before the pricing and reimbursement decision is issued. Changes to the reference price system (RPS) Specifically, the Draft Law foresaw that medicinal products that, due to a new indication, a lower dos- age, a new pharmaceutical form, a pharmacokinetic advantage or any other feature that objectively pro- vides a benefit to patients – or a strategic advantage for the NHS – could be exempt from the RPS or ben- efit from the application of a coefficient that increases their price. Similarly, the Draft Law allowed for upward revision of the prices of strategic medicines included in the RPS. This flexibilisation of the RPS represents a significant step forward and acknowledges a long-standing concern: the rigidity of the RPS could have undesired
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