SPAIN Trends and Developments Contributed by: Lluís Alcover, Joan Carles Bailach and Claudia Gonzalo, Faus Moliner
and patient quality of life aspects. The guidelines that will be used to prepare these reports will be developed later by the MOH. Once these two reports have been completed, the positioning group will make a final assessment of the clinical and non-clinical evaluation reports and will issue a recommendation. This recommendation, together with the two evaluation reports will serve as a basis for the decision-making body to decide on its reimbursement. One element of the draft Royal Decree that has raised concerns among the national industry is the obligation for health technology developers to provide the “reli- able costs of production, research and development, as well as the sources of financing of these costs, whether public or private”, because of the confidential nature and difficulty of obtaining such information. Fol- lowing stakeholder feedback, the MOH has amended the wording in the current (still provisional) draft. The obligation is now limited to providing “information on public sources of funding or funding from non-profit entities, where applicable, as well as reliable informa- tion, regarding production and development costs, that is necessary to carry out the economic analysis”. This revised wording narrows the scope in two rel- evant ways: • first, it no longer refers to private sources of financ- ing; and • second, it qualifies the cost information required by linking it to what is strictly necessary for the pur- poses of the economic analysis, which may help limit the breadth of information to be disclosed. This new Royal Decree is expected to be approved during Q1–Q2 2026. Pricing and reimbursement of medicinal products The MOH launched a public consultation on the draft Royal Decree on pricing and reimbursement of medicinal products, which seeks to repeal Royal Decree 271/1990 and establish an updated regulatory framework. This new regulation intends to regulate the process of reimbursement for medicinal products, the establish-
ment of special reserves and special reimbursement conditions, the system for revising the PVL, the inclu- sion of new indications and the exclusion of medi- cines from reimbursement, among other things. It is expected that the draft of this new Royal Decree will be published during 2026. Cannabis In October 2025, the MOH published a Royal Decree establishing the conditions for the elaboration and dispensation of standardised magistral formulae of standardised cannabis preparations. Its purpose is to establish the conditions for the prescription, prepara- tion, dispensing and use of standardised cannabis- based magistral formulas. This new Royal Decree stems from the mandate of the Health and Consumer Affairs Committee of the Congress of Deputies, which in 2021 requested the creation of a subcommittee to study experiences in the regulation of cannabis for medical use. One of the conclusions reached by the subcommittee was the need to adopt measures to allow the availability of standardised cannabis preparations to address the needs of certain patients when authorised treatments have not been effective. The Royal Decree allows the use of standardised cannabis-based magistral formulas. These formulas would be prepared in response to a medical prescrip- tion and, under the supervision of a pharmacist, by hospital pharmacy services, in compliance with appli- cable good preparation practices. The National Formulary, which contains standardised magistral formulas, would include monographs for the use of standardised cannabis preparations. These monographs would establish the uses and indications for which these magistral formulas could serve as an alternative when other therapeutic options have failed. Initially, the monograph will cover four indications: chronic pain, spasticity related to multiple sclerosis, epilepsy, and intractable chemotherapy-related vomit- ing (all refractory to other treatments). In these cases, cannabis would be authorised as a last-line treatment.
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