SPAIN Trends and Developments Contributed by: Joan Carles Bailach, Lluís Alcover, Laia Rull and Pablo Mansilla, Faus Moliner
A health technology evaluation includes evalu- ation of both clinical and non-clinical aspects, with the latter including economic, environmen- tal, ethical and patient quality of life issues. The guidelines that will be used to prepare the evalu- ation reports will be developed later by the MOH. Once completed, the positioning group will make a final assessment of the clinical and non-clinical evaluation reports for a given health technology, and issue a recommendation thereon that will provide a basis for decision-making in respect to reimbursement. One element of the draft Royal Decree that has raised concerns at the national industry level is the obligation for health technology develop- ers to provide the “reliable costs of production, research and development, as well as the sourc- es of financing to cover these costs, whether public or private” , given the difficulty of obtaining such information – especially considering that research and production can be done in other countries. This new Royal Decree is expected to be approved during 2025. Cannabis In October 2024, the MOH published a draft Royal Decree establishing the conditions for the elaboration and dispensation of the standard- ised magistral formulas of standardised can- nabis preparations. The purpose is to establish the conditions for the prescription, preparation, dispensing and use of standardised cannabis- based magistral formulas. This proposed Royal Decree stems from a man- date from the Health and Consumer Affairs Committee of the Congress of Deputies, which in 2021 requested the creation of a subcommit-
tee to study experiences in the regulation of can- nabis for medical use. One of the conclusions reached by the subcommittee was that there is a need to adopt measures to make standard- ised cannabis preparations available, to in turn address the needs of certain patients for whom authorised treatments have not been effective. The MOH proposes to allow the use of standard- ised cannabis-based magistral formulas. These formulas would be prepared by hospital phar- macy services in response to a medical prescrip- tion, under the supervision of a pharmacist and in compliance with applicable good preparation practices. The National Formulary, which contains stand- ardised magistral formulas, will include mono- graphs for the use of standardised cannabis preparations. These monographs will establish the uses and indications for these magistral for- mulas, allowing them to serve as alternatives when other therapeutic options have failed. For now, the MOH intends for the monograph to cover four indications: chronic pain refractory to other treatments, spasticity related to multiple sclerosis refractory to other treatments, epilepsy refractory to other treatments and intractable vomiting refractory to other treatments related to chemotherapy in cancer patients. For these four indications, the use of cannabis would be authorised as a last-line treatment. This Royal Decree is expected to be approved during 2025. Advertising of Medicinal Products and Medical Devices In April 2023, a public consultation on the new Royal Decree on the promotion of medicinal products for human use was launched. This
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