SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
Decree 1030/2006, however, does specifically require that any new technique, technology or process that aspires to be eligible for reimburse- ment must “bring about an improvement, in terms of safety, efficacy, effectiveness, efficiency or proven usefulness, over other currently avail- able alternatives” . Notably, this requirement is much stricter than the one applying to medici- nal products in Article 92 of Royal Legislative Decree 1/2015, which states that “cost effec - tiveness” analysis “shall be taken into account” . 8.5 Regulation of Prescriptions and Dispensing by Pharmacies Royal Legislative Decree 1/2015 governs the prescription and dispensing of medicinal prod- ucts. The general rule is that prescriptions in the NHS should be based on the active ingredient/s. Prescriptions based on trade name are possible if the principle of greater efficiency for the NHS is respected, and for medicinal products consid- ered non-substitutable (eg, biological medicinal products). When the prescription is made based on the active substance/s, the pharmacist shall dispense the lowest-priced medicinal product in the so-called homogeneous groups – ie, lists of products available for substitution.
Further, it is worth mentioning that the MOH may impose “singular dispensation reserves” on medicinal products, under which the affected products may only be dispensed by NHS hos- pital pharmacy services – ie, not by community pharmacies.
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