An extract from The Life Sciences Law Review, 8th Edition
Pricing and reimbursement
Once a medicinal product or medical device has complied with the requirements to be legally marketed in Spain, the first step to determine its price is to decide whether or not it can be included in the NHS, and thus if its price can be reimbursed. Pursuant to Royal Legislative Decree 1/2015, competence on this matter is attributed to the DGCB of the MoH.
The decision regarding inclusion would be made on the basis of objective criteria, such as severity, nature of the pathologies that the product was approved for, special needs of certain social groups, therapeutic and social value, rationalisation of public expenditure, availability of other products or the level of innovation.
Once a product is included in the NHS, the Interministerial Commission for Pharmaceutical Prices (CIPM) would determine the laboratory selling price. By adding the commercial margins and VAT to this price, the public retail price for wholesalers and pharmacies is determined. For the products to be dispensed through public hospitals, the final price would be fixed by the tender entity by means of public bids. All these prices are subject to a second intervention through the prices of reference, which determine the maximum amount the NHS would allocate for each product.
If the products are not included in the NHS, the laboratories would notify the prices to the CIPM, which can either accept the prices or make objections.
