SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
Spain, and the judgments of the Supreme Court of 28 October 2015 and 11 November 2015 con- firmed this. However, in practice, external reference pricing influences price rulings in Spain. The fact that this practice has no legal basis makes it quite difficult to identify precisely how the MOH fac- tors in international prices, and the sources from which these prices are obtained. In any case, as per the firm’s experience in dealing with the MOH, it has become clear that the MOH requests the MAH to provide information about how the medicinal product has been priced in other EU countries, and that EU prices operate as a cap for Spanish prices, meaning that prices in Spain are rarely fixed above the price of the same medicinal product in other EU countries. In relation to medical devices, the current regula- tion does not provide for price comparisons with other European countries. However, it is impor- tant to highlight that the draft of the new Royal Decree on the financing of medical devices for non-hospitalised patients does mandate, as a requirement for obtaining public reimbursement, that the company marketing a device submit, along with the price request, documentation regarding the status and price of the medical device in the EU member states where it is mar- keted. Additionally, the offering company must provide information, if available, on the prices of similar medical devices marketed by the com- pany, both in Spain and in other EU countries. 8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds Medicinal Products For the reimbursement of medicinal products, two hurdles must be overcome. First, the prod- uct must not be specifically exempt from reim-
bursement; such products include those that are not subject to medical prescription; are not designed to cure a specific illness; are consid- ered cosmetics, dietetics, mineral waters, elixirs, dentifrices or other similar products; are indicat- ed for syndromes or illnesses of minor severity; or do not meet current therapeutic needs. Second, a price and reimbursement proceeding must be completed before the MOH, in which the decision to reimburse a given product is taken considering the following criteria (Article 92 of Royal Legislative Decree 1/2015): (i) the severity, duration and sequelae of the different pathologies for which the product is indicated; (ii) the specific needs of certain groups; (iii) the therapeutic and social value of the medicinal product and its incremental clinical benefits, tak- ing into account its cost-effectiveness; (iv) the rationale for public expenditure; (v) the existence of medicines or other therapeutic alternatives for the same condition/s at a lower price or with a lower treatment cost; (vi) the degree of innova- tion of the medicine; (vii) the contribution of the product to Spain’s gross domestic product; and (viii) return mechanisms that may be proposed by the MAH (discounts, price reviews). It must be acknowledged that item (vii) in the foregoing list is rather peculiar, as it suggests that local manufacturing or development opera- tions could influence price and reimbursement decisions, which would be entirely contrary to EU law principles. Nevertheless, in the authors’ experience, this criterion is occasionally applied by the Spanish authorities. Item (viii) in the foregoing list reflects the growing significance of risk-sharing schemes in Spain. Many companies, particularly those with high- budgetary-impact products, are required to propose specific arrangements to obtain reim-
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