SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Joan Carles Bailach and Laia Rull, Faus Moliner
However, in practice, external reference pricing influ- ences price rulings in Spain. The fact that this practice has no legal basis makes it quite difficult to identify precisely how the MOH factors 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. With regard to international reference pricing for medi- cal devices, Article 6.1 (i) of Royal Decree 90/2026 provides that, when applying for reimbursement, the applicant must submit information on the status and price of the medical device in those EU member states where it is marketed. In addition, the company must provide, where available, information on the prices of similar medical devices marketed by the same com- pany in Spain and in other EU countries. It remains to be seen how this provision will be implemented in practice, in particular whether and to what extent such cross-country price information will effectively influence the pricing decision. 8.3 Reimbursement From Public Funds Medicinal Products For the reimbursement of medicinal products, two hurdles must be overcome. First, the product must not be specifically exempt from reimbursement; such products include those that: • are not subject to medical prescription; • are not designed to cure a specific illness; • are considered cosmetics, dietetics, mineral waters, elixirs, dentifrices or other similar products; • are indicated 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 prod- uct and its incremental clinical benefits, taking 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 innovation of the medicine; (vii) the contribu- tion 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 forego- ing list is rather peculiar, as it suggests that local man- ufacturing or development operations could influence price and reimbursement decisions, which would be entirely contrary to EU law principles. Nevertheless, in the firm’s experience, this criterion is occasionally applied by the Spanish authorities. Item (viii) in the foregoing list reflects the growing sig- nificance of risk-sharing schemes in Spain. Many com- panies, particularly those with high-budgetary-impact products, are required to propose specific arrange- ments to obtain reimbursement. These arrangements may take various forms, including caps on the number of units reimbursed by the NHS and charge-backs if predefined therapeutic outcomes are not satisfied. Medical Devices Royal Decree 1030/2006 and Ministerial Order SCO/3422/2007 regulate the process of updating the package of benefits provided within the NHS. The rules state that any new technique, technology or process cannot be included in the NHS’s package of benefits unless it contributes effectively to: • the prevention, diagnosis or treatment of diseases; • the maintenance or improvement of life expec- tancy; • self-resilience; or • the elimination or reduction of pain and suffering. Moreover, an improvement in safety, efficacy, effec- tiveness, efficiency or usefulness over other currently available alternatives must be demonstrated.
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