The system of reference prices, applicable in the field of financing of medicines by the National Health System and established in Article 98 of the recast of the Law on guarantees and the rational use of medicines and Sanitary products, approved by the Royal Legislative Decree 1/2015 of 24 July, has been manifested as an essential tool for controlling pharmaceutical expenditure, which is necessary for the sustainability of the public health system.

The regulatory development needed to be able to make effective the legal mandate to establish, on an annual basis, the new reference sets of medicinal products, as well as to proceed with the revision of the reference prices of the already existing sets, it is established in Royal Decree 177/2014, of March 21, for which the system of reference prices and homogeneous groupings is regulated in the National System of Health and certain systems of information on the financing and pricing of medicinal products and medical devices.

Article 5.1 of Royal Decree 177/2014, of 21 March, entrusts the head of the Ministry of Health, Social Services and Equality to, on an annual basis, by means of a corresponding order and after the Government's Delegated Committee for Economic Affairs, establish the new sets and their reference prices, as well as to review the reference prices of the presentations of drugs included in the existing sets and, in where appropriate, the removal of the assemblies shall be the case where they no longer comply with the requirements for their establishment.

The last update of the reference sets of medicinal products and their reference prices was produced by Order SSI/1225/2014 of 10 July, which is the result of the updating of the reference price system. Reference for medicines in the National Health System.

Through this ministerial order, the update of the reference sets and prices established by Order SSI/1225/2014 of 10 July 2014, and to this end, the new sets are determined and their Reference prices, as well as the reference prices fixed by the reference prices. It is also appropriate to delete the reference sets previously determined by failure to comply with the requirements for their establishment due to overcome causes.

For the establishment of new reference sets of medicinal products and the maintenance of sets established by means of the aforementioned order, as well as for the deletion of reference sets, they have been the provisions contained in Article 3 of Royal Decree 177/2014 of 21 March 2014.

For the fixing of the reference prices of the presentations of drugs integrated in the new reference sets of medicines and for the review of the reference prices of the presentations of medicinal products integrated into pre-determined sets, the provisions laid down in Article 4 of the said royal decree have been followed.

This order is issued in accordance with the specific rating provided for in Article 5.1 of Royal Decree 177/2014 of March 21, and in the process of hearing it has been transferred to the health administrations of the communities. (a) to the pharmaceutical companies concerned, to the pharmaceutical laboratories concerned, to the pharmaceutical companies concerned, to the pharmaceutical companies concerned, and to the entities representing the sectors concerned; affected, including consumer and user associations.

In its virtue, I resolve:

First.

Set new reference sets and reference prices for drug presentations included in them, as well as review reference prices for drug presentations included in the previously existing sets.

In Annex 1 of this order reference sets of medicinal product presentations dispensed by pharmacy offices through official medical prescription or dispensing order, with indication of the price reference industry and PVPIVA reference fixed for each presentation.

The listed sets of C-427 to C-465 of the said Annex are newly created.

In Annex 2 of this order, reference sets of medicinal product presentations of hospital scope and presentations in clinical packaging are related, with indication of the reference industrial price fixed for each presentation.

The listed sets of H-99 to H-107 and EC-138 to EC-141 are newly created.

For the purpose of facilitating compliance with the provisions of the additional provision of Royal Decree 177/2014 of 21 March 2014, Annexes 1 and 2 identify the presentations of medicinal products whose reference price has been determined by the rules laid down in Article 4 (3) and (4) of that royal decree.

Second.

For information purposes, in Annex 3 of this order, all reference sets of medicinal products with indication of the reference price of each set (PRC) are related, identifying the presentation of medicinal products. cost/treatment/day (CTD) has determined the same.

Also included are the information of the defined daily doses (DDD) of each reference set of drugs used for the calculation of the cost/treatment/day (CTD) of the presentations of drugs integrated into the the same as in Article 4 of Royal Decree 177/2014 of 21 March 2014.

Also, reference sets of medicinal products formed by the existence of a biosimilar medicinal product and those formed without the existence of a generic or biosimilar medicinal product as established are identified. In Article 3 of Royal Decree 177/2014, of 21 March.

Third.

In application of the provisions of Article 5 of Royal Decree 177/2014 of 21 March 2014, reference sets of medicinal products which no longer meet the requirements for their establishment are deleted.

In Annex 4 of this order reference sets of deleted drugs are related, with indication of the reason for their deletion.

Fourth.

In Annex 5 of this order, the presentations of drugs declared as Gallic innovations of therapeutic interest are related before the entry into force of Royal Decree-Law 16/2012 of 20 April, of measures urgent to ensure the sustainability of the National Health System and to improve the quality and safety of its benefits, excluded from the reference price system, the declaration of which as a Greek innovation expires after the date of effects of this order.

In Annex 5, as set out in paragraph 1 of the additional provision of Royal Decree 177/2014 of 21 March 2014, the period for the exclusion of the reference price system for each of the Member presentations of medicinal products. After the expiry of the period of exclusion, the provisions of paragraph 2 of that provision shall apply.

Fifth.

For the purposes of the provisions of the additional seventh provision of Royal Decree 177/2014 of 21 March 2014, the presentations of medicinal products and their licences for which medicinal products have not been formed are listed in Annex 6 of this order. reference set in accordance with the provisions of Article 3.2 of the said royal decree.

Sixth.

For the purposes of applying the provisions of Article 5.3 of Royal Decree 177/2014 of 21 March 2014, the reference price is fixed for the presentations of medicinal products included in the pharmaceutical supply of the National System of Health prior to the date of effect of this order, but whose effectiveness of inclusion in the pharmaceutical provision, in accordance with the provisions of the additional provision sixth of the said royal decree, had not been produced to date 13 April 2015, the start date of the procedure for drawing up this order.

In Annex 7 of this order, the presentations of medicinal products with indication of the reference set in which they will be integrated and the industrial reference price for each presentation are related.

Seventh.

This order will produce effects from the day following your publication in the "Official State Bulletin".

Eighth.

Against this order, which ends the administrative route, a judicial-administrative appeal may be brought within two months from the day following that of its publication before the Chamber of Judicial-administrative dispute of the Supreme Court, in accordance with the provisions of Article 12 of Law 29/1998 of 13 July, regulating the Jurisdiction-Administrative Jurisdiction or, as a matter of prior character, an appeal The Office of the Minister for Health, Social Services and Equality shall, within one month, the provisions of Articles 116 and 117 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure.

Madrid, October 14, 2015. -Minister of Health, Social Services and Equality, Alfonso Alonso Aranegui.

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