Article 93 of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices establishes the reference price system for the financing of medicinal products prescribed and dispensed with through the official medical prescription of the National Health System. This legal precept entrusts to the Minister of Health and Consumption the determination, with the agreement of the Government Delegation for Economic Affairs and the report of the Interterritorial Council of the National System of Health, of the assemblies that they serve as the basis for the fixing of the reference prices, as well as their value and the provision of the necessary measures for the application of the formula for the calculation of the reference prices. Article 5.1 of Royal Decree 1338/2006 of 21 November 2006 implementing certain aspects of Article 93 of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices in the framework of the Reference price system provides that the determination of new reference sets and prices shall be carried out at least once a year. For its part, Order SCO/3997/2006 of 28 December, determining the sets of medicinal products and their reference prices and regulating certain aspects of the application of the provisions of Law 29/2006, of 26 May In July, guarantees and rational use of medicines and medical devices, fixed, for the first time after the entry into force of the law, the reference prices, established the formula for its calculation and the procedures for the exercise of the option envisaged in the case of industrial prices affected by more than 30% by the the reference price system and for the application of the voluntary reductions in the marketing price of the presentations. In addition, in order to facilitate the correct understanding and application of the system, they were published together with the order, the comprehensive annex of the presentations temporarily excluded from the price system for being declared as Gallic innovations and the price of the lower prices of the presentations for the purposes of their supply and their replacement by the pharmacist, and, on a transitional basis, the system of return of stocks with a higher price than that established by the order was also regulated. By this order the new sets of medicines and their reference prices are determined, as provided for in Article 5.1 of Royal Decree 1338/2006 of 21 November. Moreover, through the provisions of the fourth additional provision, the exercise of the option provided for in Article 93.5 of Law 29/2006 of 26 July is possible. In addition, this order is intended to make it easier to dispense with Article 85 and the replacement provided for in Articles 86 and 93.4 of Law 29/2006 of 26 July. For these purposes, the lower prices for the presentation of medicinal products, whether or not included in the reference price system, are determined in the fifth additional provision. In its preparation, the sectors affected have been heard, it has been submitted to the Interterritorial Council of the National Health System, and the agreement of the Government Delegation for Economic Affairs has been obtained. In its virtue, according to the State Council, I have:

Article 1. Determination of new sets and reference prices.

1. The new sets and their reference prices are the ones that are determined and related in Annex 1.

2. Annex 2 lists the defined daily doses taken into account for the calculation of the amount of the reference price in each set, as provided for in Article 2 of Order SCO/3997/2006 of 28 December 2001, for which the determine the sets of medicinal products and their reference prices and on which certain aspects are regulated for the application of the provisions of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and products health.

Article 2. New presentations temporarily excluded from the application of the reference price system.

For the purposes of applying the provisions of Article 3 of Royal Decree 1338/2006 of 21 November for the development of certain aspects of Article 93 of Law 29/2006, of 26 July, of guarantees and the rational use of the medicines and medical devices in the framework of the reference price system, in Annex 3 the new presentations of medicinal products which are excluded from the reference price system, and their period of exclusion, are related to the been declared as Gallic innovations.

Additional disposition first. Presentations of generic medicines with a higher price than the reference price and of medicines that do not have the same generic medicinal product presentations.

In accordance with the provisions of Article 93.3 of Law 29/2006 of 26 July 2008, as of 1 March 2008, presentations of generic medicines with a higher price than the reference price not included in the case provided for in the sixth provision of Order SCO/3997/2006 of 28 December, as well as the presentations of medicinal products which do not have the same generic medicinal product presentations for the purpose of the replacement provided for in the Article 93.4 of the said law and as long as the situation of non-availability is maintained, they will be supplied by the laboratories at an industrial price corresponding to one or less of the reference. In these cases, the national code for the presentation of the medicinal product shall not be amended.

Additional provision second. Voluntary price reductions without modification of the national code.

1. Laboratories that voluntarily decide to market the presentations of medicinal products at a lower price than the one authorized to adapt it to a level equal to or lower than the reference level, without modifying the national code, must communicate it to the Directorate-General of Pharmacy and Health Products of the Ministry of Health and Consumer Affairs within 15 working days from the date of entry into force of this order.

2. The presentations of medicinal products referred to in the previous paragraph shall be supplied by the laboratories at the new price as from 1 March 2008.

Additional provision third. Price applicable to the presentations of medicinal products concerned by the provisions of Article 93 (6) and (7) of Law 29/2006 of 26 July.

As of 1 March 2008, the new presentations of medicinal products affected by the provisions of Article 93 (6) and (7) of Law 29/2006 of 26 July, which are listed in Annex 4, will have the price (a) industrial activity in that Annex, without amending the national code.

Additional provision fourth. Industrial prices affected by the reference price system by more than 30%.

The pharmaceutical laboratories holding the medicinal products listed in Annex 6 which, in accordance with Article 93.5 of Law 29/2006, of 26 July, in conjunction with Article 4 of Royal Decree 1338/2006, On 21 November, they shall decide to take the reduction resulting from the application of the reference price system to the industrial prices of their products at a minimum of 30% per year. They shall exercise that option within the time limit specified in the royal decree, formally communicating it to the Directorate General of Pharmacy and Health Products of the Ministry of Health and Consumer Affairs and specifying in the communication the annual quantity for which the respective products will be dispensed until the corresponding reference price is reached. The quantity communicated shall be effective as from 1 March 2008.

Additional provision fifth. Update of Annex 5 of Order SCO/3997/2006 of 28 December.

Annex 5 of Order SCO/3997/2006 of December 28, which relates the lower prices of medicinal products for the purpose of dispensing and replacement by the pharmacist, is replaced by Annex 5 of this provision.

First transient disposition. Coexistence of prices and return of stocks.

1. Stocks of medicinal products held by distribution stores affected by the price reductions provided for in this order may continue to be placed on the market by the distribution stores at the price before this reduction to 31 March 2008.

2. The stocks of medicinal products held by the pharmacy offices concerned by the price reductions provided for in this order may continue to be placed on the market by the pharmacy offices at the price before the price. reduction to 30 April 2008. 3. Under the provisions of Article 6.2.5 of Royal Decree 726/1982 of 17 March 1982 regulating the expiry and return of proprietary medicinal products to pharmaceutical laboratories, distribution stores and offices From 1 May 2008 and in accordance with Article 8 of the royal decree, the pharmaceutical laboratories may return to the pharmaceutical laboratories the stocks of the presentations with a price on the packaging prior to the reductions. established in this order.

Second transient disposition. Expenditure financed from public funds.

1. The National Health System, as well as the special regimes of the General Mutuality of Civil Servants of the State (MUFACE), of the Social Institute of the Armed Forces (ISFAS) and of the General Judicial Mutuality (MUGEJU), will maintain, until 30 April 2008, the previous price of the medicinal products concerned by the provisions laid down in the first, second, third and fourth provisions in relation to this second transitional provision, for the purposes of invoicing and for refers exclusively to the part of the expenditure directly satisfied by that system and by the special schemes mentioned.

2. The new prices shall be settled with the new charges for the National Health System and for the special schemes referred to in the previous paragraph, which shall be closed as from 1 May 2008.

Final disposition first. Amendment of Order SCO/3997/2006 of 28 December.

The fifth additional provision of Order SCO/3997/2006 of 28 December, which is worded as follows: ' For the purposes of Articles 85, 86 and 93.4 of Law 29/2006 of 26 July, is amended as follows: corresponding to different drug presentations are those listed in Annex 5 of this order.

The Ministry of Health and Consumer Affairs will update the Anejo 5 on a six-monthly basis, and may postpone this update for a period of six months, if the variations in the prices of the drugs thus advise, prior to the agreement of the Permanent Commission of Pharmacy of the Interterritorial Council of the National Health System. The medicinal products referred to in the single Article of Order SCO/2874/2007 of 28 September 2007 laying down medicinal products for which medicinal products are established shall not be replaced by the pharmacist or included in the reference price system. derogating from the possible substitution by the pharmacist in accordance with Article 86.4 of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices. '

Final disposition second. Competence title.

This order is issued under the state competition law on pharmaceutical products, in accordance with the provisions of Article 149.1.16. of the Constitution.

Final disposition third. Entry into force.

This order shall enter into force on the day following that of its publication in the "Official State Gazette".

Madrid, 27 December 2007.-The Minister of Health and Consumer Affairs, Bernat Soria Escoms.

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