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Order Sco/3997/2006, Of 28 December, Which Sets Of Drugs And Their Reference Prices Are Determined And Which Regulate Certain Aspects For The Implementation Of The Provisions Of Law 29/2006, Of July 26, Garant...

Original Language Title: ORDEN SCO/3997/2006, de 28 de diciembre, por la que se determinan los conjuntos de medicamentos y sus precios de referencia y por la que se regulan determinados aspectos para la aplicación de lo dispuesto por la Ley 29/2006, de 26 de julio, de garant...

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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. The legal precept entrusts to the Minister of Health and Consumption the determination, prior to the agreement of the Government Delegation for Economic Affairs and report of the Interterritorial Council of the National System of Health, of these sets that they serve as the basis for the fixing of the reference prices, as well as the amount of the reference prices and the provision of the necessary measures for the application of the formula for the calculation of the reference prices. By this order, the mandates and the powers contained in Article 93 of Law 29/2006 of 26 July, in particular the determination of the new sets and their reference prices, as well as the formula, are to be completed. for the calculation of these from the defined daily doses corresponding to those officially assigned by the Collaborating Centre of the World Health Organization in Methodology and Statistics on Medicines or, failing that, with the calculated by the Ministry of Health and Consumption in accordance with the methodology used by the Ministry of Health and Consumer center. Moreover, through the provisions of the second transitional provision of this order, 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. To this end, it incorporates an additional provision and a comprehensive annex of the lower prices for the presentations of medicinal products, whether or not included in the reference price system, which will be adapted and updated in a semi-annual basis. to facilitate their application. Therefore, after agreement of the Government Delegation for Economic Affairs and prior report of the Interterritorial Council of the National Health System, it should be formally completed as soon as it is derived from the above mentioned. In its virtue, according to the State Council, I have:

Article 1. Determination of new sets and reference prices.

1. The new sets, created in accordance with the provisions of the first paragraph of Article 93.2 of Law 29/2006 of 26 July, of guarantees and the rational use of medicinal products and medical devices, are those which are determined by this order and are related in Annex 1.

2. The reference prices, approved in accordance with the second paragraph of Article 93.2 of Law 29/2006 of 26 July, are also determined by this order and are listed in Annex 1.

Article 2. Formula of calculation of reference prices.

For the calculation of the value of the reference price in each set, the following shall be taken into account: (a) The three presentations of medicinal products with the lowest cost/treatment/day shall be selected.

b) The defined daily doses are those related in Annex 2.

Under the terms of the second paragraph of Article 93.2 of Law 29/2006 of 26 July, the minimum threshold for the reference prices which are the subject of the price of the reference price is fixed at EUR 3,12 of the selling price to the public, including taxes. the present order. In addition, a reference price of EUR 3,12 is set for those presentations of medicinal products to which, as a consequence of the provisions of this Article, a lower reference price corresponds to them.

Article 3. Presentations temporarily excluded from the application of the reference price system.

For the purposes of applying the provisions of the third paragraph of Article 93.2 in relation to the sixth transitional provision of Law 29/2006 of 26 July, the presentations referred to in the second transitional provision of Royal Decree 1338/2006 of 21 November, for which certain aspects of Article 93 of Law 29/2006 are developed, of 26 July, are those relating, together with the corresponding period of exclusion, in Annex 3 of this order.

Article 4. Information to the patient.

As provided for in Article 15 (4) of Law 29/2006 of 26 July, the pharmacist, when dispensing the medicinal product, shall make delivery to the recipient of the corresponding receipt in addition to the name of the medicinal product and of its selling price to the public, the patient's contribution.

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 2007, as of 1 March 2007, presentations of generic medicines with a higher price than the reference price not included in the case provided for in the first transitional provision of this order, as well as presentations of medicinal products which do not have the same generic medicinal product presentations for the purposes of the replacement provided for in Article 93.4 of that law and in the situation of non-availability is maintained, will be supplied by the laboratories at a price industrial corresponding to one or less of the reference. 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. The laboratories which 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 Ministry of Health and Consumer Affairs before 31 January 2007.

2. The presentations of medicinal products referred to in this order will be supplied by the laboratories at the new price as from 1 March 2007.

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

As of 1 March 2007, the presentations of medicinal products referred to in Article 93 (6) and (7) of Law 29/2006 of 26 July, the price of which is reduced by 20% and which are related in the Annex 4. they shall have the industrial price shown in that Annex, without amending the national code.

Additional provision fourth. Return of stocks.

1. The stocks of medicinal products, with a price prior to the reductions laid down in this order, which are held by warehouses and pharmacy offices, may continue to be placed on the market until 28 February 2007.

2. 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 March 2007 and in accordance with Article 8 of the said 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.

Additional provision fifth. Determination of the lower prices of medicinal products for the purpose of dispensing and replacement by the pharmacist.

For the purposes of Articles 85, 86 and 93.4 of Law 29/2006 of 26 July, the corresponding lower prices for different presentations of medicinal products are those listed in Annex 5 of this order, which will be adapted and updated semi-annually by resolution of the General Directorate of Pharmacy and Health Products.

No substitution shall be made by the pharmacist or included in the reference price system for the medicinal products referred to in Article 1 of the Order of the Ministry of Health and Consumer Affairs of 28 May 1986. The prescribed medicinal products which cannot be substituted by others in the supply, or the provision to replace it.

Additional provision sixth. Generic medicines included in the pharmaceutical delivery of the National Health System for a period of less than one year.

Where a generic medicinal product has a sales price to the public, including taxes, higher than the corresponding reference price and, as provided for in Article 91.6 of Law 29/2006 of 26 July, one year has not elapsed. from the date on which its inclusion in the pharmaceutical provision of the National Health System is resolved from public funds, that generic medicinal product shall not be incorporated into the sets as determined in Article 1 of this order until the time limit for a given year has not elapsed.

First 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 28 February 2007, the previous price of the medicinal products concerned by the provisions laid down in the first and second additional provisions, for the purpose of invoicing and for 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 March 2007.

Second transient disposition. Industrial prices affected by the reference price system by more than 30%.

The pharmaceutical laboratories holding the medicinal products listed in Annex VI 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 this royal decree, formally communicating it to the Directorate General of Pharmacy and Products Health and Consumer Health Ministry 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 2007.

The Director-General of Pharmacy and Health Products is empowered to adapt Annex V to the modifications resulting from this order.

Final disposition first. 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 second. Entry into force.

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

Madrid, December 28, 2006. -Minister of Health and Consumer Affairs, Elena Salgado Méndez.

Here are several images in the original. See the PDF document for this disposition.