Article 93 of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices establishes the system of reference prices in the public financing of medicinal products. System which, as an essential element of control of pharmaceutical expenditure, appears reinforced following the modifications introduced by Royal Decree-Law 9/2011 of 19 August, of measures for the improvement of the quality and cohesion of the National System of Health, contribution to fiscal consolidation, and elevation of the maximum amount of State guarantees for 2011, constituting as a measure of economic control over the drugs subject to public financing, necessary for the sustainability of the healthcare system.

The legal precept entrusts the holder of the Directorate General of Pharmacy and Health Products of the Ministry of Health, Social Policy and Equality to, by means of a reasoned resolution and a favourable report of the Commission Drug Price Interministerial, determine the new sets and their reference prices, as well as review those that were already created.

According to Article 93 (2) cited above, all submissions of funded medicinal products which have the same active substance and the same route of administration as those which will be included are understood as a whole. in the pharmaceutical delivery of the National Health System, at least one generic or biosimilar medicinal product presentation. In addition, the presentations indicated for treatments in pediatrics, as well as those for medicinal products in the hospital, will constitute separate sets. With this, and for the purpose of controlling the pharmaceutical expenditure produced in the pharmaceutical provision of the National Health System, the Law allows the creation of new sets of medicines, whether or not they can be substituted for each other. of the supply of medicinal products in Article 85, in relation to the additional provision fourteenth.

Article 93 (2) provides that the reference price, understood as the maximum public financing price, shall be, for each set, the lowest cost/treatment of the presentations of medicinal products in the grouped by each route of administration, calculated according to the defined daily dose, which is why it is necessary to fix the sets and their respective reference prices.

Similarly, Article 93 (3) states that the determination of new assemblies and their reference prices, as well as the revision of the reference prices of the sets already determined, will be carried out at the highest level. As soon as possible, and at least once a year, it is therefore concluded that it is appropriate to make use of the power granted by that Article.

Furthermore, and in accordance with the last subparagraph of the first subparagraph of Article 93 (2), assemblies may be set up from the moment ten years have elapsed since the date of the initial authorisation of the the marketing of the reference medicinal product in Spain, or 11 in the case of a new indication being authorised.

Consequently, by this Resolution, it is necessary, for the purposes of complying with the provisions of Article 93 of Law 29/2006, of 26 July, regarding medicinal products not considered to be of hospital scope, to the determination of the sets of medicinal products to be dispensed at the pharmacy offices by official medical prescription or dispensing order and their reference prices, as well as the revision of the reference prices determined in the Order SPI/30 52/2010 of 26 November.

In another aspect, in point 2 of this resolution, reference is made to those new drug presentations which, because they have been declared as Gallic innovations, will be excluded from the price system. reference, in application of the provisions of Article 93.5 of Law 29/2006 of 26 July, in conjunction with Article 5 of Order SPI/30 52/2010 of 26 November 2010.

Likewise, and in accordance with those same articles, taking into account that there are certain presentations of medicinal products whose declaration as a gallic innovation will expire within the following 12 months after the date of the This Resolution has an effect on point 3 of which its incorporation into the reference price system is facilitated.

This Resolution also incorporates, for the purposes of the formation of certain assemblies, four presentations of generic medicinal products subject to a precautionary measure of immobilization as a result of a judicial decision rendered in the procedure for the protection of industrial property rights. These sets shall not produce any effects until such time as a presentation of a generic marketed medicinal product which is not affected by a precautionary measure of immobilisation, or is notified, by the Court or judged to the Ministry of Health, is included. Social Services and Equality, the final judgment which dismisses the claims of the holder of the patent of the medicinal product or the order in which the precautionary measures for immobilisation of the generic medicinal product are not taken into effect, for which entered the corresponding annotation in the official Nomenclator of pharmaceutical products of the National Health System. If the judgment is in favour of the interests of the holder of the generic medicinal product, or the incorporation of a presentation of a generic marketed medicinal product not subject to precautionary measures of immobilization, the annotations shall be deleted. Otherwise, the sets remain inactive until they are deleted, if any, by the corresponding review resolution.

This Resolution has obtained the prior favorable report of the Inter-Ministerial Drug Prices Commission.

For the above, in the development of the forecast contained in article 93 of Law 29/2006, of July 26, and in accordance with the privileges given to this Directorate General under Article 10 of Royal Decree 263/2011, 28 February, for which the basic organic structure of the Ministry of Health Social Policy and Equality is developed, resolute:

1. Reference sets and prices

1. In application of Article 93.2 of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices, the sets of medicinal products to be dispensed in pharmacy offices by means of an official medical prescription or supply and their reference prices are those listed in Annex 1 to this Resolution.

The listed sets of C-200 to C-230 of the said Annex are newly created.

The sets indicated in Annex 2 are deleted due to the fact that the requirements on which their creation was based, in one of the cases for the annulment of the marketing authorisation, have disappeared in such a way as to have disappeared. of the presentations of generic medicinal products that were part of the set, and in the others as the reference price of the set below the minimum threshold set out in paragraph 3 of this point.

2. The defined daily doses, as well as the presentations and their cost/treatment/day, taken into account for the calculation of the reference prices are those listed in Annex 3.

3. Furthermore, pursuant to the power conferred by the second subparagraph of paragraph 2 (2) and point (a) of Article 93 (6) of Law 29/2006 of 26 July, it is fixed at EUR 3,12 for the sale price to the public, including taxes, the threshold minimum of the reference prices covered by this Resolution.

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

For the purposes of applying the provisions of Article 5 of Order SPI/30 52/2010 of 26 November, the new presentations of medicinal products, which have been declared as Gallic innovations, are listed in Annex 4. excluded from the reference price system, as well as the corresponding period of exclusion.

3. Medicinal products whose declaration as a galenic innovation expires from the entry into force of this order

The presentations of medicinal products listed in Annex 5 to this Resolution, the declaration of which as a galenic innovation expires in the period from December 2011 to November 2012, will be incorporated into the from the first day of the month following the expiry of the said declaration, in accordance with the provisions of Article 93.5 of Law 29/2006 of 26 July 2010 and Article 5 of Order SPI/30 52/2010 of 26 July 2010, November.

4. Drug presentations with price higher than reference

1. In order to adapt to the provisions of the last indent of Article 93.2 of Law 29/2006 of 26 July, the presentation of medicinal products with a price higher than the reference price, will be supplied by the laboratories at an industrial price which is corresponds to one or less of the reference from day 17 of February 2012, inclusive. The National Code for the presentation of the medicinal product shall not be amended in these cases.

2. In the case of presentations of medicinal products forming part of the inactive assemblies as provided for in the preceding paragraph, it shall apply from the 50th calendar day following the notification by the Directorate-General of Pharmacy and Health Products to all interested parties the express declaration referred to in paragraph 2 of the Additional Provision of Order SPI/30 52/2010 of 26 November 2010.

5. Updating the information on the lower prices of homogeneous drug clusters

1. Therefore, under the last paragraph of Article 93.2 of Law 29/2006 of 26 July, the presentations of medicinal products affected by the reference prices may not exceed the reference price of the corresponding set. In such a case, in accordance with Articles 93.4 and 85.1 in accordance with the additional provisions of the 14th Law, where the abovementioned presentations are integrated into homogeneous groupings, the pharmacist shall dispense the presentation of the medicinal product with the lowest price.

2. Therefore, on the basis of the agreement reached on 16 December 2011 by the Standing Committee on Pharmacy, which considered it appropriate that the update of the lower prices should be matched with the application of the new reference prices, that this resolution produces its effects, the Directorate-General of Pharmacy and Health Products shall proceed, in accordance with the provisions of the additional fourteenth provision of Law 29/2006, of 26 July, to deal with the update of the information on the minor prices for the homogeneous groups of medicinal products.

6. Voluntary price reductions without modification of National Code

1. With regard to the presentations integrated in the homogeneous drug groupings, the laboratories may request the voluntary reduction of their prices, without modifying the National Code, and must inform the General Directorate of Pharmacy. and Sanitary Products of the Ministry of Health, Social Services and Equality through telematic registration through the http://registrotelematico.mspsi.es/ link within the ten calendar days since this Resolution produces its effects.

2. With regard to the presentations of medicinal products affected by this Resolution and not integrated into these homogeneous groupings, which the laboratories voluntarily decide to place on the market at a lower price than the reference price, they may do so without amend the National Code, and must also communicate it to the Directorate-General of Pharmacy and Health Products of the Ministry of Health, Social Services and Equality through the telematic register through the http://registrotelematico.mspsi.es/ within the ten calendar days since this Resolution produces its effects.

3. The Directorate-General for Pharmacy and Health Products of the Ministry of Health, Social Services and Equality may agree on an additional period of voluntary price reductions, in no case more than two calendar days, depending on the applications received, making public the agreement to be adopted through the website of the Ministry of Health, Social Services and Equality.

4. The presentations of medicinal products referred to in the preceding paragraphs shall be provided by the laboratories at the new price from 17 February 2012.

5. In the case of presentations of medicinal products forming part of inactive assemblies, the provisions of the preceding paragraph shall apply from the 50th calendar day following the notification by the Directorate-General of Pharmacy and Health Products to all interested parties the express declaration referred to in paragraph 2 of the first provision of the first provision of Order SPI/30 52/2010 of 26 November.

6. For medicinal products concerned by the provisions of paragraph 3 of this Resolution, the time limit laid down in the first three paragraphs shall be applied on the same terms, whereas the time limit laid down in paragraph 4 may apply from 50%. natural days prior to the date of expiry of the declaration of galenic innovation as set out in Annex 5, and must be supplied in any event from the first day of the month following that in which the declaration of innovation is produced; expiry of the declaration of Welsh innovation.

7. Coexistence of prices and return of stocks

1. Stocks of medicinal product presentations held by warehouses affected by the price reductions provided for in this Resolution may continue to be placed on the market at the previous price until 9 March 2012. inclusive.

2. The stocks of medicinal product presentations held by the pharmacy offices concerned by the price reductions provided for in this Resolution may continue to be placed on the market at the previous price up to 31 March 2012 inclusive.

3. In the case of presentations of medicinal products forming part of inactive assemblies, the time limits referred to in the preceding paragraphs shall be 70 calendar days for warehouses and 90 calendar days for pharmacy offices, and shall be computed from the moment when the General Directorate of Pharmacy and Health Products is notified of the express declaration referred to in paragraph 2 of the first provision of the SPI/30 52/2010 Order of 26 November 2010.

4. 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 The pharmacy, at no additional cost to them, may be returned to the pharmaceutical laboratories from the day following the end of the period referred to in paragraph 2, and in accordance with Article 8 of the said Royal Decree, stocks of the presentations with price on the packaging before the reductions established in this Resolution.

8. Expenditure funded from public funds through official medical prescription or dispensing order

1. The National Health System, including 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 On 31 March 2012 inclusive, the previous price of the medicinal products concerned as set out in point 1 for the purpose of invoicing and, in the case of exclusively, the part of the expenditure directly satisfied by that system. In addition, the current lower prices for homogeneous drug groupings will remain until that date, incorporating into the National Health System's billing nomenclature for pharmaceutical products corresponding to 1 April. 2012 the update of the lower prices of drug groups, as well as the new reference prices.

2. The new charges shall be settled with the new charges for the National Health System, including the special schemes referred to in the previous paragraph, which shall be closed from 1 April 2012.

3. In the case of presentations of medicinal products forming part of inactive assemblies, the date referred to in the first subparagraph shall be understood as the last day of the month in which the period referred to in the third paragraph of point 7 expires for the pharmacy offices, while the date referred to in the second paragraph shall be the date of the date of the next month.

9. Effects of Resolution

In accordance with Article 57.2 of Law 30/1992, of November 26, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, this Resolution will produce effects from the day of publication in the "Official State Gazette".

10. Resources

Under the provisions of Article 93.10 of Law 29/2006 of 26 July, and in accordance with Articles 114 and 115 of Law 29/1992 of 26 November, this Resolution may be appealed to the Registrar General of Health of the Ministry of Health, Social Services and Equality within one month.

Madrid, December 28, 2011. -Director General of Pharmacy and Healthcare Products, M. Dolores Vaquero García.

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