Law 25/1990, of 20 December, of the Medicamento, as amended by Law 13/1996, of December 30, of Fiscal, Administrative and Social Order Measures, establishes, in Article 94.6, the basis for the regulation of a the reference price system for which the financing of the presentations of bioequivalent medicinal products is governed by Social Security funds or by State resources affected by health.

Likewise, Law 66/1997, of December 30, of Fiscal, Administrative and Social Order Measures, adds to Article 94 (6) of the aforementioned Law of the Medicament a third paragraph in which it is determined that the (a) to replace the presentation of the prescribed medicinal product where the medicinal product exceeds the amount established as the reference price, except where the beneficiary opts for it.

This Royal Decree develops the provisions of these provisions, thus continuing the normative actions aimed at rationalizing the financing of medicines with public funds under conditions similar to those of other Community countries. The mandatory intervention of the Government in determining the reference prices, in accordance with the provisions of the first paragraph of Article 94.6 of Law 25/1990, is based on the action of the Commission Government for Economic Affairs.

The measures taken are compatible with Community law in the absence of any discriminatory treatment as to the origin of the products, whether they are national or other Member States of the European Union.

On the other hand, the reference price system is respectful of the interests of the citizens when the financing of the presentations of bioequivalent pharmaceutical specialties that do not exceed the amount fixed. Similarly, the balanced criteria laid down for their calculation and implementation, in which the specific characteristics of the Spanish market are taken into account, avoid the possible negative effects that this financing system could entail. the pharmaceutical sector.

This Royal Decree is dictated by the jurisdiction conferred on the State by Article 149.1.1. and 17. of the Constitution, and in the development of Article 94.6 of Law 25/1990 of 20 December of the Medication.

In its virtue, prior to the report of the Interterritorial Council of the National Health System, on the proposal of the Minister of Health and Consumer, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting on 18 June 1999,

DISPONGO:

Article 1. General provisions.

1. The present Royal Decree regulates the reference price system whereby the financing of the presentations of proprietary medicinal products will be governed by funds from Social Security or from State resources affected by health. include in the homogeneous assemblies that are determined by the Minister of Health and Consumer Affairs and which are prescribed and dispensed through official medical prescription to users who are entitled to it.

For the purpose of determining the homogeneous sets, it should be noted that the presentations of the proprietary medicinal products in them must be qualified as bioequivalent and must be in the same way, at least one generic pharmaceutical specialty.

The qualification of bioequivalence will be carried out by the Director of the Spanish Medicines Agency, and therefore consider the possibility of exchanging the specialties with each other due to the same composition. qualitative and quantitative in medicinal substances, pharmaceutical form, dosage, route of administration and therapeutic equivalence.

2. For the purposes of the preceding paragraph, the reference price shall be the maximum amount to be financed, either from Social Security funds or from State resources affected by the health, from the presentations of specialities (a) pharmaceutical products included in each of the homogeneous assemblies to be determined in accordance with the provisions referred to in that paragraph.

3. This Royal Decree does not apply, without prejudice to the provisions of the following Article, to non-bioequivalent medicinal products which shall be governed by the relevant rules applicable to them.

Article 2. Calculation of the amount of the reference price in each homogeneous set.

1. For the purposes of fixing the amounts of the reference prices, criteria shall be taken into account which shall apply to all the presentations of approved medicinal products, with the same qualitative and quantitative composition in medicinal substances, doses, pharmaceutical form, route of administration and presentation, whether or not they have a bioequivalent rating. These criteria are as follows:

(a) A reference price shall be calculated for each homogeneous set which shall be the weighted average of sales of the sales prices to the public, including taxes, of the minimum number of presentations of minor specialties price, necessary to reach a market share in units of 20 per 100.

(b) In cases where the difference between the price obtained and the highest price presentation of the homogeneous set considered is less than 10% of the price, the reference price shall be fixed as the reference price. decrease by 10 per 100 the highest price.

(c) If the difference between the presentation of the highest price of the homogeneous set considered and the reference value is greater than 50 per 100 of the first price, the reference price shall be the price of 50 per 100 of the highest price.

(d) In any case the reference price shall not be less than that of the presentation of the generic pharmaceutical specialty, which in the homogeneous set has a lower marketing price.

2. For the calculation of the weighted average the consumption in units by the Social Security shall be taken into account through offices of pharmacy, according to the latest available data referred to twelve months, and the marketing prices in force the last one of the same period.

Article 3. Approval and revision of the reference prices.

1. The Minister for Health and Consumer Affairs, after agreement of the Government Delegation for Economic Affairs, will approve the reference prices applicable to each of the homogeneous sets of presentations of proprietary medicinal products to the referred to in Article 1 of this Royal Decree. It shall also, at a minimum annual intervals, approve the corresponding new homogeneous assemblies which may be established as having been marketed, since the last agreement of the said collegiate body, previously non-existent presentations of generic pharmaceutical specialties.

2. The presentations of proprietary medicinal products which are authorised and which, by their characteristics, can be included in one of the existing homogeneous sets, will be integrated into the same from the moment of their marketing, an explicit declaration to effectively record such integration.

3. The Minister for Health and Consumer Affairs, after agreement of the Government Delegation for Economic Affairs, may revise the reference prices, taking into account the criteria set out in Article 2. In any case, the price of a reference for each homogeneous set shall be valid for at least one year.

4. The Ministry of Health and Consumer Affairs shall submit annually to the Government Delegation for Economic Affairs, a report on the changes in the amount of the reference prices as a result of the evolution of sales and the prices of the presentations included in the calculation for the purposes of the calculation.

Article 4. Labelling.

The presentations of the proprietary medicinal products which have the qualification of bioequivalents and which are included in a homogeneous set, shall bear the initials EQ in the seal coupon in order to ensure their correct identification and allow the effectiveness, if any, of the replacement provided for in Article 5 of this Royal Decree. The foregoing shall also apply to the presentations of generic proprietary medicinal products which, in addition, bear the initials EFG in accordance with the provisions of the third paragraph of Article 16.1 of Law 25/1990 of 20 December 1990. Medicinal product.

Article 5. Substitutions.

1. Where the presentation of the prescribed bioequivalent medicinal product exceeds the amount established as the reference price, the pharmacist must replace it with a generic pharmaceutical specialty of the same homogeneous set price does not exceed the reference price.

The above shall not apply in the case referred to in the second subparagraph of paragraph 3 of the following Article.

2. In addition and on an exceptional basis, the provisions of the first subparagraph of the previous paragraph shall not apply where the doctor accompanies the prescription of a detailed report in which he gives evidence of the origin of the replacement. for reasons of allergy, intolerance or any other incompatibility of the beneficiary to the change of excipient which may lead to the replacement of the prescribed speciality.

Article 6. Financing of presentations of proprietary medicinal products affected by reference prices.

1. The financing from the Social Security Funds or from State resources affected by the health of the pharmaceutical specialities affected by reference prices, as well as the corresponding contribution of the beneficiaries of the security Social, of the General Mutuality of Civil Servants of the State (MUFACE), of the Social Institute of the Armed Forces (ISFAS) and of the Judicial Mutual General (MUGEJU), will be governed by the provisions of the following paragraphs.

2. The presentations of the proprietary medicinal products included in homogeneous sets, the prices of which do not exceed the corresponding reference price, shall be the subject of financing from Social Security funds or from State resources affected by the health, in accordance with the provisions of the scheme applicable to them.

3. Presentations of proprietary medicinal products included in homogeneous sets whose prices exceed the corresponding reference price, shall only be the subject of financing from Social Security funds or from State resources affected by the health up to its reference price, and in accordance with the provisions of the scheme applicable to them.

Consequently, when at the request of the beneficiary, the presentation of a medicinal product prescribed by the physician and included in a homogeneous set, the price of which is higher than the corresponding reference, the the beneficiary will pay the difference between the price of the medicinal product dispensed and the reference fixed, in addition to making, where appropriate, the economic contribution which may correspond to it on the reference price.

4. In the case provided for in the second paragraph of Article 5 of this Royal Decree, the pharmaceutical specialty dispensed shall be financed from Social Security funds or from State resources affected by health, without prejudice to the the economic contribution, where appropriate, to satisfy the beneficiaries, on the sale price to the public of the speciality, on the basis of the arrangements applicable to them.

Additional disposition first. Marketing.

1. The marketing authorization holders of a generic medicinal product shall take the necessary measures to ensure that the specialty is marketed within four months of the authorization, without prejudice to the conditions laid down in the other obligations under Royal Decree 767/1993 of 21 May 1993 governing the assessment, authorisation, registration and conditions for the supply of proprietary medicinal products and other medicinal products for human use industrially.

2. The holders of a marketing authorization for a generic pharmaceutical specialty, granted on the date prior to the entry into force of this Royal Decree which has not been placed on the market on that date, shall have the right to do so four months from the date of validity of this Royal Decree.

Additional provision second. Basic character.

This Royal Decree is dictated by the jurisdiction attributed to the State in Article 149.1.1. a and 17. a of the Constitution, and develops article 94.6 of Law 25/1990, of December 20, of the Medicamento.

Final disposition first. Effectiveness of the requirement of incorporation of the acronym EQ in the seal coupon.

As from the date set out in the Order of the Minister for Health and Consumer Affairs for the determination of the homogeneous assemblies, the laboratories shall, at their headquarters, complete the requirement laid down in the Article 4 of this Royal Decree, either by using new cartonages, or by relabeling the current with adhesive labels.

Final disposition second. Faculty of development.

The Minister of Health and Consumer Affairs is empowered to dictate how many rules are necessary for the development of this Royal Decree.

Given in Madrid to June 18, 1999.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

JOSE MANUEL ROMAY BECCARIA