LEI No. 10,742, DE October 6, 2003.

Defines regulation standards for the pharmaceutical sector, creates the Medicare Market Regulation Chamber-CMED and amends Law No. 6,360 of September 23, 1976, and gives other arrangements.

THE PRESIDENT OF THE REPUBLIC

I make it known that the National Congress decrees and I sanction the following Law:

Art. 1º This Act sets out regulatory standards for the pharmaceutical sector, with the purpose of promoting pharmaceutical assistance to the population, by means of mechanisms that stimulate the supply of medicines and the competitiveness of the sector.

Art. 2º Applies the provisions of this Act to companies producing medicinal products, pharmacies and drugstores, representatives, distributor of medicinal products, and, likewise, to any legal persons of public or private law, including associations of entities or persons, constituted in fact or in law, albeit temporarily, with or without legal personality, which, in some way, act in the pharmaceutical sector.

Art. 3º For the purposes of this Act, the following definitions are adopted:

I-pharmacy-establishment of magistral and workshop drug manipulation, drug trade, pharmaceuticals, pharmaceutical inputs, and correports, understanding of dispensation and the deprivation of unit care hospital or any other equivalent of medical assistance, in the terms of art's inciso X. 4º of Law No. 5,991 of December 17, 1973 ;

II-drogaria-establishment intended for the dispensation and trade of drugs, medications, pharmaceutical inputs and correports in their original packaging, pursuant to the inciso XI of the art. 4º of Law No. 5,991, 1973 ;

III-representative and distributor-company that directly or indirectly exercises wholesale trade in drugs, medications in their original packaging, pharmaceutical inputs and correlation, pursuant to the inciso XVI of the art. 4º of Law No. 5,991, 1973 ;

IV-medicinal product-every pharmaceutical product, technically obtained or elaborate, with prophylactic, curative, palliative purpose or for diagnostic purposes, in the terms of the inciso II of the art. 4º of Law No. 5,991, 1973 ; and

V-companies producing medicinal products-industrial establishments which, operating on raw material or intermediate product, modify them the nature, finish, presentation or purpose of the product, generating, by half of that process, medications.

Single Paragraph. They have equipped themselves with medicinal products companies the importing establishments of foreign provenance medicines that have records of the respective imported products together with the National Health Surveillance Agency-Anvisa.

Art. 4º Medical-producing companies should observe, for the adjustment and determination of their prices, the rules set out in this Act, from their publication, staying vetoed at any adjustment at odds with this Act.

§ 1º The price adjustment of medicines will be based on price-ceiling model calculated based on an index, on a productivity factor and on an intra-sector relative price adjustment factor and across sectors.

§ 2º The index used, for the purposes of the adjustment provided for in § 1º, is the National Index of Broad Consumer Prices-IPCA, calculated by the Brazilian Institute of Geography and Statistics-IBGE.

§ 3º The productivity factor, expressed in percent, is the mechanism that allows you to pass on to consumers, through drug prices, productivity gains projections from drug-producing companies.

§ 4º The relative price adjustment factor, expressed in percent, is composed of two installments:

I-the share of the intra-sector relative price adjustment factor, which will be calculated on the basis of market power, which is determined, among others, by the monopoly power or oligopoly, in the information asymmetry and in the barriers to entry ; and

II-the share of the relative price adjustment factor between sectors, which will be calculated on the basis of the variation in inputs costs, provided that such costs are not recovered by the statement of the index provided for in § 2º of this article.

§ 5º Compete to the Board of Regulation of the Medicines Market-CMED, created by art. 5º of this Act, propose composition criteria of the factors referred to in § 1º, as well as the degree of breakdown of such factors, whether by product, by relevant market or by groups of relevant markets, to be regulated until December 31 of 2003, in the form of art. 84 of the Federal Constitution.

§ 6º CMED will give transparency and publicity to the criteria referred to in § § 1º and 2º of this article.

§ 7º The price adjustments will occur annually.

§ 8º The first adjustment, based on the criteria set out in this Act, will occur in March 2004, considering, for the purpose of this adjustment:

I-the manufacturer price of the medicine on August 31, 2003 ; and

II-the IPCA accrued from September 2003, inclusive.

§ 9º Exceptionally, the CMED Council of Ministers may authorize a positive price adjustment or determine a negative adjustment on August 31, 2003, having as a reference the manufacturer price on March 31, 2003.

Art. 5º It is created the Board of Government Regulation of the Medicines Market-CMED, which has for objectives the adoption, implementation and coordination of activities concerning the economic regulation of the medicinal products market, aimed at promoting the pharmaceutical assistance to the population, by means of mechanisms that stimulate the supply of medicines and the competitiveness of the sector.

Single Paragraph. The composition of CMED will be defined in act of the Executive Power.

Art. 6º Compete for CMED, among other acts necessary to achieve the goals to which this Act is intended:

I-define guidelines and procedures relating to the economic regulation of the medicinal products market ;

II-establish criteria for fixing and adjusting prices of medicines ;

III-define, with clarity, the criteria for fixing the prices of new products and new presentations of medicinal products, in the terms of art. 7º;

IV-decide on the exclusion of groups, classes, subclasses of medicinal products and pharmaceuticals from the incidence of establishment criteria or price adjustment, as well as to decide by the eventual reinclusion of groups, classes, subclasses of medicines and pharmaceutical products to the incidence of determination criteria or price adjustment under this Act ;

V-establish criteria for fixing marketing margins of medicinal products to be observed by the representatives, distributors, pharmacies and drogaries, including from the margins of pharmacies specifically aimed at the private care of hospital unit or any other medical assistance equivalent ;

VI-coordinate actions of the CMED component organs aimed at the implementation of the intended objectives in art. 5º;

VII-suggest the adoption, by the competent bodies, of guidelines and procedures aimed at implementing the policy of access to medicines ;

VIII-propose the adoption of legislations and regulations regarding economic regulation of the medicinal products market ;

IX-opinion on regulations involving taxation of medicines ;

X-ensure the effective repass to the prices of the medicines of any alteration of the tax burden ;

XI-suggest the celebration of international agreements and arrangements concerning the medicinal products sector ;

XII-monitor, for the purposes of this Act, the market for medicinal products, and may, for so much, request information on production, inputs, raw materials, sales and any other data that it believes necessary for the exercise of this competence, in power of persons of public or private law ;

XIII-to care for the protection of the consumer's interests of medications ;

XIV-decide on the application of penalties provided for in this Act and, in respect of the medicinal products market, those provided for in Law No. 8,078 of September 11, 1990, without prejudice to the powers of the other organs of the National Consumer Defense System ;

XV-draw up your internal regiment.

Art. 7º From the publication of this Act, new products and new presentations of medicines that come to be included in the list of products marketed by the producing company should note, for the purposes of setting initial prices, the criteria established by CMED.

§ 1º For purposes of the calculation of the price referred to in the caput of this article, CMED will use the information provided to Anvisa on the occasion of the application for registration or its renewal, without prejudice to other ones that come under she requested.

§ 2º CMED will regulate deadlines for price analyses of new products and new presentations.

Art. 8º The discompliance of acts emanating from CMED, in the exercise of its regulatory and monitoring skills of the medicinal products market, as well as the standard discompliance provided for in this Act, subject to the administrative penalties provided for in art. 56 of Law No. 8,078, 1990.

Single Paragraph. The refusal, omission, falseness or unwarranted retardation of information or documents required under this Act or by act of CMED, subject to the daily fine of R$ 10,000.00 (ten thousand reais), and may be increased by up to 20 (twenty) times, if necessary, to ensure effectiveness.

Art. 9º It is extinguished the Chamber of Medicines, created by Law No. 10,213 of March 27, 2001, whose competencies and assignments are absorbed by CMED.

Single Paragraph. The processes, documents and other expedients concerning the competencies and assignments absorbed by CMED will have their plan for disciplined.

Art. 10. Law No. 6,360 of September 23, 1976 passes vigorously with the following changes:

" Art. 16. The registration of drugs, medications, pharmaceutical inputs and correports, given their health, medicamentous or prophylactic, healing, palliative, or even diagnostic purposes, is subject, in addition to the care of the own requirements, the following specific requirements:

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VII-submitting the following economic information:

a) the price of the product practiced by the company in other countries ;

b) the acquisition value of the active substance of the product ;

c) the cost of treatment per patient with the use of the product ;

d) the potential number of patients to be treated ;

and) the price list that you intend to practice in the domestic market, with the discrimination of your tax burden ;

f) the discrimination of the product marketing proposal, including the planned spending on the sales effort and with advertising and advertising ;

g) the price of the product that has undergone modification, when it is a change of formula or form ; and

h) the relation of all existing substituted products on the market, accompanied by their respective prices.

§ 1º (Revised as a single paragraph by Law No. 6,480, from 1º December 1977).

§ 2º The presentation of the information contained in inciso VII may be dispensed, in part or in whole, in accordance with specific regulations. " (NR)

" Art. 22. Drugs, pharmaceuticals and pharmaceutical inputs containing narcotic substances or determine physical or psychic dependence, being subject to the special control provided for in Decree-Law No 753 of August 11, 1969, as well as in other legal diplomas, regulations and other relevant standards, and medications in general, will only be registered or have their records renewed, if, in addition to the fulfillment of the conditions, the requirements and the procedure set out in this Act and its regulation, their packaging and their labelling fall into the standards approved by the Ministry of Health. " (NR)

" Art. 23. (Revoked). "

" Art. 24. They are exempt from registration the new medicines, intended exclusively for experimental use, under medical control, and may even be imported upon express permission from the Ministry of Health.

.................................................. " (NR)

Art. 11. The realization of the meeting of accounts between the Union and Petroleum Brazilian S.A. -Petrobrás, predicted at art. 74 of Law No. 9,478 of August 6, 1997, is expected to occur by June 30, 2004.

Art. 12. This Act shall enter into force on the date of its publication.

Art. 13. They stay revoked the art. 23 of Law No. 6,360 of September 23, 1976, Law No. 10,213 of March 27, 2001 and the Provisional Measure No. 2,230 of September 6, 2001.

Brasilia, October 6, 2003 ; 182º of Independence and 115º of the Republic.

LUIZ INACIO LULA DA SILVA

Marcio Thomaz Bastos

Antonio Palocci Filho

Humberto Sérgio Costa Lima

José Dirceu de Oliveira e Silva