LEI No. 10,213, DE March 27, 2001

Defines regulation norms for the sector of medicinal products, institutes the Parametric Formula of Medicines Price Adjustment-FPR, creates the House of Medicines 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. 1 ° This Act lays down rules for regulating the medicinal products sector, with the purpose of promoting pharmaceutical assistance to the population, by means of mechanisms that stimulate the supply of medicines, the competitiveness of the sector and the stability of prices.

Art. 2 ° Consider companies producing medicinal products, for the purposes of this Act, the industrial establishments which, operating on raw material or intermediate product, modify them the nature, finish, presentation or purpose of the product by generating, by means of that process, medications.

§ 1º Equipped for medicinal products companies:

I-the importing establishments of foreign provenance medicinal products that give way to these products ; and

II-the establishments, even if retailers, that they receive for commercialization, directly from the distribution that has released them, medicines imported by another establishment of the same firm.

§ 2º Consider medicinal product all pharmaceutical product, technically obtained or elaborated, with prophylactic, curative, palliative purpose or for diagnostic purposes, in the terms of the inciso II of the art. 4 ° of Law No. 5,991 of December 17, 1973.

CHAPTER I

OF REGULATION ON MEDICATIONS

SETION I

Das General Provisions

Art. 3 ° As of December 19, 2000 and until December 31, 2001, the companies medicinal producers will observe, for the readjustment of their prices, the rules set out in this Act.

Single Paragraph. No price increases will be allowed for medications during the period between December 19, 2000 and January 15, 2001.

SETION II

Of The Parametric Formula of Price Readjustment of Medicinal Products-FPR and Price Readjustment

Art. 4 ° The Parametric Formula of Commodity Prices Adjustment-FPR, contained in the Annex, defines the parameters for price readjustments of medicinal products, as well as lays down the determinants of the regulatory regime of prices that it treats this Act.

Single Paragraph. The formula referred to in caput will determine the maximum value of the Average Price Readjust-RMP for all pharmaceutical producing companies, to be allowed in January 2001.

Art. 5 ° Each medicinal producer, classified as the difference, in values absolutes, between its Average Prices-EMP Evolution and the Parametric Index of Medicinal Products-IPM, set out in the Annex, is expected to present to the House of Medicinal Products, by January 15, 2001, Marketing Report, containing:

I-EMP verified, for each company, in the period between August 1999 and November of 2000, and the elements used in their calculation ;

II-the difference, in absolute value, verified between the EMP and the IPM ;

III-classification of the Company as per § 2 of this article and, when couber, the price adjustment for each presentation of medications that you intend to practice for the month of January 2001, respected the parameters set out in the following article ;

IV-list containing the maximum prices of the producer company, for each of the presentations of its medications, obtained from the parameters defined in this Act ;

V-documentation containing the information referred to art. 11 of this Act, referring to the period elapsed between August 1999 a to November 2000.

§ 1 The prices listed on the list to which the inciso IV refers should be accompanied by the values discriminated against the following tributes:

I-Contribution to the Social Integration and Formation Programs of Public Server Heritage -PIS/PASEP;

II-Contribution to the Financing of Social Security-COFINS ; and

III-Taxation on Operations Relative to the Circulation of Goods and on Service Prestations of Interstate and Intermunicipal Transportation and Communication-ICMS.

§ 2º Medicinal producing companies will be classified in the following Groups:

I-Group I-made up of the companies that have submitted EMP of the period equal to or higher than IPM ;

II-Group II-made up of the medicinal producing companies that have submitted EMP of the lower period than IPM.

Art. 6 ° In January 2001, comply fully with the requirement that it treats the caput of the previous article, the price readjustments of medicines, permitted for each company, will observe the following criteria:

I-for companies classified in Group I will not be allowed price elevations ;

II-for companies classified in Group II:

a) will be allowed RMP up to the limit of difference, in absolute value, between the EMP of each of the companies and the IPM of the period ;

b) will not be allowed RMP higher than the value of the IPM ;

c) the price adjustments, by presentation of medicinal product, to be effected in January 2001, will not be able to exceed the value resulting from the multiplication by an integer and thirty-five hundredths of the IPM, observed the limit set out in paragraph "to" this inciso.

Single Paragraph. In any case, the prices of medicinal products should be adjusted in accordance with the rules of readjustment set out in the Annex.

Art. 7º The maximum prices fixed by the companies, for each drug presentation, in January 2001, will not be able to be high until December 31, 2001, ressaved the provisions in the inciso I of the art. 12 of this Act.

Art. 8º When there is the inclusion of new product presentations to the list of products sold by the company, initial unit prices will not be able to exceed the average unit prices of the existing presentations, and nor be high up to 31 of December 2001.

Art. 9º When there is the inclusion of new products to the list of products sold by the company, the initial price cannot be raised until December 31, 2001.

Art. 10. Changes occurring in the tributes referred to in § 1º of the art shall be incorporated into the calculations of the prices of medicinal products of the companies subject to the regulatory regime of this Act. 5º.

§ 1º When the change to which you refer to caput results in reduced tributes, the company benefited should make the reduction in the prices of medicines hit by the new systematic, in the form established by the House of Medicines.

§ 2º For the purposes of the special scheme for the use of the tax presumed tax instituted by the art. 3º of Law No. 10,147 of December 21, 2000, shall be exempted from the conclusion of commitment to adjustment of conduct, provided for in that device, the producing companies of medicinal products which comply with the systematic establishment established by the Chamber of Medications in the form of this article.

Section III

From Commercialization Reports

Art. 11. They are companies producing medicinal products required to submit to the Chamber of Medicines the Marketing Report, containing the relationship, by presentation, of the medicines sold by the company, the quantity sold out of each product, its respective maximum and average prices, "the cost of the raw material acquired", deducted from the tributes mentioned in § 1º of the art. 5º, values paid in wages and charges, as well as gross and liquid billing with medicinal products, without prejudice to other information required for the monitoring of compliance with the provisions of this Act.

CHAPTER II

DA MEDICINE CHAMBER

Art. 12. It is created the Chamber of Medicines with the following competencies:

I-judge the requests for extraordinary price readjustments ;

II-decide on the exclusion of groups or classes of medicines from the incidence of the regulation regime of which it treats this Act ;

III-define the documents to be submitted by the medicinal companies in the Reports of Marketing, as well as the periodicity of the submission of the reports and the respective procedures for delivery and analysis ;

IV-receive the Marketing Reports of the medicinal products producing companies ;

V-regulate the reduction in prices of medicinal products that are the subject of reducing tributes ;

VI-decide on the implementation of the administrative penalties provided for in the arts. 14 and 15 of this Act, in the form of the Regulation ;

VII-elaborating the internal regiment, regulating its functioning, the criteria for granting of extraordinary readjustment, as well as procedures for submission of applications, instruction and judgment ;

VIII-adopt the measures necessary for the fulfilment of this Act.

Art. 13. The Chamber of Medicines will be composed of the Council of Ministers and the Technical Committee.

§ 1º Compose the Council of Ministers:

I-the Chief of the Civil House, who will chair him ;

II-the Minister of State for Justice ;

III-the Minister of State of the Farm ; and

IV-the Minister of State for Health.

§ 2º Compose the Technical Committee:

I-the Secretary for Investment Management in Health of the Ministry of Health ;

II-the Secretary of Economic Law of the Ministry of Justice ;

III-the Secretary of Economic Monitoring of the Ministry of Finance ; and

IV-a representative of the Civil House, designated by the Chief of the Civil House.

§ 3º The decisions of the Council of Ministers shall be taken by unanimity.

§ 4º The Chamber of Medicines will have a Secretariat-Executive, to be exercised by the Ministry of Health, with the following assignments:

I-receive the applications of the companies submitted to the scheme that it treats this Act, for the granting of extraordinary price increases ;

II-instruct the applications, drawing up the proposals for a decision, which will be submitted to the Technical committee, as defined in internal House regiment.

§ 5º It is solely for the Council of Ministers to the competences referred to in the incisos I, II and VIII of the previous article.

CHAPTER III

DAS FINAL PROVISIONS

Art. 14. The company that contravenes the rules on raising and reducing prices of medicinal products set out in this Act shall be subject to the administrative penalties provided for in art. 56 of Law No. 8,078 of September 11, 1990.

Art. 15. The refusal, omission, deceptiveness, or unwarranted retardation of information or documents required under this Act constitutes infraction punishable by a daily fine of R$ 10,000.00 (ten thousand reais), and may be increased by up to twenty times, if necessary, to ensure its effectiveness.

Art. 16. The acts practiced on the basis of the Provisional Measure No. 2.138-4, of February 23, 2001, shall be convalidated.

Art. 17. This Act shall enter into force on the date of its publication.

Brasilia, March 27, 2001 ; 180º of the Independence and 113º of the Republic.

FERNANDO HENRIQUE CARDOSO

Jose Gregori

Amaury Guilherme Bier

Jose Serra

ANNEX

1? PARAMETRIC FORMULA OF PRICE READJUSTMENT OF MEDICINES? FPR:

1) If EMP ³ IPM then:

a) RMP = 0 ; and

b) Price January 2001 £ Price November of 2000.

1) If EMP £ IPM then:

a) RMP = IPM? EMP, being compulsorily RMP £ IPM ;

b) upper limit for the readjustment of each product presentation = 1.35 of the IPM ;

c) Price January 2001 = Price November 2000 X (1 + unitary rate of readjustment of the presentation of each medicinal product).

2? COMPONENTS OF THE FORMULA:

2.1) Average Prices Evolution? EMP

n

EMP = S (FPi x DPiEMP),

i= 1

where:

a) i represents each of the presentations of the medicines produced by the medicinal producer company ; and

b) FPi represents the weighting factor of the presentation i and is calculated as follows:

Fi

FPi = _____,

n

S Fi

i= 1

where:

b.1) Fi represents the cumulative billing between 1º November from 1999 and October 31, 2000 obtained with the sale of the presentation i and is calculated as follows:

out/00

Fi = S (Pij x Qij),

j=nov/99

where:

b.1.1) Pij is the average price of the presentation i on month j, with j varying between November 1999 and October 2000 ; and

b.1.2) Qij is the quantity sold from the presentation i in month j, with j varying between November 1999 and October 2000.

c) DPiEMP represents the variation percentage of the price of the presentation i between 1º August 1999 and November 30, 2000 and is calculated as follows:

DPiEMP = (Pinov/00? Piago/99) x 100,

Piago/99

where:

c.1) Piago/99 is the maximum price of the presentation i in the month of August 1999 ; and

c.2) Pinov/00 is the maximum price of the presentation i in the month of November 2000.

2.2) Parametric Index of Medicines? IPM = 4.4%.

2.3) Average price adjustment? RMP, calculated as follows:

n

RMP = S (FPi x DPiRMP),

i=n

where:

a) i and FPi are defined as in the in 2.1 ; and

b) DPiRMP represents the variation percentage of the price of the presentation i between 1º November 2000 and January 31, 2001 and is calculated as follows:

DPiRMP = (Pijan/01? Pinov/00) x 100,

Pinov/00

where:

b.1) Pinov/00 is the maximum presentation price i in the month of November 2000 ; and

b.2) Pijan/01 is the maximum presentation price i in the month of January 2001.