PROVISIONAL MEASURE NO. 2,063, OF December 18, 2000

Defines regulation norms for the medicine sector, institutes Formula Medicare Readjustment of Medicines-FPR, creates the Chamber of Medicines and gives other arrangements.

THE PRESIDENT OF THE REPUBLIC, in the use of the attribution that gives it the art. 62 of the Constitution, adopts the following Provisional Measure, with force of law:

Art. 1º This Provisional Measure establishes standards of regulation of the medicine sector, with the purpose of promoting assistance pharmaceuticals to the population, by means of mechanisms that stimulate the supply of medicines, the competitiveness of the sector and price stability.

Art. 2º Considerate companies producing medicinal products, for the purposes of this Provisional Measure, the industrial establishments which, operating on raw material or intermediate product, they modify them the nature, the finishing, the presentation or the purpose of the product, generating, by means of that process, medications.

§ 1º Equipped themselves to drug-producing companies:

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

II-the establishments, albeit retailers, which they receive for marketing, directly from the apportionment that released them, medications imported by another establishment of the same firm.

§ 2º The considered medicinal product every 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. 4º of Law No. 5,991 of December 17, 1973.

CHAPTER I

OF REGULATION ON MEDICATIONS

Section I

Of General Provisions

Art. 3º As of December 19, 2000 and until December 31, 2001, the drug producing companies will observe, for the readjustment of their prices, the rules set out in this Measure Provisional.

Paragraph single. No elevations of drug prices will be allowed during the period from December 19, 2000 to January 15, 2001.

Section II

From the Parametric Formula of Readjustment of Prices of FPR and Price Readjustment Medications

Art. 4º The Parametric Formula of Drug Readjustment-FPR, contained in the Attachment, defines the parameters for readjustments of drug prices, as well as establish the conditions determined by the price regulatory regime of which it treats this Provisional Measure.

Paragraph single. The formula referred to in the caput will determine the maximum value of the Medium Price Readjustment-RMP for all drug-producing companies, to be allowed in January 2001.

Art. 5º Each drug producing company, ranked as the difference, in absolute values, between its Average Price Evolution-EMP and the Parametric Index of Medicines- IPM, set out in the Annex, is to present to the Chamber of Medicines, by January 15, 2001, Report of Commercialization, containing:

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

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

III-classification of the company as per § 2º of this article and, when couber, the price readjustment for each presentation of medicinal products that it intends to practise for the month of January 2001, respected the parameters set out in the following article;

IV-list containing the maximum prices of the producing company, for each of the presentations of their medications, obtained from the parameters defined in this Provisional Measure;

V-documentation containing the information referred to in art. 11 of this Provisional Measure, concerning the period elapsed between August 1999 a to November 2000.

§ 1º The prices set out in the list referred to in inciso IV should be accompanied by the discriminated values of the following tributes:

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

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

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

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

I-Group I-composed of the companies that have presented EMP of the period equal to or greater than the IPM;

II-Group II-composed of the drug-producing companies that have submitted EMP of the period lower than the IPM.

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

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

II-for the companies classified in Group II:

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

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

c) price readjustments, by presentation of medicine, to be effected in January 2001, will not be able to exceed the resulting value of the multiplication by one integer and thirty five hundreth of the IPM, observed the limit set out in the "a" of this inciso.

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

Art. 7º The maximum prices set by the companies, for each presentation of medicine, in January 2001, will not be able to be raised until December 31, 2001, ressaving the provisions of the inciso I do art. 12 of this Provisional Measure.

Art. 8º When there is the inclusion of new product presentations to the list of products sold by the company, the initial unit prices will not be able to exceed the average price unitary of the existing presentations, and not to be elevated until December 31, 2001.

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

Art. 10. They shall be incorporated into the calculations of the prices of medicinal products of the companies subject to the regulatory regime of this Interim Measure the changes that occurred in the tributes referred to in § 1º of the art. 5º

Paragraph single. When the amendment referred to in caput results in a reduction of tributes, the benefiting company is expected to effect the reduction in the prices of medicines hit by the new systematic, in the form established by the Chamber of Medicines.

Section III

Dos Commercialization reports

Art. 11. They become the companies producing medicinal products obliged to submit to the Chamber of Medicines the Report of Commercialization, containing the relationship, by presentation, of the medicines sold by the company, the quantity sold of each product, its respective maximum and average prices, deducted from the tributes mentioned in § 1º of the art. 5^o, values paid in salaries and charges, as well as gross and liquid billing with medications, without prejudice to other information necessary for the monitoring of compliance with the provisions of this Interim Measure.

CHAPTER II

OF THE DRUG CHAMBER

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

I-judge the requests for extraordinary price readjustments;

II-decide by the exclusion of groups or classes of medications from the incidence of the regulation regime of which it treats this Provisional Measure;

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

IV-receive the Reports of Commercialization of the drug producing companies;

V-regulating the reduction of the prices of medications that are the object of tax reduction;

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

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

VIII-adopt the necessary measures for the fulfillment of this Provisional Measure.

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 Head of the Civil House, who will preside it;

II-the Minister of State for Justice;

III-the Minister of State for Finance; and

IV-the Minister of State of Health.

§ 2º Compose the Technical Committee:

I-the Secretary of Health Investments 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 Head of the Civil House.

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

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

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

II-instruct the applications, elaborating the decision proposals, which will be submitted to the Technical Committee's assessment, as defined in internal regiment of the House.

§ 5º Compete exclusively to the Council of Ministers the skills referred to in the incisies I, II and VIII of the previous article.

CHAPTER III

OF THE FINAL PROVISIONS

Art. 14. The Company that contravenes the rules on elevation and price reduction of medicinal products set out in this Provisional Measure shall be subject to the administrative penalties provided for in the 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 pursuant to this Interim Measure constitutes infringement punishable with 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. This Interim Measure shall come into force on the date of its publication.

Brasilia, December 18, 2000; 179º of Independence and 112º of the Republic.

FERNANDO HENRIQUE CARDOSO

Jose Gregori

Pedro Malan

José Serra

Attachment (s)