Law No. 10213, 27 March 2001

Original Language Title: Lei nº 10.213, de 27 de Março de 2001

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Law No. 10213, of 27 MARCH 2001 Sets regulatory standards for medicines, imposing the Parametric price adjustment Formula of Medicines-FPR, creates the Board of Medicines and other matters.
The PRESIDENT of the REPUBLIC do I know that the National Congress decrees and I sanction the following law: Art. 1° this law establishes rules for the regulation of medicinal products sector, with the purpose of promoting the pharmaceutical assistance to the population, through mechanisms that stimulate the supply of medicines, the competitiveness of the sector and price stability.
Art. 2° consider themselves producers of medicines, for the purposes of this law, industrial establishments, operating on raw material or intermediate product, modify them to nature, the finish, the presentation or the purpose of the product, generating, through this process, medicines.
(1) are the companies producing drugs: I-importing establishments of foreign origin that give out these products; and II-establishments, although retailers, they receive for marketing, directly from the distribution released, medicines imported by another establishment in the same firm.
§ 2 it is considered medicine every pharmaceutical product, technically obtained or prepared, with prophylactic, curative, palliative purpose or for diagnostic purposes, pursuant to item II of art. 4 of Act No. 5991, of 17 December 1973.
Chapter I of the REGULATION on MEDICINES section I General provisions Art. 3° from 19 December 2000 and until 31 December 2001, the companies producing medicines will notice, to reset their prices, the rules laid down in this law.
Sole paragraph. Will not be allowed price highs of medicines during the period between 19 December 2000 and 15 January 2001.
SECTION II of the Parametric price adjustment Formula of Medicines-FPR and price adjustment's Art. 4° the Parametric price adjustment Formula of Medicines-FPR, contained in the Annex, define the parameters for tariff adjustments of prices of medicines, as well as establishes the conditions determinants of price regulatory regime contemplated in this law.
Sole paragraph. The formula referred to in the caput shall determine the maximum average Price Adjustment-RMP for all companies producing medicines, be allowed in January 2001.
Art. 5° each manufacturer of medicines, classified as the difference, in absolute value, between the Average evolution of Prices-EMP and the Parametric Index of Medicines-IPM, defined in the Annex, shall submit to the Board of medicine, until 15 January 2001, Marketing Report, containing: I-EMP checked, for each company, in the period from August 1999 to November 2000 , and elements used in your calculation;
II-the difference, in absolute value, between the EMP and the IPM;
III-company as the # 2° of this article and, where applicable, the adjustment of rates for each submission of medicines that you intend to practise for the month of January 2001, respected the parameters set out in the following article;
IV-the list containing the maximum prices of the production company, to each of the presentations of their medicines, obtained from the parameters defined in this Act;
V-documentation containing the information referred to in art. 11 of the Act, for the period from August 1999 to November 2000.
§ 1° the prices appearing on the list referred to in subparagraph (IV) should be accompanied by detailed values of the following taxes: (I)-contribution to the Social Integration and training programs of the wealth of the public server-PIS/PASEP;
II-contribution to Social security financing-COFINS; and III-Operations tax relating to the movement of goods and on services Interstate and Inter-municipal transportation and communication-ICMS.
§ 2 The companies producing medicines will be classified in the following groups: I-group I-comprised of companies that have presented EMP the period equal to or greater than the IPM;
II-Group II-comprised of companies producing medicines that have presented EMP of the period below the IPM.
Art. 6° in January 2001, accomplished fully the requirement that it is the caput of the previous article, the adjustments of prices of medicines, allowed for each company, will observe the following criteria: I-for companies classified in Group I shall not be allowed price highs;
II-for companies classified in Group II: a) will be allowed to the extent of the RMP difference, in absolute value, between the EMP of each company and the IPM for the period;
b) will not be permitted RMP greater than the value of IPM;
(c)) the price adjustments, for production of medicine, to be carried out in January 2001, may not exceed the value resulting from the multiplication by an integer and 35 hundredths of IPM, subject to the limit set in paragraph "a" of this item.
Sole paragraph. In any case the prices of medicines should be readjusted in accordance with the rules set out in annex adjustment.
Art. 7 The maximum prices set by the companies, for each presentation of the medicinal product, in January 2001, will not be lifted until 31 December 2001, except for the provisions of paragraph 1 of art. 12 of this law.
Art. 8 when the inclusion of new presentations of medicines to the list of products sold by the company, the initial unit price may not exceed the average unit prices of existing presentations and not be raised until 31 December 2001.
Art. 9 when the inclusion of new products to the list of products sold by the company, the price cannot be raised until 31 December 2001.
Art. 10. Will be incorporated into the calculation of prices of medicines of the companies subject to this law the regulatory regime changes in the taxes referred to in §1 of art. 5.
(1) when the change referred to in the caput result in reduced taxes, company shall benefit the reduction in prices of medicines affected by the new rules in the form established by the Board of medicine.
(2) for the purposes of the special use of the presumed tax credit established by art. 3 of law No. 10147, of 21 December 2000, are exempted from the conclusion of commitment of conduct adjustment provided for that device, the companies producing drugs that meet the established by the Board of Medicine in the form of this article.
Section III of the Art Marketing Reports. 11. Are the drug companies must submit to the Board of Medicines marketing report, containing the relationship, for presentation, of medicinal products sold by the company, the quantity sold of each product, their respective maximum and average prices, "the cost of raw materials purchased", minus the taxes referred to in §1 of art. 5, amounts paid in salaries and charges, as well as the gross and net revenues with medicines, without prejudice to any other information necessary for the monitoring of compliance with the provisions of this law.
CHAPTER II of the MEDICINES. 12. Is created the Board of Medicines with the following skills: I-judge applications for extraordinary adjustments of prices;
II-decide by the exclusion of groups or classes of medicines of the incidence of the regulation of this Law;
III-set documents to be submitted by the companies producing medicines marketing reports, as well as the periodicity of submission of reports and their procedures for delivery and analysis;
IV-receive reports of marketing of companies producing medicines;
V-to regulate prices for medicines that are object of tax reduction;
VI-to decide on the application of the administrative sanctions provided for in arts. 14:15 of this law, in the form of regulation;
VII-to elaborate the internal regulations, regulating its operation, the criteria for granting extraordinary adjustment, as well as the procedures for submitting applications, education and trial;
VIII-to adopt the measures necessary to comply with this law.
Art. 13. The Board of Medicines will be composed by the Council of Ministers and by the Technical Committee.
(1) the Council of Ministers: (I)-the Chief of staff, that the presiding;
II-the Minister of State for Justice;
III-the Minister of finance; and IV – Minister of State for health.
(2) make up the Technical Committee: I-investment management Secretary in the Health 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 Cabinet, appointed by the Chief of staff.
(3) the decisions of the Council of Ministers shall be taken by unanimity.
§ 4 the Board of Medicine will have an Executive Secretariat, to be exercised by the Ministry of health, with the following responsibilities:

I-receive requests from companies subject to this Law, for the grant of extraordinary price increases;
II-instruct applications, developing proposals for decision, which will be submitted to the Technical Committee, as defined in the internal regulations of the Board.
§ 5 lies entirely to the Council of Ministers the powers referred to in sections I, II and VIII of the previous article.
CHAPTER III FINAL PROVISIONS Art. 14. The company that infringe the rules on lifting and lowering of prices of medicinal products laid down in this law shall be subject to administrative sanctions provided for in art. 56 of law No. 8078, to September 11 1990.
Art. 15. refusal, default, enganosidade, or unjustified delay of information or documents required under this Law constitutes infraction punishable by a daily fine of 10000.00 R$ (10000), and may be increased by up to 20 times, if necessary, to ensure its effectiveness.
Art. 16. Get convalidados the acts performed on the basis of provisional measure no. 2,138-4, 23 February 2001.
Art. 17. This law shall enter into force on the date of its publication.
Brasília, 27 March 2001; 180 degrees of independence and 113 of the Republic.
FERNANDO HENRIQUE CARDOSO José Gregori Amaury Guilherme Bier José Serra ANNEX 1? PARAMETRIC PRICE ADJUSTMENT FORMULA OF MEDICINES? FPR: 1) If EMP ³ IPM then: a) RMP = 0; and (b)) January 2001 Price £ Price November 2000.

1) If EMP £ IPM then: a) RMP = IPM? EMP, being necessarily RMP £ IPM;
b) upper limit for the readjustment of each submission of medicine = 1.35 IPM;
c) January 2001 Price = price November 2000 X (1 + rate reset unit of presentation of each drug).

2. COMPONENTS of the formula: 2.1) Average price Developments? EMP EMP = S n (FPi x DPiEMP), i = 1 where:) i represents each of the presentations of medicines produced by the company producer of medicines; 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 accumulated turnover between 1st November 1999 and 31 October 2000 from the sale of the presentation i and is calculated as follows: Oct/00 Fi = S (Pij x Qij) , j = nov/99 where: b. 1.1) Pij is the average price of the presentation i in j j month ranging between November 1999 and October 2000; and (b). 1.2) is the quantity sold of Qij presentation i in j j month ranging between November 1999 and October 2000.
c) DPiEMP represents the percentage change in price of the presentation i between 1 August 1999 and 30 November 2000 and is calculated as follows: DPiEMP = (Pinov/00? Piago/99) x 100, where: Piago/99 c. 1) Piago/99 is the maximum price of the presentation i in August 1999; and c. 2) Pinov/00 is the maximum price of the presentation i in 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:) i and FPi are defined as in section 2.1; and (b)) DPiRMP represents the percentage change in price of the presentation i between 1 November 2000 and 31 January 2001 and is calculated as follows: DPiRMP = (Pijan/01? Pinov/00) x 100, Pinov/00 where: b. 1) Pinov/00 is the maximum price of the presentation i in November 2000; and b. 2) Pijan/01 is the maximum price of the presentation i in January 2001.

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