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Drug Registration in BrazilThursday, July 28, 2005 08:00 IST Product registration in Brazil is a lengthy task. Only companies with local operations have standing to apply for registration of medical products. Depending on the product, the registration may be valid from two to five years and can be renewed continuously for the same period. In the case of pharmaceutical drugs, one must inform the active and inactive ingredients. Instructions, directions, cautions, labels, brochures, and pertinent information about the products must be translated into Portuguese. The product registration process often takes more than one year. If the process takes longer than three months, importers and producers are allowed to use a protocol number provided by the Brazilian authorities to distribute their products in Brazil. Only countries that offer incentives for the registration of generics/copies/similars are Argentina, Brazil and Chile. These three countries discount the registration application fee for generic drugs and in addition Brazil offers a shorter evaluation time for generic and similar products. The cost of registering a product is $27,000 as on March, 2005. According to the Brazilian legislation, the production, manufacturing, imports, exports and sales of any medical, pharmaceuticals and cosmetics products can only be handled by authorized companies, registered with the ANVISA - National Sanitary Vigilance Agency, an agency of the Brazilian Ministry of Health. Manufacturers have to disclose to the local authorities, through their agents (local distributors), the quantitative and qualitative formula of their products, which should be patented in Brazil before the product is introduced into the market, and at the time of registration. This has to be described on the registration document. Time & Fees The length of time taken to approve drugs in each country is different. All countries in Latin America, except Brazil, Chile and Cuba have shorter drug approval time than more developed countries, such as Australia (17 months), countries in European Union (14-30 months), Canada (17 months) and USA (14 months). The cost of registering a product is low in Latin America. While Chile offer higher fees for the registration of generics and similars than for the registration of a new product; Brazil offer incentives for the registration of generics/copies/similars and discount the registration application fee for generic drugs. Time and Cost for registering a pharmaceutical product in Latin American Countries
Source: HNP Discussion Paper (World Bank) Types of Product Registration For registration purposes, ANVISA classifies products in the following categories (Law 9.782/99): 1. Medicine Products (Drugs): for human use, their active substances and other inputs; 2. Pharmaceutical Raw Materials: drugs or raw materials to be used in medicines. 3. Health Product: Medical-hospital, Odontological and Hemotherapic equipment and materials and those intended for laboratory and image diagnosis. Drugs Classifications " New Medicine Product: Innovative product that has patent protection whose efficiency, safety and quality have been scientifically proven and identified by its brand. " Similar product: A product which contains the same active principle or principles in the same concentration with the same pharmaceutical form, manner of administration, posology and therapeutic, preventive or diagnostic indication as the reference medication registered with the Agency. " Generic Product: Medication similar to a reference product or innovative product with which it is intended to be exchangeable, generally produced after the expiry or waiver of patent protection or other exclusive rights, with its efficacy, safety and quality having been scientifically proven, and named in accordance with the Common Brazilian Name Listing (DCB) or the Common International Name Listing (DCI). Documentation Needed for Registration The followings are the basic documents required from the local agent of the foreign company for the registration of products in Brazil. " Application form obtained from the Brazilian Ministry of Health. " Original copy of the machine stamped bank slip, which serves as proof of registration fee payment. " Trade Permit ("Alvará de Funcionamento") issued by the State authority to the manufacturer's distributor. " Same type of document ("Autorização de Funcionamento"), issued by the Federal authority to the manufacturer's distributor. " Document showing the technical responsibility of the distributor/ manufacturer, issued by the certification entity. " Technical Report on the product, informing the components of the formula, instructions, directions, cautions, etc. " Label sample, brochures, pertinent information about the products, all translated into Portuguese; " For products not clearly mentioned in the Brazilian law, it is mandatory to provide information about their utilization in order to demonstrate its efficacy and safety; " Copy of the registration granted to the products at the country of origin (or copy of the Free Sale Certificate); " Copy of legal document, by which the manufacturer authorizes its distributor to trade and distribute the products. " If a medical equipment, all documents showing product safety, country of origin, detailed (exploded view) of the equipment's inner parts and user manual, have to be presented for registration. Registration of Company in Brazil Setting up new companies is relatively easy and inexpensive in Brazil. There are four steps to launch business viz. procedures required to establish a business, the associated time and cost, and the minimum capital requirement. Entrepreneurs can expect to go through 17 steps to launch a business over 152 days on average, at a cost equal to 11.7 per cent of gross national income (GNI) per capita. There is no minimum deposit requirement to obtain a business registration number, compared with the regional average of 28.9 per cent of GNI and OECD average of 44.1 per cent of GNI. A company should go for registration if any of the following parameters exists " It is a limited liability company " It operates in the country's most populous city " The business is 100 per cent domestically owned and has five owners, none of whom is a legal entity " It has a start-up capital of 10 times income per capita at the end of 2003, paid in cash " It leases the commercial plant and offices and is not a proprietor of real estate " It does not qualify for investment incentives or any special benefits " The business has up to 50 employees one month after the commencement of operations, all of them nationals " The turnover is at least 100 times income per capita, and " The business has a company deed 10 pages long. Regulatory Issues In the early 1990s, the market for pharmaceuticals in Brazil was slackening. In the mid-1990s, it was realized that drug prices had risen substantially and some control was needed to be reintroduced. The failure of market forces in relation to pharmaceuticals is attributable to the fact that pharmaceuticals are essential products with inelastic demand and high technical complexity. A new regulatory body, CMED was established in October 2003 to regulate prices and establish regulatory guidelines for the pharmaceutical sector in Brazil. This development followed a change in the law in June 2003, when the Ministry of Health and the Brazilian national healthcare monitoring agency, ANVISA, took over full responsibility for drug pricing and pharmaceutical industry regulation from the Ministry of Justice. The new agency is responsible for overseeing pharmaceuticals, as well as medical equipment, cosmetics and hospital services. The agency also has the additional responsibility for authorizing products on the market, as well as the licensing of manufacturers. TRIPS allow the government to grant licenses allowing the country to manufacture generic versions of patented drugs. Brazil's intellectual property law allows the government to break patents in a health emergency or if it decides prices are exorbitant. In recent years, Brazil has repeatedly obtained price reductions from big pharmaceutical companies by threatening to break patents on the drugs. Intellectual Property Rights (IPR) Protection Brazil's industrial property law (Law 9,279/1996) became effective in May 1997. Concerns continue about a provision in Brazil's industrial property law that disallows importation as a means of satisfying the requirement that a patent be "worked" in Brazil. Law 10,196 (2001) includes some problematic provisions, including a requirement that Health Ministry approval be obtained prior to the issuance of a pharmaceutical patent. This raises concerns with respect to Article 27 of the TRIPS Agreement, and U.S. officials have raised this concern with their Brazilian counterparts. Due to a lack of government focus and resources, Brazil's patent office, the National Institute for Industrial Property (INPI), has total a backlog of more than 60,000 patent applications - an estimated 18,000 for pharmaceuticals -- and 500,000 trademark applications. Law 10,603 (2002) on data confidentiality covers pharmaceuticals for veterinary use, fertilizers, agrotoxins, and their components and related products; the law does not cover pharmaceuticals for human use. If the product is not commercialized within two years of the date of sanitary registration, third parties may request use of the data for registration purposes. Patent applications filed in Brazil on or after May 15, 1997, including PCT applications having a later international filing date, fully benefit from the new law, particularly concerning the patentability of pharmaceutical products and processes and the 20-year patent term. According to Article. 68 of the new law, a patent is subject to a compulsory license upon request by a third party if (i) the patentee exercises patent rights in an abusive manner or (ii) by means of the patent the patentee practices abuse of economic power that is proven under the terms of the law by an administrative or court decision. A patent will also be subject to a compulsory license if (iii) the invention is not effectively worked in Brazil or (iv) if commercialization does not meet the needs of the market. Pressure Rises on Drug Patents in Brazil Brazil, leader on international intellectual property issues, has come under pressure at home and abroad over whether to lift domestic patents on foreign pharmaceuticals for AIDS to allow cheaper generic versions to be produced. Nearly 200 non-governmental organizations from around the world signed onto a letter urging the Brazilian government to issue compulsory licenses allowing domestic pharmaceutical companies to produce anti-retroviral drugs used against HIV/AIDS. -- Compiled by Cygnus Business Consulting & Research, Hyderabad. ww.cygnusindia.com
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