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SPECIAL FOCUS REPORTWorkforce and Supply Chain TopLocation Must-Have Lists forBiopharma
Despite historic risk during themetamorphosis from glamoroushigh-tech startup to pillar-of-the-community manufacturer-employer,biopharmaceutical companies remainnear the top of the list of industries thatUS states see as key to their economicfuture. Biotechs looking for a place tothrow down roots . . .
Executive Training & DevelopmentEntering the Brazilian Pharmaceutical Market
By: Marcelo Sicoli, EnterBrazil Date: 2009-02-22
Stable economics and growing healthcare concerns make Brazil one of the topemerging markets, with a current growth rate >20% Many analysts argue that the future for Brazil,which has been called for decades “the country of the future,” has finally arrived. With inflation undercontrol and economic growth above the worldaverage (5.4% and 5.3% in 2007 and 2008,respectively) its considerable population of almost200 million presents very attractive prospects forpharmaceutical companies all over the world.The health sector as a whole represents 8% of theBrazilian GDP, around US$80 billion per year.Government purchases represent 50% of the marketfor medical equipments, and more than 90% of thevaccines and 25% of all drugs (Brazilian Ministry of Health).In 2008, the Brazilian pharmaceutical market wasestimated to reach US$ 14.9 billion, 34% of Latin America, jumping 23% from 2007(IMS Health). Twenty percent of that is made up of generic drugs, which cost onaverage 35% less than reference drugs (Progenericos). Brazilian companies have amarket share of around 20% only.On the foreign trade side, Brazilian products totaled more than US$961 million inexports in 2008, a 29% increase from 2007. The main export markets are Venezuela(14%), Argentina (13%) and the USA (12%). On the other hand, imports amountedto US$ 4.28 billion, an increase of 21% year over year, coming mainly from the USA (19%), Germany and Switzerland (13% each). For example, all 450 tons of amoxicillin (antibiotics) consumed per year are imported.Estimates point out that 30% of the drugs sold in Brazil are not registered. According to the Brazilian Federal Police, 500 thousand units (130 tons) of non-registered and counterfeit medications were seized in 2008, mainlyamphetamines, steroids, contraceptives and drugs for erectile dysfunction. Newlegislation (to be implemented gradually during the next three years) was passed inJanuary of 2009 by the Senate to enforce monitoring of medical products viaelectronic bar code systems on the production, commercialization, distribution, andmedical prescription of drugs.
Federal regulatory bodies
The National Health Surveillance Agency (ANVISA), created in 1999, is the equivalentof the American FDA. ANVISA is an independently managed, financially-autonomousregulatory agency, with security of tenure for its directors during the period of theirmandates. ANVISA is managed by a board of directors, comprised of five members.Within the structure of Federal Public Administration, the Agency is linked to theMinistry of Health, under a Management Contract.The agency incorporates additional mandates: coordination of the National SanitarySurveillance System (SNVS), the National Program of Blood and Blood Products andthe National Program of Prevention and Control of Hospital Infections; monitoring of drug prices and prices of medical devices; attributions pertaining to regulation,control and inspection of smoking products; technical support in granting of patentsby the National Institute of Industrial Property. ANVISA is headquartered in thecapital of Brazil, Brasilia, presently the fourth-largest city in the country.In addition, ANVISA exercises control over ports, airports and borders and alsoliaises with the Brazilian Ministry of Foreign Affairs and foreign institutions overmatters concerning international aspects of sanitary surveillance. More information,as well as many relevant laws in English can be obtained from the agency’s website.[1]US Pharmacopeia recognized the value of the Brazilian market by opening its fourthoverseas location (after Switzerland, India and China) in Sao Paulo last August. “Brazil has one of the fastest-growing pharmaceutical industries in the world, [and]is increasingly adhering to international quality standards,” said Dr Flavio Vormittag,MD, MS, VP, international, for USP.Key trade associations include Febrafarma, the Brazilian Pharmaceutical Industry
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harmaceutical Commercehttp://www.pharmaceuticalcommerce.com/frontEnd/1091-Brazil_ANVI...1 de 222/6/2009 18:23
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