The aim of this study is toevaluate the regulatory action by the Brazilian government on the segment of ethical drugs in the private pharmaceutical industry in the last decade. Two important facts guide the period: the generic Drug Law and the regulation of controlling price cap, enforced after 1999, together with the creation of the new Medicines Regulatory Board (CMED) after 2003. The article discusses the main implications of regulation from the point of view of competition, in particular on condition of entry. The discussion considers, in parallel, North American regulatory environment and its production process which, unlike Brazil, doresearches and develop pioneer drugs. The analysis points out to the increasing of competition in the sectorof drugs with expired patents.
Generic drugs; Regulationentry conditions; Pharmaceutical industry