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Estimations of generic drug entry in Brazil using count ... - EPGE/FGV

Estimations of generic drug entry in Brazil using count ... - EPGE/FGV

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3 Literature on pharmaceutical <strong>entry</strong>: a surveyTo the best <strong>of</strong> our knowledge, only two econometric estimations have been applied to thepharmaceutical <strong>in</strong> <strong>Brazil</strong>, all <strong>of</strong> them try<strong>in</strong>g to measure the impact <strong>of</strong> <strong>generic</strong> <strong>drug</strong> <strong>entry</strong>on prices. Fiuza and Lisboa [12] po<strong>in</strong>ted out that branded <strong>drug</strong> prices would go up <strong>in</strong>face <strong>of</strong> similar <strong>drug</strong>s´ market power <strong>in</strong>crease, a result similar to Frank and Salkever’s [13],but the data base utilized was previous to the Generic Dug Act.Nishijima and Biasoto [21] used a di¤erent sample (cover<strong>in</strong>g both before and afterthe Generic Drug Act) and a slightly di¤erent model from Fiuza and Lisboa’s and gotdi¤erent results, namely that reference <strong>drug</strong> prices would go down as they faced greaternumbers <strong>of</strong> <strong>generic</strong> copies. Lopes [18] recently replicated Fiuza and Lisboa’s model withmore <strong>drug</strong>s <strong>in</strong> a more recent period and reached the same conclusions as the latter.A better understand<strong>in</strong>g <strong>of</strong> the process that generates <strong>generic</strong> <strong>drug</strong> <strong>entry</strong> is therefore<strong>of</strong> extreme <strong>in</strong>terest for <strong>Brazil</strong>ian policymakers, for the <strong>in</strong>dustry and for the academia <strong>in</strong>general. A few models <strong>in</strong> the <strong>in</strong>ternational literature may then become a start<strong>in</strong>g po<strong>in</strong>tfor our work.As Rei¤en and Ward [22] po<strong>in</strong>t out, the <strong>generic</strong> <strong>drug</strong> <strong>in</strong>dustry is a useful …eld forstudy<strong>in</strong>g empirically how competition evolves with<strong>in</strong> a market: (i) each chemical representsa dist<strong>in</strong>ct experiment; (ii) <strong>in</strong>formation about the market for each <strong>drug</strong> is observableto researchers; e.g. date <strong>of</strong> open<strong>in</strong>g <strong>of</strong> the market (the patent expiration date); (iii) …rmsmust s<strong>in</strong>k signi…cant costs to apply for the authorities’approval prior to know<strong>in</strong>g when,or how many, rivals will enter the market.Papers by Danzon and Chao[5] and Lanjouw[16] <strong>in</strong>dicate that price regulation underm<strong>in</strong>escompetition <strong>in</strong> o¤-patent markets because they discourage <strong>generic</strong> <strong>drug</strong> <strong>entry</strong>. Inthe same direction –even though look<strong>in</strong>g for <strong>in</strong>dustrial policy, scale economies, and safetyregulation explanations – Thomas[26] also …nds that the same <strong>count</strong>ries with weakeror non-existent price control – and consequently higher prices (US, UK, Germany andSwitzerland) –have stronger competitive performance, and ac<strong>count</strong> for most <strong>of</strong> the global<strong>drug</strong>s launched (<strong>drug</strong>s sold <strong>in</strong> more <strong>count</strong>ries, and with greater market shares), whileother developed <strong>count</strong>ries tend to launch more <strong>of</strong>ten local <strong>drug</strong>s.The ma<strong>in</strong> empirical references <strong>in</strong> <strong>generic</strong> <strong>drug</strong> <strong>entry</strong> are Scott-Morton [24], [25] andRei¤en and Ward [22]. The three papers studied the US market.8

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