Pharmaceutical market regulation: CMED and the price control policy.

Author(s)

Nathália Molleis Miziara

• Document type: Master's Dissertation
• Press: São Paulo.
• Institution: Universidade de São Paulo (USP). Faculdade de Direito (FD/SBD)
• Defense date: 2013-04-10

Examining board members

Diogo Rosenthal Coutinho; Carlos Pagano Botana Portugal Gouvêa; Vera Cristina Caspari Monteiro

• Advisor: Diogo Rosenthal Coutinho

Abstract

This is a case study about the pharmaceutical market regulation accomplished by the Pharmaceutical Market Regulation Chamber (CMED). This institution was created by the Law n. 10.742/03, with the objective to promote pharmaceutical assistance to Brazilian population through instruments able to stimulate supply of drugs and sector competition. The nature of the regulation practiced by CMED is mainly social and it is justified to promote access to drugs in Brazil, regarding product acquisition in retail and public acquisition. Through qualitative and quantitative research techniques the purpose of this study was to evaluate the effectiveness of this regulatory policy of CMED, considering effectiveness as the ability to promote access to drugs, as determined by the Law 10.742/03. In order to accomplish this objective specialists and members of the regulation chamber were interviewed. Moreover, data regarding the evolution of drug prices since CMED was created were analyzed. In addition, difficulties and problems related to implementation of the regulatory policy were identified, specially in regards to the implementation of the coeficiente de adequação de preços to public acquisition of drugs. Problems connected to instruments responsible for transparency, participation and accountability were also diagnosed. Finally, once detected the problems, solutions were considered and they imply change in the Law 10.742/03, which guides the regulatory process. (AU)

• FAPESP's process: 11/04911-2 - Regulation of the pharmaceutical market: CMED and the price control policy
• Grantee: Nathália Molleis Miziara
• Support Opportunities: Scholarships in Brazil - Master