Pedro Fugita de Oliveira, autor em Grinberg Cordovil Advogados

CADE decides to close preparatory proceeding on abusive prices in the pharmaceutical sector

Pedro Fugita de Oliveira — Tue, 11 Oct 2022 14:19:55 +0000

The Administrative Council for Economic Defense (CADE) decided in September to close a Preparatory Proceeding (PP) that investigated the alleged conduct of patent law abuse in the sales of medications for the treatment of Hepatitis C, without imposing any penalty.
The PP was launched due to a complaint filed by entities in the consumer protection and health sectors, who alleged abuse of dominant position by the companies of the Gilead group. The alleged conducts practiced would be: (i) price discriminating the federal entity that purchases its products; and (ii) arbitrary price increases for certain medications. In addition, the Representatives requested the imposition of a preventive measure on the Gilead companies to market sofosbuvir (an antiviral drug for the treatment of Hepatitis C) at competitive prices.
In its defense, Gilead said there were legitimate economic justifications for the difference in the prices being practiced, such as the need to offer better prices to those who purchase larger quantities of the drug. Since price discrimination is not an offense per se, there would be no illicit act being committed here. Regarding the alleged excessive prices, it sustained that there was no abuse of patent power, because its medications are innovative and bring benefits to the consumer. They also stated that there are substitute medications for those supplied by the company, and furthermore, the prices of the medications are regulated by the Drug Market Regulation Chamber (CMED).
Given this, after conducting econometric analyses, CADE’s General Superintendence (GS) issued a Technical Note concluding that there was no evidence of alleged anticompetitive conduct by the Respondents, since the price limits imposed by the pharmaceutical regulation were observed, as well as the gradual and recurring reduction in the price of their products.
It is also important to note that the GS emphasized that it is not its competence to decide whether the prices set by the regulatory agency are abusive. Therefore, the Representatives must present such discussion to the competent bodies to satisfy their interests.
The Preparatory Proceeding can be accessed here.

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Conex apresenta primeiro relatório de seu Plano de Trabalho para o período de 2021-2022

Pedro Fugita de Oliveira — Fri, 19 Aug 2022 19:22:40 +0000

No último dia 17 de julho, o Conselho Consultivo do Setor Privado (Conex) apresentou o 1^o Relatório de acompanhamento do Plano de Trabalho do período de 2021-2022. O documento apresenta o andamento de 23 iniciativas de temas prioritários da agenda do Conselho e que visam aperfeiçoar as políticas de comércio exterior do Brasil. Essas iniciativas são divididas em seis eixos temáticos: Estratégia Comercial, Estrutura Tarifária, Agenda Regulatória, Financiamento às Exportações, Promoção Comercial e Governança do Conex.
Embora algumas iniciativas do Conselho já tenham sido concluídas, há ainda um número expressivo de iniciativas em andamento. É o caso, por exemplo, das discussões para ratificação do Acordo Mercosul–UE e o aperfeiçoamento de mecanismos aduaneiros.
Dentre aquelas que já foram implementadas, é possível mencionar a criação de um fórum dedicado à discussão de temas regulatórios que impactam a competitividade das empresas brasileiras no comércio internacional e de um fórum para discussão de temas que impactam o comércio exterior de serviços, as quais foram viabilizadas graças à cooperação de diversos órgãos reguladores federais. Até o momento, esses fóruns já discutiram diversos assuntos pertinentes ao comércio exterior, como a promoção comercial de serviços de e-commerce, a atualização do Regulatory Peer Review da OCDE e o novo modelo regulatório do Inmetro.
Dentre os temas que ainda estão em monitoramento, destacam-se os referentes à estrutura tarifária brasileira, especialmente aqueles sobre tarifas de importação e tributos relativos ao Mercosul por serem instrumentos relevantes para a concorrência externa do país. Uma das políticas em discussão é o documento que será produzido pelo Instituto Defesa Coletiva (IDC) sobre potenciais benefícios decorrentes da redução de determinadas tarifas de importação de produtos que afetam os consumidores finais. Essa pesquisa busca apresentar ao governo brasileiro um panorama de potenciais efeitos da redução de tributos sobre bens com baixa ou nenhuma oferta no país, o que viabilizaria um maior acesso da população a eles.
Há também a discussão sobre o engajamento do setor privado no processo de reforma da Tarifa Externa Comum (TEC), que ganhou força com os impactos econômicos trazidos pela pandemia da Covid-19 e o conflito entre Rússia e Ucrânia. Ambos os eventos acabaram por incrementar o custo de vida – especialmente da população de baixa renda – e os custos de empresas que utilizam insumos sobre os quais incide a TEC. Para evitar distorções econômicas, grande parte dos tributos do Mercosul sofreram reduções em suas alíquotas, o que motivou o debate sobre a possibilidade de incorporação permanente de redução temporária e excepcional da TEC. Para isso, o Ministério da Economia vem discutindo com diversas entidades do setor privado sobre como deve ser realizado esse processo de modernização do tributo.
Durante a reunião ainda foram apresentados três estudos produzidos pelos membros do Conselho de temas que são considerados prioritários no Plano de Trabalho do Conex, que são:
i) diretrizes para a política comercial brasileira de longo prazo;
ii) análise de preços de medicamentos e sua relação com a Tarifa Externa Comum; e
iii) estudo sobre a agenda de sustentabilidade e a política comercial do país.

O relatório pode ser acessado na íntegra aqui.

O conteúdo Conex apresenta primeiro relatório de seu Plano de Trabalho para o período de 2021-2022 aparece primeiro em Grinberg Cordovil Advogados.

Inmetro’s New Regulatory Model is approved

Pedro Fugita de Oliveira — Mon, 21 Mar 2022 12:54:49 +0000

On February 25th, 2022, the new Regulatory Model for the National Institute of Metrology, Quality and Technology – Inmetro – was approved. The new Model adopted measures for the debureaucratization of the agency and the adoption of less interventionist processes, providing greater freedom for companies and entrepreneurs.

The modernization of Inmetro’s regulatory activity has become essential in recent years, considering the mismatch between the agency’s actions and its goals. The Working Group for the Modernization of Inmetro’s Regulatory Model (GTMRI) identified several problems faced by the regulatory activity that compromised the effectiveness and efficiency of the agency’s performance in this sense, such as excessively bureaucratic processes, costly and time-consuming analysis procedures, and very prescriptive and detailed regulations. Thus, the need for increasingly dynamic and transparent procedures resulted in the proposition of a new model that could meet = new market demands, promote greater economic freedom as a development strategy, and enhance the competitiveness and digitalization of various sectors.

In general, the new Regulatory Model brought three significant changes:

· Creation of a regulatory environment based on more general regulations and essential quality and safety requirements, substituting very specific regulations, concerning the production process with the intention of ensuring greater flexibility to the model and better comprehensiveness and responsiveness to innovations.

· Increased focus on solving regulatory problems. In this regard, the new model considers mechanisms of surveillance actions by the market itself to assist in the identification of legal improvements for specific problems that have been verified with the provision for amending regulatory instruments, if necessary.

· Enforcement based on risk management and the accountability of suppliers. Hereby, the new model assigns the suppliers with the responsibility of (i) offering products to the market in compliance with applicable laws and regulations; (ii) monitoring, identifying, and addressing the risks of their products or services, subject to regulation; and (iii) taking the necessary measures when a product or service does not meet requirements or may cause harm to the consumer, informing the necessary authorities of implemented actions. If on one hand a new model seems to bring greater attention to the inspection and potential punishment to the suppliers, on the other hand, this also establishes the need for the agency to work on education and the prevention of bad practices.

A period of five years has been established for the implementation of Inmetro’s New Regulatory Model, from the date of the publication of the Ordinance. During this period, the institute’s Operational Units must promote actions for the transition, and new normative acts must already meet the guidelines of the new brand.

O conteúdo Inmetro’s New Regulatory Model is approved aparece primeiro em Grinberg Cordovil Advogados.