LatAm A roundup of some of the latest stories coming out of Latin American pharma and healthcare, including Merck’s new distribution centre in Brazil; the region’s record dengue surge; Roemmers Laboratory’s acquisition of 30% of Argentina’s Tuteur, and Urufarma’s new manufacturing facility in Uruguay. Merck to open new distribution centre…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Please make a general introduction to the public health sector in your country and its organization As set out in the Brazilian Federal Constitution of 1988, health is a right of all and a…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? SUS is managed collaboratively by the Federal Government, the States of the Federation,…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. What are the pricing models, processes and principles for originator drugs? To set the price of originator drugs, CMED uses Health Technology Assessment (“HTA”) to evaluate whether a drug provides an additional therapeutic benefit…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Price Control 1.1. How does price control at ex-factory prices work in your country? The Ex-Factory Price (“PF”) is defined by CMED upon application by the company requesting drug marketing authorization, in accordance with…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes, but unfortunately only in Portuguese: Proposal Application Guideline. Guideline related to Cost-effectiveness. 2. Have local Authorities published guidelines…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval Each product category has its own data requirements, foreseen in specific regulations of ANVISA (which…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Are there any Managed entry agreements in place in your country? (If so, please list them) The first public and only managed access agreement reported in Brazil was signed between the Ministry of Health…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Which are the main actors involved in public procurement and tendering? As mentioned in Chapter 2, Question 7, each entity of public administration is able to carry out public procurement and tendering in order…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Please describe the main cost containment policies in place in your country and their fundamental principles a. Pricing and impact of generic/biosimilar approval Generic drugs must have their PF 35% cheaper than the corresponding…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes. In Brazil, the National List of Essential Drugs (“RENAME”) provides the selection and standardisation of…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. What is the definition of an orphan drug in your country? There is no specific definition for orphan drug in Brazilian current rules. However, we understand that it corresponds with the definition of rare…
See our Cookie Privacy Policy Here
