China Amid geopolitical tensions and a drop in foreign investments, China continues to encourage international companies to increase their Chinese footprint. At this week’s China Development Forum (CDF), CEOs from Pfizer, AstraZeneca, Bayer, Bristol Myers Squibb, GSK, Novartis, and Takeda made it clear that Big Pharma’s interest in the country has…
USA Online pharmacies have still not captured a large share of the fragmented US pharma market, but Eli Lilly’s partnership with Amazon after a direct-sale initiative of its own may serve to shake up the establishment and show what a direct-to-consumer model can offer. Eliminating the Middleman, or Not Amazon…
UK Last year the UK-based pharma industry warned against the country’s waning competitiveness, condemning the government’s statutory scheme designed to control drug prices. UK-headquartered AstraZeneca joined the battle cry, claiming it would be choosing Ireland over Britain, a decision the company has now more than revised with a GBP 650 million…
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. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? In Brazil, CONITEC is the main HTA evaluation body, which is responsible for recommending the incorporation of health technologies…
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…
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