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…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. What is the definition of a vaccine in your country? As per ANVISA Resolution RDC 55/2010, vaccines are immunobiological drugs which contain one or more substances (antigens) that, when injected into an individual, stimulate…
Portugal Portugal boasts a well-developed universal healthcare system and saw healthcare spending increase by 6.2 percent annually between 2016 and 2021, according to the OECD. However, the representatives of innovative medicines manufacturers embedded in the country are keen to point out that access to the latest drugs remains a big issue…
Portugal Country manager at Lundbeck Portugal, Sara Barros, came to the Danish company after a number of management positions at larger pharma companies and took on the leadership of its local affiliate about three years ago. She comments on the shift in societal attitudes towards mental health, discusses Portugal’s psychiatric care…
Global 2023 was a tumultuous year for the pharma industry, with much wailing and gnashing of teeth from executives over the Inflation Reduction Act in the US as well as updated EU pharma legislation in Europe. Those companies producing COVID-19 vaccines and therapeutics saw revenues return to normal levels while others…
Pharma Legal Handbook 1. Please make a general introduction to the public health sector in your country and its organization The National Health System (“NHS”) is based on the principles of universal coverage and solidarity. Art. 43 of the Spanish Constitution establishes the right to healthcare as one of the basic principles that…
Pharma Legal Handbook 1. Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The main administrations in charge of public health and reimbursement of medicinal products in Spain are: the Spanish Agency of Medicines and Medical Devices (“AEMPS”), the Ministry of…
Pharma Legal Handbook 1. What are the pricing models, processes and principles for originator drugs? Originator medicinal products must go through price and reimbursement proceedings (P&R Procedure) where it is decided if they are to be reimbursed or not. If reimbursed, the PVL is also fixed. To determine whether a medicinal product is…
Pharma Legal Handbook 1. Price Control 1. How does price control at ex-factory prices work in your country? This question may be broken down in two parts: (i) situations in which a medicinal product may be in connection with its reimbursement status/price; and (ii) criteria to determine PVL. Situations in which a…
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