Tagged with legal

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…

India Drawing on a unique background in both medicine and law, Dr Milind Antani today leads the pharma and healthcare practice at Nishith Desai Associates, covering everything from regulatory work to corporate transactions, intellectual property matters, and dispute resolution. Dr Antani highlights the dynamic M&A landscape in Indian healthcare and pharmaceuticals…

Brazil Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece is focused on HTA Dossiers and Data requirements in the Brazilian pharma market today. Buy The Pharma Legal Handbook: Market Access & HTA – Brazil here for £359.   HTA DOSSIERS Have local authorities published…

Morocco Camilia Benani, recently promoted to partner at DLA Piper’s Casablanca office, explains why the Moroccan healthcare sector has become a lightning rod for M&A activity in recent years. Drawing on her experience advising many of the organisations involved in these deals, Benani touches on the evolution of deal structuring in…

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…

Pharma Legal Handbook 1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The main bodies in charge of HTA in Spain are the AEMPS, the MOH (particularly the DGCC) and the regional governments; all of such bodies acting in coordination through REVALMED.[1] Also note that, as…