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 Girisan Kariangal reflects on Menarini’s journey from a primarily CSO organization to a robust branded business in India, emphasizing strategic partnerships, acquisitions, and a decisive shift towards dermatology. He outlines how Menarini positions itself as a leader in dermatology by treating dermo-cosmetics with the same rigour as pharmaceuticals and continuously…
Switzerland For the Swiss Agency for Therapeutic Products (Swissmedic), one of the world’s leading regulatory authorities, 2023 was an important year. Not only did the agency gain recognition from the World Health Organisation (WHO), Swissmedic also saw a Good Manufacturing Practice (GMP) agreement between Switzerland and the US FDA come into…
UAE Globally, while there is broad stakeholder alignment on topics like clinical trials and innovation, there is real divergence in approaches to pharmacoeconomics and health technology assessment (HTA). This is perhaps in part due to the differences between systems like those in Europe where these functions are state mandates and those,…
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…
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