Spain A roundup of the latest news from Spanish pharma, including Almirall’s licensing deal with EpimAb Biotherapeutics; the opening of Insud Pharma’s oligonucleotides centre in India, and Esteve Química’s new FDA-cleared manufacturing site. Almirall licenses bispecific platform in $210m EpimAb deal (BioProcess International) EpimAb Biotherapeutics has out-licensed the rights for…
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…
Pharma Legal Handbook Before answering the questions in this Section VI, it is appropriate to make an important consideration. In Spain, at least up to the date of this publication, the HTA evaluation is carried out by public authorities, without the industry having to provide a specific HTA dossier with pharmacoeconomic studies of…
Pharma Legal Handbook 1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval Generally speaking, for getting a marketing authorization of a medicinal product, the applicant needs to provide sufficient information to demonstrate that the relevant product fulfills the established quality requirements, is…
Pharma Legal Handbook 1. Are there any Managed entry agreements in place in your country? (If so, please list them) Yes, there are managed entry agreements in Spain. The most frequent Managed Entry Agreements (MEAs) are financial and performance-based agreements (both at patient and population level). 2. Describe the fundamentals of the…
Pharma Legal Handbook 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 The entry of generics/biosimilars into the market affects the price of original drugs by three main mechanisms: (i) homogeneous groups (“HG”), (ii) reference groups (“RG”), (iii)…
Pharma Legal Handbook 1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes. Three types of lists have been published by the AEMPS: “Essential medicinal products”: according to the WHO definition, these are the necessary medicinal products for a basic health system. “Critical medicinal…
Pharma Legal Handbook 1. What is the definition of an orphan drug in your country? In Spain there is no particularity in relation to the definition of “orphan drug” derived from the Regulation (EC) No 141/2000. Under Regulation (EC) No 141/2000 a medicinal product shall be designated as an orphan medicinal product if…
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