Tagged with P

Global New methodology for the 2024 Access to Medicine Index promises a stronger attempt to quantify whether drugs, vaccines, and diagnostics are actually making it all the way to patients in poorer countries around the world.   Industry stakeholders eagerly await the biennial publication of the Access to Medicine Index, a…

Morocco Wafaa Farhat Agoumi serves as DG of the Health Engineering and Project Management Graduate School (ESISMP) in Casablanca, Morocco, as well as president of the African Association for Clinical Research (AARC). Agoumi gives an overview of her current work areas of focus, the evolution of clinical research in Morocco and…

UAE Thanks to favourable regulations from the Ministry of Health and Prevention (MoHaP) which include fast-track regulatory pathways, patients in the UAE are gaining access to innovative medicines in similar time frames to their counterparts in the US and Europe, in some cases even ahead. Against this backdrop, the representatives of…

Global Shawview Consulting’s Brendan Shaw looks back on a sombre United Nations High Level Meeting on Universal Health Coverage in New York last month, as stakeholders reflected on the long road still to travel if the goal of securing UHC for the world’s population by 2030 is to be met. Shaw…

Global Merck’s Kaushal Kishore attempts to illustrate why pharma companies have struggled to crack what he calls “the Gross to Net (GtN) code.” He outlines the maturity journey for a pharma commercial and pricing organisation which can lead to maturity on the GtN topic, and highlights a successful example that can…

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…