Tagged with HE

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,…

Global Well-informed and data-driven healthcare decision making has never been more important. Healthcare systems across the world – in both developed and developing contexts – are grappling with the challenge of providing quality treatments and services to patients while ensuring that their money is well spent. At the forefront of helping…

Morocco Women’s health specialist Versalya enjoyed a resurgent 2022 in Morocco under the leadership of Sofia Lahlou. She explains some of the key trends in the Moroccan women’s health space, how the company is supporting the healthcare transformation underway in the country, and her approach to talent attraction and retention.  …

France France’s life sciences industry is falling behind its European neighbours, its growth deeply hampered, the French life sciences think tank G5 Santé claims, by abusive paybacks. While the government has demonstrated its willingness to take steps towards levelling its pricing barometers and in so doing tackle medicine shortages and build…

Morocco With a generational universal healthcare reform underway in Morocco, the country’s Minister of Health and Social Protection Khalid Aït Taleb outlines why the ongoing updates to his country’s healthcare system far outweigh what has gone before in terms of scale and scope. Minister Aït Taleb also touches on digitalisation and…

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…

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…