Tagged with Access

China After four years away, Brendan Shaw recently returned to China to attend the ChinaBio Innovation and Investment Conference in Suzhou. Although geopolitical tensions, the fallout from COVID-19, and local market challenges have dampened stakeholder optimism around China somewhat in the last few years, Shaw feels that the country still has…

Morocco Merck Morocco’s Ahmad ALMWAKEH feels that the winds of change are blowing in the right direction across Moroccan healthcare, with a well-defined national strategy in place to expand coverage to more of the population than ever before. Merck is well-placed to support this transition as the market leader in therapeutic…

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 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…

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…