Saudi Arabia Abdul Latif Jameel is one of Saudi Arabia’s most storied distributors, with a history dating back to 1945. Although present in the healthcare space since 1995 via its philanthropic activities, it has only recently moved to set up a dedicated healthcare arm, known as Jameel Health. Led by Big Pharma…
Global The US National Institutes of Health (NIH) is the largest public investor in HIV/AIDS research globally. This means that, as Director of the Division of AIDS (DAIDS) at the NIH’s National Institute of Allergy & Infectious Diseases (NIAID) Dr Carl Dieffenbach oversees a global HIV/AIDS research portfolio of more than…
Egypt The latest news from Egyptian healthcare and life sciences, including progress towards the launch of a massive new oncology hospital, why local manufacturer EIPICO is expanding into Kazakhstan, increased governmental investment in education and health, and lessons from the country’s successful battle against Hepatitis C. Egypt gears up for…
Global ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR), and PharmaBoardroom’s content partner, continues to monitor healthcare trends and conduct horizon scanning around the world. The “ISPOR 2024-2025 Top 10 HEOR Trends” marks the fifth publication of the Society’s biennial report, which is based on input from its members…
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 Currently there are no policies in place in this regard. b. Clawback/Payback/Discounts/Rebates In Portugal, the main mechanism for cost-containment is the prior evaluation, regulated…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Please make a general introduction to the public health sector in your country and its organization The Public sector is composed of the National Health Service (Serviço Nacional de Saúde), also referred as the…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1.Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The most relevant administrations, bodies and institutions in charge of public health in Portugal…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. What are the pricing models, processes and principles for originator drugs? Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Price 1.1. How does price control at ex-factory prices work in your country? Ex-factory prices (PVA) are relevant to determine the retail price (PVP) of medicinal products and their maximum legal margins, as below.…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The CATS and the DATS are responsible for SiNATS. 2. Do regulators require HTA studies in your country?…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes. Infarmed has published methodological guidelines for pharmacotherapeutic and economic assessment. The recommendations can be consulted here. 2. Have…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval The data that must be submitted varies according to the type of medicinal product and…
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