Tagged with CCE

USA Since founding the HIV advocacy group Prevention Access Campaign (PAC) and launching its Undetectable=Untransmittable (U=U) campaign in 2016, Bruce Richman has been focused on raising awareness around a revolutionary but widely unknown fact: people living with HIV who are on treatment and have an undetectable viral load cannot sexually transmit…

China Unlike many of its Chinese biotech peers with broad portfolios, Hua Medicine has focused intensively on developing a single product, dorzagliatin, for diabetes. As CEO Li Chen notes, this strategic concentration has allowed Hua Medicine to pioneer in homeostasis control modulation and address specific unmet medical needs in diabetes treatment,…

China Yoshitaka Koketsu explains Sumitomo Pharma Group’s positioning in the China market as a relatively recent market entrant with a six-product portfolio but with plentiful opportunities for further growth, particularly in combating infectious diseases and antimicrobial resistance (AMR). Koketsu outlines how the company is well-aligned with China’s regulatory changes, and how…

Saudi Arabia With over 40 years of history in Saudi Arabia, in 2021 Eli Lilly moved to establish a regional headquarters in the country, underscoring its dedication to the country and region. Now led by Brazilian national Felipe Borges dos Reis, Lilly aims to tackle the pressing health concerns of diabetes and…

USA As healthcare costs are set to be a key issue for voters in the upcoming US presidential election, PhRMA’s Robert Zirkelbach lays out why policymakers must abandon partisan solutions that do not address underlying access and affordability issues. Instead, Zirkelbach urges for greater protection of the USA’s world-leading biopharmaceutical R&D…

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…