Switzerland Bairbre Hickie, General Manager at Takeda, discusses the company’s strategic priorities in Switzerland, focusing on its commitment to bringing innovative treatments to patients and its role in advancing the life sciences ecosystem. In this interview, Hickie explores Takeda’s approach to partnerships, its focus on rare diseases and oncology, and how…
Global Writing in the April 2025 edition of DIA’s Global Forum magazine, Christopher Morrison and Richard Xie of RA Capital Management L.P., introduce the recently published cost-effectiveness analyses methodology which incorporates key value elements and drivers that are omitted or incompletely captured in traditional clinical outcome assessments. Accelerating scientific discoveries…
Europe Stefan Barbour describes how personal loss and a multicultural, healthcare-focused background have driven a lifelong commitment to access to medicines. Now leading BeiGene’s diverse 22-country Sub Region Europe, a grouping he built from scratch, Barbour outlines his leadership style that blends trust, accountability and “aggressive talent development;” and explains how…
Saudi Arabia Osama Braiwish leverages over 26 years of industry experience across the Gulf region and Saudi Arabia. He joined Bristol Myers Squibb (BMS) in 2024, drawn to the company’s commitment to addressing significant unmet medical needs in oncology, hematology, immunology, cardiovascular and neuroscience. In his first few months at BMS, Braiwish…
Pharma Legal Handbook 1.Please make a general introduction to the public health sector in your country and its organization (a) The overview of the public health sector In Japan, the universal health insurance system allows citizens to receive medical services anytime, anywhere. The system is run by insurance premiums and other funds collected…
Pharma Legal Handbook Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The MHLW, the PMDA, and the Central Social Insurance Medical Council are responsible for public health. Their respective roles are explained in the response to Question I.-1. 2.…
Pharma Legal Handbook What are the pricing models, processes and principles for originator drugs? Drugs are provided by a medical institution or pharmacy to a patient based on the NHI Drug Price (a patient pays 10%, 20% or 30% (depending on age and other conditions) of the NHI Drug Price). As detailed in…
Pharma Legal Handbook 1.Price Control How does price control at ex-factory prices work in your country? There is no control by the government on the sales price of drugs from a market authorization holder to a pharmaceutical wholesaler regardless of whether it is a prescription drug or an over-the-counter drug. How does…
Pharma Legal Handbook Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? In Japan, it is important whether a drug or medical device is covered by the NHI (i.e., whether it is listed on the NHI Price List). If it is, the product is eligible for NHI…
Pharma Legal Handbook Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Marketing authorization holders of products designated as subject to the Cost-Effectiveness Evaluation System are required to conduct an analysis of the cost-effectiveness evaluation of the designated products and submit a report describing the analysis data. With…
Pharma Legal Handbook In addition to the clinical data obtained through clinical studies please list the data required for a. Market approval In general, an applicant for marketing authorization for a new drug is required to submit the information and data below. Documents a. Origin or background of discovery, condition of use…
Pharma Legal Handbook Are there any Managed entry agreements in place in your country? (If so, please list them) No. For each Individual Managed entry Agreement Describe the fundamentals of the Managed entry Agreement, its rationale and the process for implementing it. N/A When should this Managed Entry Agreement be considered?…
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