Tagged with Access

Global Globally some 1.8 million children and young people (CYP) live with type 1 diabetes (T1D) and in low-and middle-income countries (LMICs) prevalence of the disease is on the rise. In many of these countries, health systems lack the resources to manage this complex chronic disease and the insulin used to…

Denmark Flemming Sonne, CEO of Amgros, Denmark’s central pharmaceutical procurement organization for hospital medicines, outlines the organisation’s evolving role in ensuring affordable and sustainable access to medicines. In this interview, Sonne discusses Denmark’s forward-thinking approach to supply chain resilience, the integration of ATMPs and innovative access models, and the increasing convergence…

Saudi Arabia Amidst the hype of Saudi Arabia’s embrace of innovative therapies and technologies, the concepts of access and affordability can often be forgotten. However, the Saudi government remains the dominant healthcare payer in the country and, with medicines already consuming over 20 percent of national healthcare spending, is putting increasing emphasis…

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…

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 Please describe the main cost containment policies in place in your country and their fundamental principles   a. Pricing and impact of generic/biosimilar approval (i)  Pricing Generics and biosimilars are priced lower than their branded equivalents, reflecting lower R&D costs. When a generic drug is first listed on the NHI…

Pharma Legal Handbook Which are the main actors involved in public procurement and tendering? Please see the response to Question II.-7.   What are the main characteristics of the public procurement and tendering system? Japan has established voluntary measures, such as tendering procedures based on stricter standards than those in the WTO-GPA, for…

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?…

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 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 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…