Tagged with Market Access

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…

Denmark As Denmark and Europe enter a pivotal phase for healthcare and life sciences, Søren Granhøj Pedersen, Managing Director of MSD Denmark & Iceland, offers timely insights into how one of the world’s leading pharmaceutical companies is adapting and contributing. Drawing on a career shaped by international experience and cross-functional leadership,…

Denmark Since stepping into the role of Chair of the Danish Medicines Council in early 2025, Birgitte Klindt Poulsen has been navigating the delicate balance between accelerating patient access to innovation and maintaining the rigour of independent, evidence-based evaluation. In this interview, she shares how the Council is adapting to a…

Denmark Christof Bischoff, Country Director of AstraZeneca Denmark, draws on over two decades of international and national experience to navigate one of Europe’s most advanced yet complex healthcare environments. In this interview, he reflects on the affiliate’s evolution from a traditional commercial operation to a system-oriented partner driving innovation across clinical…

Denmark Steve Wright, General Manager of Boehringer Ingelheim Denmark and Norway, shares insights on how the company is advancing its ambitious pipeline and aligning with Denmark’s national healthcare priorities. In this interview, Wright discusses Boehringer Ingelheim’s strategic focus on innovation, access, and prevention, while reflecting on the company’s evolving role in…

Denmark Ida Sofie Jensen, CEO of Lif, Denmark’s pharmaceutical industry association, discusses the country’s bold Life Science Strategy and the ongoing healthcare reform shaping its future. She explores how Denmark is aligning innovation, access, and health system sustainability through coordinated policymaking, a new Healthcare Innovation Index, and strengthened partnerships between industry…

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…

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…