Tagged with access

LatAm Rolf Hoenger discusses Roche LATAM’s growth, emphasising patient-centric strategies, untapped access potential, and evidence-based dialogue with policymakers. He highlights accelerated regulatory approvals, digital health initiatives, and Movement Health Foundation projects, where he serves as Vice Chair. Hoenger also underscores talent development, local leadership, and framing health as investment as essential…

France With France now a cornerstone of its global strategy, Regeneron is accelerating its European expansion under the leadership of Antoine Catton. In less than two years, the affiliate has built full operational capabilities, secured major access milestones, and forged partnerships with leading research institutions, cementing its role within France’s thriving…

USA With a refreshed Ambition and Enterprise Model, Ferring Pharmaceuticals US is entering a new chapter defined by agility, innovation, and a sharper focus on patient needs. President Brent Ragans explains how this vision is setting a course for continued growth in reproductive medicine and uro-oncology.   Ferring has always been…

France France’s minority government has forced through a Social Security & Healthcare Bill for 2026 containing EUR five billion in healthcare cuts. For the country’s beleaguered innovative pharma industry, this Bill represents yet another setback, with stakeholders warning of more access delays, listing withdrawals, and unnecessary patient suffering.   PLFSS 2026:…

USA Thomas Nusbickel, Chief Commercial Officer, describes how Celltrion, founded over 20 years ago, pioneered biosimilars through a fully integrated business model. Its US office opened in 2018 and has since transitioned from partnerships to direct sales, launching several biosimilars in oncology, immunology and endocrinology. With a strong pipeline, a growing…

Pharma Legal Handbook 1.Please make a general introduction to the public health sector in your country and its organization Saudi Arabia provides universal health coverage primarily funded by the government through a tax-based model. The healthcare system is organized in a tiered structure led by the Ministry of Health (MOH), which operates: •…

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 Ministry of Health (MOH) is the primary body responsible for public health in Saudi Arabia. It sets national health policies, issues licenses to healthcare providers (public and private),…

Pharma Legal Handbook What are the pricing models, processes and principles for originator drugs? Originator drugs (innovator medicines) are priced by the Saudi Food and Drug Authority (SFDA) following the principles outlined in its 2023 Drug Pricing Guidelines. The pricing process includes: External Reference Pricing (ERP): SFDA compares prices with a reference basket…

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 Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes. The SFDA published the Economic Evaluation Studies Guideline (PDF, July 10, 2024), which outlines comprehensive methods and includes a checklist. Followed by the Pharmacoeconomic Submission Portal Manual (January 2025), detailing dossier preparation and submission protocols.…

Pharma Legal Handbook In addition to the clinical data obtained through clinical studies please list the data required for   a. Market approval In addition to clinical trial data, the following documents are required for market authorization in Saudi Arabia: Quality/CMC Module: Includes full GMP certificates (PIC/S or WHO type) and a local…

Pharma Legal Handbook Are there any Managed entry agreements in place in your country? (If so, please list them) Yes, Saudi Arabia has implemented two types of Managed Entry Agreements (MEAs) under the Ministry of Health’s “Managed-Entry Agreement Policy” issued in January 2021. These include: A. Finance-based Price/Volume Agreement 1. Fundamentals & rationale…