Pharma Legal Handbook Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The primary HTA authority is the Saudi Food and Drug Authority (SFDA), which hosts a dedicated HTA/Economic Evaluation Unit established in 2023. Its main responsibility is to evaluate clinical and economic evidence (EES) for: New…
Pharma Legal Handbook 1.Price Control How does price control at ex-factory prices work in your country? Ex-factory prices are strictly regulated by the Saudi Food and Drug Authority (SFDA) using External Reference Pricing (ERP). SFDA sets a Ceiling CIP price based on the lowest value from a basket of 34 reference countries. Manufacturers…
France France Alzheimer’s Joel Jaouen and Benoit Durand articulate a comprehensive strategic framework for addressing one of Europe’s most pressing healthcare challenges. With four decades of operational excellence, the organisation has evolved from a grassroots family initiative into France’s premier associative research funder, developing sophisticated care pathways whilst advocating for systemic…
Argentina Gala Díaz Langou, a senior analyst and executive director at Argentina’s premier think tank CIPPEC, assesses the country’s recent transformative journey under President Milei. Drawing on 25 years of institutional expertise, she outlines a framework for development based on macroeconomic stability, sustainable growth, and robust democratic institutions. Her analysis explores…
Denmark Not only can Denmark lay claim to some major life science inventions – from the design of the world’s first ever insulin pen and disposable ostomy pouch to breakthroughs in fundamental discovery such as the development of the Gram Stain as an essential methodology for classifying bacteria – but it…
Denmark Despite its diminutive size, Denmark boasts a world-renowned healthcare and life science industry containing both household pharma giants as well as a robust network of academia, a host of niche service providers, and a growing throng of biotech start-ups. And with life science exports surpassing EUR 23 billion last year…
Denmark Public Health Reimagined Denmark’s total health expenditure as a share of GDP has increased moderately over the past decade with the country spending 278 billion KKR (37.2 billion euros) in 2024, of which 83% was financed directly from government health schemes. Yet despite the country’s well-earned reputation for delivering high…
Global First published in ISPOR’s Value & Outcomes Spotlight magazine, Shirley V. Wang, PhD, MSc of Brigham and Women’s Hospital, Harvard Medical School, argues that there is an urgent need for transparency in health economics and outcomes research (HEOR). Wang posits that the growing reliance on real-world evidence (RWE) in healthcare…
Switzerland SpiroChem has evolved from a niche ETH Zurich spin-out into a global discovery partner recognised for tackling some of the most complex challenges in modern drug design. Over more than a decade, co-founder and CEO Thomas Fessard has steered the company’s transformation from a product-focused catalogue into a solution-driven, modality-agnostic…
LatAm Dr Jarbas Barbosa, Director of the Pan American Health Organization (PAHO), discusses the organisation’s evolution from pandemic response to comprehensive health system transformation, regional production capabilities, and the imperative for multilateral cooperation in an increasingly fragmented global landscape. The Americas, in their extraordinary diversity, are a living laboratory Could…
Switzerland Neil Archer, Executive Vice President International at Madrigal, discusses the company’s pioneering role in treating MASH (Metabolic Dysfunction-Associated Steatohepatitis), a progressive liver disease with no prior approved therapies. He shares insights on Madrigal’s breakthrough first-in-class treatment, the challenges of launching an entirely new therapeutic category, and the bold international expansion…
USA Chris Molineaux, CEO of Life Sciences Pennsylvania, highlights Pennsylvania’s emergence as a leading life sciences hub, with 3,000+ companies, top NIH-funded universities, and global partnerships drawing investment. He notes that Pennsylvania’s pharmaceutical heritage and growing cell and gene therapy expertise – in addition to other cutting-edge modalities – offer unique…
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