The European framework for intellectual property rights for biological medicines

Author byline as per print journal: Josette Sciberras, MBA, MA Bioethics, BPharm (Hons); Raymond Zammit, SThD; Patricia Vella Bonanno, PhD Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and […]


Variation in the prices of oncology medicines across Europe and the implications for the future

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Steven Simoens4, MSc, PhD; Amanj Kurdi1,5, BSc, PhD; Gisbert Selke6; John Yfantopoulos7, PhD; Andrew Hill8, PhD; Jolanta Gulbinovič9, MD, PhD; Antony P Martin10,11, MA, PhD1; Angela Timoney1,12, BPharm, PhD; Dzintars Gotham13, MBBS; Janet Wale14, PhD; Tomasz Bochenek15, PhD; Iva Selke Krulichova16, MSc, PhD; Eleonora Allocati17, […]


Pharmaceutical pricing policy in Saudi Arabia: findings and implications

Introduction: Many countries have introduced policies and strategies to limit pharmaceutical expenditures. These include pharmaceutical pricing policies and related strategies to control medicine prices and to ensure appropriate and stable prices. The aim of this study was to provide an overview of the current pharmaceutical pricing policy for medicines in Saudi Arabia and to provide […]


Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond

Abstract: Biosimilars policies are more controversial than those for generics. However, it is only a question of time before progress in biosimilars matches that of generics worldwide. Submitted: 21 April 2017; Revised: 28 April 2017; Accepted: 2 May 2017; Published online first: 15 May 2017 Healthcare systems worldwide are under increasing pressure due to the […]


Do pricing and usage-enhancing policies differ between biosimilars and generics? Findings from an international survey

Introduction/Study objective: This paper aims to survey the policies implemented by European countries for pricing and promoting the use of biosimilar medicines and to explore similarities and differences with policies for generic medicines. Methods: A literature review was supplemented by primary data collection with policymakers. Members of the Pharmaceutical Pricing and Reimbursement Information (PPRI) network, […]


Biosimilars: patient and physician acceptability is the fifth hurdle to market competition

Abstract: Biosimilar products confront novel market authorization and post-marketing use hurdles. Existing evidence is insufficient to fully address physician and payer acceptability thresholds. Submitted: 4 March 2015; Revised: 5 March 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 In this issue of GaBI Journal, Sandorff et al. [1] investigate payer and physician […]


Pricing of oral generic cancer medicines in 25 European countries; findings and implications

Author byline as per print journal: Brian Godman1,2,3,4, BSc, PhD; Andrew Hill5; Professor Steven Simoens6, MSc, PhD; Amanj Kurdi1,7, BSc, PhD; Jolanta Gulbinovič8, MD, PhD; Antony P Martin2,9; Angela Timoney1,10; Dzintars Gotham11, MBBS; Janet Wale12; Tomasz Bochenek13, MD, PhD; Celia C Rothe13; Iris Hoxha14; Admir Malaj15; Christian Hierländer16; Robert Sauermann16, MD; Wouter Hamelinck17; Zornitza Mitkova18; […]


Italy’s final position paper on biosimilars and new price and reimbursement pathway

Abstract: The AIFA’s position paper recognizes the relevance of biosimilars to ensure the sustainability of drug expenditure but the new price and reimbursement procedure may not favour their prompt market access. Submitted: 26 June 2013; Revised: 10 July 2013; Accepted: 11 July 2013; Published online first: 24 July 2013 In the final position paper on […]


The potential of generics policies: more room for exploitation–PPRI Conference Report

Author byline as per print journal: Sabine Vogler, PhD; Nina Zimmermann, MA Introduction: This Conference Report aims to provide an overview of key results, messages and conclusions of the Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference with regard to generics. Methods: The PPRI Conference, organized by the World Health Organization (WHO) Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, […]


The impact of pharmaceutical pricing and reimbursement policies on generics uptake: implementation of policy options on generics in 29 European countries─an overview

Introduction: To describe pharmaceutical pricing and reimbursement systems in 29 European countries with regard to medicines, particularly generics, and their possible impact on generics uptake. Method: Data collection on pharmaceutical pricing and reimbursement policies with the staff of competent authorities. Results: In most European countries the prices of medicines are controlled at the stage of manufacture (ex-factory price) […]


What lessons can be learned from the launch of generic clopidogrel?

Author byline as per print journal: Christoph Baumgärtel1, MD; Brian Godman2,3,4, BSc, PhD; Rickard E Malmstrom5, MD, PhD; Morten Andersen6, MD, PhD; Mohammed Abuelkhair7, PharmD; Shajahan Abdu7, MD; Marion Bennie8,9, MSc; Iain Bishop9, BSc; Thomas Burkhardt10, MSc; Sahar Fahmy7, PhD; Jurij Furst11; Kristina Garuoliene12, MD, PhD; Harald Herholz13, MPH; Marija Kalaba14, MD, MHM; Hanna Koskinen15, PhD; […]


A review of generic medicine pricing in Europe

Introduction: Switching from originator products to generic equivalents is a key method used by governments to reduce costs and keep their healthcare systems sustainable. The aim of this article is to review generic medicine pricing in Europe by analysing the factors that influence them. Methods: The literature review focused on selected studies that highlighted generic […]