Fighting counterfeit medicines in Europe: the effect on access to medicines

The implementation of the Falsified Medicines Directive, and its Delegated Regulation with detailed specifications of safety features, will provide an additional obstacle for counterfeiters. The implementation of the Directive aims to prevent falsified medicines from reaching patients, and is in the interest of public health. However, the financial burden for manufacturers to implement these additional safety features, as well as the repository system that will allow the verification of authenticity of individual packs of medicine, may threaten the availability of medicines.


Maarten Van Baelen, Pieter Dylst, Catarina Lopes Pereira, Johan Verhaeghe, Koen Nauwelaerts, Susie Lyddon

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US FDA Advisory committee hears first-hand about the decade of EU experience with biosimilar medicines use

Medicines for Europe Director General Adrian van de Hoven participated in the Open Public Hearing (OPH) of the July 13, 2017 Oncologic Drugs Advisory Committee US FDA Advisory Committee involving biosimilar medicines on 13 July 2017.

Letter from European and UK Life Sciences Organizations Underlining the Importance of Securing Ongoing Cooperation Between the UK and EU on Medicines

Position Paper External Reference Pricing for Generic and Biosimilar Medicines

Medicines for Europe Country Specific Market Access Policies

Positioning Statements on Physician-led Switching for Biosimilar Medicines

Essential Medicines for Universal Health Coverage

Medicines for Europe’s Contribution to WHO’s Biological Qualifier (BQ) Developments (PRESENTATION and SPEECH)





18 October 2016
Suzette Kox
Senior Director International
Biosimilar Medicines Group

Understanding the Science of Extrapolation and Defining Interchangeability – Dr. Elena Wolff-Holz, EULAR Symposium London

EGA-EBG Summary Position Regarding the WHO Biologic Qualifier Proposal (INN Working Doc. 14.342)