This e-presentation gives a critical analysis of the EU legal framework applicable to the use of healthcare personal data, particularly in the context of anonymised data, and in the framework of the recently adopted European Health Data Space.
e-Presentation | March 2023 | Learning time: 13 minutes
e-Presentation by Kristof van Quathem, Of Counsel, Covington, Brussels.
This e-presentation offers an update and useful guidelines on the opt-out system put in place by the Unified Patent Court Agreement whereby patent-holders have the faculty, during a transitional period, to exclude the jurisdiction of the Unified Patent Court for their European patent with unitary effect.
e-Presentation | March 2023 | Learning time: 28 minutes
e-Presentation by Philippe Campolini, Partner, Stibbe, Brussels.
This e-presentation offers a critical appraisal of the impact of recent merger and antitrust developments on the pharmaceutical sector. After describing how the CJEU has recently interpreted the concept of excessive pricing, it moves on to explain the consequences of the European Commission’s Guidance on the application of the referral mechanism set out in Article 22 of the Merger Regulation.
e-Presentation | March 2022 | Learning time: 48 minutes
e-Presentation by Nicolas Pourbaix, Senior Counsel, Amgen, Diegem.
This e-presentation gives an overview of the EU legal framework for public procurement in healthcare systems and explains how it has been applied to procurement procedures on vaccines during the pandemic. Furthermore, it addresses challenges and loopholes in the procurement process and proposes potential solutions.
e-Presentation | March 2022 | Learning time: 30 minutes
e-Presentation by Michael Jürgen Werner, Partner, Norton Rose Fulbright, Brussels.
In its first part, this e-presentation explains how barriers to biosimilars can have an impact on access to affordable medicines and public health expenditure. In its second part, it explores the consequences of unjustly granted preliminary injunctions in patent litigation cases in the light of a recent ruling from the CJEU (C-688/17, Bayer vs Richter) and an interim decision adopted in the Netherland.
e-Presentation | March 2021 | Learning time: 41 minutes
Marleen van den Horst, Partner, BarentsKrans Coöperatief Advocaten, The Hague.
This e-presentation looks at the EU legal framework for the promotion of pharmaceutical products (Directive 2001/83/EC) in the light of recent rulings adopted by the CJEU on online sales (C-649/18A) and on distribution of free samples (C-786/18) of pharmaceutical products. Issues related to advertising and over-the-counter products are also tackled.
e-Presentation | March 2021 | Learning time: 39 minutes
Dr Christian Tillmanns, Partner, Meisterernst Rechstanwälte, Munich.
This e-presentation presents flexible antitrust and State aid measures adopted by the European Commission in order to face the difficulties caused by Covid-19. It also looks at patent pooling, patent licensing and the EU's Covid-19 vaccine export controls.
e-Presentation | March 2021 | Learning time: 42 minutes
Domien Op de Beeck, Partner, Bird & Bird, Brussels and Baptist Vleeshouwers, Associate, Bird &Bird, Brussels.
This e-presentation explains the regulatory specificities of biosimilars in the context of competition law and gives an overview of the expected strategies of the pharmaceutical industry to restrict competition of biosimilars on the market.
e-Presentation | March 2020 | Learning time: 34 minutes
After giving a critical appraisal of the consequences of recent judgments adopted by the CJEU on access to documents held by EMA, this e-presentation presents some of the industry challenges raised by the implementation of the new in-vitro diagnostic regulation, as well as by Brexit.
e-Presentation | March 2020 | Learning time: 42 minutes