In this sixth alert in our weekly series on the EU Pharma Package, we focus on the proposals of the European Commission, European Parliament and Council of the EU for another topic with a highly debated scope and with diverging interpretations across EU Member States: the "Bolar" exemption.

The access conditionality under Article 56a has shifted from an incentive (“carrot”) to a penalty (“stick”) — Member States can request marketing authorization holders (MAH) to launch and supply products...

This article is based on a presentation made to the Montreal/Statale University 2018 Summer School in bilateral trade relations between the EU and North America, given on 28 May in Montreal Canada.

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security...

Evolving regulatory approaches taken by France, Germany and Spain and elsewhere in the UK means businesses should keep a watching brief on the changing rules.