Welcome to our blog dedicated to Life Sciences. We report on EU and national regulatory, compliance, intellectual property and transactional developments in the sector. We focus on (bio)pharmaceuticals and medical technologies, and also cover food and beverages, cosmetics and other healthcare products.

FTC launches multilateral working group with EU, UK and Canadian antitrust authorities to take tougher stance on pharmaceutical mergers

Thomas Masterman

Key points Working group’s goal is “concrete and actionable” updates to pharmaceutical merger analysis. Focus will include new theories of harm beyond the traditional approach of assessing overlaps in products and pipeline products. Stated intention is to take an “aggressive” approach to tackling anticompetitive pharmaceutical mergers. Overview On March 16, the U.S. Federal Trade Commission Read More

Regulatory considerations for Covid-19 next generation vaccines

Rafi Allos

As next generation Covid-19 vaccine developers consider whether ethical and practical clinical efficacy trials can be conducted, they might consider whether vaccine efficacy can instead be inferred. We consider the alternative routes for vaccine developers of using an immune correlate of protection or immunobridging studies and some potential risks associated with such approaches. Setting the Read More

EMA advises study sponsors to amend Informed Consent Forms

Nieke Vanavermaete

Consent Forms (ICF) to include an explicit reference as to the possibility that EU inspectors would have access to medical records and personal data of clinical trial participants. In February 2021, the European Medicines Agency updated its guidance in the form of questions and answers (Q&As) on Good Clinical Practice (GCP). GCP is a code Read More

EU – Parallel Trade: restrictions and export bans for pharmaceuticals

Nieke Vanavermaete

In 2018, the EU Commission adopted a “Paper on the obligation of continuous supply to tackle the problem of shortages of medicines”, providing that Member States may take measures to prevent or address shortages of medicines by restricting the free movement of goods within the EU. While Member State may restrict the supply of medicinal Read More

Best Reasonable Efforts to end a global pandemic

Marton Eorsi

Now that the COVID-19 vaccine contract between the EU and AstraZeneca has been published, we take a look at it and the “Best Reasonable Efforts” provisions. The production issues facing the roll-out of the EU vaccination programme have led some to question the centralised approach taken by the European Commission in its procurement of the Read More