At the end of 2020, the European Commission set out its vision to build a European Health Union with its announcement of the new pharmaceutical strategy for Europe (the new Strategy). As we discussed in a previous blog, the new Strategy seeks to introduce new policies and ideas, whilst bringing into the spotlight long standing challenges which were exacerbated by the Covid-19 pandemic. The new Strategy puts forward numerous proposals for legislative reforms that are likely to affect the regulation of the entire life cycle of a medicinal product and the regulation of medical devices. As a reminder, the key elements of the new Strategy relate to innovation, availability, accessibility, affordability, and supply of medicinal products.

In this post, we focus on the developments in the first half of 2021, including a pilot project launched by the European Medicines Agency (EMA) on market access and the Commission’s Roadmap on revisions to the pharmaceutical legislation.Continue Reading Update on the European Commission’s proposed new pharmaceutical strategy

Many things have changed since 1985, in particular in the world of technology.  The Commission’s 10 page report and evaluation of 7 May 2018 questions whether the Product Liability Directive of 1985 (“the Directive”) is still fit for purpose.  The Directive was implemented to protect consumer safety and imposes strict liability (i.e. no requirement for the injured party to prove fault) on a producer of defective products for personal injury or damage to property caused by the defect.

The Commission’s Report

Although, historically, the Commission has reported on the implementation of the Directive to the Council and Parliament every 5 years, this is the first time that the report has been accompanied by an evaluation of the relevance of the Directive in the EU today, owing to widespread concerns regarding the invention and everyday use of “products” that were not even imagined back in 1985.  The report recognises the urgent need to consider whether the Directive, in its current form, adequately deals with the challenges posed by “digitisation, the Internet of Things, artificial intelligence and cybersecurity” now and in the future, and, if it does not, what changes would be required to address the shortcomings.Continue Reading Is the EU Product Liability Directive still fit for purpose?