As part of its vision to build a European Health Union, the European Commission announced the new pharmaceutical strategy for Europe (the new Strategy) on 25 November 2020. The new Strategy introduces new policies and ideas but also brings into the spotlight long standing challenges which were recently exacerbated by the coronavirus outbreak. 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. Some of these revisions also affect the regulation of medical devices. The main elements of the new Strategy relate to innovation, availability, accessibility, affordability, and supply in relation to medicinal products.

In this post, we focus on the key proposed regulatory changes expected to impact the pharmaceutical industry. The post also discusses the implications of the new Strategy from the EU competition law perspective.


Continue Reading European Commission proposes a new pharmaceutical strategy for Europe

On 28 January 2019, the European Commission (Commission) published its Report to the Council and the European Parliament on Competition Enforcement in the pharmaceutical Sector (2009-2017) (Report). This takes stock of all the pharma cases that the Commission has pursued at EU level and that national competition authorities have investigated over the past 10 years.  It responds to recent concerns raised by the Council and European Parliament that anti-competitive practices of pharmaceutical companies may prevent patients’ access to affordable and innovative medicines.

In parallel, the UK Competition and Markets Authority (CMA) has been very active in investigating the pharma sector and currently has some eight ongoing investigations. Some of these investigations are being narrowed but the overall mood music is that authorities regard pharma cases a high priority. This trend is likely to continue for some time yet.

The key takeaways are (i) pharma cases are likely to continue to be of interest to competition authorities (ii) entry restrictions, high price strategies and loss of exclusivity are key areas of concern together with, going forward, the entry of biosimilar competition.


Continue Reading European Competition enforcement in the pharmaceutical sector: more to be expected?