As we have discussed in previous posts, 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). In 2021, the Commission has begun to implement the new Strategy, as discussed here. One area that was identified as in need of revision was the unmet medical needs in areas currently not within the scope of the legislation governing rare diseases and paediatric medicines. The Commission has been focused on this area for a number of years, and there have been a number of consultations and stakeholder engagements to explore possible changes to the legislative regime. We set out below a summary of the Commission’s proposals on orphan and paediatric medicinal products.


Continue Reading European Commission’s proposed amendments to orphan and paediatric legislation

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

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?