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

Earlier this month, the European Commission published an updated version of the 2011 Note on the handling of duplicate marketing authorisation applications for medicinal products (the 2011 Note). Following a long period of consultation and exchange with stakeholders and representatives from the EU Member States, the European Commission has sought to clarify the conditions under which applications for duplicate marketing authorisations will be assessed. In this blog post, we discuss the relevant changes, as well as the implications for the industry.
Continue Reading European Commission publishes updated guidance for duplicate marketing authorisations

On 24 December 2020, the European Union and the United Kingdom reached an agreement in principle on the EU-UK Trade and Cooperation Agreement (the Agreement). This was the result of many months of detailed negotiation within an increasingly difficult political environment. The final Agreement does not cover all of the aspects about which life sciences companies have been concerned, and there are areas that will likely be the subject of further discussion during the implementation of the Agreement. However, many view the Agreement as being an important first step in the UK’s continuing relationship with the EU. We set out below a summary of the key aspects of the Agreement relevant to life sciences companies.

Continue Reading The EU-UK Agreement and the implications for life sciences companies

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

The European Commission has published a proposal for a Regulation reinforcing the European Medicines Agency’s (EMA) role in crisis preparedness and management for medicinal products and medical devices. According to the European Commission, the COVID-19 pandemic demonstrated that the EMA has a limited ability to manage availability issues relating to medicinal products and medical devices and lacks a framework for crisis response. The aim of the proposed Regulation is to set up such a framework which will allow the EU to respond effectively to health emergencies through broader engagement with the relevant stakeholders in a coordinated and timely manner to achieve the over-arching objective of public health protection.
Continue Reading Draft EU Framework for Coordinated Approach to Addressing Emergency Public Health Threats

Although the date of application of the Medical Devices Regulation (MDR) has been delayed by a year, to May 2021, the EU institutions continue to work on its implementation to ensure that the new framework is workable in time for the revised deadline.

In this post, which is part of our series of blog posts covering the implementation of the MDR, we set out a summary of key recent developments. As indicated below, as well as our previous posts, there are several important steps that still need to be taken with regard to MDR implementation. Similarly, many companies are still working on their own compliance. While industry undoubtedly faces a range of challenges in the context of the ongoing health crisis, and the delay provides some welcome breathing room for many, it will nevertheless be important to continue to progress MDR preparedness so that supply is not disrupted.
Continue Reading EU Medical Devices Regulation: implementation progress during the pandemic

With only two months to go before the date of application of the Medical Devices Regulation (MDR) on 26 May 2020, the Commission has taken various steps towards its implementation. As we have discussed, while there are lots of good intentions, there is still much to be done –  although it now seems that a delay to the May date is on the horizon.

Last week, the MDCG published a number of guidance documents providing much needed clarity on some of the “priority” areas. These are set out below, with particular comments on the guidance relevant to the transitional provisions under the MDR.


Continue Reading Two months to go: Latest on implementation of EU MDR (Part 2)

There are now only two months to go before the date of application of the Medical Devices Regulation (MDR) on 26 May 2020. We have previously published updates on various implementation activities, and the concerns of industry and stakeholders that the deadline has been fast approaching but that there remains a huge amount to be finalised. The difficulties surrounding Brexit, and now the coronavirus pandemic, only add to these concerns. With the short amount of time remaining, we set out in this series of posts a summary of recent key developments.

As expected, the recent activity is focused on the MDR, and does not, on the whole, address the In Vitro Diagnostics Regulation (IVDR), which is due to be applicable in 2022. While this is a pragmatic approach from the institutions given current timing, it remains the case that IVD manufacturers have little clarity on how the IVDR will operate, and it seems, are unlikely to obtain any in the near future.


Continue Reading Two months to go: Latest on the implementation of EU MDR (Part 1)