Brexit Information for Life Science Companies – June 2018 Edition

The Brexit project is  ever changing and keeping up to date with how it impacts on the life sciences sector is a difficult task.  Here, we have highlighted some Brexit information for life science companies  and we assess its impact.

Recently, discussions around the UK’s departure from the European Union reached another pivotal stage.  EU Chief Negotiator Michel Barnier is due to publish a 120 page draft legal text that will map out the December 2017 agreement with the United Kingdom.  This draft legal text will include unresolved and contentious issues such as that of the border between the Republic of Ireland and Northern Ireland.

More importantly at this stage for the life sciences sector, the draft legal document should give insight into how companies will be able to trade between the EU27 and the UK during and after the mooted transition period.  There is still a distinct possibility that the talks might collapse, over an issue such as the aforementioned Irish border issue or another issue, and the UK might leave the EU at the end of March next year without a trade deal or a transition period.  Therefore, there is a need at this stage for pharmaceutical and medical device companies to be informed of current developments and to have a strategy that encompasses the many outcomes that remain on the negotiating table at the moment.  It is essential for companies to have such scenarios mapped out to ensure that supply chains are not interrupted and that Brexit does not adversely impact on the commercial success of the company.

Here, below, we have listed a wide range of Brexit resources that have been created by our expert team over the last two years.  Our team have been working with our clients to ensure that they remain informed and that their companies are not impacted by the UK’s decision to leave the EU.

If you would like to talk to us about Brexit or other regulatory issues then please call us at any time on 00353 52 61 76706.

Brexit Information for Life Science Companies

Here are just some of the Brexit resources that we have created that you might find useful.

1)How Brexit Will Impact UK Marketing Authorisation Holders

The European Medicines Agency has had to dedicate considerable resources in dealing with the complex issues related to the UK’s decision to leave the European Union.   In this article we look at  one of the main questions highlighted by the EMA relating to UK Marketing Authorisation Holders and provide additional resources to assist you in better understanding how Brexit might impact on your business. Read more here.

2)Brexit: Implications on Existing Marketing Authorisations

Almost two years on from the UK’s decision to leave the European Union the negotiations have begun. The life sciences sector is, perhaps, one of the sectors that will be most impacted by the result of the referendum and many companies are setting plans in place to deal with a new regulatory landscape. What are the implications on existing marketing authorisations? Read more here.

3)The Brexit Transition Period & The Life Sciences Sector

In this blog, Brian Cleary looks at the comments of British Chancellor Philip Hammond regarding the Brexit Transition Period. Read more here.

4)How Will The UK Life Sciences Sector Address Post Brexit Skills Shortages

The UK pharmaceutical sector employs in excess of seventy thousand people. The structure of a Brexit will have significant impact on them and the industry that they work in. For now, there is a firm belief that the UK will make a full exit from the single market and, with that, there will be restrictions on those seeking to move to the UK. How will the UK handle post Brexit skills shortages? Read more here.

5)Brexit Clinical Trials Sector Implications

In this extract from our first Brexit whitepaper we look at the implications of Brexit for the clinical trials sector.

Britain’s divorce also raises uncertainties as to how clinical trials will be affected. ‘Brexit’ comes at a time of major upheaval in clinical trial legislation in Europe with the repeal of Clinical Trials Directive 2001/20/EC and its replacement with Regulation (EU) No. 536/2014. Two key factors will determine the shape of all things clinical in Britain – (1) the timing of implementation of regulation 536/2014 and (2) whether Britain decides to join the European Economic Area (EEA) after leaving the EU. Read More Here.

6)Brexit: The Implications on Existing Marketing Authorisations

In this extract from our first Brexit whitepaper we look at the implications of Brexit for existing marketing authorisations. London, as host city to the European Medicines Agency (EMA), with a full-time staff of more than 600, is the largest EU body in Britain and has overseen pan-European drug approvals since 1995 from its headquarters tucked away among global banks in London’s Canary Wharf. The centralised procedure is compulsory for medicinal products manufactured using biotechnological processes, for orphan medicinal products and for human products containing a new active substance, which are intended for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes. Read More Here.

7)The UK Life Science Strategy Sector Deal & The Role of Regulatory Affairs

While the UK government may not have carried out sectoral analysis of the impact of Brexit, it has developed a comprehensive industrial strategy that seeks to become the road map for the UK’s place in a global economy post Brexit. Read more here.

These are just some of the many resources that we have created on the issue of Brexit and how it might impact on the pharmaceutical sector.  If you would like to talk to us about this issue or any other regulatory issue then please contact us on 00353 52 61 76706 or simply complete your details below and we will get back to you.

About the Author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD