Most Read Life Sciences Brexit News Stories on AcornRegulatory.com in 2016

We appear to have become accustomed to the phrase ‘no one foresaw this happening’.  The term certainly applies to those of us taken by surprise in the early hours of June 24th 2016 when the announcement was made that the UK had voted to leave the EU.  Here are the five most read life sciences Brexit news stories on our website in the past year.

1. 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.

2. Who Will Host The European Medicines Agency?

For those of us working in the sector, the future location of the European Medicines Agency has been a consistent topic of conversation since the outcome of the Brexit vote became known. There is no doubt that the UK’s decision to leave has caused some upset for the 600 members of staff at the agency. In a human context, their livelihoods and the location of their employer are now in the air. The EMA is one of a number of agencies that are now being courted actively by European governments in an attempt to persuade them to choose their cities. Read More Here.

3. Brexit Medical Device Implications

In this extract from our first Brexit whitepaper we look at the implications of Brexit for the medical device sector. The future implications of ‘Brexit’ for the UK medical device industry are yet to become clear. There is one certainty: until the UK exits the EU, the IVD and medical device directives apply, and CE marked goods will continue to be certified and traded as they have prior to the referendum. In the future, if the UK opts to become part of the EEA (like Norway), the free movement of medical devices under the CE Mark system will continue. Read More Here.

4. 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.

5. 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.

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