The historic decision by the voters of the UK to leave the EU marks a significant change for the UK and EU and will impact other trading partners such as the US. However, all EU directives and regulations, as well as the treaties themselves, remain in force in respect of the UK until it formally leaves the EU. Therefore on a legal level, nothing has changed, and it is not expected to do so for the time being.
Do you have a plan for navigating the unknown?
While there is much uncertainty as to how the UK will untangle itself from the various EU institutions and what its future relationship will be, it is important for life sciences companies to understand the potential tax impact of this development and the potential consequences ahead.
From a business and regulatory perspective, there will also be interesting implications to life sciences companies, including:
- Whether the UK will seek to continue to come under the banner of the European Medicines Agency and the European drug approval framework, rather than going off on its own
- Clinical trial locations, as UK sponsors may not be allowed to benefit from the new EU central portal for submitting applications
- Market access strategy and launch priorities, as only EU-based companies are authorized to apply or hold EU marketing authorization
- Supply chain considerations, as products manufactured or imported in the UK may need to pass again through EU importation and quality control procedures to be marketed in the EU
Read more about the tax and legal issues here.
EY Legal Services contacts:
Phil McDonnell – Executive Director, advising on Brexit related legal issues