Welcome to the BIA Brexit Portal
This website contains guidance on Brexit for biotech businesses and the life sciences sector.
The UK left the EU on 31 January but there is continuing uncertainty about the potential nature of the future relationship with Europe and trade with the rest of the world.
Our aim is to provide access to relevant advice and information so that businesses can make informed decisions and prepare appropriately.
Watch our latest webinar update - 30 January on our Youtube channel: Brexit Briefing Webinar
31 January 2020 update
A Brexit deal – the revised Withdrawal Agreement – was ratified and the UK left the EU on the 31 January 2020.
Under the terms of the Withdrawal Agreement a transition period is now in effect which runs from 1 February to 31 December 2020. This transition period allows the UK and EU to negotiate a future relationship, guided by the Political Declaration.
During this transition period medicines and devices regulation will stay aligned with the EU. There are no changes to market access, licensing, packaging, batch release and testing, however there are some changes to the status of the MHRA. For more details please refer to the regulation and IP page of this site.
Any extension to the transition period would need to be agreed by the UK and EU by 1 July 2020. But the government has said that it will not agree to an extension, so the UK could could still leave without a future relationship and trade agreement in place on 31 December 2020 at the end of the transition period.
BIA’s position on the future relationship remains the same and was set out in our BIA Manifesto.
BIA Manifesto: Maintaining world class medicines regulation in a post-Brexit UK
The UK’s membership of the EU ensures earlier access to medicines for patients, assures the UK’s global standing in delivering clinical trials and ensures the highest levels of safety and pharmacovigilance. Whatever happens, the UK’s future relationship with the EU must not impede the delivery of these priorities
The Government should seek the closest possible alignment between UK and EU on medicines and medical devices regulations, while assisting the MHRA to develop existing national flexibilities to modernise clinical trials to enable rapid access to innovative new treatments for patients in the UK
Continued participation in and cooperation with the EU pharmaceutical regulatory regimes, bodies and networks will help safeguard the UK as a key global launch location for new therapies securing jobs and investment in UK life sciences, while minimising duplicative red tape