BIA warns there is little time to avoid disruption as government announces ‘no-deal’ Brexit planning

The Government has today published a Written Ministerial Statement on EU Exit preparedness.

Responding to the Statement, Steve Bates OBE, CEO of the BIA, said:

“UK life sciences companies know that patients are at the end of their supply chains, and for three years they have been doing all they can to ensure that patients will continue to get their medicines whatever Brexit outcome occurs. The BIA again encourages its members to engage in the Government’s programme, which we are highlighting to them is different to last time around – both in terms of freight support and the ask of industry. Our sector has already endured considerable disruption, duplication and uncertainty, and invested significant time, effort and resource with little government support.  There is now an additional requirement around border paperwork which brings additional burden, especially for smaller companies, as much of this work is contracted out work.

 “As we have stressed before, a ‘no-deal’, disorderly Brexit must be avoided, as it will negatively impact patients, public health and the life sciences sector. 

“Government has also listened to industry about the need for extra freight capacity; only last week the BIA highlighted the need for this to Parliament’s Exiting the EU select committee. The BIA will continue to work with the Government on its planning.

“There are now only 127 days until the next possible ‘no deal’.  Making changes at short notice is not easy or simple for our sector – supply chains are complex, integrated across Europe and regulated at every stage.  Many products are temperature-controlled, and some deliveries can’t exceed three days or deviate from approved storage conditions. Some products have a short shelf life and can’t be stockpiled and most take longer than 127 days to produce.

“A ‘no deal’ Brexit would mean the biggest dis-integration in a lifetime of the complex regulated medicines market across Europe in terms of regulation, cross border movement of goods, comparative pricing and intellectual property. As we have said before, we should be under no illusions that ensuring UK medicines supply in a ‘no deal’ Brexit will be easy or smooth, but on behalf of patients we encourage all participants to again be as prepared as possible for a scenario industry really does not want.

“A ‘no deal’ Brexit will bring the duplication of red-tape for the life sciences industry, despite assurances from Ministers that this would not happen.  The Government’s ‘no deal’ Statutory Instruments have introduced elements that will adversely impact both industry and patients.  For instance, we do not understand the need for the requirement of an additional oversight system to verify Qualified Person certification of Investigational Medicinal Products imported from EEA countries that was included in the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019.  If there is a ‘no deal’, BIA calls on the Government to immediately review these and other regulations.

“Industry also needs to know if the Conservative leadership candidates support this approach to ‘no-deal’ planning.”

The Government's full statement can be accessed here: https://www.parliament.uk/business/publications/written-questions-answers-statements/written-statement/Commons/2019-06-26/HCWS1661/

ENDS 

Contact: Martin Turner, BIA Head of Policy and Public Affairs [email protected], 07850 518 075

About the BioIndustry Association

Established over 25 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives.

For further information, please go to www.bioindustry.org and twitter.com/BIA_UK.