By Aparna Krishnan, Corporate Affairs Lead
As the UK Prime Minister’s office is preparing for the cabinet meeting at Chequers this Friday, British businesses including the biotech industry are none the wiser on what lays ahead after March 29, 2019 when the UK exits the European Union.
The current discussion is focussed on the Brexit White Paper containing Britain’s position on single market, customs and regulatory alignment. Media reports suggest that the draft of the white paper could include binding regulatory frameworks for goods. This would mean following single market rules and a high level of regulatory alignment for goods. If confirmed, it would mean that the government is supporting the interests of the manufacturing industry – one of the main cogs of British business and exports.
But in the absence of alignment of other single market rules such as services and people, EU officials are unlikely to commit to such a deal. The Guardian quoted an unnamed EU official dismissing the draft as `as having the cake and eating it’.
For the biotech industry to be ready and respond to whatever challenges Brexit will bring in, guidance in key areas are essential from the government.
For instance, guidance from the MHRA on what options they are considering in the event of a no deal, a restricted deal with no customs, etc will need to be outlined. The EMA on the other hand has updated its guidance on centrally authorised medicines and the validity of inspections carried out by UK inspectors; multi-country packaging, back-up arrangements for pharmacovigilance as well as batch release among others.
There is also confusion among the biotech industry over the date at which that the UK becomes a third country: is it on March 30, 2019 or is it after the transition period.
Additionally, there is also concern over British industry’s continued involvement with Horizon 2020 and any of its successive organisation to receive funding and research and development.
To know more and to prepare yourself for the upcoming Brexit changes, contact Partners4Access, specialists in access for Cell & Gene Therapy at [email protected] or visit our website www.partners4access.com