The European Federation of Pharmaceutical Industries and Associations (EFPIA) has voiced concerns that there is too little time to move marketing authorisations (MAs) before the Brexit date. EFPIA wants regulators to exhibit flexibility with regards to the anticipated time crunch that is approaching firms with centrally approved products.
According to the European Medicines Agency (EMA), operations that are based in the UK will no longer be valid if, as expected, the UK is classified as a third country after the Brexit deadline in March 2019. As a result marketing authorisation holders (MAHs) will need to move their approvals and supporting framework to one of the remaining 27 EU member states.
If Britain leaves the EU without a trade deal, supplies of thousands of medicines are at risk of disruption, pressuring manufacturers to prepare for duplicate product testing to ensure their drugs stay on the market. Given stringent medicine regulations that will require the retesting of medicines shipped across borders in the absence of an agreed trading deal, Brexit threatens the free flow of these goods.
“Drug manufacturers also face an additional hurdle when it comes to licensing their products, since more than 12,000 medicines will require a separate UK licence in order for them to be prescribed.”
The practicality of making this transition by March 2019 has been questioned by EFPIA. Typically, only short lulls in regulatory activity fall in between the series of variations and regular safety update report submissions. Given the time it will take to gain regulatory clearances in order to transfer a marketing authorisation (MA), this could be a problem.
“EFPIA calculates 17% of all centrally authorized drugs have UK legal entities that will need transferring. That amounts to 5,000 months of regulatory review EFPIA members need to squeeze in among their existing lifecycle management activities. Moving batch release to remaining EU states will take a further 4,000 months.”
In practice there is no clarity as to how the time constraints will be addressed or if regulators will accept the idea of a “more flexible approach”. The EMA has released clear statements about companies needing to move tasks such as batch release from the UK. However the lack of progression in broader negotiations raises apprehension about the likelihood of an agreement being sorted.
If the UK falls out of the EU without a deal and reverts to World Trade Organisation rules, trade delays are expected by 45% of EFPIA’s members. With this scenario, tariffs would increase between the UK and EU, and result in the cessation of frictionless transfer of products across the English Channel.
To view the Brexit EFPIA survey results, please click here.