The findings arrive with the UK’s withdrawal from the European Union (EU) less than a year away, on March 29 2019.
In order to retain their ability to market products in the EU, companies may need to adopt a number of changes: transferring marketing authorisation to a legal entity in the European Economic Area (EEA), changing the qualified person for pharmacovigilance or relocating the pharmacovigilance system master file to within the EEA.
In addition, companies must ensure that their logistics, manufacturing sites, supply chains and contracts are suitable for the regulatory environment post-Brexit.
In total, there are 694 centrally authorised products with significant ties to the UK, with 661 being human and 33 being veterinary products.
The European Medicines Agency (EMA)’s press release on the findings revealed that part of its intention in carrying out the survey was to identify “where there are risks of supply shortages and [to] assess how critical these are.”
Communicating the risks
A spokesperson for the Agency revealed that it is attempting to forestall any issues by engaging with the industry: “We are in continuous dialogue with industry associations to emphasise the importance of planning for any regulatory steps required for their medicines to remain on the market post-Brexit. Appropriate preparation is needed to minimise disruption to medicines supply and avoid shortages. Every company has to anticipate and understand the changes ahead, and the EMA has therefore been providing guidance to help companies prepare for Brexit.”
The spokesperson continued, “in terms of specific actions to be taken, pharmaceutical associations and companies have been actively informed about the need to adapt processes and to consider changes to the terms of their marketing authorisations in due time to ensure their continued validity once the UK has left the EU.”
Dangers to UK manufacturing
The Agency also highlighted that for 16% of the products listed, there are ‘serious concerns’ because the companies involved only have manufacturing sites based in the UK. The EMA’s spokesperson explained that to continue to market products in the EU, “certain steps in the manufacturing process need to be based in the EEA, i.e. batch release, batch control and importation.”
When contacted to discuss how the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) members were progressing in their preparations, a spokesperson replied: “In February this year, the EFPIA President sent a letter to all members stressing the need for readiness by March 2019 and the importance of having Brexit contingency plans in place. EFPIA members took note, moving marketing authorisation holders from the UK to the EU27, moving testing facilities, working on packaging and labelling issues, as well as studying how to ensure supply with respect to possible customs challenges.”
However, the spokesperson did reveal the Association would further consult the EMA’s work, “in order to better understand the status of EFPIA companies’ preparedness since the conduct of the survey at the beginning of the year”.
It would seem one of the major issues besetting planning ahead for Brexit is the lack of certainty about the direction Brexit will take – as the Regulatory Affairs Professionals Society has indicated. Yet this has not stopped the EMA and consultants, such as Parexel, from advising that the best way to prepare is to make contingency plans assuming a hard exit for the UK, in dialogue with the relevant regulatory body.