What Major Clinical Trial Material Factors are Impacted by Brexit?
The impact on current mutual commerce and regulatory recognition between the UK and other EU countries was and is still unclear. Pharma cannot afford to wait and see what the impact is on the release and distribution of Clinical Trial Material from the UK into the EU. Some of the major factors to take into consideration are:
Existing inventory to be looked at includes locations of packaging and distribution within the UK and what to do with it, as well as comparator sourcing within the UK market. New locations, partners, and sourcing options need to be examined and implemented for risk mitigation purposes.
Tax laws vary country by country and changing the supply chain and import channels may have serious tax impact and appropriate compliant tax procedures need to be developed and implemented. It is also possible to establish customs license and other governmental agreements to put a sponsor in a favorable tax position.
The regulatory concerns include license changes, qualified person (QP) release recognition, and filing amendments. If a sponsor used a QP in the UK, there is risk of recognition in the EU, and vice versa. Sponsors should be prepared to have QP options in both the UK and EU post-Brexit for release.
Post hard-Brexit, after 29-Mar, it is still up in the air on how the dust will settle and sponsors should mitigate risk by limiting material movements in and out of the UK in the first several weeks after as timing and processes are too unknown to rely on.
A technical working group under ISPE’s PQLI® Committee that is seeking to assist industry and regulators with implementation of ICH Q12 recently produced a webinar on Challenges and Successes of ICH Q12 Related Submissions .
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