BREXIT UPDATE

BREXIT

The European Council agreed to a further extension of the date for the UK’s withdrawal from the EU at its meeting on 10-11 April. The extension will last as long as necessary and, in any event, no longer than 31 January 2020.

The UK remains a Member State for the duration of the extension, with all the rights and obligations set out in the treaties and under EU law.

Based on the European Council decision, and until further notice, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood as referring to 31 January 2020.

It is clear that there remains considerable uncertainty as to the final outcome and the impact on pharmaceutical companies running clinical trials in Europe and work with contract research organizations (CROs) and contract manufacturing organizations (CMOs) based in the UK.

Exporting after the Brexit decision from the UK will be effected, however it is yet to be determined exactly what the effects might be. As no member state has left the EU under these circumstances before, the UK is in fairly unchartered waters.

EXPORTING AFTER BREXIT

Therefore, whilst we know that the process of exporting from the UK to EU countries will change, it is not possible to say now to what extent these changes will impact exporters.

There are a few options for what exit strategy the EU and the UK might agree upon. The conflict may arise as the UK will want to still benefit from the free market of the EU and push for trade leniencies.

However, the EU may be tempted to make an example of the UK to prevent more member states from leaving the Union. If the UK gets too good of a deal, this may encourage other skeptical members to consider leaving the EU more seriously.

We can expect that the final agreements will be somewhere in the middle. The UK will likely go into a bilateral trade agreement with the EU or join the EEA or EFTA.

At this time there have been no official publications, statements, laws, or regulations outlining any of the new processes, implementation times, requirements, tariff rates, or processes related to the import and export of goods for clinical trial and compassionate use/named patient use programs. Until such time as these are made public and adopted into regulation, status quo will be maintained and Caligor Coghlan Pharma Services will react as appropriate to maintain our clients’ best interest.

WHAT WILL EXPORT LOOK LIKE?

At the moment, between the UK and the EU there is free trade. It is important to note that until the new agreements have been established, there will be no changes to the freedom of movement between the UK and EU. The status quo will remain until there have been official agreements established and released.

CALIGOR COGHLAN PHARMA SERVICES BREXIT PREPAREDNESS

Caligor Coghlan Pharma Services understands the anxiety clients have during a time of uncertainty which is why we have a contingency plan in the event that our UK facility is impacted by Brexit in regard to remaining EU Member states.

As of now, there has not been a decision on how pharmaceutical products related to clinical trial, Early Access programs, and direct to patient programs, to core EU member states will be treated if Brexit occurs on the 31 January 2020 with no deal.

Brexit will not impact Caligor Coghlan Pharma Services operations in the UK related to the rest of the world such as, EEA, AsiaPac, Africa, or Latin America.

However, due to the uncertainty, Caligor Coghlan Pharma Services has implemented a Brexit contingency plan with a strategic partner located in an EU Member state where we will be able to utilize their facilities for distribution. Caligor Coghlan Pharma Services will continue to provide all other services through our UK and US facilities. Through these strategic agreements, our clients will not see a disturbance in their project timelines or project costs.

QUESTIONS

Should you have any questions please contact Caligor Coghlan Pharma Services at
Email: brexit@calcog.com

Approval

On behalf of Caligor Coghlan Pharma Services, the undersigned executive has approved and issued the foregoing statement as of the 3rd day of November 2019 and has instructed that it be posted on the Company’s website.

Geoff M. Fatzinger
Global Vice President, Regulatory Affairs

Caligor Coghlan Pharma Services
US: 1500-B Business Park Drive l Austin, TX, 78602
UK: Unit 8 Masthead, Capstan Court l Crossways Business Park, Dartford, DA2 6QG