Getting ready for Brexit

As the United Kingdom’s (UK) departure date from the European Union (EU) approaches and without a breakthrough in the negotiations ICON regulatory experts have examined what is needed to support continuity of medicines supply to patients and compliance at this critical time.

In a no deal (hard) Brexit scenario the UK will become a third country leaving the EU single market and customs union thus ending the free movement of capital, goods, services and people.

Brexit will impact clinical trials being conducted both in UK and EU and sponsors need to give due consideration to the following time-sensitive aspects to ensure continuity to patients post Brexit.

Regulatory Submissions

Various EU Regulatory Authorities (RAs) and the European Commission have published guidance drawing attention to various legal requirements arising from Directive 2001/20/EC which Sponsors must uphold post Brexit. 

Some RAs have indicated that clinical trials may be suspended if Regulatory submissions and approvals are not in place by the withdrawal date. Based on the currently available information the following aspects may require Sponsor consideration and / or prioritisation at this time:

Requirement Action required if Recommended Action for compliance

Sponsor or legal representative must be in EU/EEA

(Ref. Article 19 Directive 2001/20/EC)

Sponsor currently based in UK

EU Legal Representative currently based in UK

EU Legal Representative be appointed in an EU 27 member state ("EU 27") or an EEA country

Site of IMP release / manufacturing / import must be in EU/EEA

(Ref. Article 31(1) Directive 2001/20/EC)

Site of IMP release / manufacturing / import based in UK

Site be located in EU 27 / EEA country

Note - IMPD impacted.

These amendments are typically considered substantial amendments requiring approval prior to implementation, with 20 – 35 day approval timeline.  If you require support for submissions or seek more information please discuss with your study Regulatory Lead.
 

Supply Chain considerations

Continuity of Investigational Medicinal Product (IMP) including comparators and non-investigational medicinal product (NIMP) and other supply chain considerations may require sponsor action now to ensure continuity. Aspects for consideration include -

  •  Site of QP release / import in EU 27 / EEA country
  •  Distribution warehouse in EU 27 / EEA country
  • Increased inventory to account for potential border delays
  • Impact to IRT
  • Continuity of supply of lab kits, samples, ancillary supplies (For a copy of ICON Central laboratory Brexit preparation contingency plans please contact Brexit@iconplc.com)

Sponsors are recommended to review the entire supply chain per study and take contingency actions as appropriate to ensure continuity of supply.

*EU 27 refers to EU member states other than UK. EEA countries are Norway, Iceland and Lichtenstein.

ICON Preparation for Brexit

Brexit impacts ICON as a service provider and global multi-national organisation, in addition to sponsor organisations, Clinical Trials and marketing authorisations.

ICON’s Brexit Office developed a Brexit strategic action plan  and established a cross-functional Brexit-readiness team which has been working to understand, assess, plan and implement and/or recommend organisational and operational actions that may be required due to Brexit to ensure continuity of ICON services to Sponsors, and continuity of supply and service to patients participating in clinical trials. The plan has been reviewed by external consultants to ensure strategy is in line with industry standards and we have been advised that ICON’s preparation was found to be well under way with potential risks identified and appropriate mitigation plans established.

In line with the European Medicines Agency (EMA) ICON is working on the scenario that the UK will become a third country at the time of withdrawal. EU and UK negotiators have repeatedly stated they do not want a ‘no deal’ outcome in the negotiations. However, as the Brexit Withdrawal Agreement has not been ratified, and the current legal certainty enshrined in laws that the UK will leave the EU on the withdrawal date, ICON is contingency planning for a ‘hard’ (no deal) Brexit.

We have received various questions asking if we can rely on the ‘Transition Period’. This is a period of time (proposed from 30 March 2019 to 31 December 2020) intended to allow governments to put arrangements in place to facilitate an orderly withdrawal. However, it should be noted that the transition period will only become effective if the withdrawal agreement is ratified.

ICON’s Regulatory Intelligence group is monitoring the progress of negotiations and our study teams have been completing study-specific impact assessments to identify and flag potential issues and proposed mitigations plans to Sponsors.

To keep up to date on regulatory developments on Brexit and in other parts of the world, please sign up to the Regulatory Newsletter.

If you are a client and want to find our more about how your study will be affected, please contact your study Project Manager or Brexit@iconplc.com.