Concerned about Brexit for your patients, clinical trials or drug development? With persistent uncertainty surrounding the endgame for EU and UK, preparation is crucial - so that your compounds, devices, testing, clinical trials and manufacturing processes are best positioned for a smooth transition.
On April 11, 2019, the EU Council and UK agreed to a six-month extension with a new exit date of October 31, 2019.
Covance and its parent company, LabCorp, have been actively planning for a “no-deal” Brexit scenario for 3 years.
We have been monitoring Brexit developments since June 2016. A formal Brexit task force was convened by the company in mid-2017. Since that time, we have been working with industry associations, directly advocating to UK and EU governments to minimize potential impact on our industry, utilizing a strong partnership approach.
Key components of Covance's Brexit preparation includes . . .
- We are assessing, pre-stocking, storing and /or resourcing critical supply needs.
- We have obtained Authorized Economic Operator (AEO) status for our Harrogate (UK) and York (UK) facilities. This is a form of trusted trader accreditation that will reduce the need for border checks on our goods / materials and expedite clearance of our shipments in the event of border disruption.
- We have assessed the risk of import / export delays in shipments to and from UK (human biological samples, as well as animal samples), and have concluded that no changes are needed for our export UK procedures and our import procedures, or for Central Labs activities outside the EU27.
- Our Central Laboratory activities are carried out in Geneva, Switzerland. Switzerland and the UK have signed a deal that guarantees current trade conditions between the two countries.
- We possess – and continue to build – inventory to manage through a 2-month period of disruption post October 31 at our Harrogate, York and Leeds (clinical research unit) sites. Our other Early Development & Chemistry Solutions sites acquired in the Envigo transaction located in Eyre, Huntingdon and Shardlow have taken similar action.
- We have continued to liaise closely with UK regulators to utilize new procedures developed through a pilot project with Covance to support animal sample shipments.
- Established relationships with reliable couriers that can, if necessary, replenish dry ice stocks for in-transit clinical trial samples. Related, we have prepared contingency plans regarding road transport on and after October 31, including alternative modes of transportation as needed.
- Regulatory considerations relating to Chemistry, Manufacturing & Controls (CMC) commercial product release testing are mitigated by mutual recognition agreement between U.S. and EU (fully implemented in July 2019), which makes our Greenfield (U.S.) facility a viable alternative for testing to support EU product release.
- We have added shipping documentation for clearance procedures for shipments coming from EU 27 countries.
- We have assessed the need to increase kit inventory levels at our sites and concluded that we have several options to bypass transit through the EU.
Vendor / Non-IMP Planning
- We are actively planning with our vendor network site activations and other startup activities, such as Investigator Meetings, having supplies well in advance of Initiation Visits, etc.
- Additionally, we continue to monitor that our vendors’ plans are sufficient to mitigate the import/export risk for products, samples and kits crossing UK borders.
- We are assessing the impact on data transfer from the EU to the UK. Currently the Company relies on standard contractual clauses for data transfers outside of the EU. We implemented model clauses where necessary.
- We have confirmed that sufficient stock is in place (either at site or depot) for all products crossing UK border; depots are being arranged as needed for both UK and EU distributions.
- For IMP products that are temperature sensitive and/or are prepared on a per patient basis, alternatives are in place (such as advance shipping and/or re-icing stations at UK border) to mitigate risk of shipping delays.
LabCorp/Covance have prepared extensively to mitigate risk associated with the UK potentially leaving the EU without a deal. While some things - such as border delays - are outside of our control, we look forward to working with our clients and partners to minimize any disruption to drug development.
If you're a device manufacturer, you might also want to read our article on device preparation for a no-deal Brexit.
For specific information related to your development project, please contact us at CovanceBrexit @ Covance.com.