In March 2017, the United Kingdom (UK) Government officially notified the European Union (EU) of UK’s intention to withdraw from the EU.
The UK formally left the EU on 31 January 2020 and a transition period running to 31 December 2020 was initiated. During this period arrangements have largely remained the same while UK government and EU representatives have been negotiating a deal on the future relationship between the UK and the EU. At the time of writing a deal has not been struck and it is not clear what the future relationship will look like.
As a business with Head Offices in the UK and multiple entities across Europe, Illingworth is putting in place actions and measures to ensure continuity of the business and operational services. Illingworth has established a BREXIT working group to review and finalise planning and actions to ensure readiness for BREXIT by the end of the year.
The purpose of this document is to provide clients with an understanding of the actions taken by Illingworth to maintain business continuity.
Considerations as to the impact of BREXIT on the conduct of business have been made across Contracting and Proposals, Data Protection, Finance, Recruitment, and Human Resources, Information Technology (IT), Operations and Vendors/Suppliers functions.
Contracts and Proposals:
- Illingworth Research Group Ltd is the Illingworth main entity that contracts with clients and partners. Requirements for updates to our contracts will depend on the final deal the UK reaches with the EU and will be kept under review.
- Where Illingworth contracts refer to EU standards of service it will be necessary to update them to refer to UK standards for projects conducted solely in the UK.
- Illingworth Proposals and Contracts will specify any alterations in costs, timelines and service levels as a result of BREXIT.
- Clients whose contracts will be impacted by BREXIT will be notified of these changes accordingly.
- Illingworth has appointed a consultant Data Protection Officer (DPO) to advise on General Data Protection Regulation (GDPR) matters. The consultant will conduct analysis to determine the main Establishment within the EU post Brexit and determine if Illingworth are required to appoint a EU Representative as per Article 27 GDPR. Illingworth is currently in discussion with the DPO to ensure that data processed and stored by Illingworth meet both UK and EU requirements.
- Agreements between different Illingworth entities will be put in place as necessary.
- Illingworth will consider the potential impact on contracts; it is expected that the definitions will remain the same as UK legislation is the same as EU legislation.
- Illingworth will consider the potential impact on patient facing documents; updates will be made at a project level as necessary.
- In the short term, Illingworth will be implementing the updated European Standard Contractual Clauses, along with following the six step roadmap recommended by the European Data Protection Board (EDPB), to allow for any cross-border data flows to continue in the event that there is no deal and the UK leaves the EU without an adequacy decision thus rendering the UK as a Third-Country.
- Illingworth are also analysing whether Binding Corporate Rules (BCRs) may be used to allow for data to transfer between group companies within Europe and further afield. Should this mechanism be deemed applicable and suitable we will implement the appropriate measures following consultation with a relevant supervisory authority.
- Illingworth is considering the impact of BREXIT on:
- Paying for goods and services (and resulting taxes) from the EU in the UK and UK goods in the EU
- Tax position and reporting of the Illingworth EU entities
Recruitment and Human Resources:
- Illingworth has reviewed the status of EU nationals working in the UK and concluded that all rights and permissions to work in are in place.
- Illingworth is reviewing the implications for contract staff working across the EU/UK border, especially for Research Nurses as registered professionals. Staff will be notified as appropriate, where there is any impact to the contractual relationship and their relevant contracts will be updated accordingly
- Illingworth does not anticipate any changes in staff availability as nurses are recruited within the country that they are required to work in and therefore there will not be any significant impact on resources available to continue ongoing and upcoming projects.
- Illingworth is investigating licensure requirements for Nurses, in particular in relation to the Northern Ireland/Republic of Ireland cross-border operations.
- Illingworth IT are reviewing specifications of systems for the storage of personal data with the DPO to ensure full compliance with EU/UK regulations.
- Illingworth operational teams will be conducting BREXIT related risk assessments at the individual project level with respective sponsors. Risks and mitigations will be documented on the project risk log and will drive any project level continuity efforts.
- Illingworth assumes Sponsors are assessing their studies for the impact of BREXIT and recommend that findings and steps to ensure business continuity are shared with Illingworth project teams.
- Illingworth is monitoring regulatory advice to ensure compliance with Clinical Trial regulations and legislation is maintained.
Vendors and Suppliers:
- Illingworth are reviewing the status of BREXIT readiness of vendors to ensure that they are in a position to continue services post-BREXIT. It is expected that our vendors will provide written statements/plans detailing their BREXIT plans.
- Of critical importance are couriers and suppliers shipping equipment, biological samples and materials in and out of the EU/UK to Illingworth offices, employees and trial participants.
- Equipment vendors will be asked to update on the status of Conformitè Europëenne (CE) marks (EU) and UK Conformity Assessed (UKCA) marks.
- Illingworth assumes that Sponsors will have reviewed and updated their study insurance appropriately. Written confirmation from Sponsors in relation to Illingworth services and indemnity will be requested.
There is no doubt that BREXIT will have an impact on Illingworth Services, including delays with the shipping of equipment, biological samples and materials between the UK and the EU and requirements for additional documentation and contractual arrangements between Illingworth and clients and Illingworth and contractors. The full impact is yet to be determined and will depend on the final arrangements negotiated between the EU and UK.
Illingworth has taken steps to ensure business continuity through the BREXIT process (and the COVID-19 pandemic), and at this time we are in a good position to ensure continuity. However we will continue to monitor the BREXIT process and make adjustments to our plans and notify clients as necessary.
Illingworth will identify the projects at risk of BREXIT impact and ensure that mitigations are put in place. Our Project Managers will be trained on additional steps required, to manage shipping etc, and will review timelines, service level agreements and associated costs with their respective study Sponsors.
To discuss this statement further, please contact:
Gerard Barron, VP of Operations, Gerard.firstname.lastname@example.org