Extension and variation of Whole Genome Sequencing Services contract

Concepts

• research laboratory
• sequencing contract
• wgs services
• whole genome sequencing
• whole genome sequencing services contract
• technology services
• whole genome sequencing services
• whole
• sequencing
• variation

Location

North East England:

Description

Extension and variation of a contract for Whole Genome Sequencing ("WGS") Services entered into in 2019 with Illumina Cambridge Limited ("Sequencing Contract") under regulation 72(1)(b) and regulation 72(1)(e) of the PCR 2015. The contract entered into in 2019 provided 300,000 whole genome equivalents ("WGE"). The WGS Services cover short read sequencing technology services only. The extension is necessary to manage the move to distributed WGS within the NHS.

Total Quantity or Scope

Genomics England ("the Contracting Authority") was established in 2013 to make the UK the world leader in the application of genomics in healthcare in partnership with NHS England. The Contracting Authority has a contractual relationship with Illumina Cambridge Limited ("Illumina") for WGS Services. The contract was entered into on 1 November 2019 ("Agreement") by direct award and in reliance on Regulation 32 of the Public Contracts Regulations 2015. The Contracting Authority determined through considerable due diligence and assessment of the options available, to issue a transparency notice in the Official Journal of the European Union, for the Agreement for reasons of technical skills required being limited to one supplier. The VEAT notice was issued on 20 September 2019 with reference number GeL-CR-101-19. The Contracting Authority is now granting a term extension and variation to the Agreement to Illumina to enable the NHS to transition to distributed WGS in 2026, to assist in the delivery of the Contracting Authority's Generation Study and to complete the original planned number of WGS samples. The NHS is transitioning from a central location for WGS in Hinxton to a distributed model where WGS takes place within the NHS. This transition is expected to take place during the course of 2026. The Agreement provides for 300,000 WGE to be sequenced over the life of the Agreement. The first year commenced on 1 November 2020. The Agreement was originally awarded for 5 years as it was considered this would be sufficient to carry out the desired number. However, more time is required to enable the target number of samples to be met. The Contracting Authority, for various reasons outside of its control, including the impact of Covid, has been unable to provide the guaranteed number of samples in the original term. The Contracting Authority is undertaking the Generation Study, which has now been extended to 31 March 2027, and WGS is required to deliver it. The extension and variation will include the following modifications to the Agreement: - extends its term to 31 March 2027 (with a right to terminate it earlier after 31 July 2026); - the sample types to include research sample in the total amount of samples that can count towards the 300k target in full in order to make the target more achievable for the Contracting Authority; and - to include a small additional payment from the Contracting Authority to Illumina to cover Illumina's further lab costs. For the avoidance of doubt, this payment is strictly to cover Illumina's additional lab and staff costs to be incurred under the extended contract term and does not cover any additional volumes under the contract. The contract modification will therefore benefit the Contracting Authority by allowing the original sample numbers to be sequenced; enabling the Agreement's original objectives to be achieved; allow the NHS to transition smoothly to distributed sequencing and facilitate the continued delivery of the Generation Study. The Contracting Authority considers that these amendments are permitted pursuant to the Public Contracts Regulations 2015 as more fully explained below.

Award Detail

CPV Codes

• 73111000 - Research laboratory services
• 85145000 - Services provided by medical laboratories
• 85148000 - Medical analysis services

Legal Justification

The Contracting Authority is a "body governed by public law" under the Public Contracts Regulations 2015 ("PCR") and considered a Central Government Authority. The PCR covers "public contracts", which means contracts for pecuniary interest which have as their object the execution or works, the supply of products or the provision of services. The Agreement is a services contract under PCR, therefore, caught by the PCR and therefore bound to follow public procurement rules. This VEAT Notice relates to an extension and variation of an existing contract permitted under regulation 72(1)(b) and regulation 72(1)(e) of the PCR. Regulation 72(1)(b) provides for the modification of a contract without reopening competition in relation to additional services by the original supplier which are not included in the original procurement and where changing the supplier cannot be done for economic or technical reasons, and would cause significant inconvenience or substantial duplication of costs for the Contracting Authority. As part of the current Agreement, the Contracting Authority is required to provide at least 300,000 samples to its incumbent supplier Illumina, so it is able to provide the procured WGS services. For reasons outside of the Contracting Authority's and Illumina's control, the samples could not be provided to Illumina to be processed in the original term of the Agreement. These reasons included the disruption to health services caused by the Covid pandemic and other issues connected to the method by which the samples are collected. The "additional services" being provided by Illumina under this extension related to continuing the WGS to ensure the same number of samples as provided for in the original contract can be sequenced. There are both technical and economic reasons why the remaining samples cannot be sequenced by another supplier. Firstly, this is to ensure consistency of service in the data provided for the remaining samples, as the service provision relies on Illumina's equipment and other materials. Reliance on alternative equipment or materials for the sequencing would affect the consistency of any data sets. Therefore, for technical reasons, it has been deemed changing the contractor to a supplier other than Illumina to complete the original project would not be possible. Secondly, it would result in significant duplication of costs for the Contracting Authority. There is a mechanism under the Agreement which entitles Illumina to a compensatory payment should the Contracting Authority fail to meets its sample delivery obligations by the end of the Agreement's term. In other words, the Authority would need to pay Illumina and duplicate this cost by procuring a new contract for these samples. The short extension seeks to fulfil the original Agreement without inconvenience and this duplication of cost. In any event, the Contracting Authority also considers that the exemption at regulation 72(1)(e) would apply. Regulation 72(1)(e) permits a variation where it is not considered substantial as defined by regulation 72(8). The Authority considers this amendment is not substantial as its intention is to permit the original contract outputs to be delivered at no more cost and to prevent the payment of compensation if the modification did not go ahead. The change does not materially change the character of the contract; it would not have impacted on the original award; nor does it change the economic balance in favour of the contractor; it does not extend the scope of the services themselves and while it extends the term this is due to the actions of the Contracting Authority not the Supplier. The final test is also not met as this is not a change of contractor.

Other Information

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