Contract for Reimbursement of Manufacturing Costs with Option to Purchase Goods

Concepts

• manufacture of lateral flow antigen tests
• diagnostic kits
• sars
• reimbursement of manufacturing costs
• sars-covid-2
• further tests

Location

London

Description

Manufacture of lateral flow antigen tests for Sars-Covid-2, with the option to purchase further tests.

Award Detail

Award Criteria

CPV Codes

• 33141625 - Diagnostic kits

Indicators

• Award on basis of price.

Legal Justification

1) The Covid-19 outbreak is a Public Health Emergency of International Concern as declared by the World Health Organisation on 30 January 2020. The WHO Director General characterised Covid-19 as a pandemic on 11 March 2020. 2) A key element of ensuring an effective response to the pandemic is ensuring that there is adequate testing. Therefore, ensuring surge LFT capacity, including sufficient availability of lateral flow tests, is critical. 3) Mass testing of the UK Population is a key step in bringing the Pandemic under control. (Lateral Flow Tests produce quicker results than the current PCR (Polymerase Chain Reaction) test, and do not require a lab processing step.) LFT tests have only recently become viable as a means of testing, with multiple tests being progressed through to certification and approval. This was unforeseen by the DHSC and outside its control. 4) Market analysis data demonstrates that the global market for LTF is volatile and highly competitive. Global manufacturing capability is limited to circa 120 m units per day. Demand often outstrips supply. DHSC requirement is driven by the progress of the pandemic (including emerging variants), the changing efficacy of available LTF products and the severity of the second wave/national R-number. Evolving clinical field experience, changes to treatment and testing strategy, supply market volatility and disruption has led to urgency in securing capability at volume. Market engagement identified SureScreen as being capable to manufacture the volumes within the required deadline, having availability of materials and test validation status. 5) DHSC is satisfied the tests permitting use of the negotiated procedure without prior publication (Regulation 32(2)(c)) are met: A. As far as is strictly necessary: The surge LFT capacity was identified as strictly necessary to meet the demand to scale up the testing programme in the UK. B. There are genuine reasons for extreme urgency: it is responding to Covid-19 immediately because of public health risks presenting a genuine emergency. C. The events that have led to the need for extreme urgency were unforeseeable: the Commission itself confirmed: ‘The current coronavirus crisis presents an extreme and unforeseeable urgency – precisely for such a situation our European rules enable public buyers to buy within a matter of days, even hours, if necessary.’ (Commissioner Breton, Internal Market, 1 April 2020). D. It is impossible to comply with the usual timescales in the PCR: it is not possible to comply with the timescales of another procedure due to the urgent requirement to ensure effective surge capacity. E. The situation is not attributable to the contracting authority – DHSC has not done anything to cause or contribute to the need for extreme urgency.

Other Information

This notice has previously been published in ‘Find a Tender Service’ (FTS), the UK e-Notification service. Publication in the Official Journal of the European Union was delayed by a technical issue on behalf of the EU publications Office, which has now been resolved.