British Government expects high volume of adverse effects from Covid 19 vaccine.

United Kingdom-London: Software package and information systems 2020/S 207-506291 Contract award notice Results of the procurement procedure Supplies Legal Basis: Directive 2014/24/EUSection I: Contracting authority I.1)Name and addressesOfficial name: MHRA Buyer Organisation Town: London NUTS code: UK UNITED KINGDOM Postal code: E14 4PU Country: United Kingdom E-mail: purchasing@mhra.gov.uk Telephone: +44 2030806000 Internet address(es): Main address: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency I.4)Type of the contracting authorityMinistry or any other national or federal authority, including their regional or local subdivisions I.5)Main activityHealth Section II: Object II.1)Scope of the procurement II.1.1)Title: SafetyConnect — AI II.1.2)Main CPV code48000000 Software package and information systems II.1.3)Type of contractSupplies II.1.4)Short description: The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed. II.1.6)Information about lotsThis contract is divided into lots: no II.1.7)Total value of the procurement (excluding VAT)Value excluding VAT: 1 500 000.00 GBP II.2)Description II.2.2)Additional CPV code(s)48000000 Software package and information systems II.2.3)Place of performanceNUTS code: UK UNITED KINGDOM II.2.4)Description of the procurement: The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed. II.2.5)Award criteriaPrice II.2.11)Information about optionsOptions: no II.2.13)Information about European Union fundsThe procurement is related to a project and/or programme financed by European Union funds: no II.2.14)Additional information Section IV: Procedure IV.1)Description IV.1.1)Type of procedureAward of a contract without prior publication of a call for competition in the Official Journal of the European Union in the cases listed below

• The procurement falls outside the scope of application of the directive

Explanation: For reasons of extreme urgency under Regulation 32(2)(c) related to the release of a Covid-19 vaccine MHRA have accelerated the sourcing and implementation of a vaccine specific AI tool. Strictly necessary — it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health. Reasons of extreme urgency — the MHRA recognises that its planned procurement process for the SafetyConnect programme, including the AI tool, would not have concluded by vaccine launch. Leading to a inability to effectively monitor adverse reactions to a Covid-19 vaccine. Events unforeseeable — the Covid-19 crisis is novel and developments in the search of a Covid-19 vaccine have not followed any predictable pattern so far. IV.1.3)Information about a framework agreement or a dynamic purchasing system IV.1.8)Information about the Government Procurement Agreement (GPA)The procurement is covered by the Government Procurement Agreement: yes IV.2)Administrative information IV.2.8)Information about termination of dynamic purchasing system IV.2.9)Information about termination of call for competition in the form of a prior information notice Section V: Award of contract A contract/lot is awarded: yes V.2)Award of contract V.2.1)Date of conclusion of the contract:14/09/2020 V.2.2)Information about tendersNumber of tenders received: 1 The contract has been awarded to a group of economic operators: no V.2.3)Name and address of the contractorOfficial name: Genpact (UK) Ltd Town: London NUTS code: UK UNITED KINGDOM Country: United Kingdom The contractor is an SME: no V.2.4)Information on value of the contract/lot (excluding VAT)Total value of the contract/lot: 1 500 000.00 GBP V.2.5)Information about subcontracting Section VI: Complementary information VI.3)Additional information: VI.4)Procedures for review VI.4.1)Review bodyOfficial name: Medicines and Healthcare Products Agency Town: London Country: United Kingdom VI.5)Date of dispatch of this notice:19/10/2020

Link https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML&src=0