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United Kingdom-Colindale: Medical equipments, pharmaceuticals and personal care products
Section I: Contracting authority
Section II: Object
National Microbiology Framework
The Secretary of State for Health and Social Care acting through Public Health England (PHE) is seeking to appoint suppliers to a multi-lot national microbiology framework agreement. The framework agreement relates to the supply of diagnostics goods for the qualitative/quantitative examination of specimens/samples and the development or manufacturing of assays/kits/medication and related services. It also relates to the supply of diagnostics services for the qualitative/quantitative examination of specimens/samples or the development or manufacturing of assays/kits/medication. The framework also covers clinical laboratory diagnostic testing services.
The term of the framework will be for an initial 2 years with options to extend by up to a further 2 years.
Diagnostic Goods and Services
Lot 1 is for the supply of in-vitro diagnostic medical devices and associated services including equipment, consumables, maintenance, and peripheral equipment and associated services. All goods supplied must comply with the European Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998) or Regulation (EU) 2017/746 (IVDR) as applicable. All reagents and consumables must be marked in accordance with current CE regulations (or, once superseded, the UKCA mark).
The framework agreement will be for an initial period of 24 months with options exercisable by the Authority under the framework agreement to extend the duration in increments by up to a maximum of 24 months. Therefore, the total maximum duration of the framework agreement is 48 months.
The authority will also have the option to purchase new and/or updated goods and/or services which the supplier proposes should be added to its range as described in section VI.3) below.
The value attributed to each lot is an approximate estimate only. As indicated in section VI.3). of this notice, the actual values will be to such level as those purchasing under the framework agreement consider necessary to provide suitable requirements.
Research and Development Goods and Services
Lot 2 consists of goods and services mainly for research and development, experimentation and study. The supplies may form a part of the whole diagnostic product life cycle. Products and services do not need to be CE marked (or, once superseded, UKCA marked) as they are under development and primarily used for research and development.
The framework agreement will be for an initial period of 24 months with options exercisable by the authority under the framework agreement to extend the duration in increments by up to a maximum of 24 months. Therefore, the total maximum duration of the framework agreement is 48 months.
The value attributed to each lot is an approximate estimate only. As indicated in section VI.3) of this notice, the actual values will be to such level as those purchasing under the framework agreement consider necessary to provide suitable requirements.
Manufacturing, Product Development and Commercialisation
Lot 3 is for the manufacture of diagnostic and/or therapeutic products for the purpose of research, experimentation, study, development or to establish commercial viability or to recover research and development costs. Manufacturers must adhere to the relevant regulations for example for in vitro medical devices/medical devices, the current IVDD/MDD respectively and from May 2022 the new IVDR or from May 2021 the new MDR.
The supplier may be required to discount or agree preferential terms for the products sold on the open market where the authority has given input into the development and validation of the product, including the sharing or use of the authority’s intellectual property.
The supplier may be required to supply products, materials and other services related to the sale and/or distribution of the manufactured products. There may also be other commercial exploitation arrangements, which may include the licensing of the authority’s intellectual property in return for a license fee.
The value attributed to each Lot is an approximate estimate only. As indicated in section VI.3). of this notice, the actual values will be to such level as those purchasing under the framework agreement consider necessary to provide suitable requirements.
Clinical Laboratory Diagnostic Testing Services
Lot 4 is to provide access to a range of clinical laboratory diagnostic testing services. The exact specification for each requirement will be detailed in the call-off order form. The volumes of services contracted via this lot are expected to be scalable to meet evolving demand over time taking account of long term and short term (surge) requirements, combined with small-scale or large-scale service provisions being sought.
Lot 4 is intended to enable access to clinical laboratory diagnostic testing services using extant techniques and allow for the addition of new techniques or existing techniques utilised in a new manner in the future.
The aim for this lot is to ensure that there is consistent and affordable provision of high quality, safe and compliant testing services which should be delivered efficiently and effectively to support wider clinical services.
With regards to the clinical laboratory diagnostic testing services to be offered through the framework the authority is seeking suppliers that can undertake the following types of testing:
— molecular biology; and
— microbiology including:
• Virology; and
Suppliers will also be expected to provide all necessary supporting services including but not limited to the receipting of samples, storage, accessioning, laboratory informatics and clinical waste disposal. Where necessary it is also envisaged that suppliers may be required to provide their own sample kits and logistical services.
Section III: Legal, economic, financial and technical information
If it is considered appropriate by the authority, an indemnity, guarantee, bond or other form of appropriate security may be required.
The authority reserves the right to require groupings of economic operators to take a particular legal form or to require a single economic operator to take primary liability for a contract to be performed by a group of economic operators or to require each party to undertake joint and several liability in respect of the entire contract irrespective of the form the grouping takes.
Section IV: Procedure
Section VI: Complementary information
The framework is intended to be accessed by:
Public Health England;
Department of Health and Social Care;
Public Health Wales;
Public Health Scotland;
Department for Health for Northern Ireland;
Health and Social Care Northern Ireland;
NHS Authorities, NHS Trusts, NHS Foundation Trusts, Special Health Authorities, NHS Scotland Health Boards, NHS Wales Health Boards, NHS Northern Ireland Health Boards, Special NHS Boards and any other NHS entity;
Any other bodies governed by public law (as defined in regulation 2 of the Public Contracts Regulations 2015 (SI 2015/102) (as amended); and
Academic or charitable institutions (including any such institutions that are not Contracting Authorities).
Examples of such bodies can be found at the following links (as of date of publication):
The framework value is an approximate estimate only. The actual values will be to such level as those purchasing under the framework agreement consider necessary to provide suitable requirements. PHE works with DHSC and the NHS in its role as a national and international emergency responder to current and emerging threats to public health. As demonstrated by the Covid-19 pandemic, the exact nature, timing and escalation of such threats (and the corresponding required responses) can be difficult to foresee, making any exercise in future value estimation unpredictable.
The scope of this framework agreement covers goods and services that are subject to rapid and frequent improvements, advancements and new scientific and technical developments. Therefore, to keep this framework agreement in line with the latest market and scientific developments so as to ensure that patients and other end users have ongoing access to state of the art diagnostics for the duration of this framework agreement successful suppliers will be able to propose new and/or updated goods and/or services to be added to a supplier’s range under the framework agreement if one or more of the following circumstances apply:
• where the proposed updated goods or services fall within the general scope of this procurement as set out as part of this OJEU contract notice (i.e. fall within an existing main or supplementary CPV code as may be referred to in this contract notice and/or the description sections of this Contract Notice);
• where the proposed new goods or services fall within the broad categories of goods or services covered by this framework agreement (i.e. fall within an existing main or supplementary CPV code as may be referred to in this contract notice and/or the broad categories of goods and/or services referred to in any of the description sections of this contract notice), but are new to the market. For the avoidance of doubt, for the purposes of any testing services, this will allow suppliers to offer new types of tests, new test kits, related new equipment/products, related new consumables and related new services as and when they become available during the duration of the framework agreement provided they fall within an existing main or supplementary CPV code as may be referred to in this contract notice and/or the broad categories of goods and/or services referred to in any of the description sections of this contract notice);
• where the proposed new or updated goods or services reflect a product or service line extension (i.e. are new, modified or updated products or services in the same category of goods or services already supplied by a supplier under this framework agreement); or
• where the proposed new or updated goods or services reflect a range extension (i.e. are new, modified or updated products or services that reflect an expansion of the supplier’s range in the same category of goods or services already supplied by a supplier under this framework agreement).
The authority will allow a standstill period at the point the decision regarding the award of the framework is communicated to tenderers. The standstill period shall be in accordance with Regulation 87 of the Public Contracts Regulations 2015 (as amended). Chapter 6 of the Regulations provides for aggrieved parties who have been harmed or are at risk of harm by a breach of the Regulations to take legal action. Any such action must be started in the High Court within the applicable limitation period set out in Chapter 6. The purpose of the standstill period referred to above is to allow aggrieved parties to apply to the Courts to set aside the award decision before the framework is entered into.