Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2018-04-26
Buyer: Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Country: UK
Contract type: Supplies
Procedure: Negotiated without a prior call for competition
CPV classification: 33190000
Estimated value: 1163200 GBP

Technical requirements: The Chemical, Biological, Radiological and Nuclear (CBRN) Delivery Team intends to conduct single source procurement to support the continued manufacture of L4A1 AutoInjectors (ComboPens) in order to maintain a nerve agent treatment capability.
CBRN requires the maintenance of a stockpile of ComboPens. The ComboPen is an in-service medical countermeasure that is currently provided through a contractual arrangement with Meridian Medical Technologies Inc as the Original Equipment Manufacturer. The current contract with MMT expired in August 2017. The MoD intends to award a 6 (+1 option) year contract to MMT using the Defence and Security Public Contracts Regulations (2011) negotiated procedure without prior publication of a contract notice on the grounds of technical reasons as set out in DSPCR Regulation 16(1)(a)(ii) and Article 28(i)(e) of Directive 2009/81/EC.
The Combopen is a defence-specific medical countermeasure and therefore there is no available alternative within the commercial market. MoD helped to develop the Combopen because of its defence-specific nature and as a result the Secretary of State for Defence owns the Marketing Authorisation for the product, which identifies who is licensed to fill the devices.
To maintain an MA, the manufacturer of the product has to be listed on the MA at all times. A change of manufacturer would require significant changes to the MA in a regulatory process that would be expected to take up to 2 years to complete. In addition to these changes, there would also be a requirement for a technology transfer which could also take between 18 months and 2 years to complete. Any new manufacturer would be required to prove the process of manufacturing this product by repeat production runs involving several small scale batches and 3 full scale production runs to prove consistency. Stability testing would also have to be demonstrated by the new manufacturer over an extended period of 3 years. During this period delivery of and support for the Combopens would not be contracted for.
Furthermore, the OEM holds Patents for the Combopens in the United States (Patent Number US8870827 B2) and Europe (Patent Number EP1786491 A2). Therefore, due to technical and intellectual property rights reasons, the MoD believes that only the OEM is capable of delivering the requirement.
The Authority reserves the right to amend any condition related to security of information to reflect any changes in national law or government policy. If any contract documents are accompanied by instructions on safeguarding classified information (e.g. a Security Aspects Letter), the Authority reserves the right to amend the terms of these instructions to reflect any changes in national law or government policy, whether in respect of the applicable protective marking scheme, specific protective markings given, the aspects to which any protective marking applies, or otherwise. The link below to the Gov.uk website provides information on the Government Security Classification.
Advertising Regime OJEU:- This contract opportunity is published in the Official Journal of the European Union (OJEU),the MoD Defence Contracts Bulletin and www.contracts.mod.uk GO Reference: GO-2018424-DCB-12294503.


Winner: Meridian Medical Technologies, Inc
Award value: 1163200