Diagnostics and radiodiagnostic devices and supplies

Tender description

To identify a commercial partner to develop the Radiopharmaceuticals business at the Royal Surrey County Hospital. The PIN invites potential commercial partners into a dialogue with the Healthcare Partners Limited on behalf of the Royal Surrey County Hospital NHS Foundation Trust, to review the future development of the Radiopharmacy facility and to explore partnership options. Royal Surrey County Hospital NHS Foundation Trust (the “Trust”) is seeking a partner to provide a radiopharmaceutical manufacturing service and facility which could include the rebuild of the existing Radiopharmacy facility at the RSCH site or a new build on or off-site. This unit would be for the provision of routine and developmental radiopharmaceutical services for several nuclear medicine services in and around the Guildford area, with the scope for future expansion. The selected provider will be required to demonstrate considerable expertise and experience of installing and operating radiopharmaceutical manufacturing services that support a variety of clinical specialties. Due to the range of options for the delivery of these services, the Trust will look for participants to bring forward and develop appropriate solutions to meet its needs and requirements for the design and operation of the facility and of the service in addition to the funding and financial model. The Trust is particularly looking for a new business model to establish and operate this facility and would expect a partnership arrangement with the successful provider. It is envisaged that the initial term would be not less than 10 years. The Trust will be able to provide a range of support services to the successful provider and these will be verified through the competitive dialogue process. The Facility. The dedicated facility must include storage (raw materials and consumables), radiopharmacy aseptic preparation (Tc-99m and other generator systems) and therapeutic dose preparation. The area must have controlled access and comprehensive environmental management systems and operational cleanrooms each capable of operating to EU GMP Grade B (ISO 14644 Class 6) classification for use with laminar flow cabinets or pharmaceutical isolators. The design and construction must ensure GMP compliance upon commissioning and to maintain compliance for the expected duration of the facility (i.e. 20 years after construction in an operational state), assuming the provision of a reasonable level of planned preventative maintenance and a reasonable level of operational usage, accepting general wear-and-tear. Research and Development. With the development of research collaborations between the Royal Surrey County Hospital, University of Surrey, the National Physical Laboratory and commercial partners it is hoped that once a new facility for routine Technetium-99m production is established then space could be allocated for developmental work for the production of new diagnostic and therapeutic agents. An IMP licence would be needed to do this. The Trust is willing to review other options based on the above examples. Interested potential bidders are invited to speak to the Trust in advance of the tender process to discuss current thinking and options by speaking to Professor Andrew Nisbet, Head of Medical Physics at andrew.nisbet@nhs.net and telephone 01483 464888 or his PA Michelle James 01483 464851. An expression of interest in this market engagement exercise will not automatically entitle involvement in any future procurement exercise. The subsequent procurement will be advertised separately and all organisations wanting to participate will need to respond to the procurement advertisement when published. Please note that this is not a Selection Questionnaire (SQ), we are using the functionality within the procurement portal to communicate with interested parties. A decision has yet to be taken as to which procedure will be used for this procurement but given the nature of the requirement it is likely that either the Competitive procedure with negotiation or Competitive dialogue procedure will be used.