Market Engagement for Storage & Distribution of Human Medicines, Vaccines & Associated Medical Products

Description

UKHSA is seeking to establish a contractual agreement with a pharmaceutical wholesaler for human medicines who can act as a third party on behalf of the Agency for the UK storage and distribution of the Agency’s vaccines, other medicines and associated medical products (ownership remains with the UKHSA). Lot 1: A new storage and distribution contract is needed to ensure that storage and distribution of UKHSA procured vaccines, immunoglobulins, antibiotics, medical consumables, antitoxins and antivenoms can continue to be safely received from manufacturers, stored, and distributed to the NHS and other specified recipients under controlled conditions. The products require specialist storage and distribution to ensure that they are not damaged, both physically and biologically. To support this, effective stock management and audit systems are essential.<br/><br/>The requirement is critical to UKHSA to allow the uninterrupted and continued service for:<br/>• National Immunisation Programmes - the importance of population based immunisation in protecting public health through minimising/eradicating the incidence and spread of vaccine preventable diseases is well established. The UK has one of the most comprehensive immunisation programmes in the world, with protection throughout the life course starting before birth, continuing into childhood, adolescence, adulthood including older adults.<br/>• Pandemic Preparedness Portfolio (PPP) – the stockpiling of medicines and vaccines, and associated consumable products in preparedness to respond to a future pandemic. <br/>• Covid Programme – The UK continues to respond to the threat of COVID-19 through a targeted vaccination programme for those most vulnerable to the virus. This includes older people, people with underlying health conditions, and frontline health and social care workers. The vaccination programme has been highly successful in protecting people from severe disease, hospitalisation, and death. In the UK, the vaccines have been estimated to have prevented over 14,000 deaths and over 42,000 hospitalisations; and<br/>• Emergency Preparedness, Resilience and Response programme (EPRR) – the UK has provisions in place for responding to accidental or intentional releases of chemical, biological, radiological or nuclear materials.<br/><br/>The overall need of UKHSA is to ensure that requirements and outputs are managed in a way that: <br/>• Continues to provide a high-quality flexible service that can adapt to suit changing needs;<br/>• drives maximum savings; <br/>• increases UKHSA efficiency;<br/>• promotes the use of ‘best practice’ in line with Good Distribution Practice (GDP), and Medicines and Healthcare products Regulatory Agency (MHRA) regulatory requirements; and<br/>• provides full transparency of reporting and record keeping <br/><br/>Short description<br/>The proposed requirement is to provide ambient temperature controlled, chilled, frozen and ultra-low temperature warehousing, distribution and management services across the UK (including Northern Ireland and Crown Dependencies) for the supply of human medicines, vaccines and associated medical products, covering a multi-tiered response level. Including scheduled routine deliveries and urgent same-day service levels. The provider should also have the capability for repack and thaw activities. <br/><br/>Description of the procurement<br/>UKHSA owns stocks of vaccines, pandemic and medical countermeasures which it stores and distributes for use across the UK. It uses a web-based ordering system/platform (ImmForm) to facilitate remote ordering by designated customers.<br/>The service required has the following component parts (this list is not exhaustive):<br/>• Services are to be provided throughout with regulatory compliance to the 2012 Human Medicines Regulations and adherence to Good Distribution Practice for all Sites and Warehouses used to provide the Services.<br/><br/>• The requirements are expected to include long term storage of national stock holdings of circa 60,000 pallets of stock at various temperature regimes including ambient temperature controlled, chill (+2°C to +8°C), frozen (-20°C) and ultra-low temperature (-75°C). In addition, capability to undertake repack activity required, as well as thaw activity on a weekly basis circa 4000 packs of stock held at -75°C and -20°C.<br/><br/>• A regular scheduled programme of routine chill deliveries (next day and scheduled delivery day) for vaccinations amounts to approximately 5,000 deliveries per week covering currently circa 12,000 locations across the UK including Northern Ireland and Crown Dependencies, covering a range of health care organisations, including General Practices, NHS hospitals, school-aged immunisation services, and some community pharmacies. Capability is required to expand the customer base in line with changing NHS commissioned vaccination providers. <br/><br/>• Be in a ready state for deployment of certain stockpiles in the event of a Pandemic or CBRN event. Deployment of the relevant Stockpile or part thereof could range from national deployment to predefined locations within England or to specific/restricted geographical deployments that could be anywhere in the UK;<br/>• Rapid deployment same-day deliveries for specific products, within 5 hours in response to an emergency situation (generally <1000 per year). Rapid Deployment covers the UK - the majority of products will require delivery to acute healthcare trusts, with a small number of products potentially requiring deployment to any post code location in the UK in response to a biological incident. This should be supported with 24 hour follow on despatch of replenishment goods from the Stockpile to strategically located distribution hubs where needed.<br/><br/>• A seasonal programme of frozen (-20°C) and ultra-low temperature (-75°C) deliveries which amounts to approximately 6 deliveries per week at -75°C and 30 deliveries a week at -20°C to circa 1000 locations (UK and Crown Dependencies). <br/>• Service is expected to operate 24 hour/365 days per year uninterrupted.<br/><br/>• Facility to expand chill storage and distribution capacity in GB and Northern Ireland in response to a pandemic or other major health incident/national emergency required (reserve capacity).<br/>• Be scalable to encompass future services, e.g. including but not limited to, -20°C storage and distribution, or significant thaw capability with chill distribution, for vaccines used within the national immunisation programme as vaccine platform technology develops;<br/><br/>• Capacity to manufacture "Specials” required.<br/><br/>• Provider’s warehouse management system will need to be able to interface with the Agency’s bespoke web-based ordering system/platform (ImmForm) to facilitate remote ordering by designated customers.<br/><br/>• Routine record keeping and reporting relating to receipt, storage and deployment of stock held will be required.<br/><br/>Please note that estimated volumes are provided for information purposes and are based on current information, and therefore may be subject to fluctuations dependant on numerous factors such as the impact of other potential pandemics and infectious disease outbreaks. Additional information: Should your organisation be interested in this opportunity, please respond by 3.00pm on Thursday 28th September using the attachment provided and return via email to Logisticsandto@ukhsa.gov.uk with subject title "Market Engagement for Storage & Distribution of Human Medicines, Vaccines & Associated Medical Products"<br/><br/>https://atamis-1928.my.salesforce.com/sfc/p/0O000000rwim/a/8d000001TUNX/toiIfvFWmw2nXgRQyTH0HOMUaPuqcv5HHXAJjwSHUVE