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Selling to the NHS

NIC Document

Summary

This guide outlines the structures that exist to help companies contact and sell existing and innovative products into the NHS, a huge organisation which can appear very complex.

In brief

  1. NHS Supply Chain
  2. Procurement routes – national, regional and local contracts
  3. Products for GP prescription
  4. Estates – capital equipment
  5. Innovation – new products

Introduction

The NHS is the largest single healthcare delivery organisation in the world. It constitutes a major opportunity for UK medical device companies. NHS trusts can purchase products through one of five main routes:
  • Directly from suppliers using National Framework Contracts
  • From the NHS Supply Chain which provides end-to-end supply chain services incorporating procurement, logistics, e-commerce and customer and supplier support
  • Collaborative Procurement Hubs/Confederations (regional multi-trust purchasing)
  • Local contracts managed by individual trusts
  • Pan-government National Framework Contracts

NHS Supply Chain

The NHS Supply Chain is a single organisation created for the benefit of NHS trusts, hospitals and other healthcare organisations. The organisation combines the former NHS Logistics Authority, significant parts of the NHS Purchasing and Supply Agency, expertise in healthcare logistics from DHL and procurement experience from Novation.


Procurement routes

National contracts Tenders: Contracts for products and services valued at over £90,319 (01 Jan 2008) must be advertised in the Supplement to the daily Official Journal of the European Union (OJEU). Procurement levels change, but you can confirm the current level by visiting: http://www.ojec.com.

NHS-sid: This is the official NHS supplier information database on which companies can enter their information for free: http://www.sid4health.nhs.uk. It rationalises the management of pre-qualification data during the procurement process and can only be fully accessed by authorised NHS personnel. Suppliers looking to compete for advertised NHS contracts must still submit applications in the required format. Any supplier is free to register its services on NHS-sid. The information published is made freely available to NHS users. Registering on this system does not imply that a supplier has any special or ‘approved’ status. Regional contracts Collaborative organisations: Most NHS trusts are now partners in ‘collaborative procurement organisations’ where, normally on a regional basis, they can share information and resources to achieve economies of scale.

Local contracts Individual trust contracts: Local contracts are often managed by a trust’s supplies department. Its approach to suppliers will vary according to the value, size and complexity of its requirements. DH has set down procurement guidelines indicating that for contracts valued below £3,000 a trust should ask for telephone quotes; for contracts valued between £3,000 and £10,000, it should request a minimum of three written quotes; for contracts valued above £10,000, a minimum of three formal written tenders should be sought. Actual interpretations of these guidelines vary from trust to trust.

Products for GP prescription

Suppliers wishing to list their products under the Drug Tariff for prescription by GPs or nurses must seek approval from the NHS Business Service Authority (NHSBSA). These will usually be products for self-administration, possibly with a carer’s help, and will normally fall into the following categories: dressings, bandage and associated appliances, incontinence appliances, stoma appliances, and chemical reagents. If the NHSBSA grant approval, the cost, either comparatively with other similar products, or, if it is a new treatment regime, by comparison with alternatives, will be reimbursed. You can access the application form at: www.nhsbsa.nhs.uk.

Estates – capital equipment

DH uses two major Public and Private Partnerships (PPPs) to deliver its NHS Plan: the Private Finance Initiative (PFI) and NHS Local Improvement Finance Trust (LIFT). The NHS ProCure 21 Framework brings the NHS and the construction industry together for new-build projects. You can find information on PPPs and associated procurement policies at: www.dh.gov.uk.

Innovation – new products

The procurement routes above apply to established products. If you are a supplier of innovative products, you should be aware of the organisations involved in product approval:

The UK Medicines and Healthcare product Regulatory Agency (MHRA)
This is the government agency responsible for ensuring that medicines and medical devices work and are safe.
  • Regulatory affairs: Medical devices can only be placed on the market in the UK/EU if they are certified safe, are of the required quality to fulfill the manufacturer’s ‘intended purpose’ and comply with the appropriate Medical Device Directive (CE marking). The MHRA audits the performance of manufacturers and notifies bodies responsible for granting CE marks. You can find more details at: www.mhra.gov.uk.
  • Clinical trials: The MHRA approves clinical trials/investigations and provides guidance for manufacturers. To obtain a CE mark, a manufacturer must show that the device complies with the relevant ‘Essential Requirements’ of the appropriate Medical Device Directive. In some instances, a clinical investigation will be required. The MHRA website (listed above) provides guidance on this issue.
Small Business Research Initiative (SBRI): The new SBRI is a cross-government programme for the procurement of technology development projects, including the demonstration and evaluation of new technologies. DH has run a pilot SBRI competition in Healthcare Associated Infections in conjunction with the Technology Strategy Board. The benefit to the Department and the NHS is to make new developments available faster and more effectively. National Institute for Health and Clinical Excellence (NICE) NICE (www.nice.org.uk) is responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health. Its activities include:

  • Technology appraisals – Recommendations on the use of new and existing medicines and treatments within the NHS, based upon a review of clinical and economic evidence
  • Interventional procedure guidance – Many of the procedures that NICE investigates are new, but it also looks at more established procedures if there is uncertainty about their safety or how well they work

NHS National Innovation Centre (NIC): NIC determines the need for innovative products, particularly in the development stage, and speeds up the development and adoption of those that deliver the best results for patients. It provides a point of entry to innovators of healthcare technology via its website and through a web-based assessment process. By considering ideas and products at every stage, it can direct them to the most suitable parties for further development.