The SDMA speaks on behalf of companies with an interest in wound care and associated products, representing a significant majority of suppliers of such products to the NHS and community healthcare providers. It continues to support the Drug Tariff as a preferred route to the community market, but not as the only route to that market.

Several legal opinions have recently been made available regarding the supply of medical devices to the community market and the operation of the National Health Services Act (2006). There appears to be a lack of clarity, both in the drafting of the Act and in the various legal opinions – none of which have been tested in court. Consequently the SDMA is outlining below its opinions regarding the supply of wound care and associated products under Part IX of the Drug Tariff,

1. The SDMA supports the concept of multiple routes to the community market, including the route provided by Part IX of the Drug Tariff (often referred to as FP10). Any route to the community market should ensure the following:

• Equitable access to a wide range of clinically-appropriate and cost-effective products
• Fair prices and good value for the NHS
• Robust decision-making processes involving clinicians,
• Avoidance of postcode-based availability
• Alignment with QIPP agendas
• Encouragement and facilitation of innovation
• Encouragement of sustainability in manufacturing and the supply chain

2. The market for wound care and associated products has several long-established characteristics that can differentiate it from other product areas covered by Part IX of the Drug Tariff. These include:

• A high level of involvement by healthcare professionals
• Formularies are accepted practice – and recognised as first-line guidance
• Patient treatment is generally short term
• The Drug Tariff is currently the most common route to the community sector

3. Part IX of the Drug Tariff offers transparent reimbursement pricing that acts as a benchmark for formularies and other procurement routes. It also provides a robust evidence-based approval system that is applied equally to all suppliers and manufacturers.

4. The Drug Tariff is a nationally-established route that allows new and innovative products to reach patients quickly, through a robust and transparent assessment process.

5. Part IX of the Drug Tariff has specific benefits relating the supply of wound care and associated products:

• It ensures that pharmacists are available to advise patients and practitioners
• Pharmacists can quickly supply products required by local community services
• It avoids the need for stockholding within the NHS and is effectively a national formulary that maintains local choice
• Pharmacists can supply single items, thus keeping waste to a minimum
• It keeps necessary administration arrangements to a minimum, with VAT not chargeable.
• PCTs (and their successors) do not have to pay for goods until the product has been used.

6. The SDMA fully supports flexibility in the supply route to the community market, as this will enable local NHS bodies and commissioners to make decisions that fit their local needs. Formularies and off-script supply are both established practices, and generally rely on Part IX of the Drug Tariff as a benchmark – in terms of products, quality approval and prices.

7. The SDMA is aware of opinions expressed by eminent legal practitioners concerning the operation of the Drug Tariff and the potential for alternative local arrangements to be unlawful. Although these opinions have not yet been tested in court, the SDMA feels obliged to advise NHS trusts or commissioners of their existence if local arrangements are being considered.

8. Similarly, the SDMA is aware of legal opinions that advise rebate systems under the Drug Tariff system may be illegal if paid to any third party. Rebates should only be made to organisations that have been invoiced by suppliers. Consequently, the SDMA strongly advises that legal advice be sought before entering into such rebate arrangements.

This updates an earlier SDMA Position Paper published in 2010 that detailed benefits available from the continued availability of Part IX of the Drug Tariff.