Health and Social Care Bill

Memorandum submitted by the Urology Trade Association (HS 126)

Executive Summary

· Given the impact which urology products have on a patient’s clinical health, wellbeing and ability to lead socially independent lives, it is vital that patients who require ongoing continence management can access the most appropriate choice of clinically effective urology products that suit their individual needs.

· National policy arrangements such as Part IX of the Drug Tariff provide essential protection on choice for patients, ensuring that patients can access a full range of clinically effective products on NHS prescription, while also ensuring that the NHS is guaranteed a fair price; these supply arrangements should be maintained once the new commissioning arrangements are in place.

· Steps should be taken to ensure that all those who are to be involved in commissioning decisions are aware of the principles of these national supply arrangements and the protections they provide for patients. The UTA believes there is a role for the NHS Commissioning Board to ensure that these principles are upheld by GP commissioning consortia.


1. The Urology Trade Association (UTA) is the leading urology membership organisation representing 95% of urology product manufacturers and suppliers, who supply the urology appliance market. Due to the nature of their business, UTA member companies deal extensively with PCT commissioners, as well as NHS procurement agencies. Through this experience and work, the UTA has, as a trade association, become increasingly concerned about the use of initiatives by a number of PCTs and Collaborative Commercial Hubs which restrict patient and prescriber choice in access to and the selection of stoma and urology appliances.

2. The UTA believes that the Government’s proposals to reform commissioning could potentially address some of these issues. However, there is still considerable uncertainty about how the revised system will work, and it is possible that the existing problems could be exacerbated under the new arrangements.

3. This submission aims to highlight the UTA’s key concerns that need to be addressed and to make recommendations as to how the new system can ensure adequate and equitable access to urology products for patients.

Background – Part IX of the Drug Tariff

4. There are an estimated half a million people across the UK who rely on a daily basis on prescribed urology products to maintain their quality of life and independence, manage underlying clinical conditions and prevent repeated medical consultations.

5. The supply of urology products and medical devices is determined by The new arrangements under Part IX of the Drug Tariff for the provision of stoma and urology appliances – and related services – in primary care. These regulations were published by the Department of Health in 2009 following an extensive review and over three years of consultation with industry, patients and health bodies, developing Regulations that keep the interests of patients at heart, ensuring that they can choose products and services that are right for them.

6. The Part IX Regulations list the stoma and urology products that are approved as clinically effective and value for money by the Secretary of State for Health and should be made available to people through the NHS. It is also a tariff and lists the price that the NHS should be charged for each product. Products are assessed for safety, quality of clinical health outcomes and value for money.

7. The Review into Part IX of the Drug Tariff concluded that functional equivalent products should not be recommended to patients in place of a particular preferred device. The review thus concluded that the Drug Tariff is the preferred mechanism to improve patient care, maintain local choice, and provide services and products at a fair and balanced cost to the NHS and industry. The new Regulations also stipulate that patients are entitled to ask for any product listed on Part IX of the Drug Tariff on prescription.

8. An important safeguard of these arrangements for patients is that they prohibit a postcode lottery for stoma and urology appliances. All prescribing clinicians should be able to choose any clinically appropriate product that is listed on the Drug Tariff. This is essential protection for patients given the invasive nature of urology products and the particular self care, mobility and dexterity needs that very often accompany conditions that require continence management. Inappropriate product use in primary care settings, however minor product differences may appear to non-clinicians, can cause serious discomfort and increased exposure to infections and can impede a patient’s ability to live a relatively independent life.

9. The Drug Tariff is also an aid for commissioners since it provides a comprehensive list of products that have already been assessed and approved as clinically effective and cost effective at a national level. The Drug Tariff sets a pre-defined price for each listed product which is set at a balanced and fair price to both the NHS and industry. These prices and any mechanism to alter the price in line with inflation, for example, were agreed as part of the review into Part IX.

10. Most importantly, by setting a pre-defined price, the Drug Tariff safeguards against industry exploiting different commissioning and procurement procedures across the country to drive up prices and profits. The Drug Tariff is a useful tool for commissioners and policy makers to streamline procurement within NHS bodies and ensure price transparency.

Patient Choice and the Drug Tariff

11. In September 2010, the Royal College of Physicians published a National Audit of Continence Care, which examined the quality of continence services in England, Wales and Northern Ireland. The report identified a number of significant weaknesses in the care and choices offered to patients with continence needs. Among the criticisms was that there was unacceptable variation in the choice of type, quality and quantity of continence supplies made available to patients.

12. With the reforms outlined in the NHS White Paper, and as PCTs are replaced with GP commissioning consortia and a National Commissioning Board, there will be even greater scope for local variation in provision. It is argued that this will enable GP consortia to respond more effectively to the needs of local populations but it also risks development of postcode lotteries and variation of care across the country.

13. The UTA is aware of an increasing number of PCTs and PCT Hubs that are seeking to supply and prescribe urology devices through alternative local arrangements that bypass the provisions set out by national policy through Part IX of the Drug Tariff. These local arrangements often only prescribe and supply from a restricted list of urology products, severely reducing patient choice.

14. This is reinforced by the introduction of formularies which provide clinicians with a restricted list of products that can be supplied to patients on NHS prescription. In many cases formularies do not make clear that all products on the Drug Tariff should be available to patients, and the bureaucracy involved for clinicians to prescribe off-formulary products is extremely prohibitive. Even when this caveat is in place, it still relies exponentially on patients being fully informed about their rights and the principles of national policy and additionally on determined clinicians to navigate through knowingly complex administrative processes.

15. The UTA is additionally concerned by the selection criteria that are used to identify which products are placed on Formulary. Arrangements also need to ensure that incentives are aligned with a focus on prevention to ensure that patients can choose products and services that reduce the incidence of infection, re-admissions and additional care needs. Where formularies operate, patients are often required to trial first line products before access to an off-formulary product is made available. Due to the invasive nature of many continence products, any difficulties experienced can result in the need for emergency hospital treatment or even the need for surgery to treat avoidable infections or replace unsuitable products. Less than optimal prescription can cause significant clinical repercussion as well as cost implications.

16. These local developments are contradictory to national policy as laid out in The new Part IX arrangements which stipulate that patients can demand on NHS prescription any urology product and appliance that has been approved at a national level. In practical terms, rather than enabling patients and clinicians, formularies limit the choice that patients and prescribers have when managing clinical conditions. The very principle of the Drug Tariff is to provide prescribers and commissioners with a list of approved products that have been evaluated on the basis of robust clinical evidence, patient safety and value for money.

17. Patients should be given choice on type and amount of urology products. Commissioners should not endorse the rationing of care items through the introduction of restrictive prescription and supply mechanisms. The UTA believes that, properly enforced, the national Drug Tariff ensures patients have access to the full range of approved products, while ensuring consistency, quality and value for money for the NHS. By giving GPs freedom to prescribe within these nationally set parameters, the Government can ensure that GP consortia and prescribers uphold the ideals of patient choice and equality while exercising their professional clinical judgement.

Role of the NHS Commissioning Board

18. With the reforms proposed by the Health Bill, it will be imperative to ensure that commissioning consortia abide by relevant national policies. As noted above, a number of PCTs are seeking to implement restrictive prescription and supply mechanisms at a local level that restrict patient choice and access to products. The National Audit of Continence has also found unacceptable levels of variation between PCTs.

19. It is hoped that the transfer of functions over to GP commissioning consortia and a greater ability to control services at the local level will drive forward improvement in these areas of care. However, with the already fractured nature of continence care, there is a risk that this will fragment even further, especially if GP consortia maintain the restrictive formulary polices that are already in place.

20. It will be essential that clinicians are fully aware of the principles of public policy about choice and access to products. Robust monitoring arrangements will need to be put in place by the Department of Health, the NHS Commissioning Board and/or Healthwatch to prevent further variation and ensure that national policies operate as intended.

21. The UTA has noted with interest that the NHS Commissioning Board will safeguard the core values of the NHS to ensure a fair and comprehensive system across the country, to promote the NHS constitution, and to champion the interests of patients. We understand that, as part of this, the Board will provide a national framework for local commissioning. The UTA believes that, properly enforced, the national Drug Tariff ensures that patients have access to the full range of approved products, while ensuring consistency, quality and value for money for the NHS, and prevents a postcode lottery in the availability of products and services. The Drug Tariff can therefore be a useful tool for commissioners to ensure these principles are upheld.

22. There is a role for the NHS Commissioning Board to ensure that patients who experience difficulties in accessing the right products and services can notify the national authorities of a failure to abide by national policy. We are interested in further detail about what steps the NHS Commissioning Board will be able to take in order to promote patient choice and enforce national policy principles, such as The new arrangements under Part IX of the Drug Tariff for the provision of stoma and urology appliances – and related services – in primary care.

23. The UTA would also welcome further details about the new provisions contained in Clause 43 of the Bill on pharmaceutical services expenditure. In particular, the UTA is seeking clarification about how remuneration and reimbursement will be dealt with by the NHS Commissioning Board. Further clarity is needed on whether the clause intends to provide for the re-introduction of the Global Sum with remuneration held centrally by the NHS Commissioning Board but reimbursement devolved to GP consortia.

Specialist Commissioning

24. Among the conclusions of The National Audit of Continence Care, published by the Royal College of Physicians in September 2010, it was found that there was often no designated lead for continence services in each PCT. This was identified as a principal cause of some of the weaknesses in continence commissioning and the unacceptable variation in care across the UK.

25. As GPs do not have specialist urology training, there is a need to ensure that patients can access specialist urology services and that the right care pathways are put in place to ensure early referral. An important part of this process is to ensure that patients can access the most appropriate product to match clinical and wellbeing needs at the earliest consultation stage.

26. It will be essential for GP commissioners to ensure that relevantly skilled staff are available to meet the needs of their population and involved in the commissioning process for their specialist clinical area. Where this is not possible, the GP consortium should be encouraged to bring in specialist advice or consultation. This specialist advice could come from other GP consortia, from clinical specialists, from user groups and representatives or from the independent sector. The knowledge of the independent sector, which in urology also provides services to patients through the opportunity to have Appliance Use Reviews, should not be disregarded and could be called on to provide training and advice on specific products where appropriate.

27. The UTA believes that there is also a role for the NHS Commissioning Board to ensure that GP consortia receive training on commissioning specialist products and services and that prescribing clinicians also receive suitable training and support. This could help to tackle the current problem that often prescribers do not know enough about the full range of products that are available off-formulary to make informed choices for their patients. There is a wealth of experience in the private and third sectors which could help inform this training.


28. The UTA recognises that the proposals laid out in the Health Bill offer an excellent opportunity to address some long standing issues within the NHS and we hope that these can be addressed. We are, however, concerned that the reforms should not operate at the local level so as to restrict access to the full range of products that should be available nationally. Mechanisms that already exist to guard against this occurring, such as the Drug Tariff, should be maintained, as these national arrangements provide essential protection to patients and the NHS. With reforms ongoing, the Department of Health should take a lead in guiding GP consortia to follow the principles of national policy.

March 2011