Stoma Care

Jonathan Evans Excerpts

Wednesday 25th January 2012 Westminster Hall

[Jonathan Evans (Cardiff North) (Con)]

Thank you, Mr Hollobone, for that generous introduction. It is a privilege to serve under your chairmanship for the first time in my political career, and I hope that I will enlighten you.

Every year, more than 40,000 people in this country are diagnosed with bowel cancer. Bowel cancer is the UK’s second biggest cancer killer, but if found early enough, 90% of patients can be treated successfully. Often, colon or bladder surgery will lead to the fitting of stoma products or bags. Two thirds of such patients are estimated to need stoma care for the rest of their lives. With more advanced screening and the excellent work that is being done to raise awareness, it is expected that those patient numbers will only rise to even higher levels.

Valuable work is being done by many charities in this sector, and I give particular praise to Lynn Faulds Wood for her efforts in highlighting the prevalence of bowel cancer and for campaigning for greater awareness and early intervention. The charity Beating Bowel Cancer has designated this week as “be loud, be clear” week, and the charity is at Westminster today—its members are at the Speaker’s apartments as I speak—raising awareness among our parliamentary colleagues.

We are all in debt to such individuals and organisations for their campaigning work, but I want to make it clear that the focus of this debate is not on the challenges of bowel cancer itself, but on two specific concerns in relation to the current operation of stoma care—the care of those who have had colon or bladder surgery and require the fitting of medical devices, such as stoma bags. My concern relates to the private commercial sponsorship of stoma nurses and the potential impact of major changes that are being discussed between private sector manufacturers and primary care trusts that might eliminate any patient choice in relation to the medical appliances that they receive.

I am grateful to the three major patient groups in this sector—the Colostomy Association, the Urostomy Association and the Ileostomy and Internal Pouch Support Group—all of which have supported me in drawing attention to these issues and provided helpful background information.

Let me set this debate in context. There is almost daily comment about the Government’s proposed reforms of the NHS, and any such debate regularly throws up the charge that change in the NHS inevitably means privatisation of the NHS. Only last week, the House debated those issues, and over the weekend the head of the Royal College of Nursing added his voice, on behalf of the nursing profession, to those who are calling on the Government to abandon their reforms. It has therefore been a major surprise to discover over the past 18 months that the vast majority of NHS nurses who provide stoma care through health trusts in the UK actually have their salaries met by private commercial sponsors.

[Glyn Davies (Montgomeryshire) (Con)]

I am one of the 40,000—I contracted bowel cancer in the past and have had a colostomy. I also have a commercially sponsored stoma nurse, who is a guardian angel. We need to realise that a number of stoma nurses are marvellous. My stoma nurse made it clear to me that there were alternative products that I could have used, but it so happens that I accepted one from the same company that was paying for her. It was clear that I could choose any product that I wanted, and I was not put under any pressure.

[Jonathan Evans]

I respect my hon. Friend’s views on many matters and also have only praise for stoma nurses, but that does not take away many of the concerns in relation to sponsorship. Sponsors have a direct interest in the clinical decisions made by nurses, because they are the manufacturers of the products that are being prescribed under the NHS.

If the Secretary of State for Health had proposed the introduction of such an arrangement—the sponsorship of nurses by commercial organisations—as part of his current reforms, we can imagine the outrage it would have produced. “Newsnight” and the “Today” programme would have relentlessly questioned the Minister. We might even have seen a “Panorama” special on the BBC. The reality is that this extraordinary situation started more than 30 years ago and expanded to its current pre-eminence during the years of the previous Government.

The concept was thought up not by the commercial firms themselves, but by the health care trusts, which first approached the manufacturers to explore the commercial opportunities. The Department of Health does not appear to have played any part in the dialogue, not even in terms of establishing a protocol that could reassure the public that commercial sponsorship does not impact upon clinical judgment, just as my hon. Friend the Member for Montgomeryshire (Glyn Davies) has said that he is satisfied that that was not the case in his experience.

[Jim Shannon (Strangford) (DUP)]

Does the hon. Gentleman think that it would be acceptable if sponsorship were offered to help the patient or the health board itself?

[Jonathan Evans]

I am not going to propose the end of sponsorship, but we need more robust mechanisms of managing the potential conflicts of interest. I will develop that argument in the limited time available.

The Department of Health appears to take comfort in the professional code of nurses, which states:

“You must ensure that your professional judgement is not influenced by any commercial considerations.”

Surely, we can be sure that that code is being properly observed only if the Department undertakes, at least from time to time, some assessment of the commissioning decisions being made, but it has never done so.

In January 2001, The Guardian drew the practice to wider public attention, reporting that the NHS planned to crack down on these commercial sponsorship deals. The paper claimed that more than half of stoma nurses were funded by commercial deals that were worth— remember that this was a decade ago—up to £100,000 a year to each health trust. The RCN claimed that the manufacturers specified that a minimum percentage of patients had to be fitted with the commercial sponsor’s products.

The previous Government’s response to The Guardian’s revelations was to issue new guidance requiring NHS trusts to review all such arrangements in which suppliers met all or part of the cost of members of staff, discounts on drugs and equipment, or subsidised research and training as a condition of the contract. Nevertheless, Health Ministers maintained that they did not want to prevent collaborative partnerships between the NHS and private contractors—nor do I—but they also said that clinical decisions should always be based on evidence of what was best for the patient. I agree, but how do we know? Again, the Department did not undertake any assessment of its own to reassure itself that that was being done.

By 2003, sufficient concern was being expressed over these commercial deals that the then Government launched the first of what was to be a series of consultations on the arrangements for paying appliance contractors. By 23 January 2006, the Government issued a report on the consultation, noting:

“Specific and frequent mention was made of the issue of sponsored nursing posts in secondary care, with most parties”

—I stress, “most parties”—

“feeling that this practice was inappropriate, and that it should cease.”

The Department of Health’s response to that concern was to ignore it. It maintained its policy of resisting any assessment of impact of commercial sponsorship on commissioning decisions, and that strand of concern was, interestingly, subsequently eliminated from further consultation on these matters by Health Ministers.

In Scotland, the Scottish Executive took a completely different line. The Scottish Government decided that commercial sponsors could no longer directly subsidise specialist nurses in stoma care. The nurses were taken on and paid directly by the NHS. In fact, the British Healthcare Trades Association funded transitional support to the Scottish health boards for two years because of that dramatic financial change. The outcome was also dramatic. Free samples of stoma products were withdrawn from Scottish hospitals by the manufacturers that had always previously provided them, and it is estimated that, over the following five years, the number of specialist stoma nurses in Scotland fell by up to half.

In Scotland, therefore, the policy has been to ban commercial sponsorship—this addresses the concerns expressed by my hon. Friend the Member for Montgomeryshire and the hon. Member for Strangford (Jim Shannon)—with a consequential fall in both the quality and the availability of specialist stoma care to patients. By contrast, the policy of Health Ministers here has been to refuse to undertake any assessment whatsoever of the impact of commercial sponsorship on these arrangements within the rest of the UK.

As I hope I have made clear, I am not arguing for the Government to follow the Scottish policy. Patient groups have made it clear to me—this is endorsed by the words of my hon. Friend the Member for Montgomeryshire—that they recognise that the quality and the availability of stoma care in Scotland has fallen markedly. I want to make it clear that I am not questioning in any way the commitment or the concern of stoma nurses. Again, I can say that patient groups who have briefed me for this debate have made it clear that they deeply value the services that are provided by stoma nurses.

Nevertheless, as I indicated to the hon. Member for Strangford, there are real questions about conflict of interest, which successive Governments, sadly, have ignored. Let me draw an analogy with another sector that we debate a lot in the House: the financial services sector. Today, all financial services companies are required to satisfy the regulator that they have robust processes in place that are fully understood by all staff for managing conflicts of interest. Can we imagine a Minister standing at the Dispatch Box talking about concerns with financial services and saying that he is entirely satisfied there is no need for robust conflict of interest processes because he is satisfied that the professional code of those who work in financial services will always require them to act properly? That is a ludicrous proposition. There is a need for the management of conflicts to be subject to a similarly robust process in terms of stoma care.

In March 2011, Health Ministers were asked by parliamentary colleagues some basic questions to glean information on the number of stoma care nursing posts sponsored in the UK. No helpful response was provided, and the Department had no statistics to share with colleagues. So, for this debate, I have had to turn to the British Healthcare Trades Association for the figures. According to the association, stoma care manufacturers sponsor more than 200 of the 337 departments in England at a cost of £10 million a year. However, some of those manufacturers share the same concerns about commercial sponsorship that I am outlining. They only maintain their sponsorship for fear that other suppliers will otherwise corner the market. Those manufacturers have even expressed their concern to me that the current commercial arrangements might fall foul of the new Bribery Act 2010. Have Ministers undertaken any assessment of that?

On 15 October, I wrote to the Minister and received a response from him on 9 November confirming again that the Department had not made any assessment of the commissioning decisions of PCT employees sponsored by private enterprises. Again, he highlighted the fact that Ministers relied on the code of professional conduct, but he said in his letter that he was satisfied that that was a concern and that he had asked his officials to make further studies into the activity. I hope that the Minister can tell us the outcome of those studies.

The issues that I have raised relate to the maintenance of patient choice in the appliances that are prescribed for stoma care, and the concerns are shared by patients, charities and several manufacturers. Such concerns have been shown to be very well-founded by reports of recent discussions between major manufacturers of stoma care products and PCTs about what has come to be called off-script tendering, which you mentioned in the second part of your comment, Mr Hollobone. What is being proposed is that preferred or single supplier agreements are made between commissioners and manufacturers, in which the commissioning body would get a bulk discount for requiring all patients to take one manufacturer’s products. The arrangements would then bypass the operation of the drug tariff for the provision of such products, which is regularly reviewed on an annual basis by the Department.

Currently, a GP or suitably qualified nurse issues a patient with a prescription—an FP10—and the patient is free to take that to the manufacturer of their choice to have the product dispensed by a pharmacy contractor or an appliance contractor. The drug tariff industry forum considers the advantages of that system to be patient choice, cost and value for money, quality of products and a centralised system working on a local basis. The British Healthcare Trades Association has obtained legal advice that suggests the off-script arrangements being discussed by big manufacturers might be beyond the powers of health trusts. However, the question arises whether such arrangements could be taken forward as part of the Government’s health reform.

Those questions were raised by the Urology Trade Association, which is a body representing 95% of manufacturers, and by the Urology User Group Coalition on behalf of patients in evidence given last year to the Select Committee on Health. Unfortunately, follow-up questions by parliamentary colleagues confirmed the long-standing Department of Health response that no assessment of those issues had been undertaken either.

The thousands of patients who suffer bowel or bladder cancer and require ongoing stoma care deserve better. They should be assured that the Government will defend patient choice and maintain robust processes for managing real or perceived conflicts of interest in the commissioning of services. The Government should ensure the continued provision of specialist nursing advice and support and reassure us that it is in no way influenced by financial or commercial considerations.

[Mr Philip Hollobone (in the Chair)]

All has become clear. What are the Government going to do about it?

--- Later in debate ---

[Paul Burstow]

That is a very succinct summary of the case that our hon. Friend has made in his Adjournment debate today.

Let me say something about prescribing arrangements because it may help if I set out the arrangements for these products or appliances, as they are usually called, in terms of the NHS in England. Prescribers operating under the NHS primary medical care contracts are able to prescribe as appropriate for their patients those stoma and neurology appliances listed in part IX of the drug tariff. There should be no barriers to prescribing a stoma product on the NHS, as long as it is listed in part IX of the drug tariff. NHS dispensing contractors, pharmacies, dispensing appliance contractors and dispensing doctors are able to dispense prescriptions of these products. Primary care trusts are responsible for ensuring that general practitioners are complying with their primary medical care contractual arrangements and that dispensers are complying with their contractual frameworks. Within that, there is a set of checks already in place to deal with the prescribing practices of GPs.

[Jonathan Evans]

In that context, will the Minister say that he deprecates off-script tendering arrangements, in which major manufacturers—in fact, multinationals—seek an arrangement with PCTs making them the sole supplier?

[Paul Burstow]

I will come to that part of my hon. Friend’s speech a little later, if he will forgive me.

New services associated with dispensing such appliances in primary care were introduced in April 2010—I stress that date—including emergency supply of appliances at the request of the prescriber, repeat dispensing service and, where pharmacies and appliance contractors choose, provision of appliance use, reviews and customisation of stoma appliances. Customisation—personalisation and greater choice—is an essential part of what we need throughout health care delivery.

The key point in my hon. Friend’s debate is sponsored nurses, the role that they play and possible conflicts of interest, highlighted by all hon. Members who contributed. There is concern in some parts of the industry, including companies in my hon. Friend’s constituency, which led him to write to the Minister of State, Department of Health, my right hon. Friend the Member for Chelmsford (Mr Burns).

[Jonathan Evans]

And patient groups.

[Paul Burstow]

My hon. Friend rightly mentioned patient groups and I pay tribute to their work.

Stoma specialists play a vital role, as we have heard, supporting patients adapting to a life with a stoma, which often involves a number of physical and psychological changes. Stoma care patients face a number of issues, many of which are still considered taboo and can lead to embarrassment and distress. Services provided by stoma nurses are therefore much valued, as we have heard today, by those receiving them.

I am aware that the employment of some specialist nurses is funded by some manufacturers of stoma products to support patients in hospital and in their own homes. That can also lead to concerns, which have been so well set out today, about potential conflicts of interest. Although I recognise the potential for conflicts of interest, my hon. Friend will forgive me if I repeat the code of professional conduct that he mentioned, because it is relevant to this point, and I will mention why it remains relevant.

The code states that nurses must ensure that their professional judgment is not influenced by any commercial considerations. Any concerns about professional conduct are of course within our framework of regulation of professional groups, which is a matter for the Nursing and Midwifery Council. As a result of my hon. Friend securing this debate, I have made further inquiries of the NMC and the Royal College of Nursing, asking whether they are aware of any concerns being raised. The answer was no. I suspect my hon. Friend would say that that is because they are not reviewing and monitoring this matter either.

I will follow up on the report published some years ago by the RCN, which my hon. Friend mentioned, because although it is a little bit out of date it clearly speaks to some of the issues that he talked about. I will go further than that, because officials have had discussions of the sort mentioned by my right hon. Friend, in his response to my hon. Friend’s letter of November 2010, with suppliers and trade associations on sponsorship. I understand that one prominent trade association, the British Healthcare Trades Association, is discussing the industry’s views with its members. We have yet to receive the final feedback on those issues from the industry. I hope that, through this debate, we can ensure that we get that response, because the Department will certainly want to see it.

The BHTA code of practice—another code of practice—for health care and assistive technology products and services states:

“No pressure must be exerted on the sponsored individual to favour the sponsoring company’s products over any other. At all times the products supplied should be that which the professional considers is best suited to the client’s needs.”

Clearly, the trade bodies themselves recognise that potential risk and have identified it in their own codes of conduct with regard to their members.

On localised formularies and tendering, I am sure my hon. Friend is aware of the pressures facing NHS organisations as a result of our ageing population, and the increased diagnosis and treatment of cancers that he mentioned. On top of that, the NHS obviously has to achieve the Nicholson challenge of £20 billion of efficiency savings by 2015 through a focus on quality, innovation, productivity and prevention. Every saving made from that is being reinvested in patient care to support front-line staff. As we move forward, it is very important that NHS procurement is undertaken at national, regional and local level via the NHS supply chain, regional collaborative procurement organisations and individual trusts. Some NHS organisations may also use formularies to form the basis of a recommended list of products for prescribers, which is intended to provide a sufficient range of choice to meet the clinical needs of most patients. They may also run tenders to acquire local supply of these products. Local formularies or tenders are generally prepared by multi-disciplinary teams and reflect, as far as possible, best clinical practice.

I understand the concern that the hon. Gentleman has about choice and I appreciate the importance that stoma patients often place on continuing to receive a product in which they have confidence. We want to ensure that patients are at the heart of the clinical decisions that are being made about them, which is one of the reasons that we want to see a wide range of products available through the drug tariff to meet different needs of individual patients. However, and it is important that I stress this, any local arrangements of the sort that the hon. Gentleman has described do not override the clinical judgment of the GP who is still free to prescribe products listed in part IX of the drug tariff to meet specific needs of patients. Any decisions to undertake local procurement activity rest with local NHS organisations—primary care trusts now, clinical commissioning groups in the future—and we expect them to act in accordance with the principles when they are exploring the opportunities for tendering.

When it comes to patient choice, we want to go further than that. As part of our commitment to this policy of any qualified provider, we identified continence services as a good candidate for the approach. We felt that the competition should be on quality and not on price.

[Jonathan Evans]

Before the Minister concludes his remarks, let me again raise one question in relation to sponsored nurses. He referred to the code of professional conduct, which places the onus on the nurse. Nurses have to exercise independence of thought while knowing that their salary is being met by a commercial sponsor. Is it not the case that the position of those nurses would be enhanced if the Government were to ensure that there was a robust arrangement for the management of conflicts of interest, which manufacturers knew existed, rather than leaving all the onus on the nurses themselves? That is placing too much on them and not ensuring that the public are satisfied that we have the same processes for requiring management of conflicts that we require in other public policy areas.