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The Parliamentary Under-Secretary of State for Health (Dr. Stephen Ladyman):
I congratulate the hon. Member for Lewes (Norman Baker) on securing this
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evening's debate. I have no doubt that his constituent is grateful for the interest that he has taken in the matter over a long period of time.
I am aware that the hon. Gentleman has corresponded with both the primary care trust and the relevant acute trust, which are the appropriate bodies to deal with the issue. I sympathise with Mr. Patrick. It is a tragedy for a young person to be losing their sight and not to be responding to treatment. I doubt whether any hon. Member would not sympathise with himindeed, we sympathise with all people who are not responding to the available treatments.
I listened carefully to the points that the hon. Gentleman made, but I hope that Mr. Patrick and he accept that my powers are limited. Furthermore, I hope that he agrees that, in line with patient confidentiality, it would not be appropriate for me to comment in detail on the individual aspects of that particular case. He may have been given leave to raise those issues in public, but I have not, so I must largely limit myself to general comment.
The hon. Gentleman raised several points about the handling of Mr. Patrick's case by Moorfields eye hospital and his local primary care trust. The first reason why my powers are limited is because the key trust involved, Moorfields eye hospital, is an NHS foundation trust. Foundation trusts are independent organisations that are no longer accountable to the Department of Health or to Ministers. Instead, they are accountable to four other groups and bodies: first, their members, via a board of governors; secondly, primary care trusts, for the delivery of NHS services; thirdly, Monitor, the independent body responsible for regulating foundation trusts; and fourthly, Parliament, which is responsible for the legislation that creates foundation trusts.
Because of foundation trusts' independent status and separate, local route of accountability, Ministers are no longer in a position to comment on or become involved in their day-to-day activities. We also have no powers of direction or intervention over those trusts. Freeing foundation trusts from the backstop of the Secretary of State's powers of direction and Department of Health control means setting out and applying clear sets of rules for the regulation of foundation trusts and intervening only when things go wrong, which is the task of the foundation trust regulator, Monitor.
Monitor needs to ensure that foundation trusts are fully compliant at all times with their terms of authorisationa sort of licence to operateand the legislation, so that they deliver NHS services to NHS patients effectively, efficiently, economically and confidently. It has powers to intervene where necessary in the running of a foundation trust in the event of failings in its health care standards or other aspects of its activities that amount to a significant breach of the terms of its authorisation. That ensures that a foundation trust that is failing to meet its obligations can be brought back into line. Monitor will intervene only if it feels it necessary.
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In this particular case, I am aware that Monitor has considered Mr. Patrick's treatment, which it considers a matter for Moorfields eye hospital. That brings me to the specifics on the approval or non-approval of the treatment, and I stress that the issue does not concern funding. Instead, this is a case in which the PCT and the trust have not prescribed a drug because it is not licensed for that particular indication and because no new evidence exists to support its use. When a patient is treated at any hospital, whether or not that hospital is within a foundation trust, the consultant may prescribe any drug, including unlicensed medicines, as appropriate. That is what my noble Friend Lord Warner said in his letter to the hon. Gentleman. However, trusts have multi-disciplinary drugs and therapeutics committees that oversee the clinical and cost-effective use of medicines within their organisations, and all prescribing should have the support of that committee.
Of course, consultants are ultimately responsible for their own prescribing decisions. They should always satisfy themselves that the medicines that they consider appropriate for their patients can be safely prescribed, that patients are adequately monitored and that, where necessary, expert hospital supervision is available.
In March 2002, the National Institute for Clinical Excellence recommended the use of Infliximab for highly active rheumatoid arthritis in adults who have failed to respond to at least two standard drugs. However, Infliximab is not licensed in the UK for the eye condition that Mr. Patrick has and there is no sufficient or conclusive evidence to support its use for that condition, hence the decision taken by Moorfields.
A group of expertsthe drugs and therapeutics committeehas decided that the potential harm to the patient from this treatment, including severe blood disorders and septicaemia, outweigh the unproven benefit for his condition at this time. I stress that the decision was taken by the drugs and therapeutics committee, which is a committee of experts, not a group of managers or people without expertise in such matters. Moorfields, as advised by its drugs and therapeutics committee, does not currently include this drug within its supported formulary.
If I might offer a glimmer of light at the end of the tunnel, I am assured that the position could change as further evidence regarding the efficacy and safety of the drug in ophthalmic treatment becomes available. At the moment, however, the trust's position is that further research will need to be done before the clinical governance body will review the decision. I understand that the trust will continue to explore other possibilities that might help Mr. Patrick and other patients, including access to existing or future research trials.
As the hon. Gentleman spoke, I was struck by the length of time that this case has gone on. That might indicate that the clinical governance body last reviewed it before some of the evidence that he brought to the House's attention was available. One of the courses of action that could be taken, if it has not been done already, is for the consultant to put that body of evidence before the body and ask whether it considered it before making its decision.
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The hon. Gentleman asked about the relationship between the trust and the primary care trust. Sussex Downs and Weald, the PCT that commissions services for residents, including Mr. Patrick, has considered the case. The PCT has a contract for specialist eye services with Moorfields, and general services are available locally. However, the specialist treatment that Mr. Patrick's consultant recommended is not supported by the trust, and therefore the PCT cannot fund it. I am assured by the PCT that, if different treatment options that were licensed for Mr. Patrick's condition were suggested, or if sufficient clinical evidence emerged to support the use of this unlicensed treatment, the PCT would consider funding. However, the PCT has made it clear that it cannot and would not attempt to force Moorfields to prescribe the drug when its clinical governance body has decided that the evidence does not support its use. The decision was not taken by accountants or managers, nor by the PCT. Like Moorfields, the PCT did not decide against the treatment for financial reasons.
Clinical governance is the collective responsibility of the clinicians at the hospital. Those clinicians have decided that the available evidence does not support the use of Infliximab in ophthalmology at the present time. The PCT has made it clear that it will continue to be guided by Moorfields as to the appropriateness of the drug as and when further clinical evidence is forthcoming.
If a drug is prescribed privately, the clinician will be bound by codes of clinical governance but will be held entirely responsible for the consequences if the clinician decides to prescribe it. But when, as in this case, a drug is prescribed or requested to be prescribed on the national health service, the NHS must share responsibility for the decision.
The rules for arriving at decisions about the drugs that can be prescribed, the validity of the evidence of efficacy and risk and the balance of the two are, therefore, agreed with the clinicians at the trust and they cannot be overturned by an individual clinician. Of course, that clinician has the opportunity to put forward reasons and make the case for the drug to be prescribed. The clinician has the opportunity to bring forward evidence that he or, in this case, she thinks has been overlooked and can even explore the opportunities for becoming involved in trials to establish that evidence. However, in the absence of that evidence, or having failed to establish a convincing case, the clinician cannot expect to have his or her personal judgement put in the place of that of his or her colleagues. He or she cannot try to make the case that everyone else's judgment is flawed.
I assume that the consultant has based the view that the drug may help the hon. Gentleman's constituent on evidence. If it is strong enough to convince the consultant, it should also be strong enoughif the consultant puts the caseto convince the clinical governance committee. I therefore encourage the hon. Gentleman to speak to the consultant to ascertain whether new evidence, which the committee has not yet
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considered, has recently emerged, and to have another go at making the case. If the consultant can be convinced, so can the committee.
Politicians should not question the good faith of those who made the decisionthat would be disingenuous to say the leastand claim that the decision must have been made on the ground of cost. The decision in the case that we are considering was not made on that ground, although I can understand why the hon. Gentleman is becoming angry with the trust's chief executive if he cannot even get information or responses to correspondence.
As I said earlier, I sympathise with the hon. Gentleman's constituent but I cannot and will not intervene. I certainly would not want anyone to see the decision changed until safety issues are resolved. However, if the hon. Gentleman and his constituent are dissatisfied with the answers that they have received from the trust, Mr. Patrick can, of course, complain to Moorfields about his treatment.
New regulationsthe National Health Service (Complaints) Regulations 2004came into force on 30 July this year. Although those regulations do not require foundation trusts to have a local complaints procedure, they will more than likely have their own process for addressing patients' concerns. In any event, patients can complain to the Healthcare Commission and ultimately the health service ombudsman if they are unhappy with the treatment that they have received from a foundation trust. Mr. Patrick can also complain about the actions of the PCT if he wishes by first setting out his concerns to the PCT. If he remains unhappy, he can approach the Healthcare Commission and, ultimately, the health service ombudsman.
The hon. Gentleman said that he was satisfied with the efforts that the PCT had tried to make on his constituent's behalf and I am pleased to hear that. However, he is clearly far from satisfied with the efforts of Moorfields. I therefore strongly urge him to consider the complaints route and, if necessary, approach the Healthcare Commission. The chief executive reports to a board at the foundation trust. If the hon. Gentleman believes that the chief executive is not dealing with the issue appropriately, he might wish to approach members of the board and ask for the issue to be raised. The Healthcare Commission will make Monitor aware
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of all complaints that relate to foundation trusts. It will therefore be told of the matter if the hon. Gentleman pursues a complaint.
I hope that the matter reaches a satisfactory conclusion but I must stress again that it is for the NHS to resolve on the basis of evidence and expert clinical opinion. It is not a matter of moneyit never wasand to suggest that that is the case is deeply unfair and, more important, will mislead Mr. Patrick and may indeed give him false hope.
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