Off-patent Drugs Bill

Jonathan Evans Excerpts

Friday 7th November 2014 Commons Chamber

[Jonathan Evans (Cardiff North) (Con)]

I beg to move, That the Bill be now read a Second time.

Only a handful of MPs are ever successful in the private Members’ Bill ballot, so I am delighted and honoured that, 22 years after I was first elected to the House, and now in my final year of parliamentary service, I have at long last joined this rather select group and have the opportunity to promote a Bill on such an important matter.

First, let me thank the Bill’s sponsors, and MPs from all parts of the House, who have shown such support and interest in my Bill. The passionate welcome it has received has been truly amazing, although not surprising given the challenges it addresses.

Just yesterday, the letter page of The Times led with a joint appeal to the Minister and the Government in favour of the Bill from the Association of Medical Research Charities, the Breast Cancer Campaign, Leukaemia and Lymphoma Research, Breakthrough Breast Cancer, the Alzheimer’s Society, the Multiple Sclerosis Society, Leukaemia Care, Breast Cancer Care and the Cure Parkinson’s Trust. I should particularly like to thank Jenny Goodare and Mia Rosenblatt of the Breast Cancer Campaign for all the help they have given me in introducing my Bill.

Why question access to off-patent drugs? The problem goes back many years and is caused by a gap in the licensing system. The system is set up on the basis that a pharmaceutical company that wants to market any new drug acts as the drug’s sponsor throughout the process. That is fine and clearly understandable when the company anticipates many years of patent protection for its new product, but the essence of the problem that my Bill addresses is that no mechanism is in place to ensure the routine availability of existing drugs where patent protection has expired and where the drugs may be clearly shown later to be clinically effective but in a new way and for a new purpose.

Every time previously licensed drugs are shown to be effective for a new purpose, a new licence is needed to certify the drug’s safety at whatever the dose may be and for that purpose, and it must then be authorised to be marketed for such use. However, if a drug is no longer patent protected, no organisation or individual will take on the role of seeking any necessary licence for that treatment, because, after the patent has expired, other drug companies can produce and market generic versions of the drug, so the price of the product is driven down through the simple expedient of competition. It follows that the incentive for any pharmaceutical company to act as an advocate or sponsor for an off-patent drug and apply for a new licence is lost.

The outcome of all this is that off-patent drugs that should be routinely available at extremely low cost effectively have no sponsor. Without a change in the system, no one is ever likely to make licence applications for off-patent drugs, even when they may be effective for new purposes. In fact, it remains illegal to advertise and sell such drugs for such purposes if the drug is not licensed. What this all boils down to is that off-patent, repurposed drugs are not routinely available on the NHS, despite minimal costs to the taxpayer and the clear, clinically proven health benefits.

We may hear mention today of the ability of general practitioners to prescribe a drug outside the terms defined by the licence, which is known as off-label prescribing—in fact, Madam Deputy Speaker, given our earlier experience today, we may hear a lot about that—but the reality in clinical practice is much more complex and there are many disincentives to prescribing off label. A small number of clinicians may well be comfortable prescribing drugs off label in certain limited circumstances, but we know from the chemoprevention example, which the Minister quoted in the earlier debate, that this is not happening on any substantial scale. We also know that the absence of a licence is deterring many clinicians and GPs from prescribing these life-saving drugs in their new indications. Medical charities and senior distinguished clinicians have said that it is just not good enough to rely on the promotion of better information about off-label indications between clinicians.

[Bob Stewart (Beckenham) (Con)]

Are off-patent drugs likely to be found in a chemist’s shop? Do chemists keep stores of these drugs?

[Jonathan Evans]

Invariably, such drugs have been licensed for other uses, but it transpires that they are being researched, as I will outline in my further remarks, and that research is showing that they can be used effectively in another way. The kernel of the problem that I am seeking to highlight is that, without licensing, they are not being used in that way.

A licence gives a clear indication to GPs that a drug is both safe and effective, so it is preferable that indications that could achieve such a licence are supported. We face an unacceptable situation where cost-effective drugs are not made routinely available for new and proven effective uses. Although a small number of people might be fortunate enough to get the drug, a far greater number with exactly the same condition, in exactly the same clinical circumstances but with a different GP, will not. That is the worst form of inequality.

I want to highlight one scandalous example of the failure, red tape and bureaucracy of our current licensing system. The passive approach to the flaw that I have highlighted has meant that, for all of 15 years, the chemoprevention drug tamoxifen was routinely available to women in the United States of America to prevent the development of breast cancer but not to thousands of women at risk here in the UK, not because the research evidence is any different in the United States of America and the UK but because under our licensing system there is just no one to request that this treatment should become routinely available. So for 15 long years nothing whatsoever happened, and thousands of women here in Britain were denied treatment that it has been clinically proven could have prevented the development of breast cancer in many cases.

It was not until 2013 that the National Institute for Health and Care Excellence—NICE—eventually recommended the use of tamoxifen in the UK in its guidelines on the management of familial breast cancer, but that still stopped short of licensing, because of the flaw to which I have referred. As a result, the NICE guidance has proved insufficient to ensure equal access and there is no evidence that it has significantly changed clinical practice. The uptake of these treatments is lower and less uniform than if the drug were licensed. Furthermore, owing to the infrequency with which NICE guidelines are updated and their impact, this mechanism could not be widely employed to make off-patent drugs available, and I believe that the example of tamoxifen starkly confirms this.

[Graeme Morrice (Livingston) (Lab)]

I entirely agree with what the hon. Gentleman has said so far. Indeed, I want to lend my personal support to his private Member’s Bill and wish him well on its Second Reading. Several dozen of my constituents have contacted me in support of the Bill and specifically asked me to come along today to represent them in the Chamber and to vote for the Bill on Second Reading if, indeed, there is a vote. I certainly hope that his Bill is not talked out.

[Jonathan Evans]

I am grateful to the hon. Gentleman for that contribution. If he will forgive me, I will not go further down the path of responding because of the point that he made at the end.

Sadly, all existing off-patent drugs that reduce the risk of people developing breast cancer fall into this category. The leading proven chemoprevention drugs are tamoxifen and raloxifene. These drugs, which reduce the risk of breast cancer developing in high-risk women by around a third, are not licensed for this purpose. With nearly half a million women in England and Wales eligible for these low-cost treatments, there is an urgent need to address the barriers to chemoprevention drugs being prescribed. The cost of tamoxifen is 6p a day; the cost of raloxifene is 61p a day. A third chemoprevention drug, anastrozole, originally developed as a hormone therapy, has been shown to reduce the risk of breast cancer developing by a half, and with fewer side effects. The evidence is there, but what action can be taken to ensure the routine availability of these treatments? The answer is none, or very little.

[Bob Stewart]

Without trying to talk out anything, may I say that I totally support what my hon. Friend is trying to do? Could NICE not do this sort of thing?

[Jonathan Evans]

My hon. Friend, yet again, anticipates another part of my remarks. The second part of my Bill is about giving a certain responsibility to the Secretary of State to encourage NICE to promote technology appraisals. I will deal with that in a little more detail in due course. He is quite right, but not exclusively: licensing is the major problem.

Major new research will be published in the next few months that provides evidence that bisphosphonates—drugs that were originally licensed for the treatment of bone fractures in adults with advanced cancer—are effective in the early stages of breast cancer in reducing the risk of the disease spreading to the bone in post-menopausal women. That analysis of phase 3 clinical trials is likely to show that, in post-menopausal women with early breast cancer, this therapy reduces the 10-year risk of breast cancer spreading to the bone by 34% and the risk of dying from breast cancer by 17%.

I should like us to reflect on that for a moment: a 17% reduction in the risk of women dying from breast cancer. What would be the cost of any new treatment that could deliver such results? It would probably be tens of thousands of pounds, and we would want to pay that for such impressive results. However, zoledronic acid, a type of bisphosphonate drug, can be given to post-menopausal women every six months for three to five years, and that can reduce the risk of breast cancer spreading to the bone by a third and the risk of death from breast cancer by a sixth, and it would cost less than 5p a day.

Yet bisphosphonates are off-patent drugs that are produced relatively cheaply by numerous pharmaceutical companies as generic drugs, as my hon. Friend the Member for Beckenham (Bob Stewart) mentioned earlier. It is therefore pretty certain that under the current flawed licensing system no organisation would seek a licence to use that treatment in preventing secondary breast cancer, even when the evidence is published, so the drugs will not be routinely available to the women who clearly need them.

I want to pay tribute to the distinguished breast cancer clinicians and researchers who have been speaking out about this issue for years. Sixteen of them wrote to The Times on the day of the Bill’s First Reading, stating:

“For some time it has been clear that there is a real barrier to licensing old drugs for new purposes, even when there is evidence that they are effective. This means that treatments which could bring real benefit to the lives of people and in some cases be life-saving, with minimal cost, are not routinely available”.

It is not just access to cancer treatments at stake; the current system will fail us for any medical condition in future if we do not correct the flaw. The Multiple Sclerosis Society makes it clear that strong preliminary evidence has shown that a number of repurposed medicines could be effective in the treatment of multiple sclerosis, but the UK currently lacks a system by which old drugs can be relicensed. In the past week the society wrote directly to the Minister in support of my Bill, in a letter co-signed by Professor Sue Pavitt, chair of the UK’s MS clinical trials network, and other leading specialists in the field. They cited the example of simvastatin, a drug originally licensed for treating high cholesterol that has been shown to be effective in slowing brain atrophy in secondary progressive MS by over 40%. Although final evidence from a phase 3 clinical trial is required to confirm those results, if successful that drug would address a significant unmet need, as there is currently no treatment that can slow or stop the deterioration seen in progressive MS.

The MS Society has pointed out that, given that simvastatin’s patent has expired, the treatment would require a licence in order to be made widely available on the NHS to people with multiple sclerosis, and it argues that the mechanism to achieve that just does not exist, despite the repurposing of previously licensed drugs being a fast and cost-effective way to provide new treatments. Those eminent clinicians and the MS Society strongly support my Bill and the mechanism it would create to provide access to medicines that could help tens of thousands of people with untreatable multiple sclerosis.

The treatment of Parkinson’s disease could greatly benefit from the Bill. I know that Tom Isaacs, president and co-founder of the Cure Parkinson’s Trust, has written to the Minister in the past week to point out clearly the charity’s full support for the Bill. Tom has said:

“Parkinson’s may not be a death sentence, but at the moment it is a life sentence. There is increasing evidence that a number of off-patent drugs have the ability to slow, stop or reverse our condition. Under these circumstances, the ability for patients to have a clearly defined way to make these medications accessible is now imperative.”

I think that it is now appropriate to turn to the detail of the Bill, given that the Minister might do so, Madam Deputy Speaker. To address the anomaly I have outlined, the Bill introduces a new advocate—the Secretary of State or a body appointed by him—for off-patent, repurposed drugs in the existing UK licensing system. The advocate would have to act in the public interest, and in circumstances where no other body had taken on the role of seeking a licence. The level of evidence required to trigger the advocate to seek a licence for an off-patent drug in a new indication would have to be significant. The treatments referred under the mechanism would be required to meet exactly the same standards for a licence for any other treatment, so nobody is lowering the bar in the licensing process. The Bill does not seek to make any unproven treatments available to patients; it simply seeks to address a clear market failure in the current system and to allow proven drugs to be considered for a licence after their patents have expired.

Clinicians have also suggested the supplementary provision in the Bill for NICE to appraise off-patent drugs in new indications where these are unlicensed—the point made earlier by my hon. Friend the Member for Beckenham, who sadly is no longer in his place. It is anticipated that that exceptional route would be used rarely. Regulations would outline the specific and significant standards that would need to be met before the provision was triggered. Although it may already be possible under existing legislation for NICE to appraise drugs for an unlicensed indication, the Bill would simply place a duty on the Secretary of State to direct NICE to conduct a technology appraisal for an off-patent drug in a new indication that satisfies the evidence threshold.

The Minister has stated publicly:

“The Government firmly believe that cost-effective, clinically appropriate drugs and devices should be routinely available to NHS patients.”—[Official Report, 1 September 2014; Vol. 585, c. 141.]

I recognise and applaud the admirable steps that this Government have taken to improve access to new cancer treatments. The cancer drugs fund has been established for England and now has a budget of £280 million a year. It is an incredible scheme that has improved access to treatments for thousands of patients in England, and I have seen for myself the disadvantages that my constituents have faced by not having an equivalent fund in Wales.

On the CDF, we are currently spending millions on new treatments, so why not improve access to treatments that cost just pennies but that we know can save or improve lives? In future there will be drugs for other conditions, including Parkinson’s, multiple sclerosis, breast cancer and Alzheimer’s, that could benefit from the Bill. We cannot wait 15 years longer than other countries for our constituents to get these treatments, as happened with tamoxifen, and then tolerate a postcode lottery in their availability to our constituents.

[Mr Christopher Chope (Christchurch) (Con)]

I congratulate my hon. Friend on bringing forward this brilliant Bill. If it does not succeed today, it will certainly succeed in future, because it seems to be based on unanswerable logic. Can he explain why he thinks the Government are against it?

[Jonathan Evans]

It will be for my hon. Friend the Minister to make the Government’s case, although I certainly hope that he will not be lengthier than I am being in endeavouring to make my case.

It is simply not acceptable to sit back and hope for the best: we will let our constituents down by taking such a stance. I have heard it said that the Bill is not necessary and that better information for GPs and clinicians may be the answer, but the reality is that addressing the licensing flaw in the current system, as I have outlined, is the only way to tackle the issue effectively.

I say to colleagues, let us take this opportunity to act and deliver real change for those affected by cancer, multiple sclerosis, Alzheimer’s, Parkinson’s and so many other conditions. That is what the charities supporting them, and the senior clinicians specialising in treating them, are asking for. If we take forward this Bill, we can save and improve lives. If we tinker at the margins, we will not. For those who really want change, who really want people in this country to have access to the best treatments available, the answer is before us and it is clear. A legislative solution is necessary. By passing this Bill, we have an opportunity to change and save our constituents’ lives. I hope that we take it.

--- Later in debate ---

[George Freeman]

I am not clear which particular drugs my hon. Friend is referring to, but let me answer in a generic way. I would like us to become a place where, instead of it taking 10 or 15 years and $1 billion to bring innovative drugs to market, we use the NIHR platform and our investment in genomics to become a country where for some cancers we could be getting drugs to the most needy patients through the early access to medicine scheme that I have been championing and that the Department launched earlier this year. Potentially, we could be getting drugs to patients five, six, seven or eight years earlier than would normally be the case through the traditional model of phase one, two, three, four.

[Jonathan Evans]

The drugs the Minister is talking about are new drugs. They are not a mechanism for using existing licensed drugs for which the patent has expired, which, under current circumstances, are not being prescribed to people who need them. That is what this debate is about.

[George Freeman]

I well understand that. The off-patent is a distraction; it is the question of off-label. The truth is that clinicians are free today to do it. My hon. Friend’s point about timing is very well made. I would merely say that at this stage, with the working party I am putting together and the strategy I would like us to launch—I would very much appreciate his input—I think we should be looking at setting some very clear goals and targets for speeding up that use. In particular, we should ensure that where there is evidence of an innovative and new use for an existing drug off label and there is good evidence to suggest it, we roll it out across the system. It is both the speed of first adoption and the speed of roll-out across the system.

This offers the prospect of a more appropriate and sustainable approach that can apply to a range of different drugs. We can use it to tackle this problem much more quickly and to get new drugs into use much more effectively. More specifically, we are looking to gather further evidence around potential barriers by focusing first on NICE’s updated guidelines on familial breast cancer, through the NICE associates network, and asking it further to promote its implementation. I will also ask NICE whether it would be prepared to use one of the patient decision aids it is piloting for further support.

To draw all the strands together and look at the issues at national level, we plan to arrange a national round table of the key stakeholders to be co-hosted by my Department with NHS England and NICE. We intend to use the initial meeting to identify what the various participant stakeholders might usefully do to help to address the cultural and clinical leadership issues and what other practical steps might help. The request I make to those who support the Bill is that we review the need for any further guidance or legislation in the light of that work when it has been completed. I am delighted to extend an invitation to my hon. Friend to be a part of that.

In conclusion, I very much appreciate the points that have been made today. I recognise the very real concerns that have led to the drafting of the Bill. I am absolutely committed to investigating and getting to the bottom of the reasons why new evidence is not being picked up and implemented consistently, as well as why some clinicians may be reluctant to prescribe in this way, and, crucially, the important role of NICE in supporting that with updated guidance. I am committed to doing so with the involvement of all interested parties.

The Government remain firmly of the view that improvement in this area can best be achieved through a combination of measures, and that resorting to legislation to demand regulatory measures is not a magic bullet. It will not solve the issues we believe are actually responsible for this problem, and it carries the risk of some serious and unintended consequences. It is for those reasons that the Government cannot support the Bill. However, I reiterate that we support the intention of promoting greater use of off-label medicines. We are committed to looking seriously at this and to launching a strategy and a work plan, with specific targets for increasing the rate of use of off-label medicines, with all the key agencies and to invite stakeholders in the sector, in particular medical research charities and the AMRC, to help us with that. New uses for existing drugs is something we actively support. The truth is that, as much as we would love to, we could not and should not go down the slippery road of starting to legislate for the use of medicines that should be, and are rightly, a matter for clinicians.

[Jonathan Evans]

I thank all who have contributed to the debate, including the Minister. In fact, other than the Minister everybody has spoken in favour of the proposition contained in the Bill. I am especially grateful to my hon. Friend the Member for Bury North (Mr Nuttall), who has been involved from the inception in supporting the Bill. I am grateful for the intervention of my hon. Friend the Member for Christchurch (Mr Chope), who has been such a source of great support in this process, which, even after 22 years, is relatively new to me. He, of course, is something of a Friday expert. I am also grateful to my hon. Friend the Member for Beckenham (Bob Stewart) for his interventions and his clear articulation of support for the Bill. Let me also thank the shadow Minister and those on the Labour Benches who have made it clear to me and to the charities their complete support.

The problem is that the Government take one view on the Bill, whereas charities, clinicians and others are saying that the current situation is unacceptable. It is not good enough to argue against going down the road of legislation, given that we already have a legislative process for licensing. For instance, it is the law that if a drug has not had a licence, it cannot be effectively marketed in the UK. The reason GPs often do not routinely prescribe life-saving medicines is that the rules in essence make it illegal to market them in that way. It is not surprising, therefore, that GPs, given that legislative background and the litigious world of the medical and legal profession, decide to avoid something unless it is licensed. It is not as though the charities sector has not provided the Department with a welter of information on why GPs are not doing it. The lack of licensing is at the core of it.

As the Minister knows, I respect him and his background career, and we have had several conversations about the Bill, but the proposition that passing the Bill would damage the current situation is simply laughable. I do not know who wrote that line for the Minister, but that proposition needs to be re-examined. Nothing in my Bill would cause a GP to say, “Well, actually, I was going to prescribe something, but I’m not going to now.” With due respect to him, that was the weakest of his arguments.

We heard earlier from the Labour Benches that several colleagues have received representations on the Bill from a wide coalition of charities covering a range of medical conditions. Yesterday, I spoke to several of my colleagues on a day trip to a constituency in southern England, and everyone spoke of having 50 or 60 constituents urging them to support the Bill and of being pleased to have received a response saying that the Government were speaking to me as the Bill’s promoter. Many people interpreted that to mean that the Government would be broadly supportive of the Bill.

For that reason, I am deeply disappointed to hear now that the Government are opposed to the principle of the Bill. I do not need to rearticulate its provision—it is a very simple Bill—but it says that in the absence of somebody applying for a licence, the Secretary of State has the duty to make that application or to appoint another public body to do it. Thereafter, the Bill makes provision for the drafting of regulations that present widespread opportunities for the Minister to address his concerns.

[George Freeman]

To clarify, we agree with the objective of the Bill, which, as I understand it, is to get greater off-label use of medicines for new indications, but we disagree about the mechanism. The Bill is very clear on the mechanism: it is to pass legislation to require the MHRA to issue licences. We believe that this is the wrong solution, but we are in alignment on the problem that needs to be solved.

[Jonathan Evans]

That is very helpful. I have always understood that a Second Reading debate is on the principle of the Bill; we then deal with the detail in Committee, and then we proceed to Report. Ever since I was first elected 22 years ago, that is how I have understood it to work. If my hon. Friend is saying, “We are not against the principle, but against the mechanism”, that is a reason to support the Bill on Second Reading and then to debate in Committee how we adjust it to take into account his concerns.

[George Freeman]

I congratulate my hon. Friend on making an extremely eloquent argument, but I cannot let that go. The point is that the principle to which we object is the passing of legislation to require the MHRA to issue licences. That is more than a vague guiding philosophy; it is the mechanism suggested, and that is why we are opposed to it. I genuinely believe we will make more progress in the next few months using my office and the organisations for which I am responsible, working with the supporters of the Bill, to drive forward these measures.

[Jonathan Evans]

So we are back to the Government being opposed to the principle of the Bill. It might have helped if Ministers had said, in response to those Members who wrote to them saying they were aware of my Bill, that they were opposed to the principle, as we have just heard from the Minister. Members were led to believe that the Government were not against the principle but were discussing these matters and that we might ultimately reach an accommodation. Now we understand that the Government are opposed to the principle.

The principle is one advanced by the clinician community and the AMRC and supported by editorials in leading newspapers in the UK this week. It is not surprising that almost every leading newspaper has urged the Government to pay attention to the arguments. The hon. Member for Copeland (Mr Reed) highlighted how people outside the House look at what we do here. As I said in my opening remarks, it is important that we pay attention to the clinician community and the AMRC. For that reason, I hope the House will support the Bill.

Question put, That the Bill be now read a Second time.

Oral Answers to Questions

Jonathan Evans Excerpts

Tuesday 26th November 2013 Commons Chamber

[Mr Jeremy Hunt]

Can I explain to the hon. Lady that the reason for the 4% efficiency savings is that, although we protected the budget in real terms, demand for NHS services has gone up by 4% year in, year out, so we need to find those efficiencies? Within that, it is incredibly important that we do not make false economies in relation to the number of nursing staff, which is why last week’s announcement on our response to the Francis report will make a big difference, and we have already begun to see more nurses.

[Jonathan Evans (Cardiff North) (Con)]

T7. Given the more than 30% increase in the past five years in the cost to the NHS of prescribing stoma appliances, what action is the Minister taking to promote training for stoma patients in alternative management techniques, such as colostomy irrigation?

[The Parliamentary Under-Secretary of State for Health (Jane Ellison)]

My hon. Friend may know that specialist NHS stoma nurses offer a range of support and advice to help patients adapt to life with a colostomy, and this advice can cover colostomy irrigation, if appropriate. This is supplemented with patient literature on colostomy, which is widely available in the NHS.

Hepatitis C (Haemophiliacs)

Jonathan Evans Excerpts

Tuesday 29th October 2013 Westminster Hall

[Alistair Burt (North East Bedfordshire) (Con)]

I congratulate the right hon. Member for Wythenshawe and Sale East (Paul Goggins) on securing this debate. My hon. Friend the Member for Cardiff North (Jonathan Evans) and I think that this is the first debate on this subject since the death of Lord Morris of Manchester. It is therefore highly appropriate that the first debate since Alf’s death was proposed by the right hon. Member for Wythenshawe and Sale East. I welcome my hon. Friend the Member for Battersea (Jane Ellison) to her new position as Under-Secretary of State for Health. Those of us who have followed her career for some time know that that is richly deserved. Perhaps the honour to set the seal on something that has been going on just that bit too long will fall to her.

[Jonathan Evans (Cardiff North) (Con)]

My hon. Friend and I had the honour of being in government more than 20 years ago. Looking back over those years, does he share my view—from our ministerial experience, although it was not in the Department of Health—that the outcome in this area has been less than satisfactory and that the issue should have been resolved a long time ago?

[Alistair Burt]

My hon. Friend is right. Hanging over the issue, particularly for those of us who were Ministers in successive Governments, is a sense that not enough has been done. No blame can be laid at the door of Back Benchers who have campaigned and done so much, and in their respective ways, Governments have sought over time to do something about the issue, but we are still here because of the overwhelming sense that whatever has been attempted has just not been enough.

One reason I raised the matter on the Floor of the House with the Prime Minister the other day was to capture that sense. Let me say more about that, but I shall try to be brief. I had a meeting with the then Minister with responsibility for public health, my hon. Friend the Member for Broxtowe (Anna Soubry), a few months ago. All of us have had meetings with the successive holders of that ministerial role over time. The history is familiar to us, but there is an overall sense that whatever has been tried—whatever honest attempts Governments have made—has just not been enough.

I supported the inquiry by Lord Archer of Sandwell, and in 2010, I seconded the early-day motion that called for the passage of the Bill that Alf Morris had introduced in the Lords to put into effect the recommendations of that inquiry. I was disappointed that those provisions were not put fully into effect, although the incoming Government made the changes mentioned by the right hon. Member for Wythenshawe and Sale East. We all welcomed that at the time, while recognising that it was still not enough.

Why are we making another attempt now? As has been made clear by the presence here of the right hon. Member for Leigh (Andy Burnham), there is now a different attitude towards uncovering past wrongs. The reason why I put the case so clearly to the Prime Minister is that his record in dealing both with the aftermath of the Hillsborough panel and with Bloody Sunday has demonstrated that he is a Prime Minister who is using his position and authority to right the wrongs of the past. Bearing in mind that he has a constituent affected by the issue, we know that he has a personal interest. That combination of circumstances perhaps means that the person in place has the determination to right the wrongs of the past. If information can be put together properly, something might therefore be done.

The sense of closure that must be achieved is palpable to all of us with affected constituents. I am here because of my relationship with a good—double-infected— friend, who has informed me about such matters over the years and for whom I desperately want to achieve something.

What has got wrong and what can we put right? The first point is that the process has taken too long: since the circumstances originated, it has all taken too long.

The second point relates to accepting that something has gone wrong. Undoubtedly, Ministers have said so and made that clear, but the Government’s acceptance of something having gone wrong has not been accompanied by the fullest disclosure of their full part. Even when the previous Government responded to the Archer inquiry— they published their response on 20 May 2009—they still, in relation to the release of documents on their website, stated:

“Further papers have been identified, which are being released today.”

In 2009, relevant papers were still being found and put in the public domain. The Government added the claim:

“We do not believe they add to our knowledge”.

Well, that is for other people to judge. All this is governed by a very real sense that not enough has been disclosed. The current Penrose inquiry, which has been mentioned, may provide an opportunity to revisit that matter.

The third point is that the process has been too divisive. Sufferers have been inadvertently set against other, being asked, “What have you got—hep C, or hep C and HIV, or some other variant?” It should not be like that. Everyone has suffered because they were all infected by the same process at the same time, and efforts should not be made to divide people.

The fourth point is that the premise has been wrong: it just does not work to use charity law to deliver support that ought to be the Government’s responsibility. Efforts made over the years to put matters right and make changes have not done the job. The premise needs to be scrapped—it should not be there—and colleagues have mentioned that the difficulties of separating stages 1 and 2 from hepatitis C only create new barriers and yet more unhappiness and anguish.

The problem about the Macfarlane Trust, which deals with double-infected patients, is that there is a conflict between whether it should act on behalf of the Government in disbursing funds or—as it should do—on behalf of the beneficiaries: arguing for as much support as possible and banging the drum for them. I sense that there is a conflict, because the trust is not doing that, so it is not doing its job.

Following up the Prime Minister’s response to my question, I will have an opportunity to meet him in a couple of weeks’ time, when I will be accompanied by my constituent. I hope to meet colleagues from all parties before that, just to get our lines straight, so that we can have a good go at this.

I say to those—the Minister and her officials—who will brief the Prime Minister, “Go for it this time. Don’t miss this opportunity.” There will be all the stuff in the Department about the difficulties and the things that cannot be done. They should not look at what cannot be done, but at what can be done. This is her and her Department’s chance, on behalf of those who did not get a chance in the first place, so let us go for it.

We need a proper apology and acknowledgment by the person from whom it will mean most, as well as some form of inquiry. I liked what the right hon. Member for Wythenshawe and Sale East said about doing that differently. The Government have got to take part in it, and questions must finally be answered. There should be an acknowledgment that the compensation system and the various trusts are just not working and that there must be a new system.

It is not for me to say what the figures for compensation should be, but in recent years, we have learned that we live in an entitlement culture: if someone walks away from a major job in a big corporation, their wallet is well padded; if someone walks away from a public sector job in the BBC, or even in some local authorities and public bodies, their wallet is well padded. What has happened to those who were wronged by the state?

To conclude, the cost of caring for the needs of those affected by the worst treatment disaster in the NHS are quantifiable; the laying to rest of a tragic incident and the righting of a wrong are priceless.

Mid Staffordshire NHS Foundation Trust

Jonathan Evans Excerpts

Tuesday 26th March 2013 Commons Chamber

[Mr Hunt]

My hon. Friend is absolutely right. One of the changes we are announcing today is that, in the case of foundation trusts, CQC will be delegating its enforcement powers to Monitor so that it has more powers to insist on necessary changes and ensure that fundamental standards are not being breached.

[Jonathan Evans (Cardiff North) (Con)]

Will my right hon. Friend note that the Patients Association and campaigners such as the Powell family in Wales will not be satisfied by what he has had to say about the duty of candour until we have a full statutory duty in line with what Robert Francis recommended?

Liverpool Care Pathway

Jonathan Evans Excerpts

Tuesday 8th January 2013 Westminster Hall

[Glyn Davies (Montgomeryshire) (Con)]

Mr Weir, I would like to say how much of a pleasure it is to serve under the chairmanship of a fellow Celt. I declare an interest as a board member of Living and Dying Well, which specialises in research into and opposition to the legalisation of assisted suicide.

I shall begin with a summary of the current position. The “Liverpool Care Pathway for the Dying Patient” was developed by the Marie Curie Palliative Care Institute Liverpool as a framework for health professionals to use to ensure that people who are dying have as comfortable and dignified a death as possible. The pathway was developed and has been in use since the 1990s. Today, about 130,000 of the 450,000 patients who die in hospital care every year die while being cared for on the pathway. It has also been exported and is now in use in more than 20 other countries.

However, during the past few months, the Liverpool care pathway has been the subject of some very serious criticisms and allegations in the media, which has led to questions about whether it is indeed a worthy process. I shall explain why I sought this debate and the outcomes that I would like to achieve before considering in greater detail the criticisms that have been made of the pathway.

By any measure, the Liverpool care pathway plays a very significant role in how the end of life is managed in our country. Its role is much greater than most of us realise: 30% of patients who die in hospital care die while on the pathway. The sheer scale of this is why I believe that debate about it is too important to be led by national newspapers, although I certainly do not criticise those newspapers for reporting stories in the way they have done. Indeed, they have served a valuable purpose by raising public awareness of such an important issue. However, there is, almost inevitably, a tendency for newspapers to couch the debate in sensationalist terms. It is up to us as parliamentarians to ensure that this complex and potentially controversial issue is subject to balanced and thorough debate in the House of Commons.

The outcome that I seek today is calm reflection by parliamentarians, including those on the Front Benches, on this most sensitive of issues—calm reflection on the issues without encouraging the spread of alarm and despondency among those entering care, which can result from sensationalist allegations. I also seek a response from Government—from the Minister—that they will ensure that the review on which they have already embarked includes careful and thorough investigation of the allegations that have been made of bad practice. It is important to know whether the allegations are accurate and, if they are, where the weaknesses lie and what needs to be done to put those matters right.

I am a supporter of the Liverpool care pathway, but my aim today is not to defend or to attack the pathway, those who have made allegations of shocking bad practice, or the media, which have given the allegations such great publicity. It is to promote open and genuine debate in Parliament. In any case, I am not in a position to judge how much substance there is to the various criticisms that have been made, but I do know that we cannot avoid death and I also believe that most people do not fear death so much as they fear the process of death. The aim of the Liverpool care pathway is to ensure that the process is as compassionate, dignified and free from pain and discomfort as possible and, importantly, consistent with public safety. Our aim should be that the pathway is used in a way that retains public confidence—that it is being used in accordance with the principles on which the Marie Curie Palliative Care Institute developed it.

I hope that the Minister will agree that we must ensure that the pathway is subject to the very highest levels of scrutiny and that the framework can be allowed to be implemented only against a background of total transparency. There must be discussion with patients or with patients’ families or carers and there must be clearly available avenues through which complaints and concerns can be channelled. I hope that the Minister will assure us that the very serious allegations reported in the media will be thoroughly investigated and that, if any examples of bad practice are found, action will be taken to expose those responsible, to hold them to account and to do everything possible to prevent it from happening again. The experiences at Winterbourne View and hospitals in Worcestershire and the appalling and chilling events that took place in Stafford are too raw in the memory to allow anything else. It is only through audit and disciplinary measures, if and when appropriate, that the Liverpool care pathway will retain the integrity needed for it to be acceptable and the confidence of those who might use it.

Two years ago, I had never heard of the Liverpool care pathway. I first took an interest in it as a consequence of my concerns about and opposition to the legalisation of assisted dying. I was hugely surprised by how widely the pathway was in use. I had no idea that 130,000 patients in hospital care died while on the pathway every year and I do not think that many people realise that today.

[Jonathan Evans (Cardiff North) (Con)]

I am grateful to my hon. Friend for giving way to a fellow Celt. I congratulate him not just on securing the debate, but on the tone in which he has introduced it. He referred to the number of people who are on the Liverpool care pathway, but to help the debate has he done any work on the expansion in numbers since the 1990s? Did we swiftly move to 130,000? Is that a consistent number, or has there been a gradual increase over time? I ask that because of course it is the rolling out of the pathway that may lead to some people having less expertise—less skill—and then, as a result of that, some of the instances that my hon. Friend refers to some poor reporting of?

[Glyn Davies]

My hon. Friend makes a very important point about the need for training and expertise for all those who are responsible for putting people on the pathway and for looking after them when they are on it. I want to come to that later in my comments.

The negative coverage in our national media has probably increased awareness of the Liverpool care pathway. To that extent, I think that it has been a very good thing, but because I do not believe that the scale of the pathway is widely known, I think that it is right to say something about what the Liverpool care pathway is and what it is not in order to set out the context of the debate,. It is certainly not and must never be any form of “euthanasia by the back door”—a phrase that I have heard—nor is it a form of clinical treatment or even any specific type of care. It does not instruct doctors or nurses to provide this or that treatment. What it does is prompt them to consider whether certain treatments are appropriate in individual circumstances. It supports—it does not replace—clinical care. It is no more than a framework of good practice, backed up by training and education, to guide doctors, nurses and other health professionals towards delivering the high levels of palliative care that have been available in hospices for many years. It enables them to be transferred to hospitals, care homes and patients’ homes. It is about the appropriate way to look after a patient who is clearly dying through the last few days and hours of life.

Some other points should be made in this debate. The Liverpool care pathway does not recommend, as some have suggested, that dying patients should be deprived of food and water, although food and water may be withdrawn in individual cases if clinicians believe that that is the right step to take. The Liverpool care pathway does recommend to doctors and nurses that they explain to dying patients, or more often their next of kin, exactly what is happening and why. Secrecy forms no part of the Liverpool care pathway whatever.

It is also important to emphasise that there is nothing irreversible about being placed on the Liverpool care pathway.

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.

Organ Donation

Jonathan Evans Excerpts

Wednesday 30th November 2011 Westminster Hall

[Glyn Davies (Montgomeryshire) (Con)]

This is the first time I have served under your chairmanship, Mr Crausby, and it is a pleasure to do so.

I have several brief comments to make before I start on the substance of my speech. First, I must declare an interest, although not a pecuniary one. I am a member of the Kidney Wales Foundation and it is important that I make that clear at the start. I have been interested in this subject for many years because a very dear friend of mine was one of the first to receive a heart and lung transplant at Papworth. She died about two months ago, but for 20 years we discussed the subject on a monthly basis. We did not agree, but our discussions inspired my interest in transplantation as a whole. In particular, we worked on local dialysis provision in Montgomeryshire.

I thought very carefully about becoming involved in a high-profile way because most of my friends and colleagues in the Kidney Wales Foundation take a different view from me. I am not in favour of presumed consent, whereas nearly all of them are. In my view, the way forward is to ensure that everyone knows about the issue so that people’s views are known when they die. Having a public debate is in itself a very good thing to help to achieve the objectives I want.

I think we all agree about the need to increase the availability of organ donors—those who are in favour of presumed consent and those who want to retain the informed consent system. The difference is that I do not believe that presumed consent will deliver an increase in organs for transplant. The evidence tells me that it makes no difference. The reason I sought this debate is that the Government in Wales have proposed to opt for presumed consent, which would inevitably have an impact on the rest of the United Kingdom and makes this a very proper debate for this Chamber.

I must make it clear that my opposition to presumed consent has nothing to do with ethics or morality, though I believe that there is a strong ethical case for opposition to it. Others, including the Archbishop of Wales, have articulated the ethical arguments much better than I can. It cannot be right to interpret the absence of an objection as a considered declaration of support. They cannot be seen as the same thing. Changing the system from an act of giving by the citizen to an act of taking by the state is a genuine ethical consideration, but my opposition to presumed consent is based not on ethics but on efficacy. There is simply no firm evidence that it will deliver any more organs for transplant.

In the final years of the previous Labour Government, the then Prime Minister, the right hon. Member for Kirkcaldy and Cowdenbeath (Mr Brown), began advocating presumed consent, as some hon. Members here may remember. He established a Department of Health organ donation taskforce. I believe that the chief medical officer at the time also supported a change to presumed consent. The taskforce was instructed to examine presumed consent in detail and to provide a report for the Government. The taskforce consisted of a large committee of specialists under the chairmanship of Dame Elisabeth Buggins, with several sub-committees to consider particular issues. Its report, published in 2008, made it absolutely clear that presumed consent was unlikely to increase organ donation rates in the UK and risked diverting substantial resources—it would cost £45 million to establish and several million pounds a year thereafter—from effective solutions. The report is the most comprehensive analysis of presumed consent ever carried out. It runs to several hundred pages.

[Jonathan Evans (Cardiff North) (Con)]

I have a copy of the Buggins report here. Did my hon. Friend take from his reading of it the fact that at the beginning of the process many of the people who were part of the taskforce were strongly in favour of presumed consent, and it was as a result of the detailed work undertaken that their viewpoint came to be changed? That was a crucial part of what emerged from the report and is highlighted in the conclusions.

[Glyn Davies]

My hon. Friend makes a good point. Because of the brief that the British Medical Association has circulated to Members, I want to quote the report’s conclusions so that we know what the taskforce actually said. One of the main recommendations states:

“The Taskforce’s members came to this review of presumed consent with an open mind, with many sympathetic”

to presumed consent. It went on:

“the more the Taskforce examined the evidence, the less obvious the benefit, and the more multifaceted and multidimensional the issue of increasing donor numbers was revealed to be…The Taskforce reached a clear consensus…that an opt out system should not be introduced”

as it could impact negatively on organ donation.

I was quite shocked to receive the BMA parliamentary brief because it sets out without the slightest doubt to give the impression that the taskforce recommended the opposite of what it did recommend. That is verging on a lack of professionalism. I have huge respect for the BMA and I was very disappointed to receive its parliamentary brief. It will seriously damage my confidence in such briefs in the future, whereas I depended on them in the past.

--- Later in debate ---

[Glyn Davies]

I thank the hon. Gentleman for that intervention. I referred to Spain because that is the example that all those who seek presumed consent have quoted for many years. I then referred to Belgium because when it was shown that the evidence from Spain did not support that argument, the example then used was Belgium. If there is evidence from 22 more countries, then I will have to see the results from them as well. I just do not accept that the international evidence supports the move to presumed consent at all.

[Jonathan Evans]

I would like to explore this issue for slightly longer. The evidence indicates that what is important is the awareness, not the presumed consent. The Minister, on a point that I hope to raise with her later, wrote to me to indicate that awareness-raising, from just undertaking the taskforce report, has resulted in donation rates increasing by 28% over the last three years. Nobody could say that that is because of the system – it is because of communication and information.

[Glyn Davies]

I am hoping to come to this issue if I have time at the end of my speech. It is a crucial issue. I value the help that the British Medical Association has given me over the years. However, the Parliamentary brief from the BMA, which I referred to before, shocked me a bit; so I have gone to some trouble to understand its position. The BMA agrees with the move to presumed consent, and has done for many years. The position of the BMA is of great interest. It has been a vocal supporter of presumed consent since it adopted the policy in 1998, long before the report of the organ donation taskforce, which was a comprehensive study into the issue.

The BMA’s current position was overwhelmingly endorsed a few months ago at its annual representatives meeting, a very important meeting which was held in Cardiff and attended by hundreds of doctors representing regional groups throughout the United Kingdom and some special interest groups. Many dozens of motions were discussed over three days and votes are taken. A vote of 51% of those in the hall makes what is being discussed policy for the BMA. It seems scarcely credible that an important organisation can make policy on a complex issue in this way—as a sort of public speaking competition, rather than on the basis of detailed research. I do not accept that the BMA’s position on presumed consent can be treated seriously until it reforms the way it makes policy on complex issues. Given the influence of the BMA on public opinion, and that patients’ lives are at stake, there is a powerful moral obligation for it to undertake substantial research into this position before it continues to carry forward an issue that in my view damages the cause that it purportedly supports.

What is the way forward for patients who are at the heart of the debate? I want to come to the positive way forward. We know that the rate of organ donation is influenced by three crucial factors. The first is the number of potential donors. With rare exceptions, potential donors are comatose patients on life support machines in intensive care units. Inevitably, the level of intensive care provision is a crucial aspect of organ donation, and it is relatively poor in the United Kingdom.

That is one factor. Identification of all potential donors is another. Every patient who is a potential donor should be given the opportunity to become a donor, by early identification and discussion with his or her family. The Spanish have an extensive system of transplant co-ordinators, involving mainly part-time intensive care physicians. There is a lesson there for the UK.

Consent from the patient’s family is also key. This is influenced by background knowledge of transplantation and organ donation; the professionalism of timing, as to when we approach the family; trust in the medical profession and knowledge of their loved one’s wishes. Spain has a national training programme for its co-ordinators and a 24-hour information helpline open to the press and public, and places a high priority on public relations.

Consent cannot be legislated for. In 1990, the refusal rates in the UK and in Spain were the same, at about 40%. Over the last 20 years, the refusal rate in the UK has stayed roughly the same. In Spain, it has fallen gradually to the current level of 15%. There is a dramatic difference in what has happened in Spain, as a result of the systems outside presumed consent. That is the example that we should be following.

The second report of the organ donation taskforce recommended improvement in transplant co-ordination, which is being implemented. This is where the numbers I referred to earlier become apparent: the huge 25% rise in the UK and the 60% rise in Wales. It is a fantastic achievement. This is the approach we should be taking forward, which leads me to the final part of my speech this morning.

--- Later in debate ---

[Mr Williams]

I am not going to give way to the hon. Gentleman. I will proceed because many others want to speak.

Members of the Select Committee on Welsh Affairs received the request for legislative competence on this matter, although mercifully that was superseded by the referendum result, which conveyed greater powers to the Welsh Assembly. That is why it is now able to proceed in the legislative way that it is. The debate has, of course, been triggered by the publication of the White Paper by the Assembly Government on 8 November, which proposes a soft opt-out organ donation scheme for Wales, with a view to that becoming fully operational in Wales in 2015. Both contributions we have heard this morning have acknowledged the tragically large waiting lists for donors: 10,000 people UK-wide, 500 in Wales. The wider public support was acknowledged by the hon. Member for Montgomeryshire.

It was also acknowledged that earlier committee work had been undertaken in the National Assembly, and the committee was not exactly ringing in its endorsement of a soft opt-out proposal, although it did not rule that out. The then Health Minister opened the matter to public consultation, and some 81% of respondents in 2009 indicated that they were supportive of a soft opt-out scheme.

Despite those statistics and the overwhelming public approval for a scheme, tragically only 29% of us have signed up for organ donation. There has been much mention of the international comparisons. I will not dwell on them, other than to cite again the comparison highlighted by the Kidney Wales Foundation. It looked at 22 different countries with opt-out schemes—not just Belgium or Spain—and found that over 10 years there was a 25% to 30% higher donation rate than for informed consent schemes. I appreciate what has been said about an evidence-based scheme, but we must not be selective in the evidence used. That is critical—we need to look at the whole picture.

I strongly contend that a soft opt-out approach must not be seen in isolation. The Assembly Government is not arguing that a soft opt-out scheme alone will work and do the job that we all wish to see. As the hon. Member for Llanelli (Nia Griffith) said in her intervention, we need to heighten publicity, which is absolutely critical. Initiatives such as the use of the Driver and Vehicle Licensing Agency, so that when people apply for a driving licence they are asked whether they wish to join a scheme, would play an implicit part in a soft opt-out scheme.

[Jonathan Evans]

Will the hon. Gentleman give way?

[Mr Williams]

I will carry on, because I am conscious of time.

Critically, the Assembly Government has also responded to the need to increase infrastructure to cope with transplants. It is clearly developing that: the transplant directorate of the University hospital of Wales in Cardiff is the only transplant organisation responsible for kidney and pancreas transplantation in south and mid-Wales. In March, £2.4 million was spent on the Cardiff transplant unit, which has been opened with a dedicated transplant team and with new recruits of surgical and nursing staff. The Assembly Government also committed £1.5 million to implement the recommendations of the organ donor taskforce. Infrastructure and public information, coupled with a soft opt-out scheme, is the key.

Finally, and critically, we need to address the ethical issue. The soft opt-out scheme has been described as somehow being ethically improper. I think that is probably the view—I hope I do not do him a disservice—of my hon. Friend the Member for Montgomeryshire. That view has certainly been expressed by the Archbishop of Wales. I would not dare to describe him in the glowing way that the hon. Member for Newport West did; I am a member of his Church, and I deeply respect the Archbishop of Wales. He has highlighted the issue of the relative power of the state and the individual.

As a Liberal—call me an old-fashioned liberal—I very much want to see the emphasis on individual choice. The hon. Member for Clwyd South (Susan Elan Jones) alluded to that point in her intervention. There will still be choice—the choice to opt into a scheme is still there. The archbishop’s article in the Western Mail stated:

“Organ donation…ought to be a matter of gift. If one takes organs without consent, on the assumption that a person is tacitly assenting by not opting out, then that is no longer a free gift to others. An organ donation ought to be precisely that…an act of love and generosity.”

I agree with those sentiments, but I do not accept that opting out in any way conspires against the spirit of generosity. That is where public information and the awareness issue are so important.

What we need to do, which is what the Assembly Government seek to do, is to extend that spirit of generosity so that it becomes the norm and so that the discussions that every family will have to have throughout people’s life about such matters are very much the reality. That puts the onus on the individual to make informed choices, and that should be highlighted. A point has been made about relatives and members of families. The soft opt-out option means—this has been made open to consultation by the Welsh Government—that there is a specific role for members of bereaved families, whose views will be taken into consideration.

I perhaps started this process as an intuitive supporter of soft opt-out. I remember going to a meeting organised by the hon. Member for Cardiff West (Kevin Brennan) earlier this year, when we met people who were waiting for transplant operations. There is a healthy impatience, certainly in the Assembly Government and among others of us, to see the issue resolved.

The hon. Member for Newport West talked about his constituency cases. One benefit of the House rising early yesterday was that I was able to watch a little more television than usual. I watched an excellent documentary last night about a young couple from Exeter: 21-year-old Kirstie has been waiting several years for a lung transplant. She struggled through her teenage years, and she even struggled through her wedding day while being unclear whether she could actually survive the day. The highs and the lows—the highs were that on two occasions she received telephone calls saying that a donor was available; the lows were realising that the donor was not appropriate. Miraculously, as she reached the end of her life, a suitable donor was found, and Kirstie is now recovering and enjoying an increasingly full life. Sadly, many of our constituents are not so lucky, which is why many of us are very impatient and why the National Assembly Government have taken the lead in pushing for a soft opt-out option.

--- Later in debate ---

[Jonathan Evans (Cardiff North) (Con)]

I am grateful to be called, Mr Crausby, and I shall be brief.

First, I should like to place on record my thanks to Mr Max Gabe Wilkinson, my former neighbour, who was the founder of the Kidney Research Foundation in Wales. More than 30 years ago, he signed me up to a donor card. I can say to the hon. Member for Newport West (Paul Flynn) that, as the vice-president of the Catholic Union of Great Britain, I have been a declared donor ever since, and therefore this is no prelatory speech.

My concern is to maintain the integrity of organ donation, and confidence and trust in the system. In context of UK policy and its impact on what is happening in Wales, my remarks today will be limited to what has happened in trying to promote more organ donation through the DVLA website. As part of a policy that applies to all of the United Kingdom—the Minister is aware of my concerns because I have written to her—it is legitimate to say to people, “Do you wish to opt into organ donation?” That new system has been in operation since 1 August, but in Wales, there is no capacity to say no. My hon. Friend the Member for Ceredigion (Mr Williams) put his finger on it when he said that there should be the option to say no. The Minister has helpfully written to me to say that there does not need to such an option because people can change their minds and decide to opt in later on. But if we are to have two separate systems, the option in Wales, as one of my constituents has written to me to point out, is that one cannot opt out if one is proceeding to declare a viewpoint on the DVLA website. Therefore, ultimately, if legislation is introduced in Wales—I am not expressing an opinion as to whether that legislation should be passed or not—there would have to be a different approach. Otherwise, one fundamentally undermines people’s ability to be confident that if they want to opt out, they can say so. They cannot exercise that choice on the current DVLA website.

Why is that important? It is important because we need to maintain that trust, and at the same time maintain the legal integrity of the system. Although it has been said that everything will be fine, and never mind about the legal competence, the issue relates to the position of the European Court of Human Rights. In the event of something going wrong, heaven forbid, we could end up with a negative situation in which the process that is adopted in Wales fundamentally undermines confidence in organ donation altogether. Those factors need to be in Ministers’ minds, and that is why I wanted to make a brief contribution to the debate.

[Several hon. Members]

rose—

Contaminated Blood

Jonathan Evans Excerpts

Monday 10th January 2011 Commons Chamber

[Mr Lansley]

I am grateful to the hon. Lady and I entirely endorse her opening and closing remarks paying tribute to all the patient groups. My hon. Friend the Under-Secretary of State for Health has met many of those groups and individuals, and I know that she would heartily endorse what the hon. Lady said about how they have brought these issues time and again to the forefront of attention in the House and the other place. I do not want to underestimate the many in the House and the other place who responded to that and did so very well by bringing these cases forward. I hope that they will see in today’s statement a proper response.

We do not know whether there will ever be a similar case. I hope we can avoid it—it would be much better to avoid it—but if we were ever in a situation where such a consequence flowed from the NHS seeking to do its best to treat patients but such harm nevertheless occurred, I hope we would recognise that, be able to identify it and not allow decades to pass before proper recognition took place.

That brings me to the hon. Lady’s substantive point, which is the relationship between what we are doing and the compensation provided in the Republic of Ireland. As we explained in October, we do not regard these as comparable cases. In the Republic of Ireland, mistakes were made by the Irish Blood Transfusion Service which led to a recognition of liability, leading to a determination of compensation. In this country we are not providing compensation. We are recognising the harm that occurred, notwithstanding the fact that the NHS at the time sought to provide the treatment that it thought was in the best interests of patients.

That harm occurred. As an ex gratia payment and in recognition of the harm that occurred and the distress that followed, we have sought to ensure that there is proper support, financial and otherwise, for the victims and their families. I hope that by getting rid of the anomalies and recognising—in particular, through the work of the clinical expert group—the impact on those with hepatitis C, we are giving the support that those who were damaged should expect.

[Jonathan Evans (Cardiff North) (Con)]

Although I welcome my right hon. Friend’s statement, I should point out that Lord Archer recommended that there should be compensation along the Irish lines. That is a little of the context of what has taken place.

I take the opportunity of congratulating the Under-Secretary of State for Health, my hon. Friend the Member for Guildford (Anne Milton) on all the work that she has done on the matter, which I know has been welcomed across the House.

May I ask my right hon. Friend about the position in Wales? I was a little taken aback by the fact that he said that he intends to speak to fellow Ministers in Wales. I have a statement from the Welsh Minister indicating that as far as she is concerned, these issues come next to be considered by her in 2014, which was the previous agreement with the Department of Health. Many of my constituents will want to know what discussions have so far taken place and whether the arrangements will be replicated in the Principality.

[Mr Lansley]

The Under-Secretary will have heard what my hon. Friend said. I am grateful for it, too.

I am speaking on behalf of England in this respect. As the Department of Health, we administer the payments system. We had to reach the decisions and we have done so. We always intended to do so as rapidly as we could for England, but as I explained in my statement, these decisions have yet to be made by the devolved Administrations. It is reasonable for them to see the review report that I am publishing today, not least the clinical expert review that goes with it, in order for them to make their own decisions. Those are decisions that they must make, but if they wished us to continue to administer the system on the same basis across the United Kingdom, we would be happy to do so.