New Medicines
The next item of business is a debate on motion S4M-05664, in the name of Jackson Carlaw, on health.
15:55
The Conservatives have framed the motion with a view to making qualitative progress on the subject of cancer in this afternoon’s debate. In that spirit, we will support the Labour amendment and, if the Scottish National Party amendment is supported at decision time, we will support the amended motion. Why? Because no party here has a monopoly of concern on the subject of cancer. Why are we here as politicians? We are here, sometimes, to embrace big issues and make progress on them on behalf of the people of Scotland. Such was the progress that we made on free personal care. Similarly, such must be the progress that the Parliament now makes on the treatment and the delivery of the treatment of cancer.
I acknowledge that there is commitment throughout the chamber. A quick look at motions that are available for members to support will show a motion from John Pentland on the Little Princess Trust; a motion from Jackie Baillie on international childhood cancer day; a motion from Stuart McMillan on the Ellen MacArthur Cancer Trust sailing hub; a motion from Colin Keir on nico35 and fundraising for various cancer charities; a motion from Kevin Stewart on CLAN Cancer Support; a motion from Siobhan McMahon on NHS Lanarkshire’s cervical screening award; and a motion from Jackie Baillie on cervical cancer prevention week. Every side of the chamber has members who are committed to advancing the progress that the Parliament can make on the treatment of cancer.
The majority of my colleagues have supported Sandra White’s motion on the early detection of breast cancer. I hope all members support the motion. We all have experience of family, friends and colleagues who are facing or who have faced the ordeal of cancer and who, individually, have inspired us in the way in which they face that ordeal and go about their lives as they come to terms with their condition.
As a teenager, before I was ever interested in politics, I would make my way through town on the way home from school and see, underneath the canopy outside Marks and Spencer in Argyle Street, a frail lady of I do not know what age, there in all weathers, shaking a tin on behalf of cancer research. As a young person, it inspired me that here was somebody who was committed in that way, campaigning for funds for a disease that, at the time, many people refused to talk about in public and for which many of us thought that there would never be a cure.
While Sandra White’s motion on breast cancer places the emphasis on early detection, we live in an age of remedy and relief if not yet cure. In 2010, Professor Sir Mike Richards noted that, when it came to making available drugs that had been developed in the previous five years, the UK was 12th out of 14 countries. When it came to making available drugs that been developed in the previous 10 years, we were 10th out of 14 countries. That led to the introduction in England of the cancer drugs fund, since when some 25,000 people in England have benefited from drugs that are available under that fund.
Those drugs include, famously, and now also available by exception in Scotland, abiraterone for prostate cancer; cetuximab for colorectal, breast, kidney and brain cancer; everolimus for kidney, neck and oesophageal cancer; lapatinib for breast cancer, rituximab for non-Hodgkin lymphoma; sorafenib for kidney cancer; bendamustine for non-Hodgkin; fulvestrant and eribulin for breast cancer; and ipilimumab—which I will say more about later—for melanoma and skin cancers. Those are the top 10 of 23 treatments for cancer that are available in England but not yet available in Scotland.
The only point that I will make this afternoon that may be regarded as politically partisan is that there is sometimes suspicion on our side that the reason why the Scottish Government did not introduce a fund for cancer drugs was that the initiative initially came from a Conservative-Liberal Democrat coalition Government elsewhere. It is unfortunate if that is the impression that has been created, even if it is not the reality or the truth.
Will the member take an intervention?
I will in due course.
It is not a choice between detection and making drugs available—those are two halves of the approach that the Parliament should ensure is made on behalf of people.
I know that Mr Carlaw was making a fleeting political point, but I will quote to him what Breakthrough Cancer Scotland said:
“Breakthrough would suggest that rather than introducing a Cancer Drugs Fund in Scotland at this stage, when it is likely to have limited impact before the implementation of VBP”—
value-based pricing—
“in 2014, a thorough review of the effectiveness of current drug access system in Scotland is undertaken.”
That review is under way.
Melanoma Action Support Scotland stated that it does not want
“a cancer drugs fund; treatment is required for other life limiting diseases too”,
and MacMillan Cancer Support stated:
“we do not support the introduction of a cancer drugs fund in Scotland”
The member has made his point.
Many of the quotes used by Mark McDonald are from papers that were issued at the commencement of the cancer drugs fund in the expectation that something better would follow in Scotland in the interim. However, we have not made progress in the interim. In consequence, some 25,000 people in England have had access to treatments for cancer that have not been available in Scotland. By calculation, some 2,500 people in Scotland have been denied access to life-saving treatments.
Oncologists made clear the consequences to the Health and Sport Committee during its inquiry. They said:
“If the situation remains with regard to poorer access to new medicines, it will negatively impact on this aspiration, due to a drift in oncologists from within Scotland conducting less innovative research. In addition, due to Scotland in many situations no longer treating patients with the standard of care used in other parts of the world, Scotland may not be able to take the lead or take part in global clinical research studies”.
We cannot afford to allow Scotland to be marginalised in the future development and treatment of cancer.
I pay tribute to the Cabinet Secretary for Health and Wellbeing. He has commissioned the Routledge and Swainson reviews and, in consequence of the Health and Sport Committee inquiry, he is, to some extent, seeking to escape from the electric policy chair—if I can call it that—of previous Government policy.
We recognise that, from next year, potential value-based pricing will change the emphasis and allow an assessment of the progress of a drug to be calculated. It will put the boot on the other foot and place the emphasis on the pharmaceutical companies to make these drugs available.
Nanette Milne will talk about Tina McGeever and Mike Gray. I would like, by illustration, to talk about Ken Macintosh, who hosted a dinner on behalf of Mascot Melanoma Action Support Scotland. At the event we heard from Girish Gupta, NHS Lanarkshire, and from Tim Crook, consultant medical oncologist at the University of Dundee. We also heard from Paula McIntyre, whose husband, Scott, died last year. He was given access to ipilimumab through a clinical trial—the drug gave him six additional months of life.
In Joan McAlpine’s article in last week’s Daily Record, she summarised that as:
“New drugs are often of negligible benefit—they prolong life for just a few weeks or months—and only then in particular patients.”
Will the member take an intervention?
No—I want to make the point.
I am not someone who gets overly emotional in politics—I have been around long enough to know that the hard knocks come and they must be accepted, although my children tell me that I cannot get through “ET” or the climax of “The King and I” without blubbering. Nonetheless, it would have taken a hard heart not to recognise that the six additional months that were afforded to Scott McIntyre and his family—in which he had a quality of life that allowed his family to prepare for the end that finally came—were not just to be casually dismissed but were of enormous value to him and his family.
It is essential that the Government—now that it has introduced the rare conditions medicines fund, the principle has been established—recognises that it is time to make progress on addressing the deficiency that exists in the SMC assessment process of affording access to drugs.
I do not care, frankly, whether it is now called a cancer drugs fund in Scotland—it may be called an innovation fund; it may be called a chief scientist’s fund. What is required before we get to value-based pricing—and on the back of the reviews that are taking place and following the introduction of the rare conditions medicines fund—is a recognition that cancer is the one condition that we are not serving the people of Scotland effectively with. We need a fund that allows the gap to be plugged between the two. One small step for cancer; one giant leap for cancer sufferers.
I move,
That the Parliament recognises the need to facilitate access to new medicines that are not routinely available or have not been approved by the Scottish Medicines Consortium (SMC); notes that the current arrangements potentially deny NHS patients in Scotland access to some life-enhancing and life-extending drugs that are available to NHS patients in England, particularly for the treatment of cancer; accepts that, while the routine approval of individual drugs is rightly a matter for the SMC, it is equally the case that it is a decision for ministers to allocate appropriate alternative funding for medicines that are not routinely available in Scotland; notes concern at the slow uptake of new medicines in Scotland; believes that such problems need to be addressed to promote Scotland as a centre for medical innovation and research to benefit patients in the future, and calls on the Scottish Government to come forward with funding to afford access to new medicines in Scotland for cancer patients and others.
16:05
This is a difficult and very sensitive subject. I think that we all recognise that making decisions about which medicines to provide for national health service patients in Scotland—or, indeed, anywhere else—is highly complex and sensitive. That is particularly the case when decisions are made about medicines to treat chronic or life-limiting conditions. Therefore, it is vital that such decisions are taken by people who have the necessary knowledge, skills and experience to do so—in other words, by clinicians, not politicians.
Does the cabinet secretary recognise that public trust and confidence go to the heart of the debate, and that the public have a right to expect that if their clinician believes that they would benefit from a medicine in the course of their treatment, that medicine should be made available? Does he agree that, ultimately, that will be the test on which the review of the individual patient treatment request process will be judged?
I will deal with some of those points later in my speech.
Thousands of medicines in various doses and formulations are available to clinicians in the UK. In Scotland, around 15,000 medicines can be prescribed by our doctors for various conditions. The Scottish Medicines Consortium appraises around 60 new medicines each year and publishes advice for NHS boards on their clinical effectiveness and their cost effectiveness. A significant number of those medicines are described as “me too” medicines, which means that they are one of many that are available to treat a particular condition.
The SMC was given the important task of providing national advice for NHS boards in Scotland on which medicines offer the clinical outcomes that clinicians require and represent value for money. In providing such advice, the SMC recognises that when a new medicine is one of many that are available to treat a particular condition, local clinicians are best placed to decide whether that newly launched medicine should be added to the formulary list of medicines that are available for routine prescription for the patient population, or whether there is a preference for prescribing those medicines that they have experience of using, and for which the safety profile is known and trusted.
When an NHS board chooses not to add a new SMC-accepted medicine to its formulary, clinicians may still seek NHS board agreement to prescribe it for individual patients through an extremely straightforward non-formulary request. When the SMC does not recommend a new medicine, NHS boards are not expected to routinely prescribe it, but NHS clinicians can pursue access to such medicines on a case-by-case basis for individual patients when they believe that they can provide a robust clinical case to support it. Those are local clinical decisions, which are based on the clinical circumstances of each patient.
I have listened to concerns that some clinicians and patient groups have raised about differences between the availability of medicines—cancer medicines in particular since the Department of Health launched the cancer drugs fund in England—in Scotland and their availability in England. Although I can fully understand those concerns, it is important to note that comparisons between the medicines that are available in England and those that are available in Scotland are not always valid. Indeed, there are some medicines that have been approved for use in Scotland that have not been approved in England.
Lists of medicines do not tell the whole story about available treatment for cancer or improvements in cancer care. Some improvements are the result of earlier diagnosis or developments in technologies other than medicines. The National Institute for Health and Clinical Excellence, which is the equivalent down south of the SMC, looks at a limited list of new medicines, but the SMC looks at all new medicines. That means that there are SMC-approved medicines available in Scotland that are not available in England. For example, imatinib, which is used for the treatment of certain gastrointestinal tumours, has been accepted for restricted use by the SMC in Scotland but has not been recommended by NICE. Another example is mercaptopurine, which is used for the treatment of certain leukaemias. Although it has been accepted by the SMC, there is no NICE advice for it. That can lead to significant variation in the use of the medicine in the NHS in England, never mind between Scotland and England. The appraisal of new medicines is dynamic, with new and updated advice published every month north and south of the border.
Scotland’s decision not to introduce a cancer drugs fund reflects our policy position that ring fencing funding for a single disease area effectively diverts resources away from other conditions, including those that are severe or life limiting. For the record, I point out that the fact that it was proposed by a Tory Government had nothing to do with our policy decision in Scotland.
In providing advice to the Public Petitions Committee in the Scottish Parliament just over a year ago—and well after the introduction of the cancer drugs fund in England—key cancer charities including Breakthrough Breast Cancer, Macmillan Cancer Support Scotland and Myeloma UK recognised that a cancer drugs fund was not a necessary policy measure in Scotland. The view is also shared by the Welsh Government.
That said, I remain committed to considering any way in which we can genuinely improve access to clinically and cost effective medicines that might improve outcomes for patients in Scotland. That is why I have asked Professors Routledge and Scott to oversee a review of how new medicines are introduced in the NHS in Scotland from national appraisal by the SMC through to local NHS board decision making, including IPTRs. I recognise the concerns that have been expressed about how the IPTR process is working and the review—and, no doubt, the review by the Health and Sport Committee—will want to address them.
Finally, the substantial amount of money that is needed to create a separate cancer drugs fund will have to come from elsewhere in the health budget, and those making this proposal must tell us where that money will come from and how much they want to put into the fund so that we know what the policy choices are. It is a difficult decision that politicians are going to have to face up to, but I hope that across the chamber we can at least recognise that, although we might express different points of view on this subject, we should do so in a tone that is appropriate for the patients who are looking on.
I move amendment S4M-05654.2, to leave out from “potentially” to end and insert:
“for all aspects of access to new medicines are subject to an ongoing review; welcomes the introduction of the £21 million Rare Conditions Medicines Fund as an interim measure in response to advice by Professor Charles Swainson, who is undertaking the review of individual patient treatment request processes; accepts that routine approval of individual drugs is rightly a matter for the SMC and that, should the review highlight areas where these processes can be improved, these should be enacted quickly, and believes that the actual benefit to the patient and their quality of life must be the key consideration in determining the use of any new treatment or medicine and that the voices of patients and clinical experts must be heard in the assessment process.”
16:12
I welcome the opportunity to debate access to new medicines in the NHS and the tone of the speeches made by Jackson Carlaw and the cabinet secretary. I also welcome the new medicines review that the cabinet secretary has initiated.
It is right that we consider how the SMC operates. Although its work is highly regarded, it is nevertheless operating under certain constraints as a result of the criteria that the Scottish Government has set. Equally, it is right that we review IPTRs. Clinicians and patients have made it clear to us that those are an obstacle to patients getting the medicines that they need and that the approach varies across Scotland, and we must consider those comments.
Like the SNP, Labour did not support the cancer drugs fund, not because it was proposed by the Tories but partly because we genuinely believed that other equally serious conditions also needed improved access to medicine and that an emphasis on early treatment and a preventative approach led to better outcomes. The operation of the cancer drugs fund in England has also led to a bit of a postcode lottery in places, which is not, I believe, desirable.
That said, the current IPTR system is no longer acceptable. Clinician after clinician came before the Parliament’s Health and Sport Committee to criticise it—and they were very brave to do so. They were being placed in the invidious position of recommending patients who they knew would benefit from the drug required in the knowledge that their chances of securing agreement from the health board were very slim.
Let me point members to the words of Dr Stephen Harrow, who is a consultant oncologist at the Beatson. He told the committee that he works in a deprived area in the west of Scotland and that he has to tell patients that there are more drugs that are not available than drugs that they can access.
It took the shocking case of Iain Morrison, which was highlighted in the chamber, to prompt action. He is a man with bowel cancer who had to pay £1,700 a fortnight for the drugs that help to prolong his life. The NHS charged him VAT and an administration fee for the privilege. Thankfully, he now has access to the drugs, but I understand that that took more than one request and the assistance of his constituency MSP.
We heard the case of Anne Fisher, who is a mother of three from Greenock who has cancer. She cannot get access here to drugs that would be available if she lived in England. That simply cannot be right by any measure.
There is also the case of a constituent of mine, whom I shall call Mrs Smith, although that is not her real name. In 2007, Mrs Smith was diagnosed with bowel cancer. Her daughter and her husband contacted my office in 2012 after she had had two IPTRs and appeals rejected. As a result of tests that experts carried out, we know that she would benefit from a 12-week course of cetuximab. Her third IPTR last October was also unsuccessful. In another health board area, she would have been given the treatment.
I say to the cabinet secretary that that simply cannot go on. Whatever the outcome of the review, the cabinet secretary must ensure that, at the very least, there is not that appalling postcode lottery in Scotland. Access to medicines must improve, and there must be consistency of application across all the 14 health boards in Scotland.
You are in your last minute.
Fourteen different ways of doing things is no longer acceptable.
Let me turn to the orphan drugs fund. That is very welcome, but it must not just be a sticking plaster. Clarity is needed on how it will be accessed, what conditions will apply and how it will be funded beyond April next year. Indeed, concerns have been raised by many, including the Daily Record, which reported that, if every eligible cystic fibrosis sufferer in Scotland were to be prescribed Kalydeco, that would cost £14.5 million. Kalydeco is just one of a number of orphan medicines. We need to be clear about how access will be decided.
I was reflecting on the previous, rather robust and sometimes humorous debate about capital budgets. That made me think that the cabinet secretary has no obstacle to doing something. The issue is not Westminster’s fault; it is the responsibility of all of us. I know that the cabinet secretary, unlike his predecessor, has moved quickly to set up the review. As people across Scotland are waiting for life-saving treatments, can he move equally quickly to set up new arrangements that will work in their interests?
I move amendment S4M-05654.1, to insert at end:
“; welcomes the New Medicine Review, which will consider the processes that facilitate access to new medicines, and the fund for orphan drugs that was announced in January 2013; notes serious concerns regarding the system of individual patient treatment requests, and calls on the Scottish Government to ensure that the views of clinicians are central to determining issues of access to medicines.”
The debate is extremely tight, and we have already lost a member from it. I ask members to take only their four minutes.
16:18
I welcome the opportunity to debate a very serious and sensitive issue, particularly as a member of the Health and Sport Committee, as the issue forms part of our current work plan.
I welcome the Scottish Government’s £21 million rare conditions medicines fund, which is a response to the interim recommendations from Professor Charles Swainson, who is leading the review of the individual patient treatment request system. I hope that that review, along with the work that Professor Philip Routledge and Professor Bill Scott are doing on the new medicines approval process of the SMC and the implementation of SMC advice by health boards, will help to improve access to medicines in Scotland and ensure that the system is as flexible and responsive as it can and should be. The review is on-going, of course, and we await the final report to the Government in the spring. I note the cabinet secretary’s undertaking to take forward the recommendations. The Government therefore is listening and has listened to the concerns that have been raised by some of our clinicians and patients on access to new medicines.
As the Conservative Party’s motion also refers to the need
“to promote Scotland as a centre for medical innovation and research”,
I want to reflect on the Scottish Government’s efforts in that area. If we consider, for example, its statement of intent for innovation in health, which was launched last June, we will see that it is clear that it is promoting innovation and excellence through the NHS, including new medicines, and that that is very much linked to biosciences and the employment and sustainable growth that we all hope that that sector will continue to generate.
There are projects such as the Edinburgh BioQuarter and the partnership between BioCity Scotland at Newhouse in Lanarkshire and the University of Dundee, which has attracted the biggest-ever investment of its kind in Scotland. European investment of £100 million for a drug discovery project suggests to me that Scotland’s life sciences sector, supported as it is by our world-class universities and their research capability, has every opportunity to grow and flourish.
I also want to touch on the issue of the cancer drugs fund. I recognise of course that it is a very sensitive matter and one that confronts policy makers and the medical profession in all publicly funded health systems. The difficulty in accepting the principle of a special fund for cancer drugs is that we as policy makers implicitly assert that cancer is somehow more significant than other serious long-term or life-threatening conditions. I do not believe that that is our task or that by so doing we would serve the wider interests of all those who rely on our national health service.
I understand the point that the member is making, but she has just referred to the £21 million that has been made available for the rare conditions medicine fund. Has that not, in fact, established the principle of committing funding to rare conditions, which now exclude cancer?
I speak as somebody who has worn both hats: one as a policy maker and one as a cancer victim and survivor. I am therefore acutely aware of how cancer sufferers and their families feel. However, what I want to do is help prevent people from getting to the stage where they need cancer drugs. That is why the Scottish Government’s £30 million for the detect cancer early programme is so important.
The Scottish Government is taking the issue of access to new medicines extremely seriously and is reviewing the processes involved in a detailed and comprehensive manner. Ministers have already indicated and demonstrated their willingness to act on interim recommendations and allocate significant funding. All of us in the chamber are extremely concerned that people with the clinical need to access new medicines can and should do so. The Scottish Government is no less committed to achieving that aim and it will do so while protecting the fundamental principles of universal provision that underlie our NHS. I support the Government’s amendment.
16:22
I am sure that we will hear a lot in the debate about the National Institute for Health and Clinical Excellence, the Scottish Medicines Consortium, individual patient treatment requests, quality-adjusted life years—QALY—costs, modifiers, area drug and therapeutic committees, value-based pricing, new duties and so on. If anybody is confused after hearing that list, they will know why we need a review into what is a complex set of arrangements that is supposedly designed to ensure that people get access to the medicines that they require when they face serious circumstances.
I will not say too much about the Health and Sport Committee’s point of view on the issue, because we have not come to a view on it, so I will be careful in that regard. However, I am very proud that we have been able to help push the issue along.
I would argue that pushing it along was required. The then Cabinet Secretary for Health, Wellbeing and Cities Strategy said in the chamber on 29 September 2011 that she would give “further consideration” to the role of area drug and therapeutic committees and that she would need to look at that issue and that of individual patient treatment requests to inform the Government’s point of view. Indeed, I was in correspondence with the cabinet secretary at that time and was told in January 2012 that the chief medical officer for Scotland and the chief pharmaceutical officer for Scotland had convened a clinical group that would focus on ensuring timeous consideration of SMC processes and would look at individual patient treatment requests. It has therefore taken us a wee while.
It would be remiss of me not to recognise the important role played by the people who campaigned to get access to medicines not just for themselves and who were seriously denigrated in a recent article in the Daily Record—one of them is a constituent of mine. They have done a good job in bringing the issue to the Parliament and have campaigned not just for themselves but against an unjust system that they found difficult to understand and that denied them life-changing medicines.
I think that the member was referring to my article in the Daily Record and I thank him for taking an intervention from me, which Mr Carlaw did not have the guts to do.
The article in the Daily Record was well balanced and considered the sensitivities of the issue. The drug that concerned Mr McNeil’s constituent was one for which NICE in England gave consent only after the pharmaceutical company gave a discount, which is not available in Scotland. Does the member agree that there is an issue—
Please be brief.
Does the member agree that there is an issue to do with pharmaceutical companies holding the health service to ransom—
The member will speak in the debate. I hope that I will be given additional time.
I am afraid that this is a very short debate.
I accept that the premise of Ms McAlpine’s article was that politicians should not be involved in the process at all. However, we set the parameters and we provide the money, so we have a legitimate role in the process, which I have described.
We have debated the issue, but we have delayed and dragged our feet in dealing with a process that is acknowledged to be failing people.
You must conclude, Mr McNeil.
That is why the cabinet secretary instigated a review of the process.
It matters that we lost precious time. That time was not as precious for us as it was for Anne Fisher, whose access to a particular medicine has been determined through procedures that are being reviewed and which the Parliament has found to be not fit for purpose. It is time that we reviewed Anne Fisher’s case.
I advise members that we might have to lose another speaker from the debate. Members must take interventions in their own time.
16:26
I welcome the debate, although I cannot accept the Conservative motion. I will explain to Jackson Carlaw why that is the case.
Mr Carlaw will not share this view, but I think that the Conservatives are creating the perception that drugs that are not routinely approved by the SMC should pretty much always be approved by another method. All drugs are not routinely approved, whether through method A, method B or method C. That has never happened in Scotland or anywhere in the UK. I say gently to Mr Carlaw that he is creating a false perception that all new drugs will be made available one way or another. That is not the case.
There is also a false perception about individual patient treatment requests. It is thought that any patient who is not prescribed a drug can be encouraged to fill out an IPTR form, even when there is little hope of the drug being approved.
That is the clinician’s decision.
I hear Mr Simpson speaking from a sedentary position. I point out to him that there is a patchwork approach to IPTRs across health board areas. There must be a reason for the lack of consistency across the country.
Mr Carlaw namechecked cancer, but to single out cancer for special treatment is to set a dangerous precedent. The outgoing chair of NICE, Sir Michael Rawlins, said in the context of the cancer drugs fund:
“There are other rotten diseases apart from cancer. To limit it to cancer has always made me uncomfortable”.
The incoming chair of NICE, Professor Haslam, said:
“there are other conditions that are as serious as cancer and we should not discriminate against those because they do not have as frightening a name.”
We have to be careful. We must take cancer incredibly seriously; we must also ensure that other serious and life-threatening conditions are not regarded as second class. An equitable approach must be taken. That is a difficult job and it is a job for the SMC rather than politicians. Politicians should get the process right and then ask the SMC to make its judgments based on that process.
Not just the outgoing and incoming chairs of NICE but Prostate Cancer UK, Breakthrough Breast Cancer, Myeloma UK, Macmillan Cancer Support and others support appropriate treatment while rejecting the idea of special treatment for cancer in the form of a cancer drugs fund.
Difficult as the decisions are, the SMC must make them and when it does so it must consider not just cancer but heart disease, multiple sclerosis, cystic fibrosis and other conditions—the list goes on and on. The SMC has the unenviable task of comparing such conditions and working out from the best evidence what drug has the best impact for patients and is cost effective. That is a huge challenge for the SMC, which is a world leader in the process. I am sure that the review will improve the process.
I also want to talk a little about funding. Funding of cancer drugs cannot be talked about in a vacuum.
You have 30 seconds left.
The Cabinet Secretary for Health and Wellbeing, Alex Neil, launched the bowel cancer detection hotline just the other day. I will give the number: 0800 0121 833. I encourage all men over 50 to call that hotline and get themselves screened. [Interruption.] No, Jackie Baillie, I am not over 50, but I am almost there.
Detect cancer early initiatives cost money. If Mr Carlaw wants to spend money in one place, he has to take it from another place and we have to get the balance right. I believe that we have the balance right, but the process can be improved. I wish that we could talk more about issues with IPTRs and rare conditions—
Mr Doris, you must finish.
It has been identified that rare conditions are not suitably dealt with under IPTRs—
I am afraid that you must finish now.
The review will deal with that.
16:30
I was a member of the Public Petitions Committee in 2008 when Mike Gray from my region presented a petition to Parliament while suffering from terminal bowel cancer, which was being treated by the non-formulary drug cetuximab.
Mr Gray had initially paid for that drug himself after his consultant’s request for it under the exceptional prescribing procedure had been turned down by NHS Grampian. He had found the procedure obscure and difficult to navigate, and in his state of health that was extremely stressful and upsetting. He brought the petition to Parliament to try to ensure that a better process would be put in place for future patients, so that they would not have to undergo the traumas that he experienced.
In the end, Mr Gray was allowed his cetuximab under the NHS, and, indeed, he was reimbursed for the significant costs that he had previously faced up to. Sadly he did not live to see the results of his petition, but his wife, Tina McGeever, worked tirelessly alongside the committee to secure the new IPTR procedure, which was put in place by the then health secretary to make it easier for patients to access modern non-formulary cancer drugs that had been recommended by their clinicians as being likely to extend and to benefit their quality of life.
Everyone was hopeful that future cancer patients would experience a simplified, transparent procedure across Scotland that would allow fair access to modern cancer medicines when their clinicians felt that they were justified. However, despite three CMO guidance documents issued to health boards in as many years, there is as yet no significant evidence to suggest an improvement in access or even a significantly reduced level of inequality across health boards in the implementation of the IPTR process. I know that Tina McGeever and many of us here were very concerned to learn that Christine Grahame’s constituent, Ian Morrison, is currently having a very similar experience to Mike Gray and is having to fund cetuximab treatment himself. The review of the IPTR process that the cabinet secretary has set up is very welcome.
In the meantime, a fund such as the cancer drugs fund, which was established in England but refused in Scotland on the grounds that it would be discriminatory against non-cancer patients, could have helped nearly 2,500 Scottish patients so far. Although we welcome the rare conditions medicines fund, it will clearly not benefit patients such as Ian Morrison, and it is awful to think that patients unfortunate enough to develop their cancer in Scotland are not getting some of the new drugs that are now available in England and elsewhere.
Moreover, as oncologists who gave evidence recently to the Health and Sport Committee pointed out, because patients here do not have access to the medicines, they will not get the next-generation state-of-the-art drugs when they undergo clinical trial, because the new drugs will be judged against those that are currently not approved or available in Scotland but regarded as standard therapies elsewhere in the UK.
That is already leading to some difficulty in recruiting expert staff in our hospitals, and it could result in a drift of experience from Scotland.
You have one minute left.
If that happens, we could soon lose our position as a leader in cutting edge medical research.
No one disagrees that new drugs require assessment or that the SMC does that with a high degree of expertise and professionalism, but current assessment methods have been shown to disadvantage some disease areas. I hope that the Routledge review will result in further evolution of current methods to allow a wider assessment of a medicine’s value.
The cancer drugs fund in England and the proposed rare conditions medicines fund in Scotland are intended to bridge the gap until value-based pricing is introduced next year. However, we must remember that the new pricing mechanism will apply only to drugs that come on stream after its introduction. Cancer patients who need currently available non-formulary drugs will still lose out unless some form of funding is put in place for them to gain access to those medicines.
I am afraid that you must finish.
I fully endorse the motion in Jackson Carlaw’s name and the Labour amendment.
I am sorry, but I can give the next two back-bench speakers only three and a half minutes each.
16:35
I declare an interest as a survivor of cancer who takes cancer medication every day.
It was a life-changing event for me to get a cancer diagnosis, experience the fear and loneliness that went with it, and depend totally on our wonderful national health service. Early detection, prompt and skilful treatment, and aftercare from Maggie’s Centres enabled me to get on with my life and be here today. I count myself lucky, but I now take nothing for granted.
Having had that experience, I cannot begin to imagine how it must feel for somebody to be told that they have cancer but will not get help because of anomalies in the system, whether because of money or where they live. I know that choices must be made, but we could at least allow cancer patients to retain their self-respect and not be reduced to lobbying and campaigning for the chance that was freely offered to me.
It is clear from the debate so far that we must have a robust, fair and transparent system for access to medicines in our health system. The evidence to the Health and Sport Committee’s continuing inquiry has provided a crucial insight into the issued faced not only by patients and their representative organisations but by the healthcare professionals who are trying to work within the bounds of a complex system. I thank the committee for its continuing work on the matter.
The individual patient treatment request system comes up time and again in the debate on access to medicines that are not routinely available. It seems that the number of IPT requests that are made each year is relatively low. Anecdotal evidence also indicates that the level of submissions to, and patient participation in, the IPTR system varies across health boards in Scotland. That may, of course, be down to a variety of factors, including the cumbersome nature of the process and the time required for each application. It certainly feeds into existing uncertainty about the system’s fairness, with patients being left feeling that they are in a postcode lottery.
In many cases, the reason why a patient is not offered a certain medicine or treatment is complex. However, for those who have been diagnosed with a rare or complicated illness, it is often the end of a long, difficult process and, by the point of diagnosis, many simply wish to begin treatment. For them then to discover that a series of barriers—whether real or perceived—lies in the way of access to a drug that could assist them is potentially devastating news. Although there is an appeals process, it is another matter whether the patient or their consultant will want to go through it.
We recognise the need for effective community engagement in the delivery of local health services, but we must also recognise the need for effective engagement with patients at a higher decision-making level in matters such as access to new medicines.
Among the campaigners and health professionals who recently gave evidence to the Health and Sport Committee, there appeared to be a level of confusion about different health boards’ interpretation of the current system for accessing medicines. That is despite the Scottish Government and the chief medical officer in Scotland publishing good-practice guidance on the framework for, and consideration of, IPTRs. If, as the motion from the Conservatives suggests, we move to introduce new funding, it must be done in a way that does not exacerbate the current postcode lottery but puts fairness of access for patients at its heart.
16:38
The subject is emotive and, on emotive subjects, it is really important that we ensure that the words that we use are always carefully chosen. We must be careful about using the term “life-saving” when many of the medications about which we are talking are life-extending, rather than life-saving, medicines. We must be very careful when we use such terms in the chamber.
I refer to the author Dr Ben Goldacre, who writes the “Bad Science” column for The Guardian and has also written a book called “Bad Pharma: How drug companies mislead doctors and harm patients”. In that book, he says:
“Sometimes ... a deceptively simple explanation for a complex phenomenon can be very powerful; it can prime the reader to accept a specific treatment, but it can also change our whole cultural understanding of a disease.”
To illustrate that point, he examines the media coverage about herceptin. Much of that coverage took place before the drug had even been submitted to NICE and any of the clinical data was in the public domain. However, there was already a concerted media campaign for NICE to approve herceptin.
I will focus some of my speech on that point. While we are talking about the availability of medicines, we must focus on a stark point, which relates to trials and clinical data. A briefing that I have received says:
“The current best estimate is that half of all the clinical trials that have been conducted and completed have never been published in academic journals, and trials with positive results are twice as likely to be published as others. This figure comes from a systematic review conducted in 2010”.
If we are to discuss seriously the availability of medicines, we must do so on the basis of all the available data that relates to the medicines that we are discussing—otherwise, we will fail patients and the public.
The briefing that I have received also says:
“We are not aware of any UK legislation requiring the results of all trials on all drugs in current use to be made available. There is legislation requiring disclosure of adverse events and other monitoring of clinical trials within the UK, and regulation for ‘good clinical practice’ in the conduct of trials, by the MHRA. This legislation does not address biased under-reporting of clinical trials and should not be confused with the issue of missing results.”
I signed up today to the all trials campaign, which calls for the results of all clinical trials to be published, regardless of what those results are. A huge number of individuals have signed up; I will quote just one, because time is limited. The campaigner Lynn Faulds Wood said:
“good information about drug performance & trials means life or death to many patients but we are frequently not getting it. It is appalling that pharma companies can choose how much to tell us & hide results they don’t like.”
You have 30 seconds, Mr McDonald.
I hope that all members will back the all trials campaign to ensure that, when we discuss the availability of medicines in the Parliament, all the information is available to us.
The position of rare conditions is disanalogous, because the patient cohort for such conditions is so tiny that the likelihood of medicines being affordable is virtually nil. That has been borne out in evidence to the Health and Sport Committee.
You must conclude.
The rare conditions fund does not provide an analogy that can be applied to conditions that have a much wider patient cohort.
I call Dr Richard Simpson, who has a maximum of four minutes.
16:42
Is it me now?
Yes, please.
I am sorry, Presiding Officer—and I have just used up some of my time.
Access to medicines is a difficult area. Of course it is correct that politicians should not be involved in individual decisions—that would be anathema—but it is wrong to say that we as politicians are not involved. As Duncan McNeil said, we set the framework and provide the money. The framework and funding are at the centre of the debate. Joan McAlpine’s article was not helpful in that respect.
Will the member take an intervention?
I will not—I am sorry. Joan McAlpine had a long go before.
There is general support for the Scottish Medicines Consortium, which has not wavered, although people look forward to increased public participation. The fact that all medicines that industry submits—not just those that politicians refer—are reviewed is an important differential statement made by Scotland, in comparison with what happens in England.
Spending on medicines in the UK is lower than in the rest of Europe. In Scotland, the spending level on innovative medicines used to be the highest among the four countries in the UK, but it is now the lowest. That change is of some importance and I will return to it if I have time.
Jackson Carlaw emphasised the almost universal experience of cancer and the equally universal desire for a cure—or if not a cure, then relief or a remedy. The development of cancer treatment has almost always been incremental. Mark McDonald made a point about treatment not being life-saving, but I say to him that improvements are almost always incremental. When I was a junior doctor, children with leukaemia survived for only a year or two, whereas they now survive with a normal life expectancy. That did not happen in one blinding flash; it happened because a series of drugs was added to, mixed and improved over time.
Will the member give way?
I am sorry—I do not have time.
If oncologists tell us that they do not have standard international treatments—the Health and Sport Committee was given that evidence—we really have a problem. We must be sure that medicines are available through one or another system.
Jackson Carlaw reminded us about Scotland’s place in clinical research, and Aileen McLeod mentioned the BioQuarter. It is important for our research base that we ensure that innovative medicines that we are involved in trialling are then generally available.
The IPTR system is an important area.
You have one minute.
Before I come to that, however, I want to say one thing. The system that we have, whereby the SMC approves something for unrestricted use and 14 separate committees then decide on what happens, is wrong. The chief executive letter says that it must now be done within 90 days. That was a result of pressure in the previous session of Parliament, when we insisted that 18-month delays were unacceptable, but I have to say to the cabinet secretary that the loopholes are still there. Often, the fact that there is not a clinical pathway is used to delay things much further. The system is dysfunctional and it must end. We must ensure that drugs that are approved for unrestricted use are then applied in a much more universal way.
I turn to the IPTR system in my last 30 seconds. It is generally recognised that the system is dysfunctional. Bob Doris said that we need consistency and Jayne Baxter emphasised the importance of fairness. Those are two important points, but there is a catch-22. An IPTR can be applied only to a patient who is different from the trial patients on whom the licence was applied. That is often difficult, if not impossible, for drugs.
Dr Simpson, you really need to close.
I close on the fact that we have a dysfunctional system. I welcome the review and the new £21 million, but we must have published lists of all those consulted, and the stakeholders must be consulted—
Dr Simpson, there is no time.
—before the final decisions are reached.
Thank you.
Cabinet secretary, you should have six minutes. If you can take less, I would be grateful. I have already cut Mr Carlaw’s time.
16:46
Thank you, Presiding Officer. Let me use this opportunity to clear up a number of points that have been raised during the debate.
First, on the point about consistency and the need to ensure that we do not have a postcode lottery of differing access to drugs in different areas, I have made it absolutely clear from the day and hour when I set up the Routledge inquiry that a key aim is to make recommendations to ensure that there is absolute consistency in the approach across Scotland so that there is no postcode lottery for access to drugs.
Secondly, I will make a factual point about the rare conditions fund that we set up—the £22 million. I think that it was Jackson Carlaw who said that people with cancer do not have access to the fund. That is not the case; clearly, some cancers are rare conditions, so in those circumstances people would, in principle, have access to the fund’s resources.
Thirdly, Jackie Baillie quoted the Daily Record on the costs of the fund for cystic fibrosis. Just for the record, I make it clear that we have identified 51 children in Scotland with the Celtic gene who have cystic fibrosis, who would benefit from the drug Kalydeco. The total cost of that is not £14.5 million, but £9 million. I also point out that the £22 million fund is for 13 months only—not for two or three years. Therefore, if every single penny of that £9 million was spent, there would still be a substantial amount of money left to deal with other situations. I hope that it is useful for Parliament to be made aware of those facts.
Fourthly, to deal with Richard Simpson’s final point I make it clear that the report by Professor Routledge should be with me by the end of this calendar month—by the end of February. I do not intend to make final decisions on his recommendations until two things have happened. First, I want to see the Health and Sport Committee’s recommendations and so take account of what it has to say on the subject and, secondly, I want to consult on recommendations that are made in the report. I will consult the other parties in Parliament as well as the stakeholder groups.
It is extremely important that we get the decision on the recommendations right. If we rush into a decision and we do not make the right one, we will be back here in a year debating the subject all over again. If the report recommends urgent measures, clearly I would in those circumstances implement them, but I would still do a quick consultation of the appropriate stakeholders and the other parties in Parliament. It is important that Parliament speaks with one voice.
I will stress two other points to do with why we have a difficulty with there being a specific fund for cancer. First, why would we have a fund only to deal with cancer but not with other terminal conditions such as motor neurone disease, MS or muscular dystrophy? We cannot play God and decide that someone who has terminal cancer should be favoured over someone who has terminal muscular dystrophy, MS or motor neurone disease. That is one genuine reason why I am concerned not to repeat the example from down south.
Secondly, medicines are not, in the modern world, always the only or the most effective way to deal with cancer; cancer treatment consists of much more than medicines. For example, over the past three years, the Scottish cancer task force has made available more than £3 million to develop the introduction of new technologies and to drive forward improvement to meet the ambitions of the quality strategy. NHS Scotland is in a strong position and is able to provide patients with new treatments, including intensity modulated radiation therapy. Access to such therapies is as important as access to medicines. This is not just about drugs; it is about other treatments, as well.
On the cancer drugs fund down south, the “Cancer Drugs Fund Bulletin—August 2012”, which is the most recent one, shows that in use of the fund there are inconsistent approaches to funding for many medicines in England, and that many patients receive refusals. That situation is similar to that which we are discussing in relation to the IPTRs.
A study, based on a survey across the United Kingdom, by the centre for health economics and medicines evaluation at Bangor University that was published last year, suggests that the principle of the cancer drugs fund is not supported by the public. The report also found that more than 65 per cent of people did not support paying more for cancer medicines than for other medicines for equally serious health problems. I share that sentiment; that is genuinely—it is nothing to do with party politics—why we have resisted having a cancer drugs fund in Scotland.
Mr Carlaw, I am afraid, as I have already advised you, I can give you only seven minutes.
16:52
I thought that I had only six minutes. I am quite happy to have given up time to facilitate contributions from colleagues.
I begin with a correction; I referred to Sandra White’s motion on breast cancer, but it is in fact a motion on bowel cancer. I still encourage all members to support that motion.
I thank all members for how they have contributed to the debate. I feel that it has moved on the discussion on access to cancer medicines from where we were when we last debated the subject in the chamber on a Conservative motion some 18 months ago.
I thank the cabinet secretary for some of his points in his closing speech; he has given some clarity on the rare conditions medicines fund in terms of what he expects the individual cost to be in relation to the particular drug that has been featured. I accept his point that there are cancers whose sufferers will potentially benefit from the fund, too. I also earlier paid tribute to his moving to establish the various inquiries that will be instrumental in bringing about the potential change that many on all sides of the chamber are looking for—Jim Eadie on the SNP side is one of those who hope to see progress being made as a consequence of that.
I also mentioned the Health and Sport Committee inquiry to which Duncan McNeil referred. He and others mentioned Joan McAlpine. I apologise—I was not aware that she was in the chamber earlier. I have never been accused of lacking guts in the chamber before, so I am happy to facilitate an intervention from Ms McAlpine if she would like to make one now.
I thank Jackson Carlaw for taking an intervention. I do not expect him to agree with anything that I write in the Daily Record, but perhaps he would like to reflect on comments that were made by Alan Maynard, who is a professor of health economics at the University of York and the leading authority on health economics in the UK. He has described the cancer drugs fund as allowing the pharmaceutical industry to charge very high prices for drugs whose effectiveness has not been proved.
Quickly please, Ms McAlpine.
Alan Maynard described the situation as
“‘pork barrel’ politics—bring home the bacon to your supporters in the pharmaceutical industry”.
I saw that comment from Professor Maynard. In fact, we looked into it in a little detail and it was made several months before the institution of the cancer drugs fund in England in 2010. On inquiring, we got a slightly more equivocal response in respect of how things are today.
I understand what Ms McAlpine said in her article, although I will not use the language that she used when she described me as lacking in guts. If she wanted to comment on ipilimumab and its effectiveness and the fact that it gives only a few additional months of life, I would have preferred it if she had managed to come along to that dinner and argue her case in front of the organisations that support the drug and patients who have benefited from it. That is in part where her case should be made—not just in a national newspaper.
Most of the speeches this afternoon were pertinent and to the point. I will not single any member out, except Nanette Milne, Jayne Baxter, Mark McDonald and Richard Simpson. To Bob Doris and the cabinet secretary, I point out that our motion makes no specific mention of a cancer drugs fund; in fact, it talks about cancer sufferers “and others” who have other conditions.
We accept that value pricing will make a difference in a reasonably short space of time, but until that point there is, as a result of the SMC process, unequal access to available cancer medicines that every member in the chamber has hoped all their life to see being made available to alleviate certain cancers. I hope that, in the light of the reviews that have been conducted ahead of value pricing, the Government will be able to make access to those drugs for cancer and other conditions available by exception.
The cabinet secretary asked me how I would fund that. In its recent report, Audit Scotland identified £26 million of waste. Two councils that have blue-bag schemes managed to amass 2 tonnes of unused prescription drugs. Audit Scotland also tells us that, in the three years 2012 to 2015, medicines that will come off patent or which will become generic will release £316 million in the drugs budget in Scotland, with £26 million being released in the current year from a drugs budget of £1.5 billion. I believe that the funding exists in the same way that £21 million was made available from within those resources for the rare conditions medicine fund.
A new mechanism should be introduced that would, when a new standard of care for cancer or another condition is established outside current Scottish practice, enable a consensus application for funding to be made by Scottish physicians who can provide expert opinion within their clinical field. The Scottish Government could then enter commercial negotiations with the manufacturer to ensure best value, based on the true value that medicines bring to patients. That would ensure that Scottish patients could attain the same standard of care fairly and equitably across the country and would not miss out on the opportunity to benefit from innovative treatments.
Does Jackson Carlaw accept my earlier point that we cannot legitimately talk about benefit to patients without there being available all the trial data relating to medicines? That is why it is so crucial that all trial data for all medicines be made publicly available.
Mr McDonald made his point well, and I support it. However, we are talking about drugs that are available. In many respects, Scotland is one of the countries in Europe that affords less access than most other nations. We spend less per head on drugs, particularly on cancer drugs, to cure our population. The Government seems to be ready to make that move. Because of the way in which today’s debate has been conducted, and because of what has been said in the Health and Sport Committee, I sense that progress can be made.
On behalf of cancer patients across Scotland, Scottish Conservatives have stood behind them, and other members are also ready to make the commitment, so I hope that the reviews and the cabinet secretary’s leadership will mean that, when next we debate this issue, we will be debating progress in treatment of cancer in Scotland.