Cancer Treatment Drugs Inquiry
Good afternoon and welcome to the eighth meeting in 2008 of the Public Petitions Committee. As always, I ask everyone to ensure that all electronic devices are switched off. We have received apologies from Nigel Don, who is on a visit to Brussels with the Justice Committee. The substitute member for the Scottish National Party, John Wilson, is also involved in that.
We are continuing our inquiry into the availability of cancer treatment drugs on the national health service. We have had a number of contributions to the inquiry so far. Today, we welcome the Cabinet Secretary for Health and Wellbeing, Nicola Sturgeon; Dr Sara Davies; and Elizabeth Porterfield. I am sure that the cabinet secretary knows the format of committee meetings. I invite her to make an opening statement if she wishes.
First, I thank the committee for giving me the opportunity to be here today. I will keep my opening remarks to a minimum to allow maximum time for questions and discussion.
I take this opportunity to put on the record my condolences to the family and friends of Mr Gray. His dignity and perseverance in pursuing his petition should be a lesson to us all. The inquiry that the committee is undertaking, and its outcome, will be a fitting tribute to and legacy for Mr Gray.
While we talk about policy issues and the complex decisions that always have to be made in the NHS, it is important that we remember that, ultimately, this is all about individuals and the impact of such decisions on them. That is why we are working hard on our cancer strategy, our action plan for palliative care and our support for life sciences research.
We all know that cancer and its treatment are multifaceted and often involve complex drugs and other treatments used in combination. The arrival of individual new drugs can and does raise hopes and expectations, but we need to be confident at all times that they offer real benefits to patients in practice.
The arrangements that we have in place to assess new drugs and treatments in Scotland are designed to ensure that effective new drugs and treatments are made available to patients as widely and as quickly as possible. Those are difficult decisions that involve weighing up a range of factors, including the clinical benefits and cost. As the committee well knows, the arrangement for providing such advice in Scotland is through bodies such as the Scottish medicines consortium and NHS Quality Improvement Scotland. Rightly, those arrangements operate completely independently of ministers and they are widely acknowledged to be robust.
The committee has heard evidence on and wants to pursue a range of issues, such as the top-up system for which some people are calling, whereby patients could top up their NHS care by paying for certain elements of their care privately. It is important that we keep an absolute focus on equity, safety, probity and continuity of care but, of course, we are open to listening to the wider debate. I am sure that we will pursue some of those issues this afternoon.
The evidence before the committee highlights the elements that, in combination, inform decisions about the drugs that should be recommended for use in the NHS. I underline that the decision-making processes that are in place are designed to allow a whole range of factors and perspectives to be considered and debated thoroughly before a decision is made. The key purpose of those processes is to clarify the benefits of drugs and treatments for patients. There is debate about how that is done, such as through the quality-adjusted life years system. There are important technical debates to be had, but it is important to recognise that QALY assessments provide the basis for discussion. The QALY assessment alone does not determine the decision. In the end, all such decisions have to be taken in the best interests of patients.
The issues before the committee demonstrate the complexity of the decisions that need to be made. I hope that we can remain focused on the importance of the robust decision-making process, which seeks to secure the availability of drugs and treatments on an equitable basis. However, if the system needs to be improved, I am determined that it will be.
Thanks to the work that the committee has done, I have formed initial views on some areas that we might look to improve over the coming months. We will no doubt pursue and develop some of the issues in more detail today. I look forward to discussing the issues with the committee and, ultimately, to receiving the committee's recommendations in due course.
Thanks. I echo the kind words that you said about Mike and his family. We have a series of questions that we are asking all the individuals who make presentations to the committee. Nanette Milne has the opening question.
I have a couple of questions. One is about defining roles and the other is about guidance. You referred to the complexity of the decisions on prescribing cancer drugs, and it is clear that a plethora of organisations is involved: the Scottish medicines consortium, the National Institute for Health and Clinical Excellence, NHS Quality Improvement Scotland, regional cancer networks, area drug and therapeutics committees, medicines management groups, joint formulary committees and prescribing advisers. How can you ensure that they all slot together efficiently and effectively and demonstrate an effective use of resources in the assessment and prescribing system?
That is a fundamental question. The picture is complex and an array of organisations is involved. I think that they fit together well and that they all have clearly defined roles. I will say a bit more about that in a moment.
I have detected from the evidence that has come before the committee—it is a view with which I agree—that we perhaps need more transparency and a greater understanding of some of the organisations' roles and the interrelationships between them. That is one of the issues that the Government will certainly want to consider following the committee's inquiry.
The Scottish medicines consortium perhaps has the lead role. Scotland is fairly unique in having an organisation such as the SMC, which looks at all new drugs at the point of licence and provides, as quickly as possible, advice to the NHS at large. Sometimes, for understandable reasons, there is a bit of a misunderstanding about the role of the SMC and the roles of NICE and NHS QIS. As the committee knows, NICE has very limited applicability in Scotland. When NICE conducts multiple technology appraisals, its decisions may have relevance. Unlike the appraisals of the SMC, which looks at drugs at the point of licensing, those appraisals may take place a year or two after a drug has been in use, so NICE might have more information and evidence at its disposal. If NHS QIS's view is that a NICE appraisal is relevant in Scotland, that can overrule and supersede the SMC's decision. Examples of NICE taking a view that differs from the SMC's are rare, but it is possible.
Having read the evidence that the committee has taken, I detect that there is perhaps most confusion and most need for greater transparency in relation to the area drug and therapeutics committees. It has been suggested to the committee that, given the role of the SMC, there may not be a role for the ADTCs. I am not sure that I agree with that, but I certainly think that there is a case for making the arrangements transparent. When the SMC recommends a drug that is unique, its advice should be considered to be binding and NHS boards are obliged to implement the recommendation. The ADTCs perhaps have more of a role to play when the SMC recommends a drug that is not unique and many similar drugs are on the market. In that situation, it is legitimate for the ADTCs to make decisions about where the new drug fits in and there may be, for very good reasons, local variations in their decisions—I know that you have had examples of such cases.
I think that the roles of the various organisations are well defined, but they are perhaps not well understood. We need to ensure that there is transparency in the system and understanding of how it works.
That came out clearly in the evidence that we took at our previous meeting and it leads me on to the issue of guidance. Guidance, local formularies and so on are designed to deliver cost-effective treatment for patients but, ultimately, the clinician in charge makes the decision and has the freedom to prescribe what he or she thinks the patient needs. How can you ensure that clinicians operate in an atmosphere of clarity and understanding and that they are not bombarded with too much guidance and advice?
I am sure that all clinicians would make a similar plea not to be bombarded with too much guidance and advice, but it is important that the right guidance and advice are in place to regulate the framework in which decisions are taken. When the SMC does not recommend that a drug be used widely in the NHS, the whole system ultimately comes down to clinical judgment and decision making. It is, of course, open to a clinician to make a case for a drug to be prescribed on an exceptional basis; I know that you are well aware of that.
The clinical judgment should be powerful, weighty and influential, but whether it should be the last word on an issue is another question. There must still be a transparent procedure to determine whether a drug should be prescribed on an exceptional basis. Evidence from other witnesses has noted that although all NHS boards are obliged to have procedures in place for exceptional prescribing decisions, there is no guidance about what those arrangements should be. Whether there should be a one-size-fits-all approach or whether some local flexibility is appropriate is a debate that is being usefully explored in the inquiry.
You touched on the exceptional prescribing process. Have you formed any initial views as to how well the process works, whether it is consistently applied across boards, and whether it is fair and transparent?
Before I come to that, I will make a more general point, which is again reflected in some of the evidence that you have heard. I believe, without turning round to look, that Andrew Walker might be sitting behind me in the public gallery, so I will ensure that I quote him properly and accurately. He made the point about a lack of data in the system. As a result of the inquiry and of my own thoughts, I will consider how we can ensure that we are gathering data and systematically reviewing whether SMC decisions are being implemented consistently throughout the country. I acknowledge that that is a big job, given the number of recommendations that the SMC will make every month and every year, and that it will be very resource intensive, but it is done in England and there is a case for saying that we should gather that evidence base here.
To go back to the answer that I gave to Nanette Milne, all NHS boards are expected to have procedures in place to deal with exceptional prescribing applications. The cancer networks also have a role to play in those decisions. There is no evidence to suggest that the systems are not working properly. Indeed, some of the recent high-profile cases, including the case of Mr Gray and the case—not involving a cancer drug—of a young child in Glasgow, are examples of the exceptional prescribing arrangements working. There are issues to do with the speed at which the decisions are taken, but it is important to say that there is no evidence that they are not working. There is a debate to be had about whether we need to consider standardising some of the arrangements. Without that standardisation, we may struggle to convince people of the transparency.
Following on from your comments about the process—in particular, about the speed of the process—do you think that the exceptional prescribing process as it stands places undue stress on patients and do you think that it could be improved? How service user friendly is the system for patients who have been told that the treatment that a clinician has recommended for them will not be publicly funded and who are considering avenues to challenge that?
We should always look to improve that system where we can. However, we have to be realistic about the fact that, because these decisions and processes happen at a time of stress for a patient anyway, they will always be difficult for any patient to deal with. The issues to do with when the discussions are had with patients and the degree of information that is shared and discussed with them also take us into the realm of professional and clinical judgment and decision making, which will vary from case to case. Moreover, some patients will want to be centrally involved in such discussions and, if an application for exceptional prescribing is made, will want to be heavily involved in the processes, whereas other patients will not want to be and some will not be medically fit to take part in them. Therefore, it is important that, as a rule, clinicians are in the lead.
Inevitably, there will also be situations in which the clinician does not think that there is a case for exceptional prescribing but the patient still wants to make one. Although, rightly and as you would expect, I do not know all the details of Mr Gray's case, I understand that that was the case in his situation.
We should always look to streamline the processes and make them as stress free as possible but, given the context of such decisions, we would all be misleading people if we suggested that we could remove the stress from them completely.
Given that exceptional prescribing is the clinician's decision—we have heard evidence that that is the case—different boards tend to act in different ways. We have also heard evidence about how patients can get access to drugs from one clinician but not another. That causes a lot of concern because people regard it as postcode prescribing; if a patient stayed in a certain area and had a different clinician, they would be prescribed the drug that they want.
Although it transpired that Mr Gray's clinician did not agree that the drug would help him, Mr Gray fought the case and proved that there was benefit to him in having the drug. There is a lack of confidence among such people, who are in very bad circumstances—we can only imagine what it would be like if it was our lives. How do they understand the system? What equips them to get the best treatment for themselves and to be confident that they are receiving it?
That is a fair point. It comes back to making the processes as clear, robust and transparent as possible. When a clinician decides that somebody should have a drug prescribed exceptionally, they are saying in effect that circumstances and criteria apply to that individual patient that did not apply generally when the SMC took its decision. It is a fact of life that different clinicians will, for good reasons—although they might not be easy for people to understand—reach different decisions. When clinical and professional judgment is exercised, different professionals will come to different judgments. It is important that the processes that the patients can then go through—either with their clinician's support or to challenge their clinician's view—are clearly understood, robust and transparent. If I read all the evidence correctly, we perhaps have some work to do on that point.
Good afternoon, folks. As you are probably well aware, the issue is complex. Two issues concern me and, I am sure, many of the patients, who depend on the best possible treatment when they are admitted to health care, whether a hospital or whatever. We have received evidence that the Scottish medicines consortium has rejected a drug that is effective for particular types of cancer simply because of cost—not because it was not effective for the treatment of particular cancers but just because it was too expensive. That is disappointing.
Given that, when a patient is admitted to a hospital, they expect to get the best possible care for their condition, surely it would be a retrograde step if, in the middle of their consultation with the general practitioner or hospital staff, they were to be told that they could not have a particular treatment not because it was ineffective but because of the cost. One can only imagine the trauma experienced by an individual who is told that, although there is a drug to treat their condition, it cannot be prescribed because it is too expensive. Unfortunately, that is what happened to Michael Gray—at least until he proved his case and the health board relented.
What can individuals who are caught in such a sad situation do? What avenues are open to them to question such decisions and to try to secure a different decision from the clinician?
First, I should tell John Farquhar Munro that I spent yesterday travelling around his beautiful constituency. I enjoyed my visit greatly.
I agree absolutely that these are some of the most difficult issues and decisions that any of us will ever have to deal with. Certainly, as the Cabinet Secretary for Health and Wellbeing, I cannot think of many other situations that cause more angst, anxiety and trouble than that of an individual with a life-threatening condition who knows that a certain drug can help them but that it is, for a variety of reasons, not readily available on the NHS.
However, I would probably challenge the idea that the SMC rejects drugs simply because of cost; it reaches its decisions after weighing up and balancing a variety of factors. Although such decisions are very difficult, they are necessary in any system of finite resources. Indeed, these difficult decisions have always been taken in the NHS; they have perhaps come more to the fore as more and more advanced drugs have come on to the market.
In any case, we must not say to people that such decisions can be avoided in future; instead, we must try to build confidence in the processes that lead to them. I believe that, although people might disagree and have difficulty with its decisions, the SMC system is robust and transparent—although, that said, we might consider increasing the transparency of the whole system.
The SMC's decisions are taken not by politicians but by experts. That independence from Government ministers and other politicians is crucial, because these decisions have to be defended on the basis of expert evidence.
I am sure that every single month someone will be disappointed with the SMC's decisions. However, we need to know that those decisions have been based on the right factors and considerations, and that no undue influence has been brought to bear in the process.
I quite agree that MSPs should not get involved in medical matters. They have enough problems with politics.
What avenues are open to individuals who wish to appeal decisions?
That is the purpose of the exceptional prescribing procedures that we have been discussing. As the SMC's recommendations apply to the whole population and the NHS in general, there will always be individuals who think that their situation is different and therefore justifies a different decision. That will open up the exceptional prescribing procedures that exist in every board. As I have said, there is no evidence to suggest that those procedures are not working, although I concede that we might need to make them better understood by the general public who, after all, are affected by their outcomes.
I want to ask a couple of questions about funding, which we have touched on briefly. We are talking about expensive treatments, and the issue of wastage has come up in our inquiry. What is the extent of the problem of wastage in the supply of existing cancer treatment drugs? What action is the Scottish Government taking to reduce wastage, and could money from savings be made available for other cancer drugs?
I do not have information to hand to answer your first question on the extent of the problem. I am happy to see whether we can provide any information to the committee to quantify that. I am not sure whether we will be able to but, if we can, I will ensure that the information is provided.
Reducing waste in the NHS is vital, not only in the prescription and use of drugs but across the board. Every pound that we can save from preventing a wasteful use of resources can be spent on meaningful, effective care for patients. We are constantly looking to see how we can improve our procedures.
Most important will be what NHS boards and cancer networks do on the front line. When Alan Rodger gave evidence to the committee, he gave some examples of what NHS boards are doing. For example, NHS Greater Glasgow and Clyde treats all Herceptin patients in a Herceptin clinic, so that if part of a vial of the drug is not used for one patient, it can be used for the next patient. That is a practical example of what can be done to cut waste. We need to ensure that such best practice is shared across boards. The need to ensure that we get the maximum benefit in the NHS from taxpayers' money is very important to me.
My next question is about how the price is set for the drugs and the difference between the drug costs in private treatment and on the NHS. What are the reasons for that and how does the difference apply to people who have to use private medication? How could it help someone in the same situation as Michael Gray, for example?
There are several different angles to that question. If I am following the wrong one, you can tell me, and I will go down the one that you want me to follow.
There are several issues. First, there is the pharmaceutical price regulation scheme, which controls prices for branded drugs. That is a reserved issue, and committee members will be aware that the scheme will be brought to an end early, after the Office of Fair Trading market study suggested that we could move towards a more value-based pricing of drugs. The Department of Health in England leads for all the devolved Administrations on that, but it is clearly a piece of work in which we will be closely involved.
The second issue that Claire Baker might have been getting at was co-payment and co-funding for drugs.
We were planning to talk about that in more detail soon, but if you want to talk about it now, that will be fine.
If we are to go into the issue in more detail, I will keep my comments brief. I have been struck by some of the comments and written submissions that have been made to the committee, particularly by clinicians, on the lack of clarity in the current guidance to NHS boards on co-payment. We need to take a fresh look at that.
Although the issue may superficially seem simple—somebody receiving most of their care on the NHS and paying privately for only one part of it—it is anything but straightforward for practical, financial, ethical and moral reasons, as well as reasons of clinical accountability. I will give two examples of the issues that we need to grapple with. One is an issue of practice and the other is an issue of principle.
The issue of practice involves clinical accountability. Cancer treatment is one of the best examples—probably the best. Chemotherapy usually consists of a combination of different drugs, and it is not easy to separate one drug from another in the package of care. Someone has to bear the overall clinical accountability for the package of care, but if treatment is divided between the NHS and the independent sector, the lines of clinical accountability become blurred, which can have serious implications.
My second point is about the issue of principle. The NHS provides health care free at the point of need, and equity of access is the fundamental principle of the NHS. A system that in effect allows people to top up the care that they get on the NHS by paying privately for part of their care raises the danger of a two-tier system in which people who can afford to pay for bits of their care privately do so and people who cannot afford such care are denied it.
Complex issues are at stake. I accept that we need to reconsider the guidance, to ensure that boards and clinicians are given as clear a steer as possible, but I would not want anyone to go away with the idea that this is a simple issue—not that any member would do that.
If part of a patient's treatment is provided privately, does the cost to the individual reflect the cost to the NHS of providing the treatment? Is the burden on the individual too much or is it justified, given the treatment that they will receive?
The cost that an individual might have to pay might not reflect the cost to the NHS, because the individual would be funding not just a discrete part of their care but the whole package, for the reasons that I outlined. Therefore, the cost to the individual would not necessarily be the same as the cost to the NHS would be if the NHS were providing the treatment.
The comments so far have been helpful. Rhoda Grant will focus on the issue in more detail.
Cabinet secretary, I take it from your answer to Claire Baker that you are considering the chief medical officer's guidance. We heard evidence that the guidance is ambiguous in that, on one hand, it seems to suggest that public and private provision can be mixed and, on the other, it suggests that there cannot be mixed provision.
I take on board what you said about clinical accountability, but I suppose that that is bureaucracy and can be sorted out. On the principle of the NHS, which I suppose is a moral issue, the petitioner said that he could not have paid for all his treatment without the help of his family and friends. Many people cannot pay the whole cost of their treatment, given the expense, but the petitioner thought that if it were possible to pay privately only for the part of the treatment that was not available from the NHS—the drug that he took was a small part of his treatment—many more people would take the opportunity to do so.
I understand an awful lot of what you said, but when someone cannot get life-saving or life-prolonging treatment on the NHS, is it fair that they should have to pay for all their treatment, which would be available free of charge, just so that they can access a small part of their treatment?
I understand where members are coming from. There is a slight danger that a general discussion of the issue masks very different individual circumstances.
I challenge the notion that we are talking about bureaucracy in relation to packages of care; with respect, more fundamental issues are at stake. As members know, I am not a clinician, so I hope that you will bear with me. In a course of chemotherapy for the treatment of cancer, three or four drugs might be used. One drug alone might not be life saving; it is the combination that has the effect. It is also important that drugs are given in the right doses and in the right balance. If something were to go wrong and a patient had an adverse reaction to a drug that was being provided by a provider other than the NHS, important issues about clinical governance and accountability would become blurred, as I am sure members understand. There are real dangers for patients in such an approach.
I do not want to suggest to the committee that I do not understand the motivation and sentiments behind your questions; I want you to understand—as I am sure that you do—that complex issues are at stake.
I have said that we will look again at the guidance that the previous Administration issued in February last year. There could be more clarity around how the principles enunciated in the guidance are expressed and we will take a close look at that. We will also look closely at any recommendations made by the committee after its inquiry and make sure that we reflect on them properly.
I am conscious of the time, given that you have other commitments this afternoon.
The petitioner and his family have consistently said that they believed in the principles that you have set out to do with the NHS's role in providing access to a range of treatment for people at their time of need. However, the petitioner faced the reality that, because of the nature of his illness, he had to fund an element of his treatment privately and the funding for the element that he would otherwise have expected the NHS to pay for was unavailable. Michael Gray said that there are many more people like him out there who would not have had access to the resources that he and his family put together.
What difference will we make during the next couple of years so that there are fewer occurrences of the circumstances in which Michael and his family found themselves? His testimony was very powerful. I understand the ethical issues; we unravelled some of those at the last meeting. The issue is the cold reality of how that family confronted that tragedy and its economic and personal impact.
I agree that the testimony of Mr Gray and his family, friends and many supporters was incredibly powerful. I challenge anyone not to be deeply moved by it and not to want to do whatever they can to improve the system. That is certainly where I am coming from.
It is important to recognise that difficult decisions will always have to be made. As Cabinet Secretary for Health and Wellbeing, I think that it would be dishonest of me to say to the public that such difficult decisions will not be confronted by other individuals in the future. We must make sure that the processes work better, certainly better than they did in Mr Gray's case. Again, without going into all the individual circumstances, I think that the NHS board in question would freely admit that there were shortcomings in the process that was followed that contributed to the anxiety that Mr Gray had to suffer. I am not forgetting for a minute that we are talking about individuals and real lives, but much of what I have said this afternoon is about improving processes so that even if some individuals are disappointed with some of the decisions that come at the end of those processes, they can still have confidence in what has led to and underpins those decisions. With the committee's co-operation and help, I hope to work towards improving those processes in future.
There are no other questions, and I am conscious that you have other commitments, cabinet secretary. I thank your officials for being present today although they did not get to speak and need not have bothered coming.
We anticipate that our report will be available just before recess. We would be happy to engage with you and your departmental officials on issues arising from that.
I am happy to do that.
Thank you for your time.
We will take a brief comfort break before going on to the next petition.
Meeting suspended.
On resuming—