Cancer Drug Access

– in the Scottish Parliament at 2:22 pm on 1st October 2008.

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Photo of Alasdair Morgan Alasdair Morgan Scottish National Party 2:22 pm, 1st October 2008

The next item of business is a debate on motion S3M-2598, in the name of Frank McAveety, on the Public Petitions Committee report on availability on the national health service of cancer treatment drugs.

Photo of Frank McAveety Frank McAveety Labour 3:05 pm, 1st October 2008

I thank members for being present for this debate on a report of the Public Petitions Committee, which was presented several months ago with a challenging but important petition, which we took firmly on board, on access to cancer drug treatment in the health service. I thank all those who made submissions, which we took forward as part of our inquiry. I also recognise the hard work that was done behind the scenes by the clerks to the committee and the many others who were involved in the development of the petition.

Most important, I put on record Parliament's appreciation of the work done by the petitioner, Tina McGeever, who has been in a very difficult personal situation, and by her late husband, Michael Gray. They took the time to lodge the petition in light of Michael's experience of accessing treatment from his local health board. I welcome Tina to the chamber this afternoon.

Photo of Margaret Curran Margaret Curran Labour

Many in the chamber will recognise the contribution of Mike Gray, a good friend of mine over many years, and his wife and friends, who have had an enormous impact and have helped us to look at the complex issues of provision and funding of cancer drugs, and indeed the operation of the national health service. There are many telling lessons to learn for all of us who are committed to the national health service.

Many in the Parliament are well aware of Mike Gray's outstanding record of public service in residential child care and housing. Does the member agree that perhaps the best way in which we can pay tribute to Mike Gray's contribution to public service in Scotland is by reaching for the highest possible standards of health care and ensuring that it is accessible to all? That would be a fitting tribute to the lifetime contribution that Mike Gray made to public service in Scotland.

Photo of Alasdair Morgan Alasdair Morgan Scottish National Party

Interventions, regardless of their content, should be brief. That was not a good example for members to follow.

Photo of Frank McAveety Frank McAveety Labour

I echo Margaret Curran's comments about Michael Gray's commitment, as well as that of Tina McGeever alongside him.

I welcome to the chamber today a colleague from the House of Representatives in Australia, Julia Irwin, who is convener of the Standing Committee on Petitions. I hope that she will see how the work done by the Public Petitions Committee in Scotland can influence further developments in Australia. Our approach has already been taken on board in the House of Representatives, which modelled its petitions structure on our experience since the establishment of the Scottish Parliament. I hope that we can continue our good dialogue.

The committee had in front of it a difficult issue and members reflected its seriousness in the values that they took into the inquiry. Our extensive inquiry identified several key issues on which we made recommendations. This afternoon, I will go through some of the key areas of concern or deliberation that we raise in the report. We hope that the Cabinet Secretary for Health and Wellbeing, who has responded to the committee's report, will amplify some of those areas in her speech.

We share a commitment to improving matters for everyone involved in the delicate and difficult experience of confronting the challenge that cancer throws up to all patients and their family members. It is important that we nail down some of the key issues that the report identifies. Although I welcome the cabinet secretary's comments this morning and the press release on the subject, there are still points on which to deliberate in the period leading up to the review process of which she spoke today. However, I welcome the fact that the debate has moved on since the petition was lodged and the inquiry report was published.

I am sure that many members have taken time to explore the many issues in the debate. My colleague John Farquhar Munro will touch on some of those in his concluding comments.

The key issues are defining the roles in relation to the allocation of treatment; guidance; data gathering; availability, which covers the sensitive and difficult issue of exceptional prescribing; and funding, which covers the difficult issue of co-public-private funding of treatment, or co-payment. It is important that we identify the key issues that were raised.

As we say in our report, we wanted to examine the roles that are being fulfilled by the many different bodies that are involved in undertaking clinical, scientific and cost-effective assessment of the use of cancer treatment drugs and to establish whether there is any duplication of roles.

We wanted to find out about the implementation of guidance across health boards, as evidence indicated that there were contradictory voices.

On the issue of exceptional prescribing, given that we are a relatively small nation, the range of criteria and conditions involved surprised us and struck us as anomalous. That is something that could be addressed by the parliamentary process, by health boards, and by the guidance set out by the cabinet secretary.

We also wanted to establish the reasoning behind the position whereby a person cannot be treated as a private patient and an NHS patient for one condition during a single visit to an NHS organisation.

Those are big issues. I know that the cabinet secretary has been careful to try to address them in her written response and in her comments to date. It would be useful to have further elaboration of that.

I turn to the areas of concern that the report identifies. The first area is data gathering. Eminent health professionals and people who are involved in the assessment of health needs in Scotland said that we need to resolve a number of issues. That is something that the cabinet secretary can take forward. One concern was that we have an insufficient national system of data collection; for example, there are not enough data on how many patients get one drug and how many get another. Concern was also expressed about the implementation of guidance across boards, which is highlighted in paragraph 55 of the report.

We do not know what data are being gathered locally and what data are being gathered nationally. It would be useful to have that clarified at national, health department level and at local health board level. The cabinet secretary said in her response that better data would help all of us who are involved in the process. It is important that we get clarity around what data could be captured nationally, how we capture the data and what we do with that information. That would certainly help us, because much of the debate is centred on the limited resources that are available in the NHS and their effectiveness when the individual requires support.

In its response, the Government identifies areas of development since the report was published and outlines some of the areas in which data are being captured. We would like to hear what further work will be undertaken and to be kept up to date on that. Other members will probably request further clarification on some of the issues to do with the better cancer care plan, which is the overarching strategy.

A number of the cancer care charities that made submissions to our inquiry identified that it is important that key health professionals are involved in discussing what it would be beneficial to gather together in developing a more coherent strategy. What are the broader views of those health professionals on the action that the Scottish Government can take, alongside them, to address those concerns?

Finally, will the better cancer care plan contain more detail than we have already been given? What issues of data gathering will be further considered and reported on to the Parliament? We seek further clarity on that.

Difficult issues arise with the quality-adjusted life years assessment, which John Farquhar Munro might address in the limited time that we have to address key points in the report.

The availability of drugs was the central point of the petition that Tina McGeever and Michael Gray lodged. In the anguished circumstances that faced Michael, they made a brave submission. Michael believed in the health service's principles and was committed to equity of access—that was the point of Margaret Curran's intervention. Because of his professional and personal circumstances, he happened to have money to obtain privately drugs that were not available on the NHS, but he found that, as a result, the NHS part of his care was not provided. That was outwith his control. The motivation behind the petition was not to drive a coach and horses through the important principles that many of us—if not all—in the Parliament share on equitable access to the health service. The question was whether, when we are in the most difficult circumstances that could face any of us or our families, we can find a more effective way to deal with them.

I am sure that the cabinet secretary agrees that what made the issue even more difficult was the fact that the journey through the assessment of treatment was uneven—that is a euphemism. That threw up many other issues that the cabinet secretary and health boards are responsible for resolving for the future. That is not a criticism of any individual in the process; the structure was not sensitive enough to the petitioners' needs.

Terminology such as "exceptional prescription" is used and the assessment procedure is imposing. Given the way in which the individual who was facing difficulty had to confront senior health professionals locally to justify their request to be considered for drug treatment, even the health board involved has acknowledged that it needs to do much better on that in the future.

What information is available to individuals who are involved in such a process? In response to the committee's report, the cabinet secretary has identified ways in which improvements can be made. It is important that the public, patients and consumers—whatever term we want to use—are centrally involved in shaping developments. We can use the next few months to expedite effective action on those comments and observations. I would like to hear how more public and patient involvement in the process will be achieved. I am sure that that will influence the better cancer care plan.

What is the cabinet secretary's view on appointing liaison officers in each NHS board to act as a communication link between clinicians, boards and patients, as proposed in paragraph 85 of the report? What information—in leaflets or in other ways—will be given to patients when they confront a diagnosis? When the better cancer care plan is published next month, will it set out clearly how the quality of information on the exceptional prescribing process will be improved and made available early to patients? How will that process be made fair throughout Scotland? What input will the difficult decisions short-life working group have into the process?

I will touch on another concern in the report.

Photo of Alasdair Morgan Alasdair Morgan Scottish National Party

The member should conclude his speech.

Photo of Frank McAveety Frank McAveety Labour

My final comment will be on funding; I am sure that other members will deal with other issues. I welcome the cabinet secretary's comments this morning about funding, because the health department's guidance was inconsistent. It would be useful to hear how the cabinet secretary will make that clearer.

We recognise that the issue is difficult. I have not had the time to get anywhere near a wheen of issues, which I hope that other members and the cabinet secretary will address. We are trying to achieve for patients a much better, fairer and clearer system, which minimises trauma such as that which Tina and Michael experienced in their journey through that difficult part of their lives. I await the cabinet secretary's response to the report.

I move,

That the Parliament notes the conclusions contained in the Public Petitions Committee's 3rd Report, 2008 (Session 3): Availability on the NHS of cancer treatment drugs (SP Paper 133).

Photo of Nicola Sturgeon Nicola Sturgeon Scottish National Party 3:20 pm, 1st October 2008

I welcome the opportunity to participate in one of the most important debates that the Parliament has had. There is no doubt that the process that led to the debate has highlighted many of the best features of our Scottish Parliament. The ability of a member of the public to raise issues that are not only fundamental to them but of enormous significance to many in Scotland reflects our collective values of engagement and inclusion. In turn, the matters that were brought before the Public Petitions Committee received robust, detailed and thorough examination. I pay tribute to the committee for producing a report that I believe will result in a number of positive developments in the system in Scotland for introducing new drugs—a system that the report recognises as having a number of considerable strengths.

At the outset, I take the opportunity of paying tribute to Michael Gray. His strength of character and determination shone through the deliberations on the issue. Richard Lochhead, who is the constituency member for the area in which the family lives, has told me how highly regarded Michael was in his local community. Margaret Curran has also spoken about the broader contribution that Michael made.

I place on record my thanks and appreciation to Michael's wife, Tina McGeever. My thoughts and condolences remain with Michael's family at what I know must be a very difficult time. The support that Michael got from his family and friends was unwavering. It says an enormous amount that they are determined to continue to seek what he sought for the many in Scotland: a system that does not have the faults that necessitated him and his family going through what they did.

I have no doubt that the debate this afternoon will offer all members the opportunity to consider the committee's recommendations in detail. In the time that is available to me, I am unable to go into the detail of all the issues or to answer all the detailed points that Frank McAveety raised. However, in my oral evidence to the committee, and my written response to the report, I made it clear that, where there is scope for improving and developing the existing arrangements, we will take action. I know that the Parliament will continue to pay close attention to the issues. I welcome that.

Photo of Peter Peacock Peter Peacock Labour

I echo many of the comments that the cabinet secretary has made. However, will she commit to using every power that she has to ensure that no one else has to suffer the kind of degrading and inhumane circumstances to which Michael was subjected in having to plead his own case? Will she give an absolute commitment to finding a better way of doing things in future?

Photo of Nicola Sturgeon Nicola Sturgeon Scottish National Party

I think that we all agree that we want to deliver improvements to the system, which the committee recognises in its report as being robust in many respects. One expert described it as a "model" for others to follow. In improving the system, we should manage to avoid the kind of circumstances in which Michael Gray and other patients found themselves.

I will begin my substantive comments by underlining some fundamental points. First, and perhaps most obviously, the Government—and, I believe, the whole Parliament—remains absolutely committed to the founding principles of our NHS, which is that treatment is provided free at the point of access and is based on need, not the ability to pay. We all believe in services that are comprehensive and equitable.

In the "Better Health, Better Care" action plan, which we published last year, we made a clear commitment to providing evidence-based clinical care. The arrangements in place in Scotland have never been, and never should be, focused solely on costs or health economics. They must be focused on a wider set of principles, including those of clinical effectiveness and evidence of benefit.

I attach huge importance to all processes being independent of ministers. The arrangements are designed to allow for the consideration of a range of factors and perspectives, including those of clinicians and laypeople, academics and the pharmaceutical industry. That diversity promotes thorough debate before any decisions are reached. In many cases, the decisions will be difficult to take, but it is important that they are based on the right factors. The processes and systems that we have in place assess not only the impact on the NHS but benefits for patients. That is the responsible way in which to do these things in a publicly funded NHS.

As I have said, when we talk about policy issues and complex decisions, we must never forget their impact on individuals and their families. In large part, that is why we are having the debate.

From the committee's recommendations, it is evident that much in the system works well. It ensures that the Scottish Medicines Consortium gives early consideration to all new drugs; that, when appropriate, recommendations from the National Institute for Health and Clinical Excellence are considered swiftly; and that NHS boards ensure that particular drugs or their equivalents that are recommended for use are made available equitably and in line with clinical needs. However, it is also clear from the evidence that was submitted to the inquiry that there needs to be greater clarity and transparency regarding how the arrangements work in practice and how we achieve a greater consistency of approach throughout Scotland.

I have made it clear that the Scottish Government is keen to ensure that it takes appropriate action where there is scope to develop and improve the current system. That is why, in my response to the committee, I outline the work that is under way to improve data gathering, which is essential if we are to assure ourselves on the points that have been raised, and agree the need to address a number of challenges. Much of what needs to be done will be achieved through existing work programmes—for example, the e-health strategy, the better cancer care plan and the outcome of the recent evaluation of the Scottish Medicines Consortium. I attended the SMC conference to discuss the evaluation, at which there was obvious enthusiasm on the SMC's part to address the challenges too.

However, it is also clear that the various work streams that I have talked about will not be enough in themselves. We need to take other action if some specific recommendations are to be addressed properly. For example, we need to reconsider how patients are supported through the whole process, particularly the exceptional prescribing process. I am more than happy to assure Frank McAveety and the committee that we will consider having liaison officers and better information for patients.

I have also made it clear today and in my response to the committee that the time is right to review the guidance on co-payments. It is important to highlight some of the key principles on that difficult and controversial issue. First, I stress that co-payment must and always will be the exception, not the norm. Under current arrangements, if drugs are shown to be clinically effective, they should be available on the NHS. We must ensure that we focus on ensuring equitable and improving access to clinically effective drugs on the NHS. Tina McGeever made that point powerfully on radio this morning.

Secondly, it is an important principle that the NHS cannot charge patients to provide treatment that would not otherwise be available to them. In other words, patients cannot and should not be able to pay the NHS to provide care that is not otherwise available; if they could, that would lead to a two-tier system.

However, patients already have the right to access care from the private sector. The question is the extent to which, when they exercise that right for one element of their care, the NHS can still provide other aspects of care. That must be considered case by case. If the treatment that is to be provided privately is so interwoven with NHS treatment that there can be no clear delineation between the two, concurrent treatment might not be appropriate for reasons of clinical governance and patient safety. However, if different elements of care can be separated safely, concurrent care may be possible.

Those are complex judgments, and the purpose of the revised guidance will be to provide clinicians, NHS managers and patients with the right framework for arriving at those difficult decisions. That framework must respect individual patient rights and protect the principle on which our NHS was founded: care based on need, not the ability to pay.

Photo of Mary Scanlon Mary Scanlon Conservative

Will that guidance also apply to people who pay privately for treatment in another country? When they come back here, they depend on the NHS for follow-up treatment. Will that situation also be covered in the guidance?

Photo of Nicola Sturgeon Nicola Sturgeon Scottish National Party

We can perhaps have a more substantial discussion about that later. Under those circumstances, the hypothetical patient described by Mary Scanlon would have access to NHS treatment. In many cases already, concurrent treatment would be possible.

I got the strong message from the Public Petitions Committee that there is a need to make the arrangements clearer and more transparent for patients—and indeed for clinicians.

This is an important if difficult debate. In some respects, it is controversial. However, I am determined to listen and to act where necessary. Our approach to introducing new drugs is robust and well regarded, but there is no doubt that it can be improved. I have been pleased to have been personally involved in the Public Petitions Committee's inquiry, and I will continue to ensure that the necessary leadership and commitment are in place to turn the committee's recommendations into a practical reality. I look forward to further debate and to continuing this discussion with members from across the Parliament, and indeed with the wider public.

Photo of Cathy Jamieson Cathy Jamieson Labour 3:31 pm, 1st October 2008

Like other members, I put on record my thanks to Frank McAveety and the Public Petitions Committee for bringing the report to the chamber. This afternoon's discussion is very important, and we will have to return to the issue in future.

This is my first opportunity to contribute to a debate in the subject area of my new portfolio responsibility and I know that many people have followed the issue—both professionally and as committee members—for much longer than I have. However, one of the useful things about having a fresh eye is that the key themes jump straight out of the piles of submissions and reports that I received from various organisations. I hope to identify some of those themes during my speech.

I pay tribute to Tina McGeever and Mike Gray. As the committee's report indicates, they both went through a harrowing process, but showed a great deal of dignity, strength and determination.

As Frank McAveety and Margaret Curran have recognised, Mike Gray's concern was not simply for himself; he sought to ensure that others would benefit from changes made as a result of his experience.

Everyone in the chamber will be touched at some point in their lives by cancer. Some of us will, sadly, have suffered and might suffer in the future. Others have lost, or will lose family and friends. In the face of such circumstances, every one of us would want everything possible to be done to treat the condition and to halt it, when possible, or to improve the quality of life of sufferers when that is not possible. We can all understand the scenario in which patients and their families want to pursue every possible avenue to get the best outcome possible.

At a time when they are at their most vulnerable, patients and their families need as much clarity as possible. They should have a real say in the treatment and care that is provided, and they should have confidence that everything possible is being done. They should be presented with honesty, not false hope. They should be made aware of the circumstances under which decisions are made.

I was struck by something that was highlighted in some of the briefing notes that various organisations supplied. Although the roles of the various bodies involved in decision making—such as the area drug and therapeutics committees, the Scottish Medicines Consortium and NHS Quality Improvement Scotland—might be relatively unambiguous, and although they themselves know what they are about and what they are doing, it is not easy for someone to weave their way through all those organisations and get a positive outcome if they have never come across them before.

People can experience further confusion when they discover that the guidance from the SMC is advisory, and that whether the patient actually gains access to the treatment still depends on whether the ADTC agrees to follow the guidance. As we know, there is no statutory duty to do so in Scotland, unlike elsewhere in the United Kingdom, where NICE guidance is subject to such a duty.

Frank McAveety painted a vivid picture of what Mike Gray found as he tried to make his way through the process at his local health board. Various organisations and patients have raised concerns about the processes for prescribing in exceptional circumstances being different, depending on the health board area. That is not a situation that we want to continue. Cancer Research UK has described the considerable variation in the implementation of SMC guidance, including on the processes for exceptional prescribing and the use of top-up payments. I was struck by that variation, which Cancer Research UK thinks is unacceptable. I understand that a number of organisations, including the British Medical Association, think that patients should be able to top up, but such an approach raises other issues, as the cabinet secretary said, and would potentially create more problems than it would immediately solve for the NHS.

Suggestions for improvements to the system have been made. There could be more sophisticated appraisal in the context of quality-adjusted life years, and exceptional prescribing panels could be more uniform, streamlined and transparent. Other issues must be considered. It has been pointed out that our spending does not necessarily reach the European average. More work must be done by the pharmaceutical industry with Government.

We should consider the matter from the point of view of patients and their families. Surely it is difficult enough for a person to deal with a diagnosis of cancer or other potentially life-terminating illness without having to worry about whether they have the wherewithal to afford top-up treatment, if that is the only option. Co-payments are the most sensitive issue in the report, and we will need to return to the matter.

I was pleased that the cabinet secretary said that she intends the review to consider change on the basis of the need to safeguard and preserve the fundamental principle of the NHS: equal access to care that is free at the point of use, regardless of ability to pay. I hope that all members will send a strong message of support in that regard. There are concerns that the least well off and the least well educated find it most difficult to negotiate the system. Whatever we do, we should not perpetuate existing inequalities or create new inequalities. If we are not to create a scenario in which two people on the same ward receive different treatment for the same condition, based on their ability to pay, we must resolve the difficult dilemmas that members described.

I ask the cabinet secretary to ensure that the review is based on the founding principles of the NHS and to acknowledge that the funding issues that might well arise will be considered as part of the process, so that we can ensure that the focus is not on finding ways for patients to pay for their treatment, but on ensuring that they receive timely, appropriate and effective treatment.

Photo of Nanette Milne Nanette Milne Conservative 3:38 pm, 1st October 2008

I fully endorse the comments of Frank McAveety and other members about the late Michael Gray and his wife, Tina McGeever. It is fair to say that all members of the Public Petitions Committee were deeply moved by the bravery of the couple, who, in the final stages of Mr Gray's illness, put so much effort into their petition, which aimed to secure a better experience in future for patients who suffer from terminal cancer and might benefit from drugs that are not approved for the NHS formulary. Mr Gray's evidence was delivered in a straightforward, unemotional way, as indeed was Tina McGeever's evidence when she returned to the committee a few weeks after her husband's death. That made a deep impact on committee members.

A number of important issues for the Government to take forward arose from the inquiry. If the end result is more clarity of procedure, more patient involvement and more support for people who are faced with terminal cancer, that will be a well deserved and fitting legacy for Mr Gray.

All five key areas that the Public Petitions Committee examined led to requests for Government responses. I welcome the cabinet secretary's sensitive and constructive reaction to much of what we put to her. The first area to be explored was that of defining the roles of and interplay between the bodies that are involved in appraising the clinical and cost effectiveness of a licensed cancer treatment drug. Although the committee was struck by the numbers and tiers involved in the process, we were reassured by witnesses that roles are well defined and have minimal overlap and that the system is clearly understood. However, the Patients Association thought that more transparency was needed in the appraisal process, specifically at local level, and the committee wanted to know how Government would improve the system and involve patients more at that level.

In that regard, it is interesting to note that a citizens jury that was set up by Breakthrough Breast Cancer regarded it as vital that all patients receive clear and realistic information on the true benefits, risks and limitations of new treatment so that they can make fully informed decisions on their treatment pathway. We hope that those issues will be addressed in the forthcoming better cancer care plan and that good practice at local level will be rolled out across Scotland.

On the issue of guidance to NHS boards, there is some doubt about whether the guidance is applied consistently and equally across all boards, despite the Scottish Government's expectation that health boards and clinicians should take full account of SMC advice and guidance from NHS QIS in light of any subsequent NICE multiple technology appraisal. The committee believes that more clarity is needed on how the Government monitors its expectation of health board compliance.

We were also concerned by the SMC assertion that it could not assess the uptake of its advice across Scotland because of inadequate data gathering. The current lack of data prevents the identification of areas where difficulties exist and where improvements could be made. All NHS boards would welcome a national data gathering system. It is encouraging to note that the Government's response to this section of the committee report states that steps are being taken to ensure that appropriate data are gathered, analysed and used to inform decision making.

Those roles of definition, guidance and data collection are clearly important in the equitable provision of approved and appropriate cancer drugs throughout the country. It is only right that patients receive the best recommended treatment available from the NHS.

The main focus of the committee's inquiry, in the light of Michael Gray's experience, was on the issue of exceptional prescribing, which comes into play when the SMC and the ADTCs have assessed that a drug should not be made available on the NHS, but the patient's clinician considers that the drug could benefit the patient and should be prescribed. NHS boards should have protocols in place to consider requests for non-formulary treatment, but the evidence that we received suggests that the procedure is not patient friendly and lacks equity and consistency across health boards. At a time when patients and their families are distressed and often bewildered by the realisation that they face a terminal illness, they need clear information, guidance and advice that lays out the options available to them. The patient and the clinician should be involved at every stage in the process of consideration as to whether a non-formulary drug is to be funded.

The committee believes that there should be a more consistent approach to non-formulary prescribing across health boards, with better communication between the board, the patient and the clinician. The process could be helped by the appointment of a liaison officer to guide the patient through the exceptional prescribing process. I welcome the cabinet secretary's commitment to consider that suggestion.

We also need unambiguous guidance on co-payments. For patients such as Michael Gray, who chose to pay for a non-formulary drug, the cost of the drug may be relatively inexpensive but the associated NHS costs can mean that the entire episode of treatment becomes prohibitively expensive. Of course, such issues are complex and involve financial, ethical, moral and clinical factors that need to be considered. Therefore, I very much welcome the cabinet secretary's stated intention to initiate a review of the guidance on co-payments. I also endorse Cathy Jamieson's comments. Co-payments are an issue of increasing concern, particularly in the treatment of advanced cancer, and are already being looked at south of the border. I hope that the results of the on-going reviews in England will be considered by the cabinet secretary in the course of her review.

In conclusion, the Public Petitions Committee's inquiry has revealed some extremely important and complex issues. If those can be resolved to ensure a smoother pathway of care for people like Michael Gray, the efforts of that brave man and his wife will have made an enormous contribution to terminal care in 21st century Scotland.

Photo of Ross Finnie Ross Finnie Liberal Democrat 3:44 pm, 1st October 2008

I welcome Cathy Jamieson to her new role. I also associate myself and my party with the opening remarks of Frank McAveety and of others in recognising the courage, tenacity and dignity of the petitioner, Tina McGeever, and her late husband, Michael Gray.

I congratulate the committee on producing such a comprehensive report on a difficult subject and on finding its way through the maze that is SMC, NHS QIS, NICE, ADTCs and NHS boards.

Since the report was published, we have had a constructive response from the Government, and the findings of the national medicines utilisation unit's evaluation of the SMC's impact on and engagement with stakeholders. The latter added weight to the committee's call for greater consistency in the adoption of approved medicines by recommending that medicines that are accepted for use should be included in formularies, and that by organising themselves regionally, ADTCs might achieve more consistent implementation. So some of the report's recommendations are already being picked up by others who are looking at the subject.

Without a shadow of a doubt, the Government's response accepted the principles enunciated in the report about the evaluation process, and it cited the forthcoming better cancer care plan as a potential vehicle to institute more rigorous monitoring and data gathering to monitor the implementation of advice. In his opening remarks, Frank McAveety elaborated on the need for even more development in that field, and that was broadly acknowledged by the cabinet secretary in her speech.

I have one further point on data gathering. I do not believe that there is any contention about this, but I hope that, as a matter of practical expediency, when the cabinet secretary refers to a particular report on cancer, she accepts that a number of the points made in it are applicable to a range of service delivery in the national health service.

The committee's report acknowledges the fact that, because of its intricate nature, the concept of the quality-adjusted life year was not addressed in full. However, it makes some serious and helpful recommendations about implementing health economic methodologies. I am pleased that the Government is participating in the United Kingdom research to consider methodologies and the QALY process.

There has to be such a process and Liberal Democrats believe that the QALY process plays an important, and often misunderstood, part in the current system. It is sometimes cited as an excuse for people not gaining access to drugs when that is not the purpose of applying the methodology. However, as the committee's report indicates, further research is needed.

There is no question but that the report is helpful in pointing out the range of misunderstandings, inconsistencies, and delays in the granting of exceptional prescribing across health boards. The cabinet secretary has acknowledged that, and work is in process. I thought it helpful that the cabinet secretary added the need to provide support for those who are engaged in that work. That was a key element of the report and I am in no doubt that, if all the questions that the report poses to the Government are comprehensively addressed—there is no suggestion that they will not be, but the cabinet secretary suggested that we do not have time to talk about them this afternoon—that will address the majority of the criticisms of exceptional prescribing.

The Liberal Democrats welcome this morning's statement by the cabinet secretary on co-payments, to the effect that the Government will review the matter and issue new guidelines balancing individual rights, clinical governance, and the need to avoid a two-tier health service.

The committee makes it clear that co-funding arises in only quite exceptional cases, and that has been acknowledged by members of all parties this afternoon. The more effective the system for approving drugs, and the more cost effective the commissioning and use of drugs, the more likely it is that co-funding will remain exceptional.

The Liberal Democrats hope that the cabinet secretary, in conducting a review, will take account of the Richards review that is being conducted in England, and also of the points made by the British Medical Association about the fact that, because co-payments affect a range of clinical decisions, an overarching response to the issue is required.

It is right that the matter should be dealt with on a case-by-case basis and we hope that when the concurrent treatment rule is applied after the review, it will not result in a patient being denied support through the NHS.

The committee's report addressed the critical issue of funding and paid particular attention to pharmaceutical price setting. I draw members' attention to the snappily titled recent report by the SMC, "An evaluation of manufacturers' budget impact estimates with resource use over time in NHSScotland", which revealed significant weaknesses in the quality of the budget impact information that the pharmaceutical industry provides to the SMC. It said that the manifest limitations in the budget impact data meant that meaningful and reliable comparisons with actual expenditure could not be made. It is clear that those findings have implications for budgeting for new drugs and thus for their availability, so I hope that the Government will consider the SMC's report carefully and, if necessary, issue new guidelines to pharmaceutical companies to improve health boards' ability to budget, thereby improving their ability to introduce new drugs.

I hope that that report and the findings that have been discussed in the debate will result in a much better, more transparent and more equitable way of dealing of patients, and that no one will have to experience the circumstances that the petitioner had to go through.

Photo of Ian McKee Ian McKee Scottish National Party 3:51 pm, 1st October 2008

The question of which drugs should be made available on the national health service can seem extremely confusing, so let us try to tease out some of the issues.

As the Public Petitions Committee's report tells us, no drug is allowed to be prescribed unless it has passed the scrutiny of one of the regulatory bodies. For the United Kingdom, that is usually the European Medicines Agency. A new medicine is judged for quality, safety and efficacy, so it seems reasonable for a doctor to prescribe it once it becomes available, but that is not always the case. There is no way of knowing the true safety profile of a medicine until it has been prescribed for a wide range of people, not just for the small pool of volunteers who were recruited for pre-registration trials. Likewise, efficacy becomes truly apparent only once the preparation is on the market and has been prescribed thousands, or even hundreds of thousands, of times. Some drugs have to be withdrawn as a result of unexpected serious side-effects only a year or two after becoming available. Others, which seem initially to convey only marginal benefit, flourish as their true worth slowly becomes apparent.

For those reasons, the wise doctor does not rush to prescribe the latest drug on the market unless there are compelling reasons so to do. Such a reason might be the fact that there is no alternative effective treatment for a particular illness. He or she considers all the evidence and then advises appropriately. Organisations such as the SMC and NICE provide some of the evidence to facilitate that decision. The SMC provides a snapshot of a medicine that is new to the market. NICE takes a more leisurely look, after the preparation has been widely available for some time. Their work is complementary. Along with area drug and therapeutics committees, many other organisations, such as the Scottish intercollegiate guidelines network, can offer informed advice.

However, we are in danger of allowing the presence of a horde of advisory bodies to obscure what should essentially be a very simple position. I argue—from the safe confines of the back benches—that their function should be to provide top-quality advice to the prescribing doctor, not to act as some sort of rationing institution. In a top-quality health service, prescribing decisions must be left to the doctor who is caring for an individual patient.

We are discussing cancer, and cancer patients vary enormously according to the severity or stage of their illness and the type of people they are. Gaining a few more weeks or months of productive life might be worth any risk of discomfort to one person, but such risk might be totally unacceptable to someone else. If I am ever in that position, I would like my treatment to depend on my personal preference, once I had received full information from a well-informed doctor. The few doctors who might abuse that position of responsibility should be dealt with individually. It is totally inappropriate that a health board or any other outside body should interfere routinely in that process as long as any medicine prescribed as a result is licensed for the purpose. In her evidence to the Public Petitions Committee, Tina McGeever said that it is important that the patient has someone in whom they can trust. I agree, but who better than the patient's own doctor? How sad that we think that that should not be the case.

I draw the line, however, if any proposed treatment has not been shown to be efficacious, particularly if it is wildly expensive and even if it has been given as part of a trial. A trial is to determine whether a medicine is efficacious and safe. If the preparation is shown early on in the trial to be of definite benefit, the trial is halted as it is unethical to deny it to the placebo group. The medicine should then be available for routine prescription. If it has not been shown thus, it seems unreasonable to make it prematurely available on the NHS. The same goes for alternative treatments of dubious worth. Evidence is everything.

Photo of Mary Scanlon Mary Scanlon Conservative

As an experienced prescribing doctor, does Ian McKee acknowledge that many medicines and drugs are given out to patients day and daily throughout Scotland that have never been evaluated?

Photo of Ian McKee Ian McKee Scottish National Party

I agree that many medicines and many treatments have not been evaluated. The challenge for the health service is to go ahead with the evaluation and get rid of some treatments, such as various homoeopathic remedies that are prescribed in the health service, which, to my mind, are totally useless.

Where does this leave us as far as co-payment is concerned? The danger of allowing patients to pay for medication that would not otherwise be available to them, and then to have it administered as part of the NHS, is that it could be the thin end of a wedge leading to a two-tier health service. If a medicine is of proven benefit, and both doctor and patient wish it to be prescribed, it should be allowed. As the cabinet secretary indicated, we must not fall into the situation whereby effective medicine is paid for by some and denied to others because they cannot afford it, but I do not see why a publicly funded health service should spend its time and resources and take the risk of administering treatments of no proven benefit, even if the patient is paying. There are plenty of organisations willing to administer quack treatments without the NHS joining them.

My plea is for health boards to take a step back and to trust their professional employees to make the appropriate treatment decisions for individual patients, but—as Mary Scanlon said—to insist on an evidence base to underpin those decisions. Effective cancer drugs should be available to all.

Photo of Duncan McNeil Duncan McNeil Labour 3:58 pm, 1st October 2008

I welcome the opportunity to speak in the debate, and I have enjoyed the speeches so far. We owe some gratitude to the Public Petitions Committee for securing the debate.

In many ways, the debate is just one strand of a wider debate on the future and evolution of the health service. We would all agree that the principle of free health care for all at the point of need is sound. At times, though, our health service can be bureaucratic to the point of being uncaring, as was highlighted by the circumstances of the Public Petitions Committee report. At the NHS's heart, however, are good people who deliver a good service to those who need it.

That said, we all need to accept that our health system is far from perfect. Our shared ambition of equality is not always delivered: we know that many people are already excluded from receiving appropriate services—the services that we would want them to receive—because of their social circumstances. We know that people who are disadvantaged die younger, and are less likely to go to a GP and will receive less time when they do. They are less likely to be referred to a consultant early and, as a consequence, are more likely to suffer. In my constituency of Greenock and Inverclyde a person can live 11 years longer than someone who lives three miles away.

As politicians and Governments, perhaps we should seek in our manifestos to equality-proof our health policies. We should ask whether cuts in health spending make people's situations better or worse and we should ask whether the mechanism for distributing finance to health boards really focuses on need. We should also ask whether a flat rate for efficiency savings hits urban areas disproportionately because such areas already have significant problems. We should ask—I admit to having been guilty of this—whether our focus on bricks and mortar, and on new hospitals and old hospitals, prevents us from shifting investment to areas in which it might help people to live longer and better lives.

Does reducing the cost of prescriptions really help the poor? Does greater access to general practitioners in the evenings or at weekends make it more likely or less likely that people with multiple problems or complex problems will get sufficient time with their doctors, or does it simply fuel an unrealistic expectation of the service?

Photo of Ian McKee Ian McKee Scottish National Party

Does Duncan McNeil accept that high prescription charges meant that lots of pharmacists had examples of people who could not afford all their prescriptions and would therefore ask for just one or two of them? Is he not pleased that such situations have now been removed?

Photo of Duncan McNeil Duncan McNeil Labour

It is a question of priorities. When we are spending money, and when our ambition is to put equality at the heart of service delivery, hard decisions have to be made. I do not believe that we are doing enough to end inequality. I know that Ian McKee has some sympathy with that argument.

Inequality exists, and some people are caught in a poverty health trap. However, as we have heard, other people are taking more responsibility for their own health and are taking things into their own hands. They are accessing private health care at home or abroad and are mixing and matching at the dentist. The multimillion pound business of over-the-counter medicines is testament to the culture of self-diagnosis and self- management of our health issues. NHS 24 and community pharmacists are all on hand to offer help and advice with that. In addition, we have the internet and Google.

People are empowered by knowledge and by a greater understanding of their health issues. That has fundamentally changed the relationship between doctor and patient and it is changing the health service as we know it. We cannot blame people for taking such opportunities; they are not always a bad thing. However, a consequence is that we are widening the gap between rich and poor. That prompts a question: What are we doing for those who are left behind? Now that we have lifted people's demands and expectations, we cannot suddenly say when things get serious, "Well, that's nothing to do with you. You can only fix your sore throat or your headache." When things get serious, and when family members are rallying round, we cannot suddenly say to people, "We are putting a cap on your expectations, your influence and your involvement." In reading the report of the Public Petitions Committee, I felt that no point was put better than the point that was made by a group of terminally ill women who were consulted by Breast Cancer Care. What they said lies at the heart of the matter: they described top-up treatments as "morally wrong", but confirmed that they would remortgage their homes to buy themselves and their families some extra time.

Whatever we do in the light of this debate and the subsequent review, we should consider the wider context. Our aim should be to level people up, not to level people down.

Photo of Jackson Carlaw Jackson Carlaw Conservative 4:04 pm, 1st October 2008

I begin by adding my thanks to those that have already been offered to the Public Petitions Committee for its report. My speech will principally address co-payments, but I start by saying that the committee has, in setting out the terms of its inquiry and in the clarity of the language that was used, especially in the opening section on defining roles, succeeded in producing a text that will help enormously in informing people who do not deal with such matters regularly, and in mapping a way through the various abridged terms to which Ross Finnie and Ian McKee referred. That section methodically explains a process and reviews it. Although the report accepts that the process can appear relatively complicated, it finds—as the cabinet secretary noted—that it is working well and has key strengths.

Debates about the running and future of the national health service can all too easily become tribal in character in the reality of adversarial politics. The Labour Party, which in government founded the NHS, sometimes stands accused of being prepared to ignore or be too sympathetic to any faults within it, while in turn this side is accused of seeking to identify those problems only in pursuit of some ephemeral agenda to privatise the service. Analysis and debate of important arguments often fall at that first hurdle.

It is, therefore, to the credit of the Public Petitions Committee that it has been measured in addressing an issue that has created such a sense of unease. It is clear, from the many organised submissions that have been received ahead of the debate, that that unease is deeply challenging. Events and developments in science are producing potentially life-saving treatments, but access to some of them appears to be outwith the NHS and they are not universally available. One can almost touch the very real concern that that creates. Given that it is a matter of life itself, none of the submissions is prepared to say no. However, the issue of co-payments or top-ups invites politicians to stray from the universal principles of the NHS. In her statement the cabinet secretary sought, in careful and appropriate, yet simple and impassioned language, to establish a potential route forward.

The report deals with the issues of availability dispassionately. It makes sensible points about the different approaches of health boards, illustrating that differences in the availability of treatments can often be reasonably explained by geography. What might be appropriate in an urban area with immediate access to a hospital may not be appropriate in a rural area, where the treatment may be quite different. However, that is for reasons of practicality, not reasons of cost.

On the other hand, concerns persist about there being a lottery. Last Wednesday, the BBC aired a programme that examined the availability of five top cancer drugs across the United Kingdom. All were relatively expensive and, at the time of the survey, none had the approval of the guidance bodies. The results showed huge variation of availability in the NHS and, despite the earlier argument about geography, there were many examples of variation between immediately neighbouring communities. All the treatments are refused in London, while all are funded in the north-west. In Wales, Swansea funded 8 per cent, while Pembrokeshire funded 70 per cent. In Glasgow, all the treatments were refused, while in Northern Ireland all were approved. That disparity is undermining public confidence. I agree with the cabinet secretary that our focus must ensure "equitable and improving access" to new drugs.

However, we must all surely share the anxiety that the protocols of our various systems are now found wanting in an environment in which there is such a pace of change. It is not a question of whether someone can jump a place in a queue; it is a challenge to politicians that is more complex, yet basic. Do we have a right, even with a faster approval process and a more generous budget for cancer drugs—to achieve that will, in itself, be quite a challenge—to say to people who are literally fighting for their lives that, if they accept treatment from outside the NHS, they will be denied further NHS treatment?

As other members have, I say that this is a real issue for my family. An immediate family member, a mother of three, is in the later stages of palliative care for a terminal cancer and has had the very best treatment. At no point has it been suggested that a treatment that is available outside the NHS would have made any difference. However, had that been the case, I would have done all that I could to ensure that it was made available to her. As Cathy Jamieson argued, I doubt that others would act differently. I would have been outraged if, in accessing such treatment outside the NHS, she was denied further NHS treatment. That is the human reaction that is shared by all those who have written to me.

I understand the position that the cabinet secretary outlined regarding the incompatibility of some treatments, which is of real concern. However, it is not understood in the public context of this debate, nor is it the axis around which the debate is growing in the public consciousness. Rightly or wrongly, many people see the issue as one of cost or of dogmatism—put bluntly, that we should all die together rather than reach for life and that, in trying to live, someone may be cast out thereafter from the NHS. I know that that is simplistic, but the current position is not sustainable: in all the measured words of the many submissions that I have read, and in the report itself, that is understood. I therefore welcome the review that the cabinet secretary is to initiate. If public confidence is to be sustained in the face of complex arguments, the review will need to proceed with some urgency.

I have concluded that, from today's unsustainable position, however narrow the initial dispensation, the incidence of co-payments or top-ups is likely to grow rather than to diminish. I do not share Ross Finnie's view that it will become more exceptional—it will not do so while science continues to gather pace and make substantial breakthroughs. I imagine that, in time, it will create its own insurance market, which will be quite distinct from current comprehensive private health care plans. I imagine that co-payment insurance policies will evolve and that premiums for such policies will be minimal by comparison with the comprehensive care model. It would certainly make such an option affordable to millions, rather than a few. I note this in passing not to advocate it but because I think that is how the market will eventually respond. We need only consider the experience of countries such as Denmark, where co-payments are allowed. There, specialised insurance cover has evolved and almost a third of the population take advantage of it. I accept that some people will balk at that prospect, but I do not.

Meanwhile—even in such an environment, were it to evolve—we need to be able to respond to new treatments quickly within the NHS. We have campaigned all our lives and in everyone's interests, not just the interests of some, to beat cancer and its cruelty. I appreciate the trenchant way in which Duncan McNeil addressed that point in terms of equality.

We might face what will be for many a difficult adjustment in policy, but in view of the gravity of the issue, we cannot allow ourselves to dwell on it as if it were some enigmatic puzzle, and neither should we jump to a judgment. It is important that the change is the subject of widespread agreement. The situation is, however, urgent: lives are being lost and will continue to be lost. The cabinet secretary stands ready to adjust policy guidelines within parameters. Let us establish what they are, and proceed.

Photo of Christopher Harvie Christopher Harvie Scottish National Party 4:11 pm, 1st October 2008

We are here today because of a tragedy—the illness and death by cancer of Michael Gray—and his wife's petition, which was founded on that experience.

The issue is an emotional one for me because three and a half years ago my wife, Virginia, was diagnosed with an unusual cancer that had developed between regular scans. It had moved to the liver and become inoperable. I still live out the time that was left to us and those days—there were only days—from the first consultations to the final diagnosis. I remember the kindness of nurses and doctors in the last weeks of the old Middlesex hospital, my wife's courage and composure, and the days of waiting at her bedside for death to come.

It is impossible not to feel for anyone who is facing such a situation, and to hope for some treatment that might reverse symptoms or at least prolong life. For those who know that they have only a short time, even that can be important. Anything that might enable the good death—arranging one's estate, providing for family, seeing projects through—is grasped. Surviving, at 64, I am in a minority among my friends, as many of them have died from cancer.

This issue concerns second opinions and alternatives. I telephoned my friend, Professor Theo Lippert, of the University hospital of Tübingen, who is a gynaecologist and pharmacologist. He delivered my daughter more than 26 years ago. He also lost his Scottish wife, Dr Elsie Lippert, to cancer. His view partly endorses the flexibility of the approach that is being urged in Tina McGeever's petition, which is to provide a framework for making cancer-treatment drugs available in medically justified cases to the relatively few who apply—the recent BBC availability study counted only 30 applications in Scotland in the past year—and making sure that the postcode lottery does not determine who can or cannot have access to drugs or other treatment. I agree with both aims.

Second opinions are important, and should not be sidelined due to cost or administrative considerations. However, the subject is opaque and drugs are not the only consideration. In a recent case, a constituent of mine was offered for prostate cancer a hormone treatment that would have extended his life for two to three years, but with a poor prognosis. He opted for surgery, which was not covered by the NHS. It was successful, but he had to negotiate it for himself, and became liable for the full costs. That is where we require flexibility, which is not necessarily limited to exceptional prescribing.

My Tübingen colleague, Professor Lippert, is sceptical of the treatments that rely on drugs alone and do not take an holistic view of the patient's past health and treatments, nutrition, nursing and other therapies. In general he—as I do—approves of a system of licensing and issuing of guidelines such as we have in Scotland through NICE, the SMC and NHS QIS. He is sceptical about the German experience and believes that of the roughly 1,000 well-marketed and often expensive cancer remedies on the market, only about 20 per cent benefit the patients. He believes that clinicians must concern themselves with factors such as nutrition, scanning and previous illnesses and treatments, and must work closely with pharmacologists, nursing experts and specialists, who have sometimes tended to remain marginal to the clinical process. He also insists that too much emphasis is placed on average rates of survival, rather than on concentrating on the particular situations of individual patients.

That approach—focusing on the individual patient in a more holistic view—is one aspect, but it must be viewed in the light of an Office of Fair Trading report that was published in February 2007, which accused the pharmaceutical industry of deriving £8 billion of excess profits from the national health service. I ask whether other medical approaches that do not involve expenditure on drugs, and other essential infrastructures, have advocates that are as persuasive and as well-heeled as the big pharmaceutical companies. As in so many other fields, equitability must lead to a stronger public presence.

Photo of Malcolm Chisholm Malcolm Chisholm Labour 4:16 pm, 1st October 2008

I pay tribute to Michael Gray and Tina McGeever for the general contribution that they have made to Scottish life and for their particular contribution on this issue.

In considering the topic, we should set ourselves two complementary objectives. First, we need to maximise the number of effective cancer drugs for patients and secondly, we need to achieve that equitably throughout Scotland. The difficulty with co-payments is that they help the first objective but undermine the second, which is why we face a dilemma.

I will return to that point later, but I will start with the issue of getting effective cancer drugs. I will briefly put in a plug for the Beatson translational research centre, which will put Scotland at the forefront of translational research. A fundraising appeal for the centre has been launched, to which I hope the Government will be able to chip in.

With regard to improving the number of available effective cancer drugs, we need to take two actions in the immediate future. First, it is necessary, as members have said, to review the QALY process—people will know that, in this context, it means quality-adjusted life years—to reflect rising health costs. That would mean maintaining the cost-benefit approach, but allowing a higher cost for a given level of benefit.

Secondly, we need to examine the issue of risk sharing and value-based pricing agreements with pharmaceutical companies. That started in Scotland in relation to beta interferon and other drugs for multiple sclerosis in 2002, whereby if the drugs were not fully effective, the costs that the industry charged to the NHS would be reduced.

In relation to cancer, I have come across one specific example: a response rebate scheme for the drug Velcade, which is used to treat patients with multiple myeloma. Under that arrangement, patients who are making progress have the treatment fully funded by the NHS, but for patients who show no or minimal responses, the drug costs are refunded by the manufacturer. That model should be explored further as a way of getting better value for money.

Great strides have been made on equity in Scotland over the past 10 years, as Dr Andrew Walker acknowledged in his evidence to the Public Petitions Committee. I was pleased that Professor Johnson of Cancer Research UK praised the Scottish Medicines Consortium, saying that it

"is the envy of clinicians who work in England" and that it is

"a model of good practice".—[Official Report, Public Petitions Committee, 29 April 2008; c 709.]

When the SMC was set up, there was a debate about the relative balance between centralised and localised decision making. I am sure that we support local decision making in many other areas, but in relation to this matter there must be some central direction. That is why guidance was issued that stated that NHS boards should ensure that recommended medicines are

"available to meet clinical need."

Improvements are needed in that area in relation to monitoring what boards are doing and intervening when necessary. That is highlighted in the committee's report and in the submissions that were made to the inquiry.

There are also issues about exceptional prescribing procedure, to which we need to take a more standardised and transparent approach. Various members have talked about the need to improve data and hospital prescribing. Finally, we need to explain everything to patients, and I am glad that the Government has taken that on board in its response.

I have covered those points quickly, because the heart of the debate—the big controversy—concerns co-payment. I am glad that the committee has recommended a review and that the Government will go ahead with it. I have listened carefully to what Nicola Sturgeon said about the issue on the radio this morning and in Parliament this afternoon and it seems clear to me that she accepts that there are serious clinical governance and risk issues with co-payment and that she will take those on board.

In the evidence, I was struck by a quote from Professor Alan Rodger, medical director of the Beatson oncology unit—to whom we should pay tribute as he is retiring soon. He talked about two clinicians treating a patient and said that there could be

"one in the private sector delivering one drug, the other in the NHS delivering three drugs. That is not good clinical care. It is a recipe for disaster."—[Official Report, Public Petitions Committee, 29 April 2008; c 751-2.]

I am sure that those clinical governance issues will be considered, but the heart of the matter is the fundamental issue of principle and the risk of, threat of and concern about a two-tier health service developing on the back of co-payment.

We all have sympathy with patients who are in the situation that is highlighted in the petition, and members are aware of patients who come to the committee or to our surgeries who are in that position, but it is important that we exercise our imaginations today and look ahead to a situation in which the guidance is different. In that regard, I think Jackson Carlaw's speech has been the most useful in the debate so far, because he described the future that will arise if we go down the route of co-payment. Members should read his speech and reflect on the consequences of that approach. If we go down that route, another group of patients will come to us with their concerns. There will be a situation that does not exist now in which patients are side-by-side in beds in the NHS and one is getting one treatment while the other gets a different treatment because he or she can afford it. Not only poor people but many people on modest incomes will come to us and ask, "Why shouldn't I get the treatment that's available to someone else?" Members need to reflect on that.

We should also listen to the cancer charities, which have reflected seriously on the matter. I am sure that we have all read the briefing from Cancer Research UK, which says that co-payment

"has the potential to create more problems than it solves."

We all received what is perhaps an even stronger submission against co-payments from Macmillan Cancer Support today. Yesterday I talked to a senior cancer clinician who gave the same objections. We must think long and hard about the issue. It will be interesting to hear what Mike Richards comes up with in his review in England, but we have to take a Scottish view. My current view is that we should be very wary of co-payment, but we should certainly take all the other necessary actions.

Photo of Ross Finnie Ross Finnie Liberal Democrat 4:22 pm, 1st October 2008

This has been an extraordinarily constructive debate. It has served to illustrate the fact that, as with all such matters, issues of due process arise in the complex area of approving drugs. We must get over those quickly so that we can concentrate on the outcomes that we all seek: better drugs and better availability of drugs.

Necessary though the process is, I am sure that the convener and members of the Public Petitions Committee would acknowledge that their understanding of it was greatly illuminated by having to consider the petition. I am sure that all members in the chamber this afternoon who have had to read the material, the report and the submissions would recognise that our knowledge has also been hugely improved. That is good for us, but it is the end users, our constituents—the patients—who ought to be able to understand the process. The process is, demonstrably, hugely complex, so there has to be a better way to conduct it. I hope that one of the outcomes from the report, following the further consideration that it will be given, is that we can help patients to understand the process to which they might find themselves being subjected.

Ian McKee explained—as usual, using his own background and experience—the obvious route down which one might go if the efficacy of a drug has been determined. However, its efficacy is measured against a set criterion, so the process is not necessarily as simple as we might believe. That illustrates the difficulty of such a process in a demand-led service—any Government and any minister would face such constraints. Members made the point in their speeches, as did the SMC in the report to which I referred earlier, that in making such determinations, that the SMC gets poor advice from the pharmaceutical companies about the cost appraisals of drugs. That problem must be addressed as a matter of urgency.

I share Malcolm Chisholm's view that, in his excellent way, Jackson Carlaw illustrated the genuine problems going forward. Even if I am wrong and exceptional circumstances become the norm, some form of insurance payment—I am not trying to put words in Jackson Carlaw's mouth—would serve only to illustrate the difficulties, which must be addressed by a committee of the sort that the cabinet secretary spoke about.

I repeat that this has been a constructive debate. As I said in my opening speech, I hope that not only the excellent report produced by the committee but the valuable and constructive speeches made during the debate lead to a better outcome. I also hope that the cabinet secretary will give some thought to how that is to be achieved. We cannot rely simply on the Official Report as an entirely satisfactory way of addressing all the important issues that have been raised in the chamber this afternoon.

Photo of Mary Scanlon Mary Scanlon Conservative 4:26 pm, 1st October 2008

I acknowledge Ross Finnie's point that many issues for wider debate have been raised today.

I thank the Public Petitions Committee for its excellent work on this complex issue, which was described by Professor Rodger of the Beatson Institute for Cancer Research as a

"moral, ethical and logistical nightmare and minefield."

I thank Michael Gray and Tina McGeever for raising the subject of our debate today, which I believe will lead to greater clarity, better understanding and, hopefully, as Nanette Milne said, cancer patients being given clearer options and better access to cancer drugs.

Cetuximab is widely available throughout the European Union, yet not in the UK. That raises questions about the appraisal processes of clinical cost effectiveness as well as the QALY process of NICE and the SMC.

It is worth putting on the record the fact that in Scotland we are world leaders in cancer research, yet we have the worst cancer outcomes in the whole of Europe. A study published in The Lancet Oncology last year charted patients diagnosed in 21 countries who survived cancer for more than five years. With only 48 per cent of women surviving after five years, Scotland sits at the bottom of the league table despite having three times the health budget of countries such as Poland and the Czech Republic. Our 48 per cent survival rate compares with 53 per cent in England and 52 per cent in Ireland. Only 40 per cent of Scottish men live for more than five years after diagnosis, which puts us in the bottom four of the league table. Although we might equal EU health spending, we are far from equal in cancer outcomes.

I have discovered that there is a difference between co-payments and top-ups. I understand that a co-payment is a payment for the same episode of care and that a top-up payment is for a different episode of care. Unfortunately, no one seems able to define clearly an episode of care.

When we talk about a health service that is free at the point of delivery, as Duncan McNeil did, and which based on clinical need, we are not being entirely truthful. We need to be clear that most people are not entitled to free podiatry treatment, that dentistry is certainly not free for many people and that many GPs do not even bother referring patients to physiotherapy because of the long waiting list—those patients are simply told to find a private practitioner.

Although many thousands of Scots access homoeopathy treatment—they would not have taken Ian McKee's advice—no one assumes that, having paid for such treatments, those patients are then excluded from NHS treatment. Neither has anyone been excluded from NHS follow-up treatments following surgery in other countries, which many people in Scotland access. Consultation on the issue has to be wide ranging and has to result in much greater transparency.

As I said to Ian McKee, it is worth pointing out that many hundreds of drugs that are prescribed day and daily throughout Scotland have never been evaluated. There is an assumption that we are in a perfect situation, but that is simply not the case, as he acknowledged. It is questionable whether all the drugs that are prescribed day and daily in Scotland would now pass the rigorous appraisals of NICE, the SMC, QIS, the area drug and therapeutics committees and a consultant's medical opinion.

I remember that when we arrived in the Parliament in 1999 Shona Robison joined the campaign for beta interferon to be given to multiple sclerosis sufferers. At one point, it was assumed that beta interferon would benefit all patients with MS; however, it benefited only 16 per cent of MS patients. I commend the Government for providing neurology assessments to ensure that those who would benefit from that drug would get it. I make that point because the therapeutic value of a treatment can be different in different patients. Rather than having a blanket ban on, or a blanket acceptance of, a drug or therapy, we could do more to specify which patients would be most likely to benefit from particular treatments. More clinical trials might be the answer, but I would prefer a drug such as cetuximab to be made available to the patients who are most likely to benefit from it, rather than being refused to all patients.

Michael Gray was forced to pay for cetuximab, which was recommended by his oncologist. Only after it was proved to be effective did NHS Grampian agree to fund the treatment. Surely it is not for the patient to pay for the clinical trial and for the NHS board then to decide whether to agree to pay for the drug according to whether there is a health improvement. I hope that that important point is taken on board.

In the context of arguments for private provision and those for public provision, I hope that the cabinet secretary's consultation will look at the availability of orphan drugs, which are referred to in paragraph 106 of the committee's report. There is no doubt that state intervention is essential in such cases to ensure that pharmaceutical companies carry out research on rare conditions. Given the low numbers of patients involved, the costs of those drugs can be prohibitively high.

We welcome the Government's review of co-payment guidance and we trust that all the contributions to the debate will be taken into account.

The Conservative health team at Westminster has had a huge response to its consultation on this complex issue. I understand that the UK Department of Health is also consulting on the issue.

Although the SMC was set up to end postcode prescribing, that has not happened, given the role of the ADTCs. If no data are collected on the implementation of advice and guidance across NHS boards, a patient's chances of survival could vary significantly depending on where they live and what drugs are available locally.

If we are to respect clinical judgment, more credence has to be given to the patient's clinician. We want our NHS to provide optimum patient care and advice, not to have clinicians and patients fight their way through a mass of bureaucracy.

Photo of Richard Simpson Richard Simpson Labour 4:33 pm, 1st October 2008

I join the many members who have paid tribute to the petitioners. The petition is one of the best illustrations of the petitions system working: a petitioner who had a personal problem and difficulty with the system generated a debate and pursued the issue vigorously for the greater good.

Ross Finnie said that the issue is not just about cancer. We should not lose sight of the fact that it is about many drugs other than cancer drugs. The report on cancer that is due to be published might help in relation to cancer drugs, but it will not solve the problem altogether.

A point that has not been made so far is that doctors are human beings and wish to do their best for their patients, irrespective of the realities of the evidence. They are taught to treat where possible. Sometimes treatment can be more harmful than beneficial to the patient, so the assessment of risks to and benefits for the individual patient has to be carried out in a partnership involving the doctor, the patient and, sometimes, another independent element.

Cathy Jamieson, Christopher Harvie and Jackson Carlaw referred to the fact that almost every one of us will be touched by cancer. The lifetime risk of developing cancer is one in three, and the risk applies especially to the over-65s. Annually, two in seven of all deaths in Scotland are cancer related. Many survival rates have improved, but cancer remains a massively important area of health. Cancer accounts for much palliative care and raises problems to do with extending life in a reasonable way.

No member has criticised the initial process of licensing a drug in Europe or in the UK. The question is whether that process is enough. In some countries, it is enough. Ian McKee suggested that if a drug is licensed—if it is effective and safe—it must be given if a clinician recommends it. However, we have chosen a different route, which involves another tier—the Scottish Medicines Consortium. We should take heart that many praise that system and that, in evidence, it was described as one of the best systems in Europe.

Photo of Ian McKee Ian McKee Scottish National Party

Should the benefits of that extra layer of bureaucracy be extended to private patients who are receiving treatment?

Photo of Richard Simpson Richard Simpson Labour

I am not sure—I must think about that. The important point is that the Scottish Medicines Consortium draws together the evidence—such as it is, as Ross Finnie said.

Some evidence about cost effectiveness from the pharmaceutical industry is still probably not as good as the industry would like and is certainly not as good as we would like. I will return to that.

Scotland has another tier. I understand that advice is not statutory, so the area drug and therapeutics committees decide when and at what speed drugs will be introduced in Scotland. I gather that the cabinet secretary will examine that, which is fairly important.

We do not know exactly what happens. The new national medicines utilisation unit is giving us information, but we need better data collection to allow the Government to decide whether the system is working as well as we would like.

I have described the basic system, but we are concerned about what happens beyond that. If a drug is not yet approved by the SMC, is awaiting appeal after rejection or is finally rejected, that means that a licensed drug that appears to be effective in some circumstances is not recommended for use on the ground of cost effectiveness. Here enters SIGN, which does not have to take into account cost. SIGN makes recommendations only on the basis of effectiveness. That is a potential conflict that needs to be resolved.

That brings us to the exceptional needs situation, to which many members have referred. On 11 March, I wrote to ask every health board how it deals with exceptional needs. I was staggered by the variety of their replies, which ranged from a massive document from NHS Grampian—I recommend it to the cabinet secretary as a good starting point—to four lines. The criteria, the committees that ran the system and the appeals procedure were unclear. If that is just the general information that one can gather, how much harder is it for a patient and their clinician to wend their way through that complexity? One point from the committee's report on which we agree is that we need total clarity. We cannot continue to have the situation—to which Jackson Carlaw, among others, referred—in which Sutent, which is a kidney drug, is approved almost totally in some areas but rejected in others.

Co-payment is a fundamental and really difficult issue. Perhaps the original design of the NHS is no longer adequate. Duncan McNeil argued eloquently that whatever we do must be equality proofed. We must not introduce a new system that creates further inequalities or separates groups further. The two-tier issue will remain extremely difficult.

The Richards report might help us, but one possible solution is to have a new partnership with the industry, to which Malcolm Chisholm referred. In essence, under that partnership, the industry would pay for what does not work and we would pay for what works. That is a principle to which we could sign up to with the industry if it, too, was prepared to sign up to it. Such a partnership would remove the problem that some, but not others, are eligible on the ground of wealth. No member in the chamber, whatever their party, would accept a situation in which the ability to pay affects how someone copes.

Last year, the drug bill for Scotland passed the £1 billion mark. Back in 1999, that figure would have amounted to almost 30 per cent of our total budget; today, it is about 10 per cent. As a result of the Public Petitions Committee's excellent report, we need to review the interlocking structures in the NHS, QIS, the SMC and the cancer management networks, which I have not yet mentioned. Also needing review are the SIGN guidelines, the role of NICE in relation to the SMC, and governance issues between boards and the area drug and therapeutics committees.

We must ensure that there is data collection, to inform us and to be analysed. We must also ensure that the exceptional needs criteria are generally understood and readily available to the patient and that there is transparency in the system, including the appeals system. We need to avoid postcode discrepancies. We must achieve resolution and clarity in terms of co-payment. The basis on which drugs are issued should not be the ability to pay.

Photo of Shona Robison Shona Robison Scottish National Party 4:41 pm, 1st October 2008

First, I acknowledge the extent and quality of the debate. Members in all parts of the chamber have evidenced the fact that the issues are highly emotive, complex and often contentious. The accounts of individual experiences clearly demonstrate the very real impact of processes and decisions on patients and their families. I, too, pay tribute to the late Michael Gray and his wife Tina McGeever.

What has come to the fore today is a clear understanding of the numerous strengths of the Scottish system; in very many dimensions, it works, and works well. As Richard Simpson outlined, the Scottish Medicines Consortium makes decisions on every new medicine quickly. We can have confidence in that and that debate at the SMC is robust and that many perspectives are taken into account before a decision is reached. SMC decisions are authoritative and its recommendations are widely accepted. Cathy Jamieson was right to say that its guidance is not statutory, although it is important to make it clear that SMC guidance is not advisory either; health boards are expected to adhere to it.

The recent SMC evaluation work provides evidence of just how far Scotland has come. Indeed, some might argue how far ahead Scotland is in being able to undertake assessments of all new drugs at an early stage after they have received marketing authorisation.

We have evidence that area drug and therapeutics committees have robust arrangements to ensure that SMC recommendations can be fully considered in the local context. In that context, it is important to mention the proactive role that regional cancer advisory groups take in supporting the introduction of new cancer drugs. Those who work in the system consider that the processes that have been put in place have congruence, are robust and reflect the key values of the NHS. However, as members have made clear this afternoon, and as others have set out in their oral evidence and submissions to the Public Petitions Committee in its inquiry, the public, patients and their families need to be given a much better appreciation of why arrangements are in place, how they work and how decisions will be made about patients' care. Those are, and will remain, difficult decisions.

After the evidence of benefit and disbenefit have been weighed up, decisions have to be taken in the cold light of day—on whether a new treatment will make a real difference to the quality of life and survival of a patient and whether a case can be made in the context of many competing demands. As Ross Finnie said, there will always be constraints in a health system.

In "Better Health, Better Care" we committed to providing high-quality evidence-based care. That is what we will strive to do, against a background of an NHS that faces increasing demands. Before I concentrate on co-payments, which have received considerable attention, I will take a few minutes to focus on the actions that will follow this important debate.

The forthcoming Scottish Government better cancer care plan, the e-health strategy and the outcome of the evaluation of the Scottish Medicines Consortium provide the basis for taking forward the recommendations in the Public Petitions Committee report. Further work is planned to deal with some of the more specific recommendations, but I underline that it is important that the recommendations are addressed as a whole and in a manner that demonstrates a coherent policy framework with a strategic plan for delivery. That will mean providing better information to the public, making better use of data, ensuring consistency of process based on a principled approach, undertaking further work to develop health economics methodology and continuing to engage in UK-level discussions on drug pricing. NHS boards will continue to be held to account through existing performance management arrangements, and the SMC and ADTCs will continue to develop and build on their success to date.

The fundamental point is that patients and their families will, in time, feel more supported and better informed about the decisions that are made on the care that is in their best interests. Moreover, as we see the true benefits of mutuality within integrated organisational arrangements, patients and their families will feel more involved in such decisions when that involvement is appropriate for them, when they are able to be involved and, most important, when they want to be closely involved. All that is achievable, much of it through work that is already under way or planned, and through the enhancement of existing arrangements.

It is worth mentioning the work that the Association of the British Pharmaceutical Industry and the Scottish Medicines Consortium are doing together on market access schemes—something Richard Simpson and other members raised. That is important work that could lead to a new partnership.

Duncan McNeil made some wider points about health inequalities. I recognise that, as he said, for people who live in our most deprived communities, the issue is why they present later and die earlier. Those important matters are being tackled through "Equally Well: Report of the Ministerial Task Force on Health Inequalities"—we will have the implementation plan for that by the end of the year—and the keep well programme and its expansion. They are also being tackled through our continuing discussions about the development of the GP contract and our consideration of the minimum practice income guarantee—in which Duncan McNeil is well versed—and its relationship with the funding of practices in our more deprived communities.

It is important to recognise that some of the other work that is going on has a direct relationship to important issues that have been raised in the debate.

I will now address co-payments. Patients are entitled not only to receive free NHS care but to exercise choice about receiving some or all of their care privately. The NHS cannot charge patients unless legislation specifically allows for that to happen, but the fundamental and overriding principles must be patient safety, probity and clinical accountability, as a number of members said. In taking forward the work on co-payments, we will ensure that patients can continue to receive the free NHS care to which they are entitled, that the NHS's wider interests are protected and that patients who seek private treatment have a clear understanding of what the NHS will continue to provide. The policy position remains the same: we will not preside over a two-tier health system. That point was raised in the debate, and I hope that I can give reassurance on it. We recognise that the guidance must be clarified and updated—and it will be.

The measures that we have set out demonstrate a constructive and robust response to the committee's recommendations. The focus will now be on implementation. We will be pleased to keep the Public Petitions Committee informed of progress.

I thank all members who have taken part in the debate and concur with many people that it shows the Parliament at its best. We can take the issue forward united across the chamber. The outcome will be all the better for that.

Photo of John Farquhar Munro John Farquhar Munro Liberal Democrat 4:50 pm, 1st October 2008

We have had an extensive debate. My convener said that it was a pleasure and a privilege to open this important debate on the Public Petitions Committee's report on its inquiry into the availability of cancer treatment drugs on the NHS. I echo those sentiments.

The inquiry identified where improvements are needed. As the convener said, the inquiry has been petitioner led. We have arrived at this point not because of something started by the Scottish Government, or indeed by the Public Petitions Committee, but because of what Tina McGeever and Michael Gray started all those months ago. We pay tribute to them both.

I thank fellow committee members. We worked well together as a team. I also thank those people who gave evidence to us. We took evidence from many groups and organisations, which contributed greatly to identifying what is working well and what is not working so well.

I will speak about defining roles and the guidance that is issued to NHS boards. I also wish to address some specific points that have been raised during the debate.

The committee was struck by the number of bodies that are involved in the drug appraisal and availability process. There was a lengthy debate about that. On the whole, the evidence suggests that the system works well and that the various roles and responsibilities are clearly defined. The overlap between bodies is minimal and the processes are easily understood. We were pleased about that. However, the committee asked the Scottish Government to consider the scope for monitoring the roles of the different bodies, the possibility of streamlining to produce efficiencies, how performance management arrangements would be put in place and the need to provide greater transparency in the roles of the bodies and to have more patient input into them.

The Scottish Government responded. It sought to ensure that the end-to-end process, from licensing through to exceptional prescribing panels, is explained in an understandable and accessible way. Its approach will be amplified in its forthcoming better cancer care plan.

I think that it was Ross Finnie who was anxious that the petition might not continue and that it might not receive the scrutiny it deserves. After the better cancer care plan comes to the committee, we will keep the petition alive and give it scrutiny until it is finally completed. I believe that Ross Finnie had some concerns about that very issue. [Interruption.]

Photo of Alex Fergusson Alex Fergusson None

Order. I ask members who are coming into the chamber to be quiet, please. We are in the closing stages of a debate.

Photo of John Farquhar Munro John Farquhar Munro Liberal Democrat

The Scottish Government said that it will reflect on the outcome of the impact and effectiveness evaluation of the Scottish Medicines Consortium and on its continued work with the SMC, NHS boards and other bodies, to identify further improvements for cancer patients and their families who become involved in the process. The Government said that it seeks to build on examples of best practice locally and on requirements for patient and public involvement.

Many members described personal experiences, some of which had been traumatic and difficult. The committee was anxious to improve the situation and we cannot disagree with the Scottish Government's desire to improve patient involvement, decision making and the overall process—who could disagree with such a desire? We look forward to being given proper examples of how those improvements will be made and clear evidence that backs up the Government's response. We await those details with baited breath.

The committee considered the roles of everyone who is involved in preparing guidance and was interested in how guidance is issued and implemented across NHS boards. Are there regional variations? Is the guidance applied equitably? How does it filter down to clinicians—the people at the coalface? Is there clarity and understanding among clinicians? That is a matter for debate, but members suggested that the situation is not as we might have understood it to be. The committee concluded that there appear to be regional variations in how guidance is applied, but we cannot say what level of variation there is.

We want to ensure that clinicians are not being put in a difficult position and that there are no adverse impacts on cancer patients—that is the last thing in the world that we would want.

Cancer Research UK said that it wants improved audit arrangements to record how NHS boards incorporate SMC advice into decision making, which is important. The Scottish Government said that it will keep NHS accountability and performance management arrangements under review, but we do not know how it will do that. We will take advice on the matter. The Government said that in general the present arrangements for planning and provision of services work well and that the forthcoming better cancer care plan and response to the SMC evaluation will provide an opportunity to monitor and address variations.

We look forward to being given precise details of how the Scottish Government will action Cancer Research UK's suggestion that SMC advice be incorporated into local board decision making processes. We also look forward to learning how the better cancer care plan will provide an opportunity to monitor and address regional variations in the application of SMC guidance.

I am squeezed for time. The committee will continue to investigate the issue that was raised in the petition, which is important. Questions are being asked not just in Scotland but elsewhere, for example about co-funding. We heard plenty about co-funding in the debate. Mary Scanlon asked whether people who pay for private treatment abroad are being deprived of NHS facilities on their return. That is an important issue. Questions are also being asked about exceptional prescribing processes and pharmaceutical price setting. There is much evidence on those important matters and in our report we refer to the debate that is going on in England.

We hope that the cabinet secretary and her officials will take away the many and varied points that were made in the debate and address them in the forthcoming better cancer care plan. As I said to my colleague Ross Finnie, the debate on the petition will continue in the weeks and months ahead. As the convener of the Public Petitions Committee said, we stand ready to work with the cabinet secretary as the matter is given further consideration.