Cabinet secretary, do you wish to make a statement?
I have a very brief statement, if I can find it.
I hope that it is briefer than the previous one.
It is much briefer—it is one side of an A4 sheet, which I know you welcome.
I welcome the opportunity to talk to the committee again about access to new medicines and about the questions that the committee raised in its letter to me in March. We are making progress in line with the committee’s recommendations. Most significantly, submissions are being put to the Scottish Medicines Consortium that will potentially fall within the new approach that is set out in its report. If that approach is realised in the way that the SMC report suggests, it will be a significant improvement for patients in Scotland, and I know that others around the world are already taking interest.
The committee asked me about the financial implications of the new approach, SMC resourcing and individual patient treatment request changes, and I am happy to answer any questions that you have.
Thank you for that brief statement.
We all welcome the cross-party consensual approach that the committee has taken consistently to access to new medicines and the individual patient treatment request system, which is undergoing change.
Some of us are particularly keen to get more information on the transition period. I should put it on the record that I have made a number of representations to the cabinet secretary about one particular constituent and a previous unsuccessful individual patient treatment request relating to an ultra-orphan medicine. I hope that a new request will go in soon. I will not go into the details of that, but the situation illustrates the specific point that, depending on when that request goes in, it will be dealt with under what we hope will be the new flexible IPTR system or under the so-called PAC system—the peer-approved clinical system. There is a nervousness that some patients could fall between two stools, and we are keen to ensure that that does not happen in the transition process.
On the timescale, do you have a definitive date or an estimate of when we will switch from what we hope will be the more flexible IPTR system to the PAC system?
First, our plan has always been to move to the new system by May of this year, and we anticipate that every board will be able to do that. Secondly, we have made it absolutely clear that, in the interim period, there should be maximum flexibility and that the IPTR process should have regard to the new and more flexible system that we are introducing. I looked at the submission from the Beatson oncologists and we have spoken to NHS Greater Glasgow and Clyde to ensure that it is in line with every other board in Scotland in applying a more flexible approach that is in line with the philosophy that we are now pursuing.
For me, the key issue is to ensure that, when a patient would benefit from a particular drug within a reasonable time period and the benefit is genuine and reasonably long lasting, the patient should get the drug. My understanding is that that is now happening in Glasgow, as it is throughout the rest of Scotland.
You have presupposed my next question, which is on concerns about the Beatson west of Scotland cancer centre, the west of Scotland cancer network and the fact that four health boards make referrals to that facility. Following their evidence to the committee in February, the oncologists again raised concerns, but I note that NHS Greater Glasgow and Clyde refers in its submission to a policy that was agreed to by the Scottish Association of Medical Directors and which gave rise to
“optimism that an NHS Scotland consensus could emerge”
on an
“interim arrangement which will be displaced when PACS is implemented.”
However, it is now hoped that there will be one process for IPTRs at the Beatson to ensure that the place to which the patient is referred, not the board that refers them, decides on the IPTR. Is that the situation just now with the Beatson?
I will ask Kathryn Fergusson to give you the exact detail, but I have to say that I found the Beatson oncologists’ evidence a bit strange. The week before they submitted their evidence, they met Greater Glasgow and Clyde health board and apparently raised none of the issues in question. We got in touch with Glasgow, and my understanding is that there is now a clear way forward in Glasgow as there is throughout the rest of the country.
Mr Doris is quite right about the process that Glasgow has described in its letter. The committee might recall that in June last year, before it reported on its inquiry, the cabinet secretary asked HIS to look at a specific case involving the Rankin family in Ayrshire and its particularly poor experience of the process. The subsequent report contained some quite helpful commentary about cross-board working between health boards, and what emerged quite strongly from that and from our conversations with patients and their families was the importance to those who are going through the process of putting the clinician and consultant who knows them best at the heart of the process. As a result, what we want in the PAC system is for the clinician and consultant to be part—indeed, at the heart—of the decision making. It is quite right that the process that Glasgow described in its letter has been going on for some time now, but HIS’s work identified certain changes in the process that we needed to be aware of and their pros and cons.
Mr Doris mentioned the Scottish Association of Medical Directors’s discussion about the Glasgow approach. I understand that the issue was discussed again at the association’s last meeting, which took place only a couple of weeks ago, and although the medical directors noted the Glasgow approach there was no indication from other health boards in the rest of the country that in the interim they were going to change what they were doing—which would appear to us, as people on the outside looking in, as embracing the flexibility that was requested in the committee’s report and by the chief medical officer.
I am sure that the committee is keen to move on, but I think it important to ask this question for the sake of clarity. Given that four health board areas use the specialisms at the Beatson centre, concern has been expressed that the situation for patients at the same facility could vary according to the flexibility that is demonstrated in each health board area. Are you confident that that situation has been smoothed out and that there is a consistent approach to dealing with interim IPTRs between now and the introduction of the new PAC system?
From the high-level information that we have—I must stress that it is high level, because we as the Government do not have access to the confidential patient information that we could get someone suitably qualified to trawl through—it seems to us that there has been a shift in approach. However, I must sound a note of caution. There was a lot of talk about statistics earlier; we might be talking about very small patient numbers here, but we are also talking about people and their families, and when we refer to small patient numbers, we should remember the impact that the situation has on those patients and their families. However, as I have said, the very high-level data suggests to us that there has been a shift in approach in Glasgow and elsewhere in the west of Scotland.
As a general comment, one of the things that motivated me to change this policy was ensuring that there was no postcode lottery in Scotland with regard to access to new medicines. I will take whatever action I need to take to ensure that there is no such lottery, because I think that people who are in Glasgow, whatever health board area they are from, should have exactly the same access as everyone else in the rest of Scotland. We will ensure that that happens.
12:15
My final question is on what you said about a medicine improving a patient’s condition and that being backed up by specialist advice in relation to an IPTR or the peer-approved process. If a medicine would stop a condition deteriorating, would that be regarded as an improvement in the patient’s condition? I am thinking about a particular case in my constituency, which I know is a dangerous thing to bring up at committee. However, I am pretty close to that case.
The key criterion is whether the patient will benefit. I am not a medic and I will defer to the two medics around the table, but as a layman I would regard a medicine stopping a deterioration as benefiting the patient.
I will draw that to the attention of the board of NHS Greater Glasgow and Clyde. I had to indulge myself there, convener, because I want to ensure that my constituent gets the best representation that they can.
Indeed. I am sure that you are working hard on their behalf.
I seek further clarification from the cabinet secretary on the issue that is at the heart of the Beatson situation. I do not know whether that has been ironed out by scaling everybody down at the Beatson, but the correspondence that we have received, including that which followed our subsequent request for information from the various boards, shows that there seems to be, as Bob Doris suggested, regional variation. It seems that more flexibility is being applied in NHS Ayrshire and Arran and that it is in tune with and acting in the spirit of the instruction of the chief medical officer; it has responded in a slightly different and more positive way, and more people are getting access to medication. Of course, that is being delivered at the Beatson. However, the same flexibility is not applied to someone who lives in Greenock, for example.
No one round the table is suggesting that you, or your representatives in the Scottish Government, have not tried to communicate the message about flexibility effectively. We have seen all the correspondence in that regard. However, at this stage, there still seems to be a need for clarity and resolution, and to clear up the difficulty of the concern regarding NHS Greater Glasgow and Clyde in particular, which it seems has not been resolved. It needs to be resolved, because we are dealing with individuals and their families.
We knew that there would be a problem in the transitional period. We highlighted that and spoke about it in debate, committee meetings and so on. However, we are months on now and the situation needs to be sorted out for people who will have shortened lives anyway.
I expect the Glasgow health board, like every other health board, to follow the Government’s policy, which has been made clear consistently. We have been monitoring the situation and we think that the problem has been resolved. However, if we have to intervene to ensure that there is no postcode lottery, we will do that.
There seems to be a dragging of feet.
If people give us evidence that shows that there is still a blockage, we will address that.
We have said that all along. Without knowing specific details, it is always difficult to comment. However, for the handful of cases that have been drawn to our attention—the case of Mr Doris’s constituent is one of them—we have been able to ask questions of the health board, with appropriate permission from the patient. It depends on how much we can judge from what is in the ministerial mailbag or from the people who go to MSPs’ surgeries, but we follow up all such cases. As I said, we have had just a handful of cases, but if members are aware of any other cases, I ask them please to let us know.
Work was done by the cabinet secretary, this committee and others so that the situation that Bob Doris has just gone through in pleading the case of an individual constituent would be avoided. The work that was done was supposed to sort all that out, but it has not been sorted out and it needs to be.
My impression was that it had been sorted, but if it has not been, give me the evidence and we will sort it.
Well, go and get the evidence—shake the tree. The health board has issues that it is not being completely clear about, whether they are linked to costs or detriment to other patients. The submissions seem to show that there is an underlying issue. I agree that only a small number of individuals are involved, but they are in very difficult circumstances and are paying the price for this bureaucracy.
If there are still cases like that, we will talk to Glasgow again. We have reiterated to Glasgow the Government’s absolutely clear policy, and I expect every health board, without exception, to follow that policy.
It is just the health board’s interpretation.
We had the SMC speak to us on 25 February. I want clarification of what new moneys were available for putting the new system in place. I will read from the Official Report of that meeting. The convener asked:
“Does the funding of £1 million that was announced reflect accurately the amount of resource that you believe you need to do that job? Did you bid for more than £1 million?”
In response, Professor Timoney, who is the chair of the SMC, said:
“It will cost far more than £1 million to do the work, but we are a cost-efficient organisation. We put in a bid for something like £1.1 million.”
That does not represent a great disparity, in my view, but the convener pursued that line of questioning. He asked:
“What is your estimated price tag for being able to do the job proficiently, quickly and properly?”
Professor Timoney said:
“We have not produced an official estimate for that. My personal estimate was that the price would be substantially more than £1 million”
although a bid had been made for £1.1 million. The convener continued to press the witnesses and asked:
“Would the estimated cost be above £1.5 million? Would it be £2 million or £3 million?”
Professor Timoney replied:
“It is more like £2 million”,—[Official Report, Health and Sport Committee, 26 February 2014; c 4972.]
which is double the amount that was bid for.
As a businessman, I am confused by the idea that someone would bid for £1.1 million when the estimated cost was £2 million. There are two serious questions to be asked when we receive answers such as that. First, is £1 million enough money to do the job? That is probably the most important question. Secondly, are we getting value for money?
Let me give you a three-pronged reply to your question. First, the baseline budget for SMC for the financial year that we are now in is £1.1 million. Secondly, on top of that, we are making available an additional £815,000 specifically to deal with the challenges of introducing the new policy on access to medicines. This year, SMC will have a total budget of £1.9 million available to it. Thirdly, since Professor Timoney made that statement, we have done much more detailed costing of ongoing resources that will be required to administer the SMC. Professor Timoney had overestimated many of the associated costs.
The SMC has a baseline budget of £1.1 million and will receive an additional £815,000 this year specifically to deal with the challenges of introducing the new medicines policy. That additional money will allow it to employ an additional 16 people this year, as part of its resourcing. I hope that, to all intents and purposes, we have put the issue to bed and made available to the SMC the resources that it needs to do the job that we have tasked it with.
It seems that there is a coming together of the figures when the two sums are added together.
Yes.
My other question was whether we are getting value for money. It is a serious question.
Absolutely.
If an organisation such as the SMC bid for £1.1 million and then all of a sudden, within a few lines of conversation, what is needed goes up to £2 million—and the Government has now conceded that more resources are needed—that must be explained.
To be honest, that can sometimes happen in the to-ing and fro-ing. I am a politician and am surrounded by officials; earlier you heard from two officials from NHS Lanarkshire. Professor Timoney is a medic, not a politician, so perhaps she did a bit of to-ing and fro-ing under questioning, but the absolute position, which is accepted by the SMC, is that we are resourcing it to the tune of £1.9 million this year. We believe that that is value for money, because we all agree that a key part of delivering a health service that is fit for purpose in the 21st century is an access-to-medicines policy that ensures that the people who would benefit from new drugs can get them, provided that the drugs do the job that they say they will do on the tin. I also think that improving the transparency and efficiency of the SMC and giving it a slightly wider task than it had before will provide value for money.
We obviously keep such issues under review; we will review the SMC after the first year of its being up and running under its new guise.
The committee has heard that our system is world renowned and is admired and copied in other places because it is cost-effective. You pre-empted my other question, but perhaps you could say a little more. You said that the SMC and the Government are satisfied that the resources are at the right level. Are you saying that that will do the job correctly?
We are satisfied that the resource will enable the SMC to do the job. If the SMC were to come back to us at some future date and say that it does not need as much or that it needs more, we would consider that, but we have looked at the job that needs to be done, the resources that are required to do it and the cost of those resources, and we are pretty satisfied that £1.9 million for this year is right.
When it comes to spreading the patient safety programme and the SMC to other parts of the world, I sometimes think that we should formally franchise them and earn a bit of revenue for the taxpayer.
You have just suggested that the woman who heads the SMC and gave it that reputation was intimidated by my questions in committee. That is hardly a good recipe for the future. Can you confirm that there are additional moneys of £850,000 on top of the budget to deal with the consequences of the review?
It is £815,000, convener—not £850,000.
Is it £815,000 on top of the £1.1 million?
Yes.
It might have been a slip of the tongue, but we gave Professor Timoney three figures and she said that it would cost nearer £2 million to do the job properly, and that she bid for much more than £815,000. Let us leave that aside, however. The point of my question is whether the funding will allow that body to deliver by May.
Absolutely—it will allow that.
Have you had that confirmed?
I am convinced that that is sufficient resource—
No—there has been a delay. Has the money been allocated? When does recruitment start? The SMC has a timetable to deliver on by next month.
Additional funding was requested from 2014-15 onwards, so that funding has been made available to HIS in the current financial year.
When did it get confirmation that that money would be in its budget?
A figure of around £605,000 was confirmed to Healthcare Improvement Scotland in February, and the balance to take it up to £815,000 was confirmed in early March. That money should buy us a number of additional staff, as the cabinet secretary has said, as well as the expenses of the pay system and meeting in public.
You are quite right to say that the SMC bid for about £1.1 million. As work was done on the figures with Healthcare Improvement Scotland, some costs—for example, the costs of meeting in public—turned out to be significantly less than had been anticipated.
Other costs, which were included in the first version of the business case that came to us, were not required, having been considered alongside some other HIS funding. Some costs did not directly support what we are trying to do, so the Scottish Government did not support them. Those were not related to staffing costs, however. That is the reason for the difference.
To pick up on the point that the convener made, the SMC is now taking submissions that will come under the new system; right now, pharmaceutical companies are putting through submissions that will come under the new system.
12:30
So, the SMC will deliver in May. It is not being held back; SMC will have sufficient funds to do that.
The SMC is absolutely not being held back.
The judgment of the outcome will show whether the process is right.
Exactly. That applies to the process that has been outlined to the committee. Decisions should be taken in the autumn by the SMC under the new process.
In the autumn?
That is when there will be decisions coming out at the end of the process.
That is how long decisions take.
I have a couple of questions. You were kind enough, cabinet secretary, to provide that the rare conditions medicines fund should have its resources made available to support any interim arrangements. Were those funds drawn upon?
No. I think that I am right in saying that we did not—
We are at the end of the financial year, so we do not have all the final figures, but we expect the budgeted amount for the rare conditions medicines fund to have been fully utilised in this financial year. The boards’ directors of finance are dealing with that, given the various other pressures on boards.
My other question is about continuing flexibility. You have spoken about the patient and clinician engagement—PACE—meeting. I would not expect us to comment on any particular drug, although there is one that I am interested in: ipilimumab, which I believe will be the first drug for first point of use to go through the PACE system. It was previously approved for secondary use.
You will, I hope, consider the way in which drugs that present through the new process are affected by whatever new regulatory or structural framework is in place in order to ensure that nothing in that unintentionally proves to be prejudicial at the other end. I am looking for assurance that it is your intention not to allow the new process and its structures to become set in stone—simply because we have such a process—if it turns out that they function in a way that is contrary to your original intention, or if they themselves become an obstacle to our correcting the very thing that we are trying to correct.
We have said from the beginning that we will review the process after a year on whether it is achieving its objectives. The answer to your question is yes.
If there are no further questions, I thank the cabinet secretary.
It has been a pleasure.
I am sorry. I see that Rhoda Grant has a question. I got mixed up there: I have recess lag or something. I recall that you spoke earlier, although it was on a different subject. I apologise.
I had one supplementary, but I now have two on different subjects.
My understanding was that the SMC’s concerns about funding related to when it would be confirmed. Knowing when it would be available would allow the SMC to recruit. Can you confirm whether it has now recruited the staff that it requires for May?
The recruitment programme is on-going. Some recruitment was done in the last financial year with additional support from Healthcare Improvement Scotland. Many of the jobs are highly skilled specialist jobs, so there are not a huge number of candidates, but the SMC, through Healthcare Improvement Scotland, has a recruitment plan drawn up, and it is being implemented.
You do not envisage a problem with recruitment.
Nothing has been drawn to my attention to suggest that the SMC will not be able to deliver on what we have asked it to do.
I return now to the transitional IPTR arrangements. You said, cabinet secretary, that you had spoken to representatives of NHS Greater Glasgow and Clyde to confirm that it was acting within the spirit of what the Scottish Government required.
We have spoken to representatives through my officials. I did not speak to them directly.
Okay. Have you issued new guidance to the board on the back of that, to ensure that it is clear about—
We have followed the guidance that we got from the committee’s report, which is to make the system as flexible as possible. Rather than say that we will have a flexible system, but then to issue two, three or four 20-page lists of things that boards can and cannot do, we are giving them the flexibility—at least for the first year—to see how it all works. If, at the end of that period, we think that we need more prescription, we will consider that. We wish to minimise centralised prescription with many tight terms and conditions.
Could that be the issue? Is it the case that, because the guidance is not clear enough, boards are interpreting it differently?
The overall guidance is clear. The core issue is that, if an application is made under the peer approved clinical system and the medics agree that the drug would benefit the patient, the patient should get the drug. “Benefit” must be over a reasonable period of time. Within that system, boards are free to do what they want.
So, no new guidance has been issued.
I do not plan to issue more detailed guidance at this stage but—in answer to the earlier question from Jackson Carlaw—we will keep the situation under review, and we will have a more formal review at the end of the year. If we feel that more detailed guidance is required, we will consider that. In its report, the committee encouraged maximum flexibility; that is what I intend to pursue.
I am sorry about this, but I seek further clarity. I think that Rhoda Grant is talking about the transitional arrangements. I am sure that something came across about a two-month review.
I am sorry. I thought that you were talking about the new PACS. I apologise. Kathryn Fergusson will give an update.
On the point that was made earlier, it is important that from next month we should not be here talking any more about IPTR criteria, because we will be in a new world, where we will have an SMC with a different framework and a PAC system that seeks to fill gaps. The convener is absolutely right that the transitional period is important. However, we are not losing sight of what we are all trying to achieve. It is difficult to get there.
You will give us an update on that.
Yes—of course.
Good.
I will add one comment. As I said, we will review the situation after a year, and we will monitor it. One thing that I will do by way of monitoring is to ensure that the new system is not being abused by the drug companies. In particular, I want to ensure that they do not use the new PAC system to try and circumvent the SMC process. We are not prepared to allow that to happen.
I welcome your earlier comment about there being no postcode lottery and the commitment to patients. I take the point that Bob Doris ably made regarding NHS Greater Glasgow and Clyde, which is basically saying that the situation is due to the Scottish Government guidance being open to interpretation. I just love officials who try to find ways round new policies; perhaps they should be lawyers—although I mean no disrespect to lawyers.
Do the cabinet secretary and the Scottish Government believe that, with the new system, Scotland will be at the forefront of supplying end-of-life orphan and ultra-orphan drugs to the people who require them?
Yes.
In relation to Glasgow, the only interpretation that matters is the Government’s interpretation. Our interpretation is the policy that boards should be pursuing, and I expect NHS Greater Glasgow and Clyde, along with every other health board, to pursue it.
You will have the committee’s support in that.
Thank you very much indeed, convener.
I thank the cabinet secretary and his colleagues very much for their evidence and their patience.
Meeting closed at 12:38.Previous
NHS Lanarkshire Mortality Rates