Official Report: Minutes of Evidence

The Chairperson (Ms Maeve McLaughlin): Folks, you are very welcome. Thank you for staying with us. I know that it has been a long wait for you, but it is important for you to reflect on the previous session as well.

I am pleased to say that we have Colette Goldrick, director of ABPI Northern Ireland; Alison Clough, executive commercial director; Roisin Foster, chief executive of Cancer Focus; and Tracey Martin, patient representative from Cancer Focus. You are very welcome. You are here collectively but as two organisations. I will invite each organisation to make opening comments, and we will then invite questions from members. It is over to you, Roisin.

Ms Roisin Foster (Cancer Focus Northern Ireland): That is fine. Thank you very much for inviting us along. If you are happy enough, I will make a few opening remarks and then ask Tracey to talk in detail about how the current system impacts on patients and families. I will then come back on what we are looking for the Health Committee to hopefully use its influence to deliver.

Cancer Focus was formerly the Ulster Cancer Foundation. We are the longest-established cancer charity in Northern Ireland, and we provide a range of support services to patients. We do cancer prevention. It is a big issue when we are talking about the number of people who are acquiring cancer, and we have been funding research right back to the late 1960s.

We welcome the opportunity to raise concerns about opening access to new drugs. We launched our equal access campaign in June 2014 with 14 other local cancer charities. I stress that it was the local cancer charities that got behind us on this. The bigger national charities were sorted because of the cancer drug fund, and so this was very much a local initiative by people whose hearts, souls and headquarters are in Northern Ireland.

It arose from patients calling our helpline. Patients are very well informed these days. They go very quickly to Dr Google and know what is out there. That is not how it was 20-odd years ago. We heard the previous speakers saying that NICE-approved drugs were readily available. Actually, when we started this campaign, they were not. There were long delays in NICE-approved drugs. We are very happy to see the progress we have made today and that NICE-approved drugs are very readily available.

However, we continue to be concerned about non-NICE-approved drugs. I want to lay to rest any concern that because drugs are not NICE-approved, they are somehow rogue. It is not that: they have been through very rigorous testing and clinical testing as per regulation. It is the cost that is the problem. We are deeply concerned that the use of those drugs at the moment is 75% to 80% of what we would expect compared to patients who are living in other parts of the UK. We believe that this is due in most part to this exceptionality clause, which is, we feel, inhumane. That word is a great struggle for patients. The intention may not be to say that these patients are not exceptional, but that is how it makes them feel. These views were shared by over 26,000 people who signed our campaign. That is a lot of people from our population who felt strongly enough to join an online campaign or send in postcards. I could tell you what the exceptionality clause means, but I think that it would have much more impact if I call on Tracey, who is one of our patient reps and has personal experience of this that I really could not envisage. Tracey, would you like to talk about the impact?

Mrs Tracey Martin (Cancer Focus Northern Ireland): Yes. Thank you for giving me the opportunity to come here today and tell my story. I want to thank Jo-Anne and Roisin for the help they gave my dad and indeed our whole family in his fight against cancer.

My story is about the human side of what you are discussing here today. It is not about the facts, the figures, the money and where it will come from; it is about the actual people you are discussing and how this will help. Dad was actually due to meet the review committee back in November, but unfortunately he passed away three days before the meeting took place. He called in with Jo-Anne the week before he died. He told her that it was too late for him. He knew that although he had fought this issue, it would be too late for him; but he wanted to be able to help others. That is what my dad was all about. He had no personal agenda. His view was to try to make sure that other people did not have to go through what he and the family had gone through.

Dad was diagnosed with multiple myeloma in 2006. It was just a few weeks before my youngest son was born. It is a rare blood cancer. He was told from the outset that it was incurable; it was manageable, but eventually it would get him. I was diagnosed with breast cancer in 2013, so our family has been through an awful lot.

In January 2014, it was evident that dad's bloods were starting to show that he was maybe entering a relapse phase. He had fought it for eight years. Unfortunately, as time went on, the clinician kept talking about clinical trials and other drugs that he could go back on that he had been on before. It was becoming evident to me certainly that his hands were tied to a certain extent and that a carrot was nearly being dangled in front of him to say, "Look, there is something else. There is always going to be something else for you". Reading between the lines, I knew that the pot was running dry as far as my dad was concerned. Then, they started to talk about the exceptionality clause. As Roisin said, this is a word that needs to be changed. I know what it means; I know why they call it that, but, when you are sitting there as a patient faced with death, you do not want anything that will make you feel that you are not exceptional enough for these drugs.

Eventually, it was put to dad around September time that if he wanted to try a drug that he had actually been on before and which is NICE-approved, but was not NICE-approved for his stage of his disease, he would have to pay for it. For dad, it was never about the money; it was about the principle. He had a business in Banbridge for 40-odd years. He employed people, paid his taxes and they paid theirs. That contributed to the economy. I could give you the whole list. He felt let down that he was then being asked to pay for a drug and would have to fight to pay for it to give him some extra time in life.

We knew as a family what the outcome was going to be. Had dad got access to that drug, even in the springtime, way back when his bloods started to go downhill, I believe that he would be with us today. I know that the outcome would not be different, but certainly his quality of life would have been different. Instead of going out and doing the things that he wanted to do in his last stage of life and spending the time with his family, he had to spend the last few months of his life meeting people like Jo-Anne, Roisin and that and trying to come here to meet Committee members to try to make sure that this did not happen to somebody else.

Dad was on the Stephen Nolan programme 'The Truth about Cancer', which was aired a few weeks ago. He said to Stephen that he was afraid of dying and did not want to leave his family. He asked whether his not getting those drugs equated to manslaughter or even murder, because basically he was being denied drugs that would keep him alive.

I have to reiterate that the NHS did a fantastic job with the care that he was given. His consultant and the nurses were fantastic. This is not about the care that dad received; it is about the system that is behind it and how the money is spent. It is very frustrating when you hear daily on the news that money is being spent on flag and marching issues — all these other things that, at the end of the day, really do not matter. They do not matter. I know that they matter in a place like this, but they do not matter. I would not wish it on any of you, but, until you are all touched by cancer or another life-threatening disease and are faced with incurability, you will not know what it is like to watch that happen to somebody. It could be your parent, husband, wife or child. God forbid, it could be you. Statistics show that it is becoming more and more prevalent. It is awfully hard to watch somebody's life being sucked out of them by that disease.

My dad was not just a name on paper. He was not just a healthcare number. He was a person, a husband, a dad and a grandfather. He has asked me to carry on his legacy to try to get access to drugs for people who really, really need them. I urge you to do this. I do not care where the money comes from. I know that that is the big issue and that you cannot just get money out of thin air, but it has to be found somewhere. Do not get sidetracked with this prescription debate. We have sat there for quite a wee while listening to the prescription debate. Where is the patient in all this? Think about the patient. Think about the families who are going through it. Think about the hardship that they are going through. Cancer is actually an expensive disease to have due to the amount of travelling that you have to do and the loss of income. I went a year without any income. It is a very expensive disease. We need to remember that, behind all these cases, there are human people with human stories. None of them deserve to be put on a life sentence because they cannot get access to the drugs.

Ms R Foster: Thanks, Tracey. I had the privilege of getting to know Brian quite well. I have met any number of patients over the past while who are in this position. As Tracey said very evocatively, they are all individuals, but the recurring theme is that they are people who feel let down by the system and abandoned when they need that system most. They are met with a closed door, and we have to move beyond that.

In addition to this very real impact on individuals and families, we have a concern about the impact of failing to keep abreast of the most recent treatment options in the context of being part of clinical trials for new drugs and looking to the future. I do not want to always be looking back, but back in the 1960s we were started by a patient who was in Belvoir Park Hospital and was listening to his doctor saying that there were no clinical trials or cancer research in Northern Ireland. He thought, "If I get through this, I am going to make sure that that does not continue." He set up our organisation for that. We have obviously spread our tentacles from there, but that was the seed that spawned our organisation, so it is very close to our heart. We certainly do not want to see us backsliding anywhere in that direction.

Moving to yesterday's announcements, we broadly welcome the outcome of the evaluation of the IFR process. We welcome the intention to remove this very unfair and inhumane 95% exceptionality clause, which, as you can hear, causes such distress to patients at a time when really they need support and hope, not a door slammed in their face. We welcome the intention to establish a regional scrutiny committee, but we would guard against a further layer of bureaucracy that could slow down decision-making. We would urge that this regional committee looks to the Scottish model, which has at its heart clinical and patient views, as well as peer review, so that the patient is put at the centre of this whole process.

We welcome the proposal to introduce greater transparency. Having listened in the past two hours, I think that greater transparency would be very welcome for most people around the table. We have had great difficulty getting straightforward answers to what we felt were quite straightforward questions. We certainly got answers, but they were not necessarily answers to the questions that we posed. We could not say that we did not get an answer; we did, but not necessarily. Above all, I urge the Committee to use its oversight and scrutiny powers to expedite this process, which has seen significant delays. That causes distress to patients who really do not have time on their side. We talk about six months, but there are people who will not see those six months. We have had a number of people, two of whom have been mentioned today, Una Crudden and Brian Coburn, who have been an active part of our campaign but are no longer with us. We have people sitting out there at the minute waiting for an outcome to this process now.

We believe that the mechanism for funding improved access is ultimately a political decision. We have heard the debate about prescriptions. That is ultimately a political decision. We will respond to the consultation, but we have not had the opportunity even to consult with our own stakeholders on that. We were disappointed that the opportunity to use funding from the PPRS rebate was not used to provide access to new drugs as was intended. It is being used that way in Scotland. The minute that that was announced in Scotland, they removed the exceptionality clause. Since then, they have finessed their processes. That is what I would have liked our Department to do. We appreciate the many financial pressures on the health service, but given the disappointment that we have had with regard to PPRS and the difficulties that we have in getting clear and consistent information about the value of the rebate and how it is being used, we urge that, as a Committee, you help to secure the following things. If you excuse me, I will give you a wee list. I am sorry that this is not in your pack, but things moved along rather quickly yesterday, as I am sure you know.

We want a speedy solution so that the people who we are talking about — it is 85 or 90 people a month — who are waiting for drugs right now are afforded access. We "respectfully" suggest diverting a portion of that PPRS rebate for this purpose while a longer-term solution is being developed and finessed. We want a solution that focuses on clinical input, patient views and peer review. We want a funding mechanism that is sustainable, transparent, clearly communicated and consistently applied across Northern Ireland. In the longer term, we hope that the Committee and the Department will contribute to a wider review of how specialist drugs are funded in the NICE process, which we believe is robust and reflects best practice but presents problems for very specialist and end-of-life drugs. The cost that some drug companies apply to their drugs is also to be considered. While we recognise the substantial R&D costs of getting a drug to market, it is not an easy question, which we know, but it should be part of a wider root-and-branch review.

Again, we very much welcome the opportunity to talk to you today. We are happy that, eventually, the campaign that we have brought has got attention and that we are here today. There was the announcement yesterday. We are very encouraged by that, so thank you very much indeed.

The Chairperson (Ms Maeve McLaughlin): Thank you very much. Firstly, Tracey, I thank you for sharing that with us today, and I offer my sympathies and those of the entire Committee. It is not an easy thing to come to a Committee like this and share your personal story. I appreciate that and extend those sympathies.

It is important, Tracey, that you and others are here. Whilst we need to scrutinise the detail, this is about better patient outcomes, and rest assured that that is what the Committee is focused on. A lot of what you have heard in the last few hours has been about trying to get to that point to ensure that the specialist fund, which has now been alluded to, does not create further inequalities. That is the bottom line.

I listened to what you said, Roisin. They say that a week is a long time in politics, but a day can be huge in health. It would be useful to have shared those recommendations with us, but I know that you did not have time.

Ms R Foster: I will email them through.

The Chairperson (Ms Maeve McLaughlin): You are right about the regional committee. I think that Rosie McCorley raised that when the Minister made his statement. We need to make sure that the regional committee is not just another layer. People will accept that clinicians will be on it, and that is right and proper, but it cannot be just another layer, even in considering potential delays in the system. We certainly need to be mindful of that.

This is maybe for your part of the conversation, Colette, but I am hearing a lot about the Scottish model as an example. Equally, that has been questioned and seems to have gone slowly. There is a view that it is continuing to create a bit of a postcode lottery. This is about us getting the right fit. I do not expect you to have all the answers, but I am putting that to you.

Having those recommendations shared will allow us to reflect, and we will certainly support the notion of a longer-term wider review of a process on access to NICE-approved drugs and all that. I am happy to reflect on that as it moves on.

Mrs Dobson: Tracey, that was difficult for me to hear. I knew your dad, and I know you so well. He would be so proud of how well you spoke today. Tracey is an inspiration, like her father was before. I am so glad of the day your dad walked into my office and I got to know you and your family. As Roisin said, Una Crudden and your dad, Brian, were inspirational people who showed the way to make a difference. It will be a testament to his legacy if we achieve this for him. Your dad made such a massive impact on the well-being and economic future of Banbridge and on me personally. I am so glad that my two students from Banbridge Academy, who are the future politicians, are in the audience to hear that this is what real politics should be about. It is about making things better for people in our society.

I do not know who to direct this question to first. I will maybe ask you first, Roisin, because so many questions arise from your presentation, which was so good as well. You spoke about a speedy solution. I know that you were in the audience when my line of questioning was on when the first patients will benefit from this. The aspirations were set yesterday with the announcement, and we need to not have those hopes dashed again, because time is of the essence. As you know, my best friend is suffering from cancer, and, before I came here, I spent the morning with her. It touches so many of us, and time is not on their side.

I will direct this to you, Roisin, but on a wider point, what are your thoughts on the way that the system works to get new drugs approved for patients? Do you feel that the way that we have drugs approved by NICE needs to be changed? Could you outline that a bit?

Ms R Foster: It is very complex, and I will not pretend to fully understand how NICE operates. I am sure that my colleagues in ABPI will know more about that. My understanding is that it is a formula on what additional years of life a particular process or drug will give. Therefore, it will always be difficult when we are talking about the mercifully relatively few people who will use a specialist drug, the additional life expectancy that that will afford and the easing of drugs. We see quite a long tail. You will see perhaps an average additional life expectancy of six months. However, I have met people who are doing very well after a year and a half and longer, and we are maybe not good enough at the testing beforehand. We do not have all the tests to know who will best benefit and who will get side effects and little benefit. We have not had a new cancer drug approved by NICE in how long, Colette?

Ms Colette Goldrick (Association of the British Pharmaceutical Industry Northern Ireland): It has been quite a long time.

Ms Alison Clough (Association of the British Pharmaceutical Industry): I think there was one last year out of about 15.

Ms R Foster: It is because of the cost. It is about a cost benefit because these are end-of-life drugs. It does not include drugs that potentially save lives, because they will meet the additional life requirements that the formula calls for. These are drugs for end of life, extending life and easing symptoms, but some patients have very good results from them.

Mrs Dobson: As you very eloquently said, Tracey, if your dad had them sooner —

Mrs Martin: Yes. Cancer is a very individual disease, and what one drug will do for one person, it will not do for another person. That is something to bear in mind. Yes, there is a cost, because there is a bit of trial and error involved. Dad got a drug about four years ago that gave him great quality of life, and he was treatment free for 18 months. That was absolutely fantastic, and it gave me my dad back. Last year, he started to take a serious relapse and was told that this drug would help him. It is NICE approved, but it was not approved for his stage of cancer. I cannot get my head around that; nobody could give me an argument that would make me understand that. It boils down to somebody, somewhere, deciding that it is not cost-effective to keep that person alive. That is a very bitter pill to swallow. You cannot put a cost on somebody's life like that.

Mrs Dobson: Your dad spent those final few months fighting — that will be his legacy — to give everyone that chance when he should have been spending time with his children and his grandchildren, as you so eloquently said.

Mrs Martin: Dad was so worried. We discussed everything with the family. We are a very open family, and he did an awful lot to create awareness for the particular disease that he had with the likes of Cancer Focus. He was on patient representative committees, and he did so much and put so much back in. He even did presentations to physios because he was so supportive of exercise and what getting out even for a short walk could do for a cancer patient. He did not want people to sit at home feeling sorry for themselves; he wanted them to get out, feel positive and do something about it. He was a very proactive person.

He was so ill at the end and was so upset by the whole situation that he had to get a nurse to write a cheque for him and sign it. He could not physically put pen to paper to write the cheque because he was shaking that much he was so upset about the whole thing. Nobody could give me an argument that will ever convince me why he was eligible for a drug one year and not for the next year. The way they work with this particular drug is that you get eight cycles of it. He got six, and then he started getting something called peripheral neuropathy, which affects the hands and feet, so they had to stop it.

He was told at that stage that there were two sessions left in the bank for him, but he never got them. He was told then that those did not count, because he had relapsed. He had multiple myeloma, so he was always going to relapse. That was a drug that was specifically for that disease, so patients are being put in an absolutely impossible situation because they know that they are going to relapse. They said that there were two sessions in the bank for him and then said that he could not have them. They said that he could have them if he paid for them. The system is not right at the moment.

Mrs Dobson: Colette, the Minister told me in a written response that the funds from the PPRS, which were over £12 million last year, have been used to offset the increased cost of branded medicine. In your view, did the cost of branded medicine really increase by £12 million last year in Northern Ireland? We had difficulties earlier because so many millions were plucked from here and there and were floating about. What is your opinion on that?

Ms Goldrick: I would be very happy to respond to that, Jo-Anne. Would you like us to frame it in —

The Chairperson (Ms Maeve McLaughlin): I am sorry, Colette. Fearghal, is your question specifically for Cancer Focus?

Mr McKinney: No; I am sorry.

The Chairperson (Ms Maeve McLaughlin): We can bring you in if people want to do that at this point and take questions, and then you can deal with Jo-Anne's point. Is that OK? Do you want to make a few opening comments, Colette?

Ms Goldrick: Thank you very much, Chairperson. My comments will possibly address Jo-Anne's question in any case. Thank you, again, for the opportunity to be here today. The Association of the British Pharmaceutical Industry represents research-based pharmaceutical companies operating in the UK. I am the director for Northern Ireland, and my colleague Alison Clough is the executive commercial director for the whole of the UK and is one of the architects of the PPRS. So, she really knows the accurate figures, and I am very glad that she is with us today.

We are very proud of the fact that our industry members invent, develop and provide over 90% of the prescription medicines used by Health and Social Care every day. We welcome the opportunity to discuss, in the wake of the Minister's announcement, the outcomes of the IFR review. Indeed, we welcome many of the review's conclusions, as others said. Of course, we welcome the finding that the existing IFR exceptionality criteria should be amended to remove the reference to 95%. We have previously presented evidence to the Minister, the review panel, officials and members of the Committee demonstrating that, in the field of cancer alone, Northern Ireland's approach to exceptionality was resulting in patients here having just 20% of the level of access to these innovative medicines experienced by their counterparts elsewhere in the UK.

We welcome the establishment of the regional scrutiny committees, again, like everyone else, to ensure that all IFR applications are subject to regionally consistent clinical input and peer review. As Roisin said, there needs to be clinical input and peer review, rather than introducing another level of bureaucracy. As Scotland has shown us — the Chairperson alluded to this — peer scrutiny among specialist clinicians is highly effective. Far from driving up inappropriate use of medicines out of control, it results in open, equitable and evidence-based decision-making. No one is better placed to evaluate what is best for a patient than the specialist doctor who is treating them in consultation with his or her peers. We welcome that part of the proposals too.

We welcome the recommendation that existing IFR guidance should be revised to include greater transparency for patients and doctors alike. People suffering from such serious illnesses deserve to know the basis on which access to their treatment is decided. We currently do not always know that. Clinicians need to know the numbers and the detail of unsuccessful applications, as well as those that succeed. Only by improving transparency will we see equity of access to these treatments improve. That is also to be welcomed.

Now, of course, I come to the aspects of the review's conclusions that we do not agree with. Assuming that the first three recommendations of the review are implemented, we do not think that Northern Ireland needs to, or should, establish a ring-fenced specialist medicines fund. That is in contrast with what a lot of other people have said, but we believe that these funds can serve a purpose as a least worst option to give patients access to the medicines that they need in the short term. However, they are ultimately a sticking plaster, compensating for the need to reform the way in which value is ascribed to these innovative medicines. In fact, we are working at a national level with NICE to reform the way that it looks at these medicines and ascribes value to them.

I will now come to the most fundamental aspect of the review with which we do not agree, namely, the conclusion that Northern Ireland's receipts from the pharmaceutical price regulation scheme are somehow insufficient to fund increased access to innovative medicines here. We heard a lot of data yesterday. There was a snowstorm of figures. I am going to give you some more, but I can vouch that they are pretty accurate. We heard yesterday that Northern Ireland has received at least £14·3 million from our industry to cover 2014 alone. That is the figure if you add the four payments mentioned in the Assembly questions. We heard a number of conflicting messages yesterday, however, about what has happened to that £14·3 million. First, we heard that the information was not definitive about the scale of payments that Northern Ireland was likely to receive and that, because of general financial pressures, it would not be possible to commit to using the money to fund new medicines. Then we heard that the figure was available. We heard the detailed figure, which totals £14·3 million for 2014, but then we heard that that had already been swallowed up to pay for increased use of NICE-approved treatments. Yet, the data that we have available shows a different picture. This goes back to Jo-Anne's question. Northern Ireland's expenditure on medicines in general practice is declining. GPs, who account for over 80% of all medicines expenditure, are spending less on medicines this year than they were last year, as the health board's own figures show. I am happy to share that information with the Committee.

Perhaps the growth is in hospital medicines, and we heard about some of that today. However, those figures are not as readily available as primary care figures.

Two of our largest trusts have told us that their growth in branded medicines has been static over the last year, ironically because of the constraints offered by the current IFR system. It would therefore be extremely helpful to everybody to have clarity on how exactly the £14·3 million already contributed by our industry to cover 2014 payments to Northern Ireland, so that patients here can receive the most innovative medicines, has been used. We ask for the support of the Committee to arrive at that clarity.

As I have pointed out, the 2014 PPRS is a unique new five-year scheme, representing an evolution in the way prices for medicines have been negotiated in the UK over the past 50 years. It was agreed by our industry in good faith, so that the NHS could continue to make available innovative medicines to patients across the UK at a time of great financial pressure. Our industry agreed to cover all growth across the UK arising from increased use of medicines covered by the scheme for two years and all but just under 2% of growth for three further years until the end of 2018. Yet more figures and percentages, but what does it actually mean? What it means is this: already Northern Ireland has received, as I mentioned, £14·3 million, but that £14·3 million is not for this year; it is to cover the calendar year 2014.

Let me introduce you to a new figure — one that, in the light of what we have heard earlier, I hope will be a welcome figure. In 2015, because of the growth in medicines' expenditure in other parts of the UK — not the growth in Northern Ireland — 2015 payments to Northern Ireland are likely to more than double to £30 million. That amount will be received, not in this 2015-16 NHS financial year, but the 2015 calendar year. The £30 million is additional to the £14·3 million our industry has already contributed.

This brings me to the aspect of yesterday's announcement that captured all the headlines, namely, the reintroduction of prescription charges, which was presented as necessary to fund increased access to innovative medicines. Now it may well be the case that the reintroduction of prescription charges is a societal and electoral debate worth having, but, as I hope I have made clear, prescription charges are not necessary in the short to medium term to give Northern Ireland patients equal access to the innovative medicines that they need now.

To touch on another aspect of the review's conclusions that is very pertinent to our industry: the report acknowledges that all stakeholders have commented on the impact that the current situation is having on Northern Ireland's ability to attract clinical trials and fulfil its extraordinary potential as a world-class research centre. While it was good to have this acknowledged, we were surprised by the review's assertions that there is no detailed evidence of this impact and that, yet again, further work is needed to quantify it. Just two weeks ago, DETI launched the MATRIX 'Life and Health Sciences Northern Ireland: Capability Assessment and Foresight Report'. Noting the many positive indicators that the sector is an economic-growth driver for Northern Ireland, the report stated:

That is DETI making those remarks. The MATRIX report also revealed that Northern Ireland ranks just eighth out of the twelve UK regions in private industry R&D expenditure, which is a key factor in the EU regional innovation survey evaluation. Of course, we will work with officials to give whatever other evidence is required, but we feel that these data are pretty conclusive as to the impact on the economy as well as on patients.

I will end with a reference back to patients. We have heard very eloquently from people around this table who are far better equipped to talk about the human impact of these protracted discussions than I. To take cancer alone, every month, at least 85 cancer patients in Northern Ireland fail to receive medicines that they would get if they lived elsewhere in the UK. That is 85 patients every month whose life expectancy may be shortened. That is just in one disease area. Our industry has put its money where its mouth is, to help solve the problem, and we urge the Minister and the Department to decouple the issues of exceptionality, transparency and consistency from the issues of ring-fenced funds and prescription charges and to implement the first three recommendations contained in the review without further delay. We respectfully ask the Committee to bring its influence to bear to help make that happen.

The Chairperson (Ms Maeve McLaughlin): Thank you, Colette.

Mrs Dobson: Could I just make a tiny comment?

The Chairperson (Ms Maeve McLaughlin): Sure, Jo-Anne.

Mrs Dobson: Colette has answered all my questions. How different our questioning would have been if you had presented first. Thank you for your detail and figures. You spoke earlier about a snowstorm of figures. It is great to hear it from you directly. The figure of £30 million this calendar year is quite astonishing. Thank you so much. I wish you had presented first.

The Chairperson (Ms Maeve McLaughlin): While welcoming aspects of the statement, you say that we do not need a ring-fenced specialist fund and challenge the view that receipts from the PPRS scheme are insufficient — was it £33 million this calendar year?

Ms Goldrick: Thirty million.

The Chairperson (Ms Maeve McLaughlin): Thirty million. Are you still advocating that the scheme here should be similar to the Scottish model? Is that still your view?

Ms Goldrick: The Scottish model has a number of huge advantages. First, it is a specialist medicine fund, so it covers all specialist diseases and not just one, which can be even more distorting in the longer term. Scotland was also incredibly quick off the mark and introduced its ring-fenced fund to take advantage of the PPRS payments, as it clearly stated. One of the reasons for the ring fence was the concern that costs would spiral out of control. "Costs spiralling out of control" and "opening the floodgates" are phrases that are often used. As you have alluded to, Chair, it is the reverse that is true. Expert, specialist clinicians, when they get their heads together, are quite conservative in the UK. Certainly, costs have not spiralled out of control in Scotland. In fact, many observers say that they are moving too slowly, as you have indicated, to take advantage of these innovative medicines. While ring-fenced funds have a place in the short term, we do not think that Northern Ireland needs one. The money is here and is coming reliably for the foreseeable future. If we have a proper, peer-to-peer clinical scrutiny process in place, which is transparent to doctors and patients alike, there is no need for a ring-fenced fund, which could, over time, become a hostage to fortune.

The Chairperson (Ms Maeve McLaughlin): I will just follow on from that with two points. The Minister alluded to the fact that the cancer drugs fund in England was effectively £140 million overdrawn. That is a real challenge to the fund, and certainly some charities and sectors had indicated that the fund was not sustainable. I am interested in the Scottish model, because when the changes came in, in November 2013, Scotland moved very quickly to reform the IFR process and to look at putting in place the peer-approved clinical system. There was an article in 'Herald Scotland' in November — I have the reference here — which said that cancer patients in Scotland were still facing a drugs' postcode lottery. I am interested in that, although you may not have the detail now.

Ms Goldrick: I am not aware of that. Alison, you may be aware of a postcode lottery in Scotland; I certainly am not. We have heard from across the piece that some observers in Scotland are disappointed at how slowly the system has changed and that patients are still waiting longer than they should for access to these medicines. Bear in mind that the growth in use of all these medicines above 2013 levels is funded by our industry. Affordability should therefore be off the table at a national level. There is a process in place in Scotland that should see decisions about which patients will benefit from those medicines being made quickly. It is positive to see that. I must admit, I am not aware —

The Chairperson (Ms Maeve McLaughlin): I am happy to pick that up afterwards with you.

Mr McKinney: Tracey, thank you very much indeed. For every one of you, there are thousands of people who cannot speak, so your contribution brings added value that the Committee appreciates.

Thank you both too for your contributions, particularly Colette. What you have just said is an absolute game-changing announcement to the Committee and to the people of Northern Ireland. The figures that the Minister announced yesterday were significantly lower than those you have presented today, and he has used his diminished figure to urge prescription charges. Your figure would suggest that we could have access to these drugs tomorrow, and, certainly, that is something I would welcome. My worry has been — I will call a spade a spade — that the Department and the Minister have been using this emotive issue to lever in prescription charges through this whole debate. The evidence that you have presented suggests that we would have room to do this tomorrow, if they wanted. Roisin, could you take me through briefly what would happen if the decision was made?

Ms R Foster: If the exceptionality clause were removed, what we would like to see happen is that clinicians then make decisions, in partnership with their peer groups, on what medication may have benefits. It would then go to a regional —

Mr McKinney: From tomorrow or as soon as practically possible, how many people could benefit from that, in your estimation?

Ms R Foster: Colette's figure was 85 to 90, and I have no reason to believe that it is not accurate. It is hard to be definitive about any one month. There are people waiting now. We know that there are people waiting, hoping and praying that decisions are made, because they are running out of options. We would like to see PPRS used for that purpose as soon as is feasible. There would have to be some process of change, but it should not take years.

Ms Goldrick: One leaf that we could take from the Scottish book is that, when Scotland made the decision to change the process, the Chief Medical Officer wrote immediately to all clinicians and then wrote again saying that, whilst the new arrangements were being put in place, exceptionality should not be used as a criterion to deny patients access to these medicines. It is a very simple, process-lite approach, which I think that we could learn a great deal from.

Mr McKinney: I welcome too the Minister's new approach to transparency and openness, but this conversation today, over three hours, has proved that there is a wide gap in the information. How reliable are your figures on the flow of money to here? What guarantees can we have for next year's figure?

Ms Goldrick: I will hand that question over to my colleague, Alison, because what we receive for Northern Ireland is dependent on what our industry pays in at a national level.

Ms Clough: Nationally, industry pays a cheque every quarter to the Department of Health (DH) in Westminster based on sales. They have now paid; they paid in quarter 1 last year and then quarter 2. Over the whole of last year, for the UK, industry will have paid — the final payment is just about to be made — about £300 million. You get your portion of that. The percentage payment for this year is now more than double what it was last year. Even if sales stay the same, you are guaranteed more than double what you will get this year. That is how we calculated the numbers that Colette gave you. The number for 2014 is £14·3 million. The sales are going up, so conservatively it is going to be more than double. Industry paid just short of 4% of its sales every quarter last year; this year, it is more than 10%. That is why we are confident. If anything, we have been pessimistic in what we have told you.

Mr McKinney: There is room then for us to open this project as soon as. We could have the debate. You do not have to answer this, but I am making the suggestion that we could have the prescription charges debate on the side, because the Department will argue about sustainability.

Ms Goldrick: The key word is decoupling. Patients cannot afford to wait any longer than they have already waited. Let us decouple the debate on prescription charges from the facts that we can adopt the process from our neighbour, Scotland; we have funding available from our industry; and there is a desire around the piece for greater transparency. Let us do those things now, and then spend the next four or five years debating the reintroduction of prescription charges.

Mr McKinney: May I make one final point, Chair? Clearly, there are areas in the UK and elsewhere in the world that are embracing the nature of diagnostics and new drugs etc. Does our not embracing this as fully as others have done harm us in the sense that pharmaceutical companies and others could bring jobs and drugs development here? Is our stance causing us detriment?

Ms Goldrick: The short answer — it is not even industry saying this; it is DETI — is this: yes, it is causing us harm. We have extraordinary world-class capability here in Northern Ireland in our academics and clinicians, and we have pioneered so many biomedical innovations; but because we are slow and low adopters of these innovative technologies, when global companies are looking for somewhere to place a trial, they are not going to place it here, where the latest treatments are not being used. Obviously, they will go to places where those treatments are being used. Every trial that comes to a country or to a health economy brings funding with it. It also, of course, increases levels of knowledge and expertise and enables further innovation to happen. We have got all the ingredients in place, but if Northern Ireland is to achieve its potential, this is the one thing that we need to change.

Mr McKinney: Finally, those trials in themselves provide free medication to seriously ill people that could extend their lives.

Ms Goldrick: They do.

Mr McKinney: So we are losing out. There is a double dip.

Mrs Martin: Could I add something in? This exceptionality clause and people not getting the drugs they need is not a theory. Dad's consultant went to a colleague in England and asked him off the record to put in dad's case as if he were an English patient. He passed: he would have got the drug had he lived in England; but the consultant's hands were tied here. Exceptionality is not just something on paper or that does not really happen. It does.

The Chairperson (Ms Maeve McLaughlin): Thank you, Tracey.

Mr McGimpsey: Thanks for that. I am sorry that I missed the first part, although I picked up some of it on my television in the office. You are quite right. We are having two debates here. One is about prescription charges and one is about provision of specialist drugs. As you heard me say, I take the view that if a clinician says that the patient should have something, that is what we have a duty to provide. We then get into the argument about money, and you heard some of the discussions we had with Mark and his team. You are effectively saying that the rebate is £30 million for 2015. Mark says that the headline figure he needs to fund this is £25 million, but probably around £17 will do it. I find it surprising — quite startling, actually — that this debate on prescription charges was ever introduced, because it was completely unnecessary. You do not need prescription charges to pay for this. Explain to me how the £30 million comes back and why you believe that it is going to be consistent over at least the short term.

Ms Clough: Industry, every quarter, reports the sales of all branded medicines in the scheme and then pays money. In total, through 2014, they will have paid about £300 million at a UK level. Those cheques all go to Westminster, and then the devolved nations have a discussion about how they apportion that money out to the other countries.

Mr McGimpsey: Our share is £30 million.

Ms Clough: For 2014, you will have got about £14 million. This year, the payments that industry will make from across the UK to Westminster will have gone up from around £800 million to £1 billion. You will get your proportion of that, and so we have worked out, as I would say —

Mr McGimpsey: About 3%.

Ms Clough: — realistically to pessimistically, £30 million this year.

Mr McGimpsey: So there is more than enough over the two years to cover this.

Ms Goldrick: It is a five-year scheme, not just a two-year scheme. It will last until the end of 2018.

Mr McGimpsey: I have to say, Chair, I find it extraordinary that we are in this debate at all.

Mr McKinney: Absolutely.

Mr McGimpsey: Our oncologists wish to prescribe medicines, and we have the funds to do that. I find it extraordinary that they are not being allowed to do that.

Ms Goldrick: To be fair to the Department, our understanding from Mark in his presentation earlier was that some of these funds were only just received, so it may be that they were not aware of the full extent of what was coming.

Mr McGimpsey: Also to be fair to Mark, he does not do the money in the Department. He is very much ring-fenced as chief pharmacist.

The Chairperson (Ms Maeve McLaughlin): From your perspective, what may have been the blockages or obstacles to the scheme?

Ms Goldrick: I think that one of the reasons was complexity. As somebody mentioned earlier, it is a complex scheme. It is a big, thick document and — I think we would all acknowledge — not an easy read. It was negotiated over a year with the Department of Health and all the companies in our industry, so it is a big, complex document with quite a lot of legalese. Secondly, the Department of Health in Whitehall negotiated the scheme on behalf of all four of the UK nations. The devolved Administrations were not directly involved or around that table when those discussions were taking place, and that may also have made it a bit harder to penetrate initially.

I will be honest with the Committee, and many members will know this already from our direct discussions, but we have found it frustrating that Northern Ireland has been slow, reluctant and almost unwilling to see these benefits as quickly as other parts of the UK. Scotland removed its exceptionality clause the day after the scheme was announced at the end of 2013.

Ms R Foster: Could I just ask a question for clarification?

The Chairperson (Ms Maeve McLaughlin): Sure.

Ms R Foster: If we had followed Scotland's model and removed the exceptionality clause in January, and it cost, say, £6 million, would that have come back to us in the rebate?

Ms Goldrick: Yes.

Ms R Foster: That is shocking.

Mr McKinney: Chair, I propose that we should have the Department back in here next week.

Mrs Dobson: I totally agree.

Mr McKinney: This is —

Mrs Dobson: It is astonishing.

Mr McGimpsey: Chair, I think we need the Minister in here because he made the statement yesterday. I know that, in his position, he would have taken in good faith what he was given.

The Chairperson (Ms Maeve McLaughlin): I was going to propose, certainly on the evidence that we have heard today, that we engage directly.

Ms McCorley: Thanks very much all of you for your presentation and what you have said here. Is the £30 million with no strings attached? Is that a straight £30 million for the Department to spend?

Ms Goldrick: Yes.

Ms McCorley: OK.

Ms Goldrick: It is a cheque for £30 million. Well, it will be four cheques adding up to £30 million that come in each quarter.

Mr Brady: Thanks very much for your presentation. I can empathise because I lost my wife to cancer. I just want to make that point; I understand the trauma that you are going through.

You said that it is a very complex document, but surely, at the end of it, the number crunchers here must know how much money they get, so it does not matter how complex it is. You have people who are focused on the complexity, but you have people who are focused on the money. Surely, at the end of the day, somebody gets the money, then knows how much they have and what they can do with it — or, in this case, what they cannot do with it or did not do with it.

Ms Goldrick: Mickey, it is not for want of trying. Let me just put it like that.

Mr Brady: I appreciate that, and you are still trying. Fair play to you.

Ms Goldrick: Yes.

The Chairperson (Ms Maeve McLaughlin): OK, folks. Thank you very much, all four of you, for taking the time. In relation to Cancer Focus, Roisin, if you could share those revised recommendations with us in terms of the speed of the process, I am happy to pick up on those where we can.

Ms R Foster: Yes.

The Chairperson (Ms Maeve McLaughlin): Colette, thank you very much for very useful information. It would be right not only that the departmental officials come back but that we request that the Minister comes in to address the issues around this. Thank you all for your time.