Official Report: Minutes of Evidence

Committee for Health, Social Services and Public Safety, meeting on Wednesday, 18 February 2015


Members present for all or part of the proceedings:

Ms M McLaughlin (Chairperson)
Ms Paula Bradley (Deputy Chairperson)
Mr M Brady
Mrs Pam Cameron
Mrs J Dobson
Ms R McCorley
Mr M McGimpsey
Mr Fearghal McKinney
Mr George Robinson


Witnesses:

Mr Alastair Campbell, Department of Health
Mr Jackie Johnston, Department of Health
Mr Joe Magee, Department of Health
Dr Mark Timoney, Department of Health



Individual Funding Request, Pharmaceutical Price Regulation Scheme and Cancer Drugs Fund: DHSSPS

The Chairperson (Ms Maeve McLaughlin): I welcome the witnesses from the Department: Mark Timoney, chief pharmaceutical officer; Jackie Johnston, director of secondary care; Alastair Campbell, secondary care director; and Joe Magee, secondary care director. I invite you to make a presentation, and then we will open it up to comments and questions. Jackie, are you leading on this?

Mr Jackie Johnston (Department of Health, Social Services and Public Safety): I thank the Committee for the opportunity to brief members on the findings of the evaluation of the individual funding request (IFR) process. As you know, the Minister made an announcement on this work yesterday in the Assembly. I apologise for the fact that the announcement was made public only yesterday. I know that you have not had as long to consider the content as you would have wished. I am sure that you will understand that that was unavoidable in this instance. The Minister had originally hoped to make the findings public two weeks ago, on World Cancer Day. Unfortunately, circumstances prevented that. As you said, I am joined by Mark Timoney, who is the chief pharmaceutical officer in the Department; Alastair Campbell, who is my deputy and who directed the evaluation project; and Joe Magee, who is the policy adviser and project manager for the evaluation.

You will know that the former Health Minister, Edwin Poots, announced the evaluation in response to concerns that had been raised by the Assembly, cancer patient and survivors' charities, and the pharmaceutical industry about access to new specialist medicines in Northern Ireland. To give you some context, we are dealing with two main types of drugs: first, drugs approved by the National Institute for Health and Care Excellence (NICE); and secondly, unapproved drugs that have not been assessed by NICE, those that have been assessed but not approved, and those that are unlicensed. NICE has an international reputation for excellence in its scientific rigour, independence and objectivity. When NICE approves a drug, we make it routinely available as a standard therapy.

I assure you that patients in Northern Ireland have the same access to those drugs as in England or Wales. We spend roughly £120 million a year on those drugs in secondary care alone, of which £27 million is for cancer drugs. With the IFR process, we are talking about unapproved drugs. Our current process is designed to facilitate access to unapproved drugs or if a clinician considers that a patient will derive significantly more benefit than through the standard treatment. In that case, the clinician makes an application on behalf of the patient, and the application is considered through the health and social care trusts' internal scrutiny process. If approved at this stage, it is submitted to the IFR panel, which is managed by the Health and Social Care Board (HSCB) and the Public Health Agency (PHA) and meets weekly.

The evaluation included consideration of factors influencing access to specialist medicines, including the IFR process itself and consideration of clinical exceptionality; arrangements for access to specialist drugs in other UK jurisdictions; the early access to medicine scheme; the pharmaceutical price regulation scheme (PPRS); and the potential for the reintroduction of prescription charges to finance a specialist drugs fund. That is all covered in the consultation document, which has been published.

In the course of the evaluation, the team met a variety of key stakeholders representing clinicians and other medical professionals, patients, the pharmaceutical industry, and officials from the health and social care trusts, the Health and Social Care Board, and the PHA. Through those meetings, the team identified a number of key factors that caused concerns: the definition of clinical exceptionality, particularly the use of the 95% criterion; the perceived inequality of access to cancer drugs in comparison to other models, particularly in England and Scotland; the risk of variable decision-making in Northern Ireland due to the differing approaches taken by each trust; and that the process itself lacks transparency and does not place sufficient emphasis on the clinical input to the decision to submit an IFR.

In response to those findings, we have developed a number of recommendations, which the Minister announced yesterday. I will not go into those in any great detail at this stage, as I am sure you will have questions on them. However, the key points are that the existing exceptionality criteria should be amended to remove the reference to 95%; that the establishment of one or more regional scrutiny committees should be considered to ensure that all IFR applications are subject to regionally consistent clinical input and peer review; that the existing IFR guidance should be reviewed to include greater transparency; that the Department should establish a specialist medicines fund to meet the costs of administering and maintaining increased access to specialist drugs; and that to resource the new fund, the health service should reintroduce charging for prescriptions.

The recommendations will, of course, have costs implications. Primarily the costs will be caused by increased access to those specialist medicines, although there will also be some cost associated with the proposed new structures. Although, by necessity, these are estimates at present, we believe that the changes would cost between £4·8 million to £9·5 million to implement. There are well-documented pressures on the health service budget in Northern Ireland, and it does not seem likely that it would be possible to introduce the changes from within the existing budget without causing disinvestment from other priority investments.

The Minister has therefore decided that the reintroduction of prescription charges is the most effective way to ensure that funding for these treatments is secure and sustainable in the long term. The next steps are that the consultation period, which opened yesterday, will run until 8 May. There has been a high level of interest in the proposals and the team is working through a consultation plan for the period, which will include a number of public meetings around Northern Ireland. We will release the detail of those when the plan is complete.

To conclude, I just want to say that this has been a particularly difficult evaluation for the team to carry out. We have met many patients who want to have these drugs prescribed. We see regular correspondence from yourselves and other MLAs about your constituents who have need of these drugs. Overall, we have attempted to come up with a package of proposals that we hope will meet the concerns of patients and their families but is, at the same time, placed within the context of the financial constraints facing the Department.

I will hand back to you, although I am happy to take questions. We will probably answer them depending on our particular involvement in the evaluation.

The Chairperson (Ms Maeve McLaughlin): OK. Thank you for that, Jackie. The specialist drugs fund is an important initiative that society generally will welcome. There is a lot of positivity around that concept; however, there is a lot more meat to be put on the bones. While I am mindful that there are human stories attached to all these issues, we need to get a sense of the detail. The first issue is the exceptionality clause and the 95% threshold. In his statement the Minister said that the bar was set too high, but what will replace it?

Mr Alastair Campbell (Department of Health, Social Services and Public Safety): That work is to be taken forward now, although we do not expect huge opposition to that proposition. From now, we will start working with the team that was involved in the project evaluation, which is made up of oncologists, people from the Public Health Agency (PHA) and the board and pharmacists. We want to get an agreed clinical definition. We will take this work forward in parallel with the consultation and hope to come up with something.

Mr A Campbell: No. The important thing is that it needs to be clinically agreed. We need to get the buy-in of clinicians in Northern Ireland, so there is work to do on that. The consultation is asking whether we should remove the 95% threshold. What the agreed definition will be has still to be decided.

The Chairperson (Ms Maeve McLaughlin): The important point there is that we are still, ultimately, talking about a specialist drugs fund, so criteria will be applied.

Mr Johnston: They will be clinical-based criteria because those who had concerns about the 95% criteria would like to see more transparency around the clinical basis for applying those criteria. That is a judgement for clinicians to make rather than us as administrators. We want to talk to the clinicians as we go forward and form a definition. The process will be around administering that definition. They have moved to a similar situation in Scotland, where decision-making on exceptionality is more clinically led. We have to be mindful that there is a cost to these drugs; however, the clinicians are best placed to make that balanced judgement for the betterment of the patient in the overall context.

The Chairperson (Ms Maeve McLaughlin): But you said that this would be included in the consultation process. How are people consulted if we do not know where the bar will be set?

Mr Johnston: In terms of what the clinical definition will be? It is not specified in the consultation document. We would not normally consult on that kind of definition because it is for clinicians to indicate what it would look like.

The Chairperson (Ms Maeve McLaughlin): The point is that the bar was set at a point that, literally, removed people from being able to access the help that they needed. It is critical that the bar be set in a justifiable, accessible and equal way.

Mr Johnston: Yes. I think that we can have confidence that that will happen. It will be a clinical-based assessment rather than the arbitrary 95% figure, which is what has caused most concern for patients.

The Chairperson (Ms Maeve McLaughlin): I absolutely accept that it has to be a clinical-based assessment, but people are being consulted on this and we are not quite sure what we are being consulted on.

Mr A Campbell: The question is whether, first, we should remove the 95% threshold. Secondly, as we say in the consultation paper, there is still a rationale for a level of exceptionality — the concept of exceptionality. At the moment, there may not even be a number attached to it, but it is clinicians who should decide whether there is a case to be made for an unapproved drug to be made available to a patient in that patient's specific circumstances.

The Chairperson (Ms Maeve McLaughlin): It is important that we get that information. Ultimately, it is a specialised drugs fund; therefore, it is not every drug, and criteria will be applied. It will be important that we and the wider world have a sense of what will replace the exceptionality clause. We do not want to put in a bar similar to the one that we had, as it removed people from access.

Mr Johnston: As Alastair said, that work is going on in parallel with the consultation. If we get it finished within a reasonable timescale, we will be happy to make it public.

The Chairperson (Ms Maeve McLaughlin): How much will the fund cost?

Mr A Campbell: It is difficult to assess, because much of what we are facing objections on is intangible. We heard from clinicians whom we are consulting that they felt that they were not putting applications forward because the 95% bar was too high. Obviously, in the absence of data, it is very difficult to know what that might be. Our projections are based on a doubling or trebling of the current IFR, which is around £1·9 million a year, comprising about 261 applications.

The Chairperson (Ms Maeve McLaughlin): With respect, I find that difficult to take. We know that there are about 38 drugs available elsewhere that we cannot access here. There has to be a costing attached to that to implement such a scheme here. I appreciate that NICE drugs will come in and out of the market, new drugs will come on stream, and there will be a degree of flexibility. However, the Department and the Minister have been able to tell us that they have ruled out certain schemes because that would be enough. You must have a figure.

Mr A Campbell: I understand where you are coming from. The model of the 38 drugs is specifically related to the cancer drugs fund, and that is not what we propose. We were proposing retaining the IFR process but with the specialist medicines fund to finance it. The cancer drugs fund model has a list of drugs, and if a clinician applies to that fund, the drugs are automatically given, and there is no other barrier or no other hoops to jump through. That is just for cancer drugs. If you do a direct correlation between that and Northern Ireland, we reckon that it is about £7 million.

Mr Joe Magee (Department of Health, Social Services and Public Safety): It would cost about £6 million or £7 million to replicate the cancer drugs fund here.

Mr A Campbell: We cannot directly compare that because it is a different model.

The Chairperson (Ms Maeve McLaughlin): What figure is attached to the specialised drugs fund that you are talking about?

Mr A Campbell: Again, specialist drugs is a wider area than just unapproved drugs; it comprises approved and unapproved drugs. To do the service development that we are talking about for unapproved drugs, we think that the cost will be between £4·8 million and £9·5 million. If you are looking at NICE-approved drugs —

The Chairperson (Ms Maeve McLaughlin): Between £4·8 million and £9·5 million?

Mr A Campbell: Yes, somewhere between that. If you are looking at approved drugs, the pressures in the coming year are about £12 million to £15 million. Those are the figures that we are looking at.

The Chairperson (Ms Maeve McLaughlin): We will move onto how you fund that. How have you decided, for example, that prescription charges will fund that if we do not have a rounded figure? In the Assembly yesterday, the Minister referred to £12 million, £9 million, £10 million and then £24 million.

Mr A Campbell: The Minister's rationale is that what would be required, purely for these changes to the IFR process, is in the range indicated, which is £4·8 million to £9·5 million. If you are looking also at easing the pressures on NICE drugs, that is an additional £12 million to £15 million. These are all projections, but in total you are looking at between £17 million and £25 million. Whatever prescription charges will bring in, whatever model you have, that is the kind of area you are working on.

The Chairperson (Ms Maeve McLaughlin): You are saying now that it will be between £17 million and £25 million?

Mr A Campbell: There are two distinct aspects of specialist medicines. There are the unapproved drugs, which are in the range I indicated before, plus the NICE-approved drugs, which are in the £12 million to £15 million range.

Dr Mark Timoney (Department of Health, Social Services and Public Safety): It is really about ensuring that there is financial stability to manage the specialist drugs pressures as we see them, or new and innovative medicines, which we expect to be approved through the NICE process or, indeed, through the Scottish Medicines Consortium process, which our Health and Social Care Board acknowledges also. Those pressures are likely to be in the region of £12 million to £15 million. However, the particular drugs that have led to the IFR evaluation, as we look to models such as the cancer drugs fund — we are going to expand on that area of speciality; it will not be restricted to cancer — or the new medicines fund in Scotland and read across to a Northern Ireland figure, we will see a figure in and around £4·5 million to £9 million, as Alastair has elucidated. Essentially, it is a combination of those two figures, which would address the current pressures around specialist medicines in the round.

The Chairperson (Ms Maeve McLaughlin): What is the bigger picture here? To do everything, we are talking about £25 million.

Dr Timoney: Yes.

The Chairperson (Ms Maeve McLaughlin): OK. It was not so difficult getting that figure eventually. We are talking about £25 million and the suggested source to fund that is prescription charges.

Dr Timoney: Our expenditure on specialist medicines last year, in terms of growth from the previous year, was £21 million. If you are talking about £25 million, you would anticipate that the demand coming down stream will require that type of investment.

The Chairperson (Ms Maeve McLaughlin): OK. Your proposal is that prescription charges will cover this. How do you address the fact that the Audit Office recently reported on prescribing and stated that, if GPs prescribed more effectively and efficiently, £19 million could have been saved in 2013 alone. When they looked at it in England, Scotland and Wales, the North had the potential to save £73 million. How do you answer that?

Dr Timoney: That is a very well-made point, and one that needs to be addressed because this is about efficiencies in the system. The story with efficiencies has gone on for quite some time in Northern Ireland. We have strenuously engaged with GPs in primary care on getting clinical and cost-effective prescribing, the use of generic medicines and movement for therapeutic choices to be made cost-effectively, educated into dialogue and guidelines, all as part of a scheme called the pharmaceutical clinical effectiveness scheme. That has been broadly effective. I can offer that £130 million of efficiencies were set by the HSC board in the past four years and achieved in the Northern Ireland Audit Office —

The Chairperson (Ms Maeve McLaughlin): One hundred and thirty-two million pounds.

Dr Timoney: The headline from the Northern Ireland Audit Office report refers to those efficiency schedules as they were put in place over those years. In the past six years, there has been an 18% reduction in the cost of prescribing in real terms. Therefore, the efficiency programme is working. That is not to say that we can be complacent about it; we have more work to do and we have to actively engage, educate and get into dialogue with GPs about how we get better cost-effective solutions. That is one area of a strategy to get better value out of the system. I can talk about some other areas, Chair, as we go along.

The Chairperson (Ms Maeve McLaughlin): Yes, but, I suppose, Mark, there is one identifiable area. I appreciate GPs' work on the £132 million savings and some of the efficiencies that had been made in the system over the last four years. However, the Audit Office report said that £19 million could have been saved in 2013, and comparing it to England, Scotland and Wales, it was £73 million. So, why would we be looking to impose another charging scheme if there are these savings in the system?

Dr Timoney: I think that we have a problem with medicines, in the round, in the demographics of our population. The population is getting older, and elderly members of the population consume 10 times the amount of medicines of younger members. So, as those figures increase, we will see the demand for medicines increase over the next 10 years.

The Chairperson (Ms Maeve McLaughlin): I appreciate that, Mark. We know the strains and we know the population trends and changes. Another way of phrasing it might be: in your view, in the view of the Department, have you explored — exhausted — waste in the system and the efficiencies pointed out by the Audit Office that could be used, as opposed to imposing what some people will consider a tax on the sick?

Dr Timoney: We have absolutely identified the need to drive waste out of the system, and this year we have set the board a target of £20 million of efficiencies to move out of the system against the £165 million pressure that we have. However, in order to ensure access to specialist medicines, in addition to the other pressures on the medicines that are already in the system, we need to look at an injection of money. Hence the concept of a charge.

The Chairperson (Ms Maeve McLaughlin): I am not fully convinced that we have explored the Audit Office's recommendations. Are you consulting on the cost of the charge to the person, or is it a case of doing either nothing or something? If you are consulting, what is it?

Mr A Campbell: The main thrust of the consultation is around the IFR process, and then the additional recommendation is that it should be a very high-level consultation on the idea of using prescription charges.

The Chairperson (Ms Maeve McLaughlin): So, the consultation will just ask whether people consider the implementation of a charge justified. You have not calculated? Figures were circulating yesterday of 30p and 50p in the pound, and a £25 a year "seasonal ticket", as it was called.

Mr Johnston: Mark can give you some indication of the background.

Dr Timoney: It is important that we test what is considered a reasonable and affordable amount that can be paid for a patient to access their medicines and whether there is an acceptance, with a certain community sensibility, that people will be prepared to pay that money to establish the fund so that other citizens, who may be their friends, families and even themselves, will have access to specialist medicines when they need them. That is the first area that we want to establish. Should there be a charge and should that charge be reasonably affordable to the extent of 30p per item to £1 per item? Is that acceptable?

The Chairperson (Ms Maeve McLaughlin): So we are calculating that price range.

Dr Timoney: Yes, we are indeed. We then need to ensure that, once we have some of the modelling worked out around what income those charges will deliver, I think that we will have a very detailed paper that the Minister can take to the Executive. We can share that with you and discuss what the mechanism will be in the long run.

The Chairperson (Ms Maeve McLaughlin): What I find difficult is that we know the catch-all and know that £25 million is required to do everything that you want to do in relation to specialist drugs. So, you must have a calculation of how you get that.

Dr Timoney: If we were to levy £1 per prescription item on everyone regardless, on the basis of 40 million prescriptions a year, that would give you a figure of £40 million. The Minister is talking about season tickets, about £25 and about some patients being able to buy all their medicines free after a certain amount or, in the way that we used prepayment certificates for prescriptions, if you receive more than 15 medicines per year, you get the rest free. It is that type of modelling. Do you levy for a family or do you levy at each individual, and, if you put that option in, how will it bring your figure down?

The Chairperson (Ms Maeve McLaughlin): Surely the Department and the Minister need to come up with those options.

Dr Timoney: We are working on them.

The Chairperson (Ms Maeve McLaughlin): How much will the £25 million scheme cost to administer?

Mr A Campbell: Sorry, is that the IFR scheme?

The Chairperson (Ms Maeve McLaughlin): The specialist drugs scheme.

Mr A Campbell: We think that the regional committees will probably have the highest cost — somewhere in the region of £300,000 up to a maximum of £500,000 recurrent.

Mr A Campbell: Yes, the regional committees are there to scrutinise the IFRs.

The Chairperson (Ms Maeve McLaughlin): We are talking about a specialist drugs fund that, in the proposal, will be paid for through prescription charges. There is an administration cost that comes with it.

Mr Johnston: I think that you are asking what the administration costs would be to provide prescriptions.

Dr Timoney: Previously, it was £2·5 million but —

Dr Timoney: — not running exemptions, we expect it to be less than that. I do not have a firm figure on what the cost will be.

The Chairperson (Ms Maeve McLaughlin): We are being asked to support, consolidate and challenge something when we do not even have accurate figures. We do not have a sense of how much that scheme will cost to administer. The second question is this: how much will it cost to enforce?

Dr Timoney: We have all that information and are working on it on the basis of a universal charge.

Mr Johnston: It is important to state that it is an evaluation of the individual funding request system that we took forward. As part of it, this question was asked: how would you pay for the changes? The proposal is to do so through a prescription charge. The next stage will be to make detailed proposals on a prescription charge. If you are being asked to make decisions on this now, the first set of decisions is on whether you agree with the proposals on how we change the IFR process and agree that we should fund those through a prescription charge. If we get past that part of the process, the next stage will be the detail of what the prescription charges will look like and what the process will look like, and the Minister gave an indication yesterday of his broad preference at this point.

The Chairperson (Ms Maeve McLaughlin): You know that the cost of the process to an individual, or the individual cost, can make an awful lot of difference to somebody paying £1 or somebody paying £25. It seems to me that we are consulting on processes that you cannot tell me, here and now, first, how much it will cost to administer and, secondly, how much it will cost to enforce.

Mr Johnston: Based on past —

The Chairperson (Ms Maeve McLaughlin): Jackie, there is also a concern about what guarantees there are that this scheme will go in the direction that they are saying it is going to go in. What guarantees will there be that this will not be a tax by stealth and be added to as more pressures come in the system?

Mr Johnston: The Minister clearly stated that it is not a tax by stealth. He said that this will be ring-fenced purely to fund the specialist drugs fund. He has made that quite clear.

Mrs Dobson: Thank you for your briefing. Jackie, you said in your introduction that it was difficult for you personally when you see the letters you receive from MLAs. Try being one of those MLAs who has watched their constituent fade away before their eyes and listened to him fight for access to drugs. It is very, very hard for me. I know his daughter is with us; I pay tribute to Tracey, who is sitting here today.

In his statement yesterday, the Minister mentioned the PPRS. He said that he:

"cannot be definitive about the scale of the payments".

Yet, in an answer to a written question from me in October, he confirmed £3·53 million for the first quarter of 2014. So, we are receiving the money and just using it to fill in the black hole.

Mr Johnston: I think Mark can tell you detail on that, Jo-Anne.

Dr Timoney: We can be definitive about the money received for three quarters. In quarter 1, January to March, £3·53 million was received; in quarter 2, we received £3·83 million back from the scheme; and, in July to September, we received £3·92 million. It was around about £11·2 million with one quarter left to come.

The scheme is based on the growth of medicines between 2013 and now. The scheme is working for us. We are very grateful for it and for the flexibility it brings us, but we have been spending £21 million on branded medicines in this year, and we have been addressing innovation in the spirit of the PPRS in that. I can give you a list of the types of areas in which we have invested. We have invested in multiple sclerosis, age-related macular degeneration and cancer treatments. All of those are innovative medicines, and each cost in the region of £2 million in investment. The scheme is paying us the rebates on the basis of that growth. So, there has been £21 million this year so far. We know that we have got £11·2 million back, and we know that we will get another receipt in the next quarter of the year. We, therefore, have the opportunity, as of last week — as of these figures arriving with us — to assess how well the scheme is performing. We can now present those figures to our finance colleagues and allow them to make some planning predictions in going forward in the 2015-16 year on the basis that the scheme is there. The scheme is to be much welcomed, because it is helping us manage the prioritised financial pressures that are in the system as we make these investments —

Mrs Dobson: So, it is being absorbed into the system. Essentially, it has gone into that great black hole that is the system.

Dr Timoney: We have addressed the opportunity to grow medicines in this financial year, and the scheme has rewarded us with the rebates from that growth. We have been able to factor that into the financial arrangements for the year.

Mrs Dobson: It is baffling. Why would the Minister say that he cannot be definitive about the scale of the payments and then, in turn, read out each amount?

Dr Timoney: It is a very difficult scheme. Previous PPRSs were about capping profit and cutting prices over a five-year period. So, you pretty much knew what you were going to get from year 1, and you could make your plans going forward. With this scheme, it depends on the amount of growth on a UK basis. The percentage of payments that companies make back into the scheme are adjusted on a six-monthly basis. So, there is changeability around this. For accurate financial planning, the scheme needs to be in real time so that we are able to project things over a five-year period, as we could do in the past.

It is important that we understand how much we are spending on these branded medicines in Northern Ireland. We are spending the same amount as everyone else in the UK. The companies are registering that expenditure. They are making their payments back the UK Government in London. Then, on the basis of our primary care expenditure, we are able to have our apportionment ratio calculated and delivered back to us at a time ahead. So, we must spend first; that is the important thing. We must spend the money first and do so against the current financial climate that we find ourselves in. We are making that expenditure. We are providing these much-needed treatments to patients in these specialist areas. The rebate arrives at a point further down the line.

Mrs Dobson: Just like the Chair, I have concerns about figures being bandied about. We are told that there are no definitive figures, then figures appear. You can understand how —

Dr Timoney: The quarter 2 and quarter 3 figures arrived on 12 February, which was last Thursday.

Mrs Dobson: I very much welcome yesterday's announcement of a specialist drugs fund. So many have been fighting for it for some time. Sadly, so many of those people, like my late constituent Mr Brian Coburn, are no longer here. Can you tell us when the first patient is likely to benefit from this fund?

Mr A Campbell: We will try to get it as quickly as possible. Obviously, the consultation runs for three months. We will be doing a lot in parallel. Much will depend on the financial situation. The Minister is keen to explore whether there is any way that he could possibly do this in the short term, but we cannot be definitive about that, certainly not at the minute with the pressures on the system. If prescription charges were to come in, I think that the Minister is on record saying that he hoped it could be done within a year.

Mrs Dobson: You cannot, at this stage, give us a definitive answer. There are so many ifs, buts, maybes, consultations and evaluations of the consultation. It does seem to be in the wide blue yonder. People at home will be thinking, "Brilliant, there is access to specialist drugs". They will expect it to be sooner rather than later. You have no definitive timescale.

Dr Timoney: It is important that, in raising expectations, we deliver on them. We must be absolute in securing the funding for this scheme.

Mrs Dobson: Expectations have already been raised by the announcement yesterday. You have already started the ball rolling on expectations.

Dr Timoney: So, we have to secure the fund. We have to ensure that that fund is stable. We have to put in place the infrastructure so that we have a robust mechanism for ensuring that the first patient can reliably receive the funding and access to the medicine that they require. It is very important that this fund is established on a sustainable basis for the future.

Mrs Dobson: There is no timescale. There is so much improbability with it that we do not know at this stage.

Mr A Campbell: As officials, we will make sure that everything that is in our control progresses as quickly as possible.

Mrs Dobson: And those MLAs who keep writing to Jackie Johnston will continue to do so.

Finally, we heard yesterday in the statement about the regional committees which are proposed. How much sway will the size of the drugs fund have on the decisions that committees will make? Where is the priority? Is it clinical or financial?

Mr A Campbell: The priority is very much clinical. I would hope that, when we change the system, the system will adapt to it, so it will not be capped and will just depend on demand.

Mrs Dobson: I hope that you are right or, Jackie, you will be receiving a lot more letters from me.

The Chairperson (Ms Maeve McLaughlin): Can you give us a breakdown of how the £11 million in the PPRS was used?

Dr Timoney: As I said, the two receipts for quarter 2 and quarter 3 arrived last Thursday. As I said before, we have invested £21 million in branded medicines this year, which has gone someway to generating those rebates. In the system, that has sustained the additional growth of £21 million. It will go to offset financial pressures and demands that are currently in the system as a result of our prioritising that investment of £21 million in specialist, innovative new medicines in 2014.

The Chairperson (Ms Maeve McLaughlin): Can we get that clarified from you in writing?

Mr Johnston: Yes.

Mr McGimpsey: You will appreciate that this is ground that I have been over in the past. There are two issues here. I do not want to get the two confused. One is prescription charges. The other is a specialist drugs fund.

My first point is on the specialist drugs fund. You say that you need £25 million to cover this. We are not just talking about cancer drugs, are we? We are talking about a number of other conditions. We are also not just talking about the here and now, because you have got to look to the future: £25 million is not going to look at it in the future. As you see all the drugs that are being developed by the drug companies, not just for cancer but for the other conditions that you mentioned, have you done a projection of what you will need or where you will be in terms of the income that you need to cover your specialist drugs fund in, say, five years from now? If, as I say, it is £25 million for the here and now, there must be some sort of projection that you can give us for five years from now.

Mr Johnston: Yes, indeed. We need to anticipate 3% growth in primary care branded expenditure year on year. We need to anticipate 7% growth in secondary care specialist medicines expenditure year on year going forward.

Mr McGimpsey: So, that is 10% per annum.

Dr Timoney: Yes. That is about £10 million in each of those sectors, give or take.

Mr McGimpsey: OK. So, where will that take your £25 million in five years from now?

Dr Timoney: Well, the £25 million will be an annual collected charge.

Mr McGimpsey: As I understand it, that is what you need to cover you right now. That is the bill.

Dr Timoney: There is probably a bit of headroom in the £25 million if we are looking at £4 million to £9 million on specialist approved medicines and £12 million to £15 million on the NICE-approved medicines.

Mr McGimpsey: So, you could be anywhere up to £25 million and maybe a bit less.

Dr Timoney: You could be.

Mr McGimpsey: It is always best to allow for —

Dr Timoney: The headroom.

Mr McGimpsey: — the top figure. Then, you do not have to keep going back to the well. Where will you be in five years from now, do you reckon?

Dr Timoney: In the absence of a definitive crystal ball, on current predictions, we reckon that a £50 million additional tail on specialist expenditure in trusts could be where we are. That would be where the trend is currently sitting.

Mr McGimpsey: I take the view that, if the clinician determines that the patient should have the drugs, the patient should have the drugs. I also take the view that we have a health service that is free at the point of delivery from cradle to grave. That is a key principle. Once you break that, you are heading off into charging. We have too many people in A&E; let us charge. There are too many people at the GP; let us charge. We have too many people chasing hospital beds; let us charge. I can see a trend. That is basically where we are in the Irish Republic, for example, where they charge for GPs, beds and A&Es. I have that concern. It seems to me that, on a drugs budget, if the clinicians want those drugs prescribed, they should be allowed to do that and you pay for it out of your general pharmacy budget, which is running at the minute at around half a billion a year, is that right? It seems to me that that is the principle where you should be. That is where you should be bidding with the Executive and telling them that this is what you need to sustain this level of prescribing.

The second point is this: all drugs are approved for use by the National Institute for Health and Care Excellence. That is the principle. It always was when I was in health. The clinicians would not approve drugs unless they were approved by NICE. Many of these drugs that you are talking about are not NICE-approved. They are licensed, but they are not NICE-approved. We subscribe to NICE because obviously we are too small to have our own specialist institute to deal with that. In fact, it deals with the whole of the UK apart from Scotland. We subscribe to it as well. What is the difference between NICE-approved and licensed? NICE approves 99% of all drugs. Is that right?

Dr Timoney: It may not just be as high as that, although Scotland do a lot better. They put most of their drugs through a health technology assessment. The difference is that these drugs have been tested for their clinical benefit. They have been tested for their cost benefit in recognition of that. Clinical benefit and the prices are matched. The health service has some assurance that the drug is then clinical and cost-effective and therefore merits investment. That is the position that we are in in Northern Ireland. All of those drugs that have been approved by NICE are currently being commissioned for our patients. There is no postcode lottery in that respect.

Mr McGimpsey: OK. So, these other drugs have not been able to get NICE approval but are licensed as safe. Is that what you are talking about buying with your specialist drugs fund or are they just part of it?

Dr Timoney: The specialist drugs fund and the IFR process have been designed to strengthen the system so that we can afford these medicines, but the specialist medicines fund, by its very name, should accommodate those approved medicines as well — the approved medicines which will create pressures for us in the oncoming years.

Mr McGimpsey: OK. I think it is important that we understand the difference between licensed and approved drugs.

The Chair made a strong point about efficiencies. I take it that the policy of "go generic" is still in place.

Dr Timoney: Yes.

Mr McGimpsey: Very large sums of money have been released through that. How much more are you going to get out of your go generic policy? There is obviously a limit to where you are going to be.

Dr Timoney: We reckon that, in straight generic switches, which is taking generic drug A from branded drug A — if that makes sense — there will be a couple of million left. We have almost reached the ceiling with our generic rates. We are equivalent to the rest of the UK countries in the number of generic medicines that we currently prescribe. That is an achievement. We have moved from 43%, back in 2005, to 71% today, so we are up to speed with everyone else in that respect.

We have a number of drugs — branded drug B, if you like — which is very similar to drug A, but it exists as a brand, and we need to change from that branded drug B to generic drug A. So, we need to be able to therapeutically switch these medicines which are as effective, when they are prescribed generically, as their branded cousin, which may cost up to 10 times as much. So, we reckon that quite a sum of money is to be identified there. As the Chair pointed out, the Northern Ireland Audit Office report identified some areas that we should pay attention to in that respect. I have been working with board colleagues on this for two sessions now. In March, we will have a plan developed as to how a further £20 million worth of efficiencies will be delivered in 2015-16 on the basis of that particular strategy.

Mr McGimpsey: Basically, you need £25 million maximum, it might be around £15 million or £16 million, but you have a plan to give you £20 million.

Dr Timoney: We have.

Mr McGimpsey: So, why do you need prescription charges?

Dr Timoney: We have a plan to give us £20 million to offset the pressures that we sit within. We have always had a need to assure the quality, cost-effective prescribing that is in the system. We need to ensure that that is constantly driven forward. Even if we get that £20 million, we still will not have enough in the wherewithal to address the additional, non-approved pressures that we are faced with.

Mr McGimpsey: OK. Let us turn to charging. I want to take us back to where we were when prescription charges were abolished. I did it, so I have some of the detail. I actually have one of the submissions that you guys gave me at the time, and I have many more of these in my pocket.

Mrs Dobson: To be used in due course.

Mr McGimpsey: We were charging £6·85 for our prescriptions, and that was giving us a maximum of £13 million a year. That is what we were producing. So, on the face of that, if you were following the same process to get £25 million, you would have to be charging around £14 per prescription, because you have a number of exemptions. It is the exemptions that interest me. When I took over, you were exempting people who were under 16 years of age, obviously economically inactive; the under-19s in full-time education, so economically inactive; 60-plus, economically inactive and ability to pay; the pregnant; and war pensioners. You also had to exempt, on medical grounds, those with epilepsy, some types of diabetes and so on. They were all exempt. So, the proposal is that you start to charge all those folks, as I understand it. So, babies, the over-60s, folks with dementia are all going to pay.

We also looked at this whole argument. At that stage, 90% of all prescriptions were going free under those exemptions. Then, we looked at revising the process. We were revising exemptions, because a number of patient groups were paying, and that seemed to me unfair. Those groups included people with cancer, heart disease, asthma, stroke, kidney disease, arthritis, mental ill health and so on. We decided to look at how to get those exempted, and, when we looked at exempting those, the 90% jumped to 95%. The cost of admin and the cost of looking at fraud made it almost a non-cost. In fact, we funded it out of our own budget, and I got the Executive to approve it. All parties approved what we were doing.

If you are looking at prescription charges again, I find it hard to see how you can start to charge all those folks who were previously exempt, because they were exempt for very good reasons. They were folks with cancer, asthma and heart disease. You also have to think about babies, three-year-olds, two-year-olds, people up to 16 and the over-60s. Are we really saying that we will start charging those people? Then there is the admin; we have to administer it. On top of that, there was always fraud, and the cost of fraud was about £7 million at that stage. If you are looking for £25 million and you will charge 50p, £1 or £25, even if you are doing 100%, I think you are probably light in terms of the income that you are talking about generating. It seems to me that, if you are to look at exemptions, it costs more to administer, and it seems to me that the charges that you are talking about do not begin to look at it. That is what bothers me. It is a slippery slope. It will be a £25-a-year licence this year but £50 next year and £75 the next because you are tying it to specialist drugs and the costs of specialist drugs will keep going up and up and up. In fact, it should be part of your general pharmacy budget. Finding the money for it is not your business. It is somebody else's business in the Department, and they have dreamt up this idea of prescription charges. You know what you need to cover you for the drugs that the clinicians are prescribing.

Dr Timoney: Like you said, we will put up a much more detailed model in and around all the issues that you highlighted so that it is clear to the public what the charge mechanism will realise, and we will see how acceptable to the public that charging mechanism will be if it is felt that it can get to a quantum of investment that will, in the oncoming period, offset the pressures that are raised by demand for access to those medicines.

Mr McGimpsey: One of the arguments is that, if they get it for free, people do not appreciate it and you get a surge. That did not happen. The suggestion is that, if you charge 50p or £1, people will not abuse it. You can use the same argument for going to A&E, the doctor or a hospital bed. I do not see that as an argument. If you have around 20,000 people with dementia, how will you get them a bill? If you have around 100,000 people with COPD, how will you bill them? The same applies to cancer patients. It seems to me that we need to look at a very tight cost of the direction that we are going in — I do not argue with the direction — and then we need to hear from the Department how it will pay for it. A simple prescription charge at 50p or £1 will not look at this.

Mr McKinney: I welcome the statement. It is a tribute to all those who are either suffering from cancer or are very much aware of the issues that cancer sufferers face. It is a real tribute to their ability to persuade and argue, and it is a shame that the Department struggled for so long to come to terms with the PPRS and other issues around access to the drugs, because that was a fundamental inequality that existed. I also pay tribute to the former Minister, Edwin Poots, who recognised and heard that voice first and decided to conduct a review. I pay tribute to Mr Wells, too, for making the announcement yesterday.

As Mr McGimpsey has been saying, there are two issues. Nobody can argue with the fact that we will have potential for greater access, but the secondary issue is around prescription charges.

At an emotive level, I think that you are not wrong, and some members of the public say that we should do that, because of the strength of the campaign and the link between those two issues. As is clearly emerging in this conversation, however, the devil will be in the detail.

From what you are saying, it is clear that, under the PPRS, you were not spending all the money on innovative cancer drugs.

Dr Timoney: In 2013, we invested over £21 million in branded medicines. Our current expenditure on cancer medicines, which includes extant pressures as well as new ones, totals £27 million annually. It can be seen that, in cancer treatment, we have been spending new money on those treatments. We are seeing the benefits of those in malignant melanoma and multiple myeloma, and patients are doing very well on those medicines. They are entering third- and fourth-line medicines, which we are able to provide, but the investment costs are huge: we invested £2 million in each of those cancer areas in 2014. We are making the moneys available. However, when it comes to non-NICE-approved medicines, there is a difficulty because of the pressures in the system and financial demands, which impact individual patients. If we want to move investment into the area where we want the approved drugs, we will have to disinvest in another area. That will impact individual patients who were perhaps previously denied approved treatment. That is one concern, hence the need for the injection. Every pound that we spend on medicines in the health service must derive maximum benefit. In the current structure, it will always be difficult for us to seek to invest in medicines with benefits that are less than clear compared with medicines that are coming on stream for which huge patient benefits are demonstrated. That is the conundrum, which is why we are seeking the injection: to make sure that all specialist medicine demands can be addressed.

Mr McKinney: As the conversation continues, the issue will be to reassure the public. As your processes continue, there will be a graduated increase in those accessing the drugs. The bills will not have to be paid up front. Given that you are making savings, why should we have prescription charges up front, in the sense that people would agree to those at the early stage? Why could we not look at it notionally and defer the prescription charges as we see the system moving?

Dr Timoney: If that was the only option open to us, the short answer is that, on that premise, we would struggle to identify the £21 million that we have invested in those new drugs in 2014. Waiting for efficiencies to deliver in the first instance on a year-long programme will offset our ability to be able to make that investment.

Mr McKinney: Will you give me a notional figure for year 1 of access — 2015-16 — if this came into play after three months?

Mr A Campbell: Do you mean the IFR specifically?

Mr A Campbell: Last year, the IFR cost £1·9 million, and that was with the 95%. I suspect that you would be at least doubling —

Mr McKinney: To £4 million or £5 million.

Mr A Campbell: It would be £4 million or £5 million, probably rising to £6 million, £7 million or £8 million.

Mr McKinney: What would your proposal for prescription charges, if it were at a flat rate with no exemption with 40 million prescriptions a year, give you?

Mr A Campbell: It would give you £40 million.

Mr McKinney: Which is how much more than you need?

Mr A Campbell: For the pressures —

Mr McKinney: In year 1, how much more would it give you?

Dr Timoney: It is a hypothetical question —

Mr McKinney: We are being asked to put our hands up for it hypothetically.

Dr Timoney: On a hypothetical basis, it would probably give you headroom in the region of £15 million.

Mr McKinney: Where would that money go?

Dr Timoney: That money would go to offset other medicine pressures and assist with pressures in the system, but this is not a line —

Mr McKinney: So it is not now a specialist drugs fund?

Dr Timoney: Sorry, may I make a point? We are talking about the acquisition costs of drugs. We are talking about the price that a pharmacy will pay a wholesaler. With specialist medicines, that is not the only cost. Specialist medicines require intensive diagnostics, maybe genetic mapping and specialist pharmaceutical reconstitution for a lot of the drugs —

Mr McKinney: I understand that, but you told me that, on the face of it, this is back-of-an-envelope stuff, and I do not like that.

Dr Timoney: No, I appreciate that.

Mr McKinney: You need to do your homework. You have just given me a figure of £15 million more than you need. You would have to spend that money next year, and you are telling me that that could go to other services and provision.

Dr Timoney: In the first instance —

Mr McKinney: Sorry, that makes me conclude, at this very early stage, that this is not a specialist drugs fund but a fund that will contribute to wider pressures.

Mr Johnston: That is the danger of speculating about what the income stream would be. The Minister said quite clearly that this will be ring-fenced for specialist drugs. It will not be used to finance other pressures. Detailed modelling will be done. Alongside the headline consultation question, "Do you agree that this should be introduced to fund it?", further information will be given out about the various modelling options for funding that particular requirement.

Mr McKinney: I apologise for not being here at the very start of your presentation. I was genuinely waylaid. If I missed anything, just let me know. At the same time, we are further interrogating some of the issues.

I come back to my point. You are asking people a top-tier, strategic question: are you in favour of prescription charges? I am saying that, even at this very early stage, the figures are huge, and there is massive room for people's interpretation to be wrong. If people are to respond to that emotive question, they need to be reassured. It is an emotive question, and a lot of emotion brought us to this stage, which has been too late for many people. Jo-Anne reflected on that. We need to arrive at a decision in a proper, considered way.

I am adding up the savings that you make, the PPRS income and at least £15 million. Those add up, and the savings take away the pressure. The income is undecided. We have not hit on a £1 figure for prescriptions; it could be £1·50 or 50p — we do not know. Once again, the figures are loose. The figures suggest to me that where you end up will be far greater than the specifics of a specialist drugs fund. We need reassurance. Is that fair?

Mr Johnston: We will get you more information. You said that three funding streams might be involved.

Mr McKinney: Some were subtractions, but it is unclear —

Mr Johnston: The Minister has never indicated that anything other than the prescription charge would be used to fund the specialist drugs fund.

Mr McKinney: Even this conversation points out that a sum of £1 would give you substantially more than you need, so, de facto —

Mr Johnston: I think that that is the danger of speculating.

Mr McKinney: Is there any prospect that you could call the charge a "specialist drugs charge", so that it limits, at the earliest stages, its potential and satisfies that emotive —

Mr Johnston: That is worth considering.

Mr McKinney: I will leave it at that. Lots more questions need to be asked and answered over the next while.

Ms McCorley: Go raibh maith agat, a Chathaoirligh. Thanks for the presentation. The cancer drugs fund in England is criticised as being a back-door route to access the drugs that are not NICE-approved, which undermines NICE. What would you say about that?

Mr Magee: The idea is that, if a drug does not have to meet the rigorous standards of NICE, it could still seek to be funded via the cancer drugs fund and, in that way, would undermine NICE's work.

Ms McCorley: Does NICE set the standard that has to be achieved? Are you saying that there is a lower standard?

Mr Magee: The legal opinion is that the NICE standard has to be achieved.

Ms McCorley: How do you ensure that the IFR mechanism and the specialist drugs fund do not become a route to obtaining drugs that have not been approved by NICE and are not tightly controlled?

Mr A Campbell: This is why we think that an IFR process is needed to govern access in exceptional cases. That is what the exceptionality criterion is about. We are talking about lowering it but not removing it entirely, because these are exceptional cases. The standard treatments are the best treatments for the majority of patients. A clinician would make an application when he feels that a patient may benefit substantially more than other patients with the same condition at the same stage. The structures that we are talking about setting up would involve clinical peer review to establish that the application is accurate and would be a good use of the drug.

Ms McCorley: Do you not see that happening? You do not see a rise in access to unapproved or non-NICE-approved drugs. The criticism is standard in England.

Mr A Campbell: I think that it is fair to say that the cancer drugs fund would not have the strict access criterion that we are talking about. A clinician would have to think that there would be a substantial benefit to his patient, and then other clinicians on committees would have to agree on a peer review basis that it is the right decision.

Ms McCorley: Could you foresee a time when NICE might be sidelined?

Mr A Campbell: No, I do not think so. It will remain the standard treatment for the process that we are putting forward, and it will still be for exceptional cases.

Ms McCorley: There are no guarantees.

Mr A Campbell: No, but there should be safeguards, and clinicians would be unwilling to go down that line as well. We are talking about giving more responsibility to clinicians through this system. They are very mindful of what is in the best interests of the patient, and that is certainly not unfettered access to all the drugs out there. It is about making sure that patients have the best treatment for their condition.

Ms McCorley: It sounds as if the Minister has decided that there will be prescription charges. It seems to be very vulnerable people who have more illnesses and afflictions and are less likely to be able to pay. It sounds as if everybody will have to pay something, and, while a lot of people will have no issue with that and are well able to pay, the most vulnerable will be least able, and they might be the ones in greatest need. My concern is that people who are already suffering from traumatic illnesses and conditions will be placed in the position of having to start to pay. Are you sure that we will not end up making life worse for very vulnerable people?

Mr Johnston: The Minister indicated that a universal charge is his preferred way to cover the cost of the specialist drugs fund. This is out for consultation, and we have a period during which concerns can be sent to the Department. They will all be considered and evaluated before the Minister makes a final decision on the way forward. We have an opportunity to debate, consider and air those issues and to examine the effects to which you refer.

Ms McCorley: Will you outline again the options in the consultation?

Mr A Campbell: For prescription charges?

Mr A Campbell: Mark, correct me if I am wrong, but it is fairly high level. The system for prescription charges was phased out, and then we had —

Ms McCorley: What was the first —

Mr A Campbell: The options are: the previous charging regime; do nothing — we specifically ask what exemptions people feel would be reasonable; and, thirdly, a universal charge. Mark, is that correct?

Ms McCorley: The difficulty with consultations is that the people who will probably be most affected — the people on the margins — are the least likely to respond. You could end up with a consultation result that says what you want it to say and does not ultimately provide what vulnerable people need. That is concerning. How will you go about reaching the vulnerable?

Mr A Campbell: We are working that out. I absolutely agree that this needs to be a very targeted consultation. We need to go looking for people rather than just organising events and waiting for people to come to us. One idea is to go through local charities as a way to reach people, and we are thinking about that. My focus is very much on the IFR process, and I know that it and prescription charges need to be given equal weight. Mark and I will both work on reaching the people we need to reach for both aspects.

Ms McCorley: There are lots of complicated aspects. We will keep an eye on it.

Mr Brady: Thanks for the presentation. I want to clarify a couple of things in the Minister's statement. He referred to a universal charge, and he seemed to indicate that it would be per prescription as opposed to per item.

Dr Timoney: It is per item.

Mr Brady: I understand that the Minister is not interested in a means test. Someone on a benefit, which is subsistence level, could have 10 items and be paying £10. It could be more, or it could be less, which would bring people below subsistence level. I am concerned about that. A charge per prescription is a different thing altogether from a charge per item. Some people are on huge prescription regimes. I fill in DLA and ESA forms for people who are on five or six drugs, sometimes more. If it were a charge per item, therefore, the cost is considerable and is more than the original £6 prescription charge.

Dr Timoney: That is the idea behind the season ticket. Patients with more than a certain number of items would be able to pay on a yearly or even a three-monthly basis and get all their medicines. The Minister mentioned a figure of £25 yesterday.

Mr Brady: I understand that, and we used to have that system, when people paid so much per quarter.

Dr Timoney: It was every four months.

Mr Brady: The system in England was so much per quarter, and then it was per year.

Dr Timoney: It costs just over £100. There is talk in England of pushing it up to maybe —

Mr Brady: A sum of £25 does not sound like a lot of money, but, if you are on benefits and are running a household on £72·40, which is what people get on income-based benefits at present, that can cause problems. People need to be aware of that.

Dr Timoney: A family ticket may also be considered. A lot of models could be used. Each and every one will affect that 40 million top figure, because you will have to manage that all the way down to a realistic figure every time a modification is put in. That is what the modelling is about. You need to get into that conversation.

Mr Brady: The argument against a means test is administrative cost. However, we should also be interested in taking the cost to the person into account.

Mr McKinney: That is the point: people are being asked to accept the concept. It is described as only £1, whereas it is potentially £10 or some other modification. You are right to say that it will make a difference to the overall figures and that some of that will have to be managed through. However, will it still be an equitable system? There is a public mood, and some people said yesterday that the public are ahead of us. I do not disagree. Where are they ahead of us? Are they ahead of us on when it comes to paying a big sum, or the little sum that has been advertised? If it is advertised and sold to them as the little sum, when it turns into the big sum, we have a mess. We have to be honest, open and transparent with the public, and the Minister talked about that. Unfortunately, my experience heretofore, particularly through trying to get information on the PPRS, is that there has not been transparency. I therefore welcome the introduction of the concept into this process. The devil is in the detail. We should be dotting the i's and crossing the t's at an earlier stage so that, in a consultation, we can inform people of where you are actually at as opposed to where we could end up, which might satisfy your financial bottom line but will end up with people railing against it. It is about getting the homework done. I think that we agree about that.

Mr Brady: It does not need to be sold on the wrong premise. You will have heard people being interviewed this morning on the radio. A sum of £1 sounds OK, but it may not be £1. It could be a lot more than £1, or it could be less. The proposal needs to be sold on the premise that people are made fully aware of how it will affect them.

Mr McKinney: May I jump in again, Chair? It is ironic that this is coming out of addressing an inequality. We do not want to end up with another inequality. That is against the backdrop that we acknowledge the strain on the system.

Mr McGimpsey: You could end up with patients not going for their medicines because they do not have the money, which will cost the health service a lot more.

Mr McKinney: My fundamental worry is that, while you talk about savings and efficiencies and all the rest, if we just hand over more money, efficiency will be encouraged less. That is the nature of systems.

Ms P Bradley: Having listened to the comments, I have a few quick points. I do not believe that the Minister woke up two weeks ago and decided that this was the panacea. This has been bandied about for some time since we were returned in 2011. I wholeheartedly agree with what Michael said about the reasons for doing away with prescription charges in 2010. The system was costing money. I have never paid for a prescription in my life. I have a condition that requires medication every day, and it is one of the free drugs. That also entitled me to get all my other prescriptions free throughout my adult life. I have never paid, although I have worked all my life and could have paid without any difficulty. I absolutely have worries about this and do not want to hit the most vulnerable in our society.

This is not a done deal. It is not signed, sealed and delivered. A lot of big statements have been made here this afternoon, but it is not a done deal. It has to satisfy all of us. I am not satisfied with the way in which it sits at the minute. I want to ask you about the consultation process. How widely are we consulting? As you said, we heard people on the radio this morning and yesterday saying: "Yes, I would definitely pay. It is not a problem". I would pay; I can afford to. As I said, I have never paid for a prescription, and I would be happy to pay. I entirely understand about those we heard on TV and radio, especially those with mental illness. My partner takes eight to 10 drugs a day, and he paid for his prescriptions for many years. I understand all those issues. I look forward to reading the views from the consultation. How far-reaching will it be?

Mr A Campbell: It will be as far-reaching as possible. Joe and I are working through a consultation plan, and we will make a public announcement when we have sorted it all out and know what we are doing. As I say, we want to target it. It will not be a matter of letting people come to us; we want to seek out difficult-to-reach groups.

Ms P Bradley: Will the consultation go not only to specific groups but to the general public?

Mr Johnston: Yes. We will hold public meetings across Northern Ireland and also take the standard approach of being available for responses via post and email. There will be well-publicised public meetings to ensure that we get good coverage across the Province. We will also talk to charity groups that represent vulnerable groups to make sure that their voice is heard.

Ms P Bradley: That is also extremely important, because, in one sense, we are all together in that none of us wants to hit the most vulnerable in our society — absolutely not.

Mr Johnston: This is an important decision for Northern Ireland.

Ms P Bradley: It is a big decision.

Mr Johnston: On the one hand, we have the issue of access to specialist drugs, and, on the other hand, how we pay for it, and, in paying for it, how do we get as fair a system as possible. We will try to square those three issues as best we can. It is important that we hear from a wide cross-section of the public on what can best be done.

Ms P Bradley: I have another quick point. What about pharmacists and clinicians and their involvement in the consultation? We have heard from pharmacists and clinicians in recent days, who have different opinions and do not always agree with one another.

Dr Timoney: We will engage with them fully in the consultation, as we will with everyone else.

Mrs Cameron: Thank you very much for your presentation. I too am on record as welcoming the statement from the Minister and the fact that we are looking at this. I very much welcome the fact that we are looking to remove the 95% condition, which has been a huge hindrance. I was made aware of the funding process for these specialist drugs for the first time through Una Crudden who, as we all know, sadly passed away on 4 December. We have to keep the reason for this in mind. Some of us are very happy to look at the issue and consider it very seriously, and I hope that we can get agreement across the table so that it works for those who so desperately need and want it; especially cancer sufferers, who are maybe just seeking a little bit more time on this earth with their loved ones. That, for me, is what this is about, essentially. Yes, we have to protect those who are vulnerable and need help, but we need to look at the big picture. It is very important that we do that.

Do you have any unexpected statistics on how drugs and items have been prescribed since the abolition of charges in 2010? For instance, if I go to the doctor this morning, and say, "I have got a really bad headache. Can you give me paracetamol?". I would expect him to give me a prescription for paracetamol. I know full well that I can buy it in a supermarket for 16p. It costs £1.30 or something like that to process a prescription, never mind the cost of the drug and the GP's time. Do you have any statistics or information that could not have been predicted at the abolition of the charges in 2010?

Dr Timoney: An evaluation was done by the business service organisation (BSO), and I can let you have a copy of it. The high-level outcome of the evaluation was that there was no perceived change to trends as a result of the abolition of prescription charges. The trend before was of a 5% to 7% growth in prescription numbers year on year, and it stayed largely within those limits afterwards. We are seeing an increase of about a million or a million and a half prescriptions every year in Northern Ireland; but we have had that trend for some time, and it has not really altered as a result of abolition. I am more than happy to let you see the evaluation.

Mrs Cameron: If there is to be a change in how prescriptions are dealt with, will there be any investigation into the prescribing of what I will call simple drugs — and I know that it is wrong to do that — such as paracetamol, aspirin or sun creams. Will you look at the items that are prescribed and given out freely? If I go to the doctor tomorrow and say: "I have the same headache. Can I have some paracetamol?", and there is now a £1 charge per item, I would like to think that the doctor would say: "Well, yes, I can prescribe this, and you know it is going to cost you £1; but you can buy that yourself for 16p." It all sounds very common sense, but maybe that will not be there on a whole list of items. I think that, because we get everything free, as we have done for the last five years, there is a big lack of awareness on the part of all of us. Mickey talked about the script with 10 items on it. People are not aware of how little some things cost, and how much other things cost. There is obviously huge variation in the cost of items that are prescribed, and I think people could afford many of them if they were able to access them without prescriptions. Is there any investigation into how it can be done better?

Dr Timoney: It harks back to the efficiency drive that we talked to the Chair about at the outset of the meeting. The board is developing a plan at the moment. It is looking at a number of items that are less suitable for prescribing but are being prescribed and which GPs should be advised that they should not prescribe.

GPs are broadly in agreement with this principle as well. There was a poll about four or five years ago across England and a lot of over-the-counter medicines, as they are called, were cited by GPs as items that should be looked at in a more restricted sense. Aspirin and paracetamol are used in certain chronic conditions, such as cardiovascular conditions, and it is important that patients who need those medicines can get them. However, when it comes to the wholesale prescribing of certain vitamins or less-than-proven supplements for long-term conditions that have no evidence to support them, we need to look very closely at our prescription data. We have a lot of data, and we can identify where these items are being prescribed and how much money has been tied up in them. We can take some steps to identify them and provide advice, education and dialogue at GP practice level to ensure that those items are not being prescribed when the system is under pressures as it stands.

Mrs Cameron: Finally, what investigation has there been into the wastage of drugs? It may be that I get two prescriptions for paracetamol but do not use them and they lie in a drawer. We all have drawers and cupboards full of things that, maybe, did not work or are not even out of date. I understand that there are storage and health and safety issues and I know that, at the moment, those drugs cannot be reused. However, there may be items that can be reused or recycled, whatever way you want to look at it. Has there been any investigation into the drugs that are kicking about the place and the huge wastage that is there?

Dr Timoney: You are absolutely right. We are concerned about the level of waste. The University of York and the School of Pharmacy in London conducted an investigation into waste in England a couple of years ago which indicated that about £300 million worth of medicines was being wasted. It was not all the patients' fault, by any manner of means. Sometimes, the state of their disease got better and they did not need the drugs; sometimes it got worse and they needed a different drug, so the drug prescribed for them initially was not used. There were a number of causes of waste. If we read that across to Northern Ireland, you could be coming up with figures that run into millions, so we need to address it. What have we done? We have gone to the public, sequentially, winter after winter, with a campaign saying that if you do not need a drug and you already have it at home, try not to order it from the GP practice.

You talked about recycling; once a drug is ordered and once that train leaves the station, it cannot be put back on the pharmacist's shelf again and redispensed. It is gone; it is lost to the system. We know that 30% to 50% of patients who have long-term conditions — that is an international figure — do not take their medicines as prescribed. We have to put systems in place and we need to look to our pharmacists and other health care professionals. We need to ensure that when patients have their medicines prescribed for them, selected well on the basis of evidence, the prescription is appropriate and they are supported in taking the medicine and can derive the health benefit that those medicines can convey to them. If they do not, the medicines just get wasted and we have had a double hit, so to speak. That is all part and parcel of the medicines optimisation quality standard that we will be advertising to the Minister in 2015-16 with the hope of implementation so that all health care professionals are focused on the issues that you have raised, that the opportunity for wasting valuable medicines is minimised and, most importantly, that the patients get the benefits from them.

Mr Brady: I just want to follow up on that. There has been a lot of talk, particularly on the radio, about the number of prescriptions. I am starting to sound like a sad person who listens to the radio a lot, but I have to drive here and back, obviously. The Minister mentioned a figure of £48 million a year or something like that in prescriptions issued. Statistically, more drugs are prescribed in the North per head of population. Historically, however, we have higher levels of disability and illness and we need to be careful about that. Sometimes, the media in particular puts out this view that GPs are issuing drugs like sweeties but, in my view, that is not necessarily the case. My constituency has one of the highest incidences of MS, not just in Europe but in the entire world. The Mayo clinic has done studies going back a number of years. Newry and Mourne and Newry and Armagh have a very high incidence of the likes of MS, for which people require quite large quantities of drugs. Those people are not able to work because it is a progressive condition; they need more and more drugs and they end up on benefits, so we need to be careful around all these issues. We need to take a very circumspect look at how this is dealt with.

Dr Timoney: Again, that is a very good point. We have quite the highest incidence per head in the UK but I take your point. The corollary to that is that we have a lot of patients on a lot of medicines who may not necessarily be benefiting from the medicine and for whom the side effects are causing difficulties and concerns in areas such as falls etc. We need to be sure that we are watching those patients very closely and ensuring that the medicines they have are appropriate to their needs. If there are too many medicines and they become confused as a result of having to manage all those medicines, we need to sit down with them to resolve all that in a face-to-face way to ensure that the numbers of medicines are right.

Mr G Robinson: I want to follow on from Paula, who made a critical point. We are all charged here with trying to protect the most vulnerable from any charges whatsoever. That is what we have been elected to do. The consultation exercise is critical, and Paula mentioned that as well. You may already have touched on it to a certain extent, but who will the consultation be aimed at? Who will it go out to? The Minister said yesterday that it would last for three months; when does that begin? You talked about specialist drugs. Do drugs for macular degeneration come under that category? Those drugs are critical for people with sight problems.

Mr A Campbell: We touched on the consultation earlier. You are right; it is vital that we get to all the groups we need to reach. We need to engage clinicians, pharmacists, the charities and the patients. There is a lot of thinking to be done about it, but we need to get to those people and to more vulnerable people to talk about prescription charges as well as the people who can afford to pay them or who feel that they can afford them. We will make a public announcement on how we plan to do the detailed consultation and the public meetings and we are working on that at the moment. I fully take your point.

Mr Johnston: From previous consultations, we have a very good model for working with charities. We envisage a series of town hall-type meetings and we will contact the charities and various representative groups to make sure that the invitations go out to their members and the people they represent. We will also make a call to the general public to ensure that they hear about the meetings well in advance. We will do the usual targeted consultation through our press lines, inviting people to comment on the consultation questionnaire through the post or by email. We will make sure that we get comprehensive coverage.

Mr A Campbell: I am sorry; I did not answer your question. We launched the consultation yesterday, so the documents are available online along with the questionnaire. It runs until 8 May.

Mr G Robinson: When will the consultation start?

Mr A Campbell: It is technically open already. The document is on the DHSSPS website.

Mr G Robinson: The other point was about macular degeneration.

Dr Timoney: I will give you some information that I have brought along with me for that specialist area. We have what is called an indicator of performance for that drug, which is to do with the number of patients waiting longer than six weeks to commence the drug for the first eye and six weeks for the second. Back in 2011, we had 56 patients waiting longer than six weeks for the first eye and 15 patients waiting longer than six weeks for the second. That second statistic has dropped to no patients in 2014 and we have half the number waiting to commence the drug for their first eye.

Again, we have maintained investment in those specialist drugs in 2014, supported by the types of discounts and rebates that the industry can get. Across the broader pressures in the system, we are seeing success in achieving targets as a result of that investment.

The Chairperson (Ms Maeve McLaughlin): Thank you for your presentation. There is consensus on welcoming a specialist drugs fund. That point needs to be stressed. I am not convinced that what we have heard today about the proposal around prescription charges or how we fund the specialist drugs fund has been adequate or has given us the confidence to sign off on it. It certainly has not given us enough detail to properly interrogate it. We have only been told today that the scheme will be £25 million, but we have no indication of how much, realistically, people will be charged, how it will be enforced or how it will be administered. There are huge challenges, and I remain of the view that we have not exhausted all the options in relation to generic medicines or prescribing on the back of the report. I ask that you provide us with that proper financial analysis to allow us to scrutinise it, including costings and options. Thank you for your time today.

Find Your MLA

tools-map.png

Locate your local MLA.

Find MLA

News and Media Centre

tools-media.png

Read press releases, watch live and archived video

Find out more

Follow the Assembly

tools-social.png

Keep up to date with what’s happening at the Assem

Find out more

Subscribe

tools-newsletter.png

Enter your email address to keep up to date.

Sign up