Rydym yn symud ymlaen i'r eitem nesaf, sy'n ddatganiad gan Ysgrifennydd y Cabinet dros Iechyd, Llesiant a Chwaraeon ar y gronfa triniaethau newydd, a galwaf ar Vaughan Gething.

Thank you, Deputy Presiding Officer. In our manifesto, we made a commitment to improve the introduction of innovative treatments by establishing a new treatment fund in Wales. We also agreed with Plaid Cymru, as part of the compact to move Wales forward, to undertake an independent review of the individual patient funding request process, otherwise known as IPFR.

In Wales, we are proud to take an evidence-based approach towards the introduction of new medicines in the NHS. New treatments are being discovered, licensed and approved for use in the NHS on an almost monthly basis, bringing with them the prospect of a cure or a better quality of life for people with lifelong or life-limiting conditions. Some of these new medicines come with a high price tag for the NHS, placing a responsibility on all of us to ensure our resources are invested where the proven benefits for patients are in balance with the cost. We will continue to take an evidence-based approach to determine which treatments should be routinely available in the Welsh NHS.

We rely on the expert and authoritative advice from the National Institute for Health and Care Excellence, otherwise known as NICE, and the All Wales Medicines Strategy Group, otherwise known as AWMSG. Both these organisations undertake robust appraisals of new licensed medicines by assessing evidence of clinical effectiveness for patients against the cost to the NHS charged by the manufacturer.

Over the course of the last five years, we’ve invested in our own medicines appraisal programme to ensure that Wales can determine which new medicines should be available in the NHS as quickly as possible, giving people access to the most clinically effective and cost-effective new medicines.

Since the AWMSG was set up in 2002, it has provided advice on 286 new medicines, recommending 84 per cent for use in NHS Wales. In 2015-16, 45 of the 47 medicines appraised were approved for use in Wales. To improve the likelihood of a positive appraisal, we introduced the Wales patient access scheme in 2012 to encourage the pharmaceutical industry to offer prices for new medicines more in balance with their clinical benefits. This has created new opportunities for new medicines to be routinely available in Wales. To date, 21 new medicines have been made available through this scheme.

The new treatment fund will support the early introduction of the newest and most innovative high-cost medicines that have been recommended by NICE or AWMSG. We’ll make £80 million available over the life of this Government to ensure new medicines that address unmet clinical need, and represent a significant step forward for the treatment of life-limiting and life-threatening diseases, are available. This will be delivered consistently across Wales as soon as possible following a positive recommendation by either NICE or the AWMSG. The new treatment fund will meet the cost of these new medicines for a maximum of 12 months, giving health boards the time to plan and prioritise funding from within their budgets.

The fund has developed from our experience of making new high-cost treatments for a range of life-changing conditions available to people in Wales. Last summer, for example, the Welsh Government provided significant funding from its central reserves to enable the NHS to fund four new treatments for hepatitis C and a new treatment for a rare genetic and progressive disease called aHUS. The medicines represented a major step forward in treatment and secured significant health and social benefits for patients.

It is essential that the new treatment fund is operated transparently and is widely understood. During the summer, we will be refining the criteria and mechanisms needed to manage the fund effectively, and I anticipate the fund will be operational by December. Most importantly, it will ensure patients in Wales have faster access to life-changing and life-saving treatments wherever they live.

Where a medicine or treatment has not been appraised or approved for use in NHS Wales, a clinician can apply, on their patient’s behalf, for it to be made available via the individual patient funding request process, commonly known as IPFR.

It is right that we have a process in Wales to enable access to treatments and devices that are not normally available via the NHS. Each health service in the UK has such a process, with clinical criteria to determine accessibility. The NHS Wales IPFR process has been improved following a review in 2013-14. A further review will now take place to ensure better consistency of decisions across Wales and to make recommendations about what clinical criteria should be applied when determining eligibility.

I’ve discussed the scope for an independent review of the IPFR process with health spokespeople of each of the parties represented in the National Assembly, and I’d like to thank them for the constructive and mature manner in which those discussions were held. There is general agreement for the review panel to draw on expertise and experience of the system in Wales and to bring a fresh perspective from outside Wales. The patient perspective will also be an essential element of the review. The review will consider in particular the clinical exceptionality criteria and the possibility of a single national IPFR panel.

I want the review to be short and sharply focused to address these issues, and I will provide a further update to Members in September. We will continue to place the appraisal process at the centre of our evidence-based approach to medicines in Wales, ensuring people have access to effective treatment for their illness or disease.

The new treatment fund will support this approach by providing early access to high-cost, innovative medicines, which offer new treatment options to people with lifelong and life-limiting conditions. We are also committed to reviewing the IPFR process to ensure it is both fair and consistent across Wales. Taken together, these measures will help to ensure that patients in Wales have access to equitable treatment wherever they live.

First of all, can I say that I welcome the statement from the Cabinet Secretary today? Breaking it up into two parts, on IPFR, quite simply, we welcome the independent review of IPFR and, in particular, the examination of exceptionality. We, as I know the Cabinet Secretary is aware, think that this is core to this issue. This is, of course, a review that has been won by Plaid Cymru for the people of Wales as a result of the post-election compact, and we certainly look forward to the review getting under way.

We would urge all people who have been affected by IPFR issues to feed into this review, and it would be interesting to know what plans the Minister has to publicise the review when it gets under way.

On the independence of the review, yes, it’s important that there is input from the Welsh NHS into the review, but I would welcome assurance from the Cabinet Secretary that the chair will be independent of the Welsh NHS.

On the new treatment fund, I’m certainly—and we in Plaid Cymru are certainly glad that the Government now recognise that this is a problem that needs addressing. It is important, though, to recognise here that LHBs have been under a legal obligation to make NICE or All Wales Medicines Strategy Group-approved treatments available to eligible patients for several years, with ministerial directions to boards specifically stating this. Does the Minister, therefore, accept that the failure of LHBs in many cases to abide by these guidelines is a failure of health governance and a failure of delivery?

Linked to this, I am aware of cases where patients have been wrongly told that a treatment has not been approved for general use when, actually, it has, including one case in particular where a patient had to present the actual NICE judgment and the ministerial direction on access to approved treatments to her consultant in order to get a change of heart. So, what steps are you going to take to ensure that clinicians are kept up to date on NICE guidelines as, quite clearly, not every patient is going to be able to be assertive and knowledgeable enough about the system, and people, perhaps, will not be getting treatments as a result of this?

Finally, I move to funding. You say you will make £80 million available over the life of this Government to ensure new medicines are available. To break it into a five-year term, that’s £16 million a year. We had been suggesting that money should be ring-fenced from the pharmaceutical price reduction scheme—£55 million a year—and, yes, that was perhaps more than was necessary, but £16 million appears small. How confident does the Minister feel that the budget allocated will allow the Government to meet its desired outcomes? You also said that a new treatment fund will meet the costs of these new medicines for a maximum of 12 months, giving health boards the time to plan and prioritise funding from within their budgets thereafter. How can we be sure that the cost of these new medicines will be brought within budgets within 12 months and what is the enforcement mechanism that you’re proposing if they don’t? We welcome these announcements, but they are only as good as budgets allocated and the process and the processes used to deliver the principle.

Can I thank you for that series of questions? I’ll start with the new treatment fund. We expect the financial envelope that we have announced and placed upon it to be adequate to deal with the medications we would expect. That’s based on our previous experience and some horizon scanning of likely treatments that can come on board and the high-cost medications we’ve dealt with in the past. In all of this, there is an element of forecast and there’s always an element to look at what happens if the facts do change. So, if the facts change, we need to come back to the Chamber and we’ll come back in terms of those budgetary discussions. That’s just a point of being honest, but I do think it’s adequate to deal with the expectations that we place upon the fund.

In terms of the point you make about clinicians being up to date on what is available, well, clinicians can’t contract out of their individual professional responsibility, and I don’t think it’s a matter for the Government to continually tell clinicians, ‘This is what NICE is currently recommending or making available for treatment’. I know from my previous life, from having been a professional, that it was my individual responsibility to make sure that I was up to date and up to speed with what the law required me to do, previously. But I do think that the initial publicity that the new treatment fund is likely to get—. But the ongoing work of the new treatment fund, I would expect that clinicians would not be looking to say that there are excuses for not understanding what treatment is available or the support that is available within their health board and on a national level to ensure that new and innovative treatments that have been made available are there and are available for the patients whom they have responsibilities for directly. I think our clinicians are a pretty conscientious bunch at doing that, but if he wants me to take up the individual issue that he referred to then I’d be happy to do so and understand how that has happened, because that certainly isn’t something that I would want to see repeated.

On the funding for this, you mentioned the PPRS—the pharmaceutical price reduction scheme. Income is actually dropping on the PPRS because of a change in rules. So, it’s a really significant challenge for all the devolved administrations and, indeed, for NHS England. They anticipate a significant hole in their budget as a result of the scheme dropping, and it is a matter where NHS England and Department of Health officials are looking again at the rules for the scheme to try and look again to make sure that people aren’t avoiding their responsibility to pay into the scheme. So, that in itself isn’t a stable amount of income to try and actually use to try and fund any particular commitments. So, that does bring for us extra pressure right across the health budget. So, it’s a challenge for us to manage, and that’s just honest. That goes back to the point about budget discipline as well, because our expectation is that, after 12 months, health boards should be able to properly plan what they’re supposed to do for their population. Many of these medications are for a relatively small group of patients, and we expect the price for these treatments to be properly planned for and then delivered after 12 months of additional space to allow them to do so. Again, that goes into our previous experience of how the system has been run and managed. If any health board isn’t able to live within its means, well we have an architecture around that for individual accountability; we have the escalation process and, of course, the potential to have health board accounts qualified if they aren’t able to live within their means. They’re doing all the different things that we asked them to do, that we expect them to do, and we empower them to do as well. So, there is a significant piece of work for each health board to do. Broadly, I think, our health boards discharge that responsibility seriously and sensibly.

On the points you made about welcoming the IPFR review, I’m grateful to you for the comments made today but also the discussion that we have had prior to this time. The review will be genuinely independent. The review will be publicised through the summer. It will be open for people to submit evidence to it, and we will also expect to try and manage and empower some engagement from stakeholders around that too, in particular to ensure that the patient voice is made real, so that the review panel themselves can properly understand the patient voice and experience, having gone through the process as a patient. So, I am mindful of those points as we take this matter forward but I expect that, when I update Members in September, you will be able to have some confidence in the work of the panel, but also to see that the sort of concerns you wanted raised and addressed will generally have been dealt with in that way. Also, the report, of course, will be made available without any amendment from anyone in Government.

Minister, thank you for this statement. I’m very, very well aware that my colleague Darren Millar has called before for a review on both the independent patient fund and, of course, the Welsh Conservatives have been calling for some kind of treatment fund for many, many years.

Going through your statement, I’ve just got a couple of questions. The first is that you referred to some of the new medicines that come with a very high price tag, which I think we’re all absolutely aware of, and you talk about the resources invested where the proven benefit for patients is in balance with the cost. I wondered if you might be able to give us an indication if that proven benefit would be condition related or, in a more holistic sense, where the drug may actually prevent a side effect or a continuum—you know, something that would develop in time as a successor, if you like, to whatever the ailment is that the person has. I ask that because recently in England there was a court case where a judge was talking about how the exceptionality, the way that a drug might behave on a person, made it valid whether it behaved on the person because they were unique, or their condition was unique, or whether it was simply because the—I can’t think of the word for it—continuing problems that might be associated with the condition were not unique and were coming along later but you could still bring forward the drug to prevent that from happening—a bit chicken and egg. So, I just wondered whether you were going to consider that in deciding what becomes an emergency treatment. So, therefore, that comes to my next question, which is on the stakeholders. Which stakeholders have you consulted to decide what will be? Is it just NICE; is it just the all-Wales medicines group; are you talking to consultants; are you talking to drug companies to decide what kind of drugs would be the best ones that would go into your treatment fund?

I know that the Plaid Cymru spokesperson discussed with you the resources available—the £80 million that you’re going to bring forward. It’s not just that, though. I wondered if you could outline what strategic planning and modelling has been undertaken by the Welsh Government. I did listen to your answers to Rhun ap Iorwerth about what happens when health boards take on board the drugs, and what happens at the end of the 12 months, but if I could just cite a case in point, because you refer in your statement to treatment for hepatitis C. Incredibly successful; a 90 per cent cure rate once somebody gets it, and yet it’s still a postcode lottery throughout Wales. Although the Welsh Government funded the roll-out, and that then went out to the health boards, not all health boards have picked it up because it is eye-wateringly expensive. They haven’t incorporated it into their run rate, and people are not being given it when they need it. We have evidence that we can offer to you to prove this. I would hate to see in 12 months’ time, with all of these other wonderful treatments that you are going to look at, the same kind of things happen because some of them will be extremely, extremely expensive. Therefore, I would like to understand what strategic planning and modelling you have applied to this. I would like to have greater clarity as to how some of the conditionality decisions have been arrived at, at present. I would like to understand where the money for this is coming from. I don’t think I managed to pick that up from either your statement or your answer to the Plaid Cymru spokesperson. In regard to the independent patient funding request, there’s no information on the individual patient funding request by health board. I put a written question in to you, and you came back and said that there was no central data. That kind of thing makes me very, very concerned that if we don’t have the evidence, how can we evidence the success of IPFRs? How can we evidence the methodology? How can we stop postcode funding? How can we ensure that fairness and that parity that you discussed earlier?

I really will work with you hard on trying to support a review of the IPFR. I think it is vital that we get this fairness across the board. But I have found that trying to get some of the evidence needed has been extremely difficult, and I would like to have a really clear understanding of how you see the group going forward and being able to extract the data that they will require from the health boards in order to ensure that this report is not just timely but that it is concise and, actually, that it is also really, really well evidenced. As I discussed with you when I had the good fortune to meet with you yesterday—and I am grateful to you for that meeting—I would also like to ensure, or ask, that you would ask the review panel that are going to look at the independent patient funding request to look at not just their overall strategic conclusions, but also how they think it could be delivered in an effective way. Conclusions are one thing; delivery is an entirely different thing. I think it would be really worth it if they could give some nod towards the level of resource—the level of financial resource and physical human resource—that you may have to commit to making this a uniform, consistent, fair practice across the entire country. Finally, Minister, I would like to again ask you to consider how best we get an advocate for the patient voice who can sit on this panel and really ensure that the patient voice is heard all through this. Sums are one thing, but when somebody is desperate for that little extra stretch of life because they have something very important they want to achieve—to see a wedding, to see a grandchild, or whatever it may be—or just because most of us don’t want to die, then we’ve got to try to marry that desire for life with the money that you have in your pocket. By listening to the patients, perhaps they can help show a way that we can go.

Thank you for the questions and comments. Again, I’m pleased for the constructive manner in which you have engaged in the conversation, and your welcome for the review. The IPFR review is exactly that: it is a review. I’m not asking people to sign up to what comes from it. The report will have recommendations. I’m just going to deal first with your point about the practical delivery. I would expect the report will come up with options and recommendations, and we then have to decide what to do. So, the practical delivery will be a matter for the Government to make choices over, but also the health boards then to practically implement as well. We will need to be up front about how that happens and the consequences that has. Equally, on your final point, it’s the recognition, when you have finished, of all the difficult choices that are made and what different patients want from their treatment. Different people make different choices, and there are ethical dilemmas in each of the choices that a patient would wish to make, together with the practical but very difficult principled decisions that people with these responsibilities have about how to allocate resources and priorities. This review will not be a silver bullet that will make everything easy for us. But it should provide a properly objective way to reassure ourselves about the manner in which the system is being run—that it is fair, that it is rational, and that people can understand the reason by which these prioritisation decisions are made.

If I can just deal with the point around the funding—no, sorry, the annual report on IPFRs. You asked about that, and I want to be clear that that report was previously published by Public Health Wales. There will now be an annual report published by the AWMSG. It should be published by the autumn at the latest—by September at the latest—so you should have all those data available. Those will be available for the review panel to see as well, which I hope will be helpful. Again, to be fair, you’ve mentioned the point about a patient advocate to ensure that the patient voice is heard, and that is simply a way of getting active consideration to ensure that the patient voice is there, and is real, and is properly taken account of, whether it is by a stakeholder reference group, and how that view is fed in—and, indeed, making sure that members of the panel properly take that into account. You can see that visibly in the way that the report is done. So, that is a fair point that has been taken on board.

On your broader points about the new treatment fund, I can confirm the £80 million is additional to the health budget. That’s £80 million over the course of the Government. I can also confirm that, in terms of how the new treatment fund will actually deliver new treatments, these will be approved treatments, so NICE- and AWMSG-approved treatments are what the new treatment fund will deliver, to ensure they deliver practically and quickly. So, I was concerned to hear what you had to say about the hepatitis C medication that we funded centrally. If you have practical examples of where that has not been delivered to constituents then I’ll be very interested to hear from you, and I would encourage you to write to me with those examples so I can take them up.

But in terms of the broader point you make about the condition, and the difference between treating a condition and preventing a future condition, well, this is part of the difficulty in the approval process for approved medications and treatments. It’s why we have a proper, objective appraisal process that doesn’t involve politicians, so it’s about that difficult choice of the patient benefit versus the cost of the treatment, and there are lots of ethical considerations in it, and lots of practical difficulties in terms of how we value that treatment as well. That’s why we have the two bodies that we rely on to give us that authoritative and evidence-based advice. Even that still produces difficult choices for decision makers at health board level, at clinician level and of course for politicians too. So, as I say, the reviews that we’re undertaking for the IPFR and the new treatment fund that we’re going to introduce won’t resolve all of our difficult issues, but I do think they’ll help to ensure there is greater and more equitable access to treatments across the piece, and that also we have some reassurance about a properly rational basis for us to make those decisions now and in the future.

Thank you. And finally, Caroline Jones.

Diolch, Ddirprwy Lywydd. Thank you for your statement, Cabinet Secretary. I would also like to put on record my thanks for the way you’re approaching the review into the IPFR process. On issues such as these, it is important that we rise above party politics and work constructively together to delivery life-saving treatments for Welsh patients. While there has been much criticism of the cancer treatment fund in England, we must also accept that, for some people, it did actually save their lives. We all know of people who moved to England just so that they could access treatment that was denied to them by our Welsh NHS because of the inflexibility of the IPFR process. We therefore welcome the Government’s decision to review the IPFR process and we will work with you to ensure that we have a more streamlined system that is more responsive to the needs of the patients.

The cancer treatment fund was too narrow. People with life-threatening illnesses other than cancer should not be denied access to new treatments, and we welcome the Welsh Government’s commitment to introduce a new treatment fund. As with all Government initiatives, the devil is in the detail and we look forward to seeing how this scheme will operate in practice.

Cabinet Secretary, the new treatment fund was one of your key pledges to the people of Wales, so it is important that you deliver upon your promise that the most advanced drugs for cancer and other life-threatening illnesses will be available in Wales first. How will the All Wales Medicines Strategy Group be strengthened in order to deliver faster appraisals of new medicines? Cabinet Secretary, are you working with groups such as the Association of the British Pharmaceutical Industry and the Royal Pharmaceutical Society in order to improve horizon scanning so that we are better equipped to deal with new treatments coming down the line? The discovery of new treatments requires massive research and development. What is the Welsh Government doing to ensure that Wales leads the way in medical research and development? And what role will the excellent life science centre at Swansea University, which is in my region, play in the discovery and delivery of new treatments?

I note that the new medicines fund will only fund the first 12 months of treatment. Will local health boards be required to continue treatments? With the move to three-year funding for LHBs, will they have the flexibility to continue to fund these treatments?

Finally, Cabinet Secretary, we in UKIP look forward to seeing your detailed plans for the new fund and working with you to deliver improvements to the IPFR process and patient access to new treatments. We will work with you to ensure the Welsh NHS delivers lifesaving treatments to all the people of Wales. Thank you very much. Diolch yn fawr.

Thank you for that, again, constructive contribution and also for the conversations that we’ve had with other spokespeople leading up to today. Again, I welcome the recognition about the IPFR review, that it’s the right thing to be doing. The one point of disagreement I have is about the cancer drugs fund saving lives. We don’t have any evidence that the cancer drugs fund saved lives. There was some potential life-extending conditions. There’s lots of evidence we run through in this Chamber on a regular basis about a range of different people criticising the cancer drugs fund, including the Public Accounts Committee of the House of Commons and the medical director of NHS England. But we’re now in a position where the UK Government has recognised that the fund was too narrowly drawn and there wasn’t a proper evidence base for the medications in it. They’ve now got a NICE process, I suppose—an approval mechanism that goes into it—but I do agree with you that the cancer drugs fund is too narrow. That has always been the position of the Welsh Government, because we don’t think that it was ethically acceptable or defensible to value one patient’s life with one condition above another patient with a different condition that was life limiting. That’s why we never took that approach. That’s also why we now have a new treatment fund that looks at all conditions that are life limiting. So, we’re having real fairness and equity for all patients across the piece. I do think that is absolutely the right approach to take.

I’m not aware of there being an issue with the speed at which AWSMG has undertaken its appraisals. There is often an issue about getting the right sort of information and actually getting pharmaceutical companies to agree to a patient access scheme for those conditions that are potentially effective but are often horrifically expensive. So, there is still a need for an honest and grown-up conversation with those companies. I fully expect that ABPI will be wanting to talk to us about their perspective on this and I’m sure they will want to give evidence to the IPFR review and to be engaged with this Government around a whole range of issues about research, development and life sciences. We need to have an eyes-open approach and engagement with the industry. We can’t expect there to be new research and development by constantly criticising the industry that is doing it. But, at the same time, we need to make sure there is real public value and public value is being driven through the decisions we make on what we procure and why.

I’ll just finish with a point about life sciences and research. I’m really pleased to see that there’s been a move forward in the life sciences sector here in Wales and the approach that’s been taken over a number of years is bearing more fruit. We’re seeing real interest from a range of private sector bodies who want to be engaged in the research community here in Wales. I look forward to having more discussions about this with my colleague the Minister for Skills and Science, but we have a good story to tell on health and care research. If you talk to the health and care research community in Wales, they’re really positive about our approach and it’s because we listen to them. We asked them about what we could do better with the resources we had and we listened to them. So, our approach is grounded in what they have told us that we could do more effectively. So, I hope the Members will engage more and more with health and care research here in Wales. We have a good story to tell on a range of fronts, but I’m definitely ambitious for the future and hope that other Members will get engaged and involved with the research community.

Thank you very much, Cabinet Secretary.