I am grateful for the opportunity to respond to this urgent question. As the House knows, HIV can be a devastating illness, and we know that pre-exposure prophylaxis—PrEP—can make a difference to those at risk of contracting HIV and to those who are already HIV positive. However, it is crucial that we have a full understanding of all the issues surrounding PrEP.
As with any new intervention, PrEP must be properly assessed in relation to clinical effectiveness and cost-effectiveness. That is why we have today asked NICE to conduct an evidence review of Truvada for PrEP of HIV in high-risk groups. This evidence review signifies the next step forward and will inform any subsequent decisions about commissioning. It will look at the evidence for effectiveness, safety, patient factors and resource implications. The NICE evidence summary will run alongside a pilot scheme in which we are investing up to £2 million. Public Health England is currently identifying the most effective places for the pilot to take place.
It is also important to remember that Truvada, the drug used for PrEP, is not yet licensed for this use in the UK. That is why, as well as the pilot scheme, the Government want to see the evidence review, which will help to inform future commissioning decisions about PrEP.
PrEP is only one of a range of activities designed to tackle HIV, which is of course a Government priority. It is also important to stress that the challenge remains of tackling high rates of some sexually transmitted infections, particularly in high-risk MSM—men who have sex with men—communities. Our £2.4 million national HIV prevention and sexual health promotion programme gives those at highest risk the best advice to make safer choices about sex.
The UK has world-class treatment services and is already ahead in reaching two of the three UNAIDS goals of ensuring that we have 90% diagnosed infection, 90% of those diagnosed on treatment and 90% viral suppression by 2020. In 2014, 17% of those living with HIV had undiagnosed infection, but 91% of those diagnosed were on treatment, of whom 95% were virally suppressed. We are determined to continue to make real progress to meet these goals, and we are considering carefully the role that PrEP can play in helping us to get there.
Seventeen people are diagnosed with HIV every day. Each year, there are thousands of new infections. In the UK, there are more people living with HIV than ever before. We know that PrEP has the potential to be a game-changer—it has proved effective in stopping HIV transmission in almost every case—yet as a result of this latest decision, this life-changing drug will remain inaccessible to people at risk of HIV. Does the Minister therefore share my concern about the precedent this decision sets in terms of NHS England shunting other preventive costs on to local government? Will she explain why pre-exposure prophylaxis is being dealt with differently, compared with the correct commissioning model for PEP, or post-exposure prophylaxis?
I want to ask the Minister three specific questions. First, does she accept that, under section 7A of the National Health Service Act 2006—a mechanism by which the Secretary of State can delegate power—the Health Secretary can give NHS England the power to commission PrEP? If so, why has he not done so? Secondly, if the Government expect local authorities to commission PrEP, how much additional funding will the Minister make available to them? Can we assume that there will be no further cuts to public health grants, or is this just a case of passing the responsibility and the financial buck? Thirdly, on the next steps, I understand that key stakeholders, including the National AIDS Trust, have written a joint letter to the Public Health Minister requesting an urgent meeting. Will she today agree to meet them to see whether a way forward can be found without the need for costly, protracted legal action?
PrEP has been described as the beginning of the end for the HIV epidemic. It is time for the Minister to show some leadership, to use the section 7A powers she has and to think again.
Some of the shadow Minister’s questions are simply ahead of the moment, as it were. As I said clearly in my statement, NHS England has made clear how it feels about being the commissioner, based on a legal argument that it has published. No decision has been made about who the commissioner is. Clearly, we need to reach a decision, and we discussed that earlier today in the Health Committee. However, there are a number of stages we have to go through—as I say, the drug is not even licensed for use as PrEP in the UK.
We have set out a series of stages we will go through, which will help to inform a final decision. On the questions the hon. Gentleman posed, we are not in a position to make a judgment. There is more we need to know about clinical effectiveness and cost-effectiveness and about the pilot—
No, that is not the case. There has been an important study—the PROUD study—but that looked at clinical effectiveness. There is a wider piece of work to be done—of which the pilot programme that we have announced is part—to enable us to understand where PrEP fits in in terms of clinical and cost-effectiveness, and how it fits into the HIV prevention landscape more broadly, alongside other HIV interventions that are commissioned. There is work yet to do, but we are not standing still. We have announced this important pilot and committed money to it, and we have asked NICE for an evidence review. All this will go into our consideration.
I agree with the shadow Minister apart from on one thing, which is his asking my hon. Friend the Minister to show leadership. Having campaigned on many male sexual health issues as chair of the all-party parliamentary group on HIV and AIDS, I can say that this Minister has been unfailingly supportive in addressing many of the issues facing not just men’s sexual health, but particularly gay men’s sexual health. I therefore take issue with that call for leadership.
Having said that, I have lost too many friends to AIDS over the years not to challenge NHS England’s decision not to fund PrEP. HIV infection rates in this country are on the increase and existing strategies are not working. It is not acceptable to suggest that we simply continue to do the same. I have a meeting with the Minister on
I thank my hon. Friend for his kind words. I take this issue extremely seriously. He is right to say that we face a challenge in relation to HIV rates, and particularly, as I said, STI rates in the high-risk MSM community. I stress again that while it will no doubt have an important part to play, PrEP is not a silver bullet for sexual infections, particularly in some of those high-risk groups. It is important to understand that. We have to continue to look at a whole range of measures. When I recently met the chief executive of the Terrence Higgins Trust, we touched on this.
As my hon. Friend says, we have a meeting coming up. I apologise for not responding to the shadow Minister’s question about meeting stakeholder groups. Of course I will meet all the key stakeholder groups. I have already had some formal and some informal discussions on this, but of course I am very open to having further such discussions. Stakeholders were involved in the process that NHS England has been involved in. NHS England has made its position clear, and there is a matter due to go before the courts on which I will not comment further. Yes, I will engage on this. Yes, of course I accept that we need to do more, and of course we all share the concerns about rising HIV infection rates, particularly among the MSM community. I too lost friends to the AIDS epidemic that my hon. Friend mentions. I take this issue extremely seriously, but we have to follow a sensible process, and that is what the Government are doing.
Anyone in this House will be glad to see the results of the PROUD study and the 85% reduction in new infections. However, there is more to understand, in that we did not see a good response in heterosexual women. While over 40,000 HIV sufferers in the UK are men who have sex with men, 60,000 are heterosexual or bisexual, predominantly of African origin, and we need to think of them in this regard.
My main complaint is on the failure to go through a process of looking at clinical evidence and cost-effectiveness and then making a decision. Why was the company not encouraged to get through this earlier and go to NICE? I do not understand why we are only going to NICE now, because that gives the answer that we need. It is relatively poor of NHS England to have made the decision on the basis of, “It’s not our job—it’s your job.” That is the most insulting bit for the community. In Scotland, our Cabinet Secretary asked it to go through the European Medicines Agency, which it applied for in February, and then the Scottish Medicines Consortium. It is on the right path now, but that is where we should have gone first.
It is probably worth clarifying that we asked NICE to undertake an evidence review, not a technology assessment. What drugs are licensed for are matters for drug companies to address. The Government do not initiate the process on whether a drug is licensed— the drug company must initiate it. It also worth noting that when a drug is licensed for a new purpose, as would be the case for Truvada in PrEP, the company could apply for the patent to be extended to cover this new use. Again, that is something that the drug company would do.
On the hon. Lady’s first point, I agree that we need to consider the impact on women in the circumstances she described. That is one of the arguments for carefully planning this pilot programme and taking those sorts of factors into account.
The process that the Minister has outlined is correct, but does she recognise that the French Government have already approved Truvada for pre-exposure prophylaxis, and does she understand the urgency in this? The results of the UK PROUD study, funded by the MRC, are quite unequivocal, so we really need to get this going. Will she also reflect on the fact that the study showed no difference in the incidence of other sexually transmitted diseases, because Truvada does not protect against them, so the message has to go out that a condom is absolutely essential?
My hon. Friend is quite correct on his latter point about the impact of PrEP. Whether it was commissioned or not, and whoever it was commissioned by, we would still have the significant challenge that he describes around STIs. Drug-resistant gonorrhoea, for example, is a problem that we are increasingly aware of.
There are international comparisons that we can look at, as my hon. Friend mentions. I have looked at the matter in some detail, and the picture across the world is that many countries are in broadly the same position as the UK. They are trying to understand, leaving aside the question of clinical effectiveness, more about how PrEP can be used as part of an HIV prevention programme in broader cost-effectiveness terms, and how it compares in cost-effectiveness terms with other available interventions. My hon. Friend is right that there is work to do, and we are not resting easy on this. We are moving forward, and we are working on and planning these pilots now.
When does the Minister expect the damaging buck-passing between NHS England and local authorities, which is one of the disastrous results of the Health and Social Care Act 2012, to be resolved? Does she agree that it would be far more appropriate for NHS England to be the commissioner of something like PrEP than for local government to commission it? Finally, will she be very cognisant of the danger that we are going back to the bad old days when certain groups were stigmatised? Stigma is disastrous for public health policy, and it will result in an explosion of sexual disease in this country if we do not always bear in mind the danger that decisions by NHS England—not just on this, but on drug treatment for hepatitis C —may have a disastrous impact on public health.
The NHS England position is based on a legal argument, and as the matter is likely to go before the courts, it is not really appropriate for me to comment further. There was a little discussion this morning on this subject in the Health Committee, for which some Members were present. I have laid out a process by which we will work out how and where this is commissioned. Clearly, we need to identify the commissioner.
I do not accept the right hon. Gentleman’s challenge about fragmentation, simply because if we look around the world at a series of very different health systems, we see that they are all going through broadly the same process of understanding where PrEP sits. There are a number of options, but first we need to go through this work. On his latter point about stigma, he is right to identify that it is a significant concern, but I do not accept that that is what this represents. He knows my personal commitment to tackling stigma, and we could not have made it clearer that addressing rising HIV rates, addressing STIs in the MSM community and looking at the challenges surrounding things such as chemsex are all very much front of mind, and we have given considerable time and thought to them. We must challenge stigma wherever it rears its head.
Given the challenges of HIV, I think that my constituents would be excited by the prospects that PrEP offers. They would, however, be a little disturbed by the fact that every country in the world seems to be going through the same process, and duplicating, replicating and holding up what could be a very exciting development to combat the spread of HIV across Africa. Many countries are suffering from this far worse than we are, and they would be horrified by the thought that the process could get bogged down in a court when this treatment, if it were available, could do very real good.
My hon. Friend is right to recognise that PrEP has potential. It is, in fact, being used in some places internationally. The point I was making was that there is no simple, one-size-fits-all solution. Different countries have different challenges. For example, the level of HIV prevalence and the services available to manage that prevalence, and to manage testing, are very different in different countries. That forms different landscapes into which PrEP might fit. To give an example from Africa, PrEP was licensed last year, and it will be available for sex workers in selected sites. HIV prevalence among female sex workers is estimated to be just under 60% in South Africa. There are different contexts in which PrEP is being taken forward, and that is just one of them.
Local authorities’ public health budgets are being stretched to breaking point, and this is arguably one of the false economies of this Government’s approach, in terms of its impact. Does the Minister agree that in the context of such stretched budgets, the implication that local authorities should fund PrEP is simply unworkable, and will she make it clear that her position is that NHS England is the natural commissioner of PrEP?
I have been very clear about NHS England’s position, and I have said that no decision has yet been made about commissioning. I do not accept the hon. Lady’s challenge about spending on public health. We have committed to spend £16 billion over the next five years on the public health grant. In addition to that, we have committed more than £1 billion this year alone in the section 7A agreement and £300 million on vaccines that we buy in the Department of Health, plus system-wide leadership through things such as the sugary drinks levy and the forthcoming childhood obesity strategy. All in all, this is the radical upgrade in prevention that was talked about in the NHS “Five Year Forward View”.
I join my hon. Friend Mike Freer in thanking the Minister for her work, and in particular for engaging with the LGBT community. I know that they are quite concerned about last week’s statement by NHS England. Given the disappointing outcome of NHS England’s PrEP review and the fact that we have the worst of all scenarios, which is effectively a legal challenge, will the Minister commit to finding a way round the NHS England decision while a new trial is under way? Does she agree that the accelerated medicines pathway could provide a perfect platform for bypassing the frustrating system that we are talking about?
I will reflect on the latter point with my hon. Friend the Minister for Life Sciences, who is sitting alongside me. I have made clear the NHS position on commissioning. The measures that I have announced today—the NICE evidence review and the trial that we are planning for, which we will move forward with later in the year—are all part of understanding how we get to the right decision. It is not something on which I will make a snap decision now, but we have set out a process by which we can get to that point.
As a vice-chair of the all-party group on HIV and AIDS, I share many of the concerns expressed by the chair, Mike Freer. Many people in the LGBT community share our concerns about the current situation. Much as I respect the Minister, I was a little disappointed that she appeared to cast doubt on the efficacy of PrEP. As well as the PROUD study, there have been two other major studies, and 30,000 people are using PrEP in the US. There is clear evidence of its efficacy. Can the Minister give hope to people out there that this is not a political decision or a cost decision? Will she reverse it? Will she use her section 7A powers and take the right decision on this issue?
We have not made a decision on commissioning yet. We have laid out a pathway. Let me be clear: I completely understand and accept the point about clinical effectiveness. The point I was making was that there are wider considerations about how we commission something in the context of a whole series of HIV prevention services. That is slightly different from clinical effectiveness, on which the PROUD study showed very good results. I am not saying that it is not clinically effective; we just have to understand more about how it sits in the context of everything else that we do, and we have to understand more about its cost-effectiveness. The modelling work that was undertaken indicated that PrEP can be cost-effective for some high-risk groups, but the period over which that cost-effectiveness pays back needs to be more broadly understood.
I do not doubt the Minister’s commitment to this issue, but she has to understand how it looks to the outside world. This is a Government who brought forward legislation to ban poppers, for goodness’ sake, but it looks as though they have got their head in the sand over PrEP. Israel, Kenya, Canada, France and the United States all get it. Why are we so far behind?
The first point is a red herring, because I understand that the matter has been resolved. I do not accept the hon. Gentleman’s criticism. It is slightly disappointing, although I understand the reason for it in the context of this urgent question, that Members are forgetting that the UK has a world-leading position on HIV treatment in all the ways that I laid out in my response to the urgent question. Our movement towards the UNAIDS goals is very significant, so to say that the UK is somehow not a leader in HIV treatment and prevention is not right. We have clearly acknowledged that PrEP has a role to play, but we need to understand more about what that is.
Will the Minister clarify her previous answer in which she said that she is putting aside the clinical significance of this? I find it quite confusing that she can do that. Does she agree that although the UK has been a leader in HIV prevention for decades, our progress is under threat because of her decision? Will she now think again?
Not for the first time, may I clarify that no decision has been made about the commissioning of PrEP? I am therefore not sure why the hon. Gentleman would say that. I have been very clear about the clinical effectiveness. What I am saying is that there is more work to do to understand the wider cost-effectiveness of this in the context of the commissioning of HIV prevention more broadly.
My constituency falls wholly within the borough of Southwark, which has the second highest HIV prevalence in the country. What assessment are the Minister and the Department making of the potential impact of this policy change not only on my constituents, but on the long-term costs for the NHS if PrEP is not available?
There is no policy change and I have laid out the position. It is important to understand that even in the modelling work that has been done, PrEP is not a silver bullet. It has an important part to play, but it is not a silver bullet in terms of HIV prevention and it does not affect some of the broader issues that I mentioned in my response, for example in respect of STIs.
This is another example of the over-cluttered, over-bureaucratic and confused system for approving drugs in this country. May I draw the Minister’s attention to the fact that NHS England promised £2 million to allow 500 people to be treated in this way? Does she understand people’s dismay that it is now passing the buck and saying that it is down to local authorities, which we all know are incredibly cash-strapped?
The NHS is seeking clarity through the courts on its own position. No decision has been made about who will be the final commissioner for PrEP, so what the hon. Gentleman said is not quite right. The £2 million that has been committed to the pilot is important and will inform our understanding of this important intervention.
Slough has an extraordinarily high incidence of HIV and AIDS, much of it undiagnosed. Our local authority is the smallest unitary authority in the country and has faced cuts to its central Government funding of 50%. It has no prospect of being able to fund a challenge of this size. Does the Minister understand that this delay in sorting out who will pay for PrEP will lead to the deaths of hundreds of people in Britain?
As I have mentioned, Truvada is not yet licensed for use as PrEP in this country. We have set out a process by which we can understand far more about how PrEP might fit into the landscape. The right hon. Lady mentioned undetected HIV. The Government have invested significant effort and funding into detecting HIV. We have the world’s first home testing service and last year we launched the major HIV innovation fund, which has come up with some new and extremely cutting-edge ideas on how to improve HIV detection and diagnosis. I fully accept that this is a major challenge in her area, but PrEP is only one part of a wider programme of work. [Interruption.]
I think his Whips are pleased to see the arrival of Mr Hayes. He has never knowingly been keen to be hurried on anything.
Will the Minister clarify the timescale for the decisions? Evidence reviews and trials can take months and years, but clearly, as other Members have said, people do not have months and years. Will she tell us what the process and the timescales will be, so that we can be reassured—or not?
We would expect to get the evidence review that we have called for in the autumn. NHS England is already working on plans for the pilot programme, which will happen over a two-year period. We hope to get that under way towards the end of this year. Both those pieces of work are under way. We expect the pilots to be informed by the review, hence we want to get it back in a relatively short time.
I am flabbergasted that the Minister has come before the House today to say that the legislation that her Government introduced on the reorganisation of the NHS was so incompetent that NHS England is having to go to court to work out who is entitled to commission these services. Can she tell us how much public money will be spent on the legal case?
I am not in a position to comment on that. I do not accept the hon. Lady’s central criticism. If she had been present at the Health Committee this morning, she would have heard an hour of evidence from myself, Duncan Selbie and Simon Stevens on how the new arrangements are making a significant difference to public health in this country and to the health of the public.