My Lords, with the leave of the House, I shall now repeat in the form of a Statement the Answer given by my honourable friend the Minister for Public Health to an Urgent Question in another place on pre-exposure prophylaxis. The Statement is as follows.
“HIV can be a devastating illness. We know that PrEP can make a difference to both those at risk of contracting HIV, and 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 and cost effectiveness. That is why we have today asked NICE to conduct an evidence review of Truvada for pre-exposure prophylaxis 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 the drug used for PrEP, Truvada, is not yet licensed for this use in the UK. That is why, as well as the pilot scheme, the Government want to see an evidence review, which will help inform future commissioning decisions about PrEP.
PrEP is only one of a range of activities to tackle HIV. Our £2.4 million national HIV prevention and sexual health promotion programme also gives those at highest risk the best advice to make safer choices about sex. The UK has world-class treatment services. The UK is already ahead in reaching two of the three UNAIDS goals of 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 are considering carefully the role that PrEP can play in helping us get there”.
I am grateful to the Minister but this decision by NHS England not to commission and fund PrEP is a matter of great regret. In the UK there are more people living with HIV than ever before. Without any need for an evidence review, it is absolutely clear, without any uncertainty whatever, that PrEP has the potential to be a game-changer. It is proven to be effective in stopping HIV transmission in almost every single case. There is no need for an evidence review. It is simply a delaying tactic because of this absolutely disgraceful decision not to fund this drug. The Minister mentioned our record in relation to other countries. It is a matter of shame that this drug is being used extensively in other countries but is being denied to NHS patients without any justification whatever.
At some point the Minister will pray in aid the cost of new drugs. On a number of occasions I have asked him this question but he will never answer it—because, I suspect, the answer is too embarrassing. He knows that he is in the middle of a five-year agreement with the branded drug industry through which, if the cost of drugs goes over the base level plus a small allowance for inflation, the department receives a refund every three months. That agreement should enable new drugs to be funded, but that money is not being used to invest in those new drugs. If he says that this cannot be done because of cost, that is simply not true. I very much hope that the Government will reconsider this decision. It is utterly indefensible.
My Lords, I am not going to proffer the argument that it is too expensive, because that is not the issue today. The issue today is that NHS England feels that it does not have the power to commission this particular drug. Whether or not it has that power may well be judicially reviewed, so I cannot comment on the outcome of that judicial review.
The PROUD study produced strong evidence of the effectiveness of Truvada as a preventive drug. The work that NICE is going to do, and the pilot scheme to look at the effectiveness of this drug—it will cost £2 million and will be funded by NHS England and PHE—will ensure that when the question whether NHS England has the power to commission this drug is resolved, there will be the evidence on which to make that decision.
My Lords, are the Government simply delaying until Truvada comes out of patent and becomes cheaper? Can the Minister say whether NHS England has taken into account the protection from HIV infection of the whole community that would result from a reduction in infection of high-risk groups? Can he also explain why the Government see infection prevention as a local authority responsibility in this case, given that other forms of prevention, such as vaccination, are the responsibility of the NHS nationally? This is not consistent.
As I said in response to the earlier question, this is really not about the efficacy of the drug. There is evidence that it is very efficient; that will be confirmed or otherwise by the extra work done by PHE. It is purely a question of the independent legal advice given to NHS England that it does not have the power to commission this drug.
The independent advice seems extremely curious and the Minister should go into more detail, because surely we are past the stage of needing a pilot. The international evidence on PrEP is overwhelming. Is not the underlying fear here that policy on HIV has gone off the boil, in spite of the fact that prevention measures such as this are good in both human and financial terms?
All I can say in response is that NHS England has had independent legal advice that it does not have the power to commission this particular drug for this particular purpose, and for this purpose the drug itself is not yet licensed. It is not to do with any decision made on efficacy grounds for this drug; it is purely that they have received independent legal advice.
Can the Minister confirm that that legal advice, as I understood it on reading it through, points out that there is weak evidence that NHS England does not have the power to commission PrEP? It says that NHS England does not have the power to fund PrEP but points out that under Section 7A, the Secretary of State has the power to delegate the commissioning of PrEP. Can the Minister therefore explain why, in the face of the evidence that has come through from the PROUD study and internationally, the Secretary of State has not used Section 7A to support NHS England? Is there a dispute going on between NHS England and Public Health England, and is this a fallout from the Health and Social Care Act?
I do not think that it is a fallout from the Health and Social Care Act. It is purely that the NHS specialist commissioning committee within NHS England has received clear independent legal advice, as I understand it, saying that it does not have the power to commission this product. That position may well be challenged legally, in which case it will be resolved one way or the other.
My Lords, I am sure that the Minister will be aware that for those of us who are not experts in this field but know a little about it, this is an extraordinarily puzzling thing to be confronted with. It just sounds plain daft, frankly. But will he confirm that there is very little prospect of vaccination or immunisation against HIV being developed any time in the foreseeable future and that PrEP is therefore a vital tool in preventing the spread of this infection for the next generation, and probably for subsequent generations? If this legal tangle has to be untangled, can he also say how long he anticipates that will take?
I do not know how long a judicial review will take. I guess that it will be months rather than years, but I simply cannot answer that question as I do not know the answer to it. Again, this is a legal issue, not an efficacy issue. This is a question not of the Government saying that we do not want to fund this prophylactic, but of NHS England simply saying that it has been advised it does not have the power to do so.
My Lords, there has been a lot of misunderstanding over the use of PrEP and an increase in the prevalence of other sexually transmitted infections. Will the Minister meet me, and other noble Lords who may be interested, to discuss these issues? I declare an interest as a participant in the PROUD project.
My Lords, the UK now has the worst HIV epidemic of any large western European country, having overtaken Spain, France and Portugal, and every day, seven men who have sex with men are diagnosed with HIV. In the light of the legal argument and of what the noble Baroness said, the Secretary of State, under the legal advice that was given to NHS England, has the power under Section 7A to delegate who gives these PrEP pills. Could the Minister please ask the Secretary of State to do that until the legal issue is resolved, so that lives are saved, rather than our arguing about who funds this and who has the legal ability to do it?
I am not briefed on Section 7A and am not sure what the powers of the Secretary of State are. After this debate, I will research that and find out what powers he has.