PrEP for HIV: great, but watch what happens next…

So we have judgement over who in England has the responsibility to fund pre-exposure prophylaxis for HIV, or PrEP.

Mr Justice Green has declared in favour of the National AIDS Trust and Local Government Association. NHS England has misdirected itself as to its statutory powers and duties on PrEP, and can – indeed should – see itself as the responsible commissioner.  There are reports that NHS England will now appeal.

The judgment says quite clearly that

“Notwithstanding any and all of the above the issue for the Court is a narrow one – is NHS England correct in its analysis of its powers and duties? If it is then the wider policy and budgetary issues which arise are for the Secretary of State and Parliament to sort out.”

His judgment goes on to say at paragraph 6:

“In my judgment the answer to this conundrum is that NHS England has erred in deciding that it has no power or duty to commission the preventative drugs in issue. In my judgment it has a broad preventative role (including in relation to HIV) and commensurate powers and duties. But I have also considered the position if I am wrong in this. On this alternative hypothesis I am of the view that NHS England has still erred in concluding that it has no power to commission the PrEP drugs in question. Either: (i) it has mischaracterised the PrEP treatment as preventative when in law it is capable of amounting to treatment for a person with infection or (ii), NHS England has in any event the power under the legislation to commission preventative treatments (and therefore falls within its powers however that power is defined); because it facilitates and/or is conducive and/or incidental to the discharge of its broader statutory functions.”

This is quite  significant judgment. I will be interested to see what the grounds of appeal are.

NHS England will now, if it doesn’t appeal or if it loses the appeal, have to consider PrEP for commissioning on its own merits. It isn’t, contrary to NHS England’s lately arrived at view, a duty for local authorities. Meantime if NHS England appeals we are still in limbo.

This judgment is worth studying in detail, not least because of what it says about NHS England’s powers. Paragraph 110 says

“First, the power of NHS England includes commissioning for preventative purposes and this includes for HIV related drugs. Second, in the alternative even if NHS England does not have a power to commission on a preventative basis the commissioning of PrEP is to be treated in the same way as the commissioning of PEP, i.e. both are provided on the basis that the patient is assumed to be infected. Third, in the further alternative the commissioning of PrEP is within the power of NHS England under Section 2 NHSA 2006, even if properly analysed it is a preventative treatment.”

This judgment as it stands emphasizes NHS England’s role as part of a preventive system. That’s an extremely welcome judgment for the health of the public. Whether NHS England agrees, is another matter.

The decision is important for other reasons too, because of some of the principles it reinforces is about what NHS England can do, should it wish, and how it shouldn’t take a narrow and restrictive view of its powers. I predict others will study this as part of the process of challenging NHS England decisions in future. The equality argument advanced was never going to be even the main argument of weight here, never mind the clincher. The judgement makes this clear. This was about powers and duties in the provision of a health service, and whether NHS England has them on PrEP. And the judge makes clear NHS England does. I’m not surprised NHS England are talking of appealing. The ratio of the decision is uncomfortable reading for any organization wanting to take a narrow interpretation of its powers and duties in the current financial climate. And this judgment drives right through that.

NHS England would have had us believe it’s own version of two ridiculous things before breakfast: that it had the power to fund and run a team giving healthy town planning advice to local authorities as prevention which is clearly a local authority function in law, but didn’t have the power to commission HIV treatment as prevention because that was, err…a local authority function in law.

That bizarre and unhappy rationale was forensically pulled apart and found wanting in a judgement which spans over 60 pages.

The same taxpayer meanwhile foots the bill for one part of a system (NHS England)attempting to shunt costs onto a second (local authorities) which that second part of the system rightly resisted, only to have a further part of the system (the High Court) quash it. Tax pounds went into legal fees, not HIV prevention or treatment. Meanwhile the human cost is that some people who might otherwise have remained HIV negative may have become HIV positive, at least some of whom those tax pounds could have kept uninfected.

It’s time now for NHS England to sit down and have the discussion about a proper strategy to end HIV, and get us to the UNAIDS 90 – 90 – 90 targets. It can be done. It ought to be done. And NHS England needs to be at the table as a welcome partner, not a grudging paymaster.  England needs a proper HIV strategy, and an end to this unedifying shirking of responsibility.

The upside for NHS England is that if it does this properly it will gain financially from reduced costs for HIV anti-retroviral treatment for those whose infections are avoided, and from the costs for related ill-health and complications. It will also gain £520million by some estimates from the money it will save on switching to generics.

I put my hand in my own pocket to contribute to the National AIDS Trust’s costs. I’d do it again with no hesitation.  But just like you I’ve also paid through my taxes for NHS England’s intransigence and bad grace. I’ve also paid like you through my taxes for local authorities to take their side of the matter to court.

Don’t get me wrong. I am very, very, grateful for this decision.  Not just because it establishes NHS England does indeed have the power to commission anti-retrovirals as it kept saying in all its documentation until its Damascene u-turn earlier this year. But also because it should give NHS England pause for thought before it tries this with something else it doesn’t want to fund. And NHS England seems to have acquired an appetite for cost shunting.

NHS England asked us to believe for over eighteen months that on the face of it, it wanted to be the commissioner, said it was the commissioner and then in March this year had a blinding flash of realisation that it had no powers. The judge has clearly traduced that clunky and wholly unsatisfactory story.

We have, as a system, some big issues to be discussed now and NHS England needs to come to the table as a partner. On the agenda we need to consider:

  1. Will NHS England fairly prioritise this through the commissioning process, or will we get further tactics and cost-shunting attempts in an attempt to avoid commissioning PrEP?
  2. What happens to the participants on the PROUD study, which announced the closure of access to PrEP on 29th July?
  3. Similarly what will happen with acces to PrEP through the forthcoming DISCOVER study?
  4. What happens now to the £2m NHS England funding for early implementer sites?
  5. Who pays for the associated testing (kidney function etc) for people on PrEP?
  6. How do we roll it out for those most at need?
  7. How will we get a proper Treatment as Prevention strategy with a partner – NHS England – that seems difficult to communicate with and is struggling with so many challenges?

But all these things notwithstanding, there are two other things foremost in my mind. First, that this at the end of the day has been about money. Second, that we are not out of the woods yet, we will need to watch very carefully to ensure that NHS England puts the issue of PrEP fairly and reasonably through its commissioning process.

Why do I say this?

First, the money. Those more cynical than I might conclude this story is and always has been about money and the fact NHS is struggling to contain a burgeoning set of demands for specialised commissioning, and the use of statutory responsibilities as a flag of convenience. There is no doubt NHS England faces tough financial challenges, with the Treasury watching very closely and the Public Accounts Committee recently saying NHS England hasnt communicated clearly how its specialised commissioning function fits with the future strategy of the NHS or its need to save £22billion.

NHS England is heading to overspend its specialist commissioning budget, at a time when the pressure is on. You can read more here. . NHS England is clearly  struggling to control the costs of specialised commissioning and avoiding bills for PrEP would have helped, even a little. They do face an extremely difficult task.

Second, we need to make sure that the future decision making process on PrEP is conducted rigorously, equitably, and based on its merits. one of the reasons advanced by NHS England for not taking PrEP to its specialised commissioing process was the argument that other providers and manufacturers of drugs and technologies might legally challenge. I wonder whether further, similarly creative and equally implausible , arguments will be adduced during any appeal or the next stages of considering PrEP. NHS England has made it repeatedly clear that it does not want to commission PrEP.  It even blamed – in what some have suggested is a tactical move to remove sympathy from the PrEP lobby – the delay in commissioning eighteen other procedures, including specialised procedures for children, on the PrEP judicial review, .

None of this, however, excuses the process we have just been through. What it does mean is that we must keep a very close eye on what happens next. We need to be scrutinising every paper on PrEP from NHS England very, very carefully.