National Aids Trust v NHS England – Public Health and the Interpretation of Statute

The Court of Appeal judgment in R (National Aids Trust) v NHS England is concerned with the allocation of responsibility for funding certain types of HIV treatment on the NHS.

At its narrowest, the case addresses the specific (though important) question of whether the power to fund prophylactic medicine for HIV lies with local authorities or with the NHS Commissioning Board (NHS England).

More generally, it serves as an unflattering critique of the legislation which underpins the allocation of roles and responsibilities within the health service.

And, at its widest, it adds usefully to the case law on how to understand the vires of a public authority when it lies within a badly-drafted, and hard to interpret, statutory regime.

Background

The background to the case is unusual. It relates to a treatment called PrEP (pre-exposure prophylaxis). This is a course of medication given to those who are not yet HIV positive, but have a high risk of infection. It does not prevent them becoming infected, but it does significantly inhibit the spread of the HIV virus in those who contract it.

NHS England is responsible for commissioning a range of specialist healthcare services, including those relating to HIV. For 18 months between September 2014 and early 2016 it was engaged in an evidence gathering, assessment and consultation process to establish whether it should routinely commission PrEP. By the end of this period, all the indications were that it was likely to do so.

However, having gone so far down that road, NHS England then received legal advice – it is unclear why this was not sought or provided at an earlier stage – that it would be acting beyond its powers if it funded the provision of PrEP, since the responsibility fell instead within the ‘public health’ remit of local authorities.

On 21 March 2016 it issued a press release which said that it was not going to pursue the matter further because it was concerned about the ‘risk of legal challenge from proponents of other “candidate” treatments and interventions that could be displaced by PrEP if NHS England were to commission it‘. In other words, in a world of finite health budgets and almost infinite need, where money spent on one thing is money not being spent on something else, NHS England was unwilling to run the risk of commissioning anything for which it lacked clear vires.

However, in trying to avoid one type of legal risk, NHS England stumbled into another. It was subject to judicial review by the National Aids Trust on the ground that its legal advice was wrong and that it had no good reason to .

To confuse matters further, NHS England already commissioned a more or less equivalent treatment called PEP (post-exposure prophylaxis). This involved administering the same medication, but doing so after, rather than before, the activity which gave rise to a risk of HIV infection. Whether there was any material difference between these two treatments became a question in the litigation.

The Legal Issues

In its early days, the NHS was run centrally by the Ministry of Health. More recently, its functions have been allocated between a range of bodies – providers and commissioners, national and local – subject to the overarching duty of the Secretary of State to promote a comprehensive health service.

In this environment, it is essential to be clear who is responsible for doing what. In reality, the legislation which is designed to allocate functions is poorly-drafted and confusing.

The core provisions are in the National Health Service Act 2006 (the Act). The Secretary of State has his duty to promote a comprehensive health service (section 1(1)). NHS England also has the same duty, running concurrently with that of the Secretary of State (section 1H(2)).

However, there is an exception from NHS England’s duty. It does not apply ‘in relation to the part of the health service that is provided in pursuance of the public health functions of the Secretary of State or local authorities‘. This appears to say that whatever else NHS England has to do, public health is not within its remit.

So far, so good. But from this point, to follow the legislation is to disappear down a rabbit hole of words which are ill-defined or not defined at all, ultimately leading, via a lengthy excursion through various vague and overlapping concepts, nowhere at all.

For example, under the Act, ‘public health’ includes prevention but also treatment (section 2B(3)), while the ‘health service’ includes treatment but also prevention (section 1(1)(b)).

Under a related set of regulations allocating functions between NHS England and Clinical Commissioning Groups – the NHS Commissioning Board and CCGs (Responsibilities and Standing Rules) Regulations 2012 (the Regulations) – ‘health care services’ are defined as being about treatment, but treatment is then defined to include prevention (regulation 2).

Finding clear distinctions within this legal framework is effectively impossible.

The Judgment

When the case reached the Court of Appeal, one thing that was clear to all three judges was that the definition of ‘public health’ in the Act was so wide – ‘impossibly wide‘ [31] – that to exclude everything falling within it from the responsibilities of NHS England would be to blow a huge hole in that body’s statutory remit. This was, almost certainly, not what Parliament had intended.

In his first instance judgment, Mr Justice Green attempted to sidestep the problem by holding that the apparent public health carve-out was no such thing, but just a provision about concurrency. This was treated dismissively by the Court of Appeal, which thought that the language of the Act incapable of supporting that conclusion ([30], [50], [61]).

However, since it was also plainly not viable to distinguish health and public health on the basis of a simple difference between prevention and treatment [33], the Court had to find some other way of avoiding the apparent absurdity of the statutory drafting. It did this by using two techniques.

Interpretive Techniques

First, it reached for the Regulations as a guide to interpreting the Act. This is a counter-intuitive move, since in principle the Regulations, as subordinate instrument, must follow the Act and cannot dictate its meaning [57]. However, in certain limited circumstances, it is possible to reach through to secondary legislation in order to interpret a primary statute drafted at the same time. The rule is found in Hanlon v Law Society [1981] AC 124 at 193-4, and its key element, as far as this case was concerned, is that:

‘Where the Act provides a framework built on by contemporaneously prepared regulations, the latter may be a reliable guide to the meaning of the former.’

The Court of Appeal thought it ‘not only permissible but right‘ to apply that rule here [32].

Problematically, however, the Regulations were also ambiguous in key respects, and far from providing a clear answer to the question.

Second, therefore, in order to address this, the Court adopted an approach of overriding pragmatism, interpreting the Regulations as a working document intended for a non-legal audience. On this basis, it was important not to take –

‘…too technical and legalistic an approach to a regulation which must be intended to be read and applied not by lawyers but by health service managers and doctors in their daily lives.’ [38]

Application

Applying these interpretive techniques, the Court found that while the Regulations did not define the meaning of public health, they were useful in understanding what was intended to fall within the remit of NHS England, and therefore by implication outside the scope of the public health functions of the Secretary of State and local authorities [39].

Since NHS England was responsible for ‘Adult specialist services for patients infected with HIV‘ (Schedule 4, paragraph 17), it must have been envisaged that all HIV treatment should fall within its remit. For Lord Justice Longmore ‘The whole thrust of the Regulations is that local authorities are not to be responsible for HIV patients but rather that NHS England is to be responsible for them‘ [38].

Pragmatism was highly important here. Lord Justice Underhill agreed with the conclusion but only after struggling with the statutory wording – if the entire point of PrEP was that it was given to patients not yet ‘infected with HIV‘, in strict terms it fell outside the language of the Regulations.

However, he thought it ‘inherently very unlikely that the Secretary of State when making [the Regulations] intended that functions which were substantially identical should be split between different bodies‘ [55].

Moreover, he was sustained in this conclusion by finding no effective difference between PrEP and PEP. What was important in his view was not when the medication in each case was administered, but when it had effect. Since neither course of drugs stopped infection, but only mitigated the consequences if it did occur, each was best thought of as a form of treatment rather than prevention, where the key moment in time was the point of efficacy rather than administration [55].

This neat piece of logic, with which Lady Justice King agreed [68] helped to bring the literal reading of the legislation into line with the pragmatic one.

A Postscript – Incidental Powers

Like the majority of public bodies created by statute, NHS England has what are generally described as ‘incidental’ or ‘supplemental’ powers –  using a fairly standard formulation: ‘to do anything which is calculated to facilitate, or is conducive or incidental to, the discharge of any function‘ conferred by the Act (section 2).

If they had otherwise identified a gap in NHS England’s powers, Longmore and King LJJ would have been prepared to find that it was plugged by this general power ([43], [70]). Underhill LJ was much less sure that he would have been prepared to give them such an expansive interpretation [58].

Nothing in the case turned on it, but these differences in view identify how reluctant any public body should be to place reliance on the uncertain scope of its incidental powers, in particular in a controversial case.

The Outcome

The outcome is not that PrEP has to be funded by NHS England, but merely that it can be, and in any event that it is not a matter for local authorities. NHS England now has to make a choice whether it wants to commission PrEP as against other competing treatments to which its resources could be directed.

Conclusions

In public law terms, National Aids Trust is a case about using creative interpretive solutions in order to avoid absurdities in legislation. But it is worth asking why those absurdities arose at all.

A great deal has been written and said about the porous and often arbitrary dividing line between the provision of ‘health’ and ‘social care’ services. From time to time, this also generates litigation, as in the recent case of Forge Care Homes v Cardiff & Value University Health Board. My colleague Ravi Randhawa wrote an excellent piece about the detailed and rather painful parsing of the distinction in that case – ‘Dividing responsibilities between healthcare and social care‘.

National Aids Trust draws attention to the equally fluid and no less arbitrary line between ‘health’ and ‘public health’ functions.

What both types of case have in common is that these categorisations represent nothing that has any substance in the real world. That is also why it is so difficult for legislation to capture the differences between the categories in any meaningful way, and therefore why disputes arise.

The reason for this is that the terms have no inherent meaning because they are merely labels applied by bureaucrats to reflect the often arbitrary way in which duties and powers are (or for historical reasons have been) allocated between institutions. They proceed from an institutional, rather than a patient-centred, view of the world. The resulting arguments about who is responsible for what were rightly characterised by the Court of Appeal as ‘bureaucratic squabbles‘ [46].

As the renowned Cleveland Clinic model of integrated care shows, this kind of thinking is of the past, and does not reflect the best way of organising healthcare provision to serve the interests of patients – not even within an individual hospital; still less across an entire health and social care system.

In National Aids Trust the Court made a glancing criticism of the fact that the dispute ended up before it, with public money spent on ‘expensive solicitors and barristers‘ [46]. This is fair enough. But solicitors and barristers merely find themselves having to deal with the legal mess. Perhaps the criticism would have been better directed at the policy makers and legislative drafters who created it.