Is it within the remit of the NHS to commission and pay for preventative HIV drugs?

15 August 2016 by Paul Reynolds

National Aids Trust v National Health Service Commissioning Board (NHS England)  [2016] EWHC 2005 (Admin) (Local Government Association intervening)

Summary

In this case NHS England argued it lacked the power to commission (and be responsible for paying for) preventative HIV drugs. It said this was solely the responsibility of local authorities and, in so doing, disavowed any responsibility for preventative medicine.

The High Court rejected this. It undertook a purposive interpretation of the legislation and found that NHS England had broad and wide-ranging powers of commissioning, and could commission preventative HIV drugs. NHS England is appealing.

The interest in this case extends beyond Mr Justice Green’s interpretation of the particular provisions. The judge was ready to find that the provisions were to be interpreted purposively, and was then very ready to look to the overall objectives and duties of the NHS as expressed in other parts of the relevant legislation, and in the NHS Constitution and Mandate.

Background

This case arose in relation to a drug regime called PrEP (pre-exposure prophylaxis).  PrEP consists of an HIV anti-retroviral drug, taken on a regular basis by an HIV-negative patient, in order to provide protection if the patient is exposed to the virus. A recent UK study found that PrEP could reduce infection by at least 86% when provided to people at high risk of infection.

HIghhIn September 2014 NHS England set up a committee to develop a policy on PrEP. After reviewing the evidence it issued a draft policy recommending the routine commissioning of PrEP by NHS England for targeted at-risk groups. In December 2015 this was published for consultation of certain key groups, before a proposed full public consultation.

In March 2016 NHS England issued a press release stating that, following legal advice, NHS England had come to the conclusion that it was not responsible for commissioning HIV prevention services. Instead, responsibility lay with local authorities.

This result was challenged by the National AIDS Trust (NAT). They said NHS England’s new stance was a complete U-turn. As NAT and the Local Government Association (intervening) pointed out, local authorities simply had no budget for this drug regime. If it was their responsibility, PrEP would never be commissioned.

It was against this factual backdrop that Mr Justice Green found himself interpreting three key pieces of legislation, to decide whether Parliament intended to make NHS England responsible for decision-making in relation to this innovative drug regime.

First legislative issue:  what is the scope of NHS England’s general duty to commission services?

The first issue was whether the general commissioning duty imposed on NHS England included or excluded a duty to commission services with “public health functions”;  and if it excluded this, whether preventative HIV medicine such as PrEP fell within that term.

The legislation

Section 1(1) of the NHS Act 2006 provides that the Secretary of State has a general duty to “continue the promotion in England of a comprehensive health service designed to secure improvement, …(a) in the physical and mental health of the people of England, and (b)in the prevention, diagnosis and treatment of physical and mental illness.”

By section 1H(2) of the NHS Act 2006, “[NHS England] is subject to the duty under section 1(1) concurrently with the Secretary of State except 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.” (emphasis added).

The 2006 Act goes on to set out “public health functions” of local authorities and the Secretary of State. These functions are extremely broad – for example they state that each local authority “must take such step as it considers appropriate for improving the health of the people in its area” which may include “providing services or facilities for the prevention, diagnosis or treatment of illness”.

The issue – the section 1H(2) ‘exception’

The key question was what was meant by the exception in section IH(2) of the 2006 Act: “…except 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.”

NHS England said that the exception went to the scope of its general duty. Section 1H(2) imposed a general duty on NHS England to promote and commission health services, except in relation to the public health functions carried out by the Health Secretary or local authorities. It had no duty in relation to those functions.

It said the “public health functions” should be read purposively, to mean health focused towards the public at large, or subsets of the public, as opposed to identified individuals. Preventative treatment was the paradigm example of such a public health function: it was aimed at subsets of the public. It would include PrEP – which was aimed at high-risk sections of the public. The public function exception under section 1H(2) meant that NHS England had no duty, and no power, to  commission PrEP.

NAT and the local authorities said that the exception relates only to the identity of the person with whom NHS England is to perform its commission duties concurrently.  NHS England has a concurrent duty only with the Secretary of State, except in relation to public health functions, where it has a concurrent duty with the Secretary of State or local authorities.

Green J’s decision on the first legislative issue

Mr Justice Green stated that the meaning of the “public health function exception” in Section 1H(2)  was ambiguous in and of itself. As such it had to be interpreted purposively.  He would interpret it with the assumption that the legislature “did not intend to legislate so as to produce a result which (i) is inconsistent with the statutory purpose or (ii) makes no sense or is anomalous or illogical.”

He noted that the public health functions conferred on local authorities and the Secretary of State by the 2006 Act were defined so as to “cover just about all of the possible activities, tasks and functions that the Secretary of State or a local authority could conceivably perform in relation to the provision of a health service”.

He went on, “There is no logical way of construing Section IH(2)” in the way suggested by NHS England. It would mean ignoring the extremely broad meaning of public health functions set out in other parts of the 2006 Act, and giving the phrase “public health functions” its own separate meaning in section IH(2), and one very different to the meaning provided in other parts of the Act. Such an anomalous meaning would have to be spelled out expressly, not through implication. “I do not find it credible that for such an important issue as preventative medicine Parliament would have created a carve-out which came about through a very far from obvious drifting side-wind”.

In addition, if NHS England’s interpretation of the section IH(2)  ‘exception’ was preferred: it would lead to the conclusion that NHS England lacked any power to commission any preventative medicine (and indeed any health service targeted at the public or subsets of it, rather than specified individuals).  Mr Justice Green could not accept this. It was inconsistent with many parts of the NHS Act, which emphasises NHS England’s role in prevention. The 2006 Act requires NHS England to act in a way that promotes the NHS Constitution. That states the need to devise services that “prevent” physical and mental health conditions.

Mr Justice Green decided that the reference to public health functions in Section 1H(2)  was not about limiting scope, but was simply clarifying that NHS England shared its duty concurrently with local authorities and the Secretary of State when it came to public health functions, and did so with the Secretary of State in respect of other functions.

He said this did no violence to the statutory language and it made sense. Imposing concurrent responsibility for public health functions on NHS England, local authorities and the Secretary of State would mean a more joined up and effective service. This was in contrast to the fragmented result that would arise if those functions were only the responsibility of local authorities.   It would also promote geographic equality in services. The 2006 Act expressly stated the objective of avoiding the unequal provision of services.  This was another reason for preferring NAT’s interpretation of the exception.

Section 1H(2) of the NHS Act 2006 therefore meant that NHS England had a broad duty and power to commission services, extending to public health functions, including preventative medicine.

Second legislative issue: the specific commissioning duties of NHS England in relation to HIV preventative services

NHS England had a second aspect to its argument. It said that regulations specifically setting out its responsibilities for HIV services provided only that it had duty to commission HIV treatment for those who are already infected with HIV.  It did not have a duty to provide any HIV preventative services for those seeking to avoid infection.

The duties specifically relating to HIV are set out by the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, “the 2012 Regulations”.

These refer to “Services to be commissioned by the Board [NHS England]” The key item in that list is: “Adult specialist services for patients infected with HIV”.

NHS England argued that the wording of that item meant that it only had a duty to arrange services for those presently infected with HIV, rather than services to prevent people becoming infected with HIV.

Mr Justice Green’s decision on NHS England’s specific duties relating to HIV services

Mr Justice Green rejected NHS England’s restricted interpretation of this duty for four reasons.

First, while “Adult specialist services” was not defined in the Regulation, “health care services” was defined as meaning services “consisting of the provision of treatment”.  “Treatment” expressly includes services aimed at   “prevention, examination and diagnosis”.  Mr Justice Green said it was clear, from the Regulations themselves, that “Adult specialist services for patients infected with HIV” included health services preventing people from becoming infected with HIV.

Second, this more expansive interpretation, which included prevention, was consistent with the NHSA 2006 read as a whole. As seen above the duties imposed by it on NHS England were broad and wide-ranging. The 2012 Regulations were made pursuant to powers conferred by the 2006 Act and so it made sense to interpret them with that same broad and wide-ranging approach in mind.

Third, given that preventative treatment is an integral part of the NHS England’s role if the Secretary of State had intended to exclude preventative HIV treatments then it would have been done expressly. This could easily have been done by referring to “Adult specialist services for patients infected with HIV excluding preventative treatments”. (underlined section added).

Fourth, Mr Justice Green noted that in related 2013 Regulations, discussed below, there is an express distinction made between preventative medicine and treatment for those already infected with HIV. He said that this supported his view that “when the legislature seeks to differentiate between preventative and other services it does so expressly and not by implication.”

Third Legislative issue: The specific powers and duties of local authorities in relation to the prevention of HIV, and other sexually transmitted infections.

A further line of argument for NHS England was that a second set of regulations, passed in 2013 – (the Local Authorities (Public Health functions etc) Regulations 2013) – the “2013 Regulations”, meant that local authorities now have the sole duty to provide preventative medicine in the field of sexually transmitted diseases, including HIV.

The 2013 Regulations were made by the Secretary of State for Health as part of a power conferred under the NHS Act 2006 allowing him to direct local authorities as to how they must exercise the public health duties and powers that they exercise concurrently with him (and, if Mr Justice Green was correct on the first issue, concurrently also with NHS England).

Regulation 6 of the 2013 Regulations provides:

“(1) Subject to paragraphs (4) and (5), each local authority shall provide, or shall make arrangements to secure the provision of, open access sexual health services in its area—

(a) […]

(b) by exercising its functions under section 2B of the Act—

(i) for preventing the spread of sexually transmitted infections;

[…]

(2) In paragraph (1), references to the provision of open access services shall be construed to mean services that are available for the benefit of all people present in the local authority’s area

[..]

(4) [Relates to sterilisation and vasectomy]

(5) The duty of the local authority under paragraph (1)(b) does not include a requirement to offer services for treating or caring for people infected with Human Immunodeficiency Virus.”

Mr Justice Green rejected NHS England’s arguments that the 2013 Regulations constrained NHS England’s powers to provide preventative HIV treatments.

The 2013 Regulations were adopted under different statutory powers to the 2012 Regulations. They are parallel measures, and so the promulgation of the 2013 Regulations does not have any effect on the 2012 Regulations. It does not, for example, curtail the scope of the earlier Regulations. Had this been the intention the 2013 Regulations would have made that express. The 2013 do not anywhere say that they limit or affect the scope of the duty on NHS England. There is no reason to interpret them as doing so.

As noted above, Mr Justice Green also remarked that the 2013 Regulations made the express distinction between preventative services for sexual health, and treatment of those already infected with HIV. He said this confirmed his view that when Parliament sought to make that distinction it did so expressly. If Parliament had intended to draw a distinction between prevention of HIV and treatment of HIV in the 2012 Regulations it would have done so expressly and not by implication.

Two additional reasons why NHS England has the power to commission PrEP

(i) PrEP is not a preventative drug after all

Mr Justice Green’s interpretation of the Act and Regulations was more than enough for him to conclude that NHS England has the power to commission PrEP. However he did not stop there.

He went on to decide that even if NHS England was correct, and its commissioning duties and powers were limited to commissioning treatment for those already infected with HIV, then it would still have the power to commission PrEP.

He reached this conclusion by looking to PEP (post-exposure prophylaxis). This is a drug regime consisting of the same anti-retroviral drug as PrEP (Truvada) plus one other drug. However, this regime is started after the patient has potentially been exposed to HIV. NHS England was clear that it considered that it did have the power to commission PEP and it has routinely commissioned and paid for this for years.

Mr Justice Green noted, that when the PEP regime is started, it cannot be known if the patient has in fact been exposed to the virus. Instead, the patient’s doctor will assess the relevant risk factors (location of exposure, duration, any information about the source of exposure) and make an informed clinical decision.

Counsel for NHS England said it had the power to commission PEP because the patients for whom it was prescribed were assumed by their doctor to be “infected with HIV” within the meaning of the 2012 Regulations. He said the term “infected with HIV” did not only mean “people who can be scientifically proved to have HIV” but instead it also meant people who are assessed clinically and are assumed to have been infected with HIV. It is for that reason that PEP should properly be seen as being a treatment for those “infected with HIV”.

Mr Justice Green said that this interpretation of “infected with HIV” had much to commend it. It recognised that the question of infection will often be a skilled clinical value judgment rather than scientifically provable fact. However, he then turned that same argument back against NHS England. He said that he could see no real difference between the characterisation of PEP, and the proper characterisation of PrEP.  Like PEP, PrEP was given in response to a clinically-assessed risk, albeit a likely future risk rather than a past risk. PrEP operated within the patient’s body in exactly the same way as PEP – neither prevented the virus entering the body, but instead stopped it replicating when it did enter. For these reasons PrEP, “by parity of reasoning to PEP” is a treatment provided to those who should be assumed to be infected. It is therefore properly seen not as a preventative treatment, but as a treatment for those who are “infected with HIV” within the meaning of the 2012 Regulations.

(ii) Section 2 of the NHS Act 2006 grants broad general powers

Finally Mr Justice Green accepted NAT’s further alternative argument. Even if NHS England is not granted the power to commission PrEP by section 1H(2) of the 2006 Act, and the Regulations, it can still fall back onto section 2 of the NHS Act. This states that NHS England, as well as the Secretary of State and a clinical commissioning group “may do anything which is calculated to facilitate, or is conducive or incidental to, the discharge of any function that is conferred on that person by this Act.”

Mr Justice Green said that it was plain from the generous and broad wording of this provision that Parliament was “deliberately seeking to avoid the argument that the provision of a particular treatment that might otherwise be on the margins of NHS England’s powers is outside its jurisdiction”.  Mr Justice Green again noted that PrEP is extremely closely related to PEP, and if NHS England can provide one then it can rely on the general powers provision in section 2 to provide the other.

NHS England sought permission to appeal the judgment, which was granted.

Comment

NHS England’s stance – that it lacked power to commission this drug – is surprising. As Mr Justice Green made clear, the powers conferred on NHS England by the 2006 Act are extremely broad. Mr Justice Green agreed that the reference to the “public health function” exception was ambiguous. However, NHS England were forced to cast their nets hopelessly wide in trying to explain what that exception could mean. The suggestion that the reference “public health function” meant that NHS England lacked any power in respect of services not targeted at an identified individual was quite the claim. Mr Justice Green was surely correct in deciding that if that was the intended outcome, Parliament would have made it clear, not required it to be divined from that phrase or interpreted “purposively” (It is not clear whether NHS England suggested a purpose that was consistent with their proposed interpretation, or any a basis for that alleged purpose).

On the other hand, Mr Justice Green’s interpretation of the 2012 Regulations may be accused by some embracing a meaning of “services for people infected with HIV” that goes beyond the natural meaning of those words. He interpreted “people infected with HIV” as including those not infected with HIV, but at risk of such an infection.  He did this by reference to the statutory language (his first reason) as set out above, but also by engaging in what looks a lot like purposive interpretation of the 2012 Regulations. However, he reached for that purposive interpretation, taking into accounting broader policy considerations, without identifying any ambiguity in the meaning of the relevant regulation itself (unlike in s.1H(2)). In his judgment Mr Justice Green was careful to state that purposive interpretation was not about identifying the policy issues and then “selecting what the Court considers to be the most felicitous”. It would be unfair to conclude that the Judge did go down that path; he plainly engaged with the statutory language. But it would be fair to say that it is likely that the 2012 Regulations will be firmly in the centre of the battleground on appeal.

It should of course be remembered, that even if Mr Justice Green’s decision is upheld, the question will still remain as to whether NHS England will commission PrEP. That decision, should it be reached, will one taking into account cost-effectiveness, finite resources and other possible services. It is also the kind of decision in respect of which a wide margin of discretion is likely to be accorded by the courts.