No power to pay, no money to pay

In National Aids Trust v NHS England [2016] EWHC 2005 (Admin), there was seemingly only one narrow issue for Mr Justice Green to decide: did NHS England have the power to commission pre-exposure prophylaxis (known as 'PrEP')? However, in an era of ever-increasing budgetary constraint, the financial implications of any decision 'lurked only marginally' below the parties' submissions on this narrow issue.PrEP is a preventative antiretroviral drug designed to be offered to those at high risk of contracting HIV. Trials have shown that PrEP is highly effective: one found that it has an 86 per cent success rate in preventing HIV when taken by those most at risk. In the US, PrEP was licensed in 2012 and now more than 30,000 people are taking it.

NHS England argued that it had no power to commission PrEP. It made two main submissions. First, pursuant to section 1(1) of the National Health Service Act 2006 (NHSA 2006), NHS England did not dispute that it was under a broad duty to secure improvement in the physical and mental health of the people of England, and in the prevention, diagnosis, and treatment of physical and mental illness.

However, NHS England sought to rely on the exception to this duty at section 1H(2): 'The Board [i.e. 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.'

Given this exception, NHS England submitted that the scope of its duty did not include 'public health functions' that were carried out by the secretary of state or local authorities pursuant to their respective statutory powers and duties.

'Public health functions'

Green J rejected this submission. Instead of limiting the scope of NHS England's duty, section 1H(2) could also be interpreted as an exception only to who NHS England would perform its duty concurrently with. This concurrent partner could either be the secretary of state, which was the default position under the NHSA 2006, or local authorities.

Green J preferred this interpretation. While in my view not the most natural reading of section 1H(2), it is an interpretation which makes eminent practical sense. Crucially, the 'public health functions' referred to in section 1H(2) are defined in the NHSA 2006. They are incredibly wide ranging. As noted by Green J, they encompass 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. If the 'public health functions' of the secretary of state and the local authorities did serve to limit the duty of NHS England pursuant to section 1H(2) (as NHS England argued), the scope of the duty would be practically reduced to nothing. This could not be what parliament had intended.

NHS England tried to overcome this difficulty by submitting that 'public health functions' should be construed purposively to refer to health provisions that were directed to the public generally or subsets of the public, rather than identified individuals.

The effect of section 1H(2), it submitted, was to exclude health measures aimed at the public generally from the scope of NHS England's duty.

However, as correctly noted by Green J, this completely ignores the express statutory definition of 'public health functions'. Even leaving this aside, Green J stated that the test proposed by NHS England was very imprecise. It would be difficult to draw the line between services offered to an identified individual (which would be within NHS England's duty) and those offered to the public generally or a subset of the public (which would not be).

NHS England's second main submission was that, under the relevant regulations, there is a division of labour between NHS England and local authorities, with the latter assuming responsibility for preventative medicine in relation to sexually transmitted diseases.

Green J also rejected that submission. There are two relevant sets of regulations: the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 (the 2012 Regulations), and the Local Authorities (Public Health Functions and Entry to Premises by Local Healthwatch Representatives) Regulations 2013 (the 2013 Regulations). Green J found that the 2012 Regulations were free standing and imposed a duty on NHS England in relation to HIV which included preventative medicine. He concluded that the 2012 Regulations were not revoked or altered by the 2013 Regulations.

Budgetary considerations

While expressly stating that he had not taken into account any financial ramifications when interpreting the legislation, Green J said that it was an argument that 'lurked only marginally' below the submissions of the parties.

It is not difficult to see why. From a human perspective, the case for preventative medicine is compelling: anyone who can be prevented from suffering from a disease or illness should be. On top of this, the economic case for preventative medicine in an era of increasingly tight health budgets is persuasive. It is estimated that it costs around £360,000 to treat a person with HIV over the course of their lifetime. The claimant's case, borne out by the various trials of PrEP that have taken place all over the world, was that PrEP could significantly reduce the number of people contracting HIV and, consequently, the massive cost accruing to the NHS on a daily basis.

Financial considerations were also deployed to support the parties' submissions as to who could pay for PrEP. NHS England submitted that PrEP, along with any other preventative medicine in the field of sexually transmitted diseases, was the responsibility of local authorities. The local authorities disagreed. As well as saying that NHS England was wrong in law, they further submitted that the consequences if NHS England was correct were illogical and inefficient. The local authorities would bear the costs of commissioning PrEP, but the savings, namely the costs of providing lifetime care for those with HIV, would accrue to NHS England. This did not make budgetary sense. Even leaving this aside, the local authorities stated that they had no money to pay for PrEP.

Green J summed up this dilemma: 'No one doubts that preventative medicine makes powerful sense. But one governmental body says it has no power to provide the service and the local authorities say that they have no money. The Claimant is caught between the two and the potential victims of this disagreement are those who will contract HIV/AIDS but who would not were the preventative policy to be fully implemented.'

From a common-sense perspective, Green J's conclusion therefore instinctively feels like the right outcome: NHS England, the body that could pay for PrEP, has been told it has the power to do so. However, NHS England has indicated its intention to appeal the judgment and some aspects of the legal reasoning are, in my view, open to question. For instance, in the 2012 Regulations, NHS England is under a duty to arrange, to the extent that it considers necessary, adult specialist services for patients 'infected' with HIV. Green J concluded that this conferred jurisdiction on NHS England to commission treatments for HIV on a preventative basis. This seems a very wide interpretation of the Regulations which, on a literal reading, refer to those already infected with HIV.

Even if the appeal is unsuccessful, the issue to be determined was only whether NHS England had the power to commission PrEP, not whether it should do so. If NHS England is ultimately found to have the power to commission PrEP, financial considerations will be of central importance again as NHS England decides how best to achieve its target duties to make use of scarce financial resources.

In clinical trials, PrEP has been proven to be highly effective. Despite this first instance decision, it may be some time before the issue of whether NHS England has the power to commission PrEP is finally determined and, if so, whether or not it will do so.

Melissa Shipley is a barrister at 39 Essex Chambers>

@39EssexChambers

www.39essex.com