At the Court of Appeal in London this morning, three judges confirmed that NHS England is responsible for providing PrEP. Key to the case is the fact that NHS England already commissions post-exposure prophylaxis (PEP) which is not substantially different to pre-exposure prophylaxis (PrEP).
Nonetheless NHS England may still try to put obstacles in the way of NHS provision of PrEP. As Lord Justice Underhill wrote, the judgement “does not mean that NHS England is obliged to commission PrEP treatment but only that it is empowered to do so.” It remains for NHS England to decide whether providing PrEP constitutes a “reasonable requirement … as part of the health service.”
Responding to the judgement, NHS England have said that they will now formally consider whether to fund PrEP but that they will ask Gilead to reconsider “its currently proposed excessively high pricing” and will also explore options for using generic medicines.
In August, National AIDS Trust (NAT) brought a judicial review to challenge NHS England’s decision to withdraw PrEP from its own process for prioritising interventions and its view that only local authorities could commission PrEP. NHS England lost the case in August but appealed against the judgement. Today, they lost their appeal.
In the Court of Appeal’s ruling, Lord Justice Longmore outlined the regulations which define the responsibilities of NHS England and local authorities. HIV treatment is clearly the responsibility of NHS England, whereas the treatment of other sexually transmitted infections is the responsibility of local authorities. He noted that ‘treatment’ has a broad definition in the regulations: “an intervention that is intended to manage a person’s disease, condition or injury and includes prevention, examination and diagnosis”. The judge felt that this could be read to suggest that preventative interventions are part of HIV treatment – and so could be provided by NHS England.
However the lawyers for NHS England argued that NHS England was specifically responsible for “patients infected with HIV” and so could not provide PrEP, an intervention for people who are HIV negative. At the same time they struggled to make a distinction between PEP and PrEP: “The provision of PEP was entirely different from provision of PrEP because PEP was only provided when the patient had been exposed to a particular event which was highly likely to result in transmission and establishment of the HIV virus while PrEP would be provided to those who had not yet had any significant exposure at all.”
The judges were not convinced by this reasoning. PEP and PrEP use the same drugs, working in the same way, and are provided to the same kinds of high-risk individuals. The expertise needed to commission the two services is the same. The government had not intended for specialised services for rare health conditions to be fragmented in such a way, wrote Lord Justice Underhill.
Furthermore, NHS England provision of PrEP might contribute to its function of commissioning treatment for people living with HIV. “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,” wrote Lord Justice Longmore. “If there is medication that can prevent susceptible persons from becoming infected and it is desirable that such medication be administered to reduce the overall bill for HIV services, NHS England has the power to commission such medication.”
The substance of the judgement appears to be that NHS England should consider providing PrEP in order to reduce the amount it needs to pay for HIV treatment in the future.
The Court of Appeal disagreed with Mr Justice Green’s judgement in August over the question of which bodies can provide public health interventions. The appeal judges found that services which are primarily public health interventions should not be provided by NHS England.
However the Health & Social Care Act does not define ‘public health’ precisely and the appeal judges found it difficult to find a satisfactory way of deciding whether an intervention is or is not ‘public health’. In particular they said that it does not work to define all preventative interventions as ‘public health’ and treatment interventions as ‘not public health’.
In a public statement, NHS England said it welcomed the legal clarification of the ruling, including that it has “the ability but not the obligation” to fund PrEP.
“In the light of the Court ruling we will therefore now quickly take three actions,” NHS England said. “First, we will formally consider whether to fund PrEP. Second, we will discuss with local authorities how NHS-funded PrEP medication could be administered by the sexual health teams they commission. Third, we will immediately ask the drug manufacturer to reconsider its currently proposed excessively high pricing, and will also explore options for using generics. We expect to be able to update on these developments shortly.”
The case was brought by National AIDS Trust (NAT). Its chief executive, Deborah Gold, commented: “We are delighted to have been vindicated by the Court a second time. HIV is a critical issue in the UK where over 4,000 people acquire HIV every year. PrEP works, it saves money, and most importantly it has the power to prevent HIV acquisition for thousands of people, at the same time as beginning to end the HIV epidemic. This judgement brings that possibility one step closer.
“We look forward to what we hope will be a balanced and evidence-based decision on PrEP by NHS England, as well the opportunity to work alongside NHS England collaboratively for the benefit of people living with and at risk of HIV.”
“We are pleased that today’s ruling by the Court of Appeal confirms our position that NHS England has the power to commission the HIV treatment PrEP,” commented Izzi Seccombe of the Local Government Association. “We now hope this decision will provide much-needed clarity around the roles of councils and the NHS on prevention services. It also demonstrates that both parties have the joint responsibility of ensuring we can deliver an integrated sexual health system as Parliament originally intended.”
Ian Green of Terrence Higgins Trust noted that every day the NHS delays access to PrEP, 17 people are diagnosed with HIV. “PrEP must be prioritised and made available now to those at risk,” he said.
By Roger Pebody