A High Court judge has ruled that NHS England was wrong to decide that it cannot fund a “game changing” drug that can prevent HIV infection.
The decision by the court, which followed an application for a judicial review, could open the door for HIV pre-exposure prophylaxis (PrEP) to be made routinely available and funded by the NHS in England.
The National Aids Trust (NAT) charity went to the High Court seeking permission for a judicial review after NHS England said it had no duty or power to commission PrEP because it is a preventive treatment and ill-health prevention falls under the remit of local authorities.
The judge, who gave NAT the go-ahead for a judicial review on 2 August 2016, said the issue was about “the allocation of budgetary responsibility in the health field”.
In a written judgement, Mr Justice Green said: “No one doubts that preventative medicine makes powerful sense. But one governmental body says it has no power to provide the service and local authorities say 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 [contract the infection] were the preventative policy to be fully implemented.
“In my judgement, the answer to this conundrum is that NHS England has erred in deciding that it has no power to commission the preventative drugs in issue.”
“This is fantastic news,” says Deborah Gold, chief executive of the NAT. “It is vindication for the many people who were let down when NHS England absolved itself of responsibility for PrEP. The judgement has confirmed our view — that it is perfectly lawful for NHS England to commission PrEP. Now NHS England must do just that.”
However, NHS England says it will appeal against the ruling.
Jonathan Fielden, NHS England’s director of specialised commissioning and deputy national medical director, says: “Queen’s Counsel has advised NHS England that it should seek to appeal against the conclusions reached by the judge as to the scope of NHS England’s legal powers under the National Health Service Act 2006.
“In parallel with that we will set the ball rolling on consulting on PrEP so as to enable it to be assessed as part of the prioritisation round.”
He adds: “Of course, this does not imply that PrEP — at what could be a cost of £10m–20m each year — would actually succeed as a candidate for funding when ranked against other interventions. But in those circumstances, Gilead — the pharmaceutical company marketing the PrEP drug Truvada — will be asked to submit better prices, which would clearly affect the likelihood that their drug could be commissioned.”
The Local Government Association (LGA), which represents local councils, welcomed the high court ruling. Izzy Seccombe, chair of the LGA’s community and well-being board, says: “It would also have been wrong and unfair for councils to have to pay for a drug that would see the NHS reap the rewards of not having to provide lifetime care for those with HIV.”
She says the ruling provides “much-needed clarity around the future roles of councils and the NHS on prevention services”, adding that “it also demonstrates that both parties have the joint responsibility of ensuring we can deliver an integrated sexual health system as parliament originally intended”.
“We hope NHS England now works without further delay to bring this matter forward to decide whether PrEP should be commissioned,” she concludes.
Heather Leake Date, the Royal Pharmaceutical Society’s spokesperson on HIV medicines, says: “I hope and expect that NHS England will now make a quick decision about funding this very effective medicine. People with undiagnosed HIV infection are much more likely to pass on the virus, so PrEP not only reduces the risk of infection for individuals but will also further reduce infection levels in the whole population, leading to fewer HIV cases overall.”
She adds that national guidelines on how to use PrEP in the most cost-effective way already exist. “The HIV Pharmacy Association (HIVPA) calls on NHS England to expedite a decision and make PrEP available for people who need it at the earliest opportunity.”