The National Aids Trust (NAT) has won a high court battle in London to have a preventative treatment for HIV legally funded by NHS England.
NHS England was challenged by NAT after it said it did not have the legal power to fund pre-exposure prophylaxis (PrEP).
PrEP is a “highly effective” anti-retroviral drug which is used to stop HIV from becoming established in the event of transmission. Clinical studies used Gilead Sciences’ drug Truvada against HIV and findings showed that it can reduce the risk of acquiring the virus by 90 percent.
PrEP use is rapidly increasing in the USA, where tens of thousands of people are using the drug Truvada to prevent HIV transmission.
The National AIDS Trust had brought the legal case, arguing that PrEP was a potential “game changer” urgently needed in Britain, where over 4,000 people per year acquire HIV.
In March, the NHS decided that the HIV treatment was a preventative service and therefore the responsibility of the local authorities. The body then agreed to a re-evaluation after the NAT launched a legal challenge against the decision. However, in May it said it has “considered and accepted NHS England’s external legal advice that it does not have the legal power to commission PrEP”.
It also said that under 2013 regulations, “local authorities are the responsible commissioner for HIV preventative services.”
The high court judge Mr Justice Green upheld the NAT’s legal challenge and ruled that NHS England “has erred in deciding that it has no power or duty to commission the preventative drugs in issue”.
Green also said that primary concern of the legal challenge was “the allocation of budgetary responsibility in the health field”.
“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.”
“In my judgment 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.”
The judge added that NHS England has “mischaracterised the PrEP treatment as preventative when in law it is capable of amounting to treatment for a person with infection”.
NAT chief executive, Deborah Gold, said “This is fantastic news. It is vindication for the many people who were let down when NHS England absolved itself of responsibility for PrEP. The judgment has confirmed our view that it is perfectly lawful for NHS England to commission PrEP. Now NHS England must do just that.”
“Over 4,000 people are getting HIV every year in the UK – we desperately need further prevention options to add to condom use. PrEP works. It saves money and it will make an enormous difference to the lives of men and women across the country who are at risk of acquiring HIV. The delay to commissioning PrEP is both unethical and expensive.”
Although the high court ruled that the NHS was responsible for funding PrEP, the drug is not guaranteed to be automatically funded by the state health service.
NHS England said it planned to appeal the court decision. The body also said that even if it loses the legal challenge again, PrEP would have to be ranked against other priorities.
“Of course, this does not imply that PrEP – at what could be a cost of 10-20 million pounds ($13-26 million) a year – would actually succeed as a candidate for funding when ranked against other interventions,” said Jonathan Fielden, NHS England’s head of specialized commissioning.
“But in those circumstances, Gilead … will be asked to submit better prices, which would clearly affect the likelihood that their drug could be commissioned.”