England: Charity successfully challenges NHS decision not to consider preventative treatment for HIV and AIDS

The National Aids Trust (NAT), a charity specialising in achieving the best policy for treatment and prevention of HIV and AIDS, challenged a decision of NHS England to refuse to consider in its commissioning process an anti-retroviral drug – PrEP – to be used on a preventative basis for those at high risk of contracting AIDS.

The charity argued that both medically and economically the case for NHS England to commission the drugs for this prophylactic treatment was overwhelming.

In the High Court (Queen’s Bench Division), Justice Green stated that treating a single person with HIV over his/her lifetime cost approximately £360,000, and that an estimated 103,700 individuals in the UK live with HIV. Furthermore, uncontested evidence given on behalf of NAT estimated that a record number – 2,800 gay men in the UK acquired HIV in 2014, equating to approximately 8 gay men contracting HIV on a daily basis and an additional cost of £2.88m accruing to the NHS daily. Therefore, ‘a quick comparison of the cost of treating HIV related infections across a person’s lifetime, compared to the relative cost of providing drugs on a prophylactic basis’, made it clear that the savings from PrEP would be considerable.

NHS England argued that the reason why it decided not to commission PrEP on a preventative basis was because it had ‘no legal power to do so under the governing legislation’ – the National Health Service Act 2006.

NHS England argued that under the relevant legislation it did not possess a power to perform ”public health functions” carried out by the Secretary of State or local authorities pursuant to their respective statutory powers and duties. Further, pursuant to regulations promulgated by the Secretary of State 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.

Accordingly, it was argued that since the proposed commissioning of PrEP was squarely for preventative medicine in the field of sexually transmitted diseases – this was now the sole task of the local authorities (or the Secretary of State) but not NHS England.

The local authorities disagreed with this argument, contesting that they considered NHS England to be wrong in law, and additionally, that (1) the proposed consequences were illogical and inefficient because NHS England would then have responsibility for dealing with the greatest portion of the HIV/AIDs policy which includes treatments identical or extremely closely related to PrEP but would leave it to the local authorities to deal with the tail end and (2) the local authorities have no money and no budget for such preventative health in this field in any event.

Justice Green therefore stated that at its core, this judicial review was about the allocation of budgetary responsibility in the health field. The issue the Court had to consider was whether NHS England was correct in its analysis of its powers and duties.

Preventative treatment

In considering NHS England’s arguments regarding preventative treatment, Justice Green identified several preventative treatments already funded by NHS England – including post-exposure prophylaxis (PEP) for those individuals who have been clinically assessed as having had a high risk of HIV exposure event in the preceding 72 hours and who are therefore at risk of having contracted the infection but who are not proven actually to be infected.

In response to this, NHS England’s primary argument was that those treated with PEP were infected but those treated PrEP are not, however Justice Green held that as a matter of pure science this was not a sustainable proposition. Both PEP and PrEP would be administered to persons who have not been diagnosed with HIV and as such in neither case can it sensibly be said that they are necessarily “infected” in a manner which could be scientifically proven.

Conclusions

Justice Green held that NHS England erred in deciding that it had no power or duty to commission the preventative drugs in issue, finding that NHS England has a broad preventative role (including in relation to HIV) and commensurate powers and duties.

Firstly, the power of NHS England includes commissioning for preventative purposes and this includes for HIV related drugs.

Secondly, in the alternative even if NHS England did not have a power to commission on a preventative basis the commissioning of PrEP is to be treated in the same way as the commissioning of PEP, i.e. both are provided on the basis that the patient is assumed to be infected.

Third, in the further alternative the commissioning of PrEP was within the power of NHS England under Section 2 NHSA 2006, even if properly analysed it is a preventative treatment.