Why was a judicial review required to allow the English National Health Service to commission pre-exposure prophylaxis for HIV?

Abstract Background Following research trial evidence, pre-exposure prophylaxis (PrEP), consisting of the drug combination tenofovir disoproxil and emtricitabine taken daily or episodically, was licensed to prevent HIV in high-risk individuals. In 2014, an NHS England (NHSE) HIV Clinical Reference Group outlined the position for commissioning PrEP. Despite stakeholders' belief that NHSE would adopt PrEP as a prevention strategy, NHSE announced in March 2016, that it did not have the legal authority to do so owing to the 2012 Health and Social Care Act, which devolved sexual health services to local authorities. This decision was met with criticism, and a judicial review was brought against NHSE by activists, which NHSE lost. This interview study explored the reasons for NHSE's original decision not to commission PrEP and the implications this has for commissioning prevention strategies. The transparency of NHSE's decision-making process, and the effect of recent health-care reforms were also explored. Methods Purposive and snowball sampling methods were used to invite individuals to take part in semi-structured interviews. 15 interviewees (commissioners, activists, and individuals from national health bodies) were recruited. The interviews were anonymised and transcribed verbatim. Data saturation was reached, and two coders analysed the data using content analysis. Findings Participants cited the cost of PrEP as the reason behind NHSE's decision, especially in the context of austerity. Although NHSE's decision-making process was viewed positively, the final decision lacked transparency, highlighting a disconnect between the decision process and decision outcome. The Health and Social Care Act was viewed negatively with respect to deprioritisation of public health. Interpretation The commissioning of prevention strategies is unclear while local authorities face budgetary cuts. This could mean future tensions leading to judicial reviews. However, NHSE losing the judicial review and the level of criticism may act as a deterrent to prevent future cases. Improved communication about roles and responsibilities, not least on the part of policy makers, are needed to help overcome tensions arising from the Health and Social Care Act. Funding King's College London provided funds for expenses. PL and KK are supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) South London at King's College Hospital NHS Foundation Trust. The views expressed are not necessarily those of the NHS, the NIHR or the Department of Health.