Back HIV Prevention Pre-exposure (PrEP) England's PrEP Policy in Disarray After National Health Service Turnaround

England's PrEP Policy in Disarray After National Health Service Turnaround


Activists, individuals at risk of HIV, and clinicians have reacted with anger to an official U-turn on provision of HIV pre-exposure prophylaxis (PrEP) in England, where National Health Service (NHS) officials have refused to allow a draft policy on PrEP to go forward for further consideration. "By denying full availability of PrEP we are failing those who are at risk of HIV," commented Ian Green of Terrence Higgins Trust, a leading U.K. HIV/AIDS organization. "PrEP has already been approved in the U.S., Kenya, South Africa, Israel, Canada, and France. And yet, our own government refuses to take responsibility for PrEP."

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Although the stated reason for blocking PrEP was that NHS England should not be paying for it, officials did not present a clear path for a way forward. "Today’s statement makes it no clearer who is responsible -- is it the Department of Health, local authorities, the NHS, or Public Health England?" said Green. "We need answers, we need access, and we demand both."

Questions were even asked in parliament. MP Catherine West said that NHS England’s scrapping of plans to fund PrEP "totally fails those at risk of contracting HIV." She also asked whether anything could be done to put an end to NHS England’s erratic and inconsistent decision making.

Who's Responsible for Commissioning PrEP?

The argument advanced by senior managers at NHS England for the U-turn is that they shouldn’t have been considering commissioning PrEP in the first place, as HIV prevention services, and many other public health interventions, are the responsibility of local authorities.

Moreover, NHS England argues that if they did commission PrEP, there is a risk that proponents of other interventions that are not commissioned might make a legal challenge, on the basis that the specialized commissioning budget is not there for prevention but for treatment. 

Advocates believe these arguments to be disingenuous, pointing out that NHS England already pays for vaccines, HIV post-exposure prophylaxis (PEP), some contraceptives, and cervical cancer screening. For 18 months NHS England managers had overseen a formal process to determine the circumstances in which the organization could provide PrEP -- before abruptly pulling the plug on it.

"It is extraordinary that such legal concerns were only raised at the eleventh hour, after months of work," commented Yusef Azad of the National AIDS Trust.

"We are perplexed and deeply concerned by NHS England's decision," the British HIV Association (BHIVA), representing clinicians, said in a statement. "We will now urgently seek clarification of the process required to reach a commissioning decision. If a decision cannot be reached by NHS England, supported by a comprehensive array of stakeholders including local authorities, then we need to know who can make the decision and how it can be made."

Councilor Izzi Seccombe of the Local Government Association denounced the decision: "This is a missed opportunity to launch a ground-breaking prevention method that could halt the spread of HIV, potentially save lives, and make a significant breakthrough in reducing the risk of HIV infection." She also challenged the idea that cash-strapped local authorities should foot the bill for the antiretrovirals used for PrEP. "NHS England's statement is a selective and untenable reading of the Public Health Regulations of 2013 and an attempt to create a new and unfunded burden on local authorities."

An Alternative Proposition

Although NHS England argues that it should not be providing PrEP, it simultaneously offered a sliver of funding for a pilot project.

"Given the potential benefits in this area, NHS England is keen to build on the excellent work to date and will be making available up to £2 million over the next 2 years to run a number of early implementer test sites," the organization said. "These test sites will aim to provide protection to an additional 500 men at high risk of HIV infection."

NHS England presents these projects as seeking to answer "remaining questions" about PrEP, in particular about cost-effectiveness and commissioning arrangements. But the plans appear to have been pulled together at the last minute without being thought through.

"We strongly disagree with the inference that more 'real-life' evidence is required to assess the cost-effectiveness and affordability of PrEP as part of an integrated service," commented Professor Sheena McCormack of the PROUD study. "This is exactly what PROUD has already established -- and in the most astounding and scientifically robust way due to the very high rate of HIV among those who came forward for PrEP, but did not have access to drug for the first year."

The policy that NHS England has dropped aimed to achieve a high uptake of PrEP so as to make a real impact on the country’s HIV epidemic -- PrEP would have been available for up to 6000 people a year and would have cost up to £25 million a year.

In contrast, the ambitions of the new proposal are minimal. Whereas around 6000 people are newly diagnosed with HIV each year, only 500 individuals -- all gay men, spread over 2 years -- will receive PrEP. In the PROUD study, 1 HIV infection was prevented for every 13 men who received PrEP. This suggests that less than 40 new infections will be prevented by the proposed policy.

Iain Reeves of Homerton University Hospital also asked how cost-effectiveness could be evaluated in more detail with a sample size of only 500 -- and how those 500 men would be selected. Well-informed men are likely to be the first to seek out PrEP while less informed men, some with greater needs, will miss out. "This seems to represent officially sanctioned inequity, creating winners and losers. Has NHS England considered an ethical review of this approach?" he asked.

"The decision is not informed by any due process; the amount of money is arbitrary; the claim that more 'testing' of PrEP is needed is disingenuous," commented Deborah Gold of the National AIDS Trust."500 does not remotely cover the number of gay men at high risk of HIV nor meet the needs of heterosexuals at risk."


"The UK once had a reputation for being a leader in HIV prevention and that reputation now lays in tatters," said Will Nutland of the website Prepster. "NHS England has turned its back on a process that could have significantly contributed to turning the tide of HIV in this country. The decision is ill-conceived, is not based on evidence, and will directly contribute to the on-going sexual ill health of the nation."

"PrEP is a powerful HIV prevention tool and avoids the need for NHS England specialist services to fund a lifetime of treatment," said McCormack. "The risk of legal challenge is negligible compared to the benefits, which are financial for NHS England, and personal for the thousands of individuals destined to otherwise catch HIV."

"Thousands of gay and bisexual men have been let down by the decision of NHS England not to offer pre-exposure prophylaxis (PrEP)," said Matthew Hodson of GMFA, the gay men's health charity. "Here was the opportunity to make a significant contribution towards ending HIV and the authorities have muffed it."

Others speculated on the reasons for the U-turn. "It is my personal belief that this decision has been kicked into the long grass allowing time for the main medication in question to come to the end of its patented life and a [cheaper] generic version become available," commented Paul Decle of the HIV patients group Forum Link, referring to Truvada (tenofovir/emtricitabine).

PrEP also appears to be a victim of the split of commissioning responsibilities between the NHS and local authorities. "This is yet another adverse outcome of the disastrous Health and Social Care Act," commented the British HIV Association. Martin McKee, Professor of European Public Health at the London School of Hygiene and Tropical Medicine, tweeted: "We said repeatedly NHS reform [would] cause chaos & confusion. Debacle over PrEP proves our case, tragically."

Campaigning and Advocacy

Activists are calling upon government ministers to intervene and reverse the decision. U.K. residents are invited to write to their MPs, asking them to raise the issue with the Secretary of State for Health, Jeremy Hunt. You can do so by clicking this link.

There is also a public petition to parliament, asking for PrEP to be made immediately available under the NHS. This petition already has over 8000 signatures and the government must respond if more than 10,000 people sign. You can sign the petition by clicking this link.