What is PREP?
PrEP (Pre-Exposure Prophylaxis) is the use of an anti-retroviral drug (emtricitabine/tenofovir disoproxil fumarate - brand name Truvada) which may be prescribed to HIV negative people who are at high risk of contracting HIV. Using PrEP can prevent them from becoming infected. Results from a number of trials, including English trials, have shown that PrEP can be highly effective in preventing HIV negative people, who are not consistently using condoms, from becoming infected with HIV.
It is still the case that the best way to prevent contracting both HIV and sexually transmitted infections (STIs) is to use a condom, and the fact that PrEP may become available does not change the recommendation that condoms should always be used to prevent the spread of HIV and other STIs. Using PrEP does not prevent people from contracting sexually transmitted infections (STIs) in the way that using a condom does.
NHS England loses its appeal
NHS England has lost its appeal as the Court of Appeal rules it has the power to fund PrEP. NHS England claimed earlier this year that it does not have the power to commission PrEP but a judicial review brought by the National Aids Trust determined that NHS England could commission PrEP. NHS England appealed this ruling on Thursday 15 September 2016.
The Court of Appeal issued its ruling on their appeal, in a judgement that confirms that NHS England can legally fund PrEP. To read London Councils statement on the ruling in full click here.
PrEP public consultation has now ended
NHSE decided, that while the judicial review appeal is ongoing, to start the public consultation process on PrEP. This started on 10 August and finished on 23 September. Once it has received feedback from the public consultation, the next step is to take any decision on PrEP to the NHSE Clinical Priorities Advisory Group (CPAG). The CPAG makes recommendations on NHS England's approach to commissioning services, treatments and technologies, and weighs potential services and treatments against each other to decide which is most effective and offers best value for money. A detailed background to the build up to judicial review can be found below.
How can I protect myself from HIV?
PrEP will not protect people from STIs even though it is effective in preventing people at risk from contracting HIV. The most effective way for people to protect themselves from HIV is still to always use condoms, and to get tested regularly for HIV and other STIs if they have had sex without condoms. If someone is worried about their sexual health then they should talk to their GP, local sexual health clinic or attend a GUM clinic. More information about HIV generally can be found at nhs.uk/HIV and more information about HIV testing in London is available at Do it London.
If you’re at higher risk of contracting HIV, you can now order a free HIV sampling kit to use at home, which is a simple finger-prick test to take in the privacy of your own home to send off to your local lab for an HIV test. More information is available at Do it London.
Background to the judicial review
NHSE’s decision not to fund PrEP drugs in March
An expert group including representatives from medical research, patients, local authorities and sexual health providers worked for 18 months with NHSE to advise whether PrEP drugs should be funded by NHS England, who have the responsibility to fund this class of drug.
NHSE announced on March 21 that it will not fund PrEP drugs and that there will therefore not be a consultation about PrEP and who might be eligible for it. London Councils issued a statement in response to this news. The NHSE statement is available here.
NHSE is proposed that, rather than introduce PrEP across the country, it will set up ‘test sites’ for two years in some local authorities, where PrEP will be available to those most at risk of contracting HIV. The test sites would aim to reach up to 500 people in total, and funding of £1million would have been available for each of the two years to pay for the PrEP drugs.
Further lobbying on PrEP in April
Representatives from the LGA, ADPH (UK), ADPH (London), London Councils, and Public Health England (PHE) met with representatives from Department of Health (DH) to discuss PrEP. All of the visiting representatives were in agreement about their disappointment following the NHSE decision not to fund PrEP drugs.
The Department of Health representatives stated that the regulations which set out Local authorities’ statutory public health responsibilities, did not specify who is the responsible commissioner for PrEP so guidance may have to be written to clarify this, and legal advice taken.
Joint letter from LGA, LC and ADPH (UK) in April
LGA, ADPH (UK) and London Councils wrote a joint letter to Simon Stevens, Director of NHSE on April 12 which was copied to Jeremy Hunt, Jane Ellison, Greg Clark and Duncan Selbie. The letter stated that:
- During implementation of the NHS and Care Act 2010, NHSE sought to retain commissioning of HIV therapeutics, to which PrEP and PEP belong. As PrEP is an ARV treatment as prevention, it is and should remain the responsibility of NHSE
- Attempting to pass responsibility for funding PrEP drugs onto local authorities is a new burden and the new burdens doctrine and guidance has not been followed
- PrEP has been shown to be cost-effective, and even cost saving, to NHSE, when compared to treatment costs for someone with HIV.
- The arguments made in NHSE’s statement do not stand up – many other countries provide PrEP and there have been no legal challenges, we all agree that PrEP needs to be used with other preventative measures such as condoms and regular testing and not just used alone, and PrEP drugs will come out of patent in 2017 and will therefore become much cheaper.
Delays to the introduction of PrEP meant more HIV infections which could have been avoided. Local authorities want to protect the health of their populations and worked with NHSE for some time to try to find a way to provide PrEP to those most at-risk. London Councils asked that NHSE negotiate with partners to implement PrEP across the country.
National Aids Trust (NAT) threat of legal action
On April 12 the NAT solicitors wrote NHSE a letter before action, saying they would take NHSE's decision not to take PrEP forward to the consultation process, or to take it to the NHSE Clinical Priorities Advisory Group (CPAG), to judicial review. This was on the grounds that the decision was wrong in law, that the NHSE were unlawfuly fettering their discretion and that no equality impact assessment had been carried out as to whether the decision would have a disproportionate impact on a particular disadvantaged group. As a result, NHSE announced it was reconsidering its decision at its Specialised Services Committee (SSC) at the end of May.
NHSE SSC decision not to fund PrEP on May 31
NHSE announced on May 31 that it will not fund PrEP as it stood by its legal advice that it does not have the legal power to commission PrEP. It also announced that it will continue to work in partnership with Public Health England to run a number of test sites, funded with £2m over the next two years, to research how PrEP could be commissioned in the most clinically and cost effective way.
Judicial review outcome August 2 2016
On August 2 in the High Court, Mr Justice Green ruled on the judicial review taken by National Aids Trust (NAT) against NHSE and decided that:
- There is nothing to prevent NHSE paying for PrEP drugs. NHSE had been arguing it had no power under the National Health Service Act 2006 to pay for public health functions, and that councils were responsible for providing PrEP drugs as they are responsible for preventative health
- Even if NHSE does not have the power under the 2006 Act, NHSE could still pay for PrEP on the basis that it could be viewed as a treatment for a person with HIV infection, and that NHSE has a broad power to commission preventative treatments and could pay for that reason.
We were delighted with this news. Details of the London Councils press release can be read here.
However, this decision did not mean that NHSE would automatically fund PrEP drugs for those at most risk of contracting HIV. NHS England decided to appeal the decision at the Court of Appeal.
NHSE have said that they will only fund PrEP if they consider it is effective enough to meet NHS criteria. NHSE will put PrEP through its consultation process, starting with a public consultation. This would be followed by a prioritisation process, where all potential new drugs and treatments which NHSE could commission are ranked against each other, to see which is most effective and best value for money. NHSE has also said it will negotiate with the PrEP drug manufacturers to try to reduce the price.