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Sunday 09 April 2017

PrEP and Medicine Regulation

Posted in: Health & HIV
By Craig Young - 22nd August 2016

In the United Kingdom and Australia, the vexed question of Truvada/PrEP access has become a fraught and complex issue. Let's clarify it in this article.

Until late July 2016, the core drug Truvada had been entirely removed from the National Health Service England drug commissioning and distribution process, which would have insured greater accessibility, as NHS England wanted more clinical trials before it made up its administrative mind about more open access. That is, until the UK National AIDS Trust took NHS England to the High Court to overturn its decision, which indeed is what has just happened.

Frustrated at the obstacles to access, some gay men in the United Kingdom have sidestepped this cumbersome process, and ordered Truvada from overseas. As Ryan Butcher suggests inGay Times(August 2016), there may be an ulterior motive, however. In July 2017, Truvada will go off patent and its creator Gilead will no longer have exclusive intellectual property rights, which means other drug companies could then produce cheaper generic copies and costs for funding access to it would go down. Butcher discussed these issues with several leading figures in the UK PrEP access debate- outgoing Gay Men Fighting AIDS executive director Matt Hodson and gay Scottish National Party and Conservative MPs Stewart MacDonald and Mike Freer.

Hodson argued that large-scale British and French clinical trials show that combined with continued rigorous condom use, HIV transmission could be halted, but that NHS England obstructionism was delaying this solution. Without NHS subsidies, Truvada costs four hundred pounds in the United Kingdom, although cheaper generic versions cost only forty pounds.

PrEP doesn't block other STIs, though and can affect kidney function and bone density, so monitored medical oversight is important to avoid such complications arising.

GMFA, the Terrence Higgins Trust, the National AIDS Trust, National AIDS Manual, LGBT Foundation, British HIV Association and BASHH all support greater access and availability, especially given the spectre of chemsex. Together with condom use, PrEP could make serious inroads into new HIV+ exposure amongst men who have sex with men. As for the two Members of Parliament, Stewart MacDonald (Scottish National Party, Glasgow South) understandably expressed relief that National Health Service policy is devolved, which means that the Scottish Government can act independently after the issue of licensing is resolved. He excoriated the then-Cameron administration for its lassitude and lack of coherent strategy for HIV prevention and sexual health matters generally. Without such a strategy, he argued, 2500 more British gay men will test HIV+ this year.

Conservative MP Mike Freer noted that (as with New Zealand's own Medsafe and Pharmac), the approval process for new pharmaceutical uses can take time, and explained that in the case of Truvada, the problem in question was licensing for preventative as well as HIV treatment use. He also pointed out that off patent use would slash the costs for the NHS and individual patient users to five hundred pounds and enable greater availability and access. He was concerned that Truvada manufacturer Gilead might apply for patent extension, noting that public health access means that pharmaceutical expenditure factors need to be involved here, like it or not. Clinical management regulator NICE is also compiling existing international clinical data into a report at the same time a large scale clinical trial is scheduled to publish its findings, which won't be until October 2016.

However, the recent (August 2) High Court decision has sent the debate into a new arena, with its ruling that NHS England can commission and license Truvada for both treatment and prevention roles. NHS England senior management are to appeal the decision, but UK HIV prevention NGOs have applauded the decision as allowing greater access and availability to men who have sex with men in the United Kingdom. The question is, will this decision mean that lower income gay, bisexual and other men who have sex with men be unable to access the medication in question, as would have happened had they awaited the off patent phase of its drug development process? Be that as it may, the High Court decision has led to further NHS England consultation with stakeholder gay, bisexual, MSM and other HIV prevention groups, and it is to be hoped that progress can be made on this regulatory front in that country.

Unfortunately, a similar situation has now surfaced in Australia, where the Pharmaceutical Benefits Advisory Committee (its Pharmac analogue) has rejected an application to list PrEP on its Pharmaceutical Benefit Scheme, which would mean subsidised acccess can occur across the Tasman. Although there are currently PrEP clinical trials available in Victoria, New South Wales and Queensland, these will not avail those who do not live in the relevant states, or who miss out on the window of opportunity for trial enrolment. One HIV prevention group, the Institute of Many, is calling on Gilead, the manufacturer, to resubmit to PBAS with appropriate estimates of cost as opposed to broad conjectures or shareholder profits. PBAC also came in for criticism from this quarter after comments that PrEP effectiveness depended on continuous adherence to safe sex, which was 'lacking' in gay, bisexual and men who had sex with men's communities. PrEP Access Now called for the federal Australian government to step in and approve PrEP for subsidised access. Even if Gilead did so, it would then have to wait further, until March 2017, for an outcome.


Ryan Butcher, Mike Hodson, Stewart MacDonald and Mike Freer: "How do we solve a problem like PrEP?"Gay Times(August 2016):30-33.

Joe Williams: "Breaking: High Court overturns decision not to fund HIV preventing PrEP drugs"Pinknews:02.08.2016:http://www. breaking-high-court-overturns- nhs-decision-not-to-fund-hiv- preventing-prep-drugs/

Joe Morgan: "NHS England will officially not offer PrEP"Gaystarnews: 31.05.2016:http://www. england-will-not-provide-prep- gay-men/#gs.kNNByhU

Tom Hayes: "This HIV+ campaigner explains how England's PrEP ruling will save lives"Gaystarnews:02.08.2016:http://www. positive-activist-explains- prep-ruling-will-change- peoples-lives/#gs.kQ1EsVQ

Daniel Megarry: "Campaigners and critics react to PrEP ruling"Gay Times: 02.08.2016:http://www. positive-activist-explains- prep-ruling-will-change- peoples-lives/#gs.kQ1EsVQ

Sarah Neville "Health Service chiefs to challenge HIV ruling" Financial Times: 02.08.2016: cms/s/0/93b2b3ca-58a0-11e6- 8d05-4eaa66292c32.html# axzz4GKu70LRv

Nick Duffy: "NHS England launches consultation on PrEP after losing legal battle:" Pinknews: 10.08.2016:http://www. launches-consultation-on-hiv- preventing-drugs-after-losing- legal-battle/

Samuel Leighton-Dore: "PBAC rejects application to list PrEP on PBS" Samesame: 19.08.2016:http://www. PBAC-rejects-application-to- list-PrEP-on-PBS

Craig Young - 22nd August 2016

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