PrEP in Ireland Update: High Court clears the way for generic Truvada in Ireland

On Tuesday, November 7, the High Court in Dublin rejected an application from Gilead Sciences for injunctions that would have prevented two companies from marketing generic versions of Truvada in Ireland. With initial prices for these generics expected to be about 60% lower than what Gilead charges for brand-name Truvada, the timeline for PrEP access in Ireland could be shortened dramatically.

Gilead has faced global criticism for price gouging and tax dodging, and the high price it demands for Truvada is the single biggest obstacle to PrEP access in Europe. We protested at Dublin’s Four Courts to demand that Gilead drop the price of Truvada when they were in court at the beginning of October.

This Irish Times article covers the details of the judgement, and we published this report after the hearings at the High Court.

So what does this actually mean right now? Unfortunately, not much.

PrEP still won’t be available through the HSE, people wanting to use PrEP now will still be sourcing it online, and Irish Customs will still seize any shipments of generic PrEP that it intercepts.

Although generic manufacturers Teva and Mylan appear to be ready to enter the Irish market, generic versions of Truvada won’t be in pharmacies here next week. And when the generic versions do become available they’ll likely cost around €180 per month. That won’t be much use for individual users, but it makes a big difference for the HSE’s cost-effectiveness calculations.

So what’s happens next? First a generic manufacturer must submit an application for reimbursement for their product as PrEP to the HSE. This will go through a “rapid review” process that will assess whether or not it’s cost effective at the price offered. If not, it will start a more in-depth and lengthy review process.

Gilead Sciences submitted an application in June, but it failed to pass the initial “rapid review” process. Although Gilead is now involved in the drawn-out pharmacoeconomic assessment process (much of which involves haggling over price), an application from a generic manufacturer could make that process irrelevant.

Even after the HSE agrees to reimburse for PrEP, there are significant challenges to be addressed in actually providing PrEP. Although rates of STI and HIV testing in Ireland are low to begin with, the rates of diagnoses are increasing and the existing sexual health services in Ireland are already badly overstretched. Without a commitment to provide funding to properly support and expand the capacity of these services, access to PrEP may be severely limited.

Although we welcome this ruling and hope that it will hasten PrEP access in Ireland, it’s imperative that we keep pressure on the HSE and the Government. We need a real commitment from the highest levels of the HSE and the Government to make PrEP available without further delay.

The Irish response to the HIV crisis has been shamefully inadequate. We have an opportunity to change that, but it’s not going to happen unless we demand it.

Online PrEP and the law

Last year the HSE obtained legal advice regarding accessing medicines over the internet and related issues of concern for prescribers, users of generic PrEP, and non-medical groups sharing information about accessing online PrEP.

The full legal advice was published in June of this year and we’ve uploaded it here.

Of particular note for people currently using PrEP or considering it, the advice makes clear: “There is no law in Ireland prohibiting an individual patient from accessing medicine via the internet with a prescription.” However, it also notes that “It is a criminal offence to obtain prescription medicine without a prescription.”

So what does that mean? It means that the biggest risk you face if you get a prescription and order PrEP online is that it will be seized by customs. It seems unlikely that the authorities would want to prosecute people for ordering generic PrEP without a prescription, but since getting proper medical support is an important part of using PrEP safely, it’s probably a good idea for people to talk to a doctor about using PrEP and ask the doctor for a prescription.

The advice letter goes on to state that “there is no law restricting the specific information that a physician can and cannot provide to their patient” about PrEP, including referring them to sites like iwantprepnow.co.uk that provide comprehensive information about PrEP as well as links to sites that can supply generic PrEP.

Doctors will also be glad to know that they’re “not under a legal obligation when providing a prescription to either state where the medicine is to be sourced, or to satisfy himself/herself that a patient is not sourcing the medicine online.” You don’t necessarily have to talk to your doctor about where you’re going to get PrEP, but it’s not something they need to ask you about as a condition for writing a prescription or not.

The legal advice was obtained in July of 2016, but was released in June as an appendix to the “Action plan: Response to the national increase in HIV and STIs in MSM” report from the HSE’s National MSM HIV/STI increase response group interventions subgroup.

Press release for HPRA demonstration

Today ACT UP Dublin held a demonstration outside the HPRA offices in Dublin to demand action from the Government and HSE to make PrEP available in Ireland without further delay. Our press release is available for download here.

This is the full text of the press release:

FOR IMMEDIATE RELEASE
August 4, 2017  2:00pm

Contact: act.up.dublin@gmail.com
www.actupdublin.com

PrEP STOPS HIV: Ireland needs PrEP now.

ACT UP Dublin today called on the Irish Government to make PrEP (Pre-Exposure Prophylaxis) available through the HSE immediately.

Angered by recent reports of increased seizures of generic PrEP by Irish Customs, and the HSE’s failure to provide even limited access through a pilot PrEP programme, advocates gathered in front of the HPRA offices on Earlsfort Terrace at lunch time to demand that the Minister for Health, Simon Harris, make a commitment to address Ireland’s HIV crisis and make PrEP available and accessible in Ireland without further delay.

New HIV diagnoses in Ireland are at record levels with one new HIV diagnosis every 18 hours. Delays on PrEP lead directly to entirely avoidable new HIV infections.

We know more about HIV treatment and prevention than ever before…
yet new diagnoses continue to rise.

Powerful new tools like PrEP have the potential to dramatically impact the epidemic…
yet they are unavailable here.

It’s time for this Government to show that it’s serious about Ireland’s HIV crisis. 

It’s time for leadership instead of foot dragging.

It’s time for PrEP in Ireland.

————————

In 2015, Ireland reported the highest number of new HIV diagnoses in the history of the epidemic. Preliminary figures from 2016 are even higher. The LGBT community has been particularly impacted as new HIV diagnoses among gay and bisexual men quadrupled between 2005 and 2015.

Pre-Exposure Prophylaxis for HIV—better known as PrEP—is a safe and highly effective way for HIV-negative people to prevent HIV using antiretroviral medication. The World Health Organization recommends that PrEP be offered to people at substantial risk of HIV as part of a comprehensive HIV prevention package.

Currently only one medication, Truvada, has been approved for use as PrEP in Europe. Although doctors in Ireland can prescribe Truvada as PrEP, the HSE does not yet provide reimbursement for the medication. Purchased privately through a pharmacy in Ireland, Truvada would cost hundreds of Euro per month—much more than anyone can realistically afford.

A growing number of people in Ireland, fed up with the Government’s failure to provide access to PrEP, are taking responsibility for their own and the community’s health. Following a model established in the UK (where it is legal to import generic medication for personal use) they are purchasing generic versions of PrEP online. In the UK, the widespread use of these generics is credited with helping to produce a dramatic reduction in new HIV diagnoses among gay and bisexual men in the last year.

UK-based websites like iwantprepnow.co.uk provide comprehensive information about PrEP—how it works, how to use it, how to get the necessary clinical support—and provide links to sites known to be reliable sources for authentic generics.

Unfortunately, the HSE currently provides no formal, dedicated clinical support services for PrEP users. Although the tests can be obtained through existing health services, those who are able to source more affordable generic versions online must manage their own clinical care. There is no consistent clinical monitoring by properly-trained medical providers, no systematic data about current PrEP users is being collected, no official information is available for current or potential PrEP users.

Instead of making PrEP available directly, or offering badly needed clinical support services to those who are taking initiative and already using PrEP, Irish health authorities are seizing packages, harassing suppliers, and trying to undermine public confidence in the only available route to obtaining PrEP for people in Ireland.

It’s time for Minister of Health, Simon Harris, to show leadership in tackling Ireland’s HIV crisis. 

Making PrEP available in Ireland without further delay must be a priority of this Government. 

What is ACT UP?

ACT UP Dublin is a local chapter of ACT UP, The AIDS Coalition to Unleash Power, an international HIV activist organisation. ACT UP Dublin was founded in July 2016 to take action on Ireland’s HIV crisis. We seek a more urgent and effective response to HIV from government, community organisations, and the public at large.

Demonstrate for PrEP in Dublin!

In response to the news that Irish Customs has been cracking down on imports of affordable generic versions of PrEP into Ireland, ACT UP Dublin has organised a demonstration for Friday, August 4th. We’ll be outside of the HPRA offices on Earlsfort Terrace (across from the National Concert Hall) from 12 to 2pm.

Please join us as we call on the government to show it’s serious about addressing Ireland’s HIV crisis by making PrEP available now.

PrEP in Ireland Update

The Medical Independent published a well-researched and detailed article on July 20th looking at where we are in the campaign to make PrEP available in Ireland. Unfortunately the news isn’t great.

Throughout the last year the HSE and Government pointed to a demonstration project that was set to “commence later this year or in early 2017.” However in the MI article Fiona Lyons, clinical lead for the implementation of the National Sexual Health Strategy, admits that “the window of opportunity for doing a PrEP demonstration project has closed.” This means that until the HSE provides PrEP, the only option for people to access PrEP in Ireland will continue to be self-sourcing affordable generic versions.

Unfortunately, as the MI also reports, that is becoming more difficult. Customs has been seizing shipments of generic PrEP coming into Ireland and the Health Products Regulatory Agency (HPRA) has been investigating the sources that people are using to obtain these drugs. This has resulted in the primary supplier of generic PrEP suspending shipments to Irish addresses, leaving current and potential PrEP users scrambling to find other ways to access the medications.

Following contact with the HPRA, the HSE PrEP Working Group recently circulated recommendations to healthcare providers to discourage patients from self-sourcing PrEP. They specifically request that they “do not direct patients” to iwantprepnow.co.uk, one of the most comprehensive and respected sources for information about how to use PrEP, how to self-source it safely, and how to make sure you get the proper medical support.

The working group’s email doesn’t mention that the generic versions and suppliers listed at iwantprepnow.co.uk are the same ones that the 56 Dean Street clinic in London tested and found, in every case, to be genuine. To this point the HPRA have offered no evidence that would suggest that anything has changed since the 56 Dean Street testing occurred or that anyone who is self-sourcing PrEP has obtained anything but the real thing.

All of this underscores the urgent need for HSE to provide PrEP through conventional channels. In one significant step towards that, Gilead in June applied to the HSE for reimbursement for Truvada as PrEP. This initiates a process where the costs involved in providing PrEP are analysed by the National Centre for Pharmacoeconomics (NCPE).

After an initial rapid review—which is supposed to take “approximately 4 weeks“—the NCPE will either approve Truvada for reimbursement, or (much more likely) will require a full pharmacoeconomic assessment. This process is supposed to take no more than 3 months from the formal submission of evidence, but before that happens there’s a period of notifications and consultations.

Overall, it seems unlikely that PrEP would be available until 2019 if nothing is done to accelerate this process or to provide PrEP on an interim basis. According to a July 26th written answer from Catherine Byrne to a Dáil question, the time frame for the HSE reimbursement process “would be in the order of at least 6 to 12 months.”

However, even when that is concluded, funding needs to be budgeted for PrEP and for the support services that will be required to make it available. That is unlikely to happen mid-year, so even if things go relatively smoothly in the reimbursement approval process, we’re likely to have to wait until the 2019 budget to see funding for PrEP.

One further wrinkle is that Gilead Sciences, the maker of Truvada, has filed suit in the High Court to block generic manufacturers from entering the market in Ireland with significantly cheaper generic versions of Truvada. The original patent for Truvada expired this month, but Gilead has obtained extended protection with a Supplementary Protection Certificate. A lawsuit over the validity of that SPC is currently awaiting a hearing at the European Court of Justice, but a decision isn’t expected before mid-2018.

It’s not clear whether an SPC is currently in force in Ireland or what the basis of the Gilead lawsuit is, but it seems clear that Gilead is not going to allow their patent to expire without a fight.

A lower price for the medication would mean much faster provision of PrEP by HSE and other European national health systems. So the outcome of the suit before the EU Court of Justice is being watched closely across the continent.

PrEP Policy Review for Ireland

Last Thursday, June 15th, HIV Ireland and the Gay Health Network launched a new policy paper on PrEP in Ireland and called “for Pre-Exposure Prophylaxis (PrEP) to be made a public health priority in Ireland,” adding that in light of record levels of new HIV diagnoses in Ireland, “PrEP must be introduced as a key HIV prevention intervention.”

The report, titled Pre-Exposure Prophylaxis Scoping and Policy Options Review, was commissioned to “provide evidence-based guidance on PrEP efficacy, while establishing the views of key populations affected by HIV, and stakeholders directly and indirectly involved in the provision of HIV services throughout Ireland.”

Author Ann Nolan conducted an extensive review of the evidence around PrEP and conducted interviews with a range of healthcare providers and advocates, as well as current and potential PrEP users.

This document will be a valuable resource for advocates for PrEP availability in Ireland, and adds strong new voices to the campaign for PrEP in Ireland.

masc.life Interview with Will St. Leger

We’re big fans of masc. The interviews and photos are consistently engaging and provocative, touching on topics too rarely given the attention they deserve.

So we are delighted that our own Will St. Leger is the subject of an interview published today. Will talks about the frustration and anger that animates our HIV activism, and about how activist art has helped to focus and guide that energy in productive ways throughout the history of the epidemic.

Will has been the driving force behind our event “All Together Human”, an exhibition of protest art for Irish AIDS Day . The one-day show is on June 15, 2017, and runs from 6 to 10pm at Filmbase in Temple Bar. Please come down and have a look and a chat!

All Together Human – protest art show for Irish AIDS Day 2017

We’re delighted to announce that we’ll be hosting an art exhibition for Irish AIDS Day, June 15th, called “All Together Human”. The show will be at Filmbase in Temple Bar and will feature work from a range of Irish artists, with proceeds from sales going to support ACT UP Dublin.

We’ll be sharing more details as we get closer to the day. To keep up with announcements you can also check out our Facebook event page.

Come Out Fighting – download here!

On Wednesday, April 26th, we launched our new zine Come Out Fighting at Pantibar in Dublin. The zine was created by Butcher Queers and Masc. for ACT UP Dublin and features work from writers, activists, photographers and artists.

It was a fun evening, fantastic for everyone involved in creating the zine to get a chance to meet each other in person. We gave away dozens of copies and had a lot of lively conversations about the zine and what ACT UP is doing.

We think there’s something special about holding an actual paper copy of a zine in your hands, but we also want to make sure people who weren’t able to get a copy have a chance to read the zine. So we’ve put the whole thing online. Click here to view or download a copy.

If you’d like to contribute to our next issue, please get in touch! You can reach us through our Facebook page, or directly by email at act.up.dublin@gmail.com.

Undetectable = Untransmittable

Have you noticed the hashtag  #UequalsU? Wondered what it means? Well it’s pretty simple, it stands for “undetectable = untransmittable” and this is what it means:

People living with HIV who have an undetectable viral load do not transmit HIV to their sexual partners.

Did you know that? Did you know that if you have HIV and are on treatment and virally suppressed, it doesn’t just reduce the risk that HIV can be transmitted, it effectively eliminates it?

Well it’s true. Results from the PARTNER study published last year showed that among 888 mixed-status couples (one parter was HIV positive, the other HIV negative) who reported more than 58,000 individual acts of condomless sex, there was not one instance of transmission from someone with an undetectable viral load to a negative partner.

These decisive results—added to finding from previous studies, as well as 20+ years of real-world experience with effective combination therapy for HIV—are about as conclusive as they can be. That’s why we’re comfortable saying that people with an undetectable viral load pose no transmission risk to their sexual partners.

In February, ACT UP Dublin became a community partner with the Prevention Access Campaign. That means we’ve joined dozens of researchers, organisations and individuals who’ve also endorsed the U=U Consensus Statement.

We think it’s a message that everyone who’s living with HIV deserves to hear loud and clear. We are committed to sharing this incredibly important information as widely and as often as we can.