Gilead: Stop Blocking PrEP

ACT UP Dublin has renewed the call for pharma giant Gilead Sciences to stop blocking access to its anti-HIV medication, Truvada. ACT UP demands that Gilead end its efforts to extend its expired patent and significantly drop the price where the patent is still in effect.

Members of ACT UP Dublin gathered outside the High Court in Dublin this morning as Gilead’s legal team arrived for the first day of a trial on the validity of the Supplementary Protection Certificate (SPC) for Truvada. The original patent expired in 2017, but the disputed SPC would extend Gilead’s monopoly on Truvada until 2020 in Ireland.

ACT UP Dublin member Andrew Leavitt said:

“Gilead has earned an international reputation for price gouging and dodging taxes. Here in Ireland, Gilead has done nothing but obstruct access to PrEP. They rebuffed HSE efforts to create a PrEP demonstration project in 2016, then refused to engage with the NCPE in the HSE’s pharmacoeconomic review process in 2017, forcing the Government to take exceptional measures by requesting a review from HIQA.” 

“A victory in this suit might bring a windfall for Gilead, but it would be a disaster for Ireland’s HIV prevention efforts,” Leavitt warned.

While it is widely anticipated that the Irish court will find the SPC invalid, a ruling in Gilead’s favour could upend plans for provision of PrEP by the State. A draft Health Technology Assessment report from HIQA found that PrEP is safe and highly effective, and—based on the lower prices charged by generic companies—that a PrEP programme would be cost saving for Ireland, noting that “providing PrEP is less costly… than not providing PrEP.”

Scheduled to run for three weeks, the trial is the latest round in a dispute which began in July 2017. In November 2017 the court denied an injunction sought by Gilead to prevent the sale of generic versions of Truvada in Irish pharmacies prior to a ruling on the validity of the SPC.

Truvada—a combination of anti-HIV drugs tenofovir and emtricitabine—is widely used in combination with additional drugs in the treatment of HIV. It is also the only medication approved for use in the prevention method known as pre-exposure prophylaxis (PrEP).

Two generic versions of Truvada—marketed by Mylan and Teva, the defendants in the current litigation—are currently available in Irish community pharmacies, retailing for as little as €50 for a month’s supply. Before the launch of generics in December 2017, PrEP users in Ireland would have had to pay over €400 per month for branded Truvada. 

The Irish case goes to trial as Gilead Sciences faces increasing criticism around patent claims for Truvada in the United States. Since last year a coalition of activists has called on the US National Institutes of Health to break Gilead’s patent on Truvada in the US to allow generic manufacturers to enter the market there.

Following revelations in March of unenforced patents held by the US Centers for Disease Control on the use of Truvada as PrEP, US activists have called for the CDC to enforce the patents or use them as leverage to force Gilead to drop the exorbitant price it charges for Truvada in the US.

A group of US senators has also called on the Dept. of Health and Human Services to enforce its patents, decrying multinational companies who reap “billions of dollars in profits without properly compensating the government for its investments.” And last week it was reported that the US Justice Department is reviewing the unenforced CDC patents.

ACT UP Dublin member Andrew Leavitt said, “Gilead’s behaviour has been disgraceful. The high price Gilead demands for Truvada has delayed PrEP access across Europe—including here in Ireland—and continues to be a huge obstacle to access in the US. This is not how a responsible, community-minded company—especially one supposedly concerned about health—should act.”

Download our press release as a pdf here.

Draft HIQA Report on National PrEP Programme for Ireland

Earlier this week the Health Information and Quality Authority (HIQA) released the long-awaited draft report on their Health Technology Assessment (HTA) of a national PrEP programme for Ireland.

The draft report—which was released as part of a public consultation—affirms what we already knew: PrEP is safe and highly effective at preventing HIV. But it also offered something new and really exciting: a PrEP programme for Ireland would not just be cost-effective, but actually cost-saving. 

As HIQA explained in the press release accompanying the draft report: “Providing PrEP is less costly… than not providing PrEP.”

That’s fantastic news, and underscores the clear-cut benefits of getting a functioning PrEP programme up and running without further delay.

The draft report was welcomed by the Government, with the Taoiseach and the Minister for Health both reaffirming their commitment to introducing a national PrEP programme this year—although they provided no specifics about *when* exactly this will happen.

HIQA will be taking public feedback on the draft report until

Which brings us to the less encouraging news in the draft report: an Irish PrEP programme will depend on the already greatly overburdened and underfunded existing public sexual health infrastructure to provide the clinical support needed to use PrEP safely and effectively.

The report is blunt, noting that “The primary barriers to introducing a PrEP programme are staffing and infrastructural issues,” and that “significant investment in STI services is required for a national PrEP programme to ensure a safe, sustainable and holistic service”. 

We raised precisely this issue with the Minister when we met with him and officials from the Sexual Health and Crisis Pregnancy Programme and the Department of Health last September. As we emphasised in a follow-up email: “The success of PrEP in Ireland largely depends on the ability of existing sexual health services to deliver it properly… it is vital that there be substantial investment to ensure that that these services can expand their capacity and improve their accessibility.”

This has not yet happened. While a slowly growing number of clinics offer support for PrEP users, the demand still far exceeds the capacity of these clinics—and this demand will grow exponentially when HSE begins to cover the cost of the medication.

With HIV diagnoses at an all-time high in Ireland we desperately need a national PrEP programme that makes PrEP freely available and truly accessible across the country. This HTA draft report contains good news, but it also highlights how much more work remains to be done. 

We must keep pressure on the Government and HSE to provide the necessary funding to sexual health services to enable them to support PrEP users, and to do so immediately.


If you’d like to participate in the public consultation you can provide feedback online or download a form here:

For information about PrEP for people living in Ireland visit