There are few drugs, since Viagra, that have captured the global imagination more than Truvada

HIV preventative care is a huge issue for activists. Gilead Sciences in Cork manufactures the drug Truveda. Caomhan Keane meets the head of commercial operations.

There are few drugs, since Viagra, that have captured the global imagination more than Truvada

HIV preventative care is a huge issue for activists. Gilead Sciences in Cork manufactures the drug Truveda Caomhan Keane meets the head of commercial operations.

There are few drugs, since Viagra, that have captured the global imagination more than Truvada, the most common tablet taken for pre exposure prophylaxis (PrEP) which can significantly reduce risk of infection among HIV-negative people at high risk.

The most pressing issue for gay rights activists since the passing of Marriage Equality, the fight to attain accessible HIV preventative care has been the dominant topic of conversation on social media, at public meetings and even on lampposts, where “PrEP NOW” stickers were spotted around Dublin landmarks, as HIV activist group ACT UP demanded that the drugs manufacturer ‘drop its patent to allow fair access to this revolutionary medication’.

That manufacturer is Gilead Sciences who next year will mark their 20th year in Cork where it recently opened a €9.5 million quality control lab at its Carrigtwohill site in the hopes of improving its production levels for the European, Middle East and Asian markets.

21 of the 25 products made by Gilead- a quarter of their global output, are produced here in Cork, an operation that costs the company €100 million each year. “The product we would shift takes in only a fraction of that, so Gilead is a big investor into the Irish economy,” says Killian MacDonald, Gilead’s head of commercial operations in this country.

We’ve met to discuss the company’s sponsorship of Cork Pride which he hopes signifies the relationship between the community and the corporation. “The areas of medicine we work in, HIV and Hepatitis C, affects LGBT disproportionately. We have been working with LGBT groups for years on risk prevention and education programs, such as the My HIV, My Rules website, which helps prepare people with HIV for their life long journey with the virus, or the ‘HIV is just a part of me’ campaign which highlights the health issues that can affect them as they get older.”

“Lots of long-term patients might have been dealing with side effects associated with older medications, which might impact on their quality of life. There are lots of patients who are on the ‘older’ drugs some of which might be associated with have cardiovascular, kidney, or bone risks. So we need to insure that people with HIV are aware of this, are speaking to clinicians, and being assessed for those risks.”

Gilead have taken several pages out in the Pride Guide to highlight these issues. “We see Pride as an inclusive phenomenon. It fits with our business. It fits with our culture. If any company shows support, we should be one of them.”

But with a new HIV diagnosis in Ireland every 18 hours, ACT UP claim that Gilead are profiting off of HIV by using its patent on PrEP to block cheaper versions currently available in the Irish market. According to ACT UP generic PrEP costs around one fifth of the price of Truvada, which they say costs an inaccessible €400.

“By combining multiple HIV treatments in one tablet, Gilead created a paradigm shift, where patients went from taking multiple tablets a day, to just one,” says MacDonald. “We’re happy to spend huge amounts of money to develop drugs to make things better for those living with HIV and we continue to invest in trying to find a cure.

“But to do that, you have to make sure you get a return on your investment, and you have a tight time period in which to do that. That period is while you have intellectual copyright protection. Threaten that and you threaten access to new drugs in the future.”

However, speaking to the American publication Slate, Act Up pointed out that, during Gilead’s initial application for FDA approval, they cited three studies heavily funded by federal agencies, and that public and philanthropic investment in PrEP research and development in the past 10 years vastly exceeded commercial entities. To date Gilead has generated $14 billion in revenue from Truvada. PreP costs as much as the rent of a single room in Cork to purchase per month and Ireland has a diagnosis rate double the average EU rate. “There’s a lot of passion and I understand that. But I regret they have conflated two issues. A company defending its intellectual copyright-which it believes is the only way to have innovation in the future, is separate to making sure that any person at risk gets access to our drug, or a version of it, in a safe and affordable way.”

Gilead recently lost two separate battles, both in the Irish High Court and the European Court of Justice, relating to the sale of generics. Today they are back in the High Court again to set a date for another trial. ACT UP say, if successful, this could jeopardise the PrEP programme role out for January 2019 promised by Minister Simon Harris as Gilead have declined to partake in a Health Technology Assessment for Truvada.

After they submitted their rapid review to The National Centre for Pharmacoeconomics/HSE in 2017, Gilead were asked to submit for a Health Technology Assessment, which asked for more information. “We weren’t sure if there was any more information we could provide than what was in the rapid review, which contained the same information we gave to countries like Scotland where they were able to make a decision.

“We would rather have negotiated with the HSE now, rather than go through the HTA and then have to negotiate terms anyway, which would have included a discussion on price. I’m not saying we would have come to an agreement in those negotiations, but we were willing to at least have them. The HSE weren’t.”

Asked for comment the HSE said: “HIV PrEP requires a pharmacoeconomic evaluation to inform policy around implementation. In the absence of a submission from individual companies, the HSE asked HIQA to carry out a health technology assessment (HTA) of HIV PrEP. The board of HIQA recently approved prioritisation of a HTA of HIV PrEP and work will commence shortly.”

MacDonald is keen to impress the company’s sponsorship has nothing to do with improving its image. “I would hate anyone to suggest we were supporting Cork Pride just to improve our reputation on these other issues. The local employees in the Cork manufacturing site wanted their workplace to show it’s support for Pride.”

MacDonald does respect the work that ACT UP has been doing, since it has raised awareness of issues - even if he does find the heckling of his employer hard to take. “We delivered them those treatments in the first place and will deliver better treatments. I would love to sit down to have a calm conversation with them, if I would get a fair hearing. But we’re often not included because people think we are big bad pharma.”

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