The European Court of Justice (ECJ) today delivered a much-anticipated ruling that could lead to wider access to affordable PrEP and significant savings on HIV treatment for the HSE.
Over the last year, courts across Europe have handed down judgements on the validity of Gilead Sciences’ Supplementary Protection Certificates (SPC) for Truvada. In January of 2017 the English High Court submitted an application to the European Court for guidance in a dispute over the validity of the SPC for Truvada in England and Wales.
The original patent for Truvada—a combination medicine used both for treatment of HIV and for prevention when used by HIV-negative people as pre-exposure prophylaxis, or PrEP—expired in July of 2017.
Although the ECJ did not make a final determination as to the validity of the contested SPC, the court affirmed the English court’s conclusion that the original patent did not specify the combination of drugs in Truvada.
The case now returns to the English High Court for a final decision.
Decision is in from European Court of Justice on generic #PrEP and it’s generally in favour of generic manufacturers. In an Irish context, this sets a good precedent but continued generic PrEP access will depend on Irish High Court decision on SPC. #AIDS2018 ?? pic.twitter.com/afHxgOMwE7
— Adam Shanley (@Adlers1) July 25, 2018
Today’s ruling is positive news for advocates for fair access to medicines and is especially encouraging to PrEP campaigners in Ireland, where Gilead Sciences is currently pursuing litigation before the High Court to enforce its SPC in Ireland and force generic versions of Truvada off the market.
ACT UP Dublin’s Andrew Leavitt said “We hope this will close one of the loopholes that pharmaceutical companies have exploited to unfairly extend their monopolies even when they’ve made billions in profits during the regular patent life.”
“Gilead’s behaviour in Ireland is especially egregious as they have refused to engage in the HSE’s Health Technology Assessment process while simultaneously going to court to force generic companies off the market. This undermines efforts to bring down Ireland’s unacceptably high rate of HIV diagnoses.”
Last November, the High Court rejected Gilead’s application for an injunction preventing generic companies from entering the market, and generic versions of Truvada have been available for private purchase in community pharmacies since last December. In addition, some clinics providing antiretroviral medication for HIV treatment are now dispensing generic Truvada—a potential cost-savings of many thousands of Euro each month.
The #PharmaLies tour arrives at @GileadSciences stand at #AIDS2018. Celebration of the European Court ruling rendering the supplementary protection certificate on #Truvada invalid in the EU and opening the door for access to generics. #SPC #PrEP pic.twitter.com/sL8uRyBi5Y
— Health Action Int'l (@HAImedicines) July 25, 2018
The HSE does not currently provide PrEP, so users must pay the full cost of the medication themselves. Two generic products are currently available through community pharmacies, retailing for between €60 and €100 for a month’s supply. Gilead’s Truvada is priced at more than €400 for a month’s supply.
Gilead’s cases are listed for mention on Monday, 30 July 2018. It is expected that the parties will set dates for a trial to begin some time after the court resumes in October.
If Gilead prevails in the High Court and their SPC is upheld—as it has been in Denmark and Switzerland—generic companies will be forced to withdraw their products from the market. PrEP users will no longer be able to buy PrEP in Irish pharmacies and hospital pharmacies will no longer be able to dispense generic versions for treatment.
A decision in Gilead’s favour could also derail the Government’s recently-announced plan to roll out an HSE PrEP programme in January 2019.
ACT UP Dublin held a demonstration outside the High Court on 12 July during Gilead’s last court appearance demanding that Gilead end the uncertainty, stop blocking PrEP, and drop the remaining SPCs across Europe.
Leavitt added, “Gilead’s greedy behaviour has held up access to PrEP across Europe. It’s clear they don’t want to engage with the HSE on PrEP, so it’s time for them to get out of the way and let the HSE get on with making PrEP available here in Ireland.”
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