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THE EUROPEAN COURT of Justice has delivered a ruling that could lead to wider access to affordable PrEP and significant savings on HIV treatment for the HSE.
Pharma giant Gilead was today unsuccessful in a case relating to its HIV drug Truvada. The original patent for Truvada —a combination medicine used both for treatment of HIV and for prevention when used by HIV-negative people — expired in July of 2017.
Pre-Exposure Prophylaxis (PrEP) is a once daily medication that can significantly reduce risk of infection among HIV-negative people at high risk.
To date, PrEP has only been available to buy on prescription at a price of over €400 a month in Ireland. In December, generic drugs company Teva Pharmaceuticals confirmed its more affordable, generic version of the medication would be made available in pharmacies in Ireland, on foot of a doctor’s prescription.
Irish exclusivity for the drug hinged on Supplementary Protection Certificates (SPCs) obtained by Gilead. Gilead had sought an injunction against generics manufacturers to prevent the sale of the cheaper drugs.
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. 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.
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The case now returns to the English High Court for a final decision.
Act Up, a HIV activist organisation which campaigns for the freer availability of PrEP, said the decision was promising news.
Spokesperson 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.”
A number of groups are calling for PrEP to be introduced under the HSE general medical services scheme.
Drugs supplied under the scheme are available through prescription from a doctor, for people with medical cards, and can be received from any pharmacy that has an agreement with the HSE, who cover the costs.
The World Health Organisation released guidelines last year recommending that oral PrEP should be offered as an additional prevention choice for people at substantial risk of HIV infection.
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We always hear how drug companies make billions in drug sales over the course of a patent lifespan. What people don’t get is that it costs hundreds of millions to bring a drug to market and only a tiny proportion of drugs ever get approved. The actual profit is very small, most of the proceeds from drug sales are pumped into further drug development.
@Damon16: -The combined total revenue for all 12 companies over 13 years was about $5.35 Trillion. -The Combined total profits for these companies was about $1.05 Trillion. -All 12 pharmaceutical companies spent a total of $887 Billion on research.
@Patrick Lionnain: they make a profit so what. Why would someone invest their money in a drug company to develop drugs most of which will never be approved if there isn’t a decent ROI?
I know. Let’s abolish drug companies, hike taxes on everyone and invest 10billion in a HSE run pharma company. I’d hazard to say the results wouldn’t be great.
@Damon16: you’ve had enough( drugs) if you think for one second that’s true! There’s no money to be made by having healthy people, pharmaceuticals companies are a trillion dollar companies! Just look at the US they start their kids on sedition drugs by the time their 3/4 years old & that’s it going to be popping pills for life!
Gilead. Horrible company. Swimming in cash. Availing of our tax loopholes. That drug should be available a lot cheaper then they re ethos of helping the patient might be believable
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