A Truvada pill. Maurizio Gambarini

HIV drug may be more affordable after European court ruling

The case now returns to the English High Court for a final decision.

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.

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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