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The US drug maker Gilead may miss the exclusive sale of Truvada, the most effective antiretroviral drug used in the treatment of HIV. The ruling of the European Court of Justice was known this Thursday opposed to the American company to two generic giants who already sold their version of the drug in Ireland.
In the SNS alone, co-pay for anti-HIV drugs is estimated at about 215 million euros a year – and each patient treated with Truvada costs 700 € a month in the state . In Portugal, HIV treatment is 100% funded by the state.
Now, this bill may decrease to about 70 euros a month – since the door is open to generic entry into the market, and that is the price of these drugs in countries that already manufacture them in a generic version, such as the United States, Brazil, Mexico and India. Truvada is one of the most profitable drugs in the world and yields to the pharmaceutical giant Gilead, each year, 86 billion euros. Mylan and Teva (generic companies) have placed 85% cheaper versions.
By 2017, Gilead sued generic companies to protect their exclusive sale of anti-HIV drugs – particularly in the UK. The decision was finally brought to the European Court of Justice which only considered whether the formula was protected by the patent.
The conclusion was that Truvada's original patent did not specify the drug combination in the patent. its composition, referring only to "other therapeutic ingredients". As a result, the combination TD / emtricitabine can not be considered as protected by a basic patent in force.
The decision to ban or refuse the sale of generics is therefore referred to the High Court of
last year, in January, the US Food and Drug Administration published the production of generic Truvada – something that has long been demanded by HIV activists. In Brazil, the patent was broken in April of this year. In India and Mexico, the production of these drugs has been longer by generic manufacturers – and this patent infringement has reduced costs and improved treatment efficiency in poor countries .
with this drug which is that of preventive therapy. Truvada is the only drug used in this controversial new type of HIV infection prevention, used in adults who have not contracted but who are at high risk of infection with the virus.
In Portugal, there were about 45,000 infected cases – between 1993 and 2016, 11,000 of the 56,000 people infected with the virus died. The new infections mainly affect young people and more than 90% are in treatment, which corresponds to one of the best global averages
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