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The European Court has just authorized the placing on the market of generics of Truvada, a drug used to prevent HIV infection in cases of risky badual intercourse.
This was already the case in France but the decision now concerns the whole of Europe: the American laboratory Gilead no longer has a monopoly on Truvada, the commercial name of the "anti-AIDS pill", better known as PrEP. The European Court of Justice ruled on Wednesday, July 25, for the commercialization of generics across Europe. In France, the appearance of generics had made it possible to divide by 2.5 the cost of treatment.
Truvada is the only drug authorized in Europe for the prevention of seronegatives in PrEP (Pre-exposure Prophylaxis). This treatment makes it possible to avoid contracting the AIDS virus, even if one does not use a condom during a badual intercourse. This medicine, reimbursed 100% by the Social Security, is used by about 7000 people in France. A French study conducted for one year recently showed that PrEP is 100% effective.
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« This historic decision (…) puts an end to an undue monopoly, "reacted the badociations Coalition PLUS and Aides in a statement. The European patents on this drug had expired on July 25, 2017, allowing in theory the arrival of generics. In some European countries, however, the Gilead laboratory continued to exercise a monopoly under a "supplementary protection certificate" (CCP), a mechanism for extending the period of exclusivity of a drug. [19659003] Four competing laboratories (Teva, Accord Healthcare, Lupine and Mylan) sued this certificate, and the Court of Justice of the European Union (CJEU) ruled in their favor thanks to a legal subtlety related to the Truvada patent. Indeed, this drug combines two antiretrovirals, tenofovir disoproxil (TD) and emtricitabine. However, only the first is explicitly mentioned in the basic patent. According to the European Court, the conditions of a supplementary protection certificate were not fulfilled because the combination of the two active ingredients was not explicitly mentioned in the patent.
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Five generics are available on the French market
"In France, it is more than 760 million euros that the use of generic Truvada has saved money"
Association Aides
It is on the same reasoning that had already been supported by the French justice in September 2017. It had rejected a request of Gilead, who wishes to see prohibit the commercialization of the generic of Truvada launched in France by the Mylan laboratory. Since then, five generics are available on the French market, resulting in a significant drop in prices (about 160 euros for the box against more than 400 euros for the Truvada when he had the monopoly).
"In France, it is more than 760 million euros that the use of generic Truvada has saved money," said the badociation Aides . "At European level, this decision of the CJEU will be in billions of euros in savings and should pave the way for PrEP throughout Europe, thus avoiding thousands of contaminations," said the badociation.
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