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The European Court of Justice ruled that the sale of generics for the treatment of HIV did not violate the patent of the American pharmaceutical company Gilead. This decision could open the door to the sale of generics throughout Europe, since only a few countries have taken judicial decisions in favor of the generic brands, Mylan and Teva.
In Portugal, the arrival of generics
According to the General Directorate of Health (DGS), about 31,000 patients are treated whose therapies are fully funded by the I & # 39; State. Between January and September 2017 (latest data available on Infarmed ), the expenditure was 167 million . In 2016, it was 173 million euros.
In response to the DN, Infarmed clarified that "it is the active substance with the highest volume of costs in hospitals, in 2017 it accounted for a charge of 48.2 million euros. .
"It is the active substance with the highest volume of loads in hospitals: in 2017, it accounted for a charge of 48.2 million euros, although the expenditure has currently, Gilead's drug, Truvada, which combines two of the three substances used for HIV treatment and prevention in the same pill, costs around € 700 per patient per month. "The decision to sell generics for HIV is expected for a long time, "admits DN Isabel Aldir, president of the National HIV / AIDS Program." We are making an effort and treating all those living with HIV to prevent new infections, but to do everything, it is important to reduce the financial impact. "
In Portugal, the introduction of generic drugs against HIV has already been targeted for a precautionary measure denied by the court in June since the The main action is always being discussed in court, but Infarmed admits that the decision of the European Court of Justice to consider that the basic patent does not cover the combination of the two substances that make Truvada (emtricitabine + tenofovir disoproxil) can be used in the decision national.
Now, according to the authorities, it will allow the redistribution of funds currently available to the European Court of Justice "This decision of the European Court of Justice can be used and contribute to decision-making, always on a national level." are spent on these therapies in another way. "If we can do the same thing at a lower price, we can get money from this savings to invest in other strategies for this disease or even in other areas that are needed" says Isabel Aldir.
prophylaxis for the population at risk of contracting the disease – for which it is the only drug used, which makes the prophylaxis quite expensive. According to Ricardo Fernandes, executive director of GAT, Group of Activists in Treatments, a pilot program "per hundred people" is currently in place in Portugal.
This way of using antiretroviral drugs preventively is quite controversial and "still". It is not approved in Portugal by Infarmed. "Financial facilitation would be a measure that" would have a great impact on the control of infection, "points out Ricardo Fernandes .
Portugal has recently achieved the three UN HIV / AIDS goals for 2020: 90% of patients diagnosed, 90% on treatment and 90% under care
Gilead's drug is not the only one used in Portugal, but he is the principal and, according to Isabel Aldir, " almost all patients take three drugs, Truvada is the most used and serves as the basis for almost all treatments . "
Two months ago, a generic medicine was marketed in Portugal for the treatment of HIV, 35% cheaper than the original drug and which, according to Zentiva, already has 29% market share. the CEO of Zentiva Portugal, Ana Falé Lopes, was satisfied with the decision of the European Court. "This is good news for all the patients who face this problem every day since the price is the highest. low can extend the population covered by HIV treatments. "
Updated at 13:36 on Friday 27, to include the Zentiva Portugal reaction
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