Italian Medicine’s Agency (AIFA) Issues Ultimatum to Gilead

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Italian Medicine’s Agency (AIFA) has previously claimed: “We will not pay more than €4,000 per treatment. If you do not accept our offer we plan to produce the drug ourselves. When dealing with life-saving drugs ethics should prevail over the economic incentive and the drug should be considered a universal good.”

Article link (in Italian, English below): http://www.quotidianosanita.it/scienza-e-farm…/articolo.php…

English version via Google Translate:

February 17 –AIFA’s ultimatum to Gilead – to get lower prices for the renewal of the supply of Sovaldi and Harvoni to cure Hepatitis C – was acclaimed across the board, from politicians and doctors’ organisations to patient groups.

Italy has spent about 2 billion euro to treat a mere 50,000 hepatitis C patients. Last October, former Undersecretary of Health Vito De Filippo had declared about a possible compulsory license : “for the Ministry to do it, would first require a lengthy analysis not only of the savings this could generate, but also the other economic risks associated, for instance those arising from an appeal by Gilead. ”

Giulia Grillo (5 Star Movement), Anna Miotto (Democratic Party), Marisa Nicchi (Si), Roberta Chersevani (Fnomceo) and Ivan Gardini (EpaC Onlus), contacted by our editorial staff have supported the choice announced by AIFA’s DG, Mario Melazzini, while calling the launch of a plan for the total eradication of Hepatitis C.

Giulia Grillo (M5S): “Finally! Two years of pressure from us with questions in committee and question time in Parliament have produced something. At this point, however, one wonders why we haven’t yet issued a compulsory license. AIFA could have taken this position since June 2016. That said, we are the first supporters of this position expressed by Mr Melazzini, provided that the price for treatment is 4 thousand euro gross, otherwise it will immediately proceed to give the mandate to the military pharmaceutical plant in Florence for its own production. The goal must then be the start of a national plan for the eradication of hepatitis C in Italy.”

Margherita Miotto (Democratic Party): “This move by AIFA is a very interesting initiative, now it is absolutely necessary to continue on this road, as we advocated in recent months in a motion passed in Parliament. With the right amount of determination, even the most ambitious goals become attainable. Surely the presence of several effective hepatitis C drugs market can play an important role in lowering the cost of therapies. For this reason I consider the price proposed by Director Melazzini is right – spending more money would really incomprehensible today. The next step must be to finally launch an eradication plan for hepatitis C. ”

Marisa Nicchi (Si): “This is great news, the result of a parliamentary and social struggle that we have carried for some time. Finally, if this announcement by AIFA translates into real lower prices, then the right to health will have come before economic interests. I hope that this will be a ‘trailblazer’ for all innovative drugs at very high prices, and not just those for hepatitis C. Once we have low prices, we have to start talking about a plan for the total eradication of the disease. ”

Ivan Gardini (EpaC Onlus, Italy’s hepatitis patient organisation): “This proposal by AIFA is a kind of deal that we like a lot. More than that, we had suggested it to the Agency on the basis of what has already happened in Australia. The ‘core’ of the question is to ask the company for a reasonable price, thus eliminating the access barriers that exist today. In this way, all patients could be treated, and at the same time, companies would be able to continue to profit on volumes.”

Roberta Chersevani (Fnomceo, Italy’s doctor organisation): “I welcome the statement by the DG Alfa Malazzini with regard to the prices of treatments for hepatitis C because it goes to correct an inequity in access to care that is ethically intolerable, as this violates our Constitution, and undermines the care relationship between doctor and patient. In Italy chronic carriers of the hepatitis C virus are over one million, of which 330 thousand have reached cirrhosis.”