[Ip-health] Italian Medicines Agency (Aifa) Adopts Strong Negotiation Stance on Hep C DAAs, CL Option Raised

PERFECT, Chase cperfect at coalitionplus.org
Tue Feb 21 11:08:34 PST 2017

Hi all,

Just wanted to highlight the Italian government's current stance on pending
negotiations with Gilead over Hep C DAA prices. The head of Aifa (the
Italian Medicines Agency) 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.”

Thanks to Viviana Galli for originally catching and passing this news
along. Please excuse any cross-posting.

Article link (in Italian, English below):

English version via Google Translate (additional article links at bottom of
the post):

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

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.”

Interview of Aifa DG Melazzini with La Stampa
 and reactions from political parties and organisations
HepC medicines prices: support for the "combative" turn of Aifa
Melazzini on HepC: "We will cure all patients within 3 years"

Chase Perfect
Access to Medicines Policy Officer
HIV/HCV Drug Affordability Project
Coalition Plus (Paris, France)

Skype ID: cperfect1984
Telephone: +33 (0)6 16 28 10 44
What's App: +33 6 16 28 10 44

Chase Perfect
Access to Medicines Policy Officer
HIV/HCV Drug Affordability Project
Coalition Plus (Paris, France)

Skype ID: cperfect1984
Telephone: +33 (0)6 16 28 10 44
What's App: +33 6 16 28 10 44

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