MILAN, Feb 20 (APM) - The Italian medicines agency AIFA has sent a clear warning to Gilead that it must accept a low reimbursement price for its HCV products or Italy could apply for an obligatory licence to produce its own drugs under the international TRIPS agreement.
The regulator has been trying to negotiate a new contract with the company since the previous one ended in June last year. But talks have stalled over Gilead's reluctance to lower its prices.
On Friday, La Stampa published an interview with AIFA's director general Mario Melazzini in which it was revealed that a determined effort will be made to hammer out a final deal next week. The medicines agency reprinted the article on its website.
AIFA wants an agreement that will allow Italy to treat almost 300,000 more people who are infected with hepatitis C. The government is committed to providing 1 billion euros to pay for innovative drugs in a special fund outside normal param reimbursement budgets.
According to La Stampa, Gilead has offered a price of around 13,000 euros a treatment for a new contract. But the agency's director general told the paper that Italy will not accept a price higher than 4,000 euros. "If the ethics of common sense do not prevail we will eradicate the virus anyway using all the options available," Melazzini warned.
The first option would be to follow the example of France and tell specialist prescribing centres to only use other companies' drugs to treat the most common genotypes of the infection leaving only a small share of the market to Gilead, he told the paper.
But he also suggested a more radical solution: "If they do accept to lower the price we could decide to ask the government to use, as a last resort, the application of the TRIPs agreement which allows states to produce drugs under an obligatory license in health emergencies," Melazzini explained.
The AIFA chief explained that Italy's insistence on a lower price in the new contract is because it wants to open up treatment for everyone who needs it. At the moment, there are strict entry requirement for who can be treated with new antivirals.
Gilead's previous reimbursement contract consisted of a price/volume agreement in which successive discounts were offered each time predetermined sales thresholds were reached. The price being paid at the end of the contract was said to be around 4,000 euros.
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