MILAN, 4 Jan (APM) - A former AIFA chief warned that Italy’s new pharma policies may restrict access to drugs for patients and could be damaging for the economy, in an interview published by the current affairs magazine Formiche on 28 December.
Luca Pani, who was director general of the regulator in 2011-2016, questioned how new some of the guidelines announced in December really are. He said the medicines agency already makes use of some of them in its routine activity.
Pani cited increased use of price/volume agreements as a positive aspect, noting that such deals were one of the things he introduced as AIFA’s director general. He stressed their importance in providing treatments to hepatitis C patients. “Without those agreements we would have spent double the amount we eventually paid,” he said.
What worries Pani most about the new policies is the government’s new attitude to pharmacology. The strategy is based on reimbursing only the lowest-costing therapies. He suggested this takes no account of how drugs R&D has completely changed in recent years.
“By bringing in these economic constraints, which are anyway outdated, the availability of medicines will be delayed and therapies that may give patients a better prognosis will be excluded,” he told the magazine.
Asked about the prospect of saving €2 billion through the new policies, Pani warned that excessive zeal in cutting drug costs could potentially damage the economy if pharma decides to withdraw investment.
The former AIFA chief suggested it is not in Italy’s interest to do this now. Pani told Formiche that the UK is the leading country for Phase I drugs testing, second in Phase II and third in Phase III. He predicted that this will change rapidly after Brexit.
“In three months all these economic and scientific resources will be allocated elsewhere. Does whoever wrote the document (guidelines) know this? And do they know how many hundreds of millions of euros a year this will be worth?” he asked.
Italy’s budget law criticised for removing funding for orphan drugs
Italy’s budget law has removed funding for the development of orphan drugs and will penalise rare disease patients with few treatment options, according to news agency AGI on Thursday.
The funding was created in 2013 after the government decided that there should be no payback for orphan drugs because this could mean denying patients the only treatment available to them. According to AGI, this change resulted in a system where around €200 million is provided by pharma companies as an incentive to small biotechs involved in R&D for rare diseases.
But the budget law has removed the exemption and the mechanism whereby pharma provides the funding. AGI noted that the public purse will not benefit from the change as the companies will now keep the €200 million for themselves.
“It is a sizeable gift from the government to the large drug multinationals which is also symbolic and significant. It is hard to believe that a minister from the Five Star Movement has done this, but it is there in the text (of the budget law) published in the Official Gazette,” AGI said.
The news agency suggested that parliamentary questions about the issue are likely as are protests from patients. It advised the government to take heed.
Pharmacy association wants number of OTC products increased
A pharmacy association is pressing for more non-reimbursable drugs to be reclassified as OTC products, Quotidiano Sanità reported on Thursday.
Libere Parafarmacie Italiane (LPI), which represents pharmacy businesses selling only non-prescription drugs, has written to the health ministry and medicines agency AIFA to ask why the process has stalled.
Provisions introduced in 2012 foresaw a significant increase in drugs which would be “delisted” and reclassified as self-medication and over the counter (OTC) products. But LPI says that none have been since 2014.
The organisation’s president Ivan Ruggiero suggested that there should be a rule that the formulary for non-reimbursable drugs should be reviewed at the end of every year to decide which ones can be reclassified.
Recordati completes acquisition of French OTC unit Tonipharm
Recordati has completed its acquisition of the French OTC unit Tonipharm, Corriere della Sera reported on Monday.
Based in Boulogne-Billancourt in the suburbs of Paris, Tonipharm had estimated sales of around €26.5 million in 2018. Its best known products are Ginkor, which is based on ginkgo biloba, and Alodont, an oral hygiene treatment, the paper said.