MILAN, 21 Dec (APM) - Amendments to the budget law, which is in the latter stages of being approved by parliament, will create a drugs funding shortfall to be covered by the pharma industry, the head of the biotech association Assobiotec told Il Sole 24 Ore in an interview published on Tuesday.
Riccardo Palmisano said that several aspects of regulation have been changed. “We can only view them as negative and totally inadequate, especially the changes envisaged in terms of spending ceilings and the payback level,” he said.
One amendment establishes a new cap on spending on pharmaceutical and medical gases of 0.2% of total health spending. That means the ceiling on all directly purchased drugs, including those used in hospital, will be cut from 6.89% of total health funding to 6.69%.
Palmisano suggested this will aggravate an already serious situation of under-funding and take no account of the increasing demands on the public purse from costly new therapies. “The result will be a system that becomes completely unsustainable,” he said.
Palmisano described the underfunding as a structural deficit which always has to be covered by payback. “Payback cannot and should not represent a structural mechanism in an underfunded system, but should be, as the health minister herself has said, an exceptional safeguard option,” he told the paper.
Palmisano insisted that pharma is not looking for new resources but that existing ones are used more effectively. Currently the ‘direct’ budget has huge overspends very year while the budget for reimbursed drugs dispensed through pharmacies is increasingly underspent.
He suggested that the amendments could still be withdrawn. He also urged the health minister to consider introducing a decree, after consultation with medicines agency AIFA, to set new drugs spending ceilings each year so that they reflect the real and current demands on resources.
Pharma reforms unrealistic - industry chief
Pharma reforms proposed by the government, which include a €2 billion reduction in drugs spending, are not realistic, the head of branded lobby group Farmindustria told current affairs publication Formiche in an interview published on Tuesday.
Massimo Scaccabarozzi pointed out that 90% of the reimbursed drugs dispensed through pharmacies are off-patent products. He said it was difficult to understand where the government thinks the savings will come from.
He warned about allowing different drugs to be grouped together in therapeutical equivalent categories for reimbursement purposes saying that, unless there is a scientific basis for the selection, it may put patients’ treatments at risk.
Scaccabarozzi also warned about the impact of the measure on Italy’s pharma industry. If originator drugs have to compete with generics and biosimilars in therapeutically equivalent categories, it will be a huge disincentive to investing in development of new drugs, he suggested.
National health institute chief resignation
Health minister Giulia Grillo has insisted the resignation of the head of the national health institute ISS was not as a result of conflict with the government, Il Fatto Quotidiano reported on Wednesday.
Walter Riccardi announced he was stepping down six months early. (APMHE 61179
). Subsequently three other officials at the institute also resigned.
Minister Grillo admitted there had been differences with the ISS president but denied this was what prompted him to leave. “As far as I know and from what I was told during a meeting with him, Walter Ricciardi has not resigned because of a dispute with the government, but because he wanted to return to his professional activities,” she was quoted as saying.
Pharmacy chain liberalisation blocked - then unblocked again
Pharmacy chain liberalisation, which will allow large multinational networks to expand in Italy for the first time, continues to be a legislative battle ground, Il Sole 24 Ore reported on Saturday.
An amendment to the budget law, proposed by a member of the governing Five Star Movement (M5S), would have required that at least 51% of shareholders in any pharmacy businesses should be registered pharmacists or pharmacy businesses themselves. However the amendment was later removed, the paper said.
Then, the president of the health and hygiene commission in parliament introduced a new amendment to the budget law with the same requirement.
According to Il Sole 24 Ore, pharmacy chains own just 300 pharmacy outlets in Italy They had been preparing big investments for expansion after the ownership rules were changed. However, foreign companies are said to be reluctant to put money into Italy until it becomes clear whether the liberalisation will be allowed.
The ping-pong battle continued this week, Quotidiano Sanità reported on Tuesday.
The accounts committee in parliament withdrew two amendments of the budget law which would have imposed restrictions on shareholders in pharmacy businesses, the online publication said. That means the competition law approved in 2017, which allows multi-ownership of pharmacy outlets, still stands