MILAN, 18 Oct (APM) - A new president has been chosen for medicines agency AIFA, ending a period of more than a year without one, news agency Adnkronos reported on Thursday.
The appointment of Domenico Mantoan, currently head of the health department in the Veneto region, has been backed by the regions and the coordinating body of regional and national governments.
The day before the news broke, La Repubblica reported on union criticism of the regulator for its severe organisational shortcomings.
The paper said on Wednesday that the three biggest labour organisations, Cgil, Cisl and Uil, have requested a meeting with AIFA's director general Luca Li Bassi. They claim that there are 10 departments without directors, confusion about the roles of staff and uncertainly about who is in charge.
According to the paper, an official from the health ministry, Giovanna Romeo, had been called into the agency to bring some order to an increasingly chaotic situation. She was coordinating the 10 departments left without directors in charge. But she has unexpectedly returned to her job at the ministry.
Staff in the departments have been chosen to run the offices she was supervising until new managers can be appointed. Now, the unions want a meeting with Li Bassi to understand how long the period of managerial instability will continue.
According to La Repubblica, it is highly significant that the three biggest labour organisations are expressing concern about the situation in AIFA. It said the agency is going through a very difficult time, noting that the new health minister, Roberto Speranza, has until 4 December to decide if he wants to replace Li Bassi who was chosen by his predecessor, Giulia Grillo.
HTA key to health service sustainability in era of gene therapies
Health technology assessment (HTA) is key to the national health service achieving sustainability in an era of gene therapies and other advanced products, Il Sole 24 Ore reported on Monday.
Italy's HTA society, SIHTA, held a conference last week in Milan with the recent approval of Novartis' CAR-T therapy Kymriah (tisagenlecleucel) one of the subjects discussed.
Scientists remain cautious about the outcomes that gene therapies can achieve despite sharply increase investment in these type of products by pharma, the paper said.
To transform new technologies from promises to opportunities, long-term effectiveness and safety must be shown and ways to deal with the high costs found, the meeting was told.
Concerns were raised that regulatory agencies are continuing to treat new gene therapies like other pharma products which means they will have a big impact on budgets. Instead, ways need to be found to assess and pay for the therapies over a much longer period.
Future of €1 billion annual innovative drugs funding to be decided
The future of €1 billion of annual drugs funding used to pay for products recognised as innovative will have to be decided before the end of the year. Il Sole 24 Ore reported on Monday.
Half of the funding is for oncology drugs and the other for non-oncology products, including direct-acting antivirals to treat HCV infection. The financing was introduced in the 2017 budget law and runs out at the end of this year.
According to the paper, the regions and ministerial sources have given assurances that the funding will be renewed. The resources to pay for innovative drugs will be come from outside national health funding, as happened before, the paper said.
Chiesi looking for more stability from government
Chiesi is looking for more stability in the pharmaceutical and healthcare sectors, About Pharma reported on Thursday.
The Parma-based group organised a meeting in Rome this week to discuss sustainability in drugs innovation and research. Its chairman, Alberto Chiesi, waned that the industry is going through a period of significant uncertainty, especially in Italy where there has been little clarity about policies. He called for reliable and sustainable regulation of the sector.
The company's CEO, Ugo Di Francesco, suggested that companies, government institutions and the academic world need to work together to build an effective 'ecosystem'. "Everyone needs to do their part to guarantee sustainability for the Italian health system," he said.
New reimbursement rules proposed by AIFA
Medicines agency AIFA has proposed new reimbursement rules be introduced in the 2020 budget law, Quotidiano Sanità reported on Wednesday.
It wants the regulations for the national medicines formulary to be changed so that new drugs can have the same reimbursement price or a higher one only if they show added therapeutic benefit.
This would mean the health service would only buy new drugs if the proposed price is significantly lower than the lowest price of the medicines in that therapeutic category, Quotidiano Sanità said.