Press review

 - 

Italy's medicines agency AIFA reported to be having severe organisational difficulties due to understaffing

Country : Africa, Italy, Russia, U.S.

Keywords :
MILAN, 13 Sep (APM) - Italy's medicines agency AIFA is having severe organisational difficulties due to understaffing, meaning it has achieved little in the last year, according to Thursday's La Repubblica.
The paper described the agency as "going through a period of stagnation" which could continue in the short-term after a change of government brought a new health minister.
Luca Li Bassi, AIFA's director general who was appointed a year ago by former health minister Giulia Grillo, is said to be waiting to see whether he will be confirmed as the head of the agency. Italy's system gives the incoming heath minister, Roberto Speranza, 90 days to change public officials appointed by his predecessor.
In a detailed account of the situation inside the agency, La Repubblica claimed it has been partly taken under control by the health ministry, a level of "interference" which is unprecedented. This is because of staffing and managerial shortages which have left departments unable to operate effectively, it said.
According to the paper, there are 12 areas in the medicines agency without a dedicated manager. These offices, which include the legal department and the health technology office (HTA), are being overseen by an experienced official from the health ministry, Giovanna Romeo, La Repubblica claimed.
She was sent to "lend a hand to Li Bassi" when Grillo realised that he could not do everything by himself. In September, the contracts of six or seven more top staff are due to end. According to La Repubblica, little has been done to replace them.
The paper said that, when Grillo became health minister, she committed to making AIFA into an independent, effective regulator which would focus on good management of public resources at the expense of pharma profits.
But many of the measures, including a revision of the national medicines formulary to remove old and ineffective therapies, have not been implemented. Even the flagship policy of making drugs pricing more transparent, which included adoption of a resolution by the WHO, has not lived up to expectations, the paper claimed.
"Li Bassi and Grillo rightly rejoiced after taking a resolution to the WHO which demands transparency on the price of drugs from multinationals," La Repubblica wrote. And yet, there has been little evidence that it has made any difference in Italy, the paper said.

Production at Menarini site in Russia expected to surge 170% in 2019

Production at Menarini’s site at Kaluga, 150 km south of Moscow, is expected to surge 170% this year, La Nazione reported on Saturday.
The finance director of Berlin Chemie - Menarini, Attilio Sebastio, told the paper that the aim is to double sales next year. Production is accounted for by a variety of drugs including heart and diabetes treatments.
Kaluga is one of Russia's space science centres but also includes a technology industrial sector with a growing pharma cluster, La Nazione explained. Menarini was one of the first international groups to set up there.
Sebastio said the choice of Kaluga came after a long assessment process. It was chosen for its good infrastructure, efficient local authorities which can help foreign businesses, a good university and positive experiences of foreign investors in the area.
Menarini started construction of the site in 2011, opened it in 2014 and began manufacturing its own products there in 2017. Production in 2019 is expected to total 272 tons compared to 100 tons last year. The potential capacity of the plant is 350 tons.

Italian police bust international medicines trafficking gang

Italian police have busted an international medicines trafficking gang, according to Thursday's Il Messaggero.
Eighteen people have been arrested on a variety of charges including theft and receiving stolen goods. Drugs, mostly cancer treatments, worth €4million have been seized. According to the authorities, more than 824 packs of medicines were stolen from pharmacies, hospitals and other health structures in Italy.
The gang, which appears to have originated in the Campania region in south Italy, included two Egyptians who organised sales abroad. The drugs were to be 'exported to countries such as France and Germany but most of all to North Africa and the Middle East, the paper said.
rg/tm

[RG7PXREXJ]

TRY APM HEALTH EUROPE AND GET ACCESS TO THE FULL CONTENT

Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to the latest stories

Our coverage includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.

REQUEST

an initial 10 day temporary access of APM Health Europe.