MILAN, 13 July (APM) - Parallel trading is the most likely cause of continuing drug shortages in Italy because of the higher prices products can fetch on markets in northern Europe, according to the weekly magazine L’Espresso which was published on Thursday.
The publication noted that medicines agency AIFA keeps a register of drugs reported as difficult to find or unavailable on its website. It shows there are 1,556 drugs which are scarce in Italy, 410 of them products without a generic version. According to L’Espresso, the most likely destinations for the products are Germany, England or Holland.
The list also includes 35 vaccines such as Infranix-hexa against six diseases, Energix against hepatitis B, Imovax for polio and Varilrix for chickenpox.
L’Espresso stressed that parallel trading is legal in Europe but affects countries such as Spain, Greece and Italy much more because reimbursement prices are lower. It noted that the EU believes parallel trade to be a legitimate part of the free movement of goods in the single market. But the magazine described it as a “ghost market” that is causing shortages in many countries in Europe.
It said Poland, Romania and Slovakia were reported to Brussels when they tried to limit parallel trading. However, this May the European Commission decided not to proceed with infraction proceedings against the countries.
The Commission recognised that parallel trade of medicines can be one of the reasons for which shortages occur, the paper said. But it does not intend to stop it for now.
Patients need bigger role in drugs regulation, spending decisions
A citizens rights group has called for a bigger role for patients in drugs regulation and spending decision, Il Sole 24 Ore reported on Tuesday.
Cittadinanzattiva includes an influential patients association, Tribunale del Malato (TDM). Its head, Tonino Aceti, told the paper that efforts to make medicines agency AIFA more open to patient influence have not been enough.
He said: “Active participation of patients in processes that generate new therapies: development, evaluation and real access to necessary treatments for a decisive change of pace including in the review of pharmaceutical policies. Which is in line, by the way, with what was announced by the health minister Giulia Grillo.”
Aceti suggested the Italian regulator should look at what the European Medicines Agency (EMA) has done. It invited expression of interest from people wanting to become civil society representatives on its management board and on another committee.
Aceti pointed to legislation establishing the National Coordination Centre for Ethics Committees in Italy, which foresees the participation of civic groups. But it still does not work effectively, he warned. “The involvement of citizens' organisations and patients as actors and no longer just as spectators is essential to ensure timely access to therapies and combat the inequalities that continue undisturbed in our country,” he said.
Italian pharma saw biggest rise in exports of any sector in 2017
Italy’s exports reached record levels in 2017 with pharmaceuticals playing a leading role, La Repubblica reported on Thursday.
The paper cited a report by Italy’s trade and investment agency ICE which showed that exports rose 7.4% over the year to €448 billion. The pharmaceutical industry saw its sales abroad rise 16% to 24.8 billion, a bigger increase than any other sector.
Janssen uses Italian plant as model for site in China
Janssen is replicating production facilities at Latina, south of Rome, in China because of the levels of efficiency, according to Wednesday’s Corriere della Sera.
The new factory, which is taking shape at Xian in the province of Shaanxi, will serve the whole of Asia, the paper said. Latina was chosen because it produces innovative oncology drugs and antiviral therapies which are exported round the globe.
The Italian staff are now working in China to introduce the appropriate machinery, technology and automised systems as well as manufacturing processes used at Latina, the paper said. The factory is already operative but skills and know-how still have to be transferred, it added.
AIFA report on vaccines says safety issues not a concern
A report by AIFA on vaccines has decided there are not any significant safety issues, Corriere della Sera reported on Wednesday.
It said the results of analysis of adverse reactions for different types of vaccine in 2017 showed “no possible association between suspected additional risks and vaccines has emerged and therefore there is no problem that should raise concern about the safety of vaccines.”
The paper said the report reinforces the message that vaccines are a necessary and safe form of prevention. However it doubted that the report and its scientific data will be enough to stop opposition to vaccines in Italy.