One of the three lots Canada’s Aurora Cannabis won in July to supply the Italian market has been canceled, Italy’s minister of health explained in a parliamentary inquiry this week, citing noncompliance with European Union Good Manufacturing Practice (GMP) standards.
In July, Alberta-based Aurora was the sole winner of the contract after all other bidders were disqualified.
The tender to supply the Italian market consisted of three different cannabis lots:
- Lot 1: 320 kilograms (705 pounds) of high-THC cannabis.
- Lot 2: 40 kilograms of similar THC and CBD content.
- Lot 3: 40 kilograms of high-CBD cannabis.
Aurora won all three lots, offering an average price of 1.73 euros ($1.94) per gram.
In September, however, the Ministry of the Defense decreed that the tendered Lot 3 was canceled.
The agency cited “autotutela,” a self-protection privilege of Italian administrative law that refers to the power of the public administration to unilaterally revoke administrative acts already taken.
In the decree, the Ministry of the Defense justified the decision based on the opinion of the Stabilimento Chimico Farmaceutico Militare (SCFM) in Florence, which considered that the supply of Lot 3, a variety with a high-CBD content, was “not necessary.”
Aurora did not immediately respond to a query from Marijuana Business Daily.
The SCFM is the only domestic cultivator of medical cannabis in Italy, but the agency estimates it will produce only 350 kilograms of flower in 2019, which means domestic patients must rely mostly on imported products.
Most of the Italian supply is being imported from the Netherlands, produced by Bedrocan.
The only Canadian company from which the SCFM currently imports is Aurora.
Deputies of the Italian Democratic Party asked the Minister of Health on Oct. 23 about the medical cannabis program. In particular, the deputies wondered why one of the lots was canceled with Italian patients facing supply issues.
In a reply published Oct. 31, the minister of health said the lot rejected by the SCFM did not comply with EU-GMP specifications. The reason given was that stability studies to define the shelf life of the products were not carried out.
In the parliamentary inquiry, the legislators estimated there are currently 30,000 patients in need of about 1,000 kilograms a year.
The minister emphasized that efforts are being carried out to ramp up the SCFM’s production, but if that fails, the ministry may authorize the cultivation by third parties.
Alfredo Pascual can be reached at email@example.com