Uruguay-based Fotmer Life Sciences exported another large shipment of medical cannabis to Portugal in May – this one totaling almost 1.5 metric tons (3,307 pounds), according to Uruguayan customs documents viewed by Marijuana Business Daily.
The overseas shipment comes about six months after Fotmer sent 1 metric ton of high-THC cannabis flower to Portugal.
The Uruguayan shipments could spur other European importers to follow suit, a move that would increasingly underscore the growth of the global medical cannabis industry.
The two huge shipments, meanwhile, are unusual for their secretive nature – at least from the importer’s standpoint. Cannabis companies, particularly those from Canada, typically boast about the smallest of international shipments.
But, so far, no company has publicly taken responsibility for importing the shipments into Europe from Uruguay.
The declared customs value of the latest shipment was about $2 per gram, including costs, insurance and freight, according to the Uruguayan customs documents dated May 19, 2020.
Uruguay positioned as key exporter
Since last October, Fotmer’s exports have totaled roughly 3,000 kilograms of flower – effectively positioning the South American nation among the handful of countries exporting meaningful quantities of high-THC marijuana.
By comparison, the Netherlands is believed to be the largest exporter of cannabis flower in the world, with MJBizDaily‘s recent European medical cannabis report estimating the country shipped a total of 4,400 kilograms overseas in 2019.
The catch: Unlike Dutch exports, all the flower exported from Uruguay was not processed in a European Union-Good Manufacturing Practice (EU-GMP)-certified facility.
Fotmer CEO Jordan Lewis told MJBizDaily the company produces in facilities certified with Good Agricultural and Collection Practice (GACP) and Uruguayan-GMP certification and that the firm has the “near-term goal of achieving EU-GMP certification.”
“As has been demonstrated by Fotmer as well as other companies, the pathway for GACP product as an input into an EU-GMP supply chain is both viable and cost-effective,” he said.
Lewis added that he could not comment on the identity of the European buyer.
The means whatever entity is conducting these transactions on the Portuguese side is effectively paving the way for other medical cannabis companies to export into the European Union without first obtaining costly EU-GMP certification – provided the cannabis is grown and harvested under certain quality standards and processed in an EU-GMP facility in Europe before being sold to patients.
“We are OK with the large public companies competing at the point of sale through branding initiatives while we provide private label and contract cultivation solutions to those myriad competitors,” Lewis said.
Last week, Tilray obtained EU-GMP certification for its Portuguese facility “to manufacture medical cannabis extracts in-house.”
Tilray neither confirmed nor denied whether it was the importer of the October shipment and did not reply to another query from MJBizDaily about the May shipment.
Not without precedent
If the non-EU-GMP flower exported from Uruguay is being used to manufacture extracts for medical use in a EU-GMP facility, it would not be the first time.
“The application of GACP versus EU-GMP, and where in the process GACP transitions to GMP, is a subject that is still debated in industry,” Karina Lahnakoski, partner in Risk Advisory at CCI Deloitte in Canada told MJBizDaily.
“A full understanding of the supply chain and the jurisdictional requirements is required to apply the right quality controls,” she added.
German herbal medicine manufacturer Bionorica – which in 2019 sold its cannabinoid division to Canadian cannabis giant Canopy Growth – started doing this many years ago.
Flower exported from Austria has been used to manufacture dronabinol in Bavaria, Germany. The unprocessed Austrian flower is grown based on GACP guidelines.
This was confirmed to MJBizDaily by Bernhard Föger, head of the Institute for Sustainable Plant Production of the Austrian Agency for Health and Food Safety – the only legal grower of high-THC cannabis for commercial purposes in Austria.
Föger said his agency continues to export flower to Germany, and Austrian authorities understand cannabis cultivation “cannot be GMP-certified. Only the further processing of the vegetable raw material into a drug is subject to the GMP requirements.”
That’s why the Austrian agency grows cannabis under GACP conditions.
“All of our flowers are processed by our customers,” Föger said.
The majority of the dronabinol Canopy sells is plant-derived, as confirmed to MJBizDaily via email by Christian Goertz, Canopy’s director of corporate communications in Europe.
Goertz wouldn’t comment on whether the company still uses flower imported from Austria for the purpose of dronabinol manufacturing.
While flower grown under GACP can be used as raw material, all flower sold to patients in German, Italian or Dutch pharmacies has so far been produced in an EU-GMP-certified facility.
For instance, German domestic cultivators – which grow and harvest but not extract the flower – must comply with both GACP and GMP requirements, distinguishing between both areas of production.
The Netherlands exports flower to Germany both for pharmacy dispensing and to be used for dronabinol manufacturing, but all the Dutch-exported flower is produced in EU-GMP facilities.
Alfredo Pascual can be reached at firstname.lastname@example.org