Blog

What does the Bedrocan bankruptcy mean for medical cannabis supply?

Bedrocan went bankrupt on 7 October and Dutch exports stop at the end of 2026: what that means for Italy and what importers can check now.

Riccardo Longato

Pharmaceutical GMP Lead Auditor (CQI/IRCA)

Published

Dutch patients are covered from stock until at least mid-2027 and then from imports, while the countries that import Dutch flower lose it at the end of 2026. On 7 October 2026 the District Court of Northern Netherlands declared Bedrocan International and Bedrocan Nederland bankrupt. Bedrocan was the only grower under contract to the Dutch Office of Medicinal Cannabis. The bankruptcy follows two decisions of the Dutch government: the office stopped placing new orders with Bedrocan from January 2026, and in July the health minister announced that the office will stop exporting at the end of 2026. Bedrocan then told foreign buyers to order from its Danish plant, and its Danish company entered court restructuring on 1 October. Italy estimated it would need up to 2,400 kg of cannabis in 2026 and authorised its state plant in Florence to make 400 kg. AIFA’s shortage list will not flag the gap, because cannabis flower has no marketing authorisation and the list covers authorised medicines.

What happened to Bedrocan, and when?

The Dutch state stopped placing new orders with Bedrocan at the start of 2026, and on 28 September the company told the regional broadcaster RTV Noord that it no longer had enough orders in the Netherlands to pay its bills. The dates, from Dutch government and court records:

  • 21 February 2025: the Dutch health minister tells parliament that the Office of Medicinal Cannabis will stop ordering from its contracted grower from 1 January 2026.
  • 1 January 2026: the framework agreement between the office and Bedrocan ends.
  • 3 July 2026: the minister announces that the office stops exporting at the end of 2026 and will switch to imported cannabis during 2027.
  • 10 September 2026: Bedrocan advises foreign pharmacies and wholesalers to order from it directly, as its Danish plant can keep supplying.
  • 24 September 2026: the court grants Bedrocan International and Bedrocan Nederland a provisional suspension of payments.
  • 1 October 2026: a Danish court opens restructuring proceedings for Bedrocan’s Danish company.
  • 7 October 2026: the court declares the two Dutch companies bankrupt.
  • 30 June 2027: the latest released batches of all five Dutch varieties expire.
  • 1 July 2028: the date the Dutch government aims for to end the office’s trade monopoly and let licensed parties supply pharmacies, through an Opium Act amendment due in parliament in the second half of 2027.

Why does Italy lose Dutch medical cannabis at the end of 2026?

The Dutch office will soon receive no more cannabis from a Dutch grower, and it keeps what it has for Dutch patients. The July letter to parliament gives both reasons for ending exports at the end of 2026, and warns that the stock is limited and has a finite shelf life. The office plans to buy imported cannabis during 2027, and the 2027 budget, published on 15 September, reserves the stock for domestic use and books 8 million euros of lost export revenue.

The bankruptcy covers the two Dutch companies only, and the Danish company is in restructuring, so its future depends on a proposal its creditors must adopt and a court must confirm. Bedrocan itself told RTV Noord in September that the Danish plant is a small facility that cannot serve all of Europe. In the Netherlands the public broadcaster NOS reported hundreds of kilos of cannabis stored at Bedrocan, which the receivers can sell only with the cooperation of the Dutch office.

The Italian Ministry of Health’s page on imported cannabis, last updated in January 2022, still says that imports of Dutch products will continue to be authorised in line with the Dutch office’s willingness to export.

How much of Italy’s medical cannabis comes from the Netherlands?

We found no published figure. The Ministry of Health publishes how much flower reaches pharmacies and through which channel, without the country of origin. The earliest source we found for the 80% that Italian coverage of the bankruptcy repeats is an article a pharmacist published in March 2026, which cites no data. The Ministry’s figures give an 80% that measures something else: authorised wholesalers supplied 1,356.4 of the 1,694.8 kg that reached pharmacies in 2024, from any origin.

The estimate Italy filed with the International Narcotics Control Board for 2026 is 2,400 kg, a legal ceiling on what the country may acquire. Pharmacies received 1,694.8 kg in 2024. Florence may produce 400 kg in 2026, less than a quarter of what pharmacies received two years earlier.

Italy has run short of imported flower before. In 2018 the Ministry asked the Netherlands for 250 kg on top of the 450 kg already agreed, while patient groups reported delays and empty pharmacy shelves. A Senate question of July 2021 reported that by that March patients had documented supply problems in 16 Regions.

Why won’t AIFA’s shortage list flag it?

Italy’s shortage rules attach to a marketing authorisation, and cannabis flower has none. AIFA defines a medicine in shortage as one whose marketing authorisation holder cannot ensure continuous supply, and Article 34 of Legislative Decree 219/2006 obliges that holder to notify AIFA at least two months before an interruption. Italian pharmacies dispense cannabis as a magistral preparation made from an active substance, and the Dutch office states that its cannabis is not a registered medicine. AIFA’s shortage list of 13 October 2026 has no cannabis entry.

The EU pharmaceutical legislation now awaiting the European Parliament’s final vote builds its shortage prevention plans on the same holder. For flower, planning rests on the yearly estimate of patients’ needs that the Regions send the Ministry, which together with past consumption sets the Florence plant’s manufacturing quota. This reading of the rules is ours: AIFA has not published one, and we found no comment from an Italian authority by 14 October.

What happens when the only supplier of a medicine fails?

In the cases below the shortage lasted more than a year, and where substitutes were studied they did not behave like the original.

  • Akorn, 2023. The US generics maker filed for liquidation on 23 February 2023 and shut down its US sites. It was the only US manufacturer of four injectables, among them dimercaprol, an antidote for heavy metal poisoning, and its trustee recalled a list of products still within expiry.
  • Ben Venue and Doxil, 2011 to 2013. Manufacturing problems at the Ohio plant that made Doxil, a liposomal doxorubicin, left the US short from November 2011. The FDA allowed temporary imports of Lipodox, an unapproved product, and a retrospective matched study in recurrent ovarian cancer found responses in 1 of 23 patients on Lipodox against 20 of 111 on Doxil.
  • Genzyme, 2009 to 2012. A viral contamination at the Allston plant cut supply of Cerezyme and Fabrazyme. The EMA asked doctors to treat only the patients in greatest need, at reduced doses, and a 2016 observational study found declining kidney function in Fabry patients switched to another product, with or without a dose reduction first.
  • Cisplatin, 2023 to 2024. An FDA inspection at an Indian plant that supplied about half of US cisplatin and carboplatin started a shortage that lasted from February 2023 to June 2024.

The Akorn recall states the risk that a bankruptcy adds to a shortage:

The discontinuation of the Quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product.
Akorn recall notice, published by the FDA, 2023

In the Dutch system the Office of Medicinal Cannabis certifies the release of each batch. The certificates of the batches now on the market were signed before the bankruptcy and name Bedrocan Nederland as grower, and we found no statement on who now supports those batches to their expiry date.

Is another cannabis variety an equivalent substitute?

Not automatically, and the Dutch office says so itself: on 9 October it wrote that a comparable product is not automatically an equivalent alternative for every patient. The specifications show where Italy has a counterpart and where it has none.

  • Bedrocan: THC 17.6 to 26.4%, CBD up to 1%. Florence’s FM1 has THC 13 to 20%, and the Florence plant also resells an imported flower with 22% THC and 1% CBD.
  • Bediol: THC 5.0 to 7.6%, CBD 7.0 to 10.6%. Florence’s FM2 has THC 5 to 8% and CBD 7.5 to 12%.
  • Bedrolite: THC up to 1%, CBD 6.5 to 9.7%. Italy makes no counterpart.

Cannabinoid ranges leave out the terpenes, which change with drying and storage, as our article on terpene loss shows. A prescriber switching a patient between varieties faces the question the Doxil case raised.

What should importers and pharmacies do now?

Qualify the next supplier before the Dutch batches run out. ICH Q9(R1), the quality risk management guideline revised in 2023, counts availability as part of quality risk:

Risk to quality includes situations where product availability may be impacted, leading to potential patient harm.
ICH Q9(R1), 2023

The same guideline notes that in some cases a supply chain needs a new entity, for example “a pre-qualified alternative option”. For flower, that means five checks.

  • Record the expiry date of every Dutch batch in stock. The latest released batches expire on 30 June 2027.
  • Map which preparations depend on Dutch varieties, and which supply in Italy comes closest on cannabinoid range.
  • Check the new manufacturer’s GMP certificate in EudraGMDP, the EU database, and audit the site: a certificate reflects the status of the site at the time of the inspection.
  • Ask for release certificates that state compliance with the European Pharmacopoeia monograph on cannabis flower and name the decontamination method. Dutch batches are gamma irradiated.
  • Plan for permits: each import needs its own import permit from the Ministry of Health and an export permit from the producing country.

Written by

Riccardo Longato

Riccardo Longato

Pharmaceutical GMP Lead Auditor (CQI/IRCA)

CQI/IRCA certified lead auditor, certificate no. LA113.

Has spoken at PTMC Lisbon, JIHE Tokyo, AIHEF Bangkok and IndicaSativa Trade Bologna.

Would you rather talk it through first?