Alberta Advances $70M Turkish Drug Contract with Health Canada Review of Generic Acetaminophen
Key Insights
Health Canada accepted Atabay (search)'s submission for generic acetaminophen review in August, potentially fulfilling Alberta's $49 million prepaid balance from a 2022 contract.
The original $70 million deal imported Turkish-made Parol (search) acetaminophen and ibuprofen, but only $21 million worth was approved due to dosage and consistency issues.
Alberta Health Services discontinued Parol (search) use after four months due to concerns about its thicker consistency and non-standard dosing in hospital settings.
Alberta may be closer to resolving its troubled $70-million pharmaceutical contract with Turkish manufacturer Atabay (search) after Health Canada accepted the company's generic acetaminophen submission for regulatory review in August. The development could help fulfill the province's outstanding $49 million prepaid balance from the controversial 2022 deal.
Contract Background and Initial Challenges
In December 2022, Alberta announced it was importing five million bottles of acetaminophen (branded as Parol (search)) and ibuprofen from Atabay (search) through Edmonton-based importer MHCare (search) to address a Canada-wide shortage. However, the implementation faced significant obstacles from the start.
Of the $70 million contract value, Health Canada approved only approximately $21 million worth of medication—about 1.5 million bottles total. The imported Parol (search) acetaminophen proved problematic for clinical use due to dosage differences from North American standards and its thicker consistency, which raised concerns in hospital settings.
Alberta Health Services (AHS) advised discontinuing Parol (search) use just four months after its introduction, leaving the province with a substantial unused inventory and unfulfilled contract obligations.
Regulatory Review Process
Health Canada's current review of Atabay (search)'s generic acetaminophen submission represents a potential pathway to utilize the remaining contract funds. The regulatory agency evaluates drug safety, efficacy, and quality while weighing benefits against risks before authorization.
"As the review is still ongoing, it is not possible to predict when a regulatory decision will be made," Health Canada told Postmedia, noting that review timelines depend on multiple factors.
If approved, the generic acetaminophen could provide a more suitable alternative to the original Parol (search) formulation for Alberta's healthcare system.
Alternative Medication Strategies
Internal documents obtained through freedom of information requests reveal that AHS has been exploring contract fulfillment options since March 2023. Four drugs were under consideration, including an intravenous form of acetaminophen (acetaminophen IV).
A June 2023 briefing note prepared for then-AHS president and CEO Mauro Chies outlined plans to fulfill the contract balance with alternative medications. "The manufacturer will initiate Health Canada approval process for the acetaminophen IV as soon as the contract is signed," the document stated.
However, AHS pharmacy services noted significant cost concerns with the IV formulation. "This product has been recently added to the AHS drug formulary but it is severely restricted in criteria for use, mainly due to the high cost of the drug, compared to equivalent steroidal and opioid-based treatments," an internal email explained.
The approval process for acetaminophen IV was expected to take six to twelve months, according to government communications.
Current Status and Ongoing Investigations
AHS and MHCare (search) signed a contract in July 2023 to apply government prepayments to additional purchases over a five-year duration. However, no final decisions have been made regarding specific medications or purchase volumes.
"No decisions or purchases have been made, and we continue to review all options," AHS stated, declining to provide details about potential medication volumes, costs, or the remaining credit value.
The contract has become entangled in broader allegations of procurement impropriety. Former AHS head Athana Mentzelopoulos claimed in a wrongful dismissal lawsuit that she was fired for investigating the province's dealings with MHCare (search) and Atabay (search), though these claims remain unproven in court.
The allegations have prompted multiple investigations, including reviews by the government, provincial auditor general, and RCMP. Former Manitoba judge Raymond Wyant was appointed in March to investigate procurement and contracting allegations, with his final report deadline recently extended to October 15.
Medication Disposal Efforts
Meanwhile, Alberta reached an agreement over the summer to donate up to 1.4 million bottles of the remaining children's pain medication from 2022 to international charity, with much of the surplus directed to war-torn Ukraine. The donated medication expires early next year.
The donation represents a practical solution for the unused inventory while the province continues working to resolve the broader contractual obligations with Atabay (search).