Sandoz's role in Canadian drug shortages adds to calls for regulation

The possibility that Sandoz, the generic arm of Novartis ($NVS), might benefit from the shortage of drugs caused by problems at its Canadian plant is fueling the debate there over how to handle drug shortages in the country.

Health Canada told the Ottawa Citizen that 15 of the 23 applications being considered for quick approval to produce some of the drugs in shortage at the Boucherville, Quebec, plant came from other Sandoz facilities. Some might see this as Sandoz stepping up to help fix a problem it helped create, but the suggestion that a premium may be paid for the drugs in short supply adds even more edge to the discussion.

"The bottom line is, if we want these particular drugs, we're going to have to pay more for them," said Michael Blanchard, clinical director of pharmacy services for HealthPro Canada, the country's largest drug supplier to hospitals.

The troubled Sandoz plant supplies an estimated 50% to 90% of the injectable drugs sold in Canada. Problems at the plant were made public in February when the company said remediation efforts to meet FDA concerns would require it to slow production of some products and halt production of others. Then a fire broke out at the plant, requiring operations to be halted for cleanup.

The Toronto Star reports that Sandoz is the only supplier in Canada for 140 of the 225 injectable drugs made at the Boucherville plant, and dozens may not be back in supply until next year. There is even a hint of nationalism in the debate over how to handle shortages in Canada. While the majority of the drugs made at the plant are sold in Canada, and a Canada Health inspection passed the plant in the fall, Sandoz still cut production at the plant to make improvements expected by U.S. regulators.

"As part of Novartis, Sandoz applies one Novartis quality standard across the organization and is committed to ensuring that all plants operate with this one standard consistently," the company has said in a statement.

The situation has caused some government officials to threaten new regulations governing how and when the industry reports issues that might lead to shortages, not unlike discussions in the U.S.

- read the Ottawa Citizen story
- more from the Toronto Star