The generic drug manufacturer Sandoz promises to sell its products from abroad at the same price as those manufactured at its plant in Boucherville if Health Canada authorizes the import accelerated its products that are currently the subject of a shortage here.
To address the shortage of injectable drugs affecting the country for over a month, Health Canada is to facilitate the massive importation of replacement drugs by accelerating the approval process. So far, 15 of the 19 applications submitted under the fast-track system come from Sandoz. If applications are accepted, the 15 products from Sandoz awaiting authorization approval will be sold at negotiated prices in the tender, the company confirmed to The Press.
Despite this, the crisis will result in additional costs necessarily for taxpayers, said yesterday the Health Minister Yves Bolduc. The pharmaceutical company is required to financially compensate health facilities for the purchase of generic molecules if they are available on the market, said Dr. Bolduc, but if the generic option is no longer available, Sandoz will not have to foot the bill for patented medicines, considerably more expensive.
"Sandoz does not enrich the shortage," he assured yesterday afternoon Mr. Bolduc, on the sidelines of the inauguration of the new training center in Santa Cabrini Hospital in Montreal. "But there are places where it is certain that we will not ask them to compensate. If there was a product they made [in Boucherville plant] and I am obliged to substitute a molecule that is good for the patient, but is more expensive, there are some costs that we will incur. "
Buying groups
In Canada, the purchase of medicines for hospitals through group purchasing. They number 11 in Quebec, divided by administrative region. These buying groups have a mandate to bring the needs of the institutions they represent and find the lowest bidder through joint tenders. The buying group SigmaSanté, which provides health centers and social services in Laval and Montreal, says that the terms negotiated with Sandoz states that if out of stock, Sandoz must assume the cost difference with the substitute product.
Mr. Bolduc also indicated that Quebec should be within two weeks a centralized system which identifies stocks of all establishments in the province, and inspired by the computer system designed for the influenza A (H1N1) .
In the study
For its part, Health Canada says it considers 26 drug submissions for additional supply. "Fifteen are from Sandoz (dexamethasone, granisetron, clindamycin, dobutamine, flumazenil, diazepam, neostigmine, fluconazole, rocuronium, ketamine, furosemide, buprenorphine, naloxone, fentanyl, midazolam) and eleven from other manufacturers," wrote in an email the spokesman for Health Canada, Christelle Legault. "Seven were already waiting and are now handled on an expedited basis and four were received during the last two weeks."
Health Canada says that five plants abroad were added to the license for establishment of Sandoz. "Four are used to produce alternative products, while the fifth is used to test the active ingredients of drugs," said Ms. Legault.
The process of approval from Health Canada can take six to eight months. The federal government hopes to approve the first products in the coming weeks.
Quebec manages the hospital system for over a month the most significant shortage of injectable drugs in its history. Sandoz Canada is the leading supplier of injectable drugs for several Quebec hospitals. These products are essential for critical and intensive care, as well as surgery.
On February 16, the pharmaceutical company announced it would provide fixes at its plant in Boucherville, following a warning from the Food and Drug Administration (FDA), which identified "significant violations" in its production standards. In early March, the plant suspended production for about a week to clean up the damage caused by fire.
To address the shortage of injectable drugs affecting the country for over a month, Health Canada is to facilitate the massive importation of replacement drugs by accelerating the approval process. So far, 15 of the 19 applications submitted under the fast-track system come from Sandoz. If applications are accepted, the 15 products from Sandoz awaiting authorization approval will be sold at negotiated prices in the tender, the company confirmed to The Press.
Despite this, the crisis will result in additional costs necessarily for taxpayers, said yesterday the Health Minister Yves Bolduc. The pharmaceutical company is required to financially compensate health facilities for the purchase of generic molecules if they are available on the market, said Dr. Bolduc, but if the generic option is no longer available, Sandoz will not have to foot the bill for patented medicines, considerably more expensive.
"Sandoz does not enrich the shortage," he assured yesterday afternoon Mr. Bolduc, on the sidelines of the inauguration of the new training center in Santa Cabrini Hospital in Montreal. "But there are places where it is certain that we will not ask them to compensate. If there was a product they made [in Boucherville plant] and I am obliged to substitute a molecule that is good for the patient, but is more expensive, there are some costs that we will incur. "
Buying groups
In Canada, the purchase of medicines for hospitals through group purchasing. They number 11 in Quebec, divided by administrative region. These buying groups have a mandate to bring the needs of the institutions they represent and find the lowest bidder through joint tenders. The buying group SigmaSanté, which provides health centers and social services in Laval and Montreal, says that the terms negotiated with Sandoz states that if out of stock, Sandoz must assume the cost difference with the substitute product.
Mr. Bolduc also indicated that Quebec should be within two weeks a centralized system which identifies stocks of all establishments in the province, and inspired by the computer system designed for the influenza A (H1N1) .
In the study
For its part, Health Canada says it considers 26 drug submissions for additional supply. "Fifteen are from Sandoz (dexamethasone, granisetron, clindamycin, dobutamine, flumazenil, diazepam, neostigmine, fluconazole, rocuronium, ketamine, furosemide, buprenorphine, naloxone, fentanyl, midazolam) and eleven from other manufacturers," wrote in an email the spokesman for Health Canada, Christelle Legault. "Seven were already waiting and are now handled on an expedited basis and four were received during the last two weeks."
Health Canada says that five plants abroad were added to the license for establishment of Sandoz. "Four are used to produce alternative products, while the fifth is used to test the active ingredients of drugs," said Ms. Legault.
The process of approval from Health Canada can take six to eight months. The federal government hopes to approve the first products in the coming weeks.
Quebec manages the hospital system for over a month the most significant shortage of injectable drugs in its history. Sandoz Canada is the leading supplier of injectable drugs for several Quebec hospitals. These products are essential for critical and intensive care, as well as surgery.
On February 16, the pharmaceutical company announced it would provide fixes at its plant in Boucherville, following a warning from the Food and Drug Administration (FDA), which identified "significant violations" in its production standards. In early March, the plant suspended production for about a week to clean up the damage caused by fire.
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