Health Canada monograph for Tamiflu outlines Health Canada’s evidence for and recommendations about the drug

Q1: Is Health Canada aware of the gaps in evidence base on Tamiflu? Will Health Canada consider these gaps before investing more into Tamiflu?

Health products such as prescription drugs, over the counter products, biologicals, vaccines, medical devices and natural health products have benefits and risks associated with their use.

Before a health product, including Tamiflu, is authorized to be used in Canada the manufacturer must present substantive scientific evidence of a product’s safety, efficacy and quality as required by the Food and Drug Act and Regulations. Drugs are only authorized for sale in Canada once they have successfully gone through the drug review process. This process is the means by which a drug application is reviewed by scientists at Health Canada, and on occasion, outside experts, to assess the safety, efficacy and quality of a drug. Throughout the process, the safety and well-being of Canadians is the paramount concern.

Once a product is on the market, Health Canada continues to monitor the safety of the products to ensure that the benefits of the product continue to outweigh the risks. The manufacturers of the product are also responsible for the continuous assessment of the benefits and risks of their health products. The risks of a health product should never be considered in isolation, but instead, the balance between possible risks and potential benefits needs to be taken into account, with benefits always outweighing the risks.

Q2: Will Health Canada and the Public Health Agency of Canada consider the effectiveness of Tamiflu when replenishing the supply in the National Emergency Stockpile System?

In this specific case, the agreement signed between the Public Health Agency of Canada and Roche Canada ensures that Roche Canada will replace the Tamiflu supply provided from the NESS. The replacement is to be completed by the end of summer 2013.

Only products approved for use in Canada are considered to be stockpiled in the NESS.

The NESS maintains a limited supply of select drugs for surge capacity to supplement the extraordinary needs of provinces and territories in times of emergency.

Q3: What evidence does Health Canada have regarding Tamiflu. Do we have full clinical trial reports? Is there missing data? How did Health Canada come to its decision regarding the recommendations for Tamiflu.

The product monograph for Tamiflu clearly describes for what condition and for which patients the product can be used in a safe and efficacious manner. The indications are based on the evaluation of clinical trials data submitted by the sponsor to support the indications. The supporting clinical trial data is described in the product monograph. It is only when the benefit outweighs the risk that a drug product is authorised for sale in Canada.

The product monograph for Tamiflu can be found on Health Canada’s Drug Product Database (http://webprod5.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp <http://webprod5.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp> ). Enter the term “Tamiflu” in the “product name” field found under the subheading “Search by other criteria.”

Q4: How big is the National Emergency Stockpile System?

For operational reasons, the Public Health Agency of Canada does not disclose specific numbers of items in the National Emergency Stockpile System (NESS).

The NESS maintains a limited supply of select drugs for surge capacity to supplement the extraordinary needs of provinces and territories in times of emergency.

On a case-by-case basis, the Public Health Agency of Canada has offered some of its holdings of drugs to help alleviate shortages as a result of production issues.

There is enough Tamiflu in the NESS to ensure that the assistance we provide Roche Canada will in no way affect our ability to respond to an emergency should one arise.

 




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