Mr. Steven Fletcher (Parliamentary Secretary to the Minister of Health, CPC)
Mr. Speaker, I thank the member for Laval for raising awareness of this important issue. In the original question in June, the member asked why one product was allowed under the special access program and why one was not. I will take a moment to discuss this.
Health Canada has two special access programs, one for drugs and one for medical devices, and both are governed by different regulations and administered differently. Both programs are administered with the aim of providing Canadian health care professionals with access to therapeutic products to meet the treatment needs of their patients.
Neither of the two special access programs were intended as a means of marketing a product without appropriate regulatory oversight. The drug special access program allows physicians to access drugs for the emergency treatment of serious or life-threatening conditions of their patients. Health Canada must be assured that sufficient evidence exists to support the safe use of the drug.
The drug special access program is not intended to replace clinical trials. A drug clinical trial is most often the best option for manufacturers, patients and physicians to ensure both continued access and protection of patient safety. It is a means for manufacturers to collect the necessary safety and effectiveness data for the marketing applications.
The medical device special program allows physicians access to medical devices for emergency use or conventional therapies that are not available or unsuitable. The medical device special access program, which is the program dealing with breast implants, was not intended to replace general marketing authorizations. Health Canada must be assured, through the review of safety and effectiveness data for the device, that the device will provide a benefit for the patient without causing undue harm.
In the case of the drug special access program request for the access to combination treatment for HIV-AIDS, the physician that was referred to in the original question in June was unable to supply the necessary data to support the authorization of access to the drug combination.
In August 2005, Health Canada offered to consider early access to the same combination through a clinical trial. Had this offer been taken, the patients would have had the medications they were seeking at the time and been protected by inherent checks and balances in the clinical trial settings.
A clinical trial application was not received from the physician until December 2005 and once received it was subsequently reviewed and approved within 24 hours by Health Canada. Each medical device special access request for a silicone gel breast implant was supported by the safety and effectiveness data contained in the licence application.
In addition, the specific benefits and conditions to be treated are provided for each individual patient by their surgeon in support of their special access authorization application. As we made that decision on silicone gel breast implants, the special access program is no longer relevant in this case. The fact remains that there have been many trials that have taken place within the margin of reasonable risk and they have been approved.