In an interview with Dr. Joel Lexchin, Global News explores the problems with Health Canada's drug approval process. Health Canada's lack of transparency in terms of the level of data and analysis conducted on summary basis of decisions (SBD) documents. Furthermore, the quality of the information provided by industry to Health Canada to approve drugs is unknown.
This is reason for concern, says Dr. Lexchin, because Health Canada does not make information during their approval process known to experts or the public. Given this, medical experts, physicians and the public are not privy to Health Canada's drug approval process and the basis on which drugs are approved for the Canadian market.
A 2012 study by Dr. Lexchin found that Health Canada drugs that were approved after a standard review (300 business days) had a 1/5 (20%) chance of having a serious safety warning after being on the market. Comparatively, drugs that Health Canada approved after priority review (180 business days) had a 1/3 (33%) chance of having a serious safety warning after release onto the market.
According to the study, the difference in approval times by 120 days is an important factor in determining the likelihood that a drug will be associated with serious safety warnings after its approval by Health Canada. In the 120 days between the standard review and priority review times, Health Canada has less time to look at the data and misses information and inferences from data that later result in serious safety warnings and patient harm
New Drugs and SafetyWhat Happened to New Active Substances Approved in Canada Between 1995 and 2010?Transparency in drug regulation: Mirage or oasis?
Provision of information on regulatory authorities’ websites
Who Needs Faster Drug Approval Times in Canada: The Public or the Industry?
Secrecy and the Health Protection Branch
Hear No Secrets, See No Secrets, Speak No Secrets: Secrecy in the Canadian Drug Approval System
Legislative regulation and ethical governance of medical research in different European Union countries
This is reason for concern, says Dr. Lexchin, because Health Canada does not make information during their approval process known to experts or the public. Given this, medical experts, physicians and the public are not privy to Health Canada's drug approval process and the basis on which drugs are approved for the Canadian market.
A 2012 study by Dr. Lexchin found that Health Canada drugs that were approved after a standard review (300 business days) had a 1/5 (20%) chance of having a serious safety warning after being on the market. Comparatively, drugs that Health Canada approved after priority review (180 business days) had a 1/3 (33%) chance of having a serious safety warning after release onto the market.
According to the study, the difference in approval times by 120 days is an important factor in determining the likelihood that a drug will be associated with serious safety warnings after its approval by Health Canada. In the 120 days between the standard review and priority review times, Health Canada has less time to look at the data and misses information and inferences from data that later result in serious safety warnings and patient harm
New Drugs and SafetyWhat Happened to New Active Substances Approved in Canada Between 1995 and 2010?Transparency in drug regulation: Mirage or oasis?
Provision of information on regulatory authorities’ websites
Who Needs Faster Drug Approval Times in Canada: The Public or the Industry?
Secrecy and the Health Protection Branch
Hear No Secrets, See No Secrets, Speak No Secrets: Secrecy in the Canadian Drug Approval System
Legislative regulation and ethical governance of medical research in different European Union countries
RSS Feed
