Read Shawn Buckley’s latest Discussion Paper, written on March 17, 2023 and join him for a full LIVE legal review of the document on Wednesday April 5, 2023 details and registration link below.
Within this Discussion Paper, Shawn delineates alterations to the drug approval process that were applied to COVID-19 vaccine authorizations. He points out a disconnect between Health Canada’s messaging that “All COVID-19 vaccines authorized in Canada are proven safe, effective and of high quality.” and the fallout that we have seen.
Discussion around COVID-19 vaccines can still easily become polarizing. In fact, this is why the NHPPA would like to open a time for conversation. Our community will be offered clear and accurate insight to be able to better discuss their concerns when the subject comes up! The discernment that comes from a deeper understanding of these legal issues paired with open dialogue can help all of us grasp the implications of seemingly small changes in language within our drug regulations.
DISCUSSION PAPER ON “CHANGES TO THE DRUG APPROVAL TEST FOR COVID-19 VACCINES:
PERMITTED VACCINES TO BE APPROVED WITHOUT OBJECTIVE PROOF OF
(1) SAFETY, (2) EFFICACY, OR (3) THE BENEFITS OUTWEIGHING THE RISKS”
The Discussion Paper has also been made available in French: télécharger la traduction française du document de travail
Excerpts from the Discussion Paper:
“The test does not require Health Canada be given sufficient evidence “to conclude” that the benefits associated with the vaccine outweigh the risks of the vaccine. Rather the test only requires that there be “sufficient evidence to support the conclusion” that the benefits outweigh the risks. Evidence “to support” a conclusion is much different than evidence “to prove” a conclusion.”
“Whenever there is doubt concerning safety, efficacy or whether the benefits outweigh the risks, there is normally no approval – but for the COVID-19 vaccines, the Minister [i.e. Health Canada] had to approve even if unsure whether the benefits outweighed the risks.”
“This is a direction to approve vaccines while specifically and deliberately exempting them from: objective proof of safety, objective proof of efficacy, and objective proof that the benefits outweigh the risks. It is difficult to conceive of a less-scientific test for drug approval than that found in the Interim Order.”
“It is a fundamental safeguard that the Minister can ordinarily cancel a market authorization if new evidence raises a safety or efficacy concern or if fraud is discovered. This fundamental safeguard was removed by the Interim Order.”
REGISTER BELOW TO SAVE YOUR SPOT TODAY.
WEDNESDAY APRIL 5, 2023 @ 7PM ET/4PM PT
• How COVID-19 vaccines were exempted from the normal regulatory requirements
• That safety, efficacy, and that the benefits outweighed the risks did not have to be proven for COVID-19 vaccines
• Fundamental safeguards that were removed by Interim Order
• Inconsistencies in Health Canada’s messaging as compared to their actions