Vanessa’s Law

Health Canada is getting 50 times tougher on companies selling mislabelled and counterfeit medical devices and drugs.

Vanessa’s Law, now in second reading in the Parliament of Canada is an amendment to the Food and Drugs Act, providing substantial new powers to the Minister of Health in stopping the flow of counterfeit and mislabelled medical devices in Canada.

 

Among the new powers granted to the Minister are:

  • Information gathering for serious risk
  • Ordering the modification or replacement of labelling and packaging
  • Power to force recall without consultation
  • Power to prohibit sale (issue injunction)
  • Power to require additional assessments of risk post market
  • Power to require additional tests and studies post market
  • Power to require health care institutions (not facilities) to provide information about adverse effects and incidents.

In addition to these new powers, individuals and companies found to be in contravention of the Medical Device Regulations will be subject to substantially higher penalties.

The previous penalties under the Food and Drugs Act ranged from a $500 to $5,000 fine. The new penalties are:

1. Negligence Penalties

  • If proceeding by summary offense; up to $250,000 and/or 6 months for first offense; up to $500,000 and/or 18 months for subsequent offences
  • If proceeding by indictment; up to $5 Million and/or 2 years
  • Each day of violation is a separate offense
  • Minister has the power to use injunctions to stop offender

 

2. Intentional with Patient Harm

  • If proceeding by summary offense; up to $500,000 and/or 18 months; up to $1 Million and/or 2 years for subsequent offenses
  • If proceeding by indictment; fine is determined by the court with no ceiling and/or 5 years.
  • Each day of violation is a separate offense
  • Minister has the power to use injunctions to stop offender

 

More about Vanessa’s Law at: http://www.hc-sc.gc.ca/dhp-mps/legislation/unsafedrugs-droguesdangereuses-eng.php