J
jwosmond
Hi All,
I want to kick-start a discussion on Vanessa's law to see how people are reacting and preparing. The following is my summary of the information found on Health Canada's website. I hope it is helpful and sparks some conversation.
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On November 6, 2014 the 'Protecting Canadians from Unsafe Drugs Act', also known as 'Vanessa?s Law', was given Royal Ascent. The law applies to equally to medical devices and drugs and gives Health Canada more power to enforce post-market surveillance regulations.
Overview:
? Require strong surveillance, including mandatory adverse drug reaction reporting by healthcare institutions;
? Recall unsafe therapeutic products;
? Impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million per day instead of the current $5,000;
? Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;
? Compel drug companies to revise labels to clearly reflect health risk information, including potential updates for health warnings for children; and
? Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.
My understanding is that Health Canada is partially enforcing Vanessa's Law at this time. The current enforced aspects are:
? Ability to recall unsafe therapeutic products
? Ability to impose tougher fines and penalties
? Ability to direct label changes/modifications, and
? Ability to seek an injunction
Further to these measures, the law also mandates that Health Canada implement a ?life-cycle? approach for regulating drugs and devices. Health Canada now has the ability to:
? Require tests and studies
? Order a reassessment of a product
? Attach limiting terms and conditions to market authorizations
The embodiment of the law will be worked out through Health Canada?s regulatory development process. So, in some respects, it remains to be seen how Health Canada will use its new enforcement powers.
-----
Is my summary accurate? How will this impact medical device and drug manufacturers? Are any of you tightening up post-market surveillance and reporting procedures in anticipation of more enforcement? Right now it is an enforcement measure, but will this eventually lead to changes in the CMDR?
All comments are welcome. Thanks!
I want to kick-start a discussion on Vanessa's law to see how people are reacting and preparing. The following is my summary of the information found on Health Canada's website. I hope it is helpful and sparks some conversation.
-----
On November 6, 2014 the 'Protecting Canadians from Unsafe Drugs Act', also known as 'Vanessa?s Law', was given Royal Ascent. The law applies to equally to medical devices and drugs and gives Health Canada more power to enforce post-market surveillance regulations.
Overview:
? Require strong surveillance, including mandatory adverse drug reaction reporting by healthcare institutions;
? Recall unsafe therapeutic products;
? Impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million per day instead of the current $5,000;
? Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;
? Compel drug companies to revise labels to clearly reflect health risk information, including potential updates for health warnings for children; and
? Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.
My understanding is that Health Canada is partially enforcing Vanessa's Law at this time. The current enforced aspects are:
? Ability to recall unsafe therapeutic products
? Ability to impose tougher fines and penalties
? Ability to direct label changes/modifications, and
? Ability to seek an injunction
Further to these measures, the law also mandates that Health Canada implement a ?life-cycle? approach for regulating drugs and devices. Health Canada now has the ability to:
? Require tests and studies
? Order a reassessment of a product
? Attach limiting terms and conditions to market authorizations
The embodiment of the law will be worked out through Health Canada?s regulatory development process. So, in some respects, it remains to be seen how Health Canada will use its new enforcement powers.
-----
Is my summary accurate? How will this impact medical device and drug manufacturers? Are any of you tightening up post-market surveillance and reporting procedures in anticipation of more enforcement? Right now it is an enforcement measure, but will this eventually lead to changes in the CMDR?
All comments are welcome. Thanks!
