G/TBT/N/CAN/405/Rev.1  
 
26 August 2014  
(14-4901)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English/French  
 
  NOTIFICATION 
Revision 
The following notification is being circulated in accordance with Article 10.6. 
 
1. Notifying Member: CANADA 
If applicable, name of local governme nt involved (Articles 3.2 and 7.2):    
2. Agency responsible:  Department of Health 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
 Canada's SPS & TBT Notification Authority and Enquiry Point 
Foreign Affairs, Trade and Development Canada 
Technical Barriers and Regulations Division (TIB) 111, promenade Sussex Drive 
Ottawa, ON K1A 0G2 
Canada Tel: (343) 203-4273 Fax: 613-943-0346 
E-mail: enquirypoint@international.gc.ca   
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Drugs and 
medical devices (ICS: 11.040, 11.120) 
5. Title, number of pages and langua ge(s) of the notified document: Bill C-17,  
Amendments to the Food and Drugs Act, introd uced as Protecting Canadians from Unsafe 
Drugs Act (Vanessa's Law) (18 pages, available in English and French) 
6. Description of content: The new legislation will update the laws that apply to drugs and 
medical devices to increase patient safety in key areas of concern and will enable the Government to: 
 Require strong surveillance including mandatory adverse drug reaction reporting by 
healthcare institutions; 
 Recall unsafe 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 G/TBT/N/CAN/405/Rev.1 
 
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   Compel drug companies to do further testing on a product, including when issues 
are identified with certain at-risk populations such as children. 
On June 12, 2014, the House of Commons Standing Committee on Health (HESA) 
introduced and passed the following amendmen ts to Bill C-17. These amendments were 
added in order to provide greater transpar ency about Health Canada’s regulatory 
decisions, enhance transparency concerning clinical trials, and clarify the scope of 
confidential business information (CBI) and disclosure. They include: 
 An obligation on the Minister to make label change, recall, test and studies and 
information orders publically available; 
 New regulation-making authority permitting the Governor in Council to make 
regulations requiring the Minister to ensure that positive and negative decisions, and reasons for them, are publically available; 
 A new requirement for therapeutic product authorization holders to make publically 
available information about clinical trials; 
 A new regulation-making authority allowing the Governor in Council to make 
regulations concerning how, where, when and what information about clinical trials 
and investigational tests an authorization holder will have to make publically available; 
 A new section to make clear that the Minister may disclose CBI for the purpose of 
identifying or responding to a serious risk  of injury to the health of Canadians; 
 A new section that permits the Minister to share CBI with her regulatory 
counterparts, other federal departments, provinces and territories, and scientific and 
medical experts if the purpose of the disclosure is related to the protection or 
promotion of human health or the safety of the public; and 
 A new regulation-making authority allowing the Governor in Council to clarify what 
information obtained under the Act in relation to a therapeutic product authorization 
is not or ceases to be confidential business information. 
7. Objective and rationale, including th e nature of urgent problems where 
applicable:  Protection of human and animal health and safety  
8. Relevant documents:  
Additional and background information on Bill C-17 is available from the following web sites, 
in English and French. 
http://www.hc-sc.gc.ca/dhp-mps/legislation/ unsafedrugs-droguesda ngereuses-eng.php   
http://www.hc-sc.gc.ca/dhp-mps/legislation/ unsafedrugs-droguesdangereuses-fra.php   
9. Proposed date of adoption:   The Bill is currently before Parliament - the date of adoption 
is unknown at this time. 
Proposed date of entry into force: On the date the measure is adopted 
10. Final date for comments: 28 October 2014 
11. Texts available from: National enquiry po int [ X ] or address, telephone or fax 
numbers and email and website addresse s, if available, of other body:  The 
electronic version can be downloaded at:  
http://www.parl.gc.ca/LegisInfo/BillDeta ils.aspx?Language=E &Mode=1&b illId= 6365510  
http://www.parl.gc.ca/LegisInfo/BillDeta ils.aspx?Mode=1&billI d=6365510&Language=F