1. Health Canada’s Collaboration with the NAC – Provincial TM Network
April 17, 2015
Angela Tonary, BSc, MSc, PhD
Senior Scientific Evaluator
Marketed Biologicals, Biotechnology and
Natural Health Products Bureau
Marketed Health Products Directorate
Health Canada

2. Background
Nov. 6, 2014: The NAC expressed willingness to communicate with HC about blood and blood product safety issues and asked who to contact at HC
Discussions with internal stakeholders (BGTD, Canada Vigilance Program, Inspectorate) led to our request to meet with you today

3. Outline Team Members Collaboration in blood and blood product safety
Which safety issues?
HC contact mechanism
The MHPD’s responsibilities
Changes in AR reporting for blood and blood components
Consultations now open for Vanessa’s Law

4. Team Members Duc Vu, MSc, PhD – Director of the MBBNHPB
Miriam Ostroscki, MD – A/Manager of BTO Scientific Section
Vicky Hogan, PhD – Manager of BTO Scientific Section
Mano Murty, MD, CCFP, FCFP – Manager of Medical Section
Alba Toledo, MD – Scientific Evaluator
Alexandra Simniceanu, MD – Senior Scientific Evaluator
Angela Tonary, BSc, MSc, PhD – Senior Scientific Evaluator
Mélanie Derry, BSc (Hon), PhD – Scientific Evaluator
Maria Faraci, MD, MDCM, FRCSC – Medical Evaluator
Tonja Stothart, BSc, BEd, MD, CCFP – Medical Evaluator

5. Collaboration
HC really appreciates the NAC – Provincial TM Network’s willingness to create a sentinel system and is pleased to collaborate with clinician-experts to address safety issues involving blood and blood products
HC recognizes our common goal of minimizing health risks and providing safe and efficacious treatments for Canadian patients

6. Which Safety Issues? Can include:
serious and unexpected ARs (e.g., IGIVnex and hypersensitivity)
non-serious ARs (suggesting increased incidence)
What types of safety information does the NAC – Provincial TM Network envision sending?
Does not preclude submitting AR reports to HC
TTISS forms are welcomed

7. HC Contact Mechanism
For post-market safety issues, the MHPD is the lead and will contact/ involve program partners as appropriate
The MHPD includes the Canada Vigilance Program and our review bureau, MBBNHPB
Sentinel communications from the NAC – Provincial TM Network should be sent via to the following MHPD listserv:
<MHPD

8. The MHPD’s Responsibilities
Receipt and processing of AR reports
Scientific and medical evaluation of AR reports and other safety information
Risk management (e.g., risk communications)
Communicating with internal (BGTD, HPFBI) and external (CBS/H-Q, PHAC, Manufacturers) stakeholders
What feedback/information would the NAC – Provincial TM Network like from Health Canada?
HC recognizes that Manufacturers, Blood Operators and Hospitals are the leads for investigating safety issues with their blood products or blood units

9. Changes in AR Reporting for Blood and Blood Components
Responsibilities for the receipt, processing and evaluation of AR reports are being transferred from the BGTD to the MHPD; the anticipated transfer date is now Sept. 1, 2015
Guidance Document: Blood Regulations (effective Oct. 23, 2014) will be updated to put the Canada Vigilance contact information for reporting
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10. Vanessa’s Law
The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) received Royal Assent on Nov. 6, 2014
Vanessa’s Law amends the Food and Drugs Act:
to improve Health Canada’s ability to collect post-market safety information and take appropriate action when a serious risk to health is identified; and
to increase the overall transparency of regulatory decisions involving therapeutic products

11. Vanessa’s Law: Consultations
Stakeholder assessment of information needs about therapeutic products
open for comments until May 25, 2015
Guide to New Authorities (power to require and disclose information, power to order a label change and power to order a recall)
open for comments until June 8, 2015
Both available via:
Consultations with P/T stakeholders have commenced regarding mandatory reporting of serious adverse drug reactions and medical device incidents by healthcare institutions to Canada Vigilance

12. Thank you! Comments … Questions?