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

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

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

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

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

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

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 email to the following MHPD listserv: <MHPD Blood@hc-sc.gc.ca>

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

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 http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/blood-reg-sang/blood-guid- sang-ligne-2014-10-23-eng.php

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 http://www.hc-sc.gc.ca/dhp-mps/legislation/unsafedrugs-droguesdangereuses-faq-eng.php

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: http://news.gc.ca/web/article-en.do?nid=957929&tp=1 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

Thank you! Comments … Questions?