BIOTECanada Vaccine Industry Committee (VIC) Bilateral Meeting - Meeting notes - June 14, 2011

Tuesday, June 14, 2011
1:30 PM to 4:00 PM
200 Tunney's Pasture Driveway
Ottawa, Ontario

Attendance:

BGTD participants:

Elwyn Griffiths, Director General, (Co-Chair)
Aline Rinfret, Chief, Viral Vaccines Division, Centre for Vaccine Evaluation
Catherine Parker, Director, Office of Policy and International Collaboration
Andrea Bedard, Junior Policy Analyst, Office of Policy and International Collaboration
Agnes Klein, Director, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
Georgette Roy, Director, Office of Regulatory Affairs
Christopher Antonio, A/Manager, Office of Regulatory Affairs
Martin Nemec, Senior Biologist/ Evaluator, Monoclonal Antibodies Division
Maria Baca-Estrada, Chief, Bacterial and Combination Vaccines Division, Centre for Vaccine Evaluation

Marketed Health Products Directorate (MHPD) participants:

Carole Légaré, Manager, Medical Section (Biologics and Biotechnology Products),
Heather Sutcliffe, Director, Marketed Health Product Safety and Effectiveness Info,
Martina Polakova, Adverse Reaction Information Specialist

Patented Medicine Prices Review Board participants:

Robert Squires, Senior Policy Analyst (observer)

VIC participants:

Aline Silahian, Pfizer
Margaret Kanters, Pfizer
Jennifer Chan, Merck
John Dorsey, Novartis (Chair)
Graeme Fraser, BIOTECanada
Cynthia Ban, GSK
Rob VanExan, sanofi pasteur
Denis Macina, sanofi pasteur
Christian Blouin, Merck
Jeff Malawski, Merck
Gay Parsons, Janssen
Mark Fleming, Janssen
Loretta Del Bosco, Abbott

1. Welcome and opening remarks

E. Griffiths (co-chair) welcomed everyone to the bilateral meeting between Health Canada's Biologics and Genetic Therapies Directorate (BGTD) and the BIOTECanada Vaccine Industry Committee (VIC).

Dr. Griffiths commented on the growing global interest in vaccines. There was a recent meeting with The Global Alliance for Vaccines and Immunization (GAVI) where billions of dollars were pledged toward the Decade of Vaccines. It is an exciting time in terms of where the vaccine industry is headed. Dr. Griffiths recently attended the Workshop on International Regulatory Capacity Enhancement for Influenza Vaccines in Sao Paulo, Brazil which was hosted by the World Health Organization and the US Department of Health and Human Services. He also attended the International Association of Biological Sciences meeting in Baltimore. There is interest in adopting new technologies and advancing methods for risk assessment. This enhanced global interest makes bilateral engagements between the BGTD and VIC even more critical.

J. Dorsey (co-chair) gave some opening remarks on behalf of VIC. They have quite a bit of interest in these meetings and are pleased with the diversity of issues addressed on today's agenda.

2. BGTD's intent for a more active role in lot release network of EDQM/OMCL

M. Baca-Estrada briefed the VIC on the BGTD's desire to play more active role in the lot release network of EDQM/OMCL. A Memorandum of Understanding (MOU) between EDQM and the BGTD is currently being prepared. Under the MOU the BGTD will be requested to submit a detailed report to the Network on the products released, what was tested, what was rejected and why, etc This involvement would be a great advantage for proficiency testing, information sharing and taking advantage of information on lots that have been tested. Since the sharing of certain lot release information may require the consent of the sponsor, ORA may be contacting VIC members in the future for permission to share information with EDQM. G. Roy stated that the staged implementation of the MOU needs additional internal discussion, and as such it would be difficult to give it an exact timeline as to when this increased role would commence but it could possibly be in place by late Fall or early Winter. A. Rinfret stated that with the BGTD playing this enhanced role in the network, there will be more harmonization.

3. Submission disclosure form for releasing information to NACI

The BGTD frequently receives requests from the National Advisory Committee on Immunization (NACI) for information on vaccine submissions under review, including target dates for completion. As this information cannot be released without the sponsor's permission G. Roy presented a draft "Submission Disclosure Form" which has been developed to solicit this permission from sponsors.

C. Blouin and J. Dorsey confirmed that sponsors meet regularly with NACI prior to submission. These meetings ensure the sharing of scientific information, Canadian burden of disease data, and the anticipated timelines/target dates. As such, VIC is unclear as to why NACI is now requesting this information from Health Canada (possibility of overlap, duplication of efforts, and increased concern regarding the distribution of confidential/proprietary information.

Action Item:

G. Roy to follow up with NACI regarding a need for the BGTD to provide this information to NACI if the manufacturers are providing it already.

4. Adoption/implementation of PAHO vaccine guidelines

A. Rinfret stated that the BGTD is fostering the implementation of the Pan American Network for the Drug Regulatory Harmonization (PANDRH) guidance document entitled Proposed Harmonized Requirements for Licensing of Vaccines in the Americas, and an accompanying attachment entitled Guidelines for Preparation of Applications.

The BGTD has played an important role in fostering the drafting of these documents which were approved in November 2008 at the 5th PANDRH conference in Buenos Aires. E. Griffiths stated that there is pressure from the Pan-American Health Organization (PAHO) for regulatory agencies to implement this guidance so Canada is taking the lead on implementation. However, for manufacturers filing vaccine submissions to Canada, there will be little to no impact due to the close alignment to the Common Technical Document format used here in Canada.

As a result of numerous questions, it was reinforced and clarified to the sponsors that this would support and align with the current process currently practiced here in Canada.

5. Updates following Jan 2011 meeting between PHAC/VIC/HPFB on vaccine adverse event reporting

C. Légaré presented a slide deck detailing clarification on vaccine pharmacovigilance in Canada. This presentation gave an in-depth review of the activities for monitoring the adverse events following immunization submitted to Canada Vigilance and the responsibilities for vaccine pharmacovigilance. It also reviewed the roles the MHPD, the BGTD, and the Public Health Agency of Canada (PHAC) in pharmacovigilance and risk management activities. There are bi-weekly meetings between HPFB and PHAC to share and discuss safety information and coordinate vaccine safety issues management. The MHPD also participates in the monthly PHAC-led Federal/Provincial/Territorial Vaccine Vigilance Working Group. There will be further discussions with PHAC in the future in regard to vaccine research; vaccine effectiveness/vaccine failures; and, linkage with immunization registries.

H. Sutcliffe presented a different slide deck detailing an overview of the regulatory requirements and electronic reporting for pharmacovigilance. This presentation included: the scope of adverse reaction information collection, management, data entry and assessment; mandatory reporting; Annual Summary Reports and case reports; Issues-related Summary Reports; Health Canada's AR reporting guidelines, and project initiatives. There was also emphasis on electronic reporting, how it works, how it is more effective and solves the problem of emailed reports not being accepted. It is still in development but the initiation of pilots for the gateway solution is planned for June 2012. The development of the Canada Vigilance Web (CV Web) is planned for completion by Fall 2012 and the launch is targeted for June 2013. The presentation also detailed the mandate, member composition, and roles and responsibilities of the Canada Vigilance Expert Working Group. Additionally, the Canada Vigilance Online Database is available on the MedEffect^™ Canada website.

6. Vaccine labeling with age of indication

D. Macina presented a slide deck regarding medication errors associated with vaccines injections and the importance of accurate, informative labeling. There are significant differences between the labeling requirements between Canada, the US, and Europe and there is uncertainty on the part of industry on future requirements for vaccine container labels. Furthermore it is felt by industry that the current Canadian labeling regulations do not adequately address the needs of small-container biologics. The age of indication can be viewed as key information for safe and efficacious vaccine administration, but it is likely not a solution to preventing medication errors on its own. VIC recommends a thorough analysis of the role of labels and their graphic and information contents in the prevention of medication error. A clear, comprehensive and consistent guidance is needed on information required on vaccine container labels. VIC and its members are committed to a collaborative effort with Health Canada for addressing this topic.

C. Parker commended the VIC for addressing this and stated the BGTD has plans to consult with VIC in near future on a proposal for the overall revision of the labeling requirements for biologics, including the addition of special containers labeling for biologics. She also indicated that the BGTD plans to rewrite the labeling regulations for biologics and that Industry would be consulted in the Fall 2011. G. Roy stated that at the previous meeting, the BGTD had expressed the fact that inclusion of the age of indication on the inner/outer labels may be a good approach to help prevent possible medical errors and some vaccine manufacturers have already agreed to implement this.

C. Blouin added that it may be difficult to put new information on age as some vaccines go by different genders. Manufacturers strongly support and endorse increased patient safety. The examples of the vaccine related medication errors provided thus far were not a result of information missing from the label, but rather examples where the information provided was either misused or neglected. If manufacturers remove or add information, changes will occur such as the text may be smaller, or some of the current information may be removed. He strongly suggested that an assessment be conducted to truly determine the root cause of the medication-related errors.

J. Malawski added that as part of the AIVP (Bar Code) Working Group, a Cost Effectiveness Study was completed regarding changes to Vaccine Labels and that this should be consulted and part of the analysis.

C. Parker stated that the BGTD will present on the new labeling requirements proposal at the fall bilateral meeting.

A. Klein noted that in addition to the analysis moving forward, the BGTD would initiate contact with the individual sponsors on a case-by-case basis to determine the appropriate solution.

Even though the agenda item read Vaccine Labeling Age of Indication, the sponsors requested an assessment be conducted to truly determine the root cause of the medication related errors and question whether labeling changes in isolation will solve or prevent medication errors moving forward.

7. Template for Yearly Biologic Product Reports

M. Nemec presented a slide deck on the BGTD's proposal for a new Yearly Biologic Product Report (YBPR) template. When the requirement for the YBPR was first introduced in 2005, to reduce the burden of implementation of this requirement on sponsors, a decision was made to accept reports prepared for other competent regulatory authorities, if they were updated with Canadian-specific information. However, the BGTD has subsequently determined that these reports often do not include enough specific information and/or present challenges in their review.

The new template would standardize the content by specifying the type of information and level of detail required as well as the organization and presentation of the document. It would also be submitted electronically, eliminating the need to create a separate review document. M. Nemec presented the new template that was formulated by several quality reviewers from various divisions.

Sponsors acknowledged that this was a significant departure from the current process/practice and as such, VIC Member Companies will meet off-line to further discuss and provide comments to the BGTD.

C. Parker confirmed that following this initial consultation with VIC, the BGTD will continue to consult with stakeholders on the YBPR template and would appreciate comments from VIC by the end of the summer.

Actions:

The BGTD to send VIC copies of the blank and annotated versions of the new YBPR template.

VIC to provide comments on the template to the BGTD.

8. Roundtable

R. Van Exan stated that GS1 is doing work involving the Inspectorate on product recall systems and will keep the BGTD posted. The BGTD and the VIC will continue to meet bi-annually. The next meeting will be held mid-Fall.

The meeting was adjourned at 4:00pm.