BIOTECanada Vaccine Industry Committee (VIC) and the Biologics and Genetic Therapies Directorate (BGTD) - Record of Decisions - November 13, 2012

Tuesday, November 13, 2012
1:00 pm to 4:00 pm
100 Eglantine Driveway, Room 1278, Tunney's Pasture
Ottawa, ON

Attendance

Health Canada participants

Robert Cushman, Director General, BGTD (Co-Chair)
Catherine Parker, OPIC, BGTD
Agnes Klein, CERB, BGTD
Georgette Roy, ORA, BGTD
Lindsay Elmgren, CVE, BGTD
Kiran Nath, OPIC, BGTD
Carole Légaré, MHPD
Alan Thom, CIRID, PHAC
Joanne Garrah, OLRM, PPIAD
Alexandra Bray, BPSIP, TPD
Scott McCash, OPIC, BGTD

BIOTECanada participants

Jeff Malawski, Merck (Co-Chair)
Cynthia Ban, GSK
Ron Boch, BIOTECanada
Kacy Chow, Janssen
Loretta Del Bosco, Abbott
Jon Flemming, BIOTECanada
Terry Gunter, Pfizer
Louis Lamarche, Novartis
Aline Silahian, Pfizer
Janice Teel, Janssen
Rob Van Exan, Sanofi Pasteur

By teleconference:

Irene Clement, Medicago
Frederic Ors, Medicago
Denis Macina, Sanofi Pasteur

1.0 Welcome and introductions

The Co-Chairs made introductory remarks, with R. Cushman introducing himself as the new Director General of BGTD and expressing his commitment to maintaining a productive bilateral relationship with VIC. Co-Chair J. Malawski thanked BGTD for its continued effort to hold bilateral meetings specific to vaccines. A round table followed.

2.0 Review of agenda

The agenda for the meeting was approved.

3.0 Drug shortages database

C. Parker noted that although BIOTECanada has been extremely diligent in encouraging its members to post known and pending shortages of drugs on the  Canadian Drug Shortages Database website, BGTD has become aware that some manufacturers are not reporting. There appears to be some confusion about the applicability of this website to biologics, and in particular vaccines.

A. Thom added that although it is recognized that there are other avenues for reporting shortages for vaccines, that shouldn't preclude manufacturers from using the Canadian Drug Shortages Database website.

J. Flemming responded that following a meeting with Paul Glover, the Associate Deputy Minister of the Health Products and Food Branch, BIOTECanada have agreed to sit on a Federal Steering Committee on this issue and look forward to working with Health Canada moving forward.

4.0 Submission disclosure form

G. Roy provided a verbal update on the status of revisions to the submission disclosure form discussed at the last bilateral meeting. The proposed revision would have seen the addition of an option for manufacturers to agree that BGTD could share submission information with the National Advisory Committee on Immunization (NACI) in the Public Health Agency of Canada. Since that meeting, it has become evident that manufacturers have already begun sharing this information directly with NACI, so the proposed revision to the submission disclosure form has been withdrawn.

5.0 WHO Expert Committee on Biological Standardization

L. Elmgren provided an update on the World Health Organization (WHO) Expert Committee on Biological Standardization (ECBS) conference that he attended from October 15 - 19, 2012. Topics covered included the development of a global vaccine action plan, a number of WHO standards being updated and a report on the WHO Vaccine Network of Collaborating Centres.

Action item:

BGTD will monitor the status of the WHO standards being updated and notify the VIC when they are finalised and posted on the WHO website.

6.0 Guidance on Plant Molecular Farming

K. Nath presented an update on the forthcoming Health Canada Guidance document on biologic drugs derived from plant molecular farming (PMF). The presentation outlined the reasons for PMF-specific guidance and its primary objectives and noted that BGTD will invite BIOTECanada to participate in the external consultation in December 2012 or January 2013.

It was noted that the document itself will not be posted on the Health Canada website, so BGTD requests that BIOTECanada distribute the draft Guidance to relevant members during the external consultation period.

7.0 VIC Feedback on INSPIR report recommendations

J. Malawski presented the VIC feedback on the recommendations made in a recently released INSPIR report on Canada's vaccine recommendation process. The presentation provided an overview of the findings of the INSPIR report, noting the strengths and weaknesses of the current recommendations process. While the VIC agrees with the report's conclusion that the current approach to developing vaccine recommendations is no longer viable and that resources need to be increased, it disagrees with some of the proposed improvements contained in the report.

VIC recommendations touch on the following gaps identified in the INSIR report:

• Public Health Agency of Canada/NACI and BGTD information sharing
• Limited two-way dialogue between industry, NACI and the CIC
• A proposal that NACI and CIC be combined into a single recommendation body
• Sequential NACI/CIC timing delays
• Inadequate resources and expertise

In response to the VIC recommendation that NACI communicate and collaborate directly with the individual manufacturers, G. Roy asked if manufacturers ever consider inviting NACI to pre-submission meetings, noting representatives from the Common Drug Review are sometimes invited to participate in pre-submission meetings for other types of biologic submissions. J. Malawski expressed thanks for the suggestion and the information.

8.0 Plain Language Labeling

J. Garrah provided an update on the Plain Language Labeling (PLL) regulatory initiative. The aim of the initiative is to ensure that drug labels and product information is clear, accurate, easily understandable and accessible. At this stage, only minor changes to the regulations are envisioned, with much of the detail to come through guidance. It was noted that although the timing for the project has not yet been announced, PLL is planned as one of the deliverables of Phase I of the regulatory modernization process.

L. Del Bosco suggested that this initiative may offer an opportunity for BGTD to engage with pharmacies at the corporate level in an effort to increase accessibility of drug information for patients. J. Garrah was thankful for the comment and noted that jurisdictional issues are certainly a factor for this initiative.

9.0 Small container labeling

D. Macina made a presentation on the challenges of small container labeling which outlined the different regulatory requirements in Canada, the United States and the European Union and proposed a new standard for labeling small containers in Canada.

C. Parker noted that BGTD is currently undertaking a complete review of Division 4 of the Food and Drug Regulations, where the vaccine labeling requirements are housed, and that part of that review is to revise the current requirements for small container labeling. BGTD will take the proposed standards presented by VIC into consideration when developing the new requirements.

Action item:

BGTD will provide an update on the proposed changes to Division 4 and the impact on vaccines at the next bilateral meeting.

10.0 Administration list of clinical trials

A. Bray provided information on the forthcoming administration list of clinical trials to be posted on the Health Canada website by April 2013. This initiative is in line with the Department's transparency and openness agenda and in response to the Auditor General's recommendations following the audit of the pharmaceutical drugs programme.

While the details are still being finalized, the administrative list will be a public listing of all Health Canada authorized drug clinical trials in target patient populations. A News Release was issued on October 18, 2012 and a stakeholder Notice regarding this initiative was posted on Health Canada's website on October 19, 2012. It is expected that external consultations will begin in late 2012.

11.0 Health Canada interface on vaccine safety and effectiveness monitoring

C. Légaré provided an update on the BGTD-MHPD-PHAC interface on vaccine safety and effectiveness monitoring. In January 2011, all regulatory aspects of vaccine surveillance, and specifically the reporting of serious Adverse Event Following Immunization (AEFI) by industry, were brought back to the Health Products and Food Branch (HPFB) from PHAC and aligned with that of other health products and international regulatory practices.

Mechanisms have been put in place to allow for sharing of information between regulatory and public health authorities. Further discussions are ongoing on the topic of data sharing.

C. Légaré provided an update on the status of information sharing, an overview of the regulatory safety monitoring activities for vaccines to date and a look forward at other vaccine-related projects, including the publishing of a joint Health Canada-PHAC vaccine safety report to be available early in 2013 and published annually moving forward.

12.0 Adoption of PAHO-PANDRH vaccines guidelines

C. Parker provided an update on Health Canada's adoption of the Pan-American Health Organization (PAHO)-Pan American Network for Drug Regulatory Harmonization (PANDRH) vaccines guidelines. In 2006-2007, in response to an issue identified by PAHO member countries that there was a lack of consistency in the technical data requirements demanded of manufacturers for vaccine submissions, BGTD led an initiative to develop guidance for industry which outlined specific data requirements. The resulting guidance document entitled Proposed Harmonized Requirements for Licensing of Vaccines in the Americas, and accompanying attachment entitled Guidelines for Preparation of Applications were approved by PANDRH in 2008.

In 2011, in an effort to encourage PAHO countries to implement the guidance, BGTD committed to adopting the guidance and consulted with external stakeholders. C. Parker thanked the VIC for the comments it provided during this consultation period. BGTD brought the comments received from the consultation to the PANDRH Vaccines Working Group meeting in September 2012. BGTD committed to updating the guidelines provided that there was a firm commitment from PAHO members to adopt and implement them, which there was.

C. Parker reiterated that for manufacturers filing vaccine submissions to Canada, there will be little to no impact in Health Canada adopting this guidance due to the close alignment to the Common Technical Document format used here in Canada.

13.0 Roundtable

VIC members reiterated their interest in continuing to meet with BGTD biannually and that there was great value in maintaining a bilateral relationship specific to vaccines.

The meeting was adjourned at 3:30pm