Key Messages from the Second Stakeholder Committee Meeting May 1 and 2, 2003, Ottawa

Background:

• This is the second meeting of the Veterinary Drugs Directorate's Stakeholder Committee. The first was held in September, 2002.
• The objectives of this second meeting were to:
  • Follow-up on priority issues identified in the initial meeting of the Committee (in particular MRLs, AMR, collaboration between Health Canada and the CFIA, animal welfare);
  • Provide an update on the developments related to these issues; and
  • Work through the priority issues identified by Committee members.

What happened at the meeting (Presentations):

Overall Progress

We received a summary of the progress that has been made since the first meeting on the issues identified as priorities by stakeholders. Diane Kirkpatrick's presentation centered on highlighting progress in priority areas:

• A special stakeholders meeting was convened in November 2002 which led to the development of a joint Health Canada/CFIA policy on MRLs and AMRLs;
• Catching up on outstanding MRLs for NOCs for vet drugs already issued;
• Establishing a dedicated unit within the VDD clinical division to focus on Pharmacovigilance;
• Confirming reduction in the backlog of submissions

Ms. Kirkpatrick also noted that the Directorate now has a strategic plan which was based on Branch and Departmental priorities, as well as priorities identified by the VDD Stakeholder Committee. The progress made in these key result areas is as follows:

• Timely review: the number of active submissions pending review continues to decrease. Further progress has been made towards timely access to safe and effective drugs with the establishment of an internal submissions committee and work on the development of draft guidelines for new drug submissions and a draft submission management policy is nearing completion. The next step will be consultation with our stakeholders.
• Policy development on AMR: stakeholders have contributed in an extraordinary way to moving this forward; VDD held a special consultation with the provinces and territories in February 2003. Within VDD, a peer review policy was developed and posted on our web site.
• National partnerships and international cooperation: Canada participated at the October 2002 VICH Steering Committee meeting as well as a number of Working Group meetings and is moving to adopt 27 VICH guidelines; VDD is a very active participant on Codex Alimentarius on residues of vet drugs in food; and VDD is collaborating with the U. S. Center for Veterinary Medicine on a number of initiatives.
• People: The Directorate has been building capacity through intensive hiring and training, growing from less than 30 people in April, 2001 and now approaching 80 highly skilled and qualified people.

Health Protection Legislative Renewal

Mario Simard, Legal Counsel to the Health Products and Food Branch, gave a presentation on the proposed renewal of health protection legislation, noting that the current legislation comprises twelve statutes, some dating back to the 1950s. The Health Protection Legislative Renewal will address:

The provision of a set of guiding principles (as is the case in the Canada Health Act) including: values to reflect what Health Canada heard during the consultations in 1998, the primacy of health and safety, openness and public involvement, cooperation, accountability, and risk decision-making principles.

The new legislation will allow policy- and decision-making on a risk-based approach and is also likely to include a new system of categorization, built on updated definitions; stronger rules on advertising and provisions for enforcement and dispute resolution.

Regarding the timing of the Renewal, Mr. Simard indicated that Health Canada is entering the second round of consultation (the first was in 1998) by releasing a discussion paper in June, 2003. Bilateral meetings with key stakeholders will be held over the summer to start the dialogue, followed by the drafting of a Bill, with a view to introducing it in 2005.

Update on Timely Review of Submissions

Louis Boulay focused on three topics: performance measurement, tools and methods (policies and e-review) including:

• Identification of bottlenecks
• Focusing on those submissions which are over two years old
• Priority Review of submissions (policy to be developed with stakeholder input)
• Improving the quality of incoming submissions
• E-Review: will not replace paper but would reduce paper records. Industry readiness is variable, Act and Regulations need to be made "e-ready", need for secure transmission and processing capabilities. Most of the technical solutions and lessons learned from human drug initiative on e-review can be directly transferred to vet drugs.

Overview of Federal Initiatives on AMR and growth promoters

Dr. Lateef Adewoye provided a detailed presentation on AMR as a global as well as a national issue, including how Health Canada is addressing this issue:

• Need to establish firm scientific basis for decisions that will lead to development of policies
• Canadian Integrated Program for AMR Surveillance (CIPARS) will provide a baseline for AMR relating to human and animal sources - animal component from September 2002 to September 2003 (abattoirs) - human component from Jan 2003 to Jan 2005 (retail study)
• Involvement of stakeholders at both national and international levels
• Outputs include Final Report of the AMR Advisory Committee and Health Canada's proposed response; an issue identification paper; professional and public awareness information and the on-going work of the Canadian Committee on Antibiotic Resistance (CCAR).

Key Take-Away Messages

• Before leaving the meeting, we agreed that the next meeting would focus on dealing with one or two specific issues with a view to achieving consensus on how to address them.
• There is increasing understanding of others' positions among stakeholders.
• We have the impression that VDD is doing a great job on consultation both nationally and internationally.
• We understand the importance and difficulty of legislative renewal and want to engage as a committee in this initiative.
• Participants expressed the need and desire to provide more input into the agendas for these meetings, to participate in the content of the discussions/presentations and support VDD in its initiatives. It was agreed that stakeholders would discuss the next focus for discussion - priority review - to see if all issues, including animal welfare could be addressed. Mr. Clare Schlegel and Mr. Paul Doig offered to assist with this initiative in consultation with VDD staff.

Next Steps

• Table discussions will be recorded and included in the highlights of the meetings. These highlights will be posted on the website by the end of May.
• The next stakeholder meeting will take place mid-November. Participants were asked to identify their schedule opportunities for the weeks before and after November 15 to Dhurata Ikonomi.