Notes from the first Stakeholder Committee Meeting

Thursday, February 7, 2002, Holiday Inn, Plaza de la Chaudière,
Hull, Québec

Please note that this workshop was not audio-taped. Notes were taken and then synthesized to reflect the major points indicated by each speaker. Particular attention has been paid to the Questions and Answer periods, as well as to the results of the stakeholder working session in the final part of the agenda, as these are reflective of the major issues, concerns and recommendations coming from stakeholders to the management team at VDD.

Welcome by Diane Gorman, Assistant Deputy Minister, Health Products and Food Branch (HPFB), Health Canada

On behalf of Health Canada, the Branch and the Veterinary Drugs Directorate (VDD), Ms.Gorman welcomed all participants and looked forward to a fruitful day together. She appreciated participants taking time from their busy agendas, recognizing that this is not always easy and which, for a number of people, had meant travel to Ottawa.

She indicated that there is a broad representation of industry and other stakeholders present, as well as representatives of various levels of government, the private sector, the Health Products and Food Branch (HPFB), the Department of Foreign Affairs and International Trade (DFAIT) and the Canadian Food Inspection Agency (CFIA).

She emphasized that the VDD management team is committed to working with stakeholders. In recent public opinion research findings, food safety is the highest concern of Canadians, who also have a high level of confidence in the ability of governments to ensure that food safety standards are high. However, this means that we must continue to be diligent in our oversight and our efforts.

Ms. Gorman indicated that it was important that she was here this morning to signal support from the most senior levels in Health Canada. Both the Deputy Minister and she herself are very proud of the progress that VDD has made in a relatively short period of time, and of the efficiencies that have transpired.

She indicated that participants' agenda for the day is extremely important. There are tremendous opportunities that can be seized by working together in an achievable way - particularly in areas where we can measure progress. This synergy can be a great formula for success based on commitment to implement new ideas and a new era of collaboration. She wished all participants well during this demanding and full day and looked forward to the report that would come from this first workshop.

Agenda Review

Marc Valois (Facilitator) outlined the plans for the morning, indicating that this was a basis for the afternoon session where VDD would be looking for recommendations for moving forward.

Each table was then asked to indicate (as a collective) what were their top three expectations for the day. A consolidated list of these expectations is attached as Annex 1 to this document.

Introductory Presentation:
Diane Kirkpatrick, Director General, Veterinary Drugs Directorate

Ms. Kirkpatrick introduced her presentation and indicated that she was extremely pleased to have the opportunity to engage with stakeholders in an atmosphere of increased transparency and increased communication as we work together. We are mutually looking to make great strides in moving towards common objectives.

A copy of the full presentation "Turning the Corner" can be located on the VDD web site.

IM/IT Knowledge Management Presentation:
Louis Boulay, Chief, Submission and Knowledge Management Division, VDD

A copy of the full presentation "The Role of Knowledge Management and Information Technology in Submission Review" can be located on the VDD web site.

Working Together - Therapeutic Products Directorate (TPD) and VDD:
Dr. Robert (Bob) Peterson, Director General, TPD

Dr. Peterson made a presentation, where he indicated that both Directorates were working together on many common issues, that require the wise use of resouces leading towards economies of scale. He also welcomed the session today and looked forward to the help that stakeholders can give to establish priorities.

Current common areas include submissions management, IM/IT, DINs, the generation of drug regulations, user fees, patents and the public posting of notices of compliance through common, accessible web site postings.

A copy of the full presentation "Therapeutic Products and Veterinary Drugs: Common Issues; Working Collaboratively" can be located on the VDD web site.

Questions for Bob Peterson

Question: Who is in charge of risk managment at the Branch level?

Answer: In TPD there is a weekly risk meeting which brings forward all issues to Directorate Management. Then, if there is a decision to take an issue forward to the Branch level, all senior managers sit at the risk table, including the compliance representatives (Inspectorate), Communications, plus Biologic and Genetics. There is a common approach for all areas of the Branch and important questions are asked and answered. The Branch can then choose to move the issue forward in the Department to the Health Canada risk committee. This is a committee where all the major players attend -it is largely oversight at that stage using an approach that is consistent with department's risk management framework.

Question: There seem to be areas that are less transparent for vet drugs, such as compliance and enforcement, that seem to play more of a role in TPD? I am referring to issues such as the use of unlicenced products-Diane Dionne to answer

Answer: I believe Danièle Dionne of the Inspectorate will shortly be able to brief you more fully on that during her presentation. In relation to TPD, with departmental realignment compliance now resides with the Inspectorate (Directorate) which can recognize different yet comparable issues such as vet drugs, natural health products and new products (nutraceuticals) that sit with all directorates in the Branch.

Question: In relation to Direct-to-Consumer advertising, consultation on vet drugs occurred in 1999 on this. We were told that it went to a rulings committee, then no information. What happened?

Answer: - I believe this is an issue of regulations. When we go to the Department of Justice for their advice, we are bound by Solicitor-Client privilege when we receive that advice. In fact there are few opportunities for direct-to-consumer advertising for schedule F drugs. In the past, we had been looking towards new legislation, as you may know, and at that time we had extensive public and stakeholder discussions on human drugs, etc. With a new Minister we may revisit regulations and concepts ie Schedule F to give it a more specific focus. This is clearly a very important issue and we will pick it up again carefully.

Panel Discussions

Panel Member #1: Dr. Brian Evans, Chief Veterinary Officer for Canada and Executive Director, Animal Products Directorate, CFIA

Dr. Evans talked about his relationship within the animal/ food continuum, everything from feed to emergency, red meat, eggs and many other foods. He has regular contact with VDD. This contact is not new, and has been long-standing before VDD and CFIA were created. In the past this had been based on individual personalities. Now although personal interaction is important, Diane Kirkpatrick and I have established a process to formally interact, which includes technical working groups, quarterly meetings, etc.

Our work is a very delicate balancing act where we have defined responsibility related to public health, and consumer confidence and trust are very important. But animal health is also important, as well as international access and economics.

There are obviously emerging issues:

• extra label use in Canada
• with Fisheries and Oceans Canada - aquaculture and health of fish
• to ensure validated test methods
• to address issues of privacy of information and intellectual property
• transgenic animals
• ISO beyond gFARAD

We will continue to work collectively and collaboratively to take our issues of workload to central agencies and to look at our legislative basis together.

A copy of the full presentation "Veterinary Drugs Directorate:Panel Presentation" can be located in on the VDD web site.

Panel Member #2: Carl Block, Chair, Canadian Animal Health Coalition, cow-calf operator in Saskachewan and past President of the Saskatchewan Stock Growers' Association

The livestock industry has an extremely important place in the Canadian economy with annual exports totalling over $17 billion (out of $28 billion) - second only to auto exports. This makes it a critical part of our social and economic fabric. Over one third of Canadians are either directly or indirectly linked to agriculture. It is so important that our food is of the safest and highest quality.

Canadian pork is the largest export in the world with beef being the third largest. We strive to deliver safe food from healthy animals. In our business, good animal husbandry is good business!

I am the chair of the Animal Health Coalition, which strives to be upstream on animal health issues and policy. It includes a number of members, as well as provincial governments, and allied industries. The Canadian Veterinary Medical Association (CVMA) is also a member. The issues that we raise include emergency animal health, BSE/TSE, and the drug review process. We are doing this to address, as a group, what we have been unable to do independently.

Canada needs this safety element. We need to be safer than our competitors, giving us good advantage. But if others can access newer, lower cost drugs and we are faced with these drugs coming into the country, this raises serious issues of competitiveness. This applies to animal welfare as well - we all speak to animal welfare - we are business men primarily.

To date, the Coalition has been encouraged by receptiveness on the part of the federal government. We have met with the Deputy Minister, Health Canada and the DG, VDD in December. We heard first-hand about the confidence that the Deputy has in the new Directorate. We hope that this will translate into approvals coming out of the front door. There has been important ground work laid - with changes made at the client level. For example, we see the contract through CVMA (pets) and the Atlantic contract. This is good progress. We must strive for better ways to work and ensure that we keep resources. We must encourage competition with the US, and as well work towards the harmonization and recognition of equivalency. We must fast-track on our accountability and transparency. We must establish milestones and track our timelines towards goals.

What I/we can offer is assistance in pushing for changes, as well as frank dialogue. We can assist in pushing for resources through lobbying. We have asked for another review meeting (with Health Canada's Deputy Minister) in eight months and hope that this comes to fruition.

(NOTE: There was no overhead presentation for this part of the panel discussion.)

Panel Member #3: Danièle Dionne, Associate Director General of the Health Products and Food Branch Inspectorate (HPFBI)

Ms. Dionne indicated that she was present today because of a very strong common interest. The Inspectorate was established just less than a year ago, in April 2001. They are delivering a much more national service related to all drugs, medical devices and soon to come, natural health products - everything except for food.

The Inspectorate's Compliance and Enforcement Policy is on their website, and they are very open to comments from stakeholders as they encompass a management approach that values and encourages continuous improvement. This approach speaks to transparency and fairness, and is based on risk management, a commitment to quality policy and qualified, trained staff.

A copy of the full presentation "HPFB Inspectorate" can be located on the VDD web site.

Panel Member #4: Jennifer Hillard, Vice President, Policy and Issues, Consumers' Association of Canada(CAC)

Ms. Hillard introduced the history of the CAC to participants. So far they have not had much interaction around veterinary drugs, but they are keeping a watchful eye on food policy and food safety in Canada, from a policy perspective.

Given the fact that CAC is a voluntary organization, they have to choose their issues and interventions carefully. The structure of the organization is uneven across the country. Some provincial associations are small, therefore there is an unevenness in activities, although traditionally the Prairie organizations have been the strongest.

Issue priorities are set by the volunteers at the Annual General Meeting. Food and Health are always the top two, but there are always many others including trade, telecommunications, energy and the environment.

Ms. Hillard indicated that CAC was very pleased to attend this first VDD stakeholder workshop and that it would give CAC more knowledge in this area both for policy development and for communicating factual information to consumers. This could help to counteract news from the EU.

Ms. Hillard closed by saying that Canada has great superiority for safe food products. As in the case of Brazilian beef, the Canadian public needs to see confidence portrayed by their public servants around the safety of the food system.

A copy of the full presentation "VDD Stakeholders Meeting, February 7, 2002" can be located on the VDD web site.

Question and Answer Session - Panel Discussion

Question (to Brian Evans and Diane Kirkpatrick): When it comes to administering Health Canada standards, there seems to be an issue with products having no Maximum Residue Limit (MRL), or MRLs that are approved in other jurisdictions. There should be zero tolerance for this...

Answer: There is a legal interpretation which can be applied to the level of compliance. In the absence of an MRL, we can see the risk assessment, which may not be legally binding, or a true perspective of the risk involved. There may be an international standard. In Canada we try to work to see if there is a real health risk. We tend to work with manufacturers/producers so that the product is brought into compliance, rather than go the prosecutorial way. We try not to be heavy-handed and to work collaboratively on these issues, using these as educational opportunities.

Question: What about MRLs approved in US?

Answer: We are currently bringing forward administrative MRLs so that they can be promulgated, and apparent. We are also looking at how we can ensure that the Notice of Compliance includes information so that the residue limits are visible. Right now we do not want to hold anything up, so we are sharing (with CFIA) all residue limits for which some assessment and conclusions can be used for enforcement and compliance methodology. We want to do away with the grey zone.

Question: What are the regulations for the manufacture of medicated feeds? In the absence of MRLs how can we work within safe standards? Are standards attainable?

Answer: We are working on the results of risk assessments. This allows for adjustment of enforcement and compliance activities. Right now, the levels are basically acceptable. The next step is to make sure that the industry is informed . We want to work in a transparent manner, so that industry is aware and informed.

We are working on this issue in a phased implementation approach. We have to be practical - and ask "what is the result in the food chain?" - not in the animal - and then we enforce our decision in line with the Health Canada standard .

Question: - When it comes to animal welfare and health, when inspectors implement the Good Manufacturing Practices (GMPs) component is there a measure of concern for the animals? And in test situations as well?

Answer: This is a very important area - a question of values and ethics also comes into it. At present not sure of role of the Inspectorate, but there is a link to the regulatory environment.

The Inspectorate does work with all kinds of partners and, although not mandatory for the private sector, industry would likely use good laboratory practice, and hopefully, good animal practice as well.

Question: What about GMPs for API s - doesn't this put Canada at a competitive disadvantage and compound our problem?

Answer: There is a need to amalgamate standards. Right now manufacturers need a licence for compounding. For our part, we need to make sure that we are capturing everything and that we mesh with APIs and GMPs. In terms of enforcement and compliance, we can table the real concerns within the right framework and discuss how best to be able to work together on this so that we move slowly to make this an even playing field.

Question: APIs (even anti-microbials) are coming across the border in truckloads. We have been talking about it for some time. We think that there has been no serious action from Health Canada. Surely we must put a process together that reflects both the need and the balance?

Answer: We agree with what is being said - there should be no "wiggle room". We acknowledge that there are many areas for quick resolution and gaps that we must address. Indeed we must make sure that we identify these issues, work on them and validate with a number of stakeholders that we are on the right track on these issues.

Some countries are developing their own systems. This means that manufacturers have to meet the law internally and then for customers to meet the law from abroad.

But because the list is great - for CFIA, the Inspectorate and stakeholders - this signals that this kind of compliance issue is on top of bilateral issues to be addressed.

Question: Pest Management Regulatory Agency (PMRA) dealt with the issue. Maybe Health Canada should look at what they have done?

Answer: The difference for PMRA is that they have a Sales Act, rather than a public health framework. But it would be good to consider what they have done and more discussion is needed.....

Wrap Up (Diane Kirkpatrick) There are many areas of challenge. We have to prioritize and decide which ones are most pressing. Then we need to identify and hit the most pressing ones first. We (VDD) will be looking for your best advice and recommendations as we move forward.

Afternoon Working Sesssion

Marc Valois (Facilitator) outlined the plans for the afternoon. He indicated that VDD staff were interested in hearing stakeholder recommendations on up to ten of the most pressing issues. The tables were then asked to write down their three (or so) issues that they thought would be most useful to discuss in more detail. These issues were then consolidated and participants were asked to self-identify which of the five common issues identified they wanted to discuss in a group setting.

Participants were asked to then, for each issue (one per table), to craft a preferred outcome statement, and indicate the first three most crucial steps that they felt needed to be undertaken to get there. An informal "rapporteur" then captured that information on a one-page chart and presented that back to the plenary session.

Issue/Challenge #1: Use of Unlicenced Products

Preferred Future: Not allow the use of products not assessed by Health Canada [- for food producing animals in particular]

Actions:

1. Control/monitor/track importation of APIs
2. Monitor distribution - "authorized" US? Licence holder
3. Discontinue "own use" policy - [circumstances for pet owner for individual animals across border okay but no more use in herd and flock context]
4. Proper compliance/enforcement (capacity)

Issue/Challenge #2: Timely review of veterinary drug submissions.

Preferred Future: Approval of new veterinary drugs within established VDD performance standards.

Actions:

1. Establish and communicate clear requirements for drug submissions to minimize extra test and information requests to manufacturers
2. Clear backlog of evaluations through special measures and ensure staff have the capacity to meet performance standards
3. Improve internal processes i.e synchronize flow of submissions through VDD divisions
4. Proactively pursue international standardization and "equivalency" with the US and the EU

Issue/Challenge #3: Communication

Preferred Future: Should inform, get feed-back from and to the community of interest. Have comprehensive communication: what we are, what we do.

Actions:

Principle: Process needs to be continuous, using plain language, to build trust and acceptance

1. Identify good spokespersons
2. Define what information can be released, then do it (recognizing constraints)
3. Visibility of consultation processes
4. Better site maps on website to find information
5. Establish stakeholder advisory committee on communications

Issue/Challenge: Equivalency

Preferred Future: Established equivalency for veterinary drugs as for other animal/food products ultimately leading to mutual recognition (Harmonization).

Actions: VDD to:

1. Participate in Veterinary International Committee on Harmonization (VICH) - as partners or observers
2. Conclude comparative study (Canada/US) by June 2, 2002 (in progress)
3. Investigate legal requirements to recognize equivalent status
4. Initiate a process for joint reviews with FDA/CVM organizations
5. Utilize CVMA proposal for pilot testing in/for non-food animals to demonstrate effectiveness of procedures and to assist in elimination of submission backlog
6. On-going consultation with stakeholders and public service employees
7. Evaluate adverse event reporting systems (equivalency) so that cancellation/withdrawal of compliance is coordinated.

Issue/Challenge: Establishing MRLs for all products

Preferred Future:

• MRLs for currently licenced products are promulgated
• MRLs for new products are promulgated in a concurrent manner (synchronicity!)
• Congruence with MRLs and international standards [e.g., CODEX] or other recognized standards

Actions:

1. Resourcing a position in VDD to manage MRL promulgation process in concert with Notice of Compliance
2. Trilateral consultations with other jurisdictions to review and update MRLs previously established.
3. Review of criteria used to establish MRLs including:

• baseline determination of consumption patterns
• target tissue determinations

Closing Comments by Diane Kirkpatrick

Ms.Kirkpatrick indicated that from an organizational perspective, the workshop had accomplished more than it set out to do. She believed that participants were able to establish good connectivity with each other and an understanding of respective challenges. The VDD alone cannot undertake these issues by themselves; we all need to work together and we all have a responsibility in making this [VDD] a successful enterprise.

In this afternoon's session, there were no surprises on issues and challenges that were identified. For example, VDD staff had identified a number of them, such as communications, in anticipation of the workshop.

Other issues such as the timely review of submissions are already on our agenda, and we appreciate your contributions and suggestions this afternoon on how we move this issue forward. Now our job in VDD is to take these proposals and action recommendations and to move them forward in a visible way.

Equivalency is always a big issue for us as for other organizations, and the group discussing this has given us good suggestions to augment our current discussions and to move this issue forward.

In terms of the unlicenced products, Ms. Kirkpatrick indicated that she liked the emphasis placed by the group on the safety of the food supply - from a consumer point of view.

In relation to MRLs, this intimately connects to a number of issues that have come up for discussion . With confirmation on this from stakeholders here today, we can now push a little faster on moving forward.

She thanked members of her management team who were present - Lucye Galand, Ian Alexander, Mike Crocker, Vasu Dev Sharma, Louis Boulay and Danielle Shanefield; and the organizing committee, in particular Kathy Dobbin and her team, Dhurata Ikonomi and Rita Gaetano, for their support and hard work which made the day possible.

In closing, Ms. Kirkpatrick thanked everyone for giving their best today and indicated that VDD did need their help to become a successful and proud organization. She wished everyone a safe trip home and hoped to see them again at the next VDD workshop - if not sooner!

Annex 1

Consolidated List of Table Expectations for the Workshop

• Information on the structure of the VDD and the drug review process within the framework of the new Directorate.
• That there be consideration of socio-ethical issues such as animal welfare, as decisions concerning drugs and therapeutic products are made, and for research animals used in departmental research and testing.
• Quicker and more meaningful response to EDRs (Emergency Drug Releases).
• Access for new drugs for livestock through a timely, predictable process which is similar to our major trading partners in the US and European Union.
• Access to information on withdrawal times for specific drugs.
• Identify processes to monitor progress re: turn-around times on submissions; efficiency/effectiveness of approval review process; address outstanding compliance issues.
• Transparency of decision-making process and communications.
• Addressing the credibility (of VDD) issue.
• Food safety related to chemical residues and antimicrobial resistance.
• International trade - quality products have to be available.
• Recalls have serious implications for food processors.
• Risk communications and public opinion perceptions.
• Drug availability - how are quality products that increase food safety made available?
• See progress at VDD to resolve long-term issues of slowness in reviewing products - competitiveness issues and access to new and potentially "better" drugs i.e., less residue issues.
• Feed manufacturers have had a positive relationship with VDD over the years, but recently there has been a lack of transparency during crisis times (i.e., Carbadox). There is a slowness and lack of information to stakeholders - need to improve communication and industry-government co-operation.