MUMS - Canadian Perspective

Dr. Elaine Jetté

DR. JETTÉ:  Hi.  I would like to congratulate the workshop organizers and Art, Meg, and Alistair, and the greater men and women behind them.  I would also like to thank the workshop sponsors for having invited Canada.  The timing of our presentation could not have been better, because we are in the midst of coping the issues related to MUMS in Canada.
  (Slide.)

Canada shares many MUMS issues with other jurisdictions, and today we heard many of them.  So I will concentrate my talk on the aspect of MUMS that are unique to Canada, and those already covered I will give it a little Canadian twist or --- to them.

DR. GRIFFITH:  May I interrupt just a second?  I am sorry.  I was supposed to announce that your talk was at the back end of the booklet.  That is my mistake.  For those of you who are looking for that, it is the very back.

DR. JETTÉ:   Thank you.  So we will introduce ourselves.  Health Canada, who are we, then we will define the MUMS issue from a Canadian perspective by talking on the husbandry practices and trends, and we will discuss why MUMS is an issue in Canada.  Then we will end up how we are addressing the issue.
  (Slide.)

So who are we?  The Veterinary Drugs Directorate is part of Health Canada, which is a federal department, and we are responsible to make sure the safety of food treated -- or derived from animals treated with veterinary drugs.  Our mandate does not cover biologics or pesticides.  So drugs excluding biologics or pesticide ---.  So we have a human safety aspect to our mandate.  We also have a animal safety and efficacy aspect to our mandate, and we carry this mandate by using the Food and Drugs Act and Regulations.
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We do not have a legislative or regulatory definition for minor use or minor species.  It is all in the works.  We also have proposed to our partners and stakeholders the following definition for minor species:  Any animal species or than cattle, swine, chickens, turkeys, dogs, cats, and horses.  Horses is at the end of the list because it is a special case.  If we look at it from a food animal point of view, it is a minor species.  But from a companion point of view it is a major.  Also minor species has a connotation of a small number, but this is not always the case.  For example, we have a big aquaculture industry in Canada.  For minor use definition we propose:  Small scale, limited or infrequent use of drugs on major species of animals.
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So let’s talk a little bit about the husbandry practices and their trends.  Well, comparatively speaking, Canada is a big country, but the human and animal populations are small.  So that means we have a small animal production, and so there is a small market for drug sponsors.  When I say I live in Canada, the first reaction of many percent of people say, "Well, it’s cold down there."  Well, yes we have some parts of Canada that has a cold climate, but we have four seasons and it is a temperate country.  There are big bodies of water.  It is milder like along the ocean coast and near the Great Lakes.  So we have a diversity of climates, and we also have a diversity of production.  Certain production sectors are more intense in certain regions.  For example on the east coast, we have the concentration of dairy cattle and swine, and on the central plains we have a lot of cattle for beef purposes.

In parallel to those intensive traditional farms, very specialized, mechanized, industrialized, we have a lot of small, fragmented, non-traditional farms.  This is where most of the minor species farming is done.  As example, we have alpaca, lama, emu, ostriches, bison farming, and there is also an increasing number of organic farms because these type of farming are perceived as more animal friendly and environmentally sustainable in their practice and are healthier and safer in their outputs.

One thing that I would like to mention is wildlife conservation act, I think there is a niche there for us to exploit this aspect in MUMS because we have a moral obligation to conserve biodiversity, and with the destruction of wildlife habitat, and the increasing contact between domestic and the wildlife species we may need an increased number of drugs to take care of wildlife and translocate wildlife if needed.
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So why is MUMS an issue in Canada?  Well, the take-home message from the last slide is that we have a very small animal production, so a small market.  So there is no incentive for drug sponsors to submit data to have MUMS drugs approved.  So we have an acute lack of MUMS drugs approved.  As a consequence of this lack of availability, well, we have an increased probability of unapproved use of drugs such as extra-label, other use of unapproved drugs such as illegally-imported drugs.  This is increases the risk to human and animal health and safety.
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So what are the contributing factors to this lack of availability of drugs?  Our act and regulation does not make any distinction between MUMS and non-MUMS drugs.  We don’t have any separate framework, so MUMS drugs have to be approved according to the same rule as non-MUMS drugs.  Also, VDD has a policy of first come, first served for the review of submissions, and MUMS are no exception.  This is generally speaking because it has happened in the past that we have made exceptions for MUMS drugs that were really needed like new therapy, but for very minor use and very limited distribution.  In these cases, we reduced the actual amount of submission data that we requested to approve those drugs.

This morning we have seen that in science doesn’t really keep pace with changes in disease and conditions, and despite all the efforts and the resources that we put, it is very difficult to research and develop, and submit for approval and have those MUMS approved on a timely basis.  In other words, when they are really needed for uses.  So these are the contributing factors.  There are more, but these are the major ones.
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So what is our approach to address the issue?  To increase the availability of drugs we have initiated an exercise where we asked the users of drugs, in other words, the veterinarian association and the animal producers, to submit to us a list of drugs that they see as mostly needed drugs.  We are in the process of reviewing this list, and we are considering setting up a mechanism to allow for those drugs to be reviewed on a priority basis.  In the future, we are looking at the feasibility of developing incentives for drug sponsors so that more drugs are approved for MUMS use.  Example of approaches, well, we can look at ways to simplify the data requirements by identifying the data that is really necessary rather than asking for data that would be nice to have, by simplifying the gathering of such data:  For example, data gathered in other jurisdictions would be acceptable for review.  We would also look at exploiting better the use of existing data.  For example, extrapolation of MRLs from major species to minor species, and also we are looking at the monetary and logistical incentives.  Monetary would mean reduce cost recovery fees or logistics would mean to allow major species drug sponsors to piggyback on a submission for minor species so that the minor species submission would bump the queue along with the major species submission.
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So as Peter said this morning, what is a minor species in one country is -- can be a major species in another country, and I think we all agree that minor species, minor use is a major problem, and we agree that the only -- well, the most favorable result is a collaborative approach, and Canada is looking forward to work with you to resolve this issue.  Thank you.
  (Applause.)

DR. GRIFFITH:  We have a few moments here if anyone has an questions Dr. Jetté. 
  (No response.)

If not, while we are getting the next speaker up here, Rick Clayton, if you would like to stand up.  I always tell my students that they need to get the circulation going.  I saw a few eyes closing just momentarily.  Not because of the talk, but because of the hour and having just eaten lunch.  So don’t leave on us, but just stand up and stretch.  

I will go ahead and introduce the next speaker then.  Rick Clayton is a native of Great Britain, and did his early education there.  He is currently the technical project manager for IFAH Europe, and I will just make it very brief. It is doctor here, and you said it wasn’t, right?  Okay, but ---.  We will just have to fight over people moving around just a little bit here, but at least they won’t be asleep.