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U.S. Department of Health and Human Services

Animal & Veterinary

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Office International des Épizooties, OIE by M. Kathleen Glynn, DVM, MPVM

DR. GLYNN: So, just a point of clarification, I am a CDC employee but I’m assigned long-term to the World Organization of Animal Health and I’ve been there about, just a little over a year and a half as a part of an effort by CDC to really expand their collaboration between human and animal health sectors. I am kind of a person with a foot on each side of the bridge.

(Slide)

So, I am talking today on behalf of OIE. And what I would like to do is just after a brief introduction, talk a little bit about OIE and the development and establishment of international standards for those of you who might not be familiar with the process. As well, as OIE’s specific activities to support the implementation of those standards. Briefly review a decade of the key OIE activities on antimicrobial resistance and related activities. And finally some ongoing and future international cooperation efforts.

(Slide)

So, first, for those of you who are not very familiar with OIE, the World Organization for Animal Health used to be called the Office International des Épizooties and it changed its name in the early 2000s to actually be its official name of World Organization for Animal Health, but kept the OIE acronym to drive all scientific publication editors quite insane.

It was established in 1924, actually preceding most of the creation of the UN and currently we have 176 members. And this is a member based organization. OIE is present in its headquarters in Paris with five regional representations and six sub-regional offices. As well as five fully functional regional commissions in Africa, The Americas, Asia-Pacific, Europe and the Middle East.

The mandate of OIE has really matured over time, but the current OIE global mandate is “Working for better worldwide animal health, animal welfare and public health protection.”

(Slide)

The authority under which OIE functions is very closely linked to international trade. And in fact in 1995 the World Trade Organization signed the Sanitary and Phytosanitary Agreement in which it officially identified international organizations as the reference and the standard setting organizations for issues related to international trade. And in fact in the SPS Agreement OIE is recognized as the reference organization for international standards related to animal health and zoonoses.

(Slide)

And these standards are developed in collaboration with the OIE members, all of the standards are developed in debate by the OIE member countries and are passed by vote by the member countries each year at the annual meeting.

(Slide)

As I mentioned a lot of the authority and most of the focus of a lot of the standards are related to ensuring the safety of international trade, minimizing the spread of pathogens and animal diseases associated with international trade, as well as ensuring and trying to support and minimize the unfair restrictions against trade. So, there is both a mixture of trade associated as well as health associated issues in that mandate.

And the standards are actually published. They’re updated annually and the two codes that are published, the Terrestrial Animal Health Code and the Aquatic Animal Health Code, are the manuals -- the documents in which the specific standards for trade, that country agree, member countries agree to follow, as a part of being members of OIE.

Specifics of diagnostics, laboratory diagnostics, vaccines development and biologics are captured in the manuals, the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals as well as Aquatic Animals.

(Slide)

So, to be a little bit more specific to antimicrobial resistance, in the Terrestrial Animal Health Code, Section 6 addressed the veterinary public health. And in this portion of the Code there are four specific chapters that have been developed and modified over the years specifically addressing issues related to antimicrobial resistance.

The harmonization of national antimicrobial resistance surveillance and monitoring programs, the monitoring of the quantities of antimicrobials used in animal husbandry, the standards for responsible and prudent use of antimicrobial agents in veterinary medicine, and the standards or guidelines for risk assessment for antimicrobial resistance arising from the use of antimicrobials in animals.

And in addition, in the manual there is a chapter specifically describing, providing guidance on the methodology for laboratory testing for bacterial antimicrobial susceptibility testing.

(Slide)

I would like to go into a little bit more detail on the chapter related to responsible and prudent use. First of all the objectives of this chapter is to prevent and for this guidance and for the activities captured in this chapter, is to prevent or reduce the transfer of resistant bacteria from animals to humans and within the animal population.

To prevent the contamination of animal-derived food with antimicrobial residues that exist established maximum residues level, specifically for the protection of consumer health.

And equally as important to maintain the efficacy of antimicrobial agents used in human medicine and in food-producing animals and therefore prolong their usefulness.

(Slide)

The responsibilities, variety of different partners in the pathway that is engaging in antimicrobial product development or use are actually outlines as well in this chapter. There is a component looking at the responsibilities of regulatory authorities in countries to grant marketing authorization, to combat counterfeit or illegal drug use, to have quality control systems over drug development and to advise on control over the prescription, supply and the administration of veterinary antimicrobial products. As well as to organize trainings, to try and disseminate these messages to a variety of different stakeholders.

There is also responsibilities for distributors of veterinary antimicrobial products. That this should be done only by prescription from a veterinarian or authorized trained person. And that detailed records should be kept.

(Slide)

There are responsibilities for veterinarians. To promote good farming practices to minimize the use of and the need of veterinary antimicrobial products. That prescription should only be given to animals under their care, when necessary and for precise indications and include withdrawal periods. That veterinarians should seek to make the appropriate choice of using antimicrobial agents to target pathogens to maximize the efficacy of the treatment and again, detail records should be kept.

And finally, responsibilities of food animal producers. That they should be implementing health and welfare programs with the assistance of a veterinarian. That they should only being using veterinary antimicrobial products under prescription and that they should comply with all withdrawal periods.

(Slide)

In addition to providing this guidance, there also are some chapters in the Code about how to implement and follow a program of prudent use, specifically guidance about developing surveillance systems to monitor antimicrobial resistance, and the kind of information that should be collected. This is a very -- a brief description of the kind of information. It’s actually detailed in actually much more information in the Code.

In addition, a comprehensive methodology that can be followed is also provided in the Code.

(Slide)

There is also a chapter on how a country can conduct risk assessment for antimicrobial resistance arising from the use of antimicrobials in animals. And that’s the risk not only to animals but also to humans. And there are specific components in this chapter. I’m trying to address each of those.

(Slide)

What OIE has learned over the years with respect to any of the standards is that in many countries, maybe not the United States, but in many developing and in transition countries the ability to comply with standards to which they have agreed and to which have been identified as necessary, to achieve the goals of competent national veterinary services, that the intention to, and the ability to actually comply with these standards is directly related to the competence and the functioning of the veterinary services.

So the OIE makes a specific effort to work with countries to improve the overall functioning of the veterinary services and thereby their ability to comply with all of the issues identified in the Code, including that for antimicrobial resistance.

(Slide)

This is done a variety of ways. First of all function -- focusing on the overall functioning of the veterinary services. The OIE has an established network of 227 collaborate reference laboratories and collaborating centers who serve as sort of an expertise to a number of countries in methods and diagnosis, in understanding the pathogens.

OIE has a very strong and ongoing program of training related to understanding the standards and what it takes actually to comply with the standards. And also is increasing the training on communication and how national veterinary services can communicate with its many stakeholders.

(Slide)

I want to focus just a little bit on the issue of veterinary. One of the basic tenants of OIE is that the quality of national veterinary services functioning under a system of good governance is a global public good. We’ve heard a lot today and for those of you at the ICEID meeting about the globalization of animal trade. Live animals, animal products. Which means that the functioning of veterinary services across the globe is as important to you as the functioning of your national veterinary service.

And so OIE has recognized that simply to put out standards with no support for implementing those standards is not going to be a real solution to the problem.

So, has outlined an entire pathway of what they called the OIE Performance of Veterinary Services Pathways, to work with countries to identify the current status of the functioning of their veterinary service and work to a path to improve it. It’s all focused around what is written in the Code, what’s defined as the functioning of veterinary services.

There is a step that’s an objective evaluation on a set of now, I believe, 47 critical competencies. And countries get a score of one to five for each of these competencies. So it’s done by external auditors and trained specialists.

A country can then request what is called the Gap Analysis which says we got these results on our evaluation. For example they could say we want to improve our ability to conduct surveillance for antimicrobial resistance. And they can work with another team of specialists to actually say what it would take, what kind of investment in our national veterinary services, could raise our performance in this area from a score of two to a score or three or something like that.

There is a variety of specific targeted technical steps. And then ultimately after a five year period a followup evaluation to see how the country has improved its performance.

(Slide)

So, this is very much the OIE perspective, is to establish the standards, working with countries, and then to work with countries to improve their ability to meet those standards.

So, with again a little bit more specific focus on antimicrobial resistance, I now would like to talk about really what’s now been just over a decade of focus and concentrated activity from OIE related to antimicrobial resistance.

(Slide)

You already heard a little bit from some of the other speakers about the variety of international meetings that have taken place. And for across the sectors, FAO, OIE, WHO, Codex. Really trying to create a collaboration and harmonization across the international agencies and the standard setting agencies for these different, for the different what I would like to think of, instead of side or sectors, really the facets of the diamond that we’re all trying to get on a nice shining ring.

So, in the late 1990s there was a lot of discussion from member counties, from regions, within OIE, some expert consultations that ultimately led to in 1999 the specific request and recommendation from OIE commissions and the OIE international committees that OIE should set up an “International ad hoc Group.” And this group of experts had as their charge to address human and animal health risks related to antimicrobial resistance and the contribution of antimicrobials usage in veterinary medicine to these risks.

A series of expert meetings happened and a lot of back and forth discussion amongst member countries. And ultimately in 2003, just a couple of years later, which for an international organization that’s kind of light speed quite honestly, in 2003 at the OIE General Session four guidelines were presented and accepted by the member countries and subsequently published as OIE International Standards.

Three of those were in the Terrestrial Animal Health Code. And again, you heard already that the modern versions of these original proposals, but surveillance, the monitoring of antimicrobial use, of resistance, as well as responsible use. The original chapter in the manual was also published focusing on guidance for testing bacteria for antimicrobial resistance.

(Slide)

In 2004 the last chapter was first introduced, which was the risk assessment chapter.

In 2005 actually, there was ongoing updating of some of these chapters, in particular the chapter on responsible and prudent use of antimicrobial agents in veterinary medicine, and what was revisited really to try to increase the harmonization particularly with Codex, which you heard about before. So, the animal health guidance was now becoming more harmonized with the food side of the guidance.

(Slide)

In 2006 there was more specific discussion of veterinary critical antimicrobials. You heard a bit already about the human medicinal critical antimicrobials. And these discussions were also taking place on the animal health side as well.

In 2007 this was updated and ultimately that led to the adoption of the Veterinary Critically Important Antimicrobial List. And this actually took a lot of discussion with member countries about the process by which an international standard could be set that would really take into account the really different perhaps antimicrobial needs, usage, patterns, resistant patterns and country.

And ultimately it doesn’t say these antibiotics are on the list and these antibiotics are off the list. Rather what it does is it looks at the wide variety of classes of antimicrobial agents that are used and classifies them into critically important, which means there are perhaps not acceptable substitutes for use that will maintain and benefit animal health. There is a mid-zone that they are important but perhaps not all countries agree that there would be critical or there might be adequate substitutions. Or just veterinary important.

And then most recently in 2009, back in May of 2009, in the General Session before the one that we’re currently in, a resolution was passed again reinforcing the members’ interest that OIE continue to engage in very active dialogue, developing standards, working with partners and with stakeholders to continue this very strong engagement and the discussion of antimicrobial resistance, and the standard setting related to antimicrobial resistance.

And in fact that that should also be done in the broader framework or really thinking about the safety and the efficacy of veterinary, overall veterinary medicinal products.

(Slide)

So, this gets us up right just about to today. And so what I would like to do is very briefly talk about just some ongoing and future international cooperation. I saw that I was following some of my international colleagues, so I figured that you already would hear about the many opportunities of the different international meetings and I’m very happy that that turned out to be true.

But certainly I really want to stress that there are very -- that the international organizations are working very hard to be collaborative across these different working groups, WHO, OIE, FAO and then the Codex group as well.

(Slide)

But I would like to mention very briefly an international activity that is ongoing which is called VICH. And some of you may be familiar with this.

But VICH is the Veterinary International Conference on the Harmonization of Technical Requirements for Registration of Medicinal Products. It’s an international cooperation program. And started its main membership between U.S., Japan and European Union. But Australia, New Zealand and Canada are also participating as observers. OIE has been a part of this organization a long time. And is actually an associated member.

What this conference with this group does is really allow of forum by which veterinary authorities and industry come together and actually try to come to a consensus on what is the -- the kind of studies should be done and what kind of activities should be done to really start to answer some of the key questions related to the use and the development of antimicrobial products.

(Slide)

So, as my last slide I just want to leave you with some of the main summaries of a recent Codex task force meeting in which OIE participated this last October. And these three bullet points I think really capture where we are in this amazingly complex issue.

Antimicrobial resistance is a major global health concern inherently related to the use of antimicrobials. We need to create an acceptable balance between the need for the use of antimicrobials to protect animal health and the dangers emanating from possible misuse. And finally, the protection of human health and the prudent and responsible use of antimicrobials in animals is the ultimate objective in antimicrobial risk management. Thank you very much.

(Applause)

DR. BARZILAY: Are there any questions while we’re changing to our next speaker? Please use the microphone and identify yourself.

DR. M’IKANATHA: I just wanted to say that was an excellent presentation. We knew very little about the --

DR. BARZILAY: I’m sorry. Identify yourself if you can for the record.

DR. M’IKANATHA: My name is Nkuchia M’ikanatha, with the Pennsylvania Department of Health. My question to you is what choice has OIE made in the regards to the countries that have limited resources? I ask this because most countries, including countries with lots of resources, are running with a lot of deficits, therefore funding for programs to implement these recommendations can be very difficult. Have you considered the private public partnership or even the user field changing industry since this is related to trade to facilitate implementation of these programs. And have you considered also doing kind of an evaluation to what extent and what the barriers are.

Thank you.

DR. GLYNN: Although I used a little bit more than my allotted time, I still had to skip over a lot of stuff. And one of those is a little bit more detailed discussion to answer this question of countries’ ability to meet the standards. And particularly sometimes the sophisticated requirements that might support a really comprehensive antimicrobial resistance surveillance.

And just to go back to this PVS pathway that I mentioned, the second step here, right here, the recognition that within countries, even in many developed countries, veterinary services are usually not the best advocates for their own needs. It’s just a reality. As a veterinarian maybe this is not a skill that we are trained so much in.

And in addition, in developing countries, not only are they perhaps having a difficult time convincing their own ministry to support their programs financially and with human resources. But they have that same, even greater difficulty, trying to go out and get external partners to invest in some of the advancements.

And so the PVS gap analysis, the second step of the process here, is specifically designed, it’s an economic analysis as well as a technical analysis, which says in order for you to improve your capacity in this particular area, not only do you need this many veterinarians or other kinds of experts, but this is how much it will cost, and this is what you can feasibly expect in this five year period with this kind of investment.

And what this does, is it allows a country to actually take the results of this evaluation, go to their own government and say this is what we need, this is why we need it, and this is what we expect the country to gain from it, or similarly to go to external donors, if the country itself doesn’t have the resources.

So, it’s very much trying to get it at the complexity that you addressed in your questions.

DR. SMITH-DeWAAL: Caroline Smith-DeWaal, Center for Science in the Public Interest, and that is a great system, I think it’s a very good to see it again.

My question is, does OIE have an opinion on what animal husbandry systems are most likely to require the use of antibiotics?

DR. GLYNN: I’ll say that I don’t know that OIE has an official position on what animal husbandry systems would promote or support because within each system the variety of how that system is implemented, what kind of measures are taken and what the overall animal husbandry program is, that those are the issues that really need to be looked at, which is what kind of bio-security, what kind of animal health program is built into a system.

And at the end of that you start looking at, then where are the opportunities for spread of organisms for, you know, failures in types of procedures. For an OIE perspective it doesn’t think this system versus this system because that would suggest that all of the members of this system fit into a certain path and all the members of this system fit into a certain path. And we know that’s not true. There’s a lot more diversity across all of the different type of animal husbandry systems.

DR. BARZILAY: All right. It is my pleasure to introduce the next speaker, Doctor Jorge Matheu, is a specialist for the antimicrobial resistance for the Pan American Health Organization.