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Food and Drug Safety: Potential Solutions

"Food And Drugs: Can Safety Be Ensured In A Time Of Increased Globalization?"

Speakers: Aline Plançon, Head Of Interpol-Impact Project, And Head Of Medical Products Counterfeiting And Pharmaceutical Crime Unit, Interpol, France, Michael Robach, Vice President, Corporate Food Safety And Regulatory Affairs, Cargill, Inc., and Greg Simon, Senior Vice President, Worldwide Policy, Pfizer, Inc.
Presider: Laurie Garrett, Senior Fellow For Global Health, Council On Foreign Relations
February 2, 2011

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LAURIE GARRETT: I'd like to encourage people to please take your seats. Perhaps someone at the back there could let people who are still noshing know that it is time to cease the noshing and come for the sitting and listening.

So as people begin to get seated, I just want to remind everybody -- because I did hear a cell phone go off during the last session -- that this time any cell phones that do go off I will fine you $50 and give it to the charity of our collective choice. (Laughter.) And I also want to remind everybody that you're on the record. So when you ask questions, keep that in mind, and that our audience in Washington is listening via teleconference.

And we going to close up now with I think the most important discussion of the day. Hopefully it will be your take-home messages that will resonate with you as you leave this session. I should preface by saying you may not be aware how unusual it is for the Council on Foreign Relations to dedicate such a significant block of time to a single issue, particularly one that, from the point of view of foreign policy advocates, might be considered a rather narrow set of issues. I think it speaks very well of the council in general.

I'm incredibly pleased that the council saw this as a significant and important issue, in part because it goes to the core of our weaknesses in global governance, and that is something that increasingly is occupying the attention of the Council on Foreign Relations. The vast number of areas -- everything from climate change, to threats of pandemics, to counterterrorism and Islamism, and what have you, issues that really cannot be addressed by a government acting alone adequately, but rather require marshalling forces for some form of global governance which currently does not exist.

What we're going to be looking at in this session is precisely that problem: What can we do to begin to get closer to solving some of these safety questions, at least to begin to venture into some appropriate directions that might take us towards the G-20 next year when President Obama will be the formal host and when it might quite possibly be an issue that could rise to that agenda.

And as you all know, you have the biographies of everybody in your packets, so I won't spend a lot of time tell you who everybody is. But I want to begin with Aline Plancon, who has come all the way from France to join us -- or Geneva?

ALINE PLANCON: Geneva.

GARRETT: Geneva. She runs the Medical Products Counterfeiting and Pharmaceutical Crime Unit -- there's a mouthful, otherwise MPCPC, which is also a mouthful.

What is that in French? What are the -- what's the acronym in French?

PLANCON: MPCPC.

GARRETT: Oh, thanks. (Laughter.) That never happens. That never happens. (Chuckles.)

Now, if I understand it, it was formerly created as an entity in 2006, but you didn't really get up and running until about a year ago. And you have a massive staff -- there's two of you.

PLANCON: (Chuckles.)

GARRETT: Did everybody hear that? (Laughter.)

And yet somehow, in your first year of operation, in August you were instrumental in the arrests of 80 people and the seizure of 10 tons of counterfeit drugs in East Africa; and in October, Operation Pangea III cracked down on illegal websites hawking counterfeit drugs -- 290 websites shut down, 76 arrests and a million pills seized. I'm not quite sure what might be.

But I am at a loss to understand how we should assume that INTERPOL has a serious commitment to this problem if you are two people, even two that work so hard that you're able to pull these arrests off.

PLANCON: Yeah, well, if you think differently, is how come INTERPOL came into the loop, into a pharmaceutical crime and an issue that he was not dedicated before? And how come in the history we've been trying -- and we are building up a capacity from the police point of view in order to provide an enforcement and an adequate response to these crimes.

So we are only two, but I'm proud that we are at least two, and we started with one. So when you think of it -- (laughter) --

GARRETT: You've doubled. (Chuckles.) (Laughter.)

(Cross talk.)

PLANCON: -- kind of increase in our staff, and we are getting better and better. So all I'm saying is, all staffing for us in INTERPOL; with this initiative at the WHO, this famous IMPACT; and we had some precedence in combating counterfeit medicine in Asia, but we were just baby born with that. And we had the opportunity and the willingness to build up this multi-disciplinary approach which we believe can make a difference.

So we've pooled resources. But with a number of networks, with a share of capacity that are not necessarily the same but that are complementary, we can make miracles. Like it was 2 million pills seized during Pangea. The countries where we've been interacted are starting with nothing, with not knowing even one another when we did some meetings between the police, the health and the customs. We've been trying to open the door to the private sector, which is also something very important to this project, and to get the scientific community helping them to identify the suspicious samples where we couldn't make it.

So, all in all, I would be more optimistic, saying that INTERPOL has been raising up the awareness towards its community with these crimes that we didn't know before, that is a serious criminal activity. The gangs are very sophisticated. They are very well organized. They know what they are doing and on which rules they are playing. We know that they are very dangerous of course, and they are using all the credibility and the weaknesses of the system, and what they want to do is money.

So the fact that we realized it. And they will never stop, because, so far, we're seeing the configuration where we are in a low risk for them -- the sanctions are very low, as you know -- and very high profit. So this is perfect. If you're a criminal, you should go into this business. (Laughter.) Therefore, the more we will stay into this configuration, and the less we will try and put the resources together -- that does not cost more than what it is now, it's just thinking differently, thinking outside the box -- we could make a difference.

And in our perspective in INTERPOL, we've tried to do that, and with the support of my top management -- Mr. Noble, and our member countries, we've been able to raise this crime as a top crime priority for the member countries of INTERPOL this year. So this is where we stand.

GARRETT: We earlier heard from Paul Orhii about the great dangers that enforcers, regulators may face in a country like Nigeria, and we've heard such stories from all over the world. There seems to be very strong indications that organized crime -- traditional organized crime is moving into this space in a very dramatic way, in part because they've been engaged in the theft and sale and counterfeiting of prescription narcotic drugs for a long time -- OxyContin, and Percocet, those sorts of drugs -- and then increasingly into drugs that have an effect on speed and diet.

But this -- it's a logical transition. These guys are pros. I mean, you're not up against some kids in a basement cranking out some phony aspirin.

PLANCON: Yeah, you're right, in the sense that they are very sophisticated. And they are testing the market. Some of them are pros in narcotics, and because of this benefit, they can make in medicines, they are testing the market to dedicate their activities onto purely counterfeit medicines.

We're also facing some gangs or mafias that are also dedicating their activities in other type of, what we call, pharmaceutical crimes -- and in that, we intend -- the theft of medicines, it is very common and dramatic for us, criminal activities, as well as the diversion, which is to us encompass the safety for the patient -- safety aspect, but also they undermine the credibility of the system.

So we are confronted to all these bunch of activities where these gangs are completely directing their activities, and they developing it, which is for us -- two, four, whatever persons we are -- a very big concern, and also for the INTERPOL community definitely.

GARRETT: And Greg Simon, I am sure that at Pfizer, while you may think it's wonderful that INTERPOL has an office, an office of two does not give Pfizer comfort when it comes to defending your brand. And I don't want to talk about your brand as a copyright issue, but what happens if drugs are released, claiming to be Pfizer drugs, that are actually poisonous, made by somebody else?

And so tell us what extent you go to, to essentially try to ensure the safety of the marketplace as a private corporation?

GREG SIMON: Well, first we're trying to protect our mission. Our mission is the ethical production of medicines that help improve the health of people all over the world. So if somebody thinks they're getting a medicine to improve their health, and they think it's a Pfizer medicine, and they don't get that, then we can't fulfill our mission. It's really not about the name on the pill; it's really about what's in the pill.

We train the government on this. We have the world's best anti-counterfeiting lab in Groton, Connecticut. We recently hosted over 20 people from the Commerce Department, and USTR and others. We have ex-FBI officials. We are constantly in the business of staying one step ahead of an organized effort that can make anything look like a real Pfizer drug, or any other company's drugs, whether it's the aluminum blister pack the pill is in, or the coding, or the labeling, or the imprint, it is constant battle to stay ahead. It is that sophisticated. This is not --

GARRETT: How large is your operation? I mean, what is this costing the company? How many human beings do you have in the field and in the lab in Groton?

SIMON: I don't know the costs, and if I did know, I probably shouldn't tell you. But just like when the president goes to India, we don't say how much we're spending on security. But I know it's not $200 million a day. (Laughter.)

But we have hundreds of people around the world. And, in fact, we have training sessions all over the world -- literally, all over the world -- where we go in and train local government officials and police on how to detect, and to check on medicines. So we have hundreds of people engaged. At the Groton facility. we have about 50 to 100 people. It's also part of our research facility in Groton, Connecticut, which is one of the original Pfizer locations.

But the issue here is, anything that substitutes a product that it's intended -- anything that interferes with getting a product to you that you think is going to improve your health is an assault, because either you're being harmed or you think you're being helped and you're not. And whether it's Lipitor, or a cancer drug, or pain medicine or a malaria drug, whether we call it counterfeiting, or substandard or falsification, it is an assault on patients all over the world. And we are focused on trying to create a system where that is treated as seriously as the sale of illegal substances that people want to take.

Here these are things people need to take and it's not treated as seriously -- if I could say it -- as counterfeit music and counterfeit movie DVDs. When I was in the government, our relations with France were determined by Jack Valenti. Every year he'd go to France and argue about the right of American films to be freely distributed in France, which didn't like American movie industry, and the whole government was involved in that dispute. And here we treat illegal pharmaceutical drugs as either an IP issue, which I don't -- which I don't think it is -- or something that's not worth the full force of the U.S. government and world government getting behind it.

It depresses me to say this, but four or five years ago I testified to Senator, at the time, Enzi and Kennedy's committee about the future of the FDA. And I pointed out that their entire budget to defend the entire country from bad food and bad drugs was equal to the budget of the education department of Montgomery County. How can we get there from here if that's all we're willing to put behind it?

GARRETT: In practical terms, if your lab in Connecticut figures out that something that field agents -- let's just say, in Kenya -- have seized and sent to your Connecticut lab to analyze, they figure out that indeed it's not only phony but quite dangerous, there's something in the formulation that could have a toxic effect on people, who do you call? What do you do? What's the steps?

SIMON: Right, well, first we call both people at INTERPOL -- (laughter) --

GARRETT: Ring, ring. (Laughter.)

SIMON: We call our government. We call the --

GARRETT: What agency in our government?

SIMON: HHS. We call WHO. Depending on what it is. If it's an infectious disease, we might deal with the CDC.

And here's the -- here's the odd thing: We are moving in this detection space from a world in which the focus has been on neglected tropical diseases and infectious diseases to what is now a U.N. summit coming up this September on noncommunicable diseases, which include things like cardiovascular disease, cancers, diseases of aging, so-called, where the medicines that will be distributed around the world are going to be not the medicines that are donated, like we donate Zithromax for trachoma -- it's a blinding infection -- but medicines that we used to taking every day, like a Lipitor, like certain kinds of antidepressants or pain pills.

There's a huge market internationally for people to illegally provide those medicines because the price for those medicines around the world are automatically higher than the neglected tropical disease medicines which are intended for the poorest of the poor. And the noncommunicable diseases will be intended for people that we think of as -- in the middle income countries with a lot of poor people, like some of the Middle East countries, or some of the South American countries. We've been working with the Gates Foundation on what's called tiered pricing.

So there will be drugs that will be priced for the poorest of the poor, and drugs that are priced for the middle class, and there will be a huge effort underway to steal one and give it to the other.

GARRETT: That's bad, that's illegal, but that's not getting to our safety issue. That's a --

SIMON: Correct. That's just a --

GARRETT: -- separate problem.

Well, let me ask you about one that is at it. I was recently in a meeting with the health minister for one of the poorest states in India, and he described that they don't really have any problem with antibiotic-resistant bacterial disease, and so on, because they don't have a black market in drugs. And the reason they don't have a black market in drugs is that all drugs are provided free by the government.

And I said, well, that's great as long as you're dealing with, say, tuberculosis and malaria. But what are you going to do with your health transition when you're talking about diabetes, and therefore insulin every day; or, you know, heart disease, and therefore antihypertensive medication on a daily basis, something of that nature? Then, all of a sudden, we can see an entry point for the creation of black markets even in countries that traditionally have not had them. And so it seems like this is another potential danger point coming ahead.

SIMON: Yes. And there are two specific examples:

PATH, a nonprofit based in Seattle, recently created a meningitis-A vaccine very cheaply, and that will be distributed in many parts of Africa where this is the particular type of strain that's affected. Whenever something gets mass distributed, that's helpful, people will start producing what looks like it's the vaccine and is not. So automatically you can assume that someone's going to try to get in on that.

At the same time, when we provide new technologies that allow people who are community workers, instead of doctors, to do subcutaneous injections of treatment rather than intramuscular, which is a little more difficult, those technologies are cheaper and they're more easily distributed, and they will be the -- they will be attractive to people to mimic, with awful health effects, incredibly bad health effects.

So every time you do a step forward in a health product, you have to immediately go on the defensive. And we, as Pfizer, cannot solve this problem; and we, as the government, cannot solve this problem. We, as government and industry, can solve this problem. But we have to get over these barriers that have come up over the years that the two shouldn't be cooperating, and that's one of the problems.

GARRETT: Okay, I'm going to shift to food for a moment, because --

SIMON: Just to cheer up? (Laughter.)

GARRETT: Just to cheer everybody up, because, you know, food is a bit better organized and regulated than is the medical and drug chain.

Caroline, over at -- from your point of view, first of all, we do have this long-established Codex Alimentarius. It's been in place now for, what, five decades I believe. And it is internationally recognized, most of the nations of the world are signed on. That sounds like we have global governance. Does it work? Is it?

CAROLINE SMITH DEWAAL: Well, Laurie, it certainly is a start. But I think you have to start where public health starts, and that's at the local level. And at the national level in the U.S. we are just transitioning into this preventive system from one that's largely responding to outbreaks that are already happening. What's happening at Codex is one piece of a regulatory framework.

You've been talking on the drug side about enforcement. That's another piece. Codex does standards setting, and that's very important, but you need the whole framework under which those standards are going to be applied, and that's what's missing in many governments. What's exciting about the Codex Alimentarius is that it is international governments at the point of the FAO, the Food and Agriculture Organization, and the World Health Organization, and those two coming together to agree that these standards are important both for public health and for trade.

The difficulty with it is that -- and just to finish on what is good about it, it is an amazing experience to sit in a room with 200 countries -- people speaking many different languages, there is simultaneous interpretation, so that everyone can understand the positions and policies being established by the different governments. That is an amazing thing.

GARRETT: Just on that note, I've had some people tell me that it was easier to define brie cheese in the Codex than in the EU. (Laughter.)

DEWAAL: Yeah. Well, and the difficulty with Codex is that at times it seems like it's kind of broken down into a debate between the United States and the EU on different policy matters, and a lot of governments are sitting around, some are taking one side or another, but it's really largely sometimes just bilateral negotiation that's happening there.

It would make a lot more sense to have more commonality between those two major trading centers. For example, on the issue of growth hormones and the use of certain drugs in animals, not for the health of the animal, but to promote -- to allow them to grow faster and develop more quickly to go to slaughter. There is not an agreement between the U.S. and the EU. And so sometime those fights break down on the floor of Codex and you have a lot of people's time wasted while you watch essentially something being debated in a forum where it can't be resolved. It's got to be resolved between the U.S. and the EU.

GARRETT: In the last 10 years or so, what category would you say has represented the greatest risks to human health in terms of food contamination -- chemical contamination, bacterial, or the transmission of antibiotic resistance?

DEWAAL: Your question is an excellent one, and the answer would go to what region of the world you're talking about.

And this goes to another central point that I think is important for this group to understand. If the U.S. tries to manage food safety risks based on the standards that are important to food produced in the U.S., we will be missing the mark when it comes to imports. We have to actually know what the hazards are coming from those different countries. Things like -- we did a research project looking at outbreaks in different global regions, and I can tell you from that research, the chemical contaminants come up much more in the Asian region as an issue of public health concerns than they do in other regions of the world.

Antibiotic resistance is clearly a hazard that I believe has actually emerged through certain food products in the U.S. already. For ground beef, it's shown up in numerous outbreaks, and also in dairy products, especially raw milk, which I wouldn't advise anyone consuming. So we have already emerged various strains of salmonella that are showing up in the food supply that are antibiotic resistant.

But I think the issue of pathogens and chemical contaminants, as they're moving across the borders, needs the type of comprehensive approach that I think the commissioner was referencing in her first talk today. It's critically important, but we need to recognize that some of the tools to accomplish it already exist and need to be strengthened and further developed.

GARRETT: Michael Robach, I want to ask you a question about complexity, and before I get to it, I want to start with an anecdote, if you'll forgive me.

A few years ago there was an outbreak of E. coli 0157, including deaths in school children in Japan. The Japanese agencies were able to determine that it had something to do with school lunches, but couldn't figure out exactly what was responsible -- how these kids were getting E. coli -- and ended up shutting down schools all over Kyoto and Tokyo.

It was eventually determined, through about two years of investigation involving scientists at academic and government levels in at least four countries I know of, that it was all because the daikon seeds for those horseradish sprouts, that are so popular in sushi and sashimi, had grown in Idaho downstream from a big cattle site. And the E. coli had been shed by the cattle into the water supply; ended up absorbed into the seeds, so they could not be washed off, and they could actually be passed multi-generationally in the daikon.

This was an incredibly complicated chain of events. No one could have imagined such a thing. And nobody's regulatory or research systems are in place in any country I know of that could quickly track that one down, and have made it resolved in less than about the two years it took to figure it all out. I wonder if you can describe to us the complexity of the chain of what we call our food supply? Where is it coming from, and how much more complex is it as you escalate up to processed foods?

MICHAEL ROBACH: Well, I think you make a very good point. It's an extremely complex system. We look at the food system from origination, starting in a farm field, all the way through final consumption, and you can take many, many steps along the way. I remember being at a meeting -- the International Association of Food Protection last summer out in California, and there was an Irish professor giving a talk. And he put a hamburger -- a cheeseburger, actually -- up on the board. And as he went through all the components of that hamburger, with the lettuce, the tomato, the condiments, the salt, the spices, the bread, everything, I think he counted 54 countries that were involved in the production of that particular hamburger --

GARRETT: Wait. Let me just get that right. When you eat a hamburger, you're eating 54 countries? (Laughter.)

ROBACH: You very well could be. It is possible. It is possible.

And I take this -- I live this every day. I work for Cargill. We're a large international agribusiness firm. We operate in 67 countries around the world. We have about 1,200 food processing plants around the world. So this is my world. You know, this is what we live with each and every day and it is extremely complex. It's not simple. And it takes an awful lot of work, not only within the company, but then also with our suppliers, and our suppliers' suppliers, to really be able to focus in on what's really important from a positive public health standpoint.

And I want to go back and talk a little bit about something that Dr. Hamburg mentioned this morning, and that's something around alignment, and that's really getting focused on those elements that are extremely critical to the safety of our food supply. And one of the things that we've done within Cargill is we've taken the principles of Codex Alimentarius -- the principles of good hygiene, prerequisite programs and HACCP, and used that as the basis of our food safety systems around the world. So regardless of where we're producing, processing, marketing and selling, and eventually having consumption, we're operating against a single standard that are focused on those elements that are critical to the safety of the food.

People often get food safety and quality mixed up. They're very different. I mean, safe food is safe food, and those criteria are very clearly identified as you go through your risk assessment and do your hazard analysis, and understand what are those emerging issues or those existing issues that could impact your food supply? And you need to understand that, and have appropriate interventions in place, and be able to manage that risk to the best of your ability -- not that you're always going to be able to eliminate it, but manage it to the best of your ability.

And then, working with your downstream customers -- as we do with the McDonalds, the Nestles, the Krafts, the General Mills, the Coca Colas of the world -- working with them to make sure that what we've done to our products are also then carried on, so that they have the same systems we have in their products, and then working with consumers to assure that they understand their responsibility in handling and preparing food properly.

GARRETT: I'm going to ask you a question that Greg so skillfully dodged. (Laughter.)

If the FDA's budgetary capacity to deal with food and drug safety is about the same as the school system of Montgomery County, I'm going to take a wild guess and say that Pfizer is probably spending closer to the school system of New York City on their side of ensuring drug safety, at least for their product lines. What do you think is the ballpark of what kind of expenditure the private sector is making to take care of food safety?

ROBACH: I think the private sector is, you know, spending a tremendous amount of money and putting a tremendous amount of resources against food safety and assuring our food supply chain.

Clearly, the industry spends a lot more money than governments are capable of spending. And that's the way it should be, because it's our responsibility to make sure that we have a safe and a secure supply chain. So it is something that I feel personal about. I know my company, Cargill, our mission is to be the global leader in nourishing people, and we take very seriously.

And I look at the role of government as not necessarily to control what I do, but to make sure, and assure that companies are doing what they said they were going to do to produce safe food. They have an oversight responsibility. They don't have an active management responsibility. That's the responsibility of the private sector. Government's role is there to assure that what we said we were going to do, we're doing, and that what we said we were going to do is producing safe food.

And in that way I look at it as a partnership. And there should be alignment between the public sector and the private sector which, to me, gets embodied in those principles of Codex, the prerequisite programs and HACCP. And if we're all operating against those same criteria -- government from an oversight position, and industry from a business practice standpoint -- we're going to be in much better shape from a global food supply chain than we are today, where we've got things all over the board, and a lot of the things that we do for regulatory compliance have very little to do with food safety.

GARRETT: Well, let me come back to the "who do you call" question. We've heard that Paul Orhii has a blacklist in Nigeria of repeat offenders -- essentially, companies putting out fraudulent or unsafe products. That's one method of approaching it.

We heard from Greg a long list of who to call: There's some WHO (to) call, there's a call to INTERPOL, there's calls to CDC and the FDA, but not one sort of 911 version of: we found a violation; this is who I call.

If in food you -- I mean, your first thing of course is to say we're not taking your product into our system, our chain, because it's not reliable, but if you have a grower, a distributor, a processor that you see violations in repeatedly, is there a phone call?

ROBACH: Well, there's always a phone call.

There's an organization that we're part of in Europe right now that was formed within the animal feed industry -- because we were having folks coming up through Rotterdam with barges full of tainted soy beans and trying to sell those soy beans into the food, into the feed industry. And we finally formed a consortium of feed manufacturers, so that when somebody rejected that barge the first time, an e-mail went out to everybody else up the river. Because, they would just go up the river until they finally could find somebody to buy it. So now we have this early-warning system in place where an e-mail goes out, everybody knows what's going on, and then the Dutch government is informed. And that has really stopped that trade.

So we have a number of organizations that we work through. We have the GMA organization here in the United States. We work within some European, some Asian, some Latin American organizations where industry talks to one another. And when we know somebody is trying to move something that is economically adulterated or it's not what it purports to be, we have mechanisms so we can talk to one another. And we do talk to the FDA and we do talk to the USDA about things like that, because that is part of the partnership, and that's part of --

GARRETT: But there's no 911 for food --

ROBACH: There is no 911, you know. I mean, if I've got an issue with food, I'll pick up the phone and we'll call Mike Taylor at the FDA and say, hey, Mike, you know, this is going on, so he can get ORA involved and they can take appropriate action. Or we can call USDA, we can call FSIS and say, hey, something's going on out there. And we talk to our inspectors every day in our plants.

SIMON: Let me -- (inaudible) -- your question. (Inaudible) -- than us calling other people, we now are distributing technology for people who receive the drugs to text the supplier -- the legitimate supplier to see if the code matches this legitimate code. This is done in Africa so that you have a way of verifying that the lot you got is the lot that was supposed to be distributed. And this involves the pharmacist and the distributors locally, as well as the company internationally, so that we're using texting technology, because cell phones are far more distributed than anything else. We can now help people verify that they've gotten the real thing, and that's much better than us trying to chase the bad thing down.

GARRETT: Well, one of the big issues, Aline, that is an increasing problem on the drug side -- and there is evidence of it all over the world -- is stolen drugs intended for humanitarian relief purposes or for distribution through The Global Fund to fight AIDS, tuberculosis and malaria, or any of a number of bilateral programs that are part of health and development.

I know that I had the experience -- I traced one supply on the ground from -- donated by UNICEF and a host of other humanitarian groups to Ethiopia. And the drugs then were -- ended up in -- the drugs were then hijacked by Ethiopian thugs, basically, then sold through to Ingushetia, inside of Georgia, the often contested and recently source of warfare between Russia and Georgia. It was a sort of lawless state run by criminal gangsters, and their main source of income was stolen pharmaceuticals.

They didn't even remove the donation labels off these things. But I found them in marketplaces from Central Siberia all the way into the Czech Republic, all intended originally to help dying people in Ethiopia. We now have the scandal where The Global Fund is facing some real serious charges because they found that many of the funds distributed to key countries in Africa have, quote, unquote, "disappeared," and a lot of the antimalarials, the bed nets and anti-HIV drugs have, quote, unquote, "disappeared."

Now, one of the trends in all of this is realizing: Hey, you know, I make a certain amount of money. If I take the stolen drug and sell it somewhere, well, I can make twice as much money if I dilute the stolen drug down by 50 percent, repackage it, and now I sell twice as much elsewhere.

And this seems to be a rising trend. Now, are you -- do you have any capacity to intervene in these situations?

PLANCON: Thank you. First, I've got a question. Do you want to join my unit in INTERPOL? (Laughter.)

GARRETT: (Chuckles.)

PLANCON: Now, regarding these crimes, that's true that the first time we've been developing our capacity with (the Codex ?). So INTERPOL is a big family. We've got a network of 188 member countries, and we've got this automatic exchange of intelligence and also criminal information instantaneously -- oh, it's difficult in English. And so we are able to connect all these people together. You know, that you -- when you've got a guy who is arrested and identified in one country, you can immediately identify and inform the other countries where he stands.

So this is the criminal models behind, so now what about the products? And the problems that we are facing is sometimes it's difficult to know where the products are coming from. It's like we know where they are, we know -- we can identify some of the criminals behind, but we don't really know the whole picture, because we need to develop our capacity with the member countries, with the agencies we are working with, the private sector and all the others.

Now, we've been also facing this situation regarding the diversion and the theft. For the first time last year INTERPOL provided its capacity, services and communication to support the major theft that happened in the U.S. in order to alert the police forces all around the world of the possibility for them and for the health agencies to find out some products that were part of the theft. And therefore --

GARRETT: What was the -- can you tell us what the product was?

PLANCON: The product, no, but the company was Eli Lilly --

GARRETT: Okay.

PLANCON: -- and they are -- we are working, such as the others, through some networks. And so this went through the attention also of the police that we are also are trying to educate in investigating that crime.

As far as the diversion is concerned, it's also something that we've been immediately confronted with when we started this operation that we coordinated. And we found that some products could come in one country and would be found on the opposite side of the continent. But still no traceability and no -- (inaudible) -- from the, you know, people who sent it.

And so what we believe we've got is that there should be a change of mentality from all these donors and also the countries receiving these goods, so that we could develop a monitoring system that would not be constrained for anybody, but to involve this enforcement part of it that makes the chain safer, and that would allow the patients who should be getting these medicines to really get it, because at the end of the day sometimes they don't have it.

So by developing this investigation, and we are involved in some of the investigation of major diversion, we would like really to see a change into this -- into this approach of, you know, trying to investigate this crime, or at least to address it from everybody's perspective, and of course including ours.

GARRETT: Well, Caroline, everything comes down, whether you're on the food or drug side, to the ability to enhance surveillance and monitoring on the ground. You want countries, regardless of where they stand in GDP and where they stand in categories like "poor country," "emerging market," "developed," and so on, to have the capacity to do surveillance, and to be able to tell that the powdered milk actually is made from milk, as opposed to a chemical like melamine that was meant to be a coating on kitchen cabinets, or that the cough syrup is really cough syrup.

When we talk about enhancing surveillance capacity, sometimes it sounds like empty words. Who's doing the enhancing, and who's paying these people to do the surveillance? And how real is this, quote, unquote, "enhanced surveillance capacity?"

DEWAAL: Well, surveillance is the real portion of our food supply today that's happening at the local level. Public health surveillance -- which is where the outbreaks are occurring, documenting illnesses, deaths, hospitalizations -- that is the function of local governments.

And today that function is being severely threatened. We just did a survey of the U.S. when it came to food-borne illness outbreak surveillance -- which we think is a key indicator for any public health monitoring system, because the outbreaks occur fairly regularly, fairly predictably -- and we found a huge range. The best states are reporting about eight outbreaks per million population, but many states in the U.S. are reporting much, much lower than that, sometimes one outbreak per million or even less.

So we have a real crisis on the ground with local public health, and that's in a country that's quite wealthy. We've been starting to look at surveillance -- informal surveillance systems in other countries, in other regions of the world and, you know, we made some very interesting findings. I mean, Africa has a lot of reporting, but the outbreaks are huge and they're not well documented. You know, it's always reported as a water-borne outbreak from cholera, but we don't really know what's going on because they don't often have the lab capacity to do that.

The World Health Organization is right now setting up regional labs and working with governments and regions to ensure that they do have capacity to do this basic monitoring, and that will be helpful also as we improve for antibiotic-resistant strains of food-borne bacteria that can be coming through the food supply. So there is an effort to make this improved surveillance, but it really -- that surveillance component is really important because it tell us what we need to know about the imports that are coming from around the world.

Melamine -- nobody predicted melamine. But it actually came here first and was put into an ingredient that was used in pet food. So, in fact, we had the canary in the coal mine there when we had a major crisis in pet health because melamine had been consumed. That same ingredient then showed up in the infant formula in China and killed at least 50 infants and sickened thousands -- tens of thousands.

So it's really -- we need to listen to the surveillance, we need to recognize the canaries, and we need to take action a lot faster than I think we are today.

GARRETT: I want to ask each of you the same question before we go to the audience, and that is: If, indeed, you did have the ear of the sherpa team planning the G-20 for next year in Washington, what might you hope them to consider as a potential global policy initiative for the area that you're most concerned with?

And I'll start with you, Mike, down at the end and work our way across.

ROBACH: Well, I think the one thing that I'd like to see is better alignment across national governments, an alignment based back on -- and I said it before -- on the principles of Codex Alimentarius, both the prerequisite programs and HACCP.

And, you know, I believe that if national governments take those principles and use those as the basis of their regulatory programs, and we do that consistently, we're going to be in a much better place from a global food supply chain. The industry is already moving in that direction. The Global Food Safety Initiative is a consortium of small, medium and large companies, both producers, processors, retailers and food service -- food service providers, and we have adopted these benchmarked audits against food safety systems that are based in Codex as the way that we're moving our industry forward. And we're not only doing that within our own companies, but we're also driving this back to our supply chains.

And we talked earlier about capacity-building, and the GFSI group has put together an emerging markets program where it provides capacity-building through training and a step-wise progression through the process, so that emerging economies can adopt the critical elements in one year, and then build on that and adopt the next 50 percent of the principles of Codex the next year, and then finally through the third year become fully complaint. So it's a way -- it's an orderly way to build capacity, and build education and training in our supply chains, so that we're all focused on those elements that are critical to safe food.

So if governments could go through that same process and come to an agreement on what's important, and let's get alignment around those issues and provide regulatory oversight accordingly, I think we'd all be in a much better position.

GARRETT: Well, so far, if I'm the G-20 sherpa, you're music to my ears because you didn't ask for money. (Laughter.) You asked me to "align," which we can all release a statement and say: We shall endeavor to align. (Laughter.)

Aline?

PLANCON: Well, first I would ask the sherpa to put the line onto the agenda, okay, pharmaceutical crimes and public health and safety protection.

I think that if I would be able to convince, or to have my wishes come true, it would be to have this (equation ?) between the global health policy and being very sincere in putting in this enforcement -- necessary enforcement aspect in order to protect the public health and ensure the safety of the patients, which is recognizing that pharmaceutical crime is there, recognizing that we need to work together, that the model that we are experiencing are good, but they are definitely not enough and we need much more support in order to develop in a proper way.

And so try and get out of this situation where -- which is completely paradoxical, where we've got technical work that is very well recognized from the experts side, but the political world that are challenging the technicians because of ideological controversy. So I would wish that this controversy would find a way so that this global governance could embrace this ideology, where we can work together with different perspectives but aiming at the same goal.

GARRETT: Okay, now, I don't -- I think you also asked for an aligned policy.

PLANCON: No, because --

GARRETT: Did you have a budget?

PLANCON: Yes, I've got a budget proposal for you. (Laughter.)

GARRETT: Oh, you do. (Laughter.)

So you're coming to the G-20, and you want to what? I think you want to more than double your two personnel at INTERPOL.

PLANCON: Yeah, what we want is to replicate the -- (inaudible) -- impact, which is really getting all these branches of systems and competencies that together are making miracles.

GARRETT: Oh, miracles. Okay.

ROBACH: Laurie, Laurie, one point before I will leave I want to make clear. You made a comment about asking for money, I'm not asking for money, but what I would ask governments to do is to take a hard look and reallocate resources against those issues that are most important around prevention and focus on positive public health outcomes, because we spend an awful lot of money in infrastructure around the world, and governments around the world, that are not, in my opinion, moving us towards a preventive system, nor is it necessarily having a positive impact on public health.

So I think we can do a lot of reallocation out there and be a lot smarter about the way we spend our money.

GARRETT: (Audio break.)

SIMON: A lot of money for implementing in the G-20, a system to track products that can be accessed in any pharmacy anywhere in the world with a cell phone.

And we know how to do this. A few years ago, my credit card went to Istanbul without me. (Laughter.) And the credit card company called and said, are you in Istanbul? And I said, no. And they said, well, your credit card number is in Istanbul. And so if we can track that, we can track food and drugs that need to be labeled and tracked.

The financial services industry knows more about you than any other business -- not your doctor, but your financial services company, and if we can use that technology to guard health, it'll be a huge improvement.

GARRETT: So you want the G-20 to fund an agency to execute that?

SIMON: I want to be able to distribute that technology all through the G-20.

GARRETT: So what do you think that price tag is? Ballpark it. One million (dollars), 100 million (dollars), 1 billion (dollars)?

SIMON: Well, there's already a standard to do this, so you don't have to invent how you do it. So the technology to do it is, I would say probably in the G-20 I would predict that it would be less than $100 million, because what you're doing is you're educating people (that) they can do it using existing technology, and we already labeled the lots of drugs and we can do that more efficiently with this new standard. So this isn't about money so much as it is about awareness and commitment.

GARRETT: Caroline, you're on.

DEWAAL: All right.

Well, first, we're going to need a lot of money. (Laughter.) No, we're going to -- I would, I would approach them, first of all -- Mike and I are generally in agreement on the framework, so let's put that to the side. We all like the framework. In order to get that framework implemented, though, in a meaningful way, first of all, I would want them to fund these regional labs, and countries that want to participate should be monitoring -- sending samples in so we can monitor and determine the highest food safety risks for those countries.

And then those participants -- I bet Nigeria is right up there at the front of the line -- will get, like, I don't know, how much would a country need for capacity-building in this area, so we can build, develop the framework for that national program that can implement the preventive control systems, that can monitor that the companies are actually doing that, the things that are already built into the new U.S. law, and we could implement that framework through capacity-building.

So, Laurie, in short, I do think it would be expensive, but I think that capacity-building in this area will provide a huge benefit to that organized consumer voice. We talked about that in the last panel. We really need consumers to demand safe food and safe drugs from their government. And the industry plays a major role, but consumers can demand from their political players that these systems be implemented. But systems shouldn't be stovepiped just for exports. They really need to benefit the consumers in those countries.

GARRETT: Well, I can't help but think, if I'm a member of the United States Congress, the European parliament, any place where budget tightening is the name of the game right now, that I am going to take note of the massive level of expenditures that private sector is already making in these spaces, and wonder why it should involve more money coming from my taxpayers as opposed to levying the industries in some way. Why not a penny for every apple sold going towards apple safety? It seems to me as a consumer, one penny per apple, especially what I'm paying for apples these days, is not bad. (Scattered laughter.)

Let me, on that pontificating note, open it for your questions. And we'll start over here with Yanzhong Huang.

QUESTIONER: Yanzhong Huang from the Council on Foreign Relations.

I have a question about the marketing of counterfeit drugs. And according to WHO, half of the counterfeit drugs are marketed online. And online marketing we know that the counterfeiters operate through sites, you know, that could conceal their locations, identities. And some actually operate through those very, completely legitimate sites. You know, I -- whenever I went to a website of a major newspaper in Singapore, I would see this, you know, advertisement marketing so-called authentic Viagra, you know, on this site. (Chuckles.) And maybe Greg could address it.

Another problem that we have seen is that, for example, in Eastern Europe we saw that the counterfeiters actually tap into those drug trafficking channels to market their drugs. You know, so there's perhaps in some cases previous drug traffickers become today's counterfeiters, because this is less risky and equally profitable, if more -- if not more.

So I wonder maybe Aline now, or Greg could answer this question about how you address this non-traditional marketing issue.

GARRETT: Let me go first to Aline with the website issue, since you have already successfully cracked down on 290 of them.

PLANCON: Mm hmm. Yeah, the Internet -- "the cloud," as we call it -- is very challenging for all type of criminality. And that's true that these counterfeiters or the criminals use -- are using the Internet facilities to develop their business and to make sure that they can create, distribute, trade and deliver the illicit and counterfeit medicines using this Internet.

So through the experience that we've got, and thanks to the support of 44 countries, I mean, police, customs and health regulatory bodies, we could see and we could really experience -- see a really big difficulty to address that crime. And the reality is that the fact that no regulation on Internet is there poses problems to us is enforcement sure, tracking down the websites. And especially where they are is a challenge for the investigators, because effectively the criminals are going very quickly and they are very well organized in shutting down their websites and opening it again.

But with the public-private partnerships -- and in that I'm thinking about the service payment providers, for example, with the support of the banking system and the anti-money laundering agencies, we could try and develop some comprehensive enforcement, and combine activities whereby we are able now to understand a bit more what they are doing. And they are not doing only counterfeit medicines, they are doing other type of activities also in Internet -- I mean, using Internet. So I will answer my question, but open it to the others.

SIMON: Well, the good thing about the Internet is that you can also get the message back out about how dangerous it is to do this.

So you probably can't see these, but if you really want to get sick, go to realdanger.co.uk where they have a series of ads, one of which shows a man taking a medicine he bought online and pulling a rat out of his mouth. Another one shows a morgue and is says: When you buy drugs online, you may end up paying with more than a credit card. There have been study after study that shows how impervious people are to the dangers of buying drugs online.

And our people in Groton, Connecticut buy drugs online that they see advertised, and test them, and they do exactly what you say: They will be advertised for some virile purpose and they'll have a tiny bit of Viagra, and then they'll have a bunch of other staff, most of which is dangerous. So it is a real problem. And the Internet community, through social media, is part of the solution too.

GARRETT: Snake oil would be safer. (Laughter.)

SIMON: Snake oil, you know, the FDA got started on snake oil, and here we are a couple of hundred years later, a hundred years later -- (laughter) -- and we're still dealing with snake oil.

GARRETT: Way over here.

QUESTIONER: Liz Wishnick, Montclair State University and Columbia East Asian Institute.

My question is about food safety. We talked a lot today about empowering consumers. And I think that's a great idea, except consumers don't have enough information. For example, during the melamine crisis milk products were not on the list, where a country of origin had to be stated. So how do you know if you're buying something safe or not? I'm also told by my colleagues in the food sciences department that even food processors don't keep track very well of the origin of different batches of ingredients, let alone inform consumers about the country of origin of these ingredients.

So how are consumers supposed to be empowered without information? And what steps are being taken by corporations and governments to provide more information?

GARRETT: Mike, I'm going to throw that to you.

ROBACH: Sure.

No, it's a highly complex question. And I think we have to be careful. There's been a lot of work done around country-of-origin labeling. And I know in the meat business we deal with that. And we have cows that are grown in Canada and processed in the U.S., so is it a -- country of origin, is it Canada, or is it the U.S. or is it both? And what you end up seeing on labels when people are being required to do that, they're going to just throw on 10, 12, 13, 15 different countries. You know, whatever that ingredient may have come from, they're going to throw, you know, the name of the country on the label, which I don't think is very helpful to consumers.

So I take a step back and get back to my -- the whole concept of having food safety systems in place that are focused on those essential criteria. And I think that's where industry can do a better job of promoting the things that we do around food safety systems; and partner better with government, so that we're working more hand in hand in making sure that the systems we're using throughout our supply chains are giving us assurances that the products we put on the marketplace are safe. Because, from a perception standpoint, we want to have safe products in the marketplace. Recalls and illnesses don't do anyone any good. It doesn't do us any good. It doesn't do the government agencies any good. We all look bad at the end of the day.

So we do have a shared, I think, goal to make sure that, that doesn't happen. But, as you say, we also need to pull consumers into this, so that they understand what their role is. And that's just a precept of risk management is, you know, making sure that people are aware of the risks so that they can do something about it, as well to protect themselves. And we haven't done a real good job in that in the past. And I think right now we're starting to move in that direction. USDA is now working with the Ad Council on a series of public service announcements that will talk about safe food handling, and you know, where consumers have responsibility and accountability to make sure that they're doing things properly.

Obviously we have the responsibility to apply the best technology, the best science to our processes, and do the best monitoring to make sure that what we put out on the marketplace is safe. But unfortunately, when it leaves our facility, that's not where the road ends, and it moves forward. So we do have to do a better job of communicating and educating.

DEWAAL: Laurie, can I just add, though, this is also where the role of organized consumer associations does play a role.

During that melamine crisis, we were watch-dogging FDA to determine whether products had been released in the U.S. And through a project called Safe Food International, we also notified consumer organizations in other countries, some of whom then brought it forward to their governments. So there is a role here for the organized consumer movement who then can watch-dog their government.

ROBACH: We actually did a project in collaboration with -- I think, I think you were involved, Caroline, and Consumer Federation of America during the H5N1 outbreak. And we actually put out a sponsored piece that Consumer Federation of America with CSPI put out to their members about, you know, how you could protect yourself from H5N1. And I thought that was a good example of that collaboration between the industry and the consumer groups to get information out to people on how they could best protect themselves.

GARRETT: Okay.

Right there. Is it Seth?

QUESTIONER: Uh-oh.

GARRETT: Oh it is. Uh-oh. (Laughter.)

QUESTIONER: No, I'd like -- I'd like to keep going on this point.

GARRETT: Introduce yourself, please.

QUESTIONER: Seth Berkley, International AIDS Vaccine Initiative.

You know, maybe people care if things were made in 15 places. And maybe it would be good if that was on the label, because then people could choose. And I'm where the previous questioner was about this. In the melamine crisis, one of the problems is you didn't have an idea of origin of anything, and if you wanted to act responsibly, it was very difficult to do that.

Now, why is that important? From my perspective one of the things we have to do, with razor-thin margins -- and clearly, a country is going to try to push out their technologies, their foods, their drugs to others -- is you're going to have to have some type of consumer standards on quality, because you can't, you know, regulate your way out of this and test your way out of it. And so if one government, one source continues to be a problem, by, you know, having consumers know that products from that source, and if they vote with their feet, that will have a profound effect then on, you know, those governments wanting to crack down. It doesn't deal with obviously the, you know, illegal side and counterfeiting and gangs, but I'm talking about the local regulations.

And I think, you know, if I look at what's going on in the vaccine area, when a national regulatory agency gets condemned by the WHO, or reaccreditation gets pulled away, you know, it changes the dynamic in that country. And so I think -- it seems to me that, that pressure has to happen here, and I'm just wondering how one can make that happen?

SIMON: I think the question belies a sense of optimism about all things.

We tell people how many calories are in the food they get now in New York in fast-food restaurants and delis. It hardly changes any behavior. I think it's putting too much on consumers to boycott things from Thailand that say -- that are one of 50 countries listed on a package. I think that's incumbent on the manufacturer.

I think that we cannot get the -- the FDA cannot inspect the world. Those of us who buy products from other countries, as Pfizer does, have to enforce our standards on them, and when they violate those standards, it's our obligation to get them out of the chain.

And I think the FDA's job is to make sure we're doing our job, because they don't have enough people to do our job. Pfizer gets an enormous number of products now from other countries, and we require them to meet our standards in every way, and we do the inspecting. And then occasionally the FDA inspects our facilities overseas. They can't possibly be the first vanguard. And consumers can't either, because if they're not noticing the salt content of their food, they're not going to notice where the salt is from.

ROBACH: I would also -- I would also agree with those points, and I think it is incumbent upon the individual company to make sure they've got control of their supply chain.

But I also don't want to go down a road where you malign an entire geography for few bad actors, because you can only take a look at -- within the United States, and we have the same issue. We had the Peanut Corporation of America, which was a U.S. corporation which was not doing what they were supposed to do.

So you've got great plants in China; you've got bad plants in China. You've got great plants in the United States and you've got bad plants in the United States. So I think we have to be very careful that we don't overgeneralize this as a geography or a country issue.

GARRETT: You know, this reminds me of a question in the earlier session regarding brand.

One would argue, based on the experience that Jack in the Box went through, when E. coli 0157 was first discovered through their sale of hamburgers and children getting sick, and came to be known as the Jack in the Box disease; or that Tylenol went through many years ago as a result of a deliberate poisoning of a Tylenol bottles, and the company took more than a decade to bounce back to their original market position.

So one would imagine that brand protection alone would put a huge pressure on, but about all those steps in production? They have nothing to do with the brand. There's no brand label on my apple -- if there is, I'm ticked off -- or on my orange, it might say it came from Florida. So where -- what do we do about those segments where the brand pressure is not really an element?

ROBACH: Well, but there's pressure from the retailers on what they're buying and how they're buying. And so it's the retailers' brand. If you buy a bad apple, and you bought it at Safeway, you're going to be upset with Safeway, or Kroger or whomever you bought it from. So there is a responsibility of the brand that's delivering the food to the consumer. And there is brand equity there, because if you have a bad experience at a retailer, you're going to go someplace else.

GARRETT: Well, if all that took place --

ROBACH: So there is --

GARRETT: -- why isn't it working?

ROBACH: Well, I think we have to put things in perspective again. You know, I mean, it's not working as well as it could because we have a lot of disconnects that still exist. We have to do a much better job of coordinating our overall approach as it relates to food safety.

On the food side -- the meat side of the business is a little more organized, with USDA and FSIS having inspectors in every facility, doing continuous inspection as we heard this morning. On the FDA side, a lot of plants never see an inspector for many, many years, and if they do, it's usually because there may be a problem associated with that plant.

So on the USDA side, the focus has been on prevention for some time. FDA now, with the food safety modernization act, is now moving in the direction where this prevention focus is going to be part of the way business is done, as opposed to reacting to a problem: Let's anticipate and prevent as opposed to just react to.

GARRETT: Okay.

Way in the back there's a hand I've seen. Yes, you.

QUESTIONER: Thanks. Nancy Turett, from Edelman.

While we're talking about what experts need to do -- big companies, people with Ph.D.s, people who are policy leaders -- and looking at short-term issues, I just wanted to put on the table, and it's not maybe for this agenda, that we have a long-term challenge as well. And as you're talking about consumers -- thinking about what are the literacy requirements that really should be part of our school curricula around the world, as we're asking consumers to be able to make more and more decisions, whether it's about what they're eating, how much they're eating, where it came from, et cetera -- When we look at the financial crisis that we had globally, very recently, and it's actually still having some impact, one of the things there was a lot of discussion around was the financial literacy of consumers, if we're actually selling very, very high-stakes things directly to them.

GARRETT: So this is an interesting question. I was recently in a meeting with -- that I referred to before -- with a gentleman from India, and we were talking about using SMS texting to alert patients that it was time to come in for an appointment, what have you. And then it suddenly dawned on me, having spent time in India, and I said, wait a second, in your state, what's the literacy rate on women? And he said, 70 percent illiterate. So, so much for texting and cell phones to ensure drug safety, and so on.

SIMON: Well, that's why Howard Zucker, who may still be here -- Howard there -- worked with my old boss, Michael Milken and Tommy Thompson to send talking books to Afghanistan for illiterate women for prenatal care -- in their dialect. They could just see the picture, touch it, and it spoke to them about what they needed to do at every stage of pregnancy. There are answers to all of these issues.

QUESTIONER: Well, but putting high-risk products in consumers' hands -- I mean, I think the food industry agrees that we want to minimize the number of truly high-risk foods. But in developing countries, educating consumers on boiling water, sterilizing their water sources, and how safe food preparation is something that's got to be done whether people are literate or not.

ROBACH: When you said --

GARRETT: We have time for one --

ROBACH: But most of them -- but most of them know how to do that better than Americans.

QUESTIONER: Yeah.

GARRETT: We have time for one last question.

Right here.

(Off mike exchange.)

QUESTIONER: (Inaudible) -- Evian (sp).

I think the root cause of this is the speed of the change, and the fact that the oversight infrastructures didn't keep up with the change. And you now have people taking advantage of it because it's extremely profitable. So the question is all about enforcement and sanctions.

And if you look around the world, of all the agencies that I know, and there's probably a dozen of them, there's only two where the inspectors are actually trained to look out for fraud. In other words, an FDA inspector will go abroad and he'll first check whether: Can I believe these people? Can I trust them? And the Italians also -- very well trained. Everybody else assumes everybody is honest. You can't do that. (Laughter.)

GARRETT: I'm going to give this to Aline to comment.

PLANCON: That point --

GARRETT: Oh, sorry. You're not done?

QUESTIONER: No, I'm sorry.

The other issue is the industry has offered to pay for inspections for over five years. And what the industry sees is the regulators inspect based on proximity and not risk. They only inspect domestically because that's their comfort zone; they never go where they really should.

And I suppose the question to Aline is, what are you telling everybody that the regulators should be doing? Or is there a way that you can communicate to the regulators on what are their weaknesses and what they need to do?

PLANCON: Yeah, well, thank you.

First, in terms of enforcement, I agree with you that it's like corruption. I mean, you can talk about transparency and, you know, be candid, but as long as you don't enforce or you don't have enforcement behind the back of your head, people will not behave well. And I believe this is exactly the same with the counterfeit medicines and pharmaceutical crime. I believe that, as far as we are concerned, the experience we've been having with the regulators has been very interesting and very enriching us. And as long as we've got some progress to make, as police, we understand that the regulators also confronted some -- a number of challenges.

And I believe exchange of information, and really a timely manner exchange of datas among themselves, and maybe combine it with a police big database that we, you know, we experience and is working fine, may help train and sort out at least some critical situation whereby the patients or the society could know, and the regulators could maybe react in a timely manner.

So I cannot say or I cannot explain what a regulator would or should do. But what I can say is, by working together and exchanging the experience and the best practices, and building up the capacity together in that crime, really made these societies or agencies make a big step in improving their own methodology and capacity in enforcing that crime.

GARRETT: Well, I want to explain to everybody what our next steps will be at the council.

It is our intention to not drop the ball with this very excellent day of discussion, but rather to see this as the beginning of a process, which will now go to a closed-door process entirely off the record, a select series of meetings in conjunction with our partners at Chatham House in London and partners that we are developing in Asia. We hope to have key players engaged in each of these meetings going out over the next eight to 10 months with some hope of providing a clear policy advisory for the White House going towards the G-20 summit of next year.

So please understand this is only the beginning of the process. Stay tuned. If you feel that you would personally very much like to engage in this, please be in touch with Dan Barker.

Dan, could you stand up, please?

Dan works with the Global Health Program. And give him your card and indicate your interest and what particular subject area you may be most keen on focusing on.

I need to thank a number of people that have made this event happen:

The Robina Foundation for their financial support, that paid the airfare to bring so many wonderful people here today.

And of course Commissioner Hamburg, both her strong interest in this area and her very dedicated staff that worked so closely and made this possible. It's unbelievable for us. We're accustomed here at the council, dealing with things like United Nations agencies, where we fire off e-mail after e-mail after e-mail for three or four months before anybody responds. And with FDA, it's same-day business. Ahh -- (laughter) -- so fabulous.

And I want to thank a number of key staffers here in New York who've played a role. I pointed out Dan Barker.

Where is Zoe?

And Zoe Liberman, also of the Global Health Program.

Yanzhong Huang.

And Stacey La Follette, who is here somewhere, who was one of the key players in making this meeting happen.

I think that as a final note, I began earlier talking about the question of global governance, one of the interesting possibilities as you look at this food and drug space is that every human being on planet Earth has a stake in seeing this resolved. This is not an abstract problem like climate change, where many people can convince themselves that either it's not occurring, or it's too big and they are just a little person, what can they do about it, et cetera. Every single person on the planet takes drugs, depends on medicines, has injections and eats food. It doesn't get much more bottom line than that.

And if there is any opportunity to really mobilize some sense of what global governance might look like, this I think is an ideal place to begin -- to begin to think about a different scale and way of organizing that involves private players, public players, multilateral players, donor players and consumers, average citizenry, and some new kind of yet-to-evolve sense of what global governance could look like. So stay tuned.

Thanks to the panel -- all wonderful -- (inaudible, applause). Thanks to all of you.

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