 We're going to begin, welcome everyone here and those online to this gathering this afternoon focused on the new Institute of Medicine study, this groundbreaking study on falsified and substandard drugs and congratulations to IOM and to the Food and Drug Administration for this very, very important piece of work. I hope you've had a chance to look at it and we're certainly going to hear a great deal about it this afternoon and we have a terrific group assembled here. I want to especially thank Todd Summers, the senior advisor and colleague here at CSIS who will be moderating the discussion for pulling all of this together. I also want to thank a number of other people who made quite a contribution in bringing us together, Kate Bond and Kenesha Peters, Kate Bond from FDA, Jillian Buckley and Kenesha Peters from IOM and Alicia Kramer and Rachel Wood from our staff here at CSIS. This is a very big problem as we'll hear. It's fundamentally and in very complicated ways tied to U.S. national interests both at home and abroad and we'll hear more about that. It's also very integral to a quickly evolving global public good that requires us to engage and think as a country about this problem and what remedies might work in new and different ways. We've had the good fortune to cooperate with Dr. Hamburg and the staff of FDA in previous sessions looking at the expanded globalization agenda of FDA and it's been fascinating and we've had the opportunity to visit with FDA staff in Beijing last fall which was also fascinating and to discuss here the dramatic new challenges that FDA faces in trying to meet the targets and the concerns that Congress is setting forth and the demands that come forward naturally in this environment and trying to both ensure the safety of American public with respect to drugs and food but also to contribute to greater capacity building among our partner countries. So coming forward to talk about this particular problem today follows on a trail of work that we've developed over the last couple of years in close partnership with FDA. We're also thrilled to partner with the Institute of Medicine. We'll be doing another session tomorrow afternoon on the IOM study of PEPFAR which I hope you'll be able to join us for that. We're delighted to have our four speakers Deborah Autor, the Deputy Commissioner for Global Regulatory Operations and Policy at US FDA will open up with some prepared remarks. She has been the head of that directorate since 2011 and that puts her really at the center of all of the thinking and implementation of the globalization and import safety strategy globally for FDA. She's been with FDA since 2002 and has served in a number of very senior positions and Deborah thank you so much for taking time out to be with us today. Following Deborah we'll hear from Professor Larry Gostin who was very instrumental in the completion of this and execution of this particular study. Larry's known to many of you here I'm certain for his role at Georgetown and particularly in leading the O'Neill Institute for National and Global Health Law. We've had the great fortune of partnering at different times with some of the students graduate students that have come in and interned with us and enormously benefited from that collaboration we want to see more of that I hope. Larry has also played very important roles with WHO in different advisory settings for the secretary general for the director general for IHR international health regulations and other other items. After those two presentations we'll move to a round table and title take take over and we'll be joined at that point by two other guests who've come to be with us today. Mr. Dilip Shah is here he took time out of personal vacation here in North America to join us thank you very much Dilip he is a chief executive officer of vision consulting group strategic planning firm in India. He has 44 years of extensive experience 30 years with Pfizer India he formed vision in 1997 and in that in since that time has served on many key associational groups within India that have brought forward the perspective of the industry. He's the chair of the management committee of the international generic pharmaceutical alliance and secretary general of the Indian pharmaceutical alliance among other duties. Thank you Dilip for being with us. We are also our fourth our fourth speaker today is Dora Akunjili. Thank you Dora for being with us for those of us who work on Nigeria and there are several people here in this building including myself who've spent a lot of time working on Nigeria. Dora is a very famous personality for her courage for the record that she earned in Nigeria as the head of the Nigerian FDA in which she put herself at enormous risk and really became a beacon of what is possible in in attempting to create these kinds of capacities under very difficult circumstances in Dora it's just it's just a delight to have you here today with us. I did have a chance to look at the report and read it over over the course of the weekend I just want to share a couple of big impressions that came across in just reading through it and one is just the how elusive this problem is it's so big but it is elusive and when I say elusive I mean that it seems to still defy precision and measurement and data it's still highly problematic field we recognize its importance but we still struggle to put our arms around this and to quantify and to and to and to build the factual basis around it this is a very fundamental problem that we face here and in just definitional in defining the scope and nature of the problem a second related impression is the number of times that the word confusion and the word chaos is used in the text throughout the text which I think is again emblematic of something out there that is in the nature of this marketplace that it is confusing it is chaotic it defies quick generalizations and it and it defies easy easy analysis and measurement a third is the excessive attention to definitional issues and this is part in part the sensitivity the sensitivities around trips and patent and trademark infringement issues the divisions between within industry in the divisions between industry and governments and interest groups it also signals I think that we're still at early days and I think that the report itself carries us forward in a very dramatic and constructive way in trying to arrive at a consensus definition that people can begin to use I was very encouraged to see that to read in considerable detail that we are making substantial progress in quantifying the impacts with respect to malaria control and I hope we'll hear more about that and that way in which people are beginning to be make factually correct or defensible assertions around the link of this problem to resistance and that the there are dollar amounts quantifying the estimated value of the substandard falsified the four hundred million dollar figure the uncertainty and continued high high high tension in how do you engage industry and how do you bring industry into these formulations it's very fundamental there's discussion around the pharmaceutical security institute and the data that is held there's discussion around the degree to which incentives keep governments in industry from not wanting to share in a timely fashion how do you change those incentives and as I said earlier that's the extreme sensitivity and controversy surrounding trademarks infringement and patents which can which can become a great difficulty here finally I'd say it left me with a very strong question around how is it really that you motivate governments and regulatory agencies to make a greater investment in the capacities of regulatory agencies and to create some kind of effective global coalition that is going to be essential in the future and I think again we're at very early days I think that FDA and Dr. Hamburg deserve enormous credit for trying to stimulate the the early discussions across a spectrum of 10 or 12 key regulatory agency leaders including some of those like China that are very vital to the solution so please join me in thanking Todd and our four distinguished speakers today and I'd like to invite Dr. Autor to kick things off thank you so much thank you Steve that was a terrific introduction and overview a lot of good insights from the report and I also want to thank you Steve and Todd and Jillian and Meg from and Patrick Kelly from the IOM for pulling together this meeting and of course Larry Gostin who chaired the IOM committee for taking on such an important task and I was sitting here reflecting and thinking back to when we first at FDA thought about asking to have this report done and it was around the summer of 2011 and it struck me that actually a lot has changed since because the discussion at that point was we've reached an impasse on definitional issues and on just about everything and so we need to find a way to get other people looking at this issue and thinking about this issue and now a couple years down the road with the report out we've actually I think moved pretty far beyond that not only did you address the nomenclature issue which is of course an important one but that one seems to be one where that we're getting passed I think globally if I can say optimistically and you were able to come up with a lot of very good recommendations for what a lot of stakeholders can do together to address this problem and we have the WHO member state mechanism and other things underway so I'm actually feeling pretty optimistic sitting here thinking about that I do want to say what I think is probably well known to people in this room but those of us sitting here can rest assured that the US prescription medicine supply chain is one of the safest in the world we're fortunate to have a strong regulatory framework here governing the production and distribution of medicines and and as I work more and more globally I learn more and more about how fortunate we really are. Global medical supply chains rely upon a complex web of component suppliers repackers distributors in a variety of locations with varying rules and regulations and they are increasingly at risk. Criminals take advantage of vulnerabilities in the system by engaging in drug counterfeiting, diversion, cargo theft, economically motivated adulteration and all of these are threats. Substandard, falsified and counterfeit medical products and I still use the term counterfeit because it's in our law but I'm comfortable with substandard and falsified as well because I think it captures a big range of what we need to capture. SFC medical products pose both direct and indirect threats to public health. They may contain too much active ingredient, too little, no active ingredient, the wrong active ingredient or they may even be toxic. They may contribute to increased drug resistance and prevent patients from getting the medical products they need to alleviate suffering and prevent death. The risk to consumers are real around the world in this country as well. In 2012 we found counterfeit versions of the Injectable Cancer Medication of Aston. In the US it came from medical clinics who purchased it from both US based and foreign distributors. That product contained no active ingredient whatsoever, so people with cancer were getting treatment that was not treatment at all. And there have been other incidents of counterfeit medicine in the US as well. No country is immune from this problem. But these risks I would submit are even more pronounced in low and middle income countries. And as the study shows, and as you will hear more from Larry and from other panelists, this is a real risk. Threats that compromise drug integrity and supply chain security present a global problem. And no one regulatory authority or health system can work in a vacuum. None of us can do this alone to curtail these threats. And Steve was kind enough to talk about global coalitions, which I think are a very, very important issue that we need to continue to talk about. How can we tackle this problem together? Our success or failure in addressing this challenge will depend on the relationships that we forge and the networks that we develop. Now what we've been thinking about at FDA is what is our framework for taking all of these different actions, all of these different recommendations and laying them out in a way that makes sense to us. And we've focused on prevention through strengthened regulatory capacity and tightened supply chains, early and rapid detection of suspicious products, and collective response when SFC medical products are found. So we need a global product safety net that protects consumers by reducing public health risks caused by SFC products. And again, through prevention, detection, and response, we think we can continue to get closer and closer to that. Critical to this effort will be effective leveraging collaboration and information sharing among regulatory and law enforcement agencies, increased public awareness and vigilance of stakeholders, including healthcare providers and patients is also of paramount importance. So why did the FDA commission the IOM to undertake this study? We wanted to advance the global dialogue and how to combat this challenge from a public health perspective. We wanted to enlist a broad range of stakeholders in this response. And we greatly appreciate the depth and breadth represented in the IOM committee and think you did an incredibly thoughtful job providing recommendations which do make that happen. And so we're thrilled to see that happen. And we've thanked the committee privately, but gives us an opportunity to do it publicly as well. We think it's a really important piece of work that helps all of us to continue this key discussion. So what FDA sees as needed steps? First, the need to prevent market entry, because that's how consumers and patients are exposed to SFC medical products. We prevent market entry by reducing the manufacturing distribution of SFC products, and by improving supply chain integrity. So the IOM report goes into considerable depth about why low and middle income countries are particularly vulnerable to SFC products. The regulatory oversight is limited, and there are numerous vulnerabilities. For this audience, we're interested in talking about the IOM recommendations aimed at reducing those vulnerabilities and suggestion that the global health and economic development sector has a key role to play. The recommendations include increasing global investment in upgrading pharmaceutical manufacturing to high quality standards, strengthening private sector distribution channels, increasing the use by procurement agencies of international procurement standards, and again, the all important increase in public awareness. So we very much look forward to hearing what the panel and the audience have to suggest in this regard. It's also really important to know that industry and regulatory authorities have a key role to play in improving supply chain integrity. Industry accountability for product quality and safety throughout the entire product lifecycle and compliance with applicable laws and regulations, particularly incorporating good practices, I would say best practices is essential. It's also important for industry to properly secure and dispose of expired or recalled products as well as outdated equipment. We found that equipment out there can become a tool for counterfeiting. And I will say we've greatly benefited from the liaison between industry and law enforcement and had had a number of very significant criminal SFC investigations that have been the result of cooperation with industry. So there really are good partnerships. improvements in drug integrity and supply chain integrity will be brought about by strength and oversight by regulators in areas with robust regulatory frameworks and those with developing regulatory frameworks. regulatory authorities help prevention efforts by developing promoting and improving compliance with guidelines and with regulations. An example of this is the Asia Pacific Economic Cooperation that's working on developing and implementing a roadmap for improving supply chain security. So an opportunity to step back and look at what is out there that's working and where the gaps are and what the strategies are going forward. In addition to preventing market entry, as I said, another key component is detection. We need to detect SFC products. If they do enter the market, this means active surveillance, effective investigation and efficient confirmation if possible the products are SFC. The building blocks of surveillance investigation of pharmacovigilance systems, technologies and also laboratory capacity. So together we need to work to build as many of these as we can and pharmacovigilance in particular is one of those things that I think cannot be done in any one country because these products are not confined to any one country. We have global drugs, we need global systems to detect and to prevent. The study does highlight FDA's collaboration with the WHO in developing a global monitoring surveillance system which we think will help to identify incidents and to monitor trends and patterns that contribute to our prevention detection and response efforts. And finally, if products do enter the market, we need to rapidly detect that they're SFC products and rapidly respond so that we can protect patients as much as possible. We need to notify partners and patients about incidents, ensure that bad product is quickly removed from the market, improve containment of the products so they do not re-enter the supply chain and take enforcement action so that we can reduce the number of bad actors. So a good example of this operation, Pangea 2012, FDA partnered with international regulatory and law enforcement agencies from 100 countries and sent warning letters to more than 4,100 internet sites that were illegally selling potentially dangerous unapproved drugs to consumers. Again, it takes a global effort because it is a global problem. And the agency has developed Be Safe RX, which is our campaign to communicate to both consumers and healthcare practitioners the risks associated with purchasing from licensed pharmacies. So I just wanted to take a moment to give those framing remarks and to restate that while the FDA is well on its way, we hope to implement many of the IOM's recommendations, we recognize this as a broad multi-stakeholder effort. Many, many of us have to work individually and together to address this problem. This global threat requires a global response by regulators, industry, consumers, enforcement agencies, healthcare providers, all of us. And so that's why being here today at CSIS is especially important as an opportunity for people from so many sectors to come together and to think about how we can each work on this problem, how we can each address it, how we can best protect patients around the world. Thank you. Good afternoon. I wanted to just begin by reiterating Deb's remarks of thanks to Steve and Todd and your colleagues at CSIS who've not only been a magnificent partners, but I think all of us understand our global leaders in this field and all of global health. And so thank you for your leadership. It's really very much appreciated. The FDA, who commissioned this study, I do echo Deb's remarks that they are global leaders and have been very brave. And what I particularly love about what I like to call the new FDA is that it's a global public health agency in the best of all world. So thanks to Commissioner Hamburg, Deb, Kate Bond, Lou Valdez and others at the FDA for magnificent leadership in this field. When we went and briefed the FDA on this report, we had such a stimulating and interesting discussion and strategy forward, and this just takes it one step beyond. And then of course, the IOM, the real brain trust behind this is Jillian Buckley, who is here and Megan Kinesha, Pat Kelly and others at the IOM. And so I'm just the spokesperson for the wonderful work that the staff did and a really wonderful committee did as well. So this is our topic. We spent a lot of effort in gathering information from multiple stakeholders. As Deb said, this really is not just one person's responsibility. It goes across stakeholders and public health. It goes to customs, trade, and of course, to law enforcement both domestically and internationally as well as regulatory capacity for drug safety in individual countries. We visited a number of countries, notably Brazil, and India, and also visited with the Europeans Medicine Agency in the UK and many others. So I think Steve and Deb really made it very easy for me because they went through a lot of this. But the poor quality medicines are a global problem and there has been disagreement on how to frame the problem. And so I think those two ideas to me were really quite critical. The one is the fact that it is well established that it's a global problem that became so clear to us in the committee that this was a deep and vast problem. If one looked at a map of how these drugs crisscross around the earth and if you look about the economic incentives that are equal to the illicit drug trade, and then you imagine that we actually don't know, we can't quantify it, the need for pharmacovigilance nationally and collaboratively among countries couldn't be clear. The other thing that struck me as a late person to this particular field was just how much the lack of common terminology was a problem. I think the report justifiably spent a lot of time on this because as we talk to different stakeholders, there were a great deal of miscommunications, sometimes lahren's trust and much of it, as Steve said, had the undertext of is this an intellectual property problem, is it a public health problem, is it a regulatory problem, is it a law enforcement problem. And our charge from the FDA made it very clear that we were concerned about primarily the public health problem. But of course in looking at the public health problem, one needs to not only engage the health sector but also law enforcement customs trade and other, and of course the industry itself. So we had a, we still use the term counterfeit, but we use it in its proper legal context. Drug under the WTO agreements, the TRIPS agreement, is a violation of a trademark. And as a trademark violation, it deserves scrutiny. But that's only one small part of it, and the problem was is that we were, and I think we have come a long way, but the world particularly lay people still talk about counterfeit drugs as a broad umbrella. And that worries folks who are most interested in access to affordable medicines and essential medicines and looking at how TRIPS flexibilities can actually help with that. So we had two broad and overlapping categories of bad drugs which were falsified drugs and substandard drugs. A falsified drug misrepresents the product's identity, source, or both. And a substandard drug fails to meet national specifications to accept the pharmacopeia or manufacturing dossier. Deb talked about the consequences of illegitimate drugs. They include toxicity, poisoning, and compromised treatments. In many ways we found that those drugs that had too little active pharmacological ingredients posed a greater problem than those with no active ingredient. Because when you're taking a subtherapeutic dose, it promotes resistance. And one could see this with anti-malarial medications and others, including antibiotics. And for those of you who think that this is a problem only for high-priced branded drugs, it's that, but it's also much more. I mean, we found it also in the generics industry because the cost of producing the product is so low and even with very small margins with antibiotics, for example, there is a huge potential market. Consumers lose confidence in medicines and the health system and the regulatory system. We clearly saw that in many low and middle income countries. And it funds criminal activities and conveys power to corrupt officials. And so corruption within the health sector and corruption with illicit trade, often combined with the illicit drug trade, makes the economic drivers of this particularly strong. As we've all mentioned, the magnitude of the problem is that it disproportionately impacts low and middle income countries. We saw it with anti-malarial, antibiotics, anti-tuberculosis drugs in sub-Saharan Africa and Southeast Asia. And that it tends to circulate more rapidly and more prevalently in countries with weak surveillance systems. And so we recommended very strongly the strengthening of drug surveillance systems in developing countries, as WHO is doing with a surveillance capacity-building project, which it's actually a very innovative model project that the FDA itself has promoted and funded, but it is still just a model and a pilot program. And we also felt that pharmacovigilance systems should be well integrated with national and global surveillance systems. For example, if one looks at Steve mentioned the IHR, the International Health Regulations, there are increasingly robust ways of trying to track emerging infectious diseases. That don't exist in the area that we're discussing now. Just look at the novel influenza that's currently circulating in China, and you can see the kind of global alert system that is being put into place. And yet with this problem, which is arguably as if not more serious to the public health, we don't have that kind of robust system. The causes of the problem are multifactorial, equipment staffing, process costs necessary to meet international good manufacturing practices. The lack of capital investment and poor infrastructure in low-income countries are a problem, and this is a lack of capacity in regulatory areas in drug manufacturing, and particularly with smaller pharmaceutical companies in the developing world that don't have the kind of capacity that's needed. Criminals and dishonest manufacturers exploit the regulatory weaknesses that actually go to the areas of the weakest link in the chain, and regulators, as Deb mentioned, need training equipment and technology, and the report emphasized the importance of national strategic plans for regulatory system development. When one understands this problem in its deepest form, and I'm sure many of you do, one can see that the supply chain in trying to secure the supply chain is critical, and the supply chain is extensive and it's fundamentally global, which is why the report uses confusion and chaos so often. I hadn't realized that, and Jillian and I had a little look at each other and said, oh yeah, does it really? In poor countries, there are a few quality drug shops outside of cities, so one can go to marketplaces in lower-income countries and see people buying products. They buy these products because they can't afford the high price for them or that they're not available through the national authorities, and even though very substantially high rates of substandard or falsified drugs are in these markets, they continue to have very little option, but to do that, so if you're sick with malaria, or your child's sick with malaria, you need to do something as a parent and the options are not great. We found that the private sector of course will invest in medicine retail if there's a good reason to do so, and the report encouraged governments to use franchising, accreditation, low-interest loans, training as tools to improve retail and create an environment where the private sector can thrive and can police itself and ensure safe, high-quality medicines. In the United States, we had a balance in this report because our charge really spanned global concerns, but also particularly concerns that the FDA is primarily charged to do, which is the safety of America's drug supply. We believe that changes to drug wholesale and tracking systems would help American consumers while also building momentum for tighter controls in other parts of the world. We also realized that there were technological and legal solutions to this problem, making innovative technologies, detection technologies accessible in poor countries, and the report recommended a central repository for detection technologies to identify falsified and substandard drugs, and it also discussed the idea of a small business innovation research program as a way to encourage research drug technologies. There are many potentially promising technologies. We need to find new ones, but we also need to find ones that not only work, but are really accessible and can be used on the ground, whether they're used by national drug regulators, by the industry itself, by smaller pharmaceutical companies, or by the consumer herself. These technologies can be very important. I think our biggest and boldest recommendation was addressed to the World Health Assembly in conjunction with other international organizations, such as the UN Office on Drugs and Crime and the World Customs Organization for an international code of practice on this problem. The WHO and others have had fairly good success. It's not perfect, but fairly good success with developing soft norms in the past. The most well-known one perhaps is the one on the international migration of health workers, but also there are a variety of global strategies on diet, nutrition, and other areas, and even hard laws such as the Framework Convention on Tobacco Control. But we thought that the world and international community was not quite ready and it wasn't really right now to have a global health treaty, and there were two nascent health treaties at the regional level that never have gotten off the ground. And so we thought starting with a soft code of practice would encourage this kind of international dialogue that's so necessary and so helpful. Although I don't have a slide for it, Deb mentioned track and trace programs. We recommended that Congress should authorize and fund the FDA to do this. It's one of those areas that she mentioned. I think it's terribly important and just simply makes sense in the United States to protect consumers. But not only that, but I do think it would also be a beacon of leadership for the rest of the world. And in the interim, we've also suggested that FDA convene stakeholders. We also talked in the United States about wholesale licensing and good manufacturing and had a number of proposals that were focused on the United States market. So I'll begin, I'll end where I began by thanking the IOM staff and the IOM committee. This was truly a collective effort and we had a really incredibly robust and important international group of people from the academy, from industry, from civil society, from low and middle income country regulators thinking hard about this problem. And then finally, and lastly of course to thank the FDA again for giving us this wonderful opportunity to try to make a contribution to this field. Thank you. So we all have portable microphones so you can turn those on. So I was at Cape-On's house for dinner and some people get little party gifts when they go to dinner. I got an IOM report. She handed me this inch thick stack of paper and said I'm going to call you on Monday. Give it some thought. And I did read through it and frankly it's exciting but it's actually a little bit aggravating. It makes you mad when you realize that the mom who raises the dollar goes down to the little kiosk at the end of the street to deal with the child who probably has malaria could very well be buying something that's completely ineffective. And it's frustrating given how much work goes on here in Washington and around the world and then many of the developing countries that try to make that opportunity meaningful for that family that there are other people in the world who are trying to subvert that and really that was what in some ways drove me to want to get into this a little bit more. As Steve mentioned early on at CSIS we spent quite a bit of time looking with FDA at a range of issues. We also do a lot of work looking at PEPFAR and PMI and the Global Fund places where the U.S. taxpayers invest a lot in terms of global health. Those are also potential places both opportunities and challenges. The Global Fund gets about a billion and a half dollars a year from the U.S. about 40, 50 percent of that actually goes into buy medical products. Most of those are actually drugs. PMI also purchased a lot of antimalarials. PEPFAR purchased a lot of antiretrovirals. So there's a keen interest here in making sure that as we try to make those programs more effective the least we can do is make sure that if we're buying drugs that those drugs actually have the potency that we would expect from them. So it's a very timely and important issue. We were thrilled to have Deb offered to come and participate with us today as long as well as Larry but we're also particularly happy to have Dora and Delape with us to bring a different perspective. Dora as Steve mentioned earlier spent some time as the head of the Nigerian FDA and as I was reading through the report again this morning all I kept thinking was what an almost impossible job you had. It's like trying to sail a boat when you know that there's a hundred holes in the hull. It's a very complex problem that goes right from the active pharmaceutical ingredient manufacturers that are often in different countries down to the little kiosk that's in a village very far away from the public sector. And a lot of that is under the remit of the regulatory associations for the importing countries. The report notes that a lot of the responsibility is put on those importing countries but clearly much of that relies on a system outside of the country which is in pieces. So Dora I wonder if you could start us off a little bit in the conversation with the perspectives from Nigeria. What is the issue of counterfeit and falsified and substandard medicines look like from your side? And since this is a U.S. audience where do you look to the U.S. for help? Where can we be helpful in equipping in Nigeria to play a better role in protecting its citizens? Thank you very much. Generally in Nigeria we call it fake drugs. It was first noted in Nigeria in 1968. So we did start to listen when a crime agent, directed at the crime authorities, criminal cases in the country, and they actually operated on the child for almost three days. And they actually had the trust for them. And people were dying. It was like a health situation. Thank you. Nobody knew what to do. The regulators were compromised. That means that everybody was put over and continued until it became so hopeless that Nigeria actually became the country with the highest incidence of counterfeit or fake medicines in the whole world. Until I came into the leadership of our regulatory agency in 2001 and started waging a war against these people. We needed to construct a safe place. We needed to confront them frontally because the situation was unacceptable where we had over 41% of drugs in circulation. We had outrightly fake. When the presentation was going on we said something like drugs containing no active ingredients. And I laughed because if a drug doesn't contain anything it's better than anti-diabetic levels of anti-hypertension and vice versa. Because nothing was beyond that. Not only drugs without active ingredients, drugs with little active ingredients, drugs with active ingredients different from what is on the level because what happened was that something like Nobus, a popular anti-hypertensive became scarce. They really brought an expired anti-diabetic and we leveled it with Nobus. If one of Nigerian senators brought our attention to it, he was a high-partisan patient who took Nobus, he collapsed and he called me directly. We collected his medicines, tested and found that it was an anti-diabetic. And so on and so forth. Drugs were registered by NAPDA drugs that were copying of original drugs. And again when people talk about counterfeit copying where it can be copied which is made good, there is no good counterfeit. Why would you copy if you want to produce the right drug for people? And people forget that you see if you copy a drug you may never get it right. If I cannot get it right because the efficacy of a drug, I don't know how many of you have found it, is not only dependent on the quantity of active ingredients. It also depends on the quality, particle size, formulation technique, excipients and other factors. So most counterfeits or almost all counterfeits are not good. So this question of a falsified substandard, for me it should not be called bad medicine. Because when you say counterfeit should be left for the court, no, counterfeit concerns the regulator. In Nigeria for instance, I never allow you to collect or sound a live demonstration. Why would you want to call your product Norbach? Because Norbach is moving in the market. You can get too many other names as a claimant. Why would you want to put the same color as Norbach when you can get other colors? It is because you want to confuse the consumer. And you see I am even more worried about the attitude of the international community. I feel too pained each time I think about the non-challenged attitude of the world to drug counterfeit or drug fetish, which is evident actually in our not having a harmonized definition. Today there is no harmonized definition. It's an eloquent testimony that generally the world is not interested. From 2002, the first time I came to speak in FDA, some of you were there, I remember Dr. Berry Jones was there, I told them in FDA to please do something, be proactive. Because if counterfeit medicine enters into the US, you'll be in trouble. It's not just a matter of helping out some of us that have weak system, corrupt system, poverty and other. We should also do it. Collaborate internationally to help yourself here in the US. And in two years, three years it came in, seroptiming some of those drugs that were sacked in this environment. Every year there was an increase. And the projects of drugs in the internet was not actually helping matter. And we also forget something, which I don't want to forget to point out, that resistance trains of antibiotics and anti-malaria, they don't need visa to travel from country to country. If one has resistance train of tuberculosis and the person comes into US, it gets transferred to people. Nobody even knows if I have such a problem inside me, I will still get a visa. So somehow we are so interconnected in the global community that what affects one country, affects the other. So it's not just the problem of the developing countries. Yes, we have a greater share of the problem because of weak system, corruption, poverty and others. That in developing countries, it's really ugly head, but the good news is that once we let us up and win and refuse to be compromised, the counter guitars can be given a round for their money. When we wage the war against them in Nigeria, we have had, as I said, over 41%. They fought back aggressively against me, against my family, against my staff, which culminated on a shooting attempt on me. It's a miracle that I am here to tell you about it. And we were able to bring down the incident of Pedro by 2006, a report done by the WHO and EF ID to 16.7%. And trust already started by NAPA from almost 70% to 90%. And by 2008, before I let NAPA in December to become Minister of Information and Communication, 180 degrees, we had single digits. But single digits is even one exception because we are talking about human beings. And we had good facts. They want artists, they want all our facilities, laboratories, every day in place we belong. You see, these people are so organized that they work in concert. They collaborate better than us. We regulators, drug manufacturers, we are trying, but the drug counterfeiters are always ahead of us, always. They are aggressive, they are making a lot of money. A fake drug business is so lucrative that their investment is unimaginable. It's even more lucrative or at the same level with that of illicit medicine. But the laws are very weak, not only in Nigeria, in other countries. I know that collaboration is poor. I shouted and screamed about international collaboration 2001, 2002. Eventually I felt a bit comfortable that impact was put in place after I had already put in place WADRAN, West African Drug Regulatory Authorities Network in our sub-region. I single-handedly did it. I called all the regulators for a meeting in Abuja and said, listen, hi, we have to work together. These counterfeiters from our records are migrating to your countries because of weak structures. We need to be advertising who and who is caught so that they cannot come to your country and re-establish and so on. And eventually they started working with us. Other countries in Africa joined us. Impact was established. WHO was the headquarters. But unfortunately, because of the lackadaisical attitude of the world to drug counterfeiting, impact is dying. WHO washed their hands off impact. They claim that definition is the problem. Now I heard the headquarters is in Italy. I think we are playing with human life. I will stop there until I can see that you want to move. No, I'm looking behind me because I wonder where all those people are that are after you. But your son is here and he's about six foot four, so I think you've got good protection. You're obviously looking at this from a somewhat of a different angle. India has been transformative in terms of manufacturing a range of medicines that have saved a lot of lives over the world. But it's often also cited as one of the places where some of the bad medicines come from. I use even simpler terms. Can you help us understand where the manufacturing industry is in this? What role do you see them playing and trying to address the problem of substandard drugs and where is the responsibility of India as the home for some of the manufacturers versus Nigeria or some of the countries that are importers? Thank you. I have two issues which I'd like to address in five minutes that you've given to me, so I'll be quick. First, the role and perspective of Indian drug manufacturers. That's what you would like me to address. Before I get into that, let me give you a very quick overview of Indian pharmaceutical industry. We have about 10,000 drug manufacturing units in the country. Out of that, about 200 are approved by US FDA. Half of what we produce in the country is exported to 225 countries. 40% of our exports are to the United States and Europe. And we started exporting to US only from 1998. Between 1998 and today, in terms of those units which have been approved by US FDA, not one instance has come to our notice where any of these 200 companies have exported either to Europe or to USA a counterfeit or falsified medicines. There may have been manufacturing defects, but the Indian industry values this market both Europe and US so much that that itself is a deterrent because they are looking for a long future in these markets and they do not want to spoil their name. Now, this is 200 companies, but then there are 5,000 other companies which even within India, our two studies showed that 8% of medicines in India are substandard, not falsified. Falsified is less than 1%. Now, these two substandard medicines are issues of regulatory enforcement and agencies. And many of the issues which were presented in the two, your presentation and your presentation that units do not have adequate equipment to validate the product is consistent with the quality it claims to be. Now, if you have units which do not, cannot validate scientifically the product that is manufactured, it is bound to be substandard. Now, this is what needs to be addressed. Now, as the large manufacturers that I represent, our concern are one revenue loss because these manufacturers also use our brand names. These are generic brand names because India is a branded generic market and flood the market. So, we run an organization of 25 investigators, very eminent people specialized in crime investigation who worked with India's intelligence branch or both domestic and international. And we as a group of industry try to track these manufacturers and distributors and prosecute them. On an average, we read about three such premises a month, but in terms of quantum or the manufacturing facilities that we have read it, we found that it is miniscule compared to the size of volume that we produce. Our second concern is it compromises India's brand equity because even if certain other out of 225 countries, some developing countries claim that all these drugs came from India, it is a matter of concern for us because it hurts our brand equity. Within the domestic market, we have concern because it leads to loss of confidence among the doctors and the patients and the medicines of a company whose product is compromised. Therefore, industry's perspective is or role that we see is that we cannot live and I am talking for India. To drug regulators and low enforcement agencies only to face this problem. And this is how we have been running this campaign for last 10 years entirely funded by the domestic Indian companies. Secondly, we need to proactively engage in not only identifying sources, but also persecuting them. Now, that is where we have been very working with government and some of the amendments which came in the India's Drugs and Cosmetics Act of whistleblower scheme or death penalty or triple damages of the quantum of counterfeit discovered is driven by the industry. Second part of this question is expectation of industry in addressing proliferation of substandard falsified. We expect countries that we deal with where we export effective implementation of laws. There are simpler measures before we get into one track and trace system as issue of registrations or procurement systems processes that are followed. We expect stringent punishment to act as a deterrent. Sharing of information, this is important to book culprits and I would illustrate one issue with even US that India has been facing. We hear from US customs repeatedly that large number of consignments they seized which I mentioned when we met in Mumbai come from India. It was simple question. If you have seized that consignment, you know on the consignment who shipped it. What is the address of the shipper? What did it contain? You also know who was the consignee. So, who in US imported that? What did it contain? What was the quantity? Was it 100 tablet and internet pharmacy consignment or was it a container load of tablets which came into US? Now, if you share this information with us and this is I have given only an example of US but this is true for every other country. We seek this information from Africa. They tell us where these consignments came to you from so that we have our own agency. We will put that agency behind this and we work very closely with police department and drug regulatory agency. We and our laws enable us to book them under the offences of cheating. We do not even try to get into the drugs but we book on the offences of cheating and invoke criminal prosecution to book this rogue manufacturers. And we urge countries to distinguish between serious and genuine manufacturers and fly-by-night operators. Now, some of our own government public sector organizations like Railways, what have they done to ensure that they get quality medicines? In the criteria, they specify that the unit must be in existence for a period of 5 years minimum. So, if he is a company which has just come up we will not qualify for supplying to Railways. Indian Railways is a government organization unless the company has a turnover of say 20 million dollar. I mean Indian values are very small that is why I am saying this but what matters is the value limit. Unless you have that much turnover you cannot qualify to supply for public procurement. Now, if government's procurement in other developing countries they were to institute such mechanism or a very simpler mechanism which I mentioned to various African delegations which came to India is you look at IMS health data and look at top 100 companies having market share in the Indian domestic market and select as a supplier some of these 100. This is information in public domain but buy from reliable supplier and this will ensure that you get consistently safe and quality medicines. Thank you. Thanks, Dilip. So, we are going to open up for questions from you. So, if you have some get them ready I want to while you are thinking of your questions start with one that I got by email from someone who started a retail pharmacy chain in East Africa and their comment is the IOM report doesn't really offer much for actual retailers. For instance, can we tap into global best practices? What technologies and processes, policies should we be putting in place? What funders are interested in ensuring that the supply chain down to that last mile that you talk a lot about is free from pilferage and graft. So, you have a lot of the retailers who are operating sometimes in network sometimes literally down to the little Dukalidawa in the village. What is the IOM report have to say to them? Well, I'll call on Jillian for this after I've just mentioned a few things but we suggest that national pharmacy councils can improve workforce efficiency by assigning some pharmacy tasks to technicians and we suggest vocational training in dispensing medicines combined with incentives to train and retain staff in rural areas and slums and so we do have a section of the report that is focused on retail, on drug retail. It's not one of the areas that is one of the big headlines of our report but we do have a substantial amount on drug retail. Jillian, did you want to come in with anything further on that? We have microphones around. I would I think refer the person who asked the question to the, there's a section in the report that talks a lot about medicines retail in developing countries that Larry referred to and what the committee suggested was that governments in developing countries use tools to create an environment where the private sector can thrive. They believed that there are examples from developing countries of programs that did a lot to improve retail. The accredited drug dispensing outlet program in Tanzania was very successful at bringing quality drug sellers to rural and remote areas. The report talks a bit about the care shop franchise in West Africa which started in Ghana and it uses franchising to extend the reach of safe and trained medicine sellers to rural and remote areas. And they also talked a bit about using task shifting, using low interest loans, using other tools that governments can use these tools so that the private sector will be willing to invest in medicines retail. Thanks. So I don't know where the microphones are. Oh, we have one in the back. Rachel's here. Questions from audience. A little bit less a question than that. My name is Joe McKinney and I'm speaking as a veteran of the track and trace industry which in fact does exist. It's not thriving yet, it's developing. And in fact there are technologies and techniques which will protect the shipment for 100% chain of custody from the active ingredient manufacturing all the way through to the retail. These are not in use other than small uses, individual company uses and the technology has been very much improving. Smaller size, lower cost, better communication standards and so forth. But the place where the most work has taken place is in the customs agencies. Notably, one in the U.S. is DHS is currently running a safe and secure borders trial with two trade lanes between Canada and the U.S. two between Mexico and the U.S. and in fact the chain of custody technology and the types of information management that are being used in that would be 100% applicable to domestic chain of custody tracking if it was adapted if the industry got behind it and so forth. The good news about Africa is that there are a number of countries and you mentioned Ghana and Tanzania. Those are two countries that in fact are doing border management programs. The reason they're doing them is to cut down on smuggling. The truck enters, for example, a truck of containers unloaded in Mombasa. Kenya and says it's headed to Kampala. Kenya is also doing this type of a program. They want to be able to track it, make sure it stays locked, gets all the way to the border with Uganda, then it gets turned over to the border. They've founded projects in each of the five countries of the East African community and they are now coming to the point where the countries are issuing purchase orders. That was great to hear about Tanzania because they actually have a very large RFP out right now for a program like this. Thanks very much. In fact, from track and trace there's a lot of technology that could be adopted and could be used today. Thank you. There's another question over here. Dora Abash is doing that. Nigeria, how secure are the borders in Nigeria? How does that work? What do the technologies look like? What are the things that actually give you hope about getting a handle on the challenges in Nigeria? Thank you very much. Our borders are very porous. There's a lot of corruption and the counterfeiters are very ingenious. I would want somebody to pass this around. This is supposed to be DVD player. It looks like DVD player but inside it are third generation antibiotics. So they hide these medicaments in various type of things that we would not ever think of. Coupled with corruption it became important for us to do something to even prevent the countries that produce counterfeit medicine, from importing them into Nigeria. And I'm sorry to say that most of the counterfeit medicine in Nigeria actually come from India and China. I was holding a discussion with Dr. Shaddit and he told me that actually some of those drugs that are claimed to have come from India are not from India but I know that we have traced some of them and traced them to India. And you see we have a very big problem which this has given me an opportunity to mention. We don't have harmonized regulation in some Asian countries especially India and China. They have very stiff regulation for drugs meant for internal consumption. But very weak regulation for drugs meant for exports. And that has actually were drug counterfeitings. And consequently we started inspecting factories to ensure that these factories we check what they produce before they are allowed to even register. And we ensure that whatever drugs that are going to be imported into Nigeria are used in country of production by getting our embassies to work with the ministry of trade in that country, not only India and China. So we have done a lot to even stop the exportation from those countries. In fact, in Nigeria you cannot even process import documents from the bank without getting clearance from NAVDAC and so on and so forth. But at the ports we are also very stringent. We have designated ports of entry. It's very important so that it doesn't come in from all ports. And if drugs coming from any port that is not designated it is seized whether it is genuine or not and destroyed we are strict as that. It's like at the extreme because we needed to do something drastic. We also have independent analysts in India and China that re-certified drugs and give documents to say that they have re-certified. And if drugs arrive these designated ports without re-certification they are confiscated and destroyed. So with these measures we work on those countries where they are produced then work on them at the port because once they enter into Nigeria in such a big country it's so diverse that once he enters the system it's almost impossible to mop up. But we also use information from the public, from patients from doctors and so on and if we get such information especially drug companies they collaborate a lot because we are not only working for the sick people especially the poor we are also working for the companies because counterfeiting provides unfair competition because when the counterfeiting was at its peak multinationals actually left Nigeria out of frustration because they couldn't compete with counterfeiters. But when these companies find their drugs counterfeited they report to us they work with us to track the drugs from wherever sold in the market or drug distribution in Nigeria is another story. In fact it's even hawkers used to carry drugs on trades, on business, on their head and selling the streets and embossing but we stopped all that. So what the point I'm trying to make is that we need more of a harmonized regulation if we don't have harmonized regulation and we keep having double standard it is still very difficult for developing countries to handle this menace. Again let me quickly bring in Let me hold on one sec Dilip I think you probably see things somewhat differently around the different standards but as you said there are companies that are legitimate that probably operate on the same standards for domestic or export use but you have a whole bunch of other countries that are maybe operating with sort of a different approach. But Indian law there are no two different standards for domestic consumption and exports. It's one drugs and cosmetics act equally applicable and there are no exceptions to that whether it's exported to US or it's exported to Africa or it's meant for domestic consumption and in addition to that when it comes to exports to US the US FDA acts as a another agency and not only US we export to Australia, we export to Europe we export to Japan all of those agencies come, visit, inspect validate facilities before they allow these companies to export to them so the Indian law is common for domestic as well as export consumption It sounds like Nigeria has done some of that there was a question over here Hi David Briden with results and the stop to be partnerships really fascinating panel so thank you my question is about USAID's role in this area and I don't know if Dr. Gostin panelists might be able to comment on that and they're recently asked when it comes to Tuberculosis our colleague from Nigeria mentioned that something that we had results are very concerned about particularly in light of the very large cut that the Obama administration has proposed to the USAID TB program USAID is doing good work in supporting countries to improve supply chain management and crack down on illegal pharmacies areas where countries really need that kind of support so we're concerned that that kind of work could get scaled back if the administration gets its way so apart from the issue around the budget one of the questions that's come up a lot with CSIS is the question around how different parts of the US government speak to each other so you have the Pathfire program which is managed out of the state but largely implemented by USAID and CDC and that's four billion dollars a year we're trying anti-HIV drugs and some TB drugs we've got bilateral programs for AID that are dealing with TB and malaria so how does FDA engage with its partners and helping them to ensure that the money that's being invested works well and Larry did you the IOM panel look at any of these large bilateral multilateral outlets for US foreign assistance and whether or not there's a particular role that they could be playing either to change their standards or to invest in the kind of regulatory and manufacturing capacity that you cite as being needed do you want to start and maybe well maybe I'll just you want to start with the it wasn't a big part of our report I'll start and then others can fill in I think that there is a lot of room for collaboration across government agencies here and I think we're starting to have more on that one small example which we're proud to talk about is last week we announced a partnership that we have with USAID, CDC, NIH, USP and Skoll Foundation to test the CD3 which is a counterfeit detection device that uses different light specters we're going to test that in Ghana for use in detecting counterfeit and malaria so that was an example where we have a lot of different stakeholders like Kate Bond and others get a great deal of credit for pulling people together there because I think there is really a recognition that these are interconnected pieces and I think we have a lot more room to explore how we can work there but I think looking at the fact that FDA has some presence on the ground but other government agencies have more USAID obviously has a strong role to play in helping to provide products and secure supply chains are an important piece of that so there's more opportunity there we can potentially do I know the Global Fund which also gets a fair amount of money from the US to do TB, HIV and malaria work they're looking at some of the devices that are even mentioned in the report the ones that use infrared analysis that are battery powered field Kate introduced me to I thought her title was the Assistant Commissioner for Complaints which I thought was a hellish title but turns out she was the Assistant Commissioner for Compliance so looking at some of these new devices that are very CSI like that really offer an incredible opportunity to pop a pill and then basically use the infrared signature of the pill to determine whether or not it's got the right active ingredients inside really amazing stuff and then there's the tracking trace there's barcodes, there's stickers that go on with the scratch off that people can call in, consumers can call in so there's a lot of things out there but it still feels like if you step back there are little bits that are trying to solve a very big problem that's probably bigger than any one actor can get at other questions here in the front there's actually two why don't you both provide questions and then we'll get answers I think we're kind of together okay my name is Rima Jued-Google I'm with the U.S. Pharmacopeia the CD3 which you mentioned is something that we're very proud of Dr. Le Calais will be I guess in Ghana to answer the AID question there's somebody here who can probably answer it better than I I'm not well versed in the protecting the quality of medicine's program or but Dr. Le Calais and so USP takes and leverages the standards that we set for medicine quality and puts that in the field to help protect anti-malarial HIV AIDS medicines and TB medicines I just had a comment and then I'll pass it to you it had to do with back in the report where you mentioned investing you know getting development organizations to invest in infrastructure I would also posit that I think it's important to engage the ministers of finance within these countries because they're the ones who actually run for lack of a better word the budgets of the ministers of finance to help address these issues so anybody on the panel that wishes to comment on that we think it's very important we're trying to pull together something hopefully in the fall we'll be able to do that but while the mic's going over you want to give a quick response yeah sure I mean the report does talk about all of that and we do see a primary role for domestic governments including health and finance ministries to be supportive and develop that capacity so we mention that more than mention it we recommend it and we also realize that in addition to what the domestic role should be that the World Bank's International Finance Group and the US government's overseas private investment corporations should begin to fund some of these initiatives and so capacity building is a very important part of our mandate and we think of capacity building at the national and the global level but we also think of it in a way that goes to capacity for regulators capacity for industry capacity for law enforcement and customs there's a substantial need out there and capacity building of course has always been the biggest problem in every area of global health thank you my name is Maria Morales I'm with USAID Office of Health Systems and to follow on my friends comments here in fact we did support the development of the report through the participation of Patrick Lifelay who's the director of one of our programs the promoting quality medicines program which is implemented by USP a large portfolio of activities through that program and through another program the systems program for access to pharmaceuticals and services which both programs complement each other in developing the regulatory systems within countries to address the issue of substandard and for quality medicines this also includes work in the area of pharmacovigilance systems to inform their responsibilities in the area of loading patient safety and product quality to add to the portfolio of capacity building though I was wondering if the panel could comment on what you see as the relative importance of also working with the civil society the issue of patients and consumer rights that was mentioned by Dr. Autor in the beginning just the demand side I think we have not been paying enough attention to the demand side of the equation and I was wondering if some of the panelists would like to comment a bit further on that Sir Dora we want to provide a quick one because I believe you actually have your own box in the report of some public education campaigns that you helped to foster when you were at the Nigerian FDA so what's your view of the role on the demand side of this how much are patients responsible how much can civil society help them have a voice I think well it's not just a matter of what I think a public enlightenment campaign is about one of the most effective strategies in converting the menace of counterfeit medicine or in preventing them from having a field day because what happened actually in the past in my own country why they were able to progress from 1968 until we started the fight was because people were not even aware my own younger sister who died from counterfeit insulin wouldn't have died if we knew it was a typical counterfeit story if we bought from shop A diabetes sugar would go down then when that insulin finished and we bought from shop B then it would go out of hand and it never occurred to us that it depended on where we bought it's like is this witchcraft you see when educated people start talking about witchcraft then there is a problem what is going on and so on and so forth or when you give antibiotic that a patient should respond and the patient does not respond if there is no public enlightenment campaign the patient would not suspect so there was everything was shrouded in secrecy even if people suspected it's like is it possible but when there is a public enlightenment campaign patients can at least ask questions they can at least start checking on labor we have aggressive public enlightenment in Nigeria where people check expiry date, check the manufacturer's name and address because some of these counterfeit they don't even have proper name and address of manufacturer you can imagine a drug packet having PO box and with adequate public enlightenment campaign the patient is able to look out for what the person is buying check properly ask questions so when you are investing in helping developed countries should also think very much on how to use public enlightenment campaign civil society can help but regulatory agencies can also even help better in propagating within the system within the country in the villages in the schools everywhere it becomes it becomes the issue on the front burner that everybody should be part of the fight because it's not just a regulatory agency fight it's fight for life by everybody collectively civil society should be part of it but not just them Hira capacity building in India is a different dimension we initiated and this is the pressure group is the industry that we want our regulator to have capacity similar to and we benchmark with usfda and what do we do to achieve that usfda has been very very supportive but our ministry of health has not been responding as it should to the usfda offers of various training programs the responses are not there so that's where the industry group has come forward putting pressure on the government that look we benchmark and we want in fact currently we are working on that that is a 5 year strategic plan that where India's fda would be 5 year hands and we want milestones to be defined this is one second issue we are asking with the government is transparency and accountability within fda and if you bring the transparency and accountability in the fda things can improve significantly and thirdly by way of resources there was a time some 15-20 years ago when any new drug approval new drug registration not approval I am not talking about IND but new drug registration the fees payable in India were 2 dollars not even worth the cost of the paper on which the application was made industry initiated this and said look look at the fees structure in other countries in Europe and raise this fees we are willing to pay this fees so that all non-serious players are out and only serious applications are there the fees have been raised to 1000 dollars now from 2 dollars but we demand a certain quality of service for the fees which we are paying and our intention when we made this proposal to the government was that this money which we give by way of fees should be utilized for upgrading the India's regulatory infrastructure unfortunately as it happens most of the funds collected goes to the general account and then only comes by way of allocation from health that never happens in this country so Larry and Deb final comments on this and then we are out of time so I wanted to give you all a chance to sort of make any concluding comments because I promise I would get out of get you all out of here on time well I can be quick first of all obviously thank you again CSIS for putting this together I guess my thought reflecting back on this discussion is what I often feel with a lot of the global issues we have they're huge and there are a lot of stakeholders and there are a lot of people looking at different parts of the elephant and that I think that the IOM report is a good catalyst for discussion laying out a lot of different interventions we're suggesting thinking about them in the buckets of prevention, detection and response because I just think it's easier to hold a few things in our heads at once but all these different pieces go into those buckets pretty easily that gives us an opportunity as a global community to step back and say where are the missing pieces, what are the networks we need to build where are the coalitions that we can create that can be effective to fill those gaps because I think that otherwise we tend to double up in important places but have big gaps otherwise and so that's what I think would be a really important next step is to really think about the strategy going forward and making sure it's comprehensive, holistic, efficient and effective Great, so the report calls on countries to develop their own strategies to build their kind of domestic response but I think what you're calling for is a bit of a global strategy take the work that the IOM has done but come up with a game plan to actually implement the recommendations Yes, I mean we totally agree and I think the prevention detection response is a really beautiful framework we do ask for national but we also suggest lots of global and inter-cooperative solutions inter-cooperative meaning horizontal among countries horizontal among different stakeholders governmental and non-governmental stakeholders and then also international organizations and others I mean I might just say that we do need this dialogue because it became very, very clear that when we talk to civil society they spoke a particular language and we did spend a lot of time talking to civil society when we talked to industry they had very similar language when we talked to ministers of health or FDA regulators we heard there but there was very little common ground and so I think common terminology a clear pathway on the prevention detection response side and really getting the stakeholders together would be a great way to do it and the international code of practice might be a great way to catalyze that because inherent in that it has civil society from the bottom up it's got government engagement it's got private engagement and it's got civil society and other groups and so I certainly think that's the pathway forward but I do think this is a solvable problem and I do think that the IOM report puts out a number of things that if we implemented it it would not be perfect we'd still have problems in lowering the problem particularly in low and middle income countries Thanks I'm going to turn to you two for very brief concluding comments while we're doing that you should have on your chairs a little 5x7 half a sheet of paper with a quick evaluation for today it's a new thing here so we'd ask you just to fill it out put a really high answer for the moderator question and leave them on your chairs or hand them back to Alicia in the back on your way out but leave them on your chairs that's fine they give us a little feedback on today's event Dilip and then Dora we're out of time so quick would be a very quick three comments my top recommendations including comments dissociate IPR issues from action plan for safety and quality of medicines this would help unite the two sides of the industry the brand name industry and the generic industry that could be a common program the civil society would be on board all government will be on board as long as you move away patents and trademark issues from that second move away from anecdotal evidence based diagnosis of the issue by region and by country and get some serious evidence India has produced such serious evidence in the last 10 years and then you know what is the issue and then your prescription would be appropriate to the diagnosis and thirdly differentiate between driving forces for falsified medicines and substandard medicines lot of substandards in the I will talk about India in the country is because manufacturers adequate facilities know how technical competence this can be addressed by equipping them by capacity building falsified the motivation is totally different and falsified needs a different action plan thank you criminal rather than capacity thank you very much I want to key into what Dr. Shah said about capacity building developing countries we need capacity building in 2008 for instance a very credible manufacturer in Nigeria used diethylene glycol antifreeze to formulate a product instead of propylene glycol and the two products are similar and this happened 50 years after the diethylene glycol tragedy of US that actually led to the establishment so if we can be helped in capacity building I think such errors can be avoided this is not falsified this is GMP error but I want to quickly talk about strengthening international collaboration the criminals I said it before are collaborating they are networking they are always ahead of us so we need to network and try as much as we can to overtake them and make sure counterfeit medicine is solvable not solvable to go to 0% it's like crime you cannot take crime to 0 but if we can get it to a manageable level it will be of great help to humanity and very importantly we have international convention on narcotics and psychotropic substances why can't we have international convention on counterfeit medicine illicit drugs are taken by those that can afford them out of choice but counterfeit drugs affect innocent victims by letting the rights of those innocent people I think we need to treat counterfeit medicine as international health emergency program and have harmonized regulation by countries you know like I think I'm keen into what gentlemen said if we have a code that everybody can keen we want to do it especially if a country like united states takes a lead we need to work together not just regulators law enforcement agencies civil societies and all that I want to point out finally that the greatest problem of regulators is corruption if a regulator looks at money and says no the job is 90 something percent done especially in developing countries and as long as a regulator is not compromised that aspect is taken care of we now talk about how do we cooperate so that the success of any country will not be an isolated success it will be a success that will rob on all the other countries around and on the international community thank you before I leave I would like to thank CSIS and IOM for providing this opportunity and be here today with you and I'm sure Dora will join me in thanking both the organizations thank you for Dora for coming thank you so much too yeah so we urge you to read the report if you have suggestions for additional sessions write them on the paper thank you for coming