tv Key Capitol Hill Hearings CSPAN December 17, 2014 10:30am-12:31pm EST
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manufacturing supply and we are happy to be part of this. congratulations for driving the community to participate in the tragic situation not only on the west african country's. what i thought i will talk about in the bucks next few minutes is the program and number two, but has been very important in helping us and others to participate in these efforts and
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number three share some future looking ideas on how we can be better prepared in the future to handle situations like these and then i would be happy to discuss these will pocket into the q-and-a part. the phase one trial which has been completed and published satisfactory we also have the enrolled in cities in the uk, switzerland and then molly. i say this with precision because our perspective is that we need to define what is the best storage to use in phase
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two. we also are planning on starting to trials in africa when including almost 3,000 subjects and the other involving about 800 in the middle of january and then the phase three where we have a commitment with the nih to purchase a piece -- participate in the trial and see the leone. that is what we have planned and we also have tuesday and we can only have a good vaccine that can protect in the short term but have a sustained long-range by providing the booster vaccine by combining the vaccines that
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we are developing. so quite a comprehensive effort that should deliver information on the effectiveness before the middle of the year if all goes well and we worked together. the trial cannot happen unless you manufacture the vaccine. over the past four months we have dedicated enormous resources from our organizations to make sure that we take the process to manufacture to the level that we can start producing the amount of the vaccine. the first one for the phase three trial if all goes well and then continue to produce to the
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make them available for usage. so that is on the status of the vaccine. on the enablers, first for any of them developed it wouldn't be without partnership. his partnership with the nih, the university's top pharmaceutical companies. it is the key that the companies here [inaudible] the second thing that's important is to think forward about delivering them to the population to make the funds
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available for the vaccines to be provided. third this critical meeting that took place to make sure that all stakeholders have that many countries come to the similar conclusion they think of us to coalesce our efforts in the right direction. it's in that unity for all the stakeholders produced. my concern it is limited
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other countries to materialize and finally very briefly on the future perspective this is in the past four or five years the major threat. what's going to be next. every time they've taken by surprise by her we have to reevaluate our resources and what is discovered under the emergency situation and to accelerate. we have a more proactive
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through this devastating disease i have a lot of sympathy working together with stakeholders and am pleased to see no borders between companies as we want to join efforts to make this successful. we wouldn't have been able to be where we were today. we want to leverage all of the capabilities. we have heavy investments and
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also in terms of diagnostics we know that today going forward. these are now very active and beyond that one we have collaborations with several such as the foundation. when you look to the vaccine which we have been working on with them working for several generations on the vaccines and just before summer we gained the schedule that was a highly
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stringent virus. what you see here were three vaccination regimens that turned out to be 100% protected. one involved platforms and the other [inaudible] as you can see all of the animals vaccinated with placebo are dying today. in vivo the emergency we decided at the moment that moment that we really wanted to develop. this was we knew very clearly that it was focused on the single vaccine that could go faster. in addition by focusing on one
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of the vaccines also felt it could shorten the timeline and that is indeed what we have achieved a. what we have is that vaccination schedule itself. there is the booster being given. the principle is that we have robust protection with the combination of the prime and the booster dose. the platforms have been used at stints as we in commercial products into their more than 7,000 subjects vaccinated today. we were very satisfied and also animal doctors have shown to be
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well tolerated like hiv, tuberculosis and malaria. we selected the dose that based on past experience is known to give good. one advantage that we see is that what we have invested in the past year has helped optimize the manufacturing process and to give you an example we have at least 150,000 doses so we already have a substantial amount of vaccines. we are confident in the doses.
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an important aspect also is that it has been conducted in the past and before using the platform it is stable up to two years to a degree. it means logistically it would be using the classical channels that already have to be used to increase. this is just about how it looks. one of the reasons is that it could do much more.
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5 million in the magnitude of 15 to $20 million. as indicated we are convinced that we should go beyond the borders of the company and worked together with the stakeholders. when we see how the partnerships work now for years and two months this'll teach us a lesson going forward. [applause] >> julie gerberding. >> thank you for hosting this.
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i thought i would do is put a little more context around some of the things we are talking about as we open up for conversation at the end of the discussion. one of the things i reflect on is the surprise. it emanated from contact with the virus that spilled over into sometimes it is over to people that we've known about this ecosystem for a long time. we didn't know that it had reached quite the way that it did but it's there now and there is no reason to believe we are not going to see this again so we have to be fully prepared as a possibility in the particular break that we are experiencing this is in the last time we are going to be dealing with ebola.
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i don't mean to sound like a pessimist but it's important to have that longer-term perspective on what lies ahead from the perspective. it's the issue of plausibility. from everything you've heard and seen in the preclinical and the early clinical studies that are going on creating a vaccine is biologically plausible and that gives me a great deal of optimism that even if the one point oh vaccines that we are working on today don't prove to be the ultimate vaccine we need to keep going because it is possible to develop a safe and effective vaccine that can prevent infection. with respect to the vaccine that we are partnering with some of these are early days.
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this is the virus that is designed to sell that there is active replication and that has the advantage for both prompting the robust and even system and watch carefully for side effects that were reported from one study that are particularly worrisome but that's why we do the clinical studies so that we are alert to things that could signal and would be the harbinger of a serious issue down the road. i think we also anticipate that the creation of the solution is going to have to be pragmatic. why wide sarcastic today while we are sitting here having this assigned to take conversation and we cannot move at the pace that we are used to moving. i don't have to speak for my
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colleagues and the other manufacturing companies, but this is an incredible disruptor of business as usual because we have to be pragmatic. we can't take our time. we can't have the conference calls and meetings and through all of the stakeholder engagement and on and on we have to do them in parallel. so we have to be willing to work faster, to move more people to come to the table inside of the company but allowing what's going on with incredible partnerships that we are experiencing outside of the company. i think you said it really well about the disturbance of other important pharmaceutical work that would otherwise be going on. a couple of the vaccine and the passion of people certainly in the vaccine business and we were passionate about this and we
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know that it's the right thing to do and we had something to contribute. we know we can't do it alone and people are leaning into the opportunity to be a part of this process at the same time we didn't budget for this or structure our company for this. it came along and as a sudden requirement we have to step up to the plate and do our share but it comes at an opportunity cost that something we feel we have concerns about but it doesn't change our commitment to its something we have to factor into and it's something we have to plan for going into the future. this challenge that we are facing is also about unprecedented partnerships that i think it's kind of a buzzword of there are some very special partnerships that are going on here and one of them is the partnership between people who
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are traditionally competitors but there's a much more robust set of partnership happening between people who may share a broad agenda that are used to working for each other to the transnational government partnerships even in the u.s. government "double partnership started with the nih and the cbc how wonderful that they've already made a commitment that it would be available to the people who need it the most by creating the macro investment commitment to bring it forward. i think the beauty of that to me is underlining this kind of glaring public-health requirement is the trust that's been developed in the past several years as we worked together on other problems into so we have developed some
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understanding of how we said they were again to some appreciation for who has a stake in blood and are willing to sort of build on that and connect these partnerships even when there is enormous uncertainty about where this is going to land and where we will ultimately end up. the last thing i wanted to talk about is the poignancy. the fact that this is about 18,000 people who had ebola. about 35% who are no longer with us and in which they shared their lives and families and loved ones and people who have suffered deeply from this tragic outbreak and the poignancy of being where we are today. and not being able to do more faster to contain this outbreak and make their lives more secure
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and reduce the incredible human suffering that surrounds us not just for the directly affected people but all the people in the community that they don't have health services and whose lives have been so disrupted and potentially the democracies are going to be so disrupted. but the other poignancy to me because i don't work for the government any more is of having been here and done this before. we do not have to keep reinventing the wheel. how many outbreaks do we need to have, how many public house infectious diseases on a global scale do we need to experience before we recognize that we cannot have a response. we have to have a sustained commitment and stick with it even when the problem goes away. that has been the ultimate poignancy and i share with you
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your final remarks about how we need to lean into the future and create new avenues to be able to sustain this effort over the long run because i don't want to have to sit on the panel like this again as much as i have enjoyed it. >> appreciate being invited to join the panel today. we've been responding and raising the alarm and looking for more resource discussions and very early on we realized as we often do we simply do not have the tools and any other response as well as effective
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communities to get the best outcomes. we are going to be launching the trials before christmas for some of the drugs and we are going to run a third trial based on whatever safety nets as well as simply having the supply of available that has excluded the specialty maps and there isn't a lot of supplies. one thing that i've been especially involved in the safeguarding of access of issues that we consider important for the immediate term and to ensure that we can use these for the compassionate use and others that are either within the trial or are in the community. we certainly are also concerned
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about the medium-term access issues and if the trial is proven to be successful that we can continue to ensure that it can be continued and certainly we are we're also very concerned about the long-term issues and in terms of the affordability of the projects and the management in the intellectual property and this is especially important because this is a importantly something that's going to keep coming back and we are not sure that there's an organization in the future all these other responders will be there but it will have to respond and we will need access in the future so we need to take the steps now to ensure that we can safeguard long-term access. in terms of the vaccines from a very early on along side others in the of the global health community, we very much for thinking about the importance of vaccination in the outbreak and that's been engaged to pull out all the stops that accelerated the trials and accelerating the
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production recognizing the companies and the donors but this wouldn't entail them to be taken in the short term and in the medium-term. so we certainly try to get a pragmatic approach to that and we really do welcome the commitments that have been made although we do have some short-term concerns in terms of the structure that's been put forward. ..
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can be a very important sum of money to encourage monies -- companies to develop vaccines. congress is just amended legislation to include ebola. these are all very important but we need to make sure in terms of how this funding is being provided to make sure it is well coordinated as we've been discussing. the last issue about equitable distribution. we are moving towards a national scale production to a lot of these vaccines but in the shorter and medium-term there will be some problems in terms of providing adequate supply and to the extent we discover these vaccines are safe and effective, we want to make sure there prioritized for the affected communities. we know there will be other interest in terms of securing supply potential for develop country but also issues in terms
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of how to manage distribution between different communities. we hope the w.h.o. can take in the central role. we are considering clinical trial in guinea with government of norway and other partners that we hope we can get off the ground by next march. moving out into issues around second generation products, certainly in terms of vaccine we would like to see a future vaccine to be more formal stable. this is the challenge for msf for many of the products the companies on the stage are currently selling to us in that we are often unable to deliver them at very remote settings because we simply cannot move them out of chain and controlled temperature change. in terms of drugs, we think the show a lot of promise and a lot of interest in msft use these drugs. we are concerned over potentially be used of biological samples from affected population in order to develop
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these products. potentially a concern that has arisen for us internally. we want to ensure that its these materials are being used from affected countries at various concerned about access are triggered in terms of managing the supply. we want to ensure there's affordability to products and their available again insufficient supply for the affected countries. just perhaps to end on some remarks, and just to note also that antibodies, the u.s. has expanded the orphan tax credit to the development of these antibodies which pay for 50% of clinical trial costs that doesn't safeguard any of the access issues which were concerned upon. so demanding that they be affordable, they be available in sufficient supply. that's also the concern we have with the voucher. with all of the funding being provided it seems like none of that is being tied to ensuring access which matters to our organization. in the long-term we will be acquiring those product and
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using them into fuel for our patients. just to end in terms of some additional thoughts. three lessons for us certainly in responding to this outbreak in terms of the drugs and vaccines. one is certainly about the challenge we continue to have a really consistent importance of access, whether the short or medium term or long term, that governments are providing links to access issues. our clinical trial partners often are not its money with these issues because it's not the course to think about these in clinical trials and that's not normal for msf to be engaged in clinical trials. this is front and center as an operational organization trying to deliver treatments in the long-term. there's a lot of challenges there to normalize this in clinical development i think now and in the future. a second thing around transparency especially funding. a lot of money being put towards this and that's important to move from the famine to feast but we think we need to understand better how this funding is spent, what conditions are attached and how
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it works together. that's important for the us government which is offering so much money from different sources towards the response. the last issue i would note, this issue of the philly of our system of research and development. i work for an entity which launched in 1999 because we're concerned our system of research and development does not ensure the drugs and vaccines are affordable, better suited to the conditions we were in the face of agenda work. that's what this represents to us. we are faced with the same situation we had 15 years ago. this failure is something we all own as a global community and is something which we're still not responded to. when you look at the vaccine which mark has now licensed in, that was to go by the canadian government -- merck. many years ago it was licensor small manufacture for 200,000 canadian dollars to which nothing was done for a long grid of time until this current
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outbreak. that is a failure. when i hear comments unfortunately of saying this is an opportunity cost, not expected, that confirms our concern. ebola is a concern for us. it is a public health problem and it needs to be front and center. when he doesn't incentives that prioritize these diseases. they should not be thought of as opportunity cost. they should be front and center. that is what is required to have changes in the future. these isn't an emergency but for other things. so is basic and about resistant. so is a range of something of the neglected diseases. they all merit our attention. it's only if we can find new ways to develop drugs and vaccines are we going to prevent ink on these panels in the future because we're going to continue to face these challenges. as an operational organization we have to continue to respond and put our staff in affected communities suffering support of
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half of this outbreak. thank you very much. >> thank you, rohit. [applause] >> it's really striking how much soul-searching and introspection this crisis has stirred, and how much effort that innovation and changing business practices and modes of operation, how much all of you have been stretched in this period to do things that are outside the normal pattern. there's three issues i'd like to quickly touch on and then open to the audience. one is the question of how these trials can be best carried forward. there is a debate going on now. there would be an ideal situation an obvious preference for the classic randomized trial, approach, double blinded trial, and that will be attempted in many settings as we go forward.
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there's uncertainty though, we know the risk environment is complicated. we know the operational environment is complicated. we know that the acceptance by communities is very fundamental. in being able to move forward with trials. and so it seems to me that as we're entering 2015, expanded multiple, expanded trial, that this unresolved debate around how to operate with greatest adheres to principles of safety and efficacy while being pragmatic and adaptive to a highly challenging and highly urgent environment, how is that likely to play through? it's an honest and open set of challenges, for which i don't know that there's any immediate and clear answer. it would be useful to hear from all of you how you anticipate navigating the environment and moving forward. tony, do you want to say a few words about that? >> sure. first of all when you're dealing
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with trials, there is a balance as i said in my brief opening remarks about trying to get a product that is potentially going to be beneficial. to people as quickly as you can while making sure it is beneficial and not harmful. that's the fundamental right now for a randomized controlled double blind trial. i think that it can only be done with complete buy-in by the people involved and those responsible for them, the reasons why we're now in our fourth visit to liberia in discussion with the liberia health authority about the feasibility and the advisability, or not, and the decision, or, as opposed or not to be a randomized controlled trial, fully being aware that the advantage of doing a placebo-controlled trial were not every single person it's the product is that from the
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standpoint of proving efficacy or not, it is really the only surefire way of doing that. you can have other trials. you can have cluster randomization. you could have step wedge, which are actually okay, but they are much less stringent from the standpoint of getting the data. the advantage of the other trial is that you can get everybody who ultimately gets the vaccine, so if it works, that's good. the other trial, the randomized trial, you can probably get an answer of efficacy more quickly. once you get the efficacy, you're going to distribute the vaccine to everybody and anybody who might benefit from it. so there's the balance that ultimately if it works, everyone is going to get. that's, you know, the framework. then you look at the bandages
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and the disadvantages. if, in fact, you are distributing a vaccine before you know it work, the advantage is that if it does work together to people quickly. the disadvantage is that you may not ever prove that it does work so when we are going to be sitting on this panel with the inevitable next outbreak, we will not know until we have a vaccine that works. that's the problem. the issue with the randomized controlled placebo trial is the some people are not getting it right away, and there is this absolute understandable desire that if something is going to be beneficial, get it there as quickly as possible. idea, and i will just finish with this because it's very important, i mentioned this at another seminar we had here about the issue of the difference between therapies that you make readily available for which i was the champion of during the hiv/aids versus a
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vaccine that you don't know works. and there's a big difference there because and wonder giving it to people who are perfectly normal and other you're giving it to people who have a terrible illness. the thing i will never forget, as i mentioned people may have heard of this, is that we have a vaccine for hiv that looked really good in an animal model. it passed phase one, was really safe, no prohibited adverse event. it even went into phase two a., and look at it. so the decision was that if you look at people as dramatic as it is, seven, 8000 people have died from ebola. over the last four days, 16,000 people have died from aids. so you could have made the argument, as soon as you had that safety data in the hiv
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trial, give it to everybody who needs it because it's a terrible, catastrophic pandemic. the only trouble is in the randomized control double-blind trial, we found out that there was a 41% increased risk of getting hiv infected if you were vaccinated with a vaccine. and it had nothing to do with behavioral changes. it have to do with the vaccine. so that's one of the reasons why when you're dealing with giving something to someone who is otherwise normal person, even though they're at great risk, seriously balanced, and i don't know, steve, what the right answer is, but i do know that your least need too seriously consider the pros and the cons. and that consideration has to be with the people in the country are going to be involved with the vaccine. if they don't want it, they shouldn't get a.
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dishy get whatever trial they feel is appropriate for them. >> so we are in a negotiating, balancing out the urgency, the demands from the temerity and the leadership itself, that is all to be determined. the mix of tools and approaches. >> would you like to say something? >> i'm very supportive for expressing, and i would like to add two dimensions to it. malaria kills between eight and 12,000 children every hour. we need to be very cognizant of the proportionality of this. a very important point about ebola is in january, february, march, april, the world doesn't have a vaccine to immunize everybody. and the issue of having people
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at risk who are normal subjects, at the risk of acquiring ebola will exist outside. this is not a situation where we could potentially immunize a whole population but even if you wanted, you couldn't. so there will be people specifically in the trial and people who don't but i think the question on keeping people away from a vaccine could be extended to the overall population there for me, it's one of the reasons why, pragmatically there something else you can do then provide vaccine to a smaller proportion of the population. but, of course, engaging and having the agreement is absolutely paramount. it's also the reason why we are not favoring any one of the trial who does not -- working very hard to make vaccine
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available to all of them. we don't know which ones. >> i do have a concern, if you look at what's happening in liberia, had we introduce the vaccine a month ago we would be thinking -- we would be seeing a decrease in defense now related to the vaccine when it's related to other things and, therefore, wouldn't know, we would know and we may be wrong. we need to have a very balanced, very persistent, very open source, scientific discussion around it. >> this is really hard, and i just wanted to jump in here with perspective because i completely agree with tony, and i think participatory is the concept that needs to be emphasized. it's one thing to sit in a corporate headquarters and think we know the best way forward. it's a different thing to have a conversation with people who on
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the front of the people in the affected countries who see medicine very different than we do and have a whole different cultural context in which they make decisions. that participatory element is will import it. probably the thing that worries me is that even if we knew the vaccine works, will people take it? that's a problem that we see with the vaccines that a been around for as long as polio vaccine has been around. we have this incredible vaccine, it's frightening as the bull is, i think it's going to be very difficult to help a population have trust and confidence in the product. so the more participatory the decisions are, the more transparent we all are, i think the better likelihood we are to bring whatever we can to find, find helpful to be at the frontline what people need it. >> i fully concur. i think the major changes, will be as accepted by local population, local committees they really get an acceptance of
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the people to participate in trial and be well prepared in trial that there will be ebola cases anyway, it can be approach every objective voice and you -- start accusing the vaccines or whatever, the social thinking around how to involve the subject and to work up any issues did arise. very important to make these trials successful. one thing i would like to add to this, is on how we will go later on demonstrating for major vaccines, whether we will have to go -- stomach which when the vaccine becomes even more controversial, or whether we should start looking into --
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survey discussion we still need to have the. >> nsf, of all the positions are, is the one with the deepest on the ground extended contact and knowledge. how, i'm sure you are holding in divergents directions in terms of this issue around ethics and trials and community relationships. how do you see this? >> the basic summer is it's about community engagement and acceptance, and we are build basically on that basis. that's just part of the dna of the organization. it's not something just to be sent. we have made a decision for our trials on drugs not to introduce randomized trial. it's a decision that was taken very early on in the organization that this is something as a medical provider that we be unable to do and we
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are relying on approaches have been criticized elsewhere looking at the historic trends in some of these communities in terms of what has been outcomes in terms of mortality rates. there's an understanding of the shortcomings but also the medical provider, and again it's because of this can we say we do not feel we would be able to engage in randomized controlled trial for the drug. taken for vaccines i believe there are discussions of ways of trying, and begin for drugs because there's reasons within which -- right. >> steve, again the point you make is an excellent point, is a big difference. people need to understand that between the drug and someone who's sick versus a vaccine. so it's no criticism of design of trials that can be anything from adaptive trials in any kind of trial, you need to really do what's acceptable and what you feel is the best so there's no space between them.
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>> now, one of the issues that have surfaced in this period is coordination, how to make sense, how to track and coordinate efforts, they took the step last week, that's to put itself forward. i would like to ask you to just a few words. there's a microphone right here, around how does this help put in place mechanisms that build confidence around the coordinated effort looking forward? could you explain a livid about that? >> i will do my best. thank you, steve, for hosting this panel. it's a terrific group of people that are really in the middle of all of this right now. it's great to be. just to give everyone a low bit of background, in september, our executive committee asked the secretary to physical look at
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ways to potentially have a role in the ebola outbreak. and in the crisis. basically over the last two months there has been a tremendous amount of work that has been done over this period, a lot of work with all of the people on the panel and pretty much every stakeholder that's involved in this process. that all came to a point at our board last thursday where the board discussed the idea of what that role would be. and the decision was, a couple of things. the first was that everybody is related in his funding envelope of up to $300 billion, procurement of an ebola vaccine, once it's been deemed safe and effective by the w.h.o. and there's also another 90 million, up to a $99 envelope for two purposes. what is around the rollout of the vaccine was becomes available, and any other piece
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is the ground recovery of immunization systems. i think everybody is aware that, especially in the three countries that have been affected, immunization systems have been decimated, a huge reduction in immunization year when the time is right this country are going to have to rebuild, and we are going to be part of that solution for them. i think it's very important for people to understand, i think some people here know that we are just weeks away from our second replenishment, which is not about ebola, the number that we're looking for $7.5 billion that was well before this crisis hit. so the numbers that we're talking about for ebola are in addition to what we are looking for replenishment. i think it's very important to note that that funding is additive and not part of our regular critical immunization work. what we are doing as far as the
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next step, we literally just made this decision for days ago, but the work has already started to really get ourselves in place to be ready when a vaccine comes about, for work streams have been created around the areas of the board's decision, procurement rollout, future outbreak, and the recovery of the system. so we are really will working to ensure that these pieces are all set, so that when a vaccine becomes available we are prepared to roll it out. and as far as the recovery piece goes, as i said i think countries are still in process of figuring out what they need to do. we are putting ourselves together so that when countries are ready to start rebuilding, that we are there to support it. as far as, i mean, we played i think what is happening the last two months really shows the important role that we have around immunization but also
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around strengthen health systems around immunization's, and we are a small piece but i think just kind of going back to what everybody said, around partnership. we will play a certain role in the vaccine process but in order to ensure that it's really getting to people that need it, you know, we will rely on our partners on the ground, along with all of the other folks that are part of this process. >> thank you very much, natasha. there seems be a pretty strong consensus among the speakers that future business needs to be done on a different basis. and that part of this introspection process is looking ahead with that in mind. could we get a little more particular around, a little more concrete into what actually would you see as the essential changes in practices, and
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coordinating mechanisms, in planning and creating incentives? julie. >> one thing i think we would all agree on is that companies crave predictability. so we would like to have the confidence that if we start something, we can move it to completion. we would like to have the confidence that, for example, if we have a government partnership, that partnership is good for the duration of whatever does we're trying to do and that something is going going to go away with the next election or the next sequestration of the next challenging circumstances in anybody's government. i think that's one aspect of it is come under the confidence that if we're going to make an investment in the partnership, that the partnership can hold. i think we have good examples where that's happened. i think barda has come through on its commitment. and i'm not criticizing anyone. i'm saying that's a necessary
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component of this. i do think all of us would benefit from a public that is more informed and more reliably informed about why these kinds of investments are imported. you just heard we have a pledging conference and people need to commit, governments need to commit, donors need to commit. in order for that to happen public has to understand what is the value proposition that we are creating and why is it important to vaccinate. and what is the benefit that not only the children are adolescents are benefiting from immunization in the case of ebola from all the people benefit most to benefit to the people who don't have a portable access, but what is the advantage to the rest of us? i think it's important that we not be shy from the fact that vaccines and vaccinations is an important public health good. sharing the good has become a very global and we only, you
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know, one traveler away from a threat in our own neighborhood if we don't do a good job assuring affordable access to the whole community. i think in terms of how we develop pipelines that vaccines, one of the heirs opportunity that we're exploring, not just in the context of ebola but for many of the other so-called neglected diseases are hard to find treatments and vaccines for diseases is a pretty competitive collaboration. they are increasingly very interesting places where companies can come together and work on projects and bring different ideas together, long before there's a product or a candidate target so that we kind of can't share in her own intellectual capabilities but also partner with the people in academia or other kinds of companies and nonprofit organizations to bring the best ideas forward long before we are
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targeting a product. and for neglected diseases, it's probably really the only way to harvest the intellectual competency, and expedite its useful fruition. >> why don't we hear from the other to? we are hearing from industry. >> companies are extended committed to. are some very specific ideas around what we should do going forward. there are the vaccines that exist. those that exist i think all the companies have approach is to ensure access. providing that to the community allows for lower prices to be available for access. the challenge actually is how do we incentivize innovation?
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investment, to go into areas of diseases that may or may not someday come? and the key element as we live through, and every time there was an outbreak, we did. [inaudible] and, frankly, and all the outbreaks that have come or in the next that have occurred, we are very fortunate that none of them actually turned out to be one. so we actually don't know whether they are represented or not. we need to be very careful as a society to be much more prepared, frankly. to the way we look at this is, at least as far as vaccines are concerned, is that vaccines work to what i would call -- [inaudible]
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there is a great technology that tends to use to make many different vaccines. and as best we can predict, with reasonable accuracy, which vector, which technology can which platform may be best suited. our recommendation is to create an organization, and exactly how we can organize and how we can fund it, is open for debate. but create an organization that is going to identify four, five or six platforms, and prepare them to gain the speed of reaction. and also use them to build that team for predictable possible
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outbreak. and have those available, but also when we haven't predicted the scalability is built into the platform so you can go at these really fast. >> said these collaborations would be a new grand collaboration of a kind you're talking about in which different industrial interests would be sharing in it. >> potentially but it can also be, frankly, imperative or pretty competitive. both models -- free competitive. they can be between we design and develop a vaccine for ebola and the way you design and develop a vaccine for another disease that's more commercially relevant to sustain the best that takes the risk of innovation like the vaccine industry does. the knowledge you generate from one cancer the other.
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i think there is a need for a concerted effort and an organization, because the other point is the following. i would like to say the following, if i may. one of the points in this particular situation is if a company didn't care about ebola, nobody talks about it. that are vaccine companies who are not doing anything for the ebola epidemic but we need to be careful that those who actually have made a commitment outside of any form of financial or any otherwise contribution from anybody, to commit the resources to make vaccines, development, manufacturing, make them available, take all the risks, are not those -- [inaudible] i think that's a big piece that we need to do and not forget.
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because what are important it is that this type of commitment to public health, to global health has to be sustained in the world we live in. the world we live in, enormous investments are made in our india, 90% in many cases fail. we need to be able to sustain the innovation area. site think, i think we need to have, i would say the courage at the same time say we need to stay in business, and at the same time we will commit outside of any conditions when ever public health needs to do. that's what a company should do. what you are proposing to do it on a grand scale for many, many more than what we have up to now. >> i think it's an accident idea that we need a lot more
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discussion, so that think both are quite similar in terms of social possibly of thinking. we do have dedicated public health group which actually is doing r&d on those types of projects. billy can have to bring a balance -- semi-cute as can afford to me of them. certainly when you're looking into irking together with a network of partners, be it companies or the institutes in this area. site you think that part of the future is there. part of the future i think, reference was made to at of alex is also that the society is just not thinking how truck specific are being compensated because it's clear in the normal setting, it just does not work. we really need to look into
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other ways, not to make them expensive, but your effort in some way is being taken into account such that -- [inaudible] >> i'm going to turn to the audience and then we'll open for questions and comments. rohit, on this question of what needs to change? >> a few thoughts. we recognize the effort the company for making right now and resort appreciate that, but if you take the example of dsk is a vaccine, those only acquired because you purchased the company for another vaccine and, unfortunately, this was sort of included in the process. we recognize that. and, of course, all of the of the vaccines, the of the vaccine was to go by the government of candidate, public funding and it is shown activity for the efforts in december was nothing to be done. spent just to take a step back. the big picture about this it would only have one system of
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innovation today. that's a patent-based system innovation. and that is something which all of these companies have pushed quite aggressively for over the decades to have globalized in the 1990s. so in a sense of the own the system of innovation practices which asked for and this is what we have today. that is what we are having to do with everyday in the field. that is one of the symptoms basically the result of a we see with the ebola outbreak today. your come to say are still pushing for higher and higher levels of intellectual property protection. in terms of the suggestion to things such as developing partnerships are platforms but this is something that has been introduced now almost 15 years ago. or organizations launched one of the first develop a partnerships in 2000. we still pay for about 25% of its operate in costs. why we don't do so disagree with
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looking for these solutions to develop technologies for platforms, for us with more of the same. there's a lot of product develop a partnership after and all we're seeing today is adding more and more of them sort of paper over the cracks or singer system. what we have been doing over the last decade is working at the world health organization to document system and countries in research and development. the w.h.o. has come out with to cover its of reports on this issue that showed the extent to which our patent system is not helping drugs and vaccines and diagnostic learned in developing countries tha and have developea range of recommendations to try to break this between innovation and access to ensure we can have the public health tools we need to respond to emergencies like this and we need everyday problems we see ended up in countries today. there's a range of recommendations that talk about new models of innovation and the outside of the system that seeks to delay the cost of research and development from the product price so we can a to focus on actual public health needs to the public health the goods which is essential are doing here today with ebola vaccine
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for substantial public investments, through procurement mechanisms being put forth by trenton. we are developing these axioms to new models of research and development. we're just doing it through sort of i guess random and stepwise process. but a lot of people and should have been fighting against these new models of research and so because they challenge our existing system of our indeed and will continue to advocate for us because we're concerned about the long-term impacts. we have seen some success in the vaccine space with the meningitis vaccine was developed or collaboration of procurement of super nationalistic of health of financing with berries partners to develop an effective second generation meningitis vaccine at 50 cents a dose. that essentially the links the cost of r&d from the product price. our concern is the solution for coming out are just more of the same. the training is complete negotiations of the 10% of partnership agreement at this time that solicits introduced the highest levels of
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intellectual property protection in the asia-pacific region individual aroun around the word none of that will do with this problem. example of more of the same problem. and and again we do think these new models are not just for ebola, not just for neglected diseases. they can be for very basic things such as animatics. we have the united states saying we cannot rely on this with current models of innovation developed the antibodies we need in our hospitals today we are going to need new models of innovation and substantial new forms of funding. we simply think this can be applied on a much broader scale and it's necessary not on for people in the united states but around the world because otherwise we're just going to continue space these problems to we need new ways of thinking but it's not going to be the solution because and not getting the job done. thank you. >> tony? >> steve, first of all, the comments of my colleagues on the panel are all right on and i agree completely with what people have said. so just maybe make one or two very brief comments that it is
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any different it can fully think what they said is probably the most important thing to do things and has to do with something that we continue with sometime, that is the issue of changing in the sense of making sure that we pay attention to something that has been start sometime ago that is recently been crystallized in what has been called the global health security agenda. in other words, to try to develop some sort of infrastructure in the developing world so that when you go in to a country for one reason or other you leave some sustainable infrastructure that could be intellectual or mostly intellectual entering so that the countries involved, if we had had some sort of an infrastructure available in guinea, liberia, sierra leone area when the first cases came out, to go to the kind of identification and isolation, we may not have had an outbreak as
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explosive as it was. it's very interesting, we've learned, we've had that far since 2003 and that far has not only have a major impact on hiv but it has left in country and extraordinary infrastructure of people committed to the health of the nation that has now transcended hiv and a way that involves a variety of other diseases, maternal health, child health, vaccinations for individuals, measles, programs that are. we need to pay attention to that because i have extraordinary respect and admiration for the courageous and amazing things that medecins sans frontieres does, but the cavalry can't keep coming in at every single time because they'll have a limited amount of resources to do that. so we need to start developing some ingrown groups that can do that. the other thing is just, i couldn't help but think when you're talking about, we all
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said it but i know julie said it right off, that these are surprises that are not surprises. if you want change with got to get the mindset to realize that outbreaks actually occur but when you're dealing with an infectious disease, you should be expecting to. i couldn't help but you were talking, thinking some you may have seen years ago that hbo series, a band of brothers come with a one and first airborne was going into vast on as the army was retreating to the guys in the anwar sang, and irregular army were saying why are you going in there? you get surrounded. he looked at the major from the 101st instead, we are paratroopers to we're supposed to be surrounded. so the same thing with infectious diseases, an infectious disease person you should expect there's going to be outbreaks and they shouldn't be surprises. so i will leave you with that. >> very good image.
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let's open for some comments and questions. we will take three or four at a time. down here in front. please identify yourself, and please be brief. there's a microphone. >> thank you very much. i am the owner of test consultants center in nigeria. we were the ones that jumped on the first and the last ebola grenade. thank you last night -- [laughter] i wanted to raise the issue that i think is very important, is the issue of stigma. now, i have, i can be because of what lies ahead.
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in the country of 160 million people, 18 people were infected, 12 were from my hospital. now, eight have survived, and they've been declared that they are zero, has the antibody but they're still suffering -- suffering from stigma. in a country and on the continent in a zone where 70-90% of the people get their health care from the private people, how are we going to be able to reduce this? when right now, the practice is stopped the fever. if you have a fever at the gate, you don't come into the hospital. so how are we going to be able to convince them? because i heard the comment about -- it means if you have to
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really go in there and talk to the people and get to know how to overcome their fears, which we now know is a stigma. >> thank you. >> let's take a few additional comments and questions. right here. >> my name is wayne. i tip my hat to all of you. i think you've done a marvelous job from the beginning of this outbreak to testing vaccines and drugs, starting next month is really quite miraculous. one observation that strikes me, given the number of patients and the deaths them if i understood some of the earlier slides, only two drugs are being tested. it seems to me in this country alone there must be many
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candidate drugs, and i wonder how the final got that narrow? >> thank you. the gentleman right behind you there. >> eight years ago the international red cross warned about the develop biological weapons that could target people based on genotype. for instance, raise. of the 16 white or yellow people have contracted ebola, all have survived except an elderly spanish priest. all the people died of ebola are black. does that mortality distinct and in addition to the off the chart number of infections and deaths that have occurred suggest that u.s. africa ebola variant may be a weaponize version of the virus? >> okay, let's take one other. right here, sir. we will come to you in a moment in the second round. >> thank you. again, i commend the effort.
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i'm the head of r&d at no backs, a recombinant vaccine company at i think the efforts to mend want to put any -- what you were doing, i think the companies have mobilize in a tremendous way vertically. i would point out that these are factors, very focuse focus on je technology, and we go to our limitations. they haven't really worked in other settings. they have pre-existing immunity. they develop very low immunity to the target. we have non-human finding data. so i think that's the best, and i believe plan b should be at the forefront for a second kind of vaccine because there is some chance that when we come to face will look at this and say i don't is that something we want to push forward in stage three. so i appreciate comments on the long-term plan b sounds like it is being discussed. is there a short-term plan?
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>> thank you. so we have a question around overcoming fears, stigma, a question around isn't only two drugs into public. a question around differentiation between black versus white versus u.s. versus africa population, is this weaponize of all, and the appeal around plan b. should t it be a formal plan b t forward right now? who would like to jump in and kick off? yes, johan. >> we so they don't have a plan for that but people organize these and we need to a lot of the sanctions specific for these aspects which reminds me that we did trials in senegal in the '90s and we really had studied nurses who went into the compounds and actually we took their time to tell you about the
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vaccine and certainly was not ejected that vaccination on that day. so it really takes a lot of time explaining and discussing such you really get to people and get people involved. i do think that socializing the vaccine is an important aspect of all steady themes that we need to take into account. >> so we should engage. there is a stigma of having fever because it could be ebola that has so many application on the social issue. for instance, if any of the vaccine induces fever, exactly how the committee will react to that is something that you really need, you really need to be able to check into so they
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work hand-in-hand with the local heads of committee and investigate to make sure there isn't an unpredictable reaction that can be extremely detrimental to the introduction of the vaccine, or to the conduct of the clinical trial. it is a concern and i think the largest population, the more concerned with the, that the movie time the association between events that are not a assist with the vaccine and an immunization. so very, very important. very important issue. spent i was going to address the second point spent i just want to add the study the history of infectious diseases we talk about smallpox, plague, pandemic flu, it's the history of stigma. is a complication of the fear that outbreaks engage.
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so we would be very naïve to think that isn't going to be a major challenge in the situation we're facing here, maybe not worse than it is anywhere else. i remember during sars people didn't even -- [inaudible] highly educated people are vulnerable to the kind of irrational response to the threat. we know that we don't have an easy solution, but one really important aspect of it, at least in my experience has been finding the local people who are trusted and help them understand the whole situation so that they can speak on behalf of their own communities and try to generate a little radical mass of trust at least. >> did you get to complete your thoughts? >> on that, yes, but the stigma is also seen in the trendy. some of you may have seen one of the television shows they had of all of the ebola survivors, one of the i took care of, nina, so
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i know very well. on you being embraced or is it a stigma? almost like 60-40. safety% of people embrace and 40% of people to stay away from them. one of them, i won't mention his name but one of the ebola survivors made a point that is there easy way to get a table at a restaurant now. [laughter] >> so it's not just in nigeria. >> may be a killer point on stigma. certainly some people missing in the news some of the treatments of the returning volunteers for doctors without borders back in the united states, a big concern for us and certainly we need to encourage people to make the sacrifice but its support to also a lot of the stuff that going including some my colleagues who know and advocacy on the the other issue we were going on now in local communities only in affected countries will work on local conditions on the ground. these are the resources that i think people don't see in the
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organizations that are in a few but they're doing hard work with people in the local community on the front lines trying to communicate what the virus is about how to respond and reduce the stigma. i think because this so focus on a model -- medical aspect it loses sight of the fact that -- also on the idea of simply this is not going to be enough. as initial decision we're doing a lot that would not stop our urgent calls for more infrastructure go into the field. certainly i'm glad to be a separate discussion on that because we do think alongside texans that is going to be critical for turning around for the future. >> on this question around my plan of drugs, we were only testing at the outset because of
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the concern of supply. there are others that we're looking at that dr. fauci put up, and to our considerations for repurposed drugs. there's very good safety data. so there are going to be others to use ugly or other trials using other drugs spent on this question around survivability -- >> too many confounding factors because if you look at the quote white people who were infected, substantial proportion of them were at the back to the united states where they got intensive care and that doesn't mean the physicians in west africa are not as good as physician should, but you one or two positions taking care of 30 patients were as their we had come when we were taking care of nina we have seven of us at one time taking care of her. i think the survival of people when you're in an intensive care and are monitoring your electrolytes and gym i decentralize makes a big difference. i don't think that's race. i think it just happens to be
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the dish vision of people who were there evacuated. >> i think in the report is making last week, absent a key that all vaccine candidates progress. we don't know if she received the vaccine, and we don't know if we have enough vaccine of anyone vaccine urgently enough commenting on how it evolves. we need to pursue all of them. and we still have each other. >> thank you. that's a very, very nice way to draw thanks to a close here. we are at the end of our time. this event and exceptionally rich and informed discussion. i thank all of you. natasha, thank you for joining us and weighing in on behalf of gavi. tony, julie, moncef, johan, rohit, thank you so much for all of you.
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>> join a c-span conversation. like us on facebook, follow us on twitter. >> this month is the 10th anniversary of our sunday primetime program q. and a. and we're featuring an encore presentation of one q. and a. from each year highlighting authors, stories, journalists, filmmakers and leading public policy makers. from 2005, kenneth feinberg interview on the september 11 and compensation fund. from 2006, the importance of the african-american experience to u.s. history. from 2007 robert novak on the 50 years of reporting in washington. 2008, the valley of higher education in america. from 2009, conservative commentator. q&a at 10, a decade of compelling conversations.
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december 22-26 at 7 p.m. eastern on c-span. >> sixty-five euro american alan gross has been released from a cuban prison where he had been jailed for five years. e. was obtained -- detained while working to set up an internet access point as a subcontractor for use governments u.s. agency for international developer. ..
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on the c-span networks and we will keep you updated on our coverage plans. apply to the united nations for the year-end news conference with secretary ban ki-moon. >> background. the secretary-general will make some opening remarks, and then we will be united decided to take your questions. >> the floor is yours. >> good afternoon, ladies and gentlemen. it is a pleasure to see you at the end of this year. i'm very glad to see you so bright eyed after last nights dinner and we have some pieces of cake left if anybody wants
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them. you're welcome. with support from the united nations work and i think you very much. ladies and gentlemen, since i have just come back after attending the climate change meeting let me begin with the climate change. the government are government are built on the success of the climate change meeting which i convened in september this year and put in place the building blocks for the meaningful universal climate change agreement in paris and next year. the member states are advanced on similar france. first the text to serve in
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geneva. second, they provided clarity on the commitments to be included in the plans of action or what we call i n. d. c. this is the obligation of the nationally determined contributions. they built trust by capitalizing the climate fund with an initial $10 million. on the action agenda is designed to show the wealth of opportunities offered by the solution to the low carbon pathway. these maintain the momentum is a great deal of work along with
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the others in the civil society now a grade that they must curb the growth in the missions. in my eight years as a secretary-general, that was the eighth meeting and that was the most encouraging conference of the parties that i have attended. ladies and gentlemen, we've also made progress towards finishing the job for the goals and laying the groundwork for the new agenda including a set of sustainable development boards and the resources needed to treat them. in the year ahead, three high-level meetings in new york and paris give us the opportunity to chart a new era
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of sustainable development. as you know, in july, there's going to be a high-level conference on the development and in june, the general assembly is going to convene the high-level meeting on climate change in the midpoint of december. and certainly, we are going to have special sessions on the sustainability development. as i indicated this month in the report the road to stability is a line for the world to take historical actions and to transform the lives and protect the planet. alongside these games.
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david, the special envoy on ebola and the special representative in ghana will join me. i want to see the response for myself and ensure my solidarity for those affected and urge even greater global action. the responders are doing herald work and the government are highly engaged. there's been an impressive outpouring of the contributions across africa and across the world. the ebola response strategy is working and we are beginning to
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see improvements. but now is not the time to ease up. as long as there is one case the risk remains that we can do everything we can. at the same time, we remain short of people and resources. the ebola continues to drive up the prices to keep children out of school and oxygen away from the activities. ladies and gentlemen, the successful chemical weapons program has been of little consolation to the people who have seen the war raged on. south of sudan a policy saved many thousands of lives but the
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situation at the peacekeeping basis where we are sheltering 100,000 people remains fragile as it does throughout the country. nigeria and iraq spread of the insurgencies and in ukraine the situation risks for using and placed the original and global implementations. the stability remains widespread in afghanistan. following the hostilities in gaza, the leaders of israel and palestine have a responsibility to step back from the brink to salvage the two state solution that is looking ever more remote. this must be the time for global action. i would like to highlight for him. it's.
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first, the world must keep in the shin high to form the agenda and secure a climate change agreement. second, 2015 must be the year that we end the nightmare in serious and avoid the escalation of the situations. third, we must do more to counter extremism and the rise of the parties that target the minorities, migrants and in particular muslims. fourth, we will continue to adapt the united nations to the new global landscape. a number of reviews in the united nations including the peace operations which i launched last month, the peace
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building review by the general assembly and the humanitarian financing and implementation of the security council resolution 1325 on the peace and security. these assessments are an opportunity to build on the other reforms we have pursued throughout the tenure. this year i have seen so much suffering in the refugee camp and i have met so many people whose lives are at risk and who are struggling to build a better life for themselves and their families. as we mark the 70th anniversary and next year we have a duty to answer across the world for shared prosperity and a sustainable future forward. i would like to extend to all of
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you were happy holidays and happy new year. thank you very much. >> thank you. we will take your questions. we don't have much time so keep your questions short and limited the preamble. >> thank you all. i will make it very fast. in the u.s. correspondents association happy new year from cbs news. my question -- [laughter] very fast. my question is about cuba. as you've seen, the u.s. is beginning the general processing processing of the assembly voted annually to lift the embargo. can you comment on where the united nations might go with that since you visited? thank you. >> this news is very positive and i would like to thank the president for the united states and for taking this important step towards normalizing.
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as much as the membership in the united nations has repeatedly emphasized through the general assembly resolutions it is time for cuba and the united states to normalize the bilateral relations. i welcome today's development and i hope that this announcement will hope to expand the exchanges between the two people who been separated quite a long time. the united nations stands ready to help both countries in the relations.
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you said you hope it is the year to end the nightmare in serious. the representative seems to be doing crisis management for the terrible event in syria. do you approve of the piecemeal approach and what makes you confident that you would renew the process collects >> of course we would like to have comprehensive peace and stability and development and that is basically our principal approach.
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after four years of killing each other, the virus must stop regardless of what kind of argument or different opinions there may be. it must stop and they should sit together to talk about their own future. this is what is demonstrated. whatever it may be, we need to sit down together. it hasn't been created and to
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substitute as you say it is not a piecemeal approach. it's part of a comprehensive approach. >> thank you secretary general. i have a question on the human rights issue. we have seen a lot of development in the issue. next year the security council is expected to talk about the discussion of the issue do you think they discuss to help the
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situation gets better? >> the human rights situation has become. from the international community mostly has adopted the resolution and the general assembly is going to take action in the agenda should be on the security council these are the matters for the member states. in many situations of the humanitarian and human rights violations there has been a risk
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of all of the social and economic and political instability. we have seen displaced people and refugees also impact inevitably. as the member states and ask your secretary general through my own report to the general assembly, i had made it quite clear that we listen closely to the course of the international community to promote and protect the human rights and also to do what they can to increase. that is my sincere wish.
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>> mr. secretary-general can earlier you mentioned the situation in your brain and its impact on the original administration and earlier they emphasized the support on the integrity of ukraine. from your point of view how can it stabilize the situation? >> the situation in ukraine has been a source of deep concern not to mention the people of ukraine and the countries in the region. the situation as very serious global implications and that is why the european unions and
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russia have been heavily engaged i am deeply concerned by the continuing situation in ukraine while the recent agreement seems to be holding but still we have a lot of casualties. just since september 5 when the parties agreed on this protocol and memorandum, more than 1,000 people have lost their lives and it has impacted the very serious quality and it's going to impact the situation. therefore i am urging again that
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the parties should sit down together and provide the memorandum. this was the result of the very intense concentration in negotiations with the help of the facilitation of many important regional countries. i am urging them again to abide by these. as far as the united nations is concerned, the human rights monitoring mission will continue next year. it was until september of this month but it has been extended. we will try to mobilize the humanitarian assistance to
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deliver wherever it may be needed. >> mr. secretary-general, thank you. you have spoken strongly. subsequently have you been in touch with the leadership and don't you think there should be stronger international response to support the countries like pakistan? >> it's been troubled by the spread of terrorism and extremism. but we have seen what happened in pakistan is totally unacceptable. that's why i've recommended in the strongest possible terms
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we've seen we have seen so many things in pakistan and afghanistan. it's important how the international community must mobilize all sources and political will and help those countries affected to address the extremism. as you know the united nations has established the counterterrorism center on the department of political affairs. now we are actively engaging with the countries for this terrorism and extremism and we
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tried to help those member states to strengthen the capacity. for example, we've been in contact with nigeria in the government to organize the sort of capacity building in january of next year and i will also consider what we can do with pakistan and other countries. >> thank you mr. secretary-general. as i'm sure you've known there've been intensive meetings going on in the past few days on the israeli-palestinian conflict and the possibilities of trying to get some action here at the united nations. what would you like to see come out of the security council,
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what kind of a resolution? >> i understand that active discussions are taking praise on the issue of the members of the security council and relevant stakeholders. this is a matter for the security council to decide. that being said, there is no guidance to advance in the middle east peace process. i have been meeting and engaging with the leaders of palestine and israel and the leaders in the region. we are strongly urging again
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that they should sit down together and reserve all of this the security council can take their actions but it is ultimately up to the two parties so that they can discuss all the issues. i believe that they have identified all of the issues and they know what are the fundamental issues to resolve. i have been urging again and again that we discussed this matter so that they can realize the two state solution. we can lead side-by-side in peace and security. this is a two state solution and i hope that we will see such peace and stability in the new
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year. >> as a follow-up, you mentioned the quartet. it seems to many people and observers that the quartet has failed to produce any significant progress. >> while it hasn't been taking place for some time, they've been continuously meeting among themselves to discuss and provide the recommendations for the leaders to engage with the concerned parties. >> the u.s. recently released its report on torture over the last 11 years or 12, 13 years.
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if the high commissioner for human rights condemned this, what lesson do you think should be taken away from this scandal if we can call it that particularly in terms of not just the torture or inhuman interrogation techniques but also countries cooperating with secret detention centers and things like that? >> the release of the torture report by the u.s. senate shows that it is still taking place in many parts of the world. as you know the countries that have joined this convention against torture it is a stark reminder that we still need to do much more.
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it has absolute principle. there are no situations that are issued under any circumstances. the release of this report is to be commended only by shining a light on what happens in the top area i think we can stop this torture and this is one of the important principles to promote human dignity and to protect the human rights. now this has started a conversation not only in the united states around the world come and i am urging that all of the countries particularly the political leaders and the security
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