REALTIME FILE

TREATMENT ACTION GROUP
DEMANDING A HIGHER STANDARD OF TB CARE
SEPTEPBMER 2, 2020
8:00 A.M. EST

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This text is being provided in a rough draft format.  It is not a verbatim transcript.  Communication Access Realtime Translation (CART) is provided in order to facilitate communication credibility and may not be a totally verbatim record of proceedings.
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     >> LINDSAY McKENNA:  Good morning, good afternoon, good evening.  Welcome to part one of our webinar series, demanding a higher stand of TB care, new tools, new challenges and new approaches to improving treatment for TB.  
	I'm Lindsay McKenna.  Before we jump in, we'll go over a couple of housekeeping items.  Live captioning is available during the webinar.  I'll put the link in the chat in a second.  Just click the link, and a captioning window should pop up alongside the webinar screen.  Let me just put that in the chat now.  
	Today's webinar will last about an hour and 15 minutes and include four presentations and a question and answer segment.  Please submit your questions using the questions or chat feature on your control panel and speakers will address questions at the end of the last presentation.  
	So, again, welcome to part one of our two‑part webinar series.  Today's webinar is focused on treatment for drug resistant TB.  You can see the agenda on the left side of the screen, and before we go over the agenda in more detail, which I promise we'll do in a couple of slides, I wanted to flag that you can still register for part two focused on TB diagnostic tools chill take place at the same time home.  
Hopeful you're familiar with the activist guide.  Earlier this year we put an active guide for TB therapies.  In July we launched the two latest editions to the series.  
     An activist guide to TB diagnostic tools and guide for drug resistant TB, the later which is the focus.  The activist guide does a nobody things.  It unpacks 2020 updates to the WHO guidelines including recommended regimens and important factors.  It highlights existing evidence supporting each of the recommended regimens and related ongoing clinical trials.  
	It discusses access barriers including data gaps, registration, intellectual property and pricing and suggests actions activists to take to overcome barriers and promote equitable access for treatment for drug-resistant TP and common excuses on overcoming resistance to implementing new regimens.  
	Of note all of these new regimens are injectable‑free.  To quickly review the recommendations are the nine to 12‑month standardized shorter regimen, 18 to 20‑month individual regimens composed of four to five medicine selected due to the priority groups of medicines previously recommended by the WHO and under operational research conditions modifications to the 9- to 12‑month standard shorter regimen and for NTRTP only, the six to nine month regimen.  
	Now more ever activist leadership is essential, especially as the ongoing COVID‑19 pandemic threatens our communities and years of progress on TB.  TAG developed this guide to break down what activists and communities need to know to take action, overcome resistance and hold governments and other actors accountable for assuring care for diagnose TB, and we hope you find is a use resource.  It will talk about challenges faced and what activists can do to promote access to DR‑TB menses and mobilize the political will to intensify global and national responses to DR‑TB.  
	I'm pleased to introduce our first speaker, Dr. Jennifer Furin, an infectious disease fission with more than 25 years of experience working with people with drug‑resistant TB all over the world.  
     >> DR. JENNIFER FURIN:  Thank you for inviting me to be part of this crucial webinar.  It's a pleasure and privilege to speak with you this morning, this afternoon and this evening depending where you are and with such a distinguished panel of experts on this topic.  
So I'm hoping to be brief in my remarks.  I hate having to say next slide, but next slide, please, Lindsay.  Sorry.  
	So I was going to talk a little bit about sort of the history of all oral shorter regimens for drug‑resistance TB.  In speaking to people who were diagnosed with I would give them well-intended advice I'm embarrassed about now.  Most of the conversations I would have, people would be sort of horrified at both how long the treatment was and how many medications were included in the regimen and trying to help them put things in perspective and be willing to initiate treatment, I would say, well, it might be two years, but two years is such a short time in a long life.  
	In many ways this became a mantra I would repeat over and over again a short time and what we hope will be a long life for you.  What we're seeing, I'm not sure it was true.  It was well‑intentioned.  If you look what many had been through, what I was trying to tell them publicly didn't resonate well with them.  
	24 months may seem like a short time and not that short.  Most of the people we were working with living with drug‑resistance TB, they haven't just been sick for a month before they got put on this regimen.  Most of them have been sick for years.  It was the lack of access to diagnostics that made things very challenging for them.  
It was still in most parts of the world people don't have access to rapid diagnostics.       
     That's the focus of things for tomorrow, so I won't belabor the point.  Most people are sick for months and years before they came to us.  It wasn't just the 24 months.  It wasn't just two years you were going to be hanging out and enjoying yourself.  
	There were miserable side effects associated with the treatment for drug‑resistance TB.  Patients who I was working with told me that treatment felt like an eternity.  Not only were the side effects miserable, many were permanent.  Particularly the hearing loss associated with the injectable medication, but it wasn't the only permanent side effect.  
	Many people who I worked with said, doctor, you ruined my life with treatment.  It wasn't really that short.  
	Treatment success was not ensured if you went through this sort of grueling 24‑month treatment.  In fact, we were able to have success in just over half patients, so, you know, when I told them it was a shorter time in a long life that was true for half the patients.  The evidence supporting the treatment was nonexistent and based on expert opinion alone.  
	When I started to work in the drug‑resistance TB, the official WHO policy was don't treat drug‑resistance TB.  It's too expensive and difficult and it will take away from drug‑susceptible TB.  It was a really dark time.  Next slide, please.  
	Sorry, Lindsay.  Thanks.  In 2000s were a dark period of time, but it was around 2010 that we had glimmers of hope that treatment could be a short time in a long life.  It came about by repurposed medications that could have a big role to play in the treatment of drug‑resistance TB.  
	For the first time in 50 years ‑‑ I just turned 50 this year, so it's striking to me.  It's a long time.  For the first time in almost 50 years we had newer drugs and the latest new drug come out is a drug called per tomorrow mean although it was around for a long time.  Short regimens are being used.  
	Bangladesh has the regimen, and for the first time we saw clinical trials happening in the field of the drug‑resistance TB including the stream trial, some drug company‑led trials and a lot of nongovernmental organizations started to get involved in the clinical trials because things were so bleak.  
	The WHO guidelines were based more on evidence, but they contained a fair amount of expert opinion, particularly around things like feasibility and patient preferences and cost.  We were moving in a better direction, but we weren't quite there yet.  Next slide, please.  
	In 2020 it's been a bad year, you know.  It's not a year many of us will look back on and relish.  From a TB standpoint at least in terms of the treatment options that should be offered to people, we are now at a time when all oral much more effective shorter regimens are what's recommended for a majority of people living with drug‑resistance TB.  We still face a major challenge with access issues 
	My dear friend speaking next will talk about the issues.  We have results from trials that support the use of shorter regimens and we have results from program use and operational research that support the use of all oral shorter regimens.  Multiple phase 3 trials are slated to have results come online in this decade, and the WHO recommendations that came out this year were actually really a beautiful set of recommendations that were the most transparent and the most community‑involved set of guidelines.  
	They make very clear recommendations that people living with drug‑resistance TB should be treated with all oral shorter regimens for a majority of people.  However, the sad news is that fewer than 20% of people who could benefit from these regimens are receiving them.  Next slide, please.  This is my last slide.  
	And, you know, I always like to end with a bang.  What I would like to say is that the older regimens for drug‑resistance TB that use injections, that use old drugs that last for 18 to 24 to 36 months, these regimens are an abomination.  They're not medical care but medical malpractice, and their continued use in routine treatment of drug‑resistance TB is absolutely not justified.  
	It's a violation of human rights and medical malpractice, the tag activist guide that we're here today to launch and discuss is one of the best tools that we have to ensure that people living with drug‑resistance TB are aware of their rights and know they should get access to the new drugs, and we can move to a space where we can mean it when we say the regimens may seem long but they're relatively short to live with drug‑resistance TB.  
	I'll stop there.  Thank you for your time and attention and inviting me to this webinar.  
     >> LINDSAY McKENNA:  Wonderful.  Thank you so much, Jen.  And yes, you definite always come in and go out with a bang.  
     So our next speaker, Sharonann Lynch, is the policy advisor for the MSF campaign.  Go ahead.  
     >> SHARONANN LYNCH:   Thank you for inviting me.  I'm going through aspects of ideas not new to any of you how to fight and win the changes and how to measure or what to measure and some of the barriers in terms of the drugs that Jen mentioned.  
	Next.  So in questions to ask.  Now, tomorrow take a baseline and then let's all work together and make sure that increases are these sort of markers around the front lines.  So with diagnosis, this is going talked about more tomorrow, but what percentage still today from TB diagnosis from smear in your country at the national level.  
	What percentage of PHC offer TB‑LAM?  We will talk about as well in high HIV/TB countries.  It's also about the facility coverage.  What percentage of hospitals have gene exert and TB LAM.  To Jen's points what at the time Russ called for, is 100% of people starting treatment, they should start on all oral.  Finally in terms of patient‑centered care, which we touch about sportily is what percentage of pH C and district and provincial facilities have what they need to provide treatment.  Next.  
	Some opportunities.  So, again, getting that necessary Intel for in‑country.  Where is the MSP changing or being reviewed?  When are you guidelines being changed?  Ahead of the guidelines is it possible if you are haven't made the switch to have it come out in a memorandum and circular, therefore codifying best practice as policy.  
	Also, for most countries global fund proposals were submitted for the window 1, window 2, window 3.  Even yesterday the deadline was window 3.  There are still opportunities.  I encourage folks to look at the request tracker to see where your country is at in terms of a proposal for TB, and then, of course, find out what's in it.  Next.  
	Even after it's been submitted, there are still opportunities both for applying for unspent funds within the global fund, which is the prioritized above allocation request.  They like to change the lingo every 18 months to keep us fresh on our toes and as well for reprogramming.  You can read this later for yourself.  
	Definitely get the Intel from your CCM.  Get your CCM to explain the process to you.  If not your CCM, then I encourage the NGO delegations and community delegations to hold webinars to talk about the opportunities, whether on a regional basis or what have you.  Next.  
	Now, in terms of what we're all fighting for, you heard from Jen what we're fighting for.  This is some of the findings from 2017 in terms of the number of countries among a survey of 29 countries that had the shorter nine‑month regimen at the time in their national policies.  With the partnership they're coming out with a new report looking at how things have ‑‑ whether things have changed for the better in order to be in line with WHO guidelines for DR‑TB treatment, including what regimen.  So what a person gets, where they get it, and what support they get with it.  
	So here is some of the indications for 2020 that we'll be looking at.  That report is coming out the 1st of October.  
	Definitely in terms of the fault lines and the policies.  What does your country dashboard look like?  We might come out with this report, but if your country it's covered what's your dashboard look like?  What's the best pathway to make change?  
	Obviously, for having that combined use of the drugs and extended beyond six months is critical.  So as science, as evidence comes in it moves the goal posts, do we need to move the policy goal posts?  Next, please.  
	The decentralized and ambulatory care, I was pleasantly surprised to see in 2017 so many countries that did offer care both outside of the hospital.  Obviously, not a surprise for countries in Africa, but there's still a lot of conservatism among other regions in terms of requiring hospitalization.  This is a big bug barrier to people like Jen Furin, who think it's unreasonable to have anything but decentralized and ambulatory care.  
	So for 2017 while there was some good news, we hope to see improvements in the 2020 report in terms of whether treatment can be offered at the district and health care level and whether there's follow‑up and whether hospitalization is required for clinically stable patients.  Next.  
	In addition, we've be reporting on among 37 countries what countries allow for self‑administered treatment as opposed to directly observed therapy.  This is both for medications and even injectables where countries still have injectables in place.  Also critical in what people have been fighting for, obviously, is in addition to SAT, the self‑administered therapy, rather than the DOT, is what measure of support is government providing, whether it be the food and transport subsidies.  We don't look at in the next report.  Adherence to counseling and treatment literacy where you put the patient at the core of the treatment and empowering them is critical.  Next.  
	Now, the opportunity in terms of COVID, I really don't think those two words have anything to do with each other, but here we go.  Yeah.  This article made the case that there are times ‑‑ there are things that can be done and should be done given in the time of COVID.  Certainly moving to all oral is one.  
	If WHO and everybody else is saying, the less contact the better, the more distance the better, then more empowerment for people living with TB the better.  That includes all oral and decentralized ambulatory.
	We need more treatment literacy to go along with that.  WHO was on it, and in May they put out a memo recommending that specially given COVID they switch to all oral as quickly as possible.  Next.  
	Now, even though you might have policies in place, there's always scale up.  Part of policies and scale up is being hindered by high prices and restrictive patterns for critical newer drugs that make up the regimens that Lindsay referred to.  
	Of course, pa Dak Lynn is the most important of them.  It's a core drug that you heard.  There's good news and bad news I will get to.  There are concerns it’s off-patent and essentially 100% funded, the research and development by a number of actors.  Next.  
	So Bedaquiline we know from Jen Furin working with Vivian Cox on how countries are reporting on their use, only 11% of people have access.  You heard Jen say this.  We hope this changes now that the price reduced.  
	The good news is the price dropped to $1.50 a day, $272 a month for six months.  It's $45 per month.  This hinges on a complex free goods arrangement with JDF and global fund that was committed ‑‑ that was tied to volume commitments of 125,000 people within 2020.  So essentially what JDF should be saying to countries is, look, you can have this drug for $1.50 a day for $45 in a month.  
	Essentially, that's the effect of this deal, the free goods deal.  That is 20%.  If you buy 100, you get 20% off.  That's what the 20% free goods is for.  
	One problem is, well, it's complicated, isn't it?  It's restricted in countries that purchase from GDF.  This is a problem for South Africa.  South Africa had originally negotiated for that $400 for six months and also Russia that continues to pay $8 a day through another licensing deal that J & J had with Pharmstand.  
	The good news, let me squeeze it out.  I hope it's measured in terms of people being treated and lives saved is the price decrease.  So as a 32% price decrease from the $400 for six months.  When you look back when J & J first came out this drug, they had the audacity frankly to charge $30,000 for high income countries for six months and 3,000 for middle income countries and $900 for low income countries.  
	Looking the at price reduction, this does represent a 91% price decrease.  We'll take it, but we want more and better, and that includes for more countries and the price should be even lower.  
Also to flag is the pediatric, which still remains high.  For Delamanid, this is the most expensive TB drug in the world.  $1700 for six months and has been that for a while.  
     This is for people with pre‑XTR, but also where people are intolerant to the DR‑TB treatment.  So they need to do better, and finally after some years they have committed to WHO prequalification project.  That means that they can submit also to the WHO collaborative registration procedure, which means that a country need not rely upon the kindness or the action about Otsuka, but rather go through the WHO procedure.  It's good news.  
     While ‑‑ you'll hear more about this others.  While they face a patent expiration sometime, although they tried to evergreen it as well, and generic companies are lining up to produce, we don't know of any generic companies that are preparing to manufacture Delamanid, even though the pattern expires relative soon.  It's 2023 for the core patent.  
     This is because generic companies are waiting to hear if there's an expanded education.  Will WHO recommend this drug for people with MDR and not just the one limited cohort with XGR.  Next.  
	Of course, there's Pretomanid.  It makes up the regimen, so we have a regimen where two of the drugs have been off‑patent for years and yet the price is still a bit higher than it should be.  For it alone it's $364 for six months.  For the regimen the cheapest price was from GTF at $905 for six months.  
	Now, TAG, MSF and others on this call have long called for a price ceiling of $500.  If you can go onto the next slide, please.  Some regimens do fight that, and I think we could go even lower.  According to a new report that we're going to have come out in October with the latest prices, so the most affordable regimen is the Bedaquiline regimen of 460.  It's good news.  For the longer treatment it's still high although a slight dip because of the Bedaquiline price.  For what includes Delamanid, it's much higher and higher if you require 20 months.  Depending on the makeup regimen, the more expense the drugs and regimen.  
	It's horrible, because essentially the sicker you are, the more resistant your treatment and the more expensive the regimen.  That's where we're going to continue to see heads in the sand in terms of lack of diagnosis and lack of scaleup.  The more pressure on the price of drugs the better.  Next.  
	Also, the pediatric formulation, so there's some good news.  So Bedaquiline is 20 milligrams for children 5 to 12 years has been approved by the FDA.  Unfortunately, it's more expensive than it should be, begin that less than half the dose for adults but it's still expensive.  
	Delamanid, there's a tablet of 25 milligrams available for children older than three years of age, but it's only available through compassionate views.  My plan is looking at 15 and 10 milligrams, which is good, and it will take a while going through the process and will be submitted to regulators.  Next.  
	So just to flag the step up for TB report is coming out in early October followed by our report with updated drug prices.  Typically each report shows really good news in terms of lower price.  We don't have that much this year.  Save again for the price reduction with Bedaquiline, mainly because Delamanid is holding onto that and still charging that $1700 price.  We also have a patent opposition database, which I hope you find useful.  Thank you so much.  
     >> LINDSAY McKENNA:  Thank you so much.  That was great.  I just saw one question coming in through the chat about whether presentations will be shared with participants.  
      Yes, we are planning to post the presentation slides themselves but also we're recording off the webinar on the TAG website in the next couple of days and will circulate the link to that all participants as soon as it's available.  
Okay.  So our next speaker Paran Winarni is from Indonesia and survived TB twice.  She finished her treatment and became an educator and patient supporter.  She's also a member of the global coalition of TB activists, TB people.  Paran recently established youth movement against TB in Indonesia.  Thank you so much.  Please go ahead.  
     >> PARAN WINARNI:  Okay.  Thank you, Lindsay.  I'm going to speak in this webinar.  I don't any slides at all.  
	So, first of all, I would like to thank TAG for organizing this webinar and giving me the opportunity to speak on behalf of TB survivors about the gaps and the care and obstacles by the affected communities.  Once again my name is Paran Winarni.  
	In 2008 I had what I know now as TB symptoms.  I went to a private clinic.  The doctor only used a chest x‑ray, and he diagnosed me with TB.  He gave me ( indiscernible ) and some other medicine that I didn't understand what those are.  The doctor did not explain more details about the treatment.  
	After taking this medicine for about two years, again, used a chest x‑ray.  The doctor said that I was cured.  Later on I know that the treatment that I received was not according to the standards of TB treatment.  
	This has happened even though many of my neighbors perceive it is good.  In early 2011 the symptoms that I have were coming back again and even more worse than before.  
	I coughed up blood and lost a lot of weight.  The same doctor in that private clinic referred me to the primary health care center.  The center gave me injections.  The health worker in the primary health care center also had to do the test and sent it to the national ‑‑ for TB treatment in the hospital.  
	At that time I was the TB person, and after two months under the injections, I was diagnosed with DR‑TB and began my journey with the DR‑TB medication.  
	So being an DR‑TB was a greatest challenge in my life because of the long duration of the treatment inside of it.  I also lost my job.  At the time I was a supervisor in the retail industry, and I have to face ( indiscernible ) including from the health worker who thought that I needed to move out of my house because I live next to a small kindergarten, and the primary health worker feared that I would infect the children.  
	This is what's expressed even though I already started my treatment.  I'm dealing with the complexity and the debilitating side effects of the DR‑TB treatment forced me to embrace all of the available support.  My main support at the time was my family.  
     So after five years cured from the DR‑TB, I'm joining a patient who is in Jakarta.  I realize the silence is the biggest issue with the sigma.  Similar to what I have experienced, stigma and discrimination is still faced by the patients.  For me it's important to see ( indiscernible ) after recovery.  
     I am the lucky one.  I tried to transfer my insecurity by sharing my experience as a TB patient and recalling my experience to people not affected by TB.  So I hope when you all in here policymakers or a public health professional or young people or anyone have the chance to influence the TB programs, I ask you to think about the DR‑TB and mental health not only during the treatment but also how a TB survivor can prepare themselves to continue their life after their recovery.  
So above I have a key take‑away message.  So we are happy that we have injectable free treatment, but the programs need to improve counseling from information giving to comprehensive therapy with the patient and family.  
	Family and patients need to be prepared on what to expect from this.  Posttreatment rehabilitation is missing in programs, especially for the people who have experienced side effects like deafness or blindness.  We need our national programs to prioritize posttreatment.  
	And most of the DR‑TB survivors feels as though their life is over after the treatment.  There are no employment opportunities.  
This is something that we really, really need to speak about it.  We all need to do something to help them breathe even after the treatment.  
     Then the last message is we need to strengthen the capacity of TB and the TB survivor to come in and tell their own story in order to improve WHO recommendations currently telling their own stories.  Today they see TB survivors on the panel discussion.  This will strengthen our voices and help our efficacy.  
      We are more ‑‑ once again, we are more than just people who have survived from TB.  Thank you.  I think that's all I wanted to talk about.  Thank you, Lindsay.  
     >> LINDSAY McKENNA:  Thank you so much, Paran.  That was really great and key tie‑away messages including how we focus on the treatment itself and don't give much thought to life after treatment for people with DR‑TB.  So definitely an important call to action to think about that as well.  
     Our next speaker is Prathiba Sivasubramanian.  Sorry about the pronunciation.  Correct me if that was poor.  Prathiba Sivasubramanian has been working on IT issues and access to medicines and has been working on patent opposition for patient groups and analyzing IP provisions in trade agreements.  Thank you for being here.  Please, the floor is yours.  
     >> PRATHIBHA SIVASUBRAMANIAN:  Thanks for this opportunity.  I'm not switching on the video because the Internet is fluctuating here.  Next slide.  
	So ‑‑ next slide.  Yeah.  So Sharonann spoke about how the drugs have high costs and how they're working.  This is what we're going to discuss in this presentation.  
	We'll get into that, and a brief, brief thing about the concept of patients.  Patients when there is a patent or a drug only a single manufacturer or supplier can supply, and it leads to a monopoly, high prices and not every country would be manufacturing these drugs.  
	So it's always ‑‑ mostly it's imported into developing countries, and imported drugs are more costly and inaccessible.  There can be multiple manufacturers that will be competition, and the prices can be low.  
	We can access affordable generics.  Next slide.  Next slide.  Yeah.  So the effective competition is very explained through this slide, and at the beginning of the HIV treatment, there are people who were not ‑‑ were unable to get medicine because the lowest price was around $10,000.  After that Brazil negotiated and reduced it to $1,767.  But in 2001 when supply went there, the cost had gone down to 350.  
	Not only the other ( indiscernible ) was reduced, the cost of the drug came down but also the originator reduced the price.  So competition is very important to get medicines at low cost.  Next slide.  
	Next slide.  It's often our view that patients promote innovation.  It stimulates technologies and et cetera.  What is often ignored is that patients don't have the same impact in every country.  
	It depends on the different industrial base, and the capacity, the availability of capital and the capacity of people to pick up and understand and invite these new technologies.  Patients generally now are used to secure markets in developing countries and LDCs as well as competitors who are coming from developing countries into developed countries.  
	When we talk about patrons and meds, the key issues are if you can see TB drugs itself regarding new drugs only after 50 years.  Innovation is actually the music.  Most of the companies focus only on follow‑on drugs like which I'll explain just now in the next slide.  
The prices of the medicines are really high, and there is lack of that's parent see in price and also small patients.  I should also talk about every evergreens.  
     This HIV drug was introduced in 1985 for about 20 years.  After that in 1997 it was again patented for approved drug.  The same active ingredient was again patented in 1998 for mineral salts.  In 2001 the same active ingredient and the product was ( indiscernible ).  Then it sold in 2012.  Then the crystal line forms in 2018.  We're talking about evergreening.  That same drug gets patented again and again, and the monopoly is increased.  
	There's years of monopoly and only one manufacturer can produce keeps on increasing.  So they cannot enter the market, so the prices cannot be low.  Next slide.  
	This is something that we all might have heard of you, trips, Doha and flexibilities and et cetera.  This describes the minimum standard of production for property.  You have to give 20 for patients, and there are some flexibilities.  Patients can granted anything that is new and that means old science can't be ( indiscernible ) and something that can have industrial application.  
	So these are not defined issues.  So this allows compulsory licenses, and Doha declaration, which had come in 2011, also saved that country and cannot be prevented from taking measures to protect the public health.  Countries have the freedom to use these flexibilities and reduce the frivolous lines and keep the ‑‑ keep the market for generations to come in and to ensure competition.  Next slide.  
	So when we talk about ‑‑ now when we talk about the DR‑TB, in this context that we should look at new drugs there are new drugs and promising new medicines.  These are the drugs that may also go ‑‑ they may also come up as older medications, which is what we're all trying to have and to avoid injectables.  Next slide.  
	This says something most of us know of.  It's from the working group on TB drugs.  This is the new TB pipeline.  
	Some of the promising drugs are mentioned here.  Next slide.  Next slide.  When we talk about some of these newer drugs that are out like Bedaquiline and Delamanid, we should understand these drugs are ( indiscernible ) that's one patent application pending for the ( indiscernible ).  So all of these can keep expanding the monopoly from 20 years to 30 to 40 years.  ( Indiscernible ).  Next slide.  Next slide.  Yeah.  So some of ‑‑ I just put this down that the status.  There are about four patients that it's covering Telecebec.  And one is a combination of Telecebec and ( indiscernible ) and they've been filed in five different countries.  Some of them have been patented in some countries and some are pending.  
     Next slide.  
Next slide.  So this is the status of OPC and the drug and then this is the ( indiscernible ).  The applications are pending in different countries and they've been granted in some countries or pending in some countries.  Yes.  Next slide.  
	So what can be done?  So what we can do is we can challenge these patients to take applications for life‑saving drugs.  If the drugs are accessible and ( indiscernible ) we need to challenge them.  How do we challenge them?  We can file oppositions.  
	Maybe we can even advocate for asking the government to revoke these patients and reduce the amount of follow‑up on patients.  Next slide.  
	Next slide.  Yeah, this is what we ‑‑ this is an opposition filed in India by ‑‑ this is about the Telecebec.  Telecebec is manufactured by Quirent.  They got a basic molecule from the Institute of Pasteur Korea and they're developing for preclinical development and they did the studies on Telecebec.  
	In the interim there's been one patient application.  One patient application and two patients ‑‑ one patient has been granted and one patient's application has been there.  One application that is pending is being opposed, and that which has been granted is a follow‑up on the patient.  It's quite shocking that despite a good law, we're unable to stop this.  This might gain ‑‑ may increase the time of monopoly.  Next slide.  
	So the opposition for Telecebec has been filed by Sankalp Rehabilitation Trust, and it's filed.  We have shown this is not a new science.  The science is old.  There are a lot of publications that talks about this mole you'll or the way the molecule is being made.  We've also shown that is this is not novel because there's an application that covers this.  
	We have also shown that you need therapy for efficacy and the plans are very broad and it relates to a gender formula and it can lead to numerous limitations and combinations of molecules that we may not ( indiscernible ).  Next slide.  
	The opposition filed is India is a BPaL application.  In July 2020 they approved the drugs to be taken in combo.  So next slide.  
So in this BPaL opposition, which has been filed by DNP and Sankalp rehabilitation truce, they have argued that the clinical trials has been published before this application.  
	It's already obvious, because TB drugs are now begin in combination.  This particular combination is already ‑‑ has been already discussed, and it does not satisfy the therapeutic efficacy and synergistic effect.  That means that the actual effect of the drug does not change with this combination, and the combination does not create a different effect or a new synergistic effect than is already known.  Next slide.  
	Next slide.  So the way forward I have to say is it's important to advocate for high‑quality patient examination with national patients.  There's a need to send officers and examiners and talk to them about the link between patents and the access to medicine and the impact on the cost of medicine.  
	We have to also ‑‑ there's also a need to work with these governments to take measures to avoid multiple patenting of the same drug, to create international awareness of the need to limit the grant of secondary patents to countries that take measures to limit the secondary patents.  To understand the concepts and also access to medicine it and to also coordinate with activist groups and networks such as HIV and help C and other countries and to also coordinate patient application, file oppositions wherever possible and to advocate inclusion of higher standards of patentability and exclusion from patent ability and law and policy and guidelines.  
	To examine, challenge arguments just at promoting the innovation.  So the ultimate argument to promote the general invention, technology transfer, local production of food quality medicine.  Finally to advocate for the license of Bedaquiline and Dell mid and ensure the availability for patients.  Thank you.  
     >> LINDSAY McKENNA:  Thank you so much.  I think that was a really great presentation and shows the importance of not just focusing on the accessibility of drugs that are currently approved but also those that are promising and earlier in the pipeline which may become important in future years.  Thank you very much for that.  
     So now we are entering the question and answer segment of our webinar.  I'm going to hand it over to Lynnette Mabote, an activist and consultant working with TAG who kindly agreed to moderate the question and answer segment.  
      Lynnette, it's all you.  Thank you again.  
     >> LYNETTE MABOTE:  Thank you very much, Lindsay, and for the policy speakers.  Number one, thank you for having an all‑girl panel.  Just to mention that I think this has been a very long journey has Jen mentioned.  I'm going straight into the question.  So I'll give you a moment to bring it up before I go to any questions.  There will be two questions each and they will have an opportunity to respond in the manner in which I ask the question.  
     Let's start with Dr. Furin.  Question from the audience is, do we have TB preventative therapy for drug‑resistant tuberculosis?  From your experience as well as from the guidelines, what are the key side effects of Bedaquiline as well as the new all oral medication?  That would be some of the side effects being seen, if there are any.  The second question goes to Sharonann.  
      The question is, is global fund the only donor at the country point funding domestic TV programs?  If not, who else do we have out there?  Your question on your first slide on fault lines, we seem to be having a major issue in access to diagnostics, and we know that without current diagnostics we can't move forward.  
      Is COVID going to be taking over this because there seems to be fears around that?  There's a third question for you Sharonann, how do activists influence more decentralization of care.  It seems like programs are dependent on hospitalization to fund the programs.  
Those are your questions Sharonann.  
	What are your ideas around some rehabilitation support services?  What would you like to see happen, for instance, at local level in Indonesia?  
	Prathiba Sivasubramanian your question is around ‑‑ this is more of actually a comment or question.  A drug can be re-patented by changing the formulation, and that is it.  
     The second question is most of the patent offices in our countries have no power.  How do we then influence them to consider these very critical issues around patent examination and so forth?  The third question was how do we keep going around the same cycle with every disease that we face?  Is there a way to advance or advocate for some sort of moratorium on the trips agreement as it impacts life‑saving commodities?  
      I'll hand over to Jen.  Please take it away.  
     >> DR. JENNIFER FURIN:  Thank you for that whirlwind of questions.  So I'll try to be brief in answering the two questions posed to me.  The first is about preventative therapy for drug‑resistance TB or treatment of infection.  Yes, we do have that, the and WHO in 2019 actually made recommendations that high‑risk household contacts of people who are newly diagnosed with drug‑resistance TB can be offered preventive therapy.  
	For many, many years now, people have argued their way out of preventive therapy for drug‑resistance TB, and I'm not really sure why.  Usually we can use Fluoroquinolone like Levoxin for preventive therapy or the new drug Delamanid.  
	They're safe and operate in the same way as isoniazid.  They should be offered to people with a high‑risk exposure to drug‑resistance TB.  It's steeped in mediocrity, unfortunately, so we have clinical and health reasons not to do what's right for people living with or exposed to the disease.  
	If people live in a household newly diagnosed, there's evidence to support giving them preventive.  Given the prolonged treatment and the poor outcomes with drug‑resistance TB, it's more important to get therapy for drug‑resistance TB than four drug‑susceptible TB.  I hate to make them be in competition with each other.  It's another area to focus a whole webinar on.  
	In terms of the side effects of the oral drugs, it's all relative in some ways.  I keep saying shorter regimen.  The regimens out there now last for nine to 12 months.  It's not short.  Think about it.  If you were offered an injectable containing regimen or an oral regimen with five to six drugs, you pick the shorter regimen.  They're want short, right?  
	What we want really is treatment that can be done in one month with drugs that have limited or no side effects.  We're nowhere near that number, but we could be if we put the same kind of political will into TB treatment that we do into diseases like COVID, for example.  So the main side effects of the newer drugs for Linezolid for anemia with a drop in the white blood count.  
	We see neuropathy or damage to the nerves in the hands and feet and eyes.  With Bedaquiline there's a change in the rhythm of heart.
So there's still there, the side effects.  It can change the rhythm of the heart and causes skin color to change, and providers will try to pass this off and say people look good. 
      They look like they have got a tan.  They don't.  The skin changes show disclosure to neighbors and family members and the subsequent mall effects of that.  The problem with side effects is we don't talk to people getting treatment about that.  The DR‑TB community is very paternity stick and backward thinking.  
     They say if we tell patients about the side effects and they won't take treatment.  A wise gentleman said it's our bodies.  Do they think we're not going to find out?  
     We have to talk to people about adverse events so they can be a participant and monitor them and manage them and prevent them.  We will still have a long way to go in terms of counseling and partnership with people living with the disease.  The regimens are much better tolerated than the older ones.  That doesn't mean their easy by any stretch of the imagination.  Thank you.  
     >> LYNETTE MABOTE:  Let's move over to Sharonann.  
     >> SHARONANN LYNCH:   Hi, all.  So I have three questions and I might need clarification on the third one.  One was about donors.  While the global fund is the largest donor for TB and DR‑TB, the USAAD also supports TB and DR‑TB.  
	I believe that the global health initiatives could be used as leverage in order to win more and better.  So there's also Petford.  Petford doesn't support DR‑TB, per se, but the ancillary service and the essential services and tools are supported by them.  So that includes more and more TB‑LAM, critical.  This is a test that is the price of a flipping toothbrush, and yet it's simply not being used.  So it's underutilized.  
      Secondly, TB prevention therapy as well as GeneXpert.  Meet with the country coordinator and insist upon civil society input.  Same with you USID and the person in charge is Sheri Vin vent.  She could give funds and use those funds in order to leverage for policymaker and scaleup.  I emphasize the global fund because it's very timely and it's the largest.  
     Even though the global fund proposals are country‑driven, meaning the country writes the application, we all have experience, I'm sure, in terms where there's money, there's a way, right?  
Even when there's money there's a way.  Reprogramming, trying to get the CCM members because even if your NSP is intransient and won't listen to you in terms of patient‑centered care to centralization, maybe you can get the other CCM members to do so, whether they're from other ministries or bilateral agencies or whether they get the civil society aligned on that.  
	In terms of drugs that are supported by ‑‑ that are supported by global fund, we've had some success in the past of trying to get the global fund to simply say no, they won't support suboptimal treatment.  Here, again, I think we have to do that for injectables.  The injectables are such a ‑‑ we can't wipe them out completely.  I would have loved to have a burn fund.  
	I talked to Jen and Lindsay about that for all injectables.  There's still data for the population.  There's an application into the global fund, they better say there's no way you need this much injectables and as well as for the global drug facility that constantly sends messages in terms of encouraging countries to make the switch.  
	The third question was about models of care.  I think it was in terms of like what can happen for more patient‑centered care.  There's a couple of ways to measure it.  There's a partnership and others on the call have written about, WHO has guidelines they put out.  They put out guidance in terms of what that means.  
	Certainly it means centralized and closer to home and ambulatory instead of inpatient and self‑administered therapies.  It should mean the necessary support in terms of transport if needed, food assistance if needed, and adherence, support and treatment of literacy.  Of course you heard from Paran in terms of the post‑TB needs and additional supports that are needed.  
	You can win them through the national strategic plan and lobbying by leveraging the global health initiatives.  The one that is ‑‑ the trickiest is the one that that's done, and that's in terms of hospitalization.  
	The TB budget for treatment used to be based on the number of beds, so that is no longer the case in many countries.  You still might have to push for that health finance reform for the TB budget so that rather than counting the number of beds and determining how much money you get for 2021, it's instead based on what do our numbers look like?  How many people do we expect in 2021 build the budget from that.  If you untie the hospital beds from the budget, that's a critical step for policy reform so we get more ambulatory and decentralized.  
	I think that question is Jermaine for everyone on the call including the panelists.  I don't consider myself the expert on that.  Thank you.  
     >> LYNETTE MABOTE:  Thanks for that.  Paran.  
     >> PARAN WINARNI:  Okay.  About the hesitation, so why I say this is one of the most important things because like me now now that I have so many things to get involved in in TB or like being a part of anything, but deep down inside of me is this scar after the treatment is still there.  I still have that.  
	The stigma I have when I have to the treatment is just like changing to myself stigma.  The stigma is needed, and no one is prepared.  The patient ‑‑ the patient never prepares if they have a permanent side effect like deafness or blindness.  
	So everyone was like telling oust, okay, you have to go through the treatment.  You have to don't spread the disease to anyone.  I guess no one asked us and no one gives you ‑‑ I mean, like to set us have our normal again after the treatment.  No one helps us to get through treatment if they have decided they're permanent in our life.  
	I also like it for raising confidence as a DR‑TB patient.  We need to improve the capacity and help the DR‑TB or TB survivor to total capacity.  There's still thinking that ‑‑ it's still useful for the community.  I was thinking about the patient after treatment.  
I have a patient that was a guy 35 years old.  
     He finished the treatment already but we have deafness before I finished this statement I was asking him, how do you feel you want to because two months again, you're going to be cured.  What do you feel?  Then what did you want to do after the treatment is over?  
You know what?  
	He just told me that I don't know what I have to do because I'm deaf now.  Who is going to ‑‑ who is going to accept me as an employee?  So, yeah, the hesitation is really, really important to prepare the patient after the treatment, and maybe we all can consider it also.  I'm thinking more about how to help them.  
	We're doing that to be the human again.  Maybe we can like ask the government to help us like to provide the ‑‑ the opportunity of a job that they can do or something like that.  Thank you so much.  
     >> LYNETTE MABOTE:  That makes complete sense.  Because we're going R running out of time I'm going to Prathiba Sivasubramanian to remember the question.  
     >> PRATHIBHA SIVASUBRAMANIAN:  I remember.  I went to the question that patients have no power.  I would like to say when we began with the patients in India, even the patient offices were very reluctant to allow us in or talk to us.  It was kind of the that.  Some of the things at that time we didn't have expertise, so learned on the goal.  
	Now what we can do is there are many options.  There are some other patient offices that are good enough, like the Egyptian office is quite good.  They have the right perspective on access and health care and patient abilities.  So we can ask these doctors to have a conversation or a dialogue or a meeting.  
	Maybe that could be in there.  We can also talk to the government and continuous engagement with the offices will change their mindset.  It's important to change their mindset to make them think in a different way, to make them understand that examination has I link with cost of drugs.  
	Secondly that's a constant and also asking experts to speak to them would be a good idea to begin with.  Secondly on the moratorium for TB drugs or all the essential neglected diseases I would go for that.  It requires a lot of political will and also probably that should be a provision within the patient with the country to have the kind of permission to allow moratoriums.  
	Since the patient is very territorial in nature, each country has to bring in these laws.  We can ask for a waiver, which with COVID‑19 we're trying to ask the government but it requires a lot of political will.  We have to see if we can ‑‑ if it can come true because the cost of these drugs, the COVID drugs are extremely unaffordable in the developing countries and even in developed countries.  The cost of these treatments is really high, and so it's also giving us an example of very ‑‑ a very live example we're unable to afford these treatments.  
	So these are the two things that I would like to say that even if there's a weekend, try this more for rum.  We can look into that patient offices and try to use the flexibility already incorporated in our acts and try to keep ‑‑ try to limit these monopolies or try to talk to the government and say that no moratorium should be granted to TB drugs.  
	That would be great.  I would go for that anyway.  Thank you.  
     >> LINDSAY McKENNA:  That was good.  Thank you so much.  
     >> LYNETTE MABOTE:  We have four minutes left, so I'm going to ‑‑ we have three more questions.  I think you addressed most of the ones that we had.  The one question is for all the panelists of course, what can we learn from the activism in South Africa with a scale‑up of new approaches is impressive.  That's the first question.  
     Are survivors of DR‑TB at increased risk of COVID‑19 and other respiratory illnesses?  The third question is what happens about these permanent side effects?  Do people have access to social protect, particularly cochlear implants.  Any of the panelists can take these questions and just give us your last parting thought.  
     >> DR. JENNIFER FURIN:  This is Jen.  A quick comment as I work in South Africa right now.  Ink what worked so well there is the advocacy, the full participation of survivors of DR‑TB, but also working with the ministry of health who took their partners very seriously and were very frank about the difficulties they were facing instead of trying to sweep it under the rug or blame people who challenged them.  They embraced them and it worked very well, very well.  Almost nothing is done for people with permanent side effects, and that's a serious problem.  
     We do know that people who have a history of TB or who currently have TB do appear to have an increased risk of mortality from COVID.  So if anything people need extra protection and extra attention from the health care system, and the way TB services are set up in most places, people are not offered that.   The best thing is the survivors having a seat at the table and being respected by all partners, especially the government.  
     >> LYNETTE MABOTE:  Thanks, Jen.  Sharonann.  
     >> SHARONANN LYNCH:   For South Africa honestly it's what we don't have in other countries, which is the political will.  They also started using the leadership on TB as they had on HIV in order to varnish their global reputation.  All the incentives lined up.  
You had the most important one, which is reducing infections, needless suffering, needless death.  
	You had smart negotiations with companies to get lower prices.  They were the ones that got that $400 price.  Partly, I mean, listen, as Jen has been tracking the nearly ‑‑ the 50% or more, Jen, now I forget of people who are started on Bedaquiline were in South Africa. 
	They also went ahead of WHO in terms of adopting better guidelines.  Part of it, obviously, government will but also that treatment neurosis.  People who were engaged and knew what to ask for and knew the science and advocated for it.  Of course, the essential ‑‑ one essential ingredient that I hope we can rely on in the future is global solidarity.  
	So, you know, if Indian activists informed the rest of us, it can be helpful in terms of putting pressure on Modi, let's do it.  We will follow your guidance.  I think as long as we keep call being for ending TB and just the global goals without this and naming and shaming then we won't have the same movement as in South Africa and so many other places where it's needed like in India and Nigeria.  If you look at where the majority of deaths are coming, it's a lack of political will, a lack of enough accountability and a lack of a spotlight.  Thank you.  
     >> LYNETTE MABOTE:  Paran, any parting last words?  
     >> PARAN WINARNI:  Yeah.  For the protection for the impact, I think, yeah we have to do efficacy for this because there is ‑‑ I mean, not all the TB survivors that have the deafness after the treatment have the opportunity to have a cochlear implant.  The example like ( indiscernible ).  
     I guess if you apply for that, if the government can apply them, maybe you have efficacy for the government to provide a job or anything to help them to still ‑‑ like I said, we hope to help them to breathe after the treatment, because it's very hard to breathe with your deafness and blindness.  
    My dream is they're all normal again as usual like before the treatment because you never said this to someone if the choice you have is like did you want to cut your left hand or cut your right hand?  Yeah, that is not an option.  Did you want to sacrifice your hearing or your eyes?  
     So it's not an option at all.  So I think, yeah with the need.  Also, the support from the government for the ‑‑ for the job that they can do and they can still be a human like user.  Yeah, I think that is a part of me.  
     >> LYNETTE MABOTE:  Thank you so much, par Ron.  And Prathiba Sivasubramanian.  
     >> PRATHIBHA SIVASUBRAMANIAN:  About South Africa I agree with most of the speakers about the political will as well as the activists.  About that, I would also agree with Sharonann that how much pressure we have to put on the Indian government to get these older regimens in our national program.  Unfortunately, we're unable to get that, and there are people in different parts of India where TB patients who are not prescribed Bedaquiline and still suffering.  It's important that the message from South Africa reaches India and there is a change.  We need to put that kind of pressure on as well.  These words I would like to say thanks.  
     >> LYNETTE MABOTE:  Thank you very much.  I'll hand over to Lindsay now.  
     >> LINDSAY McKENNA:  Thank you so much, Lynnette, and thank you Jen, Paran, and Prathiba for a great session and all the participants for excellent questions and attention this morning, afternoon or evening depending where you are.  
     One last slide beyond thanking everyone is to remind you that the discussion around the activist guides will continue tomorrow focused on diagnostics.  The details are here, and the link to register was previously entered in the chat.  So we hope to see you here the same time tomorrow.  Thank you, again, everyone.  Have a great rest of the day wherever you are.  
      ( The webinar concluded )