 So it's a great privilege to be here. It's 15 years from the day I started work as a young lawyer and Since then I've come a long way in public health and access to medicines And I've had the privilege to work with one of the finest Access units in the world, which is called the campaign for access to essential medicines It's a specialized unit of medicine so from there's and we have been working on hepatitis C for the last 11 years From the day I started work in in the access campaign I would like to acknowledge the contribution of our HIV HIV pharmacist to this presentation and the work around access to medicines And I'll just introduce My presentation it has an introduction barriers facing access strategies and responses and Conclusion based on the medicines that we require to treat hepatitis C which are direct acting antivirals So I call them DAAs. So if you just have that question, what is DAA? It's direct acting antiviral So, what's the background from 2005 to 2013? There was considerable debate on treatment for HIV in co-infected patients that means people living with HIV who also had HIV There was also considerable Data to show that if you did screen The cohorts that we had there would be much more Numbers or hepatitis C But we were stunted by the lack of availability of very effective drugs And predominantly by a very old chemotherapy drug, which is called peglated interferon It causes huge side effects It makes people very sick when they're on that treatment Some people told me that it was worse than being on any other treatment that they've ever been they felt more sick than the disease had ever made them and Most importantly it did not have a very high efficacy rate and lastly it was expensive and it was a biological medicine and MSF In its history of treating patients has not dealt very well with biologicals except for vaccines So the whole issue of biologicals faced us We were not able to procure the medicine in time and we decided to wait for the direct acting antivirals So from 2013 and 2015 you see a huge excitement speed up Off-testing in MSF to start screening our cohorts in Myanmar in Pakistan in India And and get ready to treat the most vulnerable populations in the case of Myanmar and Manipur it started with just wanting to treat co-infected patients But as you can see there was a change in prioritization to the most vulnerable community which are drug users in 2015 we started treatment in Pakistan India and in 2016 we are on the cusp of treatment in Myanmar we have the drugs starting to come in which are direct acting antivirals Multiple barriers still exist to treating hepatitis C In the region for example if you look at Ukraine or if you look at Iran or you look at Thailand Malaysia the issue of access to direct acting antivirals is definitely a burning issue So wherever you are going to be operational and wherever you're going to treat for example vulnerable communities whether they are HIV positive or Just simply drug users you are going to need to be prepared to deal with hepatitis C and need for direct acting antivirals MSF strategy was very pure and simple we were focused on getting two good direct acting Antivirals and putting them together into a combination that we could give across genotypes and Make it available to anybody who needed it So it did not matter whether you were a drug user you were HIV positive and so forth So the idea was simplify treatment so much that some of this these discussions about exclusion become moot because the treatment is simple It's like antivirals you combine the medicines you make it simple and you make sure that people have it in a simplified One day a pill or two pills a day and you may ensure that the treatment is short and effective We knew that this was a cure so that means that we did not have to sustain people on a lifelong treatment It was the debate is about eight weeks twelve weeks and so on So it was a short cure and we had if we had two drugs we could treat more people as they came along in our projects We worked very hard with the WHO Technical groups on the WHO new treatment guidelines and Dr. Isabelle was from MSF was part of those drafting committee and We made official submissions to the inclusion of so first be veered into the WHO essential medicine list So we knew that so first be veered and our class we as I call them Sofu and our class we had to get them into the WHO essential medicine list and make them affordable to be able to treat Our patients in the region and across the world Someone many few few people may not even recognize this is a doctor Andrew Hill. He's a pharmacologist He did a study to show that actually the cost of direct acting Antivirals was as cheap as what today and re-retrovirals are so so first be veered the drug that we all talked about in a different projects Is actually just $68 to 136 dollars for three months to make and then duck like a sweet is practically free You can give it free with doctor with so first be veered it's 10 to 30 dollars per treatment So if you combine these two drugs the cost of treatment wouldn't go above a hundred fifty to two hundred dollars He did that looking at the Structure of the molecule and he put that number out and I'm going to talk about why that number was so important to sort of Revolutionize MSF thinking around it because suddenly we realized that this treatment could be as cheap as antiretrovirals Which is hundred dollars per patient per year and we needed to get it down to that price So that we could treat more people and we could see that the impact would be that governments would be excited enough to start viral Hepatitis programs and treat hepatitis C So what did we do The first thing that you do when you want a new medicine is to find out if there's going to be a monopoly on it or not And we went and found the patents and as you said today everyone talks about so first be veered and duck like us We at that time they were just numbers They were seven seven nine seven and so forth and there was a chemical structure and we had to go and find these patent applications All I can tell you is this I had to learn chemistry very fast and figure out which applications related to what and I had a lot of help From a Pakistani colleague of mine mine called Aziz Uru Rehman He's by far the one of the finest patent attorneys. I know who helped me find these molecule structures Pattern oppositions were filed in Brazil China Russia Ukraine Argentina and Egypt on its own initiative rejected the pattern applications filed by a Gilead Sciences to support its own domestic production Egypt has the highest burden of hepatitis C in the world and after that is Pakistan It was challenged in Europe and so forth and of course people followed with a challenge to duck like us we The recommendation from WHO was something that was very much needed came in 2014 Treat all adults and children with chronic hepatitis C infection including people who inject drugs should be assessed for antiviral treatment And when someone just asked, you know, what about will they be stable? Will they adhere? I think this recommendation is based on the fact that you can actually treat drug users the treatment can be simple enough to to Address the needs of people who use drugs. Of course, you do need to give all the other allied support services that are required So the drug sofas baby People in this in this region of the world are obsessed with the price of gold Gram for gram it cost 67 the price of gold in the United States. That's the price of this drug thousand dollars a pill and We had to make sure that this drug was in generic production and available to patients across the region and across the board So was some of the issues that I'm going to talk about is about compassionate use for dying patients price and availability from originator companies like BMS and Gilead patent claims in generic production voluntary licenses and anti-diversion and Delay and lack of registration a regulatory barrier can be as big as a patent barrier sometimes similarly that let us we're more expensive than diamonds My family will always ask me You know, you could be as rich as anybody you should put a few bottles and carry them across the border And it's really funny because that's exactly what everyone is thinking right now Can we come to South Asia and get treated for hepatitis C? Because this has become the hub for hepatitis C treatment again similar issues BMS would not supply duck at us we to MSF for years. We've spent negotiating. We didn't have compassionate use access We had problems with registration BMS does not believe in registering its medicines It just believes in filing patents clearly and of course offering us donations when we couldn't get the drug into the country because it Was unregistered so the donation was completely unsustainable for us So what did we I would say one of the first thing we learned from hepatitis C is that compassionate use is important for patients in developing countries if you have advanced liver disease or you have If you look at HIV or you look at DRTB, you can't wait for the drug to be registered and all the studies to be completed You'll be dead by that time So some clinicians need to go and ask for the drug for those patients who urgently need them and this was something that is now Being used extensively in DRTB where delimited and and and better quillen is not have registered in those countries And we need to treat DRTB patients and now of course for hepatitis C when the drugs were unregistered Treating critical patients is a starting point for all of us and it was really important We started negotiations with Gillard and BMS asking for access to compassionate use and I must say The Manipur project played a huge role in asking and pushing for compassionate use for its patients They agreed to give us name patient access so patient by patient We did very painful paperwork to get the drug into the country and treat patients However, they still charged us so there was no compassionate use There was complete lack of compassion as I would say on the part of the companies They just excluded Asia from compassionate use particularly South and Southeast Asia MSF strategy push us push companies to give us compassionate use access Get companies to file for registration in key countries whether it's Pakistan India Myanmar Whether it's originator or generic companies find a source that will register the medicine So that the drug is available in the country and request waiver of local clinical trial from DRAs Now often we hear a lot of debate around clinical trials But sometimes clinical trials the last phase of it the local trial can take so much time that you may have to Wave it off in certain conditions not always but in certain conditions So a lot of civil society got together for the for asking for waiver on sofas bevere and dakla taswee and the Indian FDA did a Did provide the waiver which is revolutionizing treatment and making available more generics from India for other countries Quality validation of DA is it's a very important issue for a humanitarian organization to be responsible for the quality of medicines that we provide we have besides Encouraging the WHO PQ to speeden up the pre-qualification of direct acting antivirals We ourselves have taken up the whole issue of going to the companies and asking them to apply for WHO pre-qualification and validation They see it as a market entry. We see this as an important marker and quality validation in developing countries There are many license agreement license agreement is about an agreement between two parties in this case a multinational company and a generic company majority of these agreements Include countries like India Pakistan and Myanmar and then exclude countries like Ukraine Thailand So it's a dilemma for MSF to accept these licenses Because some of our medicine some of our patients are on this side of the border and some of our patients on the other side So there's no treatment without borders unfortunately for us due to these license agreements They also as I can if you look at it This is the region that is locked out of access and you will see central Asia completely locked out of ask us And I think this is a big problem with the license agreement Lastly, they said every bottle you must provide a name and you must give the bottle back And that was a very big problem for us. So it was Patient by patient we would get treatment from Gilead. Gilead was worried that the medicine would find its way back into the United States and other countries we refused we do not believe that a company is entitled to patient data and we helped Projects negotiate out of a many of those conditions We still return the empty bottles and we would like to stop doing that in many places But as soon as we have validated generics will be out of this whole issue of wanting to return having to return empty bottles to Gilead So we allied with civil society We spoke up against these unethical practices of pharma companies like Gilead and we also talked about the middle-income countries who excluded from there Outcomes generic sofas bevere has been developed and registered in India Bangladesh Pakistan in Egypt Generic companies marketing the com are marketing the combination of sofas bevere and dakhata sweet There is an internal quality assessment within MSF besides the DRA is registering it two more slides And we have now validated sources from hetero and of course far co pharmaceuticals Egypt Which gives me a great pleasure to see that you know generic production is not only Restricted in to India any longer, but it's taking root in a number of other developing countries more sources are emerging Perhaps Pakistani companies soon will come out with a validated source Treatment with sofas bevere and dakhata sweet will start the medicines are coming into our projects as we speak No more peggillated interferon. We will be free of peggillated interferon in 2016 Thank you So the lessons learned from MSF experience The partnership between medical projects and the access campaign is really important to deliver access And I think it it's also true for NACO and DNP for example I think many treatment providers and people who fight for access need to be together and talk to each other and be able to work Together to deliver access You have to tackle IP problems. You have to tackle regulatory barriers Big farmers donations voluntary licenses are always problematic People need to be more discerning about them need to take a magnifying glass and read all the Closes that exist when they offer you a donation or any other kind of agreement Medical needs need to be met by legal safeguards and pushing for policy change. So in the end Yes, medical projects are important But the whole purpose of of the projects is to push for policy change so that drug users People living with HIV who are co-infected and and people other people who need it are able to get the treatment they need Access to hep C medicines reflects the continued challenges of access to affordable medicines developed countries have reached the pain threshold As I said eighty four thousand dollars For just one drug in the United States. It's very clear. I mean I Would like to say that I have helped the bias Club in India and they take medicines across the world for people in Austria Italy Spain Canada United States and you can see that it's no longer an issue that only affects developing countries It's affecting Eastern Europe for example, and there's a need to build allies and talk to them about access to treatment as well The future Bangladesh they were the first producer of what I call a hope it avir That was a generic of so for severe and this is going to be the future of generic production It's going to go beyond India to South Asia and other countries and of course all the years that people have spent Fighting and marching in and asking for the rights for direct acting anti-virus. So this is was the presentation. Thank you