1 00:00:00,940 --> 00:00:07,568 Good morning everybody 2 00:00:05,770 --> 00:00:10,178 attending this webinar, good afternoon, 3 00:00:07,569 --> 00:00:13,240 good evening to some of you and we welcome 4 00:00:10,179 --> 00:00:15,639 to one more instalment of knowledge for 5 00:00:13,240 --> 00:00:19,210 change webinar series which is run by 6 00:00:15,639 --> 00:00:20,919 the World Hepatitis Alliance. Now for 7 00:00:19,210 --> 00:00:24,310 those who do not know the World Hepatitis 8 00:00:20,920 --> 00:00:28,630 Alliance, we are an NGO, we are the only 9 00:00:24,310 --> 00:00:30,9 global organization advocating for the 10 00:00:28,630 --> 00:00:32,320 millions of people living with viral 11 00:00:30,10 --> 00:00:35,829 hepatitis and we are here today to 12 00:00:32,320 --> 00:00:38,679 discuss the role of generics within 13 00:00:35,829 --> 00:00:41,319 the hepatitis C axis landscape. 14 00:00:38,679 --> 00:00:44,19 My name is Raquel, I'm the CEO, and here 15 00:00:41,319 --> 00:00:47,199 with me we have great experts to 16 00:00:44,19 --> 00:00:49,120 lead those discussions and I think 17 00:00:47,199 --> 00:00:52,539 the best way to start really is by 18 00:00:49,120 --> 00:00:55,149 perhaps introducing our panellists so if 19 00:00:52,539 --> 00:00:57,579 I could just ask perhaps Erica would you 20 00:00:55,149 --> 00:01:02,530 like to tell us a little bit about you 21 00:00:57,579 --> 00:01:06,820 and where are you are connecting from today 22 00:01:02,530 --> 00:01:09,70 Yes, hello, hello everybody I?m Erika Dunenas 23 00:01:06,820 --> 00:01:11,949 I work with the Medicines Patent 24 00:01:09,70 --> 00:01:17,919 Pool and i am connecting from Geneva. 25 00:01:11,950 --> 00:01:20,830 Thank You Erica. Giten. Good evening my 26 00:01:17,920 --> 00:01:23,710 name is Giten and I work with TREAT Asia amfAR's 27 00:01:20,830 --> 00:01:26,470 Foundation for AIDS research and I?m based 28 00:01:23,710 --> 00:01:30,309 in Bangkok but I?m currently speaking from 29 00:01:26,470 --> 00:01:34,300 India right now. Oh good evening then 30 00:01:30,310 --> 00:01:36,160 Giten to you and Dr. Andrew Hill. Hi 31 00:01:34,300 --> 00:01:38,440 My name is Andrew Hill, I?m from the Department of 32 00:01:36,160 --> 00:01:43,690 Pharmacology at the University of Liverpool in the United Kingdom. 33 00:01:38,440 --> 00:01:45,370 Thank you so much and just before we 34 00:01:43,690 --> 00:01:48,880 Start, perhaps a reminder to our 35 00:01:45,370 --> 00:01:50,410 participants today, if we can go 36 00:01:48,880 --> 00:01:52,539 to the next slide please, 37 00:01:50,410 --> 00:01:55,240 just a reminder that you can send us 38 00:01:52,540 --> 00:01:57,610 questions by using your functionality 39 00:01:55,240 --> 00:01:59,380 here in the control panel and we'll be 40 00:01:57,610 --> 00:02:02,409 trying to do our best to address them 41 00:01:59,380 --> 00:02:05,350 during the webinar. So okay, so why don't 42 00:02:02,409 --> 00:02:06,909 I just start very briefly by setting the 43 00:02:05,350 --> 00:02:10,000 scene of what we are going to be 44 00:02:06,909 --> 00:02:12,550 discussing today. So as some of you know 45 00:02:10,000 --> 00:02:14,530 this year was a very special year for Viral 46 00:02:12,550 --> 00:02:19,480 Hepatitis we had 47 00:02:14,530 --> 00:02:22,360 194 governments signing up and adopting 48 00:02:19,480 --> 00:02:25,899 this global elimination strategy back 49 00:02:22,360 --> 00:02:30,490 in May and essentially what it means is 50 00:02:25,900 --> 00:02:32,860 that they set this deadline of 2030 to 51 00:02:30,490 --> 00:02:35,260 eliminate Viral Hepatitis. What I 52 00:02:32,860 --> 00:02:36,340 wanted to pick out of this document, and 53 00:02:35,260 --> 00:02:38,170 by the way we're going to be making 54 00:02:36,340 --> 00:02:39,730 those documents and links to what we're 55 00:02:38,170 --> 00:02:43,929 going to be talking about here available 56 00:02:39,730 --> 00:02:46,000 Later, but what I wanted to pick out 57 00:02:43,930 --> 00:02:48,790 from that is that in this document we 58 00:02:46,000 --> 00:02:52,630 have a very ambitious target regarding 59 00:02:48,790 --> 00:02:55,840 treatment which is eighty percent of 60 00:02:52,630 --> 00:02:59,19 patients with hepatitis C being treated. 61 00:02:55,840 --> 00:03:01,180 Just to put that figure into perspective to 62 00:02:59,19 --> 00:03:03,610 all of you right now, the current 63 00:03:01,180 --> 00:03:05,650 situation is that we have less than 1% 64 00:03:03,610 --> 00:03:07,630 accessing treatment. So when talking 65 00:03:05,650 --> 00:03:12,10 about hepatitis C, which is killing 66 00:03:07,630 --> 00:03:14,260 700,000 people every year, out of 80 67 00:03:12,10 --> 00:03:16,480 million people out there, less than one 68 00:03:14,260 --> 00:03:20,410 percent is receiving treatment. Now we 69 00:03:16,480 --> 00:03:22,810 know that there is a lot to be 70 00:03:20,410 --> 00:03:26,410 discussed here. We have the high cost of 71 00:03:22,810 --> 00:03:28,329 Drugs, we have a lot of barriers, but 72 00:03:26,410 --> 00:03:29,380 again in this webinar we're going 73 00:03:28,329 --> 00:03:32,799 to be talking specifically about 74 00:03:29,380 --> 00:03:34,840 generics and we know that genetics has 75 00:03:32,799 --> 00:03:37,90 been the most effective way to drive 76 00:03:34,840 --> 00:03:39,459 down those prices so why don't I just 77 00:03:37,90 --> 00:03:43,150 give the floor and in this case actually 78 00:03:39,459 --> 00:03:45,790 The screen to a my colleague, Erika to 79 00:03:43,150 --> 00:03:47,680 just discuss a little bit more around 80 00:03:45,790 --> 00:03:49,959 the role of the Medicines Patent Pool 81 00:03:47,680 --> 00:03:53,290 and what you've been doing in the 82 00:03:49,959 --> 00:03:57,280 generic scene. Erika, if you can talk a 83 00:03:53,290 --> 00:04:00,820 little bit of about MPP for us. 84 00:03:57,280 --> 00:04:02,680 Yes first of all thank you very much 85 00:04:00,820 --> 00:04:06,160 for inviting the Medicines Patent Pool 86 00:04:02,680 --> 00:04:08,680 to this important webinar. I'd 87 00:04:06,160 --> 00:04:13,150 like to share today some information 88 00:04:08,680 --> 00:04:16,900 with the participants about how some 89 00:04:13,150 --> 00:04:20,168 of the a new HCV medicines are becoming 90 00:04:16,899 --> 00:04:25,210 available as generics in many countries 91 00:04:20,168 --> 00:04:27,340 and certain developing countries and 92 00:04:25,210 --> 00:04:28,90 how we can have access to these to these 93 00:04:27,340 --> 00:04:31,150 Drugs. 94 00:04:28,90 --> 00:04:36,39 So we go to the first slide, to the next 95 00:04:31,150 --> 00:04:39,760 slide, and this is the list of several new 96 00:04:36,40 --> 00:04:44,110 medicines and combinations for Hepatitis C. As you can 97 00:04:39,760 --> 00:04:46,930 see in the first column is the name 98 00:04:44,110 --> 00:04:49,330 of the medicine or the combination, then 99 00:04:46,930 --> 00:04:51,850 the second column, the brand name and then 100 00:04:49,330 --> 00:04:55,690 the date of approval of these products 101 00:04:51,850 --> 00:04:57,699 by the US Food and Drug Administration. As 102 00:04:55,690 --> 00:05:00,40 you can see there are very recent 103 00:04:57,699 --> 00:05:04,120 For Example, Daclatasvir was approved 104 00:05:00,40 --> 00:05:05,410 in July 2015, or very recently 105 00:05:04,120 --> 00:05:11,229 Sofosbuvir combination with 106 00:05:05,410 --> 00:05:15,580 Velpatisvir, in June 2016. If 107 00:05:11,229 --> 00:05:18,580 you go to the next slide please you 108 00:05:15,580 --> 00:05:22,659 can see also that some of these 109 00:05:18,580 --> 00:05:25,510 generic versions are becoming available 110 00:05:22,660 --> 00:05:29,530 in a number of developing countries and 111 00:05:25,510 --> 00:05:31,690 that is why I would like to tell you that 112 00:05:29,530 --> 00:05:33,760 it is very important to understand where 113 00:05:31,690 --> 00:05:36,850 these medicines are patented, in which 114 00:05:33,760 --> 00:05:40,240 countries, and also where there are 115 00:05:36,850 --> 00:05:42,700 licenses for these drugs because I will 116 00:05:40,240 --> 00:05:45,130 share with you this ______5:41 117 00:05:42,700 --> 00:05:50,289 mechanisms for access to generics in a 118 00:05:45,130 --> 00:05:53,110 country and the first possibility is if 119 00:05:50,289 --> 00:05:55,389 the manufacturers make the product in a 120 00:05:53,110 --> 00:05:58,570 country where it is not patented for sale 121 00:05:55,389 --> 00:06:02,320 in a country where 122 00:05:58,570 --> 00:06:04,659 it is not patented as well. So and then 123 00:06:02,320 --> 00:06:07,270 I'll show in another slide why it is also 124 00:06:04,660 --> 00:06:10,270 important to check in some countries if 125 00:06:07,270 --> 00:06:12,820 there is data protection exclusivity in 126 00:06:10,270 --> 00:06:15,280 some countries. Then the second 127 00:06:12,820 --> 00:06:20,889 possibility is if manufacturers have 128 00:06:15,280 --> 00:06:25,900 obtained voluntary license from 129 00:06:20,889 --> 00:06:28,930 the patent holder and it can be in 130 00:06:25,900 --> 00:06:31,450 two ways either by a bilateral 131 00:06:28,930 --> 00:06:32,919 license agreement which is a license 132 00:06:31,450 --> 00:06:36,159 between the originator and the 133 00:06:32,919 --> 00:06:38,770 manufacturer or medicines patented for 134 00:06:36,159 --> 00:06:40,180 license which is through the medicines 135 00:06:38,770 --> 00:06:41,770 patent for license. We 136 00:06:40,180 --> 00:06:44,590 we explained that in the in the previous 137 00:06:41,770 --> 00:06:48,639 screen, right? That it is available as you 138 00:06:44,590 --> 00:06:51,8 said. Then the third possibility 139 00:06:48,639 --> 00:06:53,860 is if a country were to make use of the 140 00:06:51,9 --> 00:06:57,220 TRIPS flexibility of Public Health 141 00:06:53,860 --> 00:06:59,500 Safeguard and for example the compulsory 142 00:06:57,220 --> 00:07:05,740 licence, right? So if you go to the next 143 00:06:59,500 --> 00:07:08,650 slide, you can see the list of the 144 00:07:05,740 --> 00:07:12,759 existing voluntary licenses for 145 00:07:08,650 --> 00:07:14,560 hepatitis C and it is important to know 146 00:07:12,759 --> 00:07:17,410 this information about the licenses 147 00:07:14,560 --> 00:07:19,780 because the license enables multiple 148 00:07:17,410 --> 00:07:22,240 manufacturers to make the generic 149 00:07:19,780 --> 00:07:24,909 version of the medicine even if there is 150 00:07:22,240 --> 00:07:27,430 a patent in that country. So that is why 151 00:07:24,910 --> 00:07:29,530 you see in the first column, you can find 152 00:07:27,430 --> 00:07:33,310 the license for Daclatasvir, for 153 00:07:29,530 --> 00:07:38,799 example, and if you see the license 154 00:07:33,310 --> 00:07:40,960 includes at least 112 countries and it 155 00:07:38,800 --> 00:07:42,699 is a licence negotiated by the Medicines 156 00:07:40,960 --> 00:07:45,698 Patent Pool. 157 00:07:42,699 --> 00:07:50,20 It is important to mention that 158 00:07:45,699 --> 00:07:52,840 if it is the case, it includes very a 159 00:07:50,20 --> 00:07:58,330 pro public health terms and 160 00:07:52,840 --> 00:08:00,729 conditions. And the second license is 161 00:07:58,330 --> 00:08:03,70 Sofosbuvir and the combination 162 00:08:00,729 --> 00:08:05,349 Sofosbuvir with Ledipasvir and with Velpatisvir 163 00:08:03,70 --> 00:08:08,50 in that 164 00:08:05,349 --> 00:08:10,960 case and it is licensed for 101 165 00:08:08,50 --> 00:08:13,659 countries and it's a bilateral licence, 166 00:08:10,960 --> 00:08:18,70 a license between the 167 00:08:13,659 --> 00:08:20,110 originator and some generic company. 168 00:08:18,70 --> 00:08:25,60 As you can see there are no other 169 00:08:20,110 --> 00:08:28,300 licenses so far. So next slide please. 170 00:08:25,60 --> 00:08:34,479 Now i quickly share with you 171 00:08:28,300 --> 00:08:37,870 our new tool which is MedsPaL which is 172 00:08:34,479 --> 00:08:39,490 a medicines patent tool, patent and 173 00:08:37,870 --> 00:08:42,760 licenses database. 174 00:08:39,490 --> 00:08:47,290 It is a very friendly tool that can be 175 00:08:42,760 --> 00:08:50,950 used by anybody in our website and you 176 00:08:47,290 --> 00:08:53,290 can do some search by key product or 177 00:08:50,950 --> 00:08:56,889 by countries 178 00:08:53,290 --> 00:08:58,599 or by patents number, for example, 179 00:08:56,889 --> 00:09:00,579 and you and you will find interesting 180 00:08:58,600 --> 00:09:03,339 information. I?ll share with you an 181 00:09:00,579 --> 00:09:04,750 example which is easy to see. Next 182 00:09:03,339 --> 00:09:09,190 slide please? 183 00:09:04,750 --> 00:09:13,120 In this example you can see that we find 184 00:09:09,190 --> 00:09:16,180 in those circles in green and we try to 185 00:09:13,120 --> 00:09:20,800 find information for Sofosbuvir 400 186 00:09:16,180 --> 00:09:22,750 milligrams and we decided to find it in 187 00:09:20,800 --> 00:09:25,899 Malaysia. What is happening in Malaysia 188 00:09:22,750 --> 00:09:27,850 with this drugs. So you can see that 189 00:09:25,899 --> 00:09:31,810 you have information about 190 00:09:27,850 --> 00:09:33,970 the product in the country and also in 191 00:09:31,810 --> 00:09:37,60 the Patent Status column you can see 192 00:09:33,970 --> 00:09:41,769 that there are two patents granted for 193 00:09:37,60 --> 00:09:46,689 Sofosbuvir and three filed. As you may know there 194 00:09:41,769 --> 00:09:48,430 can be many patents for one single 195 00:09:46,690 --> 00:09:51,190 product, right? There is a sample of 196 00:09:48,430 --> 00:09:53,349 different patents for the compound 197 00:09:51,190 --> 00:09:56,829 which is the main patent on other secondary 198 00:09:53,350 --> 00:09:59,769 patents that are some improvements with 199 00:09:56,829 --> 00:10:03,339 prodrug or for the processes or for the 200 00:09:59,769 --> 00:10:05,860 compositions and probably more 201 00:10:03,339 --> 00:10:08,139 but those are the ones we 202 00:10:05,860 --> 00:10:11,350 identified as the most important blocking 203 00:10:08,139 --> 00:10:15,130 patents. So if you can see in the last 204 00:10:11,350 --> 00:10:16,990 column and also the expiry 205 00:10:15,130 --> 00:10:19,329 date of each patent and it's interesting 206 00:10:16,990 --> 00:10:23,170 you can see the Sofosbuvir compound 207 00:10:19,329 --> 00:10:28,120 expires in 2024 but the Sofosbuvir 208 00:10:23,170 --> 00:10:31,60 composition expires in 2032. So there 209 00:10:28,120 --> 00:10:33,639 are differences. Right? Then 210 00:10:31,60 --> 00:10:37,180 another important information that you 211 00:10:33,639 --> 00:10:39,430 can find as well, if the country has data 212 00:10:37,180 --> 00:10:44,349 exclusivity protection you can see 213 00:10:39,430 --> 00:10:47,920 in the red circle in your left and 214 00:10:44,350 --> 00:10:51,550 you can see the expiration date of 215 00:10:47,920 --> 00:10:53,769 data exclusivity protection in 2018. So 216 00:10:51,550 --> 00:10:56,889 that's also very relevant information. In 217 00:10:53,769 --> 00:10:59,170 this case this expires before the 218 00:10:56,889 --> 00:11:01,689 patents, but in sometimes you can also 219 00:10:59,170 --> 00:11:03,939 find the opposite of that it's possible to 220 00:11:01,689 --> 00:11:04,899 have the patent expired that used to 221 00:11:03,939 --> 00:11:08,980 have data 222 00:11:04,899 --> 00:11:12,369 exclusivity protection. So next example 223 00:11:08,980 --> 00:11:14,680 please, next slide. You'll see here we try 224 00:11:12,369 --> 00:11:18,160 to find information from India and South 225 00:11:14,680 --> 00:11:21,8 Africa on Daclatasvir 60 milligrams 226 00:11:18,160 --> 00:11:23,829 and it's very interesting what we found 227 00:11:21,9 --> 00:11:27,9 there, if you can see the Patent Status 228 00:11:23,829 --> 00:11:29,679 Column that there are two filed patents 229 00:11:27,9 --> 00:11:33,399 in India and two granted patents in 230 00:11:29,679 --> 00:11:35,439 South Africa. As you can see in the first 231 00:11:33,399 --> 00:11:39,40 red circle you can find also information 232 00:11:35,439 --> 00:11:41,559 about the oppositions in the countries 233 00:11:39,40 --> 00:11:45,129 where the legislation allows oppositions 234 00:11:41,559 --> 00:11:47,589 in india the first patent has 235 00:11:45,129 --> 00:11:50,679 been opposed, so we still don't know 236 00:11:47,589 --> 00:11:53,290 what is going to happen. In South Africa 237 00:11:50,679 --> 00:11:57,639 you can see also the information on the 238 00:11:53,290 --> 00:11:59,290 patents granted and the information in 239 00:11:57,639 --> 00:12:02,949 this orange circle you can see the 240 00:11:59,290 --> 00:12:05,199 information on the patent the 241 00:12:02,949 --> 00:12:08,50 number of the patent application. If you 242 00:12:05,199 --> 00:12:10,59 click that button, you can see in my next 243 00:12:08,50 --> 00:12:12,998 slide please? 244 00:12:10,59 --> 00:12:14,679 You can find the details, the specificities 245 00:12:12,999 --> 00:12:17,620 of the patent and the details of 246 00:12:14,679 --> 00:12:21,9 each patent. If you go back again please 247 00:12:17,620 --> 00:12:22,839 to the other slide? If you see as well a 248 00:12:21,9 --> 00:12:25,569 very important information on your left 249 00:12:22,839 --> 00:12:27,939 in that blue circle you can find 250 00:12:25,569 --> 00:12:30,759 information about the medicines patented 251 00:12:27,939 --> 00:12:33,459 license on Daclatasvir. That means that 252 00:12:30,759 --> 00:12:35,679 even in South Africa, granted the two 253 00:12:33,459 --> 00:12:38,319 patents, the generics can be 254 00:12:35,679 --> 00:12:41,439 available for South Africa because there 255 00:12:38,319 --> 00:12:44,410 is a patent license signed 256 00:12:41,439 --> 00:12:46,209 by the ministers public. So this is a 257 00:12:44,410 --> 00:12:49,719 very relevant information and if you 258 00:12:46,209 --> 00:12:52,660 click in that blue thing you can go 259 00:12:49,720 --> 00:12:54,910 to my next slide. You can see the 260 00:12:52,660 --> 00:12:57,160 details on the license 261 00:12:54,910 --> 00:13:00,429 this is a licensed card we have for each 262 00:12:57,160 --> 00:13:02,589 of our licenses where you can find a 263 00:13:00,429 --> 00:13:04,689 relevant information about the product, 264 00:13:02,589 --> 00:13:06,490 the countries that are included in that 265 00:13:04,689 --> 00:13:07,589 license that can benefit from these 266 00:13:06,490 --> 00:13:11,40 license 267 00:13:07,590 --> 00:13:12,990 and also important to mention that not 268 00:13:11,40 --> 00:13:16,170 only this license card is available but 269 00:13:12,990 --> 00:13:20,310 if you go to our website you can also 270 00:13:16,170 --> 00:13:22,110 find relevant information and then the 271 00:13:20,310 --> 00:13:24,390 entire text of the license agreement 272 00:13:22,110 --> 00:13:27,30 because we as a medicines patent pool 273 00:13:24,390 --> 00:13:29,40 promote transparency of these license 274 00:13:27,30 --> 00:13:31,20 agreement, right? So you can find the 275 00:13:29,40 --> 00:13:34,170 entire text in the licence and the sub- 276 00:13:31,20 --> 00:13:37,439 licenses. And finally, very important the 277 00:13:34,170 --> 00:13:40,770 licensees are also available there, that 278 00:13:37,440 --> 00:13:43,740 means that in this green circle at the end 279 00:13:40,770 --> 00:13:46,170 you can see Aurobindo, Cadila, Cipla, Emcure, Hetero, 280 00:13:43,740 --> 00:13:50,130 many generic 281 00:13:46,170 --> 00:13:54,270 producers that are already developing 282 00:13:50,130 --> 00:13:57,30 Daclatasvir in that case. So we are 283 00:13:54,270 --> 00:13:59,730 available to us where you questions or 284 00:13:57,30 --> 00:14:01,530 to be contacted in the future. 285 00:13:59,730 --> 00:14:03,510 Oh thank you Erica, that's been really 286 00:14:01,530 --> 00:14:06,360 really great and this tool has been 287 00:14:03,510 --> 00:14:11,550 recently launched, right? 288 00:14:06,360 --> 00:14:15,510 Yes we used to have another patent 289 00:14:11,550 --> 00:14:18,180 database that was very well used by 290 00:14:15,510 --> 00:14:20,939 the public and very appreciated that is 291 00:14:18,180 --> 00:14:22,469 why now we developed, we improved the 292 00:14:20,940 --> 00:14:24,480 database, and we included also 293 00:14:22,470 --> 00:14:27,240 information or licenses on data 294 00:14:24,480 --> 00:14:30,330 exclusivity protection for each country and 295 00:14:27,240 --> 00:14:32,700 we're trying to improve that tool. This is 296 00:14:30,330 --> 00:14:34,890 great and very simple to use too and I 297 00:14:32,700 --> 00:14:39,840 already have a question which is 298 00:14:34,890 --> 00:14:41,939 around accessibility of the medicine 299 00:14:39,840 --> 00:14:45,210 to a patient, so for instance someone 300 00:14:41,940 --> 00:14:48,960 looking at the database and checking for 301 00:14:45,210 --> 00:14:50,760 availability of drugs of generics or 302 00:14:48,960 --> 00:14:53,790 their license agreement in their country so 303 00:14:50,760 --> 00:14:55,710 for instance let's just take and goal as 304 00:14:53,790 --> 00:14:57,000 an example and there is a license 305 00:14:55,710 --> 00:15:00,630 what does it actually mean to the 306 00:14:57,000 --> 00:15:02,850 patient on the ground there in terms of 307 00:15:00,630 --> 00:15:04,500 time lines, does it mean 308 00:15:02,850 --> 00:15:06,180 that they can access these drugs, does it 309 00:15:04,500 --> 00:15:08,910 mean that they have to knock on the 310 00:15:06,180 --> 00:15:10,380 government door and ask for the drugs? 311 00:15:08,910 --> 00:15:11,189 Could you explain a little bit more 312 00:15:10,380 --> 00:15:15,90 please? 313 00:15:11,190 --> 00:15:17,400 Yes. Well thank you for your question of 314 00:15:15,90 --> 00:15:20,640 course. As you said it is a very 315 00:15:17,400 --> 00:15:24,840 friendly tool so it is available 316 00:15:20,640 --> 00:15:27,210 for patients, for procurement agency, for 317 00:15:24,840 --> 00:15:29,70 anybody, so and for the patient's it's 318 00:15:27,210 --> 00:15:31,860 very important because they 319 00:15:29,70 --> 00:15:34,380 can see the information on patents and 320 00:15:31,860 --> 00:15:37,80 if the patents are granted or not granted 321 00:15:34,380 --> 00:15:40,140 in their country or if there is license that 322 00:15:37,80 --> 00:15:43,50 can allows the generic ______15:39 in 323 00:15:40,140 --> 00:15:45,569 this country. So that they can use this 324 00:15:43,50 --> 00:15:51,329 information to work together with the 325 00:15:45,570 --> 00:15:54,690 government or to try to promote 326 00:15:51,330 --> 00:15:56,250 the country to benefit 327 00:15:54,690 --> 00:15:59,640 themselves and their countries to 328 00:15:56,250 --> 00:16:01,980 benefit from these agreements 329 00:15:59,640 --> 00:16:03,750 for example, if there is a license agreement. 330 00:16:01,980 --> 00:16:06,150 So it is very important for the 331 00:16:03,750 --> 00:16:11,220 patients to have this tool and to try to 332 00:16:06,150 --> 00:16:12,840 get these drugs. Right so we can, 333 00:16:11,220 --> 00:16:15,450 perfect, and we can use it as 334 00:16:12,840 --> 00:16:17,880 an advocacy tool. That?s very good and I?m 335 00:16:15,450 --> 00:16:20,130 glad that MPP launched the 336 00:16:17,880 --> 00:16:21,960 information with the hep c drugs 337 00:16:20,130 --> 00:16:24,30 there as well and I think now we're 338 00:16:21,960 --> 00:16:27,390 talking about patients is a greater 339 00:16:24,30 --> 00:16:29,730 leeway to Giten's presentation we're 340 00:16:27,390 --> 00:16:31,770 going to be talking about real life 341 00:16:29,730 --> 00:16:34,470 experience and how patients are 342 00:16:31,770 --> 00:16:38,970 accessing those generics for their 343 00:16:34,470 --> 00:16:42,540 own individual use. Giten. Thank you 344 00:16:38,970 --> 00:16:44,550 Raquel. I?ll be talking and good 345 00:16:42,540 --> 00:16:48,329 afternoon to everybody. I will be talking about 346 00:16:44,550 --> 00:16:50,490 real life how people are actually 347 00:16:48,330 --> 00:16:53,910 accessing the direct acting antivirals 348 00:16:50,490 --> 00:16:56,100 which Erika talked about for 349 00:16:53,910 --> 00:16:58,680 individual purposes. Just to give you some 350 00:16:56,100 --> 00:17:02,940 sort of an outline I've been preparing 351 00:16:58,680 --> 00:17:05,190 you with information around 352 00:17:02,940 --> 00:17:08,520 direct acting antivirals. I?ll be talking 353 00:17:05,190 --> 00:17:11,760 specifically aboutthe license DAA?s because, 354 00:17:08,520 --> 00:17:13,650 which are coming out of India, I?ll be 355 00:17:11,760 --> 00:17:15,810 talking also about price reductions in term of 356 00:17:13,650 --> 00:17:17,699 the generic Hepatitis C 357 00:17:15,810 --> 00:17:20,760 medications and where we are right now. 358 00:17:17,699 --> 00:17:24,959 I?ll talk a little bit about how it is 359 00:17:20,760 --> 00:17:26,699 being accessed more broadly in 360 00:17:24,959 --> 00:17:29,430 countries around the world whether or 361 00:17:26,699 --> 00:17:32,130 not it is registered or formally approved by their 362 00:17:29,430 --> 00:17:33,440 FDA's and then I'll come to the 363 00:17:32,130 --> 00:17:36,49 most 364 00:17:33,440 --> 00:17:40,250 relevant point of my talk today which 365 00:17:36,49 --> 00:17:42,408 would be around the individual 366 00:17:40,250 --> 00:17:45,289 import which sometimes is also called a 367 00:17:42,409 --> 00:17:47,29 _______17:41 import and how it's been done and 368 00:17:45,289 --> 00:17:49,129 I?ll give some examples of specific 369 00:17:47,29 --> 00:17:52,309 countries as to how it has been done and I?ll 370 00:17:49,129 --> 00:17:57,860 leave you with some of the conclusions. 371 00:17:52,309 --> 00:18:01,100 So we have the direct-acting antivirals, 372 00:17:57,860 --> 00:18:04,459 we know that we have had Sovaldi 373 00:18:01,100 --> 00:18:05,449 which had started first as a 374 00:18:04,460 --> 00:18:08,179 first medication of the 375 00:18:05,450 --> 00:18:10,220 second-generation direct acting antivirals. We 376 00:18:08,179 --> 00:18:13,9 have had the Sofosburvir and Ledipasivir a 377 00:18:10,220 --> 00:18:15,590 formulation which is 378 00:18:13,9 --> 00:18:18,860 named as Harvoni and then we have had 379 00:18:15,590 --> 00:18:21,980 after that Daklinza or Daclatasvir 380 00:18:18,860 --> 00:18:24,168 these are the originated products that 381 00:18:21,980 --> 00:18:25,730 have come out as the first and second 382 00:18:24,169 --> 00:18:28,429 generation direct-acting antivirals. 383 00:18:25,730 --> 00:18:32,330 Then after that we have had the 384 00:18:28,429 --> 00:18:34,669 generic Sofosbuvir which are 385 00:18:32,330 --> 00:18:35,928 coming out of India. There are others 386 00:18:34,669 --> 00:18:37,549 which are coming off from other 387 00:18:35,929 --> 00:18:39,860 countries but as I said I?d be talking 388 00:18:37,549 --> 00:18:43,100 specifically about the Indian ones. 389 00:18:39,860 --> 00:18:44,840 We also have had generic 390 00:18:43,100 --> 00:18:48,49 Sofosbuvir and Ledipasvir 391 00:18:44,840 --> 00:18:53,29 formulated tablets and we also have a 392 00:18:48,49 --> 00:18:55,399 now the generic Daclatasvir. 393 00:18:53,29 --> 00:18:57,980 The generic Sofosbuvir we have 394 00:18:55,399 --> 00:19:00,949 around 15 companies which are marketing 15 395 00:18:57,980 --> 00:19:02,870 or 16 approximately, marketing the 396 00:19:00,950 --> 00:19:05,210 generic Sofosbuvir out of India we have 397 00:19:02,870 --> 00:19:08,870 around 10 which are 10 or 11 which are 398 00:19:05,210 --> 00:19:12,230 marketing the Ledipasvir and Sofosbuvir 399 00:19:08,870 --> 00:19:14,870 formulated tablets and also another 10 400 00:19:12,230 --> 00:19:19,429 or 11 which is marketing the generic Daclatasvir. 401 00:19:14,870 --> 00:19:20,840 That?s the _____19:18 if people 402 00:19:19,429 --> 00:19:23,000 have been receiving you would have been 403 00:19:20,840 --> 00:19:25,459 receiving some different kind of brand 404 00:19:23,000 --> 00:19:28,789 names from different companies coming 405 00:19:25,460 --> 00:19:32,779 out of India. I?m going to the next point 406 00:19:28,789 --> 00:19:37,370 about the pricing as to where we 407 00:19:32,779 --> 00:19:40,340 are right now. In late 2014 came 408 00:19:37,370 --> 00:19:44,268 the first generic Sofosbuvir at the end 409 00:19:40,340 --> 00:19:46,520 of 2014 and then we 410 00:19:44,269 --> 00:19:48,980 started tracking the price 411 00:19:46,520 --> 00:19:51,680 and in the beginning around me 2015 and 412 00:19:48,980 --> 00:19:55,160 it has a list price of approximately 330 413 00:19:51,680 --> 00:19:56,990 US dollars a bottle. Right now if you 414 00:19:55,160 --> 00:19:59,720 look, follow the blue line and if you 415 00:19:56,990 --> 00:20:03,830 follow right at the end of August 2016, 416 00:19:59,720 --> 00:20:06,350 we can get a bottle of generic Sofosbuvir for 417 00:20:03,830 --> 00:20:11,300 approximately $83 US dollars a 418 00:20:06,350 --> 00:20:13,669 bottle. At the end of 2015, exactly 419 00:20:11,300 --> 00:20:16,129 around a year later, came the Sofosbuvir and 420 00:20:13,670 --> 00:20:18,500 Ledipasvir co-formulated tablets 421 00:20:16,130 --> 00:20:21,20 and also the Daclatasvir. If you follow 422 00:20:18,500 --> 00:20:24,560 the red line against the list price of 423 00:20:21,20 --> 00:20:27,560 384 US dollars approximately you can get 424 00:20:24,560 --> 00:20:28,970 right now a bottle of Sofosbuvir and Ledipasvir at 425 00:20:27,560 --> 00:20:31,730 approximately $143 426 00:20:28,970 --> 00:20:34,280 US Dollars. If you follow the 427 00:20:31,730 --> 00:20:36,200 purple line, which is the Daclatasvir 428 00:20:34,280 --> 00:20:40,280 generic one against the list price of 429 00:20:36,200 --> 00:20:42,830 $92, you can get at approximately $38 US 430 00:20:40,280 --> 00:20:45,620 Dollars a bottle which is a 431 00:20:42,830 --> 00:20:48,919 month or four weeks supply. So 432 00:20:45,620 --> 00:20:50,959 considerably price has been dropping and 433 00:20:48,920 --> 00:20:53,810 as we speak about it, still, 434 00:20:50,960 --> 00:20:57,920 still it's dropping. So we're looking at 435 00:20:53,810 --> 00:21:01,820 approximately Sofosbuvir $249 US dollars for 12 436 00:20:57,920 --> 00:21:04,970 weeks therapy, Daclatasvir 114 US 437 00:21:01,820 --> 00:21:08,570 Dollars for 12 weeks therapy and Sofosbuvir and 438 00:21:04,970 --> 00:21:10,910 Ledipasvir combination, approximately $429 439 00:21:08,570 --> 00:21:13,730 US dollars. So SOF / DAC would be 440 00:21:10,910 --> 00:21:17,480 approximately $363 US dollars for 12 441 00:21:13,730 --> 00:21:19,130 weeks therapy and SOF / LED for 442 00:21:17,480 --> 00:21:21,470 $429 as I said. 443 00:21:19,130 --> 00:21:23,420 In India there are some specific state 444 00:21:21,470 --> 00:21:25,430 government programs which have started 445 00:21:23,420 --> 00:21:27,680 treating people in their own respective 446 00:21:25,430 --> 00:21:32,960 state health programs and they are procuring 447 00:21:27,680 --> 00:21:36,200 approximately around $270 - $280 US dollars 448 00:21:32,960 --> 00:21:39,20 for the government procurement pricing. 449 00:21:36,200 --> 00:21:41,120 So?s that's where we are and the 450 00:21:39,20 --> 00:21:43,430 slide says about our individual 451 00:21:41,120 --> 00:21:47,870 purchases as we can get in india right 452 00:21:43,430 --> 00:21:50,360 now and when I mentioned about 280 453 00:21:47,870 --> 00:21:53,000 state-specific not a national program but 454 00:21:50,360 --> 00:21:57,590 the state specific program in India 455 00:21:53,000 --> 00:22:04,460 where treatment is being provided to the 456 00:21:57,590 --> 00:22:06,168 citizens. Then 457 00:22:04,460 --> 00:22:08,779 we have this medication, we have the 458 00:22:06,169 --> 00:22:14,360 pricing across the world how was it 459 00:22:08,779 --> 00:22:17,240 being broadly accessed? We have different 460 00:22:14,360 --> 00:22:19,428 ways of getting this, now the first way 461 00:22:17,240 --> 00:22:21,679 is at the hospital level. There are 462 00:22:19,429 --> 00:22:24,559 certain countries like say, for example, 463 00:22:21,679 --> 00:22:29,809 in our region in Asia, Indonesia or Vietnam or 464 00:22:24,559 --> 00:22:33,350 Myanmar which allows import of 465 00:22:29,809 --> 00:22:34,940 medications prior to a formal FDA 466 00:22:33,350 --> 00:22:37,490 approval, so they call it a special 467 00:22:34,940 --> 00:22:39,919 import quota or special import license or 468 00:22:37,490 --> 00:22:42,200 special assistance scheme. Each country has 469 00:22:39,919 --> 00:22:45,559 its own nomenclature of how this import is 470 00:22:42,200 --> 00:22:49,309 being done but the FDA allows import of 471 00:22:45,559 --> 00:22:52,908 this medications prior to the formal 472 00:22:49,309 --> 00:22:55,10 registration approval and that's 473 00:22:52,909 --> 00:22:56,630 how a lot of patients in Indonesia or in 474 00:22:55,10 --> 00:23:00,49 Vietnam or in Myanmar are getting 475 00:22:56,630 --> 00:23:02,390 medications which are still not approved, say for 476 00:23:00,49 --> 00:23:06,710 example, SOF / LED both formulated 477 00:23:02,390 --> 00:23:09,440 tablets. At the patient level 478 00:23:06,710 --> 00:23:11,929 we have the ?Named patient import? 479 00:23:09,440 --> 00:23:14,630 which sometimes companies calls 480 00:23:11,929 --> 00:23:18,740 as compassionate use or sometimes the 481 00:23:14,630 --> 00:23:20,690 FDA's or the regulated authorities of 482 00:23:18,740 --> 00:23:22,610 the country actually allows import for 483 00:23:20,690 --> 00:23:25,880 personal use. 484 00:23:22,610 --> 00:23:27,740 We also have buyers clubs which many of 485 00:23:25,880 --> 00:23:30,649 you must have come across or have heard 486 00:23:27,740 --> 00:23:33,49 about and also if one goes to India, they 487 00:23:30,649 --> 00:23:34,939 can they can get it from large 488 00:23:33,49 --> 00:23:37,129 pharmacies and they can get in larger 489 00:23:34,940 --> 00:23:41,29 pharmacies because the medicines are 490 00:23:37,130 --> 00:23:44,600 of a higher cost so that 491 00:23:41,29 --> 00:23:46,850 smaller pharmacies cannot stock it to 492 00:23:44,600 --> 00:23:53,299 the extent that you would want. So you can go to large 493 00:23:46,850 --> 00:23:55,279 pharmacies in india you can purchase the medication. 494 00:23:53,299 --> 00:23:58,250 Let?s go to the most relevant one, how can one 495 00:23:55,279 --> 00:24:01,39 get, how is it being done at the 496 00:23:58,250 --> 00:24:04,130 patient-level? So if we go to the 497 00:24:01,39 --> 00:24:06,799 first country which started is 498 00:24:04,130 --> 00:24:09,140 Australian and the Therapeutic Goods 499 00:24:06,799 --> 00:24:10,389 Administration in Australia actually 500 00:24:09,140 --> 00:24:12,970 allows import 501 00:24:10,390 --> 00:24:15,40 for personal use so prior to the 502 00:24:12,970 --> 00:24:17,50 initiation of the treatment program by the 503 00:24:15,40 --> 00:24:20,200 Australian government, which is a very, very 504 00:24:17,50 --> 00:24:22,659 welcome move, patients there have been 505 00:24:20,200 --> 00:24:24,700 actually importing three months of doses 506 00:24:22,660 --> 00:24:27,40 with doctor's prescription by courier. 507 00:24:24,700 --> 00:24:29,710 This is totally legal and its 508 00:24:27,40 --> 00:24:33,520 allowed by the Australian drug regulators and a 509 00:24:29,710 --> 00:24:35,980 lot of patients have now been cured by using 510 00:24:33,520 --> 00:24:40,330 the Indian generics or other generics 511 00:24:35,980 --> 00:24:43,810 from elsewhere by using this route. 512 00:24:40,330 --> 00:24:45,699 The second one for example, and I assume that 513 00:24:43,810 --> 00:24:47,530 there are listeners or attendees, 514 00:24:45,700 --> 00:24:51,430 participants on this webinar from 515 00:24:47,530 --> 00:24:56,230 united kingdom and MHRA allows import of 516 00:24:51,430 --> 00:24:58,300 three months medication by courier again 517 00:24:56,230 --> 00:25:00,520 and there is no need for a doctor's 518 00:24:58,300 --> 00:25:05,50 prescription in the United Kingdom. All we need 519 00:25:00,520 --> 00:25:07,720 is the person's shipping address and 520 00:25:05,50 --> 00:25:10,659 the age and that's all 521 00:25:07,720 --> 00:25:13,690 that's needed. It is up to the patient to 522 00:25:10,660 --> 00:25:16,600 check the quality and the source of the 523 00:25:13,690 --> 00:25:20,500 medication and make sure that they are being 524 00:25:16,600 --> 00:25:24,399 monitored by a physician. You go to Hungary 525 00:25:20,500 --> 00:25:27,850 and that's where again the FDA 526 00:25:24,400 --> 00:25:29,320 allows import for three months by 527 00:25:27,850 --> 00:25:30,850 courier again with the doctor's 528 00:25:29,320 --> 00:25:32,980 prescription it has to be a Hungarian 529 00:25:30,850 --> 00:25:34,659 doctor's prescription. So patients from 530 00:25:32,980 --> 00:25:36,730 there actually gets this prescription and 531 00:25:34,660 --> 00:25:38,920 then we can send it across The only 532 00:25:36,730 --> 00:25:41,170 difference is in Hungarian patients have 533 00:25:38,920 --> 00:25:43,510 to pay a value added tax of approximately 534 00:25:41,170 --> 00:25:47,710 twenty-seven percent when the 535 00:25:43,510 --> 00:25:50,110 medicine actually arrives in Hungary. So this 536 00:25:47,710 --> 00:25:52,840 is a difference which we see different from 537 00:25:50,110 --> 00:25:55,810 Australia 538 00:25:52,840 --> 00:25:58,149 or from United Kingdom but 539 00:25:55,810 --> 00:26:02,110 in Hungary, people can actually receive 540 00:25:58,150 --> 00:26:04,870 it. When we go to the next one which is 541 00:26:02,110 --> 00:26:08,320 in the North America, which is 542 00:26:04,870 --> 00:26:10,600 Canada the FDA allows and hand-carrying of 543 00:26:08,320 --> 00:26:12,909 medication for a maximum of three months 544 00:26:10,600 --> 00:26:14,949 and it cannot be couriered. I?m talking about 545 00:26:12,910 --> 00:26:19,810 the legal grounds so if you are planning 546 00:26:14,950 --> 00:26:22,260 to get shipments to Canada, you 547 00:26:19,810 --> 00:26:24,179 cannot get it couriered but 548 00:26:22,260 --> 00:26:26,280 if you want to go somewhere else to 549 00:26:24,180 --> 00:26:29,460 India or to Egypt or somewhere and then get 550 00:26:26,280 --> 00:26:32,70 this medications in your bag and then 551 00:26:29,460 --> 00:26:35,880 go back to Canada that's allowed by 552 00:26:32,70 --> 00:26:38,490 the FDA and the Customs. 553 00:26:35,880 --> 00:26:41,310 Another Eastern European country Romania, it allows 554 00:26:38,490 --> 00:26:44,550 personal use for a maximum of three 555 00:26:41,310 --> 00:26:46,950 months and it can be couriered to the person 556 00:26:44,550 --> 00:26:49,379 along with doctor's prescription. So 557 00:26:46,950 --> 00:26:52,200 I?m just citing some examples so that 558 00:26:49,380 --> 00:26:54,990 it gives some sort of an 559 00:26:52,200 --> 00:27:00,120 idea to our listerner it's legal 560 00:26:54,990 --> 00:27:02,490 in many countries though the legalities and 561 00:27:00,120 --> 00:27:05,399 the tax system that's being used 562 00:27:02,490 --> 00:27:08,250 could be different. In conclusion, 563 00:27:05,400 --> 00:27:08,730 Can I just ask you a quick question if I 564 00:27:08,250 --> 00:27:11,10 may? 565 00:27:08,730 --> 00:27:13,50 For people that are listening that 566 00:27:11,10 --> 00:27:15,360 are interested and they are outside of the 567 00:27:13,50 --> 00:27:17,700 countries that you listed what's the 568 00:27:15,360 --> 00:27:21,330 best, is there a way, is there place where they 569 00:27:17,700 --> 00:27:23,640 can check what that is required if they 570 00:27:21,330 --> 00:27:25,139 are allowed to import the drugs and what 571 00:27:23,640 --> 00:27:30,270 it is needed? 572 00:27:25,140 --> 00:27:32,340 yeah, so one 573 00:27:30,270 --> 00:27:34,20 of the best ways of doing it which I 574 00:27:32,340 --> 00:27:37,50 would suggest is to contact their local 575 00:27:34,20 --> 00:27:39,000 HIV patient groups or harm reduction 576 00:27:37,50 --> 00:27:43,200 groups which have been working on 577 00:27:39,000 --> 00:27:44,940 promoting access to HIV medications 578 00:27:43,200 --> 00:27:46,650 or other medications that has been 579 00:27:44,940 --> 00:27:49,560 ongoing for quite some time prior to the 580 00:27:46,650 --> 00:27:52,710 Hepatitis C medication. They can also contact 581 00:27:49,560 --> 00:27:54,840 Hepatitis C patient groups that are in those 582 00:27:52,710 --> 00:27:56,940 countries and we should pass on that 583 00:27:54,840 --> 00:27:59,730 information and check with the legalities of 584 00:27:56,940 --> 00:28:01,200 importing and equip the people 585 00:27:59,730 --> 00:28:03,30 in the hepatitis C patient groups to be equipped 586 00:28:01,200 --> 00:28:05,850 with information as to how this medications 587 00:28:03,30 --> 00:28:08,730 could be imported and patients 588 00:28:05,850 --> 00:28:10,560 which are not directly 589 00:28:08,730 --> 00:28:12,600 in touch with them could be 590 00:28:10,560 --> 00:28:15,30 helped by passing on and sharing 591 00:28:12,600 --> 00:28:17,340 their information through their websites or with their 592 00:28:15,30 --> 00:28:19,530 social media channels. So that that can 593 00:28:17,340 --> 00:28:21,179 be done. So contacting an 594 00:28:19,530 --> 00:28:23,850 HIV patient group, Hepatitis C patient groups, 595 00:28:21,180 --> 00:28:27,750 harm reduction groups are a 596 00:28:23,850 --> 00:28:29,370 good way of making sure that they get 597 00:28:27,750 --> 00:28:31,470 the right information and 598 00:28:29,370 --> 00:28:34,379 they understand the legalities of how this can be 599 00:28:31,470 --> 00:28:35,880 done and also the trusted sources as 600 00:28:34,380 --> 00:28:38,250 to make sure that they're getting the quality medications. 601 00:28:35,880 --> 00:28:41,340 Thank you. You?re welcome. 602 00:28:38,250 --> 00:28:43,920 So in conclusion 603 00:28:41,340 --> 00:28:46,20 what I would like to say is cure is 604 00:28:43,920 --> 00:28:50,160 accessible but it's coming in a small 605 00:28:46,20 --> 00:28:52,980 volume and what we need to do is 606 00:28:50,160 --> 00:28:54,900 to allow larger public program?s to be 607 00:28:52,980 --> 00:28:57,840 available like the local Australian?s 608 00:28:54,900 --> 00:28:59,670 have done. We need this to be to be in 609 00:28:57,840 --> 00:29:02,159 place because the small volumes and 610 00:28:59,670 --> 00:29:05,610 individual imports are not going to be 611 00:29:02,160 --> 00:29:09,420 able to eliminate viral hepatitis by 2030. 612 00:29:05,610 --> 00:29:12,300 Medication import is legal in 613 00:29:09,420 --> 00:29:15,480 many countries including in Europe. Local 614 00:29:12,300 --> 00:29:17,250 taxes could be could be different so I 615 00:29:15,480 --> 00:29:19,320 would request hepatitis C patient 616 00:29:17,250 --> 00:29:21,450 groups or Harm reduction groups or HIV 617 00:29:19,320 --> 00:29:23,40 patient groups to check as to what are 618 00:29:21,450 --> 00:29:24,750 the legalities and put it out in their 619 00:29:23,40 --> 00:29:27,149 social media and in their 620 00:29:24,750 --> 00:29:28,740 websites as to what are the taxes 621 00:29:27,150 --> 00:29:30,870 and how it can be done so that patients 622 00:29:28,740 --> 00:29:31,440 who are following them can actually read 623 00:29:30,870 --> 00:29:34,169 it. 624 00:29:31,440 --> 00:29:37,860 There is also a need to quality control, 625 00:29:34,170 --> 00:29:39,210 to check the quality control as well as 626 00:29:37,860 --> 00:29:41,820 of the treatment implementation 627 00:29:39,210 --> 00:29:44,400 A physician monitoring these drugs don't 628 00:29:41,820 --> 00:29:47,280 have very high side effects unlike the 629 00:29:44,400 --> 00:29:49,20 PEG interferon era, but it's always 630 00:29:47,280 --> 00:29:51,540 advisable to have some sort of a physician 631 00:29:49,20 --> 00:29:53,400 monitoring because you might have 632 00:29:51,540 --> 00:29:55,200 certain side effects and it might not 633 00:29:53,400 --> 00:29:57,60 necessarily be because of the treatment but 634 00:29:55,200 --> 00:29:58,470 it's always good to have a physician 635 00:29:57,60 --> 00:30:01,260 monitoring when you're having some sort 636 00:29:58,470 --> 00:30:03,780 of treatment. Please be cautious about 637 00:30:01,260 --> 00:30:07,200 the source of the medication to 638 00:30:03,780 --> 00:30:10,680 avoid any sort of spurious or counterfeit medication. 639 00:30:07,200 --> 00:30:12,690 It?s advisable to be, I am not saying that 640 00:30:10,680 --> 00:30:16,650 people have fake medications or so, but we 641 00:30:12,690 --> 00:30:19,110 have seen a WHO advisory on 642 00:30:16,650 --> 00:30:21,60 fake medications that are coming out. So it's 643 00:30:19,110 --> 00:30:22,379 always good to know the source of the 644 00:30:21,60 --> 00:30:23,850 medication that you're getting and you're 645 00:30:22,380 --> 00:30:28,950 getting the actual genuine product 646 00:30:23,850 --> 00:30:30,540 rather than others. So in short 647 00:30:28,950 --> 00:30:34,710 hepatitis C is curable, the medications are there, 648 00:30:30,540 --> 00:30:36,570 it's becoming a lot more 649 00:30:34,710 --> 00:30:39,150 affordable but the prices need to 650 00:30:36,570 --> 00:30:41,460 actually drop down if we are to have 651 00:30:39,150 --> 00:30:43,260 larger public programs to be in place. If 652 00:30:41,460 --> 00:30:45,600 we are to eliminate viral hepatitis C we 653 00:30:43,260 --> 00:30:47,820 need these public programs to be in place and 654 00:30:45,600 --> 00:30:52,439 not just a small volume import which would 655 00:30:47,820 --> 00:30:54,960 treat individuals. And of course, please 656 00:30:52,440 --> 00:30:56,160 feel to ask any questions and I?ll 657 00:30:54,960 --> 00:30:59,220 be happy to answer those. 658 00:30:56,160 --> 00:31:01,20 Thank you. Thank you so much Giten nicely 659 00:30:59,220 --> 00:31:02,130 put very strong message at the end 660 00:31:01,20 --> 00:31:05,430 there. 661 00:31:02,130 --> 00:31:07,560 I just wanted to make a very quick comment 662 00:31:05,430 --> 00:31:10,410 around the counterfeit so we're going 663 00:31:07,560 --> 00:31:12,419 to try to put in with the 664 00:31:10,410 --> 00:31:15,330 recording of this webinar the 665 00:31:12,420 --> 00:31:18,660 announcement about what Giten mentioned on WHO 666 00:31:15,330 --> 00:31:21,810 with the pictures of these 667 00:31:18,660 --> 00:31:23,880 medicines that were there were fake so 668 00:31:21,810 --> 00:31:25,710 you are aware of that as well, but as Giten 669 00:31:23,880 --> 00:31:28,410 mentioned it's always good to contact 670 00:31:25,710 --> 00:31:29,700 your patient group or groups that are 671 00:31:28,410 --> 00:31:34,200 experience to obtain more information 672 00:31:29,700 --> 00:31:36,540 with before you purchase those drugs. Thank you 673 00:31:34,200 --> 00:31:39,480 Giten. So what I think I'll do, I?ll 674 00:31:36,540 --> 00:31:41,909 just move to Dr Andrew Hill just to 675 00:31:39,480 --> 00:31:44,160 perhaps expand a little bit more on 676 00:31:41,910 --> 00:31:46,890 the buyer's club but also give us some 677 00:31:44,160 --> 00:31:50,40 very important data on the effectiveness 678 00:31:46,890 --> 00:31:53,640 of these generics. I mean, are they as good as 679 00:31:50,40 --> 00:31:55,800 the original drugs and what else 680 00:31:53,640 --> 00:31:59,370 can be can be said about that so Dr 681 00:31:55,800 --> 00:32:07,50 Andrew. Ok thanks very much 682 00:31:59,370 --> 00:32:10,830 ok so can we go onto the next slide? My research team has been 683 00:32:07,50 --> 00:32:12,450 looking at how much drugs the hepatitis C 684 00:32:10,830 --> 00:32:17,159 and others diseases cost to 685 00:32:12,450 --> 00:32:19,350 make and also when people take these 686 00:32:17,160 --> 00:32:22,200 drugs when they bought them through buyers clubs 687 00:32:19,350 --> 00:32:25,110 or the internet how well do they work, do we have 688 00:32:22,200 --> 00:32:28,440 any evidence, are they a good quality and bad quality. 689 00:32:25,110 --> 00:32:32,340 So on this simple slide you can 690 00:32:28,440 --> 00:32:36,30 see the price of various drugs for hepatitis C 691 00:32:32,340 --> 00:32:38,970 in United States, the current lowest prices as 692 00:32:36,30 --> 00:32:41,580 of July of this year in India. I think Giten has 693 00:32:38,970 --> 00:32:43,980 even lower classes now. It's amazing how 694 00:32:41,580 --> 00:32:46,230 quickly this is changing. And what we call the 695 00:32:43,980 --> 00:32:48,720 target price, this is what the drugs could 696 00:32:46,230 --> 00:32:50,790 cost in the future based on the cost of 697 00:32:48,720 --> 00:32:53,850 the raw ingredients being exported from 698 00:32:50,790 --> 00:32:56,580 India so you can see for example Sofosbuvir, 699 00:32:53,850 --> 00:32:59,480 for a twelve week course costs approximately 700 00:32:56,580 --> 00:33:01,790 $50,000 USD in the United States. 701 00:32:59,480 --> 00:33:04,700 It?s available for around three hundred 702 00:33:01,790 --> 00:33:07,280 dollars in India for individual group. Should 703 00:33:04,700 --> 00:33:10,520 be available for much lower prices to treat 704 00:33:07,280 --> 00:33:12,860 large amounts of people and then the target 705 00:33:10,520 --> 00:33:15,80 prices even lower, it's about 60 US dollars. 706 00:33:12,860 --> 00:33:18,530 Daclatasvir is even cheaper. As a 707 00:33:15,80 --> 00:33:22,760 target price about 14 dollars but still costs 708 00:33:18,530 --> 00:33:25,700 $50,000 USD in the US. Sofosbuvir / Ledipasvir, 709 00:33:22,760 --> 00:33:27,830 Sofosbuvir / Velpatasvir all 710 00:33:25,700 --> 00:33:31,490 follow the same pricing. What we're saying 711 00:33:27,830 --> 00:33:34,189 is fundamentally these drugs are extremely 712 00:33:31,490 --> 00:33:37,340 cheap to make and it would cost approximately 713 00:33:34,190 --> 00:33:40,580 ten billion US dollars to treat 714 00:33:37,340 --> 00:33:42,409 everybody with hepatitis C worldwide 715 00:33:40,580 --> 00:33:45,770 and actually that's not a lot of money 716 00:33:42,410 --> 00:33:47,330 if we think about the potential benefits of curing over a 717 00:33:45,770 --> 00:33:56,60 hundred million people with this disease 718 00:33:47,330 --> 00:33:57,530 that kills 700,000 people a year. Next slide. 719 00:33:56,60 --> 00:34:00,919 So if you look in a bit more detail about 720 00:33:57,530 --> 00:34:05,540 costs of one drug, for example, Sofosbuvir by 721 00:34:00,920 --> 00:34:09,409 country you can see even within Europe 722 00:34:05,540 --> 00:34:12,409 and looking at Brazil, Australia, is a huge range of 723 00:34:09,409 --> 00:34:14,719 prices that have been asked for by the 724 00:34:12,409 --> 00:34:16,370 pharmaceutical companies. So if you look at 725 00:34:14,719 --> 00:34:19,699 Germany, that's the most expensive 726 00:34:16,370 --> 00:34:23,600 country in Europe followed by France 727 00:34:19,699 --> 00:34:27,259 paying between 42 and 50,000 Euros for 728 00:34:23,600 --> 00:34:31,159 a 12 week course of Sofosbuvir whereas Spain?s paying 729 00:34:27,260 --> 00:34:35,300 13,000, Brazil 6,000, Australia 3,500, 730 00:34:31,159 --> 00:34:38,960 India 288 and the target price, this is all 731 00:34:35,300 --> 00:34:40,850 in Euros by the way, 55. Now if you go onto the 732 00:34:38,960 --> 00:34:46,70 next slide we can see possibly why 733 00:34:40,850 --> 00:34:48,440 this is. Australia has managed to agree 734 00:34:46,70 --> 00:34:51,950 what what?s called an ?all-you-can treat? 735 00:34:48,440 --> 00:34:54,560 contract for hepatitis C and they 736 00:34:51,949 --> 00:34:58,879 promised to pay pharmaceutical companies 737 00:34:54,560 --> 00:35:02,630 1 billion Australian dollars, at 200 million dollars 738 00:34:58,880 --> 00:35:04,430 each year for five years and in exchange they 739 00:35:02,630 --> 00:35:07,850 are allowed to treat as many people as 740 00:35:04,430 --> 00:35:09,740 they like with Hepatitis C. So this is 741 00:35:07,850 --> 00:35:12,270 approximately a hundred and thirteen 742 00:35:09,740 --> 00:35:14,910 million euros for unlimited treatment numbers. 743 00:35:12,270 --> 00:35:18,480 Now they are on call to treat 744 00:35:14,910 --> 00:35:21,660 40,000 people with hepatitis C in 745 00:35:18,480 --> 00:35:25,650 this year 2016, as one in five people 746 00:35:21,660 --> 00:35:28,170 with hepatitis C in Australia and it 747 00:35:25,650 --> 00:35:30,330 means that their unit cost for a 12 week 748 00:35:28,170 --> 00:35:35,10 course of treatment is less than 749 00:35:30,330 --> 00:35:37,200 3,500 euros per person. Now if these prices 750 00:35:35,10 --> 00:35:40,380 are acceptable in Australia, we should 751 00:35:37,200 --> 00:35:42,600 have access to these drugs at the same prices 752 00:35:40,380 --> 00:35:45,210 across Europe and other countries to 753 00:35:42,600 --> 00:35:48,810 make sure that we can achieve elimination 754 00:35:45,210 --> 00:35:50,970 of hepatitis C across the region. You look 755 00:35:48,810 --> 00:35:53,100 at the current price being challenged and it 756 00:35:50,970 --> 00:35:55,470 would just be impossible, it would it 757 00:35:53,100 --> 00:35:57,720 would destroy health budgets if we have 758 00:35:55,470 --> 00:36:01,529 to treat everybody at the current prices, the 759 00:35:57,720 --> 00:36:05,640 levels like Germany and France with 45 or 50 760 00:36:01,530 --> 00:36:12,540 thousand euros per person, per treatment 761 00:36:05,640 --> 00:36:14,549 Next slide. So what do you do? 762 00:36:12,540 --> 00:36:17,850 Well how do you try and achieve 763 00:36:14,550 --> 00:36:19,860 elimination of Hepatitis C? The first thing to do is 764 00:36:17,850 --> 00:36:22,20 to try and get to these low prices. 765 00:36:19,860 --> 00:36:26,310 I think if treatment costs is in the region 766 00:36:22,20 --> 00:36:29,160 of 4,000 euros or less per person, a lot 767 00:36:26,310 --> 00:36:34,590 of parts of Europe, North America, 768 00:36:29,160 --> 00:36:36,270 Canada, Australia, a lot of the clients couldn?t afford it. 769 00:36:34,590 --> 00:36:38,490 We need to make sure the voluntary license 770 00:36:36,270 --> 00:36:40,710 agreements operating place and actually 771 00:36:38,490 --> 00:36:43,229 follow through so people really 772 00:36:40,710 --> 00:36:47,160 can access drugs at those prices in 773 00:36:43,230 --> 00:36:48,900 the lower/middle income earners. But that's not happening 774 00:36:47,160 --> 00:36:50,640 at the moment, there are many countries 775 00:36:48,900 --> 00:36:53,220 where the cost of treatment is out of 776 00:36:50,640 --> 00:36:55,230 reach and doctors are having to tell the 777 00:36:53,220 --> 00:36:57,000 patient's I cannot treat you because we 778 00:36:55,230 --> 00:37:00,90 don't have the budget, the drug is not 779 00:36:57,000 --> 00:37:03,540 reimbursed. Perhaps if somebody doesn't have cirrhosis 780 00:37:00,90 --> 00:37:08,40 or they have the wrong genotype or they need too long a course of treatment. 781 00:37:03,540 --> 00:37:11,970 In case like that, we are resorting to 782 00:37:08,40 --> 00:37:14,310 buyers clubs or access programs. And there are 783 00:37:11,970 --> 00:37:18,89 many companies that make these drugs, in 784 00:37:14,310 --> 00:37:20,880 India, Bangladesh, China, Egypt and they are willing to 785 00:37:18,90 --> 00:37:24,210 export generic treatments either for HIV or DAA?s for 786 00:37:20,880 --> 00:37:25,20 hepatitis into Europe and North 787 00:37:24,210 --> 00:37:27,990 America. 788 00:37:25,20 --> 00:37:33,150 Remember some of these companies already 789 00:37:27,990 --> 00:37:34,620 have approval or their production either 790 00:37:33,150 --> 00:37:37,590 from the US drug approving drug 791 00:37:34,620 --> 00:37:39,810 administration for HIV drugs and also from 792 00:37:37,590 --> 00:37:41,910 the world health organization. There was 793 00:37:39,810 --> 00:37:45,270 an announcement I think last 794 00:37:41,910 --> 00:37:48,990 week that two generic companies will have 795 00:37:45,270 --> 00:37:53,160 authorization from the global fund for use of 796 00:37:48,990 --> 00:37:56,9 their hepatitis C treatments in 797 00:37:53,160 --> 00:37:57,870 lower and middle income countries. So what I am saying is these 798 00:37:56,10 --> 00:38:00,990 companies are producing drug to a high 799 00:37:57,870 --> 00:38:04,259 standard. If you wanted to buy generic 800 00:38:00,990 --> 00:38:06,509 treatment to prevent HIV or DAA?s 801 00:38:04,260 --> 00:38:08,400 to treat Hepatitis C, it can 802 00:38:06,510 --> 00:38:11,550 actually be bought online, 803 00:38:08,400 --> 00:38:14,400 very quickly, only 10 minutes and 804 00:38:11,550 --> 00:38:17,490 there's a variety of websites we?ve put down here 805 00:38:14,400 --> 00:38:21,630 where people could potentially buy them. Next slide. 806 00:38:17,490 --> 00:38:25,229 So my research team has been looking 807 00:38:21,630 --> 00:38:28,50 at how this works for individuals and 808 00:38:25,230 --> 00:38:30,000 there are links on the slides to news 809 00:38:28,50 --> 00:38:33,240 programs that we?ve worked with on with the BBC, 810 00:38:30,000 --> 00:38:38,280 the channel 4 news, following the individual 811 00:38:33,240 --> 00:38:40,500 people as they get treated through these buyers clubs, 812 00:38:38,280 --> 00:38:43,560 with these generic drugs and how they get cured. 813 00:38:40,500 --> 00:38:46,440 So you can click on those links if you 814 00:38:43,560 --> 00:38:52,140 wanted to see what individual 815 00:38:46,440 --> 00:38:54,30 experiences are like. Next slide. 816 00:38:52,140 --> 00:38:56,609 I think Giten covered this earlier but 817 00:38:54,30 --> 00:38:59,250 just to reinforce that the TRIPS, the original 818 00:38:56,610 --> 00:39:01,260 TRIPS legislation does allow this 819 00:38:59,250 --> 00:39:04,470 flexibility that if individuals are 820 00:39:01,260 --> 00:39:08,550 allowed to bring drugs into their own 821 00:39:04,470 --> 00:39:11,339 country for their personal use and most 822 00:39:08,550 --> 00:39:14,10 countries allow some form of personal 823 00:39:11,340 --> 00:39:16,350 importation of medication and at the moment 824 00:39:14,10 --> 00:39:18,840 medicines are being sent from India, 825 00:39:16,350 --> 00:39:21,89 China, Egypt and Bangladesh to 826 00:39:18,840 --> 00:39:23,880 countries all over the world to cure 827 00:39:21,90 --> 00:39:26,190 people with hepatitis C. I?ll just show the 828 00:39:23,880 --> 00:39:29,910 results now from some research we?ve been doing 829 00:39:26,190 --> 00:39:32,460 Next slide. We?re looking at various different 830 00:39:29,910 --> 00:39:35,879 countries and different programs how they?re 831 00:39:32,460 --> 00:39:38,700 working. So this is the FixHepC buyer?s Club, 832 00:39:35,880 --> 00:39:41,40 you can see the website in the top right 833 00:39:38,700 --> 00:39:45,118 hand corner if you ever wanted to access treatment 834 00:39:41,40 --> 00:39:47,820 from FixHepC Buyer?s Club. Their cure rat 835 00:39:45,119 --> 00:39:49,829 is just under ninety percent. At the moment it's 836 00:39:47,820 --> 00:39:51,960 a little lower than some of the other buyers clubs 837 00:39:49,829 --> 00:39:54,60 because they've been treating some of 838 00:39:51,960 --> 00:39:59,160 the most difficult patients in Australia 839 00:39:54,60 --> 00:40:01,828 who have cirrhosis, who had the genotype 3. 840 00:39:59,160 --> 00:40:03,118 It was a very tough population to 841 00:40:01,829 --> 00:40:07,200 treat, but even so 842 00:40:03,119 --> 00:40:09,660 eighty-nine percent is looking good. 843 00:40:07,200 --> 00:40:12,118 As you can see from this graph 844 00:40:09,660 --> 00:40:15,270 and world map of where people have been 845 00:40:12,119 --> 00:40:18,570 treated the FixHepC Buyer?s Club has a reach 846 00:40:15,270 --> 00:40:22,589 all over the world. They have treated people in Africa, Europe, 847 00:40:18,570 --> 00:40:25,680 Australia, North and South America, Asia etc. 848 00:40:22,589 --> 00:40:28,349 And so several thousand people have been 849 00:40:25,680 --> 00:40:34,788 treated through the FixHepC Buyer?s Club. 850 00:40:28,349 --> 00:40:38,329 Next slide. 851 00:40:34,789 --> 00:40:40,789 Ok and so this is Greg Jefferys with his 852 00:40:38,329 --> 00:40:43,429 Hepatitis C Treatment Without Borders 853 00:40:40,789 --> 00:40:46,99 organisation Greg Jefferys has actually had 854 00:40:43,429 --> 00:40:49,939 hepatitis C himself and got cured 855 00:40:46,99 --> 00:40:51,499 through taking generics from India so we 856 00:40:49,939 --> 00:40:53,989 have personal experience of what this is 857 00:40:51,499 --> 00:40:56,209 like. This is the initial survey we've 858 00:40:53,989 --> 00:40:58,789 done looking at who?s been treated and where 859 00:40:56,209 --> 00:41:01,609 and see there just like Dr James Freeman 860 00:40:58,789 --> 00:41:04,39 a reach all over the world and 861 00:41:01,609 --> 00:41:09,709 cure rates already in the high ninety percent. 862 00:41:04,39 --> 00:41:11,929 Next slide. Some of this information is 863 00:41:09,709 --> 00:41:14,569 presented at the HIV Conference in Glasgow 864 00:41:11,929 --> 00:41:16,699 last week and we can see here the South East 865 00:41:14,569 --> 00:41:20,749 Asia Buyer?s Club, this is Giten?s 866 00:41:16,699 --> 00:41:23,239 program and again 92% cure rate with people 867 00:41:20,749 --> 00:41:31,459 treated in various parts of south 868 00:41:23,239 --> 00:41:34,609 east Asia. Next slide. And then finally the 869 00:41:31,459 --> 00:41:37,399 ITPC which is the International Treatment 870 00:41:34,609 --> 00:41:41,689 Preparedness Coalition in Russia have 871 00:41:37,400 --> 00:41:44,419 treated again about I think about 2,000 872 00:41:41,689 --> 00:41:47,118 people across Russia and the numbers are 873 00:41:44,419 --> 00:41:49,519 increasing very quickly. They have their 874 00:41:47,119 --> 00:41:51,380 own Facebook page and supply mechanism. 875 00:41:49,519 --> 00:41:53,238 The treatment comes in 876 00:41:51,380 --> 00:41:56,689 Sofosbuvir Daclatasvir for 12 weeks. 877 00:41:53,239 --> 00:42:00,259 Supply is currently 490 US dollars 878 00:41:56,689 --> 00:42:03,949 Sofosbuvir Velpatasvir is 879 00:42:00,259 --> 00:42:06,679 coming in from Bangladesh for 900 US dollars 880 00:42:03,949 --> 00:42:09,349 for 12 weeks. They have access to all the 881 00:42:06,679 --> 00:42:12,650 most recent drugs produced from generic companies 882 00:42:09,349 --> 00:42:15,49 and again their cure rate, very good 98%. 883 00:42:12,650 --> 00:42:18,439 Having said that, it's a younger population 884 00:42:15,49 --> 00:42:25,309 with a lot of genotype 1 as opposed to 3 885 00:42:18,439 --> 00:42:29,749 which is slightly easier to treat. Next slide. 886 00:42:25,309 --> 00:42:32,869 So we can see across these buyer?s clubs that 887 00:42:29,749 --> 00:42:35,689 it is possible to treat large 888 00:42:32,869 --> 00:42:38,150 numbers of people but only if the prices 889 00:42:35,689 --> 00:42:40,98 are affordable and I think the problem 890 00:42:38,150 --> 00:42:42,349 with hepatitis C at the moment if you 891 00:42:40,99 --> 00:42:43,939 look at the number of people in some 892 00:42:42,349 --> 00:42:47,89 countries and the cost of the treatment 893 00:42:43,939 --> 00:42:48,210 being asked for by the pharma companies it is just 894 00:42:47,89 --> 00:42:51,119 way too high and it would just 895 00:42:48,210 --> 00:42:53,190 be impossible to treat everybody 896 00:42:51,119 --> 00:42:56,430 with Hep C in some countries at the current 897 00:42:53,190 --> 00:42:58,200 prices. So we need to have new approaches 898 00:42:56,430 --> 00:43:00,868 to funding mass treatment programs either 899 00:42:58,200 --> 00:43:03,689 ?All you can Treat? pricing where you have 900 00:43:00,869 --> 00:43:08,99 unlimited treatments for a fixed price or lower 901 00:43:03,690 --> 00:43:10,530 fixed prices at least under 4,000 euros per cure for 902 00:43:08,99 --> 00:43:12,599 hepatitis C in high-income countries and 903 00:43:10,530 --> 00:43:14,820 much lower prices in the middle and 904 00:43:12,599 --> 00:43:16,980 low income countries. We just need to 905 00:43:14,820 --> 00:43:20,160 remember that most of these drugs are fundamentally 906 00:43:16,980 --> 00:43:22,530 extremely cheap to produce so pharmaceutical 907 00:43:20,160 --> 00:43:24,450 companies can make a large profit from 908 00:43:22,530 --> 00:43:26,670 selling to large numbers of people 909 00:43:24,450 --> 00:43:28,859 at lower unit prices. What they're doing at the moment is 910 00:43:26,670 --> 00:43:31,560 treating a very small number of people 911 00:43:28,859 --> 00:43:33,150 for a very high price but they could reverse 912 00:43:31,560 --> 00:43:36,210 that and still make a lot of money. Next slide. 913 00:43:33,150 --> 00:43:38,339 That if 914 00:43:36,210 --> 00:43:41,130 pharmaceutical companies just refuse 915 00:43:38,339 --> 00:43:44,460 to make these deals, we will need back up 916 00:43:41,130 --> 00:43:46,950 mechanisms to ensure access. So compulsory 917 00:43:44,460 --> 00:43:49,800 licensing where a country simply says the 918 00:43:46,950 --> 00:43:54,330 prices are unacceptable and they start 919 00:43:49,800 --> 00:43:58,619 importing the drugs on mass from these generic companies 920 00:43:54,330 --> 00:44:01,740 in India or Bangladesh. The buyer?s clubs are showing that people 921 00:43:58,619 --> 00:44:04,109 can be cured with these generics. In 922 00:44:01,740 --> 00:44:06,810 our experience we've seen almost no 923 00:44:04,109 --> 00:44:09,60 casualties, the fakes are just not an issue. 924 00:44:06,810 --> 00:44:11,490 We?re getting good quality supply, we can 925 00:44:09,60 --> 00:44:12,960 monitor people very early on to see 926 00:44:11,490 --> 00:44:15,720 whether the drugs are working. You know 927 00:44:12,960 --> 00:44:18,180 within two weeks whether somebody is 928 00:44:15,720 --> 00:44:21,270 taking a good quality drug because the 929 00:44:18,180 --> 00:44:24,450 viral load comes down so quickly. And then 930 00:44:21,270 --> 00:44:27,330 finally if the companies really refuse to 931 00:44:24,450 --> 00:44:30,359 work alongside this we need to think about how 932 00:44:27,330 --> 00:44:34,49 much money these companies are making. Gilead 933 00:44:30,359 --> 00:44:38,69 so far as so 40 billion US dollars worth of 934 00:44:34,50 --> 00:44:40,920 their Hepatitis C drugs 40 billions and if you just look to 935 00:44:38,70 --> 00:44:43,109 at the tax they've avoided by 936 00:44:40,920 --> 00:44:45,690 putting their intellectual property inn 937 00:44:43,109 --> 00:44:47,759 Ireland, that's ten billion dollars alone, that's 938 00:44:45,690 --> 00:44:49,230 enough money to treat everybody with 939 00:44:47,760 --> 00:44:51,570 hepatitis C worldwide. 940 00:44:49,230 --> 00:44:56,700 So we?ve got solutions, it is just about 941 00:44:51,570 --> 00:45:00,89 how we are actually doing it. Thanks very much. 942 00:44:56,700 --> 00:45:02,20 Thank you and again another very important message 943 00:45:00,89 --> 00:45:05,590 right there 944 00:45:02,20 --> 00:45:08,530 and I'm very wary of time I have a have 945 00:45:05,590 --> 00:45:11,860 a question here. Clarification about 946 00:45:08,530 --> 00:45:13,930 Canada, people can carry in the generics on 947 00:45:11,860 --> 00:45:16,210 them but cannot courier them is that 948 00:45:13,930 --> 00:45:19,419 right Giten? Sorry Giten can you just 949 00:45:16,210 --> 00:45:22,360 clarify importation for Canada. 950 00:45:19,420 --> 00:45:23,740 Yes legally it's not 951 00:45:22,360 --> 00:45:26,560 allowed to be couriered, that's correct. 952 00:45:23,740 --> 00:45:28,899 Alright thank you Giten 953 00:45:26,560 --> 00:45:33,9 and what I wanted to say just 954 00:45:28,900 --> 00:45:34,960 concluding from what Dr. Andrew Hill 955 00:45:33,10 --> 00:45:37,270 was saying one of the things and it was 956 00:45:34,960 --> 00:45:39,520 mentioned by Erika, was mentioned by 957 00:45:37,270 --> 00:45:41,830 Giten we're exploring the generics 958 00:45:39,520 --> 00:45:44,350 role here and again it is unquestionable 959 00:45:41,830 --> 00:45:47,200 what is being doing in terms of reducing 960 00:45:44,350 --> 00:45:49,870 the prices but when it comes to the 961 00:45:47,200 --> 00:45:53,140 buyers clubs for instance fantastic 962 00:45:49,870 --> 00:45:54,970 option but it's not even though is more 963 00:45:53,140 --> 00:45:56,589 affordable for a lot of patients it is 964 00:45:54,970 --> 00:45:58,660 still not a reality. 965 00:45:56,590 --> 00:46:01,870 So we really need to start looking at 966 00:45:58,660 --> 00:46:05,710 Public Health approaches to making sure 967 00:46:01,870 --> 00:46:07,630 that the general population out there with 968 00:46:05,710 --> 00:46:10,660 hepatitis is accessing those drugs 969 00:46:07,630 --> 00:46:13,270 and also there will be a need for 970 00:46:10,660 --> 00:46:14,500 conference, I think, of strategies and 971 00:46:13,270 --> 00:46:19,000 approaches if we are to deliver 972 00:46:14,500 --> 00:46:20,650 elimination. So just buyer?s clubs alone 973 00:46:19,000 --> 00:46:22,570 and what Giten was saying this personal 974 00:46:20,650 --> 00:46:24,700 importation alone will not deliver 975 00:46:22,570 --> 00:46:27,640 elimination. We need to be treating 976 00:46:24,700 --> 00:46:29,259 masses of people. Again we have 80 977 00:46:27,640 --> 00:46:32,109 million people out there with 978 00:46:29,260 --> 00:46:35,110 Hepatitis C and we have a cure. So I 979 00:46:32,110 --> 00:46:37,600 guess my message at least on behalf of 980 00:46:35,110 --> 00:46:39,850 the World Hepatitis Alliance is that we're 981 00:46:37,600 --> 00:46:42,520 very much pro-access and looking at 982 00:46:39,850 --> 00:46:45,69 everything that can be done, generics, 983 00:46:42,520 --> 00:46:47,500 the optimized procurement so governments 984 00:46:45,70 --> 00:46:51,130 and companies really access information 985 00:46:47,500 --> 00:46:53,50 and on that, just so viewers that 986 00:46:51,130 --> 00:46:55,540 might be interested in this but WHO 987 00:46:53,50 --> 00:46:59,110 launched a hepatitis C access report 988 00:46:55,540 --> 00:47:01,300 just last week with information on 989 00:46:59,110 --> 00:47:02,770 different prices for different countries 990 00:47:01,300 --> 00:47:07,210 as well which you can use in your 991 00:47:02,770 --> 00:47:09,370 country to help those negotiations. And 992 00:47:07,210 --> 00:47:12,460 one last question before I wrap up if 993 00:47:09,370 --> 00:47:14,500 that's ok, it's around the perhaps 994 00:47:12,460 --> 00:47:15,830 differences in prices there were some 995 00:47:14,500 --> 00:47:17,780 prices mentioned at 996 00:47:15,830 --> 00:47:21,140 Giten's presentation, some 997 00:47:17,780 --> 00:47:24,170 mention with Dr. Andrew Hill?s presentation and 998 00:47:21,140 --> 00:47:26,629 I noticed that the WHO report has also 999 00:47:24,170 --> 00:47:28,490 different prices and I just guess is 1000 00:47:26,630 --> 00:47:31,520 this because it's things are happening 1001 00:47:28,490 --> 00:47:34,220 so fast that is difficult to track those 1002 00:47:31,520 --> 00:47:36,710 price reductions, and you want any 1003 00:47:34,220 --> 00:47:40,69 panellist? Yeah 1004 00:47:36,710 --> 00:47:42,350 Yes so it's that the prices are dropping 1005 00:47:40,70 --> 00:47:46,700 so fast if you look at 1006 00:47:42,350 --> 00:47:48,770 the price 1007 00:47:46,700 --> 00:47:51,410 that Andrew had shared this was made in 1008 00:47:48,770 --> 00:47:52,940 Durban, this was in the Durban conference, 1009 00:47:51,410 --> 00:47:56,899 the international AIDS conference and if 1010 00:47:52,940 --> 00:47:59,600 that?s, after that the price has been 1011 00:47:56,900 --> 00:48:02,630 dropping as we speak even that's it even 1012 00:47:59,600 --> 00:48:05,270 further getting dropped. So and then 1013 00:48:02,630 --> 00:48:07,250 there is and I will get or someone 1014 00:48:05,270 --> 00:48:09,230 else will get it at a different price where 1015 00:48:07,250 --> 00:48:10,970 as you know someone else will also get 1016 00:48:09,230 --> 00:48:13,460 in the different price, so there would be 1017 00:48:10,970 --> 00:48:15,859 no consistent pricing as in like you 1018 00:48:13,460 --> 00:48:17,660 know just as the fixed price for 12 1019 00:48:15,860 --> 00:48:19,760 weeks of Sof/Led or Sof/Dac, that's 1020 00:48:17,660 --> 00:48:21,950 not going to be there. But the basic 1021 00:48:19,760 --> 00:48:23,360 point is that the price drop has been so 1022 00:48:21,950 --> 00:48:25,970 dramatic and there is so much 1023 00:48:23,360 --> 00:48:28,40 competition among the Indian generic 1024 00:48:25,970 --> 00:48:29,720 suppliers and like 15 suppliers want to 1025 00:48:28,40 --> 00:48:32,750 get to trying to sell this medication. 1026 00:48:29,720 --> 00:48:35,359 So that competition itself drives the price 1027 00:48:32,750 --> 00:48:37,280 drops to a large extent. So 1028 00:48:35,360 --> 00:48:39,800 it has been dropping from the time as 1029 00:48:37,280 --> 00:48:42,50 you saw in my slide, it will continue to 1030 00:48:39,800 --> 00:48:44,960 drop and that perhaps it will come out in the next 1031 00:48:42,50 --> 00:48:48,230 1 or 2 months and then we're going to even see 1032 00:48:44,960 --> 00:48:50,570 more drop. Thank and I promised it was the 1033 00:48:48,230 --> 00:48:52,430 last question but I just got one last one 1034 00:48:50,570 --> 00:48:54,380 and it's a good one as well. so may as well 1035 00:48:52,430 --> 00:48:57,140 just throw it out there. Which is 1036 00:48:54,380 --> 00:48:59,570 can a doctor get into trouble for 1037 00:48:57,140 --> 00:49:02,960 monitoring a patient using the generic 1038 00:48:59,570 --> 00:49:05,210 drugs that they procured for themselves? 1039 00:49:02,960 --> 00:49:07,280 Anyone have an answer to 1040 00:49:05,210 --> 00:49:09,140 that question? I think I have we have 1041 00:49:07,280 --> 00:49:17,120 doctors listening in. You go ahead Giten, 1042 00:49:09,140 --> 00:49:20,000 You go ahead Giten 1043 00:49:17,120 --> 00:49:23,839 it?s fine. Okay, 1044 00:49:20,000 --> 00:49:26,619 I mean as far as I know there are 1045 00:49:23,840 --> 00:49:30,670 a lot of physicians in Europe who are actually 1046 00:49:26,619 --> 00:49:33,220 monitoring in Asia anywhere in the US 1047 00:49:30,670 --> 00:49:35,49 and Canada who are actually, they don't 1048 00:49:33,220 --> 00:49:37,58 get the medication by themselves but 1049 00:49:35,49 --> 00:49:39,279 they say that ok you get the medicine 1050 00:49:37,59 --> 00:49:44,230 and then I will monitor you. So we 1051 00:49:39,279 --> 00:49:46,869 have physicians, GPs, xx, hepatologiest, 1052 00:49:44,230 --> 00:49:49,960 gastro doctors who are monitoring the 1053 00:49:46,869 --> 00:49:52,359 patient?s on generics and for me I 1054 00:49:49,960 --> 00:49:54,400 have not come across anyone who have 1055 00:49:52,359 --> 00:49:56,650 been fined or have been prosecuted or have 1056 00:49:54,400 --> 00:49:57,999 been asked by anybody to justify why 1057 00:49:56,650 --> 00:50:01,869 they are just monitoring the patient who 1058 00:49:57,999 --> 00:50:04,390 needs that treatment. Dr Andrew Hill you have 1059 00:50:01,869 --> 00:50:06,369 anything to add to that? Yeah there 1060 00:50:04,390 --> 00:50:08,558 was legal review of this situation at 1061 00:50:06,369 --> 00:50:11,200 St Mary?s Hospital not so long ago and the conclusion was 1062 00:50:08,559 --> 00:50:14,559 that if somebody comes in with their own 1063 00:50:11,200 --> 00:50:17,379 medicine, if they?ve bought ourselves, it's 1064 00:50:14,559 --> 00:50:21,339 that the monitoring of it is 1065 00:50:17,380 --> 00:50:22,779 absolutely fine, it's not the doctor 1066 00:50:21,339 --> 00:50:25,839 that's actually made that prescription. 1067 00:50:22,779 --> 00:50:27,910 The doctor is just aware that 1068 00:50:25,839 --> 00:50:31,269 somebodys taking this medicine and they are allowed to monitor them. 1069 00:50:27,910 --> 00:50:35,529 And so it's permitted in the major 1070 00:50:31,269 --> 00:50:38,49 teaching hospitals it won't affect them. Perfect, thank 1071 00:50:35,529 --> 00:50:41,349 you so much and I'm again wary of time 1072 00:50:38,49 --> 00:50:47,319 so any last words before I conclude anyone, 1073 00:50:41,349 --> 00:50:49,869 any last words or remarks? No? 1074 00:50:47,319 --> 00:50:52,210 Alright, thank you so much everybody for 1075 00:50:49,869 --> 00:50:55,599 joining in and thank you to all of our 1076 00:50:52,210 --> 00:50:58,390 lovely panellists for sharing their 1077 00:50:55,599 --> 00:51:00,39 expertise and as I mentioned we're 1078 00:50:58,390 --> 00:51:02,319 going to be posting is recording online 1079 00:51:00,39 --> 00:51:04,119 before a series of links to the 1080 00:51:02,319 --> 00:51:06,220 documents and the tools that we 1081 00:51:04,119 --> 00:51:12,150 presented here so thank you everybody 1082 00:51:06,220 --> 00:51:12,149 for attending this. Thank you.