[Ip-health] Kazakhstan to seek a compulsory license after failed negotiations on access to dolutegravir

Baker, Brook b.baker at northeastern.edu
Wed Jun 26 06:56:02 PDT 2019


This report from Kazakhstan shows the power middle-income countries have to issue compulsory licenses when they are excluded from Medicines Patent Pool licenses.  Though it would be better if countries like Kazakhstan were more routinely included in licenses and if they did not have to face excessive, unilaterally determined tiered prices, they have the power to override Pharma intransigence by means of compulsory or government use licenses.  Moreover, because of provisions in MPP licenses allowing generic licensees to supply pursuant to compulsory licenses issued in territorially excluded countries, Kazakhstan will have options to purchase from a large group of suppliers of assured quality medicines.  Hopefully one a CL is issued, Kazakhstan will take advantage of a temporary waiver to allow early introduction of generic equivalents followed by fast-track registration, fastest probably through the WHO Collaborative Registration mechanism.  Perhaps efforts like these and the earlier CL on sofosbuvir in Malaysia will force patent holders to expand geographic coverage of their voluntary licenses.

Brook

Professor Brook K. Baker
Northeastern U. School of Law
416 Huntington Ave.
Boston, MA 02115
Honorary Research Fellow, University of KwaZulu Natal
Health GAP (Global Access Project) Senior Policy Analyst
(w) 617-373-3217
(c) 617-259-0760
b.baker at northeastern.edu
Skype:  brook_baker

A compilation of publicly available materials about Kazakhstan, dolutegravir and compulsory license initiative. Please disseminate widely
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Kazakhstan to seek a compulsory license after failed negotiations on access to dolutegravir
For more than three months, Kazakhstan faced serious problems with the supply of dolutegravir – a key component of the antiretroviral therapy for treating HIV-infection. This happened due to long and, so far, unsuccessful negotiations between the Ministry of Health and ViiV Healthcare on access to generic dolutegravir. The government argued that the price for the original was too high to satisfy the demand and asked the company to include Kazakhstan in the voluntary license concluded between ViiV and the Medicines Patent Pool. This move would mean that the price of one pack of generic quality-assured dolutegravir in Kazakhstan could be as low as 5 USD instead of 165 USD – the price paid by the government for the original drug in 2018.
There were several meetings<https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.pharm.reviews%2Fstati%2Fsobytiya%2Fitem%2F3963-mz-rk-planiruet-dobivatsya-prinuditelnoj-litsenzii-ot-gsk-na-dolutegravir-v-sude&data=02%7C01%7Cb.baker%40northeastern.edu%7C661a49a6558c4730c35208d6f9be6e31%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C636970993625089253&sdata=zlFUT3%2BB2PNKGd7dixL7xs1pkhKY%2Fx2BX%2B1q02rGNA8%3D&reserved=0> involving the government and industry representatives as well as the civil society, who constantly drew the public attention to the issue of insufficient supplies. Yelena Rastokina from Answer Foundation and Sergey Biryukov from Antihepatitis C Foundations stressed the importance of solving the issue of stock-outs and developing a sustainable solution to expand the treatment coverage and ensure uninterrupted drug provision.
After several negotiation rounds, the head of SK Pharmatsia (government procurement agency) Mr. Berik Sharip said in an interview to one of the national newspapers that there was no time for negotiations left as the patients urgently needed the drug. As a result, the country had to procure original dolutegravir for 118 USD per pack. However, Mr. Sharip added that the government planned to go to court to seek a compulsory license for dolutegravir, as there were many more people in the country who needed antiretroviral treatment, and access to generic drug would mean considerable savings. “We could have increased the coverage by 20 times [if we had been given an opportunity to procure generic DTG]”, said Mr. Sharip. “There is an internationally recognized mechanism, the so-called compulsory licensing. If we win in court, we will be able to procure generics produced within the voluntary license without the consent of the patent holder”. Earlier, head of the Pharmacy Committee of the Ministry of Health Ms. Ludmila Byurabekova also mentioned that the government was considering a lawsuit with the purpose of obtaining a compulsory license for dolutegravir.
April 11, 2019, the Ministry of Health of Kazakhstan issued an official statement<https://nam05.safelinks.protection.outlook.com/?url=http%3A%2F%2Fdsm.gov.kz%2Fru%2Fnews%2Fglaxosmithkline-otkazalis-vklyuchit-v-dobrovolnuyu-licenziyu-kazahstan-dlya-vozmozhnosti&data=02%7C01%7Cb.baker%40northeastern.edu%7C661a49a6558c4730c35208d6f9be6e31%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C636970993625089253&sdata=TvuF4j%2BmLuH6lfQaT9QCO0d%2BFKmMWUF7rbgMZOQg6II%3D&reserved=0> declaring that GSK refused to include Kazakhstan in the voluntary license. Being part of the geographical scope of the license would have enabled the country to procure dolutegravir at a price 25 times lower than the originator price. The Ministry representatives said that the price offered by the originator prevented the country from covering all the patients in need with life-saving antiretroviral therapy given the allocated budget.
Sources:
Official Website of the Ministry of Health of the Republic of Kazakhstan:
http://dsm.gov.kz/ru/news/glaxosmithkline-otkazalis-vklyuchit-v-dobrovolnuyu-licenziyu-kazahstan-dlya-vozmozhnosti<https://nam05.safelinks.protection.outlook.com/?url=http%3A%2F%2Fdsm.gov.kz%2Fru%2Fnews%2Fglaxosmithkline-otkazalis-vklyuchit-v-dobrovolnuyu-licenziyu-kazahstan-dlya-vozmozhnosti&data=02%7C01%7Cb.baker%40northeastern.edu%7C661a49a6558c4730c35208d6f9be6e31%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C636970993625099249&sdata=56cmvX8qvXmyPYWcvDuzoYrv%2BgKzryMbWVatHlGll80%3D&reserved=0>
Mass media articles:
https://informburo.kz/novosti/sk-farmaciya-kazahstancam-s-vich-kupyat-britanskiy-preparat-nesmotrya-na-otkaz-v-skidke.html<https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Finformburo.kz%2Fnovosti%2Fsk-farmaciya-kazahstancam-s-vich-kupyat-britanskiy-preparat-nesmotrya-na-otkaz-v-skidke.html&data=02%7C01%7Cb.baker%40northeastern.edu%7C661a49a6558c4730c35208d6f9be6e31%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C636970993625099249&sdata=bZib1W4diYrKlOV7PcjiLU5cZjbbHNmQkfPMXDVxick%3D&reserved=0>
https://gmpnews.ru/2019/04/gsk-ne-namerena-snizhat-cenu-na-dolutegravir-dlya-kazaxstana/<https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgmpnews.ru%2F2019%2F04%2Fgsk-ne-namerena-snizhat-cenu-na-dolutegravir-dlya-kazaxstana%2F&data=02%7C01%7Cb.baker%40northeastern.edu%7C661a49a6558c4730c35208d6f9be6e31%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C636970993625109241&sdata=S1Io4TMnM29oPliSd6MM9HsVXweudu%2BfGjUsnaS%2BHiM%3D&reserved=0>
https://www.pharm.reviews/stati/sobytiya/item/3963-mz-rk-planiruet-dobivatsya-prinuditelnoj-litsenzii-ot-gsk-na-dolutegravir-v-sude<https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.pharm.reviews%2Fstati%2Fsobytiya%2Fitem%2F3963-mz-rk-planiruet-dobivatsya-prinuditelnoj-litsenzii-ot-gsk-na-dolutegravir-v-sude&data=02%7C01%7Cb.baker%40northeastern.edu%7C661a49a6558c4730c35208d6f9be6e31%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C636970993625109241&sdata=dqmm3WjCujMKE3qLZNVuj%2BwrkDZPatu9anpm8T8v03M%3D&reserved=0>
Website for monitoring stock-outs of drugs in Kazakhstan:
https://pereboi.kz/2019/06/19/o-situatsii-s-dolutegravirom-v-kazahstane/<https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpereboi.kz%2F2019%2F06%2F19%2Fo-situatsii-s-dolutegravirom-v-kazahstane%2F&data=02%7C01%7Cb.baker%40northeastern.edu%7C661a49a6558c4730c35208d6f9be6e31%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C636970993625119237&sdata=4uOwaN6oefZxc%2Fa%2B5KpL8jGyO4PFvsucqWT3e3lBWOA%3D&reserved=0>

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С уважением,
Сергей Головин,
Skype: sergej.golovin

Best regards,
Sergey Golovin



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