ViiV Healthcare and the Medicines Patent Pool expand access to dolutegravir-based regimens for people living with HIV in Azerbaijan, Belarus, Kazakhstan and Malaysia with innovative new licensing agreement
30 November 2020
Geneva – ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, and the Medicines Patent Pool (MPP) today announced the signing of a new voluntary licensing agreement to enable greater access for dolutegravir (DTG) based regimens which have been recommended by the World Health Organization (WHO) or the US Department of Health and Human Services (DHHS) in certain upper-middle-income countries (UMICs). This new licensing agreement will include Azerbaijan, Belarus, Kazakhstan and Malaysia.
Recognising the specific challenges faced by these countries and in response to feedback from the HIV community and the governments, ViiV Healthcare and MPP have developed this first-of-its-kind agreement to enable increased access and affordability to generic DTG-based HIV treatment regimens, while also supporting continued investment in much needed innovation. Through this novel agreement, generic manufacturers will have the opportunity to supply DTG-based regimens at a significantly reduced price compared to the current local price, in turn enabling greater access to these medicines for people living with HIV in each country.
Charles Gore, MPP Executive Director said, “Increasing access to life-saving medicines for low- and middle-income countries is at the core of our mission and we have been able to achieve that over the last 10 years through strong partnerships that span industry, generics manufacturers, governments and civil society. This new and first-of-its-kind agreement with ViiV Healthcare, that is specifically aimed at increasing access in these upper-middle-income countries, will mean that people living with HIV in Azerbaijan, Belarus, Kazakhstan and Malaysia will now have greater access to affordable and quality WHO-recommended dolutegravir-based treatment regimens.”
Dr. Meg Doherty, Director of Global HIV, Hepatitis and STI Programmes at the World Health Organization said: “WHO recommends the use of dolutegravir (DTG) as part of the preferred first-line and second-line regimen for people living with HIV, including pregnant women and those of childbearing potential. WHO welcomes this licence and through our regional and country offices have worked alongside governments and MPP to ensure that this agreement responds to people’s HIV treatment needs in these countries.”
ViiV Healthcare and MPP will now work closely with governments and selected generic manufacturers to make generic DTG-based regimens available as soon as possible in the four countries.
Deborah Waterhouse, CEO ViiV Healthcare said, “We are 100% committed to our mission of leaving no person living with HIV behind and are proud to have built upon our existing partnership with MPP to enable improved access to dolutegravir in these upper-middle-income countries in line with WHO HIV treatment guidelines. Through this agreement, we have created an innovative model that enables improved access to treatment and increased affordability while supporting continued investment in research and development of much needed innovative medicines to help ensure better long-term outcomes for people living with HIV.”
Supportive quotes from countries
“We are sure that, thanks to this new MPP licence for Azerbaijan, we will be able to provide people in need with the necessary treatment modalities: the DTG-based regimens. This will bring better control of the situation of HIV in the country. We hope for sustainable support from the MPP side and believe in a strong common success.” – Dr. Teymur Musayev, Head of the Department for the Organization of Healthcare, Ministry of Health of the Republic of Azerbaijan
“It was quite a long and complex process. However, the productive collaboration between the Ministry of Health of Belarus, the Medicines Patent Pool, the World Health Organization and other interested parties, has led to the desired results. We hope that, thanks to the licence agreement between MPP and ViiV Healthcare, access to dolutegravir and the TLD combination will be improved for people in need of treatment in Belarus, and will also enable us to improve adherence to HIV treatment. The licence opens the window for competition between generic manufacturers, licensees of MPP, and will bring quality-assured medicines at a more affordable price to our market.” – Dr. Dmitry Pinevich, Minister of Health of Belarus
“The possibility of access to generic dolutegravir fully meets the interests of the Republic of Kazakhstan in terms of price and quality, and makes the needed medicines more affordable. This will be of great benefit to people living with HIV infection. The Ministry of Health of Kazakhstan welcomes inclusion of Kazakhstan in the new licence agreement for upper-middle-income countries signed by the Medicines Patent Pool (MPP) and ViiV Healthcare and looks forward to further collaboration with MPP and other stakeholders.” – Dr. Alexey Tsoy, Minister of Health of Kazakhstan
“Affordable versions of WHO-recommended dolutegravir-based treatment regimens are urgently needed to end the HIV crisis everywhere. We are therefore very pleased with the MPP-ViiV Healthcare agreement signed today, as Malaysia will be able to provide WHO prequalified, more affordable versions of these essential medicines to people living with HIV, in need of treatment, in the country. We hope the competition between generic manufacturers enabled by this licence, will bring to our market quality medicines at significantly lower price. We hope that with this agreement it will open up more doors for Malaysia in the future to gain rapid access to lifesaving treatment medicine. The Ministry of Health of Malaysia wishes to thank MPP and all parties involved who have made this incredible decision a reality.” – Dr. Noor Hisham Abdullah, Director General of Health, Ministry of Health of Malaysia
“The World Health Organization recommends DTG as the preferred first-line treatment for people living with HIV, giving us the possibility to improve the quality of their lives. We have been fighting for this for years. The MPP licence opens access to generic quality DTG and TLD which is an opportunity for us to provide more people with DTG regimens in Kazakhstan and improve treatment adherence.” – Nurali Amanzholov, President of the Central Asian Association of People living with HIV, Kazakhstan
“I am delighted that Malaysia will be able to access more affordable DTG. That will allow us to provide more people with quality-assured DTG regimens. The community has been advocating for access to DTG for many years, the best WHO -recommended option that will also enable us to improve the quality of life of people living with HIV. If we want to end AIDS, we have to be able to provide the optimal level of care with minimised side effects because HIV treatment is a life-long treatment. Access to more affordable DTG will give the country incentive to test and treat more people.” – Martin Choo, Managing Director of the Asia Pacific Council of AIDS Service Organizations
“Currently, access to DTG is of crucial importance for upper-middle-income countries in the EECA region, a region which continues to lead on high HIV prevalence and low ART coverage. Patient communities have undertaken massive advocacy campaigns, aimed at removing price barriers in access to DTG. The conclusion of this MPP licence agreement is highly important for ensuring access to effective quality-assured WHO recommended HIV treatment in the region.” – Sergey Dmitriyev, Coordinator of the Access to Treatment Direction of the regional project “Sustainability of Services for Key Populations in Eastern Europe and Central Asia”
“As the organisation working with people living with HIV, we can definitely proclaim the importance of this MPP licence agreement in Azerbaijan since it will give the opportunity to increase the number of beneficiaries who receive ART therapy in our country. Transitioning to DTG and TLD treatments, as recommended by WHO, will improve access to the needed treatments and health care services. Therefore, we believe, that this licence agreement will help our country serve our people living with HIV with better treatments.” – Ramil Goyushov, Chairman of West-Resource Public Union on Civil Society Development Support, Azerbaijan
“We applaud the voluntary licence agreement that will significantly improve access to dolutegravir and TLD combination in Kazakhstan, Belarus and Azerbaijan, and are proud to have contributed to this important milestone along with other key stakeholders such as the GFATM-funded multi country SoS_project uniting MPP, WHO, civil society, community, and national governments. In the EECA region with the greatest HIV treatment gap and resource constraints, this is a real breakthrough in accessing vital treatment at substantially reduced price.” – Andriy Klepikov, Executive Director, Alliance for Public Health
“The licence agreement between the Medicines Patent Pool and ViiV Healthcare opens the door for Belarus to provide more people living with HIV with DTG and TLD, and this is good news. I hope the price will be further reduced to make it possible for the country to switch to DTG in the first-line treatment. Civil society and community welcome the productive collaboration between the Government, MPP and WHO and is looking forward to its continuation to reach licence agreements on innovative medicines for treating HIV, viral hepatitis, tuberculosis, cancers and potentially other disease areas.” – Anatoliy Leshanok, Director, People PLUS (National Network of People living with HIV), Belarus
“This new license agreement is a huge achievement, not only because it will allow many people living with HIV to switch to the WHO-recommended first-line treatment, but also because it is the proof of concept that MPP can foster access to essential HIV treatments in upper-middle-income countries.” – Peter Beyer, Unit Lead a.i., AMR Division, World Health Organization
“The new licence agreement for dolutegravir (DTG) for the upper-middle-income countries is a very welcome news in these difficult times. It can effectively increase access to more quality affordable DTG and TLD combinations for people living with HIV. We hope that this agreement will enable the participating countries to accelerate the transition to the WHO-recommended preferred treatment regimens for HIV infection and, as a result, improve treatment retention with fewer side effects, mitigate emergence of drug resistance, and ultimately become an important measure aimed at addressing the HIV epidemic.” – Masoud Dara, WHO Director’s Special Representative to Belarus, World Health Organization
“Unitaid welcomes this new licence which comes in the wake of our recent decision to renew our support to the MPP through a 5-year funding. In the context of the COVID-19 pandemic, we must ensure our efforts remain constant to eliminate HIV by increasing access to affordable life-saving treatments to people who need them the most. Collaboration between countries, the private sector and MPP is key to achieve this goal and the innovative approach used to reach this agreement highlights the flexibility of the MPP model.” – Philippe Duneton, Executive Director of Unitaid
“UNAIDS commends the announcement of this landmark agreement that will help bridging a historical gap in access to HIV treatment. Voluntary licensing agreements have proven to be an important tool to improve affordability of newer ARV formulations and products in low- and middle-income countries (LMICs), through increasing generic competition. Several upper-middle-income countries, however, have not been able to benefit from several access to medicines initiatives, with growing barriers to procure more affordable ARVs in the generic pharmaceutical market. We hope that the current agreement be the first of many to come, opening the doors for countries in other regions, which are still paying higher prices for innovative health technologies that could advance treatment outcomes.” – Vinay Saldanha, Special Adviser UNAIDS Executive Director
“Access to antiretroviral treatment remains below 40% of those in need in Eastern Europe and central Asia where the HIV epidemic continues to expand. This new voluntary licence agreement will increase affordability of DTG a part of the preferred antiretroviral regimens recommended by WHO and help broaden access to treatment in the region where many countries most affected are classified as upper-middle-income countries. Here is one more brilliant achievement of MPP in the global fight against pandemics.” – Professor Michel Kazatchkine, Special Advisor to the Joint United Nations Program on AIDS (UNAIDS) in Eastern Europe and Central Asia, Senior Fellow, Global Health Center, the Graduate Institute of International and Development Studies, Geneva
Notes to Editors
Evolving our approach to access in UMICs
The new voluntary licence agreement will enable the supply of dolutegravir-based regimens that are recommended by WHO or the US DHHS. The four countries that benefit from this agreement are not covered by the existing MPP-ViiV Healthcare licence for DTG-based regimens and are all upper-middle-income countries which are eligible for Overseas Development Assistance as defined by the Organisation for Economic Cooperation and Development (OECD) Develop Assistance Committee (DAC) list, are not members of the G20 or OECD, and where ViiV Healthcare holds a patent for dolutegravir. These four countries will also have access to our existing paediatric DTG voluntary licence.
About the Medicines Patent Pool
MPP is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups and other stakeholders, to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with ten patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals and a tuberculosis treatment. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC).
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aims are to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
Contact
Gelise McCullough
Head of Communications | Medicines Patent Pool
+41 79 685 64 36
gmccullough@medicinespatentpool.org
