ViiV HEALTHCARE’S ACCESS TO MEDICINES STRATEGY€¦ · founded in 2010 to increase access to HIV...

Making our medicines as widely available to patients regardless of income or where they live is central to ViiV Healthcare’s access to medicines strategy. By supporting global health initiatives like UNAIDS 90-90-90 targets and efforts to progress prevention of mother-to-child HIV transmission (PMTCT), we are addressing access to medicines in a number of ways.

The access issue is complex and multifaceted. There are many potential barriers that can affect access to medicines, including inadequate healthcare resources, lack of clinics and hospitals, poor distribution networks, low numbers of trained healthcare providers, high levels of patient illiteracy, significant stigma and discrimination, a lack of political will, inadequate prioritisation of HIV care in government budgets and pricing of medicines.

In this light, all HIV stakeholders need to work together to ensure access to treatment is appropriate in each country; pursuing flexible approaches that strike a balance between the needs of all involved parties is key to reducing barriers to access.

As a company 100% focused on the needs of PLHIV, we recognise the important role we play in the fight against HIV and work in partnership with stakeholders, including community organisations and national authorities, to help improve access to our medicines.

ViiV HEALTHCARE’S

ACCESS TO MEDICINES STRATEGY

THE ISSUE

Over 37 million people are eligible for antiretroviral therapy (ART) under the World Health Organization (WHO) 2015 guidelines.1,2 Scaling up access to treatment and ensuring that all people living with HIV (PLHIV) have access to HIV medicines is a crucial part of the global response to the epidemic.

UNAIDS 90-90-90An ambitious treatment target to help end the AIDS epidemic. By 2020:3

• 90% of PLHIV will know their HIV status• 90% of people diagnosed with HIV will receive

antiretroviral therapy (ART)• 90% of people receiving ART will have viral suppression

PREVENTION OF MOTHER-TO-CHILD HIV TRANSMISSION (PMTCT)A global effort, led by WHO guidelines, encouraging programmes that provide treatment, care and support to mothers living with HIV to prevent:4

• New HIV infections among women of childbearing age• Unintended pregnancies among women living with HIV• HIV transmission from a woman living with HIV to her baby

IE/HIV/0013/16 Date of Preparation: November 2016

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ViiV HEALTHCARE ACCESS STRATEGY

Voluntary licences: ViiV Healthcare enables generics companies to manufacture and sell versions of our antiretroviral (ARV) medicines in all least-developed, all low-income, all lower-middle income, and all sub-Saharan countries through our voluntary licensing policy. ViiV Healthcare has given voluntary licences for our ARVs to 17 generic manufacturers.

Flexible pricing: In middle-income countries, where incomes are higher and infrastructure is more developed, we have a flexible pricing policy that factors in the gross national income (GNI) and the impact of the epidemic in each country to improve affordability.

Local partnerships: ViiV Healthcare approaches partnerships on a case-by-case basis, taking into account the local need and situation. One key approach that ViiV Healthcare takes in middle-income countries is creating partnerships with in-country companies to manufacture our medicines locally, bringing the cost of treatment down while investing and sharing our expertise to build skills in the local economy at the same time.

Medicines Patent Pool (MPP) licence agreement: The MPP is a United Nations-backed organisation founded in 2010 to increase access to HIV treatment and help spur new innovation worldwide. In addition to its voluntary licences, ViiV Healthcare has a number of agreements in place that allow MPP to licence generics companies to manufacture and sell versions of ViiV Healthcare ARVs in specific countries.

Existing access policies include:

Voluntary licences*

Flexible pricing

Local partnerships†

Medicines Patent Pool licences*

Middle-income countries5

Low-income countries5

Least developed countries6

Sub-Saharan Africa

† considered on a case-by-case basis* includes royalty-free and royalty-bearing voluntary licences

At ViiV Healthcare, we are committed to playing our part in addressing access to medicines challenges by taking an innovative, responsible, and sustainable approach.

In partnership with the HIV community, including patient organisations and governments, ViiV Healthcare develops meaningful treatment advances, improves access to our medicines and supports communities most affected by the disease through programmes that have a direct and sustainable impact.

Our access to medicines strategy covers all countries, taking into account the specific challenges faced in terms of epidemic burden and economic status, including all middle-income, low-income, least-developed and sub-Saharan countries (138 countries in total) where the need for ART is greatest. We do this through a variety of approaches, based on the diverse needs of PLHIV in different parts of the world.


Sub-Saharan Africa

Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Cote d’Ivoire, Djibouti, DR Congo, Equatorial Guinea, Eritrea, Ethiopa, Gabon, Ghana, Gambia, Guinea, Guinea Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia, Zimbabwe

AmericasBolivia, El Salvador, Guatemala, Guyana, Haiti, Honduras, Nicaragua

MENAAfghanistan, Egypt, Morocco, Syria, West Bank and Gaza, Yemen

Eastern EuropeGeorgia, Kosovo, Ukraine

Commonwealth of Independent StatesArmenia, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Uzbekistanstan

Asia - PacificBangladesh, Bhutan, Cambodia, East Timor, India, Indonesia, Kiribati, Lao People’s DR, Micronesia, Myanmar, Nepal, Pakistan, Papua New Guinea, Dem. People’s Rep. of Korea, Philippines, Samoa, Solomon Islands, Sri Lanka, Tuvalu, Vanuatu, Vietnam

ViiV Healthcare first began collaborating with the MPP in early 2010 and in 2013 entered into an agreement with MPP that enabled it to licence generics companies to manufacture and sell paediatric formulations of abacavir.

In 2014, ViiV Healthcare entered into another agreement with MPP, this time to increase access to dolutegravir for adults in all low-income, least-developed and sub-Saharan African countries where the need is greatest. This agreement was extended in April 2016 to add all lower middle income countries, meaning that 92% of adults living with HIV in the developing world are now covered by the licence agreement.7

This extension was of particular importance in four countries, Armenia, Moldova, Morocco and Ukraine, where ViiV Healthcare has a registered patent for dolutegravir. The revised agreement means that dolutegravir and dolutegravir-based fixed-dose combinations could now be made available through generics manufacturers subject to the necessary regulatory approval to benefit an additional 270,000 people living with HIV.

The agreement with the MPP for adults includes two distinct approaches:

• a royalty-free voluntary licence in all least-developed, all low-income and all sub-Saharan African countries

• a tiered royalty licence for lower middle-income countries, where a small percentage of the net sales value is paid according to the gross national income (GNI) per capita

ViiV Healthcare also granted the MPP a voluntary licence for generics manufacturers to develop paediatric formulations of dolutegravir without paying royalties in 121 countries where most (99%) children with HIV live. In addition to the currently approved 50mg tablet for children aged 12 years and older, for the countries set out in the agreement, a commitment for future lower dose tablets* and age-appropriate formulations to meet the needs of younger children with HIV.

MEDICINES PATENT POOL LICENCES

PATENT HOLDERGENERIC

MANURACTURERSPEOPLE LIVING

WITH HIV

LICENCES SUB-LICENCES

ROYALTIES (apply to specifi c middle-income countries only)

MEDICINES

* Including those developed by ViiV Healthcare if and when approved by a major regulatory authority.

ACCESS TO ARV FOR ADULTS: ViiV HEALTHCARE SOLUTIONS– MPP LICENCE AGREEMENT COUNTRIES


Sub-Saharan Africa

Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Cote d’Ivoire, Djibouti, DR Congo, Equatorial Guinea, Egypt, Eritrea, Ethiopa, Gabon, Ghana, Gambia, Guinea, Guinea Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia, Zimbabwe

Asia - PacificBangladesh, Bhutan, Cambodia, East Timor, Fiji, India, Indonesia, Kiribati, Lao People’s DR, Malaysia, Maldives, Marshall Islands, Micronesia, Mongolia, Myanmar, Nauru, Nepal, Pakistan, Palau, Papua New Guinea, Philippines, Dem. People’s Rep. of Korea, Samoa, Solomon Islands, Sri Lanka, Thailand, Tonga, Tuvalu, Vanuatu, Vietnam

AmericasArgentina, Belize, Bolivia, Chile, Colombia, Costa Rica, Cuba, Dominican Rep., Ecuador, El Salvador, Guatemala, Guyana, Haiti, Honduras, Jamaica, Nicaragua, Panama, Paraguay, Peru, Venezuela

Commonwealth of Independent StatesArmenia, Azerbaijan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan

MENAAfghanistan, Algeria, Egypt, Iran, Iraq, Lebanon, Libya, Morocco, Syria, Tunisia, West Bank and Gaza, Yemen

Eastern EuropeGeorgia, Kosovo, Ukraine

ACCESS TO ARV FOR CHILDREN: ViiV HEALTHCARE SOLUTIONS– MPP ROYALTY FREE VOLUNTARY LICENCE COUNTRIES


CONCLUSION

Improving access to HIV medicines is a journey that countries will travel at their own pace given their own needs, capacities and burden of the epidemic. In order to be successful, all countries and relevant authorities must be at the centre of this process, taking the lead in setting direction, developing and executing strategies, as well as monitoring progress and adjusting, if necessary.

ViiV Healthcare’s access strategy is grounded in programmes aiming to scale up access to therapy and care for PLHIV in the most deprived and at-need areas of the world, in support of global health ambitions such as UNAIDS 90-90-90 targets and the elimination of mother-to-child transmission of HIV. ViiV Healthcare recognises that no one category of stakeholder can successfully achieve global access to HIV treatment alone. Stakeholders from all elements of society – government, NGOs and industry need to work together to ensure that all PLHIV have access to HIV medicines and that no patient is left behind.

www.viivhealthcare.com

References1. WHO. HIV/AIDS. Available at: http://www.who.int/hiv/en/. Last accessed: March 20162. WHO. Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV. Available at: http://apps.who.int/iris/bitstream/10665/186275/1/9789241509565_

eng.pdf?ua=1. Last accessed: March 20163. UNAIDS. 90-90-90 report. Available at: http://www.unaids.org/sites/default/files/media_asset/90-90-90_en_0.pdf. Last accessed: March 20164. WHO PMTCT guidelines. Available at: http://www.who.int/hiv/pub/emtct-validation-guidance/en/. Last accessed: March 2016 5. World Bank. How does the World Bank classify countries? Available at: https://datahelpdesk.worldbank.org/knowledgebase/articles/378834-how-does-the-world-bank-classify-

countries. Last accessed: March 2016 6. UN DESA. Least Developed Country Category: 2015 Country Snapshots. Available at: http://www.un.org/en/development/desa/policy/cdp/cdp_ldcs_countryfacts.shtml. Last

accessed: March 20167. UNAIDS. Countries (aggregated data). Available at: http://www.unaids.org/en/regionscountries/countries. Last accessed: May 2016

ViiV Healthcare is also committed to registering its ARVs in all countries where possible. At the end of 2015, dolutegravir was registered in the USA, European Union (via a centralised process) and another 64 countries, with 41 in resource poor settings including 16 in Africa. Regulatory submissions were submitted in another 34 countries, including 18 in the African continent.

ViiV Healthcare and the Clinton Health Access Initiative (CHAI), signed a Memorandum of Understanding (MOU) in 2010, to improve access to ViiV Healthcare ARVs in the poorest areas of the world. As a result of this collaboration, in mid-2015, less than two years after FDA approval of dolutegravir, Aurobindo Pharma submitted an Abbreviated New Drug Application (ANDA) of dolutegravir 50mg to the FDA for use in combination with other ARVs for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40kg. The ANDA was submitted for tentative approval by the FDA to enable Aurobindo’s product to be supplied under the President’s Emergency Plan For AIDS Relief (PEPFAR) programme.

Also as a result of this MOU, in November 2014 Mylan received tentative approval from the FDA to enable supply via the President’s Emergency Plan for AIDS Relief (PEPFAR) for taste masked oro-dispersible paediatric formulations of abacavir/lamivudine developed through the collaboration between ViiV Healthcare and CHAI, where ViiV Healthcare provided technical expertise and paid for the costs of the project.

Additionally, our local partnerships and Positive Action Community Grants to in-country HIV community organisations help to support access to HIV care at the grass-roots level. This includes working with in-country companies to manufacture medicines locally, reducing the cost of therapies while sharing our expertise to build capability and skills in the local economy.

VOLUNTARY LICENCES (IP)

GENERICS MANUFACTURERS

GENERIC MEDICINES

NGOs/PAYERS/GOVT’S

PEOPLE LIVING WITH HIV

ViiV Healthcare has given voluntary licences for our ARVs to 17 generic manufacturers, enabling them to supply our products in countries where 92% of PLHIV live.

2.VIA NGO PARTNERS

1.DIRECT


NOTES


ViiV HEALTHCARE’S ACCESS TO MEDICINES STRATEGY€¦ · founded in 2010 to increase access to HIV...

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