Viiv announces new collaborations to improve access to HIV medicine

ViiV Healthcare this week announced new collaborations with the goal of increasing access to its HIV medicine, dolutegravir (marketed under the name Tivicay®), just two months after its approval by the European Medicines Agency (EMA) and eight months after approval by the US Food and Drug Administration (FDA). 


In a statement made available to HealthNewsNG.com it said through an agreement with the Medicines Patent Pool (MPP), ViiV Healthcare will accelerate access to dolutegravir where the need is the greatest, in the countries where 99% of children and 93.4% of adults with HIV in the developing world live. 

“Our new collaborations prioritise dolutegravir access for millions of children and adults with HIV, and represent another step in our ongoing commitment to improving access and delivering innovation in the areas of highest unmet need,” said Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare.  

“We recognise that important new agents have the potential to make a real difference in resource poor settings.  In fact, the World Health Organization has recently cited dolutegravir as a development priority for future anti-retroviral treatments for children–it is currently approved for children 12 years and older. Therefore, accelerating access to medicines like dolutegravir is of the utmost importance.”


Licence to the Medicines Patent Pool 

In adults: The collaboration with MPP includes two distinct approaches to improve access for adults living with HIV in the developing world:  first, a royalty-free voluntary licence in all least-developed, all low-income and all sub-Saharan African countries; second, for specific middle-income countries including India, ViiV Healthcare has established the first-ever MPP licence with a tiered royalty structure, where a small percentage of the sale price is paid based on the gross domestic product (GDP) of the specific country. The licences will also allow for the possible development, manufacture and supply of dolutegravir-based fixed-dose combinations, including those with abacavir, if and when approved by local regulatory agencies.

Supporting children living with HIV: ViiV Healthcare will grant MPP a voluntary licence for generic manufacturers to develop paediatric formulations of dolutegravir without paying a royalty in 121 countries where most (99%) children with HIV live. Dolutegravir is currently approved for patients 12 years and older.  However, this licence also includes a commitment for future lower dose tablets and age-appropriate formulations developed by ViiV Healthcare to meet the needs of younger children with HIV, if and when approved by a major regulatory authority.   

Today’s announcement complements an earlier voluntary licence for dolutegravir signed in 2013 with Aurobindo Pharma for adults and children for our standard voluntary licence territories. 

Our Approach to Improving Access: ViiV Healthcare is committed to improving access to medicines for people living with HIV through a variety of approaches, based on the differing needs of people living with HIV in different parts of the world.

•          Royalty-free voluntary licences in those countries with the lowest incomes and/or hardest hit by the global epidemic: In 2010 ViiV Healthcare extended its royalty-free voluntary licensing policy, which includes the company’s existing portfolio in all least-developed, all low-income and all sub-Saharan countries; home to 25 million people living with HIV (i.e., 75% of people living with HIV worldwide). These licences facilitate the manufacture and sale of low-cost versions of the company’s medicines in those countries most affected by HIV and least able to pay for treatment and care. 

•          Flexible pricing and local partnerships with generics manufacturers in middle-income countries (i.e., emerging and newly industrialised economies): In countries where incomes are higher and infrastructure is more developed, the flexible pricing policy factors in the GDP and the impact of the epidemic in each country to improve affordability. Local partnerships are approached on a case-by-case basis, taking into account the local needs and situation. One key approach is creating partnerships with in-country pharmaceutical companies to manufacture medicines locally in order to bring costs down, while simultaneously investing resources and expertise to build skills in the local economy. 

Our Commitment to Children Living with HIV: Approximately 3.3 million children are living with HIV worldwide, but 66% of those needing treatment do not have access to appropriate care and medicines. Among several barriers preventing further scale up of the numbers of children on treatment is the lack of low-cost medicines that are palatable and acceptable for use by children. 

ViiV Healthcare is committed to improving scientific understanding and treatment options for infants and children living with HIV. This includes a broad range of initiatives supported through our Paediatric Innovation Seed Fund, which aims to improve paediatric HIV research, care and treatment in resource-limited settings. Additionally, the Positive Action for Children Fund supports 150 organisations across 30 countries to deliver programmes designed to prevent mother-to-child transmission of HIV.