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Dolutegravir to cover all lower middle-income countries

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Elijah Amooti
Posts: 158
Dolutegravir to cover all lower middle-income countries
Posted on: April 27 2016, 03:04 pm


ViiV Healthcare extends Medicines Patent Pool licence agreement for dolutegravir to cover all lower middle-income countries
Follows announcement by majority shareholder GSK to expand graduated approach to patents and intellectual property (IP) to widen access to medicines in the world’s poorest countries
London, 25 April 2016 – ViiV Healthcare, a global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced an extension of overall country coverage of its existing licence agreement for adults formulation of dolutegravir to the Medicines Patent Pool (MPP) to cover all lower middle income countries (LMICs).
The existing licence agreement already covers all low income, least developed and all sub-Saharan African countries. This extension to include all remaining LMICs means that more than 94% of adults living with HIV in the developing world are now covered by the licence agreement.[1]
This is 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 generic manufacturers subject to the necessary regulatory approval to benefit an additional 270,000 people living with HIV.[2],[3],[4],[5]

“Our existing collaboration with the MPP is now strengthened through this expansion of the territory coverage of our licence agreement. This is a good example of how we work with global partners to deliver on our commitments to improving access as we continue making good progress to ensure innovative medicines like dolutegravir can be available to more people living with HIV, in particular in those countries where the need is most pressing,” said Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare.
This announcement is aligned to GSK’s recent commitment to seek to offer and agree licences to allow supplies of generic versions of its current and future portfolio of patented medicines in most LMICs for 10 years

Sir Andrew Witty, Chief Executive Officer, GSK commented: “This is another very positive step by ViiV Healthcare to help accelerate access to the newest HIV medicines for more people in developing countries. It builds on the recent changes GSK has made to adopt a graduated approach to IP linked to a country’s wealth. IP protection remains vital to provide the necessary incentives for investment in research to create new treatments, such as dolutegravir. However, we believe that the global healthcare challenges we all face require us to be flexible in our approach, where appropriate. The positive progress and experience we have had with the Medicines Patent Pool gives us confidence that increasing access, incentivising innovation and achieving business success can go hand in hand.”

ViiV Healthcare entered in a licence agreement with the Medicines Patent Pool in 2014 to increase access to dolutegravir for children and adults in countries where the need is the greatest. 
The collaboration with the MPP in 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 some middle-income countries, where a small percentage of the net sales value is paid according to the gross national income (GNI) per capita



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