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Global Network of People Living with HIV (GNP+) - www.gnpplus.net

MPP license with ViiV: better, but still not good enough

March 1, 2013 - The Medicines Patent Pool (MPP) and ViiV Healthcare, a joint venture between Pfizer and GSK, have announced an agreement to license a patent for paediatric abacavir - a drug recommended by the World Health Organization in its 2010 Guidelines for treatment of infants and children as an alternate Nucleoside Reverse Transcriptase Inhibitor (NRTI) in first-line treatment.

"We welcome ViiV Healthcare's commitment in making its drug available to generic producers through the MPP and its willingness to jointly seek out partnerships with third parties for the development of much needed fixed-dose combinations for children and infants living with HIV," said Anuar Luna , the Co-Chair of the Board of GNP+. "It is our hope that the Memorandum of Understanding, signed between the MPP and ViiV Healthcare, will set a higher standard[1] for the future collaboration for paediatric HIV product development," he added.

"However, we also recognise that the ViiV Healthcare agreement has shortcomings with respect to geographical scope, as the middle-income countries such as Brazil, China, Mexico, Peru, Venezuela, Uruguay, Ukraine as well as Russia continue to be excluded from the licence agreement, leaving out approximately 47,000 children living with HIV globally,"[2] said Dr. Kevin Moody, the CEO of GNP+. "Despite the fact that access to abacavir for children living with HIV could be improved, we regret that the adult formulation of the same drug is not included in the licence and will be off-patent only after 2018 in many countries," he added.

Affordability remains an issue with abacavir due to the patent monopoly held by GSK. For example, the current lowest generic price per patient per year for abacavir 300mg tablet is still more than double the lowest generic price per year of tenofovir (TDF) 300mg and zidovudine (AZT) 300mg. [3] While the patent on the abacavir compound has expired, there remain several patents for hemisulfate salt of abacavir and adult formulations of abacavir-based combinations with lamivudine or zidovudine/lamivudine in several countries.

"This licence shows improvement as compared to the MPP's earlier licence with Gilead[4] and to some extent meets some of the standard of access maximizing provisions for the terms and conditions of voluntary licences.[5] While at this time the announcement by the MPP and ViiV Healthcare seems promising, a proper analysis is needed to assess the figures of 98.7% coverage under the recently negotiated patent licence and the potential impact for future paediatrics."

Dr. Moody further noted: "We want to call on ViiV Healthcare to immediately include post regulatory approval, a binding licence agreement for those antiretrovirals still in the pipeline, such as once-daily dolutegravir, including its combination with abacavir/ lamivudine and other ARVs for adult use, such as zidovudine, lamivudine, fosamprenavir and maraviroc that are currently under negotiation."

"We urge additional public and private patent holders to explore voluntary licences with the Medicines Patent Pool as one of many innovative ways to help improve the availability of medicines in developing countries," said Dr. Moody. "The priority focus should also be on scaling up access to lifesaving drugs for people living with HIV and key populations in low, middle-income countries who face socio-economic inequalities and can not afford to pay for the drugs."

###

[1]This also includes the licensing of products still in clinical development, formulation development and technology transfer, access to ViiV's regulatory data and the commitment by ViiVHealthcare and the MPP to jointly seek out collaboration with third parties holding relevant intellectual property for needed pediatric FDCs that could help draw other companies into negotiations with the MPP

[2]Highestimates, according to the WHO 2010 update on HIV epidemic, 2010 p 195 - 197.

[3]Untanglingtheweb, Medicines Sans Frontieres

[4]For example, no royalties, the expanded geographic scope, less restriction on manufacture and sale of both active pharmaceutical ingredient (API) and finished product, and prevention of further data exclusivity rights.

[5]'The guiding principles and access maximizing provisions for terms and conditions' were agreed by global treatment activists at the meeting organised by the Treatment Action Campaign, SECTION 27 and the MPP last year in Johannesburg.

Source: The Global Network of People living with HIV (GNP+)

The Global Network of People living with HIV (GNP+) is the global network for and by people living with HIV. GNP+ advocates to improve the quality of life of people living with HIV. Driven by the needs of people living with HIV worldwide, GNP+ supports people living with HIV through their organisations and networks. GNP+ works to ensure equitable access to health and social services, by focusing on social justice, rights and more meaningful involvement of people living with HIV in programme and policy development - the GIPA principle. www.gnpplus.net

More information please contact
GNP+ Martin Stolk, Communications officer,
by email communications@gnpplus.net )
or phone +31-20-423 4114


"Reproduced with permission - Global Network of People living with HIV (GNP+)"

Global Network of People living with HIV (GNP+)
www.gnpplus.net


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