Gilead Sciences has become the first pharmaceutical company to sign a licensing agreement with the Medicines Patent Pool to increase access to HIV and Hepatitis B treatment in developing countries.
"Today marks a milestone in managing patents for public health. The licence agreement with Gilead Sciences will help make medicines available at a lower cost and in easier-to-use formulations without delays," Ellen 't Hoen, executive director of the Medicines Patent Pool, said in a statement.
The agreement allows for the production of several of Gilead's HIV medicines, including tenofovir and emtricitabine, as well as two integrase inhibitors, which block retroviral replication, cobicistat and elvitegravir (both still in development), and combinations that include these medicines. Tenofovir is also licensed to treat Hepatitis B.
"People in developing countries often have to wait for years before they can access new health technologies. Today's agreement changed that," Hoen said.
The licences will allow for the supply of tenofovir and emtricitabine in 111 countries, for cobicistat in 102 countries, and for elvitegravir and the combination drug, Quad, in 99 countries.
The Medicines Patent Pool, established in 2010 by the international health financing mechanism, UNITAID, aims to stimulate innovation and improve access to HIV medicines through the negotiation of voluntary licences on medicine patents that enable generic competition and facilitate the development of new formulations. The US National Institutes of Health was the first patent holder to join the pool when it licensed the life-prolonging antiretroviral (ARV), darunavir, in October 2010.
An estimated 6.6 million people have access to ARV treatment; 1.6 million of these are taking generic or branded Gilead HIV medicines.
"Reservations"
"The licensing agreement is a positive step but we have some reservations; it excludes middle-income countries like Brazil and China, which will now have to issue compulsory licences if they want to manufacture the drugs still in development," Tido von Schoen-Angerer, executive director of Médecins Sans Frontières' Campaign for Access to Essential Medicines, told IRIN/PlusNews.
In addition, MSF says the licensing agreement limits "price-busting competition" by confining manufacturing to India, meaning narrow supply options for active pharmaceutical ingredients needed to make the drugs.
"This is a more managed form of competition where countries with the ability to produce drugs - such as Brazil - have been left out," Von Schoen-Angerer said. "We hope that in the future, the patent pool will be able to improve the agreements to allow for production and sourcing of raw materials from different countries."
According to Chan Park, general counsel of the Medicines Patent Pool, while the agreement is not perfect, it is an exciting and encouraging start for the pool.
"Certainly some of these issues can be improved, and during our negotiations we ensured that those countries excluded from the agreement would be able to use non-voluntary methods - such as compulsory licences - to access the drugs," he told IRIN/PlusNews. "Regarding the choice of India for manufacture, India already manufactures about 90 percent of the world's generic drugs; its generic industry is very competitive.
"We are actively involved in negotiations with other pharmaceutical companies and hope to see progressive improvements in the terms and conditions of the licences in effect," he added. "Today's licence should be seen as a floor and not a ceiling."
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"Today marks a milestone in managing patents for public health. The licence agreement with Gilead Sciences will help make medicines available at a lower cost and in easier-to-use formulations without delays," Ellen 't Hoen, executive director of the Medicines Patent Pool, said in a statement.
The agreement allows for the production of several of Gilead's HIV medicines, including tenofovir and emtricitabine, as well as two integrase inhibitors, which block retroviral replication, cobicistat and elvitegravir (both still in development), and combinations that include these medicines. Tenofovir is also licensed to treat Hepatitis B.
"People in developing countries often have to wait for years before they can access new health technologies. Today's agreement changed that," Hoen said.
The licences will allow for the supply of tenofovir and emtricitabine in 111 countries, for cobicistat in 102 countries, and for elvitegravir and the combination drug, Quad, in 99 countries.
The Medicines Patent Pool, established in 2010 by the international health financing mechanism, UNITAID, aims to stimulate innovation and improve access to HIV medicines through the negotiation of voluntary licences on medicine patents that enable generic competition and facilitate the development of new formulations. The US National Institutes of Health was the first patent holder to join the pool when it licensed the life-prolonging antiretroviral (ARV), darunavir, in October 2010.
An estimated 6.6 million people have access to ARV treatment; 1.6 million of these are taking generic or branded Gilead HIV medicines.
"Reservations"
"The licensing agreement is a positive step but we have some reservations; it excludes middle-income countries like Brazil and China, which will now have to issue compulsory licences if they want to manufacture the drugs still in development," Tido von Schoen-Angerer, executive director of Médecins Sans Frontières' Campaign for Access to Essential Medicines, told IRIN/PlusNews.
In addition, MSF says the licensing agreement limits "price-busting competition" by confining manufacturing to India, meaning narrow supply options for active pharmaceutical ingredients needed to make the drugs.
"This is a more managed form of competition where countries with the ability to produce drugs - such as Brazil - have been left out," Von Schoen-Angerer said. "We hope that in the future, the patent pool will be able to improve the agreements to allow for production and sourcing of raw materials from different countries."
 Certainly some of these issues can be improved... Today's licence should be seen as a floor and not a ceiling |
"Certainly some of these issues can be improved, and during our negotiations we ensured that those countries excluded from the agreement would be able to use non-voluntary methods - such as compulsory licences - to access the drugs," he told IRIN/PlusNews. "Regarding the choice of India for manufacture, India already manufactures about 90 percent of the world's generic drugs; its generic industry is very competitive.
"We are actively involved in negotiations with other pharmaceutical companies and hope to see progressive improvements in the terms and conditions of the licences in effect," he added. "Today's licence should be seen as a floor and not a ceiling."
kr/mw
This article was produced by IRIN News while it was part of the United Nations Office for the Coordination of Humanitarian Affairs. Please send queries on copyright or liability to the UN. For more information: https://shop.un.org/rights-permissions
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