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Public interest groups call for moratorium on pacts by patent pool with Indian generic companies
Joseph Alexander, New Delhi | Thursday, October 13, 2011, 08:00 Hrs  [IST]

Even as Aurobindo Pharma became the first major generic drug maker to join the Medicines Patent Pool that was set up by the UNITAID to bring down prices of HIV/AIDS drugs, a coalition of civil society organisations across the world has called for renegotiation of licence agreement with Gilead and moratorium on agreements with Indian generic producers until a model can be created.

A host of public interest organisations have joined this coalition that has written to the UNITAID and the Medicine Patent Pool (MPP). The petition followed a meeting of the organisations with the MPP recently.

Meanwhile, Aurobindo Pharma has become the first major generic drug maker to gain royalty-free production and supply rights for five AIDS medicines through an agreement with Pool. The company will sell these medicines in 18 developing countries at a price less than that of the innovator’s products, as per the agreement.

“We have concluded that many of the concerns raised regarding the license agreement with Gilead Sciences, Inc. (Gilead) brokered by the MPP were not clarified or addressed to our satisfaction. In general, we believe that the agreement fails to uphold the MPPF’s core and essential mandate to negotiate agreements that substantially increase affordable access to medicines for people living with HIV (PLHIV) around the world,” the organisations said in the letter.

“The MPPF, in conjunction with UNITAID, its founding partner, should substantially revise or terminate the MPPF-brokered license agreement with Gilead, including any potential or pending agreements with sub-licensees, given Gilead’s bad faith and the controversial terms of the MPPF-Gilead agreement. It should institute an immediate moratorium on negotiations of any new license agreements, including any new or pending agreements with Indian generic producers (potential sub-licensees to the MPPF-Gilead agreement) or with other multinational drug companies (potential new licensors) until such time as standard terms and conditions or a model agreement is agreed to,” the letter said.

The coalition also asked for re-evaluation of the current structure of the MPPF, including its governance and administration, goals and mission, and implement comprehensive reforms designed to enhance its transparency, accountability and adherence to core principles of health equity.

Among the community-based and non-governmental organizations are the International Treatment Preparedness Coalition (ITPC), the Initiative for Medicines, Access & Knowledge (I-MAK), the Lawyers Collective HIV/AIDS Unit (India), Grupo de Trabalho em Propriedade Intelectual da Rede Brasilieira de integração dos Povos (GTPI/REBRIP), the People’s Health Movement (PHM), the Asia-Pacific Network of People Living with AIDS (APN+), as well as organizations and activists working on HIV and access to medicines from India, Thailand, Central America, and North Africa.

According to the agreement between MPP and Aurobindo Pharma, the Indian company would  manufacture products licensed to the Pool by Gilead Sciences in July: emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG), and the fixed-dose combination of these medicines known as the Quad (a combination of FTC, COBI, EVG, and tenofovir).

Comments

Kaitlin Mara Oct 13, 2011 8:23 PM
Just a few points of clarification: the agreement between Aurobindo and the Pool covers much more than 18 developing countries -- it is 112 for emtricitabine, 103 countries for cobicistat and 100 for elvitegravir and the Quad.

Aurobindo has chosen to take advantage of one of the flexibilities negotiated into the Pool's licences in order to allow it to sell tenofovir royalty-free and to a larger number of countries.

The licences are also royalty free for paediatrics, but there is a royalty of 3-5% on other products.

We have published a Q&A on the licences with Gilead for those interested in learning more. It is here: http://www.medicinespatentpool.org/LICENSING/Current-Licences/Medicines-Patent-Pool-and-Gilead-Licence-Agreement/Q-and-A-Gilead-Licences

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