Indian pharma major Cipla has expressed apprehensions on achieving the goal of the UNITAID's patent pool initiative, which was recently created for HIV/AIDS drugs, unless and until the terms and reference, objectives and all issues of patent pool are spelt out clearly.

“We are convinced that the patent pool will not benefit anyone unless the UNITAID spells out in unambiguous terms the names of all the participating countries, royalty terms and the mechanism to ensure that only meaningful and workable valid patents are included in the patent pool, etc”, Cipla in a letter to the UNITAID said.

In its meeting recently, the board of UNITAID had voted to approve the patent pool for HIV/AIDS drugs, opening the door for greater development and production of desperately needed antiretrovirals (ARVs). Lowering intellectual property barriers on ARVs and allowing for the production and sales of generic versions of the drugs in resource-poor countries will help make the drugs affordable to the people who need them the most, and has the potential to save millions of lives.

In the letter, Cipla has raked up several issues with UNITAID to make the patent pool workable and realistic. Apart from taking objections for leaving out drugs required for TB and Malaria from the patent pool, Cipla also took cudgels with the world body for not clearly mentioning the names of the countries and the so-called stakeholders. “Just mentioning developing countries is not adequate”, the letter said.

Other issues raised by Cipla include the royalty terms and related issues which were not mentioned by UNITAID, and the products. A list of potential products have been named, but there is no mention that the originator patent holders have agreed to their products being included in the patent pool, Cipla said.

It also said that most of the potential products mentioned are already free of patents in almost all the developing countries including India. Hence country -specific patents have to be incorporated in the pool. And there has been no clarity and commitment to include only meaningful, valid and workable patents in the patent pool, Cipla said in the letter.

According to early estimates, the patent pool could also save over $1,000,000,000 a year. The voluntary initiative will ‘pool’ drug patents, allowing generic manufacturers to produce affordable versions of HIV drugs and to develop essential new fixed-dose combination and child-friendly drugs. In return the generic manufacturers pay a fair royalty payment to the originator pharmaceutical company.

UNITAID was founded in 2006 with the goal of reducing the world’s burden of the HIV/AIDS, TB, and malaria in middle- and low-income countries. Currently, 93 countries receive UNITAID funding. The founding countries of UNITAID were Brazil, Chile, France, Norway and the United Kingdom.