The Affordable Medicine and Treatment Campaign (AMTC) has expressed serious reservations against the third Amendment Patent Bill in its present form. In a representation made to the Group of Ministers who is looking into implications of the contentious issues in the Bill, AMTC, warned that the Bill proposes to extend the scope of patentability beyond the TRIPS requirements by amending Section 3 (d) to permit new use patents.

"There is no requirement under TRIPS to provide patent protection to new use of known drugs. The Mashelkar Committee had recommended restricting the patent protection only to new chemical molecules. Secondly, the Bill proposed to do away with the pre-grant opposition procedure. Currently, there are approximately 5000 applications pending in the mailbox. In the absence of pre-grant opposition, these 5000 applications would escape much needed public scrutiny. Public scrutiny becomes crucial in light of the fact that less than 500 drugs have been granted marketing approvals in India between 1995-2004," they said.

The AMTC pointed out that the Bill has not properly incorporated the August 30th Decision, which permits the grant of compulsory licence for export purposes. "The Bill proposes to permit compulsory licensing for export purpose if there is a compulsory license in the importing country having no or insufficient manufacturing capacity in the pharmaceutical sector. This ignores the fact that in many instances, there may not be any patent protection in the importing country because the time line for Least Developing Countries (LDCs) to comply with TRIPS is 2016. In that event, the Indian drug companies would not be able to export to LDCs in the absence of a compulsory licence granted by the LDC," they have noted.

AMTC also feels that the Bill fails to revamp the compulsory licensing mechanism. "The compulsory licence regime within the Patents Act contains cumbersome procedures without any time line for the final disposal of the applications. All these have serious and adverse ramifications for public interest and security of the country.

According to AMTC, the government views the issue of patent law only as a trade issue between Indian drug companies and foreign companies and not a health issue concerning the public as a whole and civil society in particular. As a result, with a few exceptions the civil society participation is negligible in intellectual property related law and policy-making. "This has resulted in the marginalisation of human rights concerns in the intellectual property law and policy. Therefore we think that civil society groups working on intellectual property, food and health issues should be consulted and heard before finalising any decision on the third amendment because people at large, as an affected party, have a right to be consulted and heard," they said.

AMTC is a national campaign aimed at creating an environment that will ensure sustained accessibility and affordability of medicines and treatment for every individual in India, including access to affordable Anti-Retroviral Therapy for persons living with HIV/AIDS. It consists of civil society organisations, NGOs, patients groups, healthcare providers and concerned individuals. The campaign was initiated in 2001.