PHA-Exchange> AMTC Letter to the chairperon of Group of minister on Patents Amenment Bill , India

[AMTC India]

8th September 2004



Mr. Pranab Mukherjee 

Hon’ble Minister of Defence

Room No. 104, South Block,

New Delhi 110 001



Dear Mr. Mukherjee



Sub: Group of Ministers (GoM) on the Patent Amendment Bill 



Affordable Medicine and Treatment Campaign (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 with the following mission statement: 



The right to life and health is a fundamental right guaranteed to every person living in India and is non-negotiable. This campaign aims to demand and create 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. This campaign shall be democratic and participatory. It will seek the mobilization of communities and civil society to make state, national and international agencies and industry accountable for securing health for all.



The AMTC attempts to encourage action on a wide spectrum of issues relating to the right to treatment. These include WTO negotiations relating to the TRIPS agreement (TRIPS), the impending amendment to Patents Act, law and regulation of drug pricing, national and state level governmental policies relating to health including vertical disease programmes, health needs of the population, transparency and accountability in the pharmaceutical sector, treatment literacy and health care infrastructure and capacity etc. 



We have learned from the newspaper reports that Cabinet has referred the Patent Amendment Bill to a Group of Ministers (GoM) consisting of Defence Minister, Health Minister, Human Resources Minister and Commerce Minister. According to the reports the intention of the referral is to study and report back to the Cabinet about the implications of the contentious issues in the third Patents Amendment Bill. We also have unconfirmed reports that the Bill before the Group of Ministers is identical to the third Amendment Bill introduced in the last Lok Sabha in December 2003. If that is the case, we have serious concerns about the contents of the Bill. The main concerns raised by public interest groups against the third Amendment Bill are as follows.



Firstly, 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 6000 applications pending in the mailbox. In the absence of pre-grant opposition, these 6000 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. Thirdly, 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. Lastly, 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.



Further we feel that Government views the issue of patent law only as a trade issue between Indian drug companies and foreign companies 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. Hence, we would request you to give us an opportunity to place our views on the Third Amendment Bill along with other interested groups and individuals.



Hope to hear from you soon in this regard



Thanking you



For AMTC

Anand Grover

Lawyers collective HIV/AIDS Unit


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