Letter to Pranab Mukherjee on Patents Amendment Bill

[Guest guest]

Hi

Please find bleow the copy of AMTC's letter to the Chairperson of the Group of

Ministers on Patent (Amendment Bill).

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

e-MAIL: <aidslaw@...>