The US-based Health GAP (Global Access Project), an advocacy organization fighting for access to affordable HIV treatment in developing countries, has expressed grave concern over the proposed amendments to the Indian Patent Act. The Health GAP felt that the changes would 'vitiate the future of medicines access for people in need-in India and around the world.'

In a letter, addressed to the Prime Minister, Asia Russell, director, International Policy of Health GAP called for a transparent process for the consideration of amendments to the Patents Act. "We are extremely troubled by rumours that the Patents Act will be amended by Ordinance, which will eliminate the opportunity for the public to comment on and influence the amendment process," the letter said.

Health GAP has requested the PM to have in place a pre-grant opposition procedure in the Act. "This procedure permits opposition to patent applications the public feels are frivolous, protecting consumers against high prices on non-innovative pharmaceutical products under consideration for patent protection. The pre-grant opposition procedure aids in protecting India from wasting limited resources conferring monopoly rights on products that do not warrant patent protection," they explained.

Simplification and streamlining of India's compulsory licensing procedure was the other demand put up by the Organisation. "Routine issuance of compulsory licenses after January 1, 2005 in India is critical if the rapid entry of generic versions of important pharmaceuticals is to continue. However, compulsory licensing in India is unnecessarily cumbersome and time consuming. The Indian regime for compulsory licensing must be reformed to facilitate routine and expedited compulsory licensing of important medicines. A strictly enforced deadline of one to three months should be established for the grant of a compulsory license, and rights of appeal should not include permission for injunctive relief that would impede the use of the license," the letter stated.

Removal of provisions for new-use or second-use patents, currently described in Section 3(d) of the Patents Act was also demanded. "TRIPS does not require the granting of additional patents for new uses or new dosage forms for known medicines. New use or second use patents do not reward or encourage true innovation; they will however increase the cost of important medicines, compromise patient access, and extend monopolies over a longer period of time. Many of the pharmaceutical patent applications filed in India's patent 'mailbox' are patent requests for second- or new-uses," it said.

The organisation also wanted full implementation of the decision of the WTO General Council (on the implementation of paragraph 6 of the Doha Declaration) for countries that lack sufficient domestic pharmaceutical manufacturing capacity (the "August 30th Decision").

Stating the current position, the organisation points out, "The draft amendment to the Patents Act would not permit export of compulsorily licensed medicines from India without a compulsory license granted in the importing country. Countries, that need to import a low-cost generic medicine produced by compulsory license in India, but do not have a patent for the compulsorily licensed medicine in force, would not be allowed to import compulsorily licensed medicines exported by India, even though the August 30th Decision clearly permits this."

The dramatic change to India's patent regime that will take place by January 1, 2005 will effectively eliminate a major source of supply of generic versions of new medicines for importing countries, while also jeopardizing access for Indians in need of affordable treatment, Health GAP fears.

The copies of the request have also gone to ministers of chemicals and fertilizers, commerce and industry, health and family welfare, US
Ambassador to India, director, UNAIDS and director general, World
Health Organization.

Health GAP is an organization of US-based AIDS and human rights activists, people living with HIV/AIDS, public health experts, fair trade advocates and concerned individuals who campaign against policies of neglect and avarice that deny treatment to millions and fuel the spread of HIV. The organisation stands for eliminating barriers to global access to affordable life-sustaining medicines for people living with HIV/AIDS as key to a comprehensive strategy to confront and ultimately stop the AIDS pandemic. It believes that the human right to life and to health must prevail over the pharmaceutical industry's excessive profits and expanding patent rights.