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The Patent Amendment Ordinance passed by the Indian government on December 26, 2004, seriously compromises people’s ability to access affordable medicines, states the Affordable Medicines and Treatment Campaign
The Affordable Medicines and Treatment Campaign (AMTC) has expressed its concern over the Patent Amendment Ordinance promulgated on December 26, 2004 by the Indian government.
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.
An AMTC press release states:
“The provisions of the Patent Amendment Ordinance contradict the National Common Minimum Programme and seriously affect the constitutional right to health and life.As per the Common Minimum Programme, the UPA government promised, ‘to take all steps to ensure availability of life-saving drugs at reasonable prices’.
“Despite the detrimental effect that the TRIPS agreement is going to have on its citizens’ right to health, India has to a large extent already implemented its obligations under TRIPSby amendments to the Patents Act 1970 introduced in 1995 and 2002. These amendments effectively provide protection for both product and process patents, extend the period of protection from seven to 20 years, set up the mail box facility for product patent applications and provide for the granting of Exclusive Marketing Rights in the interim period between 1.1.95–1.1.2005. Compulsory licences have also been incorporated with all the required safeguards. Thus the only amendment required to be made by the government to comply with TRIPS are minimal amendments which are required to process product patent applications.
“However ‘TRIPS-PLUS’ standards are being introduced through the Patent Amendment Ordinance that takes India way beyond the commitments agreed to under the multilateral agreement of TRIPS governed by the WTO.The Third Patent Amendment Bill was to be tabled in Parliament by the UPA government during the winter session (December 2004). However, due to concerns being raised by members of the government and civil society the UPA government failed to introduce the proposed Bill. The government has now amended the Patent Act by converting the draft bill into an Ordinance and avoided all informed public debate on the issue (a copy of the Ordinance is available at http://lawmin.nic.in/Legis.htm and is reproduced on this website also). The ordinance route of amending law allows no public debate on an issue of vital public interest and falls short of the transparency requirement of a democratic government.Public Interest Groups working on health are gravely concerned that India through the Third Patents Amendment Bill and now the Ordinance will trade away its rights to protect the public health of people who need access to low-cost, quality generic medicines. The Ordinance in its present form seriously compromises people’s ability to access affordable medicines.
“Objections Against the Ordinance -- Why is the Ordinance TRIPS PLUS?
- The Ordinance extends the scope of patentability beyond the TRIPS requirements by amending Section 3(d) of the Patents Act to provide patents to new use of known medicines. There is no obligation under TRIPS to provide a patent to either new use or new dosage of known medicines. (Pg 2 of the Ordinance)
- The Ordinance has limited the right of pre-grant opposition. The objector is no longer treated as a party, and will not have the right to participate in all the proceedings in the grant of the patent. At the most a written representation is allowed. There is no obligation under TRIPS to change the pre-grant opposition procedure. Currently there are approximately 6,000 applications for patents pending in the mailbox. In the absence of an effective pre-grant opposition mechanism, these 6,000 applications would escape public scrutiny. Pre-grant opposition is absolutely essential for blocking trivial patents (Pg 9 of the Ordinance).
- The compulsory licence regime within the present Patents Act contains cumbersome procedures without any time line for the final disposal of the application. Issuing compulsory licences for various products is quite common in the developed countries, but it has seldom been done in developing countries like India . Therefore for the effective working of the compulsory license mechanism, procedures provided for compulsory licensing need to be simplified.
- The Ordinance requires compulsory licensing by an importing country with no or insufficient manufacturing capacity in the pharmaceutical sector. In this case, the Indian drug companies would not be able to export to Least Developing Countries (LDCs) in the absence of a compulsory licence granted by the LDC. This provision only helps Multi-National Pharmaceutical Companies who want to block generics from entering countries that desperately need cheap drugs (Pg 16 of the Ordinance).
“The people at large, as an affected party, have a right to be consulted and heard. Neither the contents of the Patent (Amendment) bill nor the text of the Ordinance were made public until the Ordinance was promulgated on December 26, 2004 .The AMTC protests the manner in which the government is circumventing democratic participation in passing of this law and demands that a transparent public debate be initiated on the provisions of the Ordinance and proposed Bill. AMTC also demands that ‘TRIPS-PLUS’ provisions be removed from the proposed Bill/Ordinance as vital concerns of the Indian people i.e. their health interests should supersede the profit motives of MNCs.”
For more information contact the Affordable Medicines and Treatment Campaign.
The Affordable Medicines and Treatment Campaign (AMTC)
C/o Lawyers Collective HIV/AIDS Unit
Address: 63\2 Masjid Road , Jungpura, Delhi 110 014
Phone no: 011 24321101/2
Email:
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Contact person: Leena Menghaney, 9811365412
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