Certain clauses in the Bill threaten to delay the entry of affordable generic products in the market
The
Bill has the potential to create legal monopoly for agrochemicals and
pesticides, making them unaffordable to small farmers ( Credit: Meeta
Ahlawat)While the Centre failed to introduce the
Pesticides (Amendment) Bill, 2008, in the budget session of the
Parliament, which adjourned sine die on Wednesday, a clause in the text
of the Bill poses a definite threat to India’s existing patent regime.
The pesticides Bill, which is supposed to replace the existing
Insecticides Act, 1968, includes “data exclusivity” (DE) for
agrochemicals which would delay the entry of affordable generic products
in the market.
However, the introduction of DE has been a long-pending demand of
multinationals, besides the removal of section 3(d) of the Indian Patent
Act, 1970, which bars them from extending unwarranted patents.
Why is DE undesirable?
Multinationals have been pushing for exclusive rights to
pharmaceutical test data submitted by them to drug regulation
authorities. It is a must for agrochemicals and pesticides companies to
submit data on the safety and efficacy of a new product to regulatory
authorities.
If multinationals get exclusive rights, then they can keep data
regarding a drug’s safety and efficacy confidential for almost five
years.
According to experts, this will block competition because generic
manufacturers, even if they want to register a drug, will not be allowed
to show that their products are therapeutically equivalent to
originator products.
Talking to Down To Earth, Medecins Sans Frontieres’ (MSF) Leena
Menghaney said that if any product is given patent on data exclusivity,
no approval to any other generic version can be granted for the next
five years.
“This is even if the competitor proves that the physico-chemical
attributes are equivalent to those of the first applicant’s product,”
she added. MSF ensures the availability of medicines to the poor.
Earlier, secretary general of the Indian Pharmaceutical Association D
G Shah had alerted about the government’s plan to introduce the Bill
this session.
In a note written on a website dedicated to patents issues, he said,
“The Bill has a provision that not only makes India’s Intellectual
Property (IP) regime TRIPS plus, but would also eliminate competition
and create legal monopoly for agrochemicals and pesticides, making them
unaffordable to small farmers. The Bill proposes to introduce Data
Exclusivity for a period of five years.”
The Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS Agreement) sets the standards for intellectual property
protection in the world today.
It came into force on January 1, 1995 and is binding on all members
of the World Trade Organization (WTO). But nowadays, many developing
countries are being pressurised to adopt TRIPS Plus, a step beyond
TRIPS.
If India were to go TRIPS Plus and introduce data exclusivity for
agrochemicals, pesticides and medicines, farmers and poor patients will
be denied access to affordable products.
Experts say this is not an unexpected development. In the past few
years, US multinationals, backed by their government and the United
States Trade Representative (USTR), have been seen pushing the Indian
government to grant patent on DE for agrochemicals and pharmaceutical
products.
Experts have highlighted that granting DE would amount to a TRIPS
Plus agreement, which will adversely affect farmers and reduce access to
medicines in India.
The Bill was introduced by the previous government in which DE for
agrochemicals was included. The Bill is still pending in the Rajya
Sabha. The new government is under pressure from the US on introducing
it, according to experts.
