Biosafety Guidelines
Due to the growing concerns arising from
Genetically Modified Organisms (GMOs) throughout the globe the WHO has built an
informal working group on biosafety in 1991. This group prepared the ‘voluntary
code for the release of organisms into the environment’. ICGEB (International
Centre for Genetic Engineering and Biotechnology) has played a significant role
in issues related to biosafety and the environmentally sustainable use of
biotechnology. The main ‘topic of concern’ related to the release of GMO’s are
risks for human health, environment, and agriculture which is found on the
website of ICGEB.
In India, DBT has evolved ‘rDNA safety
guidelines’ to exercise powers conferred through the Environmental Protection
Act 1986 for the manufacture, use, import, export and storage of hazardous
micro organisms and genetically engineered organisms, cells etc., These
guidelines are implemented and monitored by the Institutional Biosafety
Committees (IBSCs), the Review Committee on Genetic Manipulation (RCGM) and the
Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment
and Forest.
The physical objects like household goods or
land or properties of a person and the ownership and rights on these properties
is protected by certain laws operating in the country. This type of physical property
is tangible; but the transformed microorganisms, plants, animals and
technologies for the production of commercial products are exclusively the
property of the intellectuals. The discoverer or inventor has complete rights
on his property or invention. The rights of intellectuals are protected by laws
framed by a country. The intellectual property is an intangible asset. Legal
rights or patents provide an inventor only a temporary monopoly on the use of
an invention, in return for disclosing the knowledge to the others who may use
the knowledge to develop further inventions and innovations.
The laws are formulated from time to time at
national and international levels. Development of new crop varieties is also an
intellectual property right. It is protected by ‘plant breeders rights’ (PBRs).
PBRs recognize the fact that farmers and rural communities have contributed to
the creation, conservation, exchange and knowledge of genetic and species
utilization of genetic diversity. IPR and IPP are granted by the Government to
plant breeders for producing a specific plant variety that is new and never
existed before.
IPR is protected by different ways like patents,
copyrights and trade marks.
The science of biotechnology involves the
production of enormous number of commercial products of economic importance.
The inventions include biotechnology products
and processes. The products include living entities like micro organisms,
animals, plants, cell lines, cell organelles, plasmids and genes and naturally
occurring products like primary and secondary metabolites produced by living
systems e.g. alcohol, antibiotics.
The biotechnological processes involve
isolation, purification, cultivation, bioconversion of novel, innovative,
simple and cost effective processes, and creation of biotechnological products.
A patent is a Government issued document that
allows the person for an exclusive right to manufacture, use or sell an
invention for a defined period (usually 20 years). It is a legal document
safeguarding the rights and privileges of an inventor / invention. The purpose
of patenting in biotechnology ensures fair financial returns for those who have
invested finances, ideas, time and hard work for an invention.
·
The invention must be novel and useful;
·
The product must be inventive and reproducible;
·
The patent application should provide the full description of the
invention and the invention must be patentable.
GATT was framed in 1948 by developed countries
to settle dispute, among the countries regarding share of world trade. The
benefits of GATT was enjoyed only by developed countries. In 1988 US congress
enacted a law ‘the omnibus trade and competitiveness act’ (OTCA) which gave
powers to US to investigate the laws related to trade.
A geographical indication is a name or sign used
on products which correspond to a specific geographical origin and possess
qualities or a reputation that are due to that origin. Geographical indications
are typically used for agricultural products, food products,handicrafts and
industrial products. Darjeeling tea was the first GI tagged product in India in
2004-05. In Tamilnadu, Kancheepuram silk, Coimbatore wetgrinder, Thanjavur
paintings, Madurai Malli and Temple jewellery of Nagercoil are GI tagged.
The protection of authorships of published work
comes under copyrights of IPRs. Copyright protection is given for form of
expressions of ideas. For example the authors, editors, publishers or both the
publisher/ editor of a book have copyrights. The content of the book cannot be
reproduced or reprinted without written permission from copyright holders.
Patents and trade secrets provide protection for the basic knowhow but
copyright protects the expressed materials in printed, video recorded or taped
forms. In the field of biotechnology the data base of DNA sequences or any
published forms, photomicrographs, etc., are subject to copyright.
Any specific symbol or words to identify a
particular product or process of a company constitute trademark. This enables
the public to distinguish between a trader’s goods from similar goods of other
traders
Biotechnology as an independent discipline has
drawn world wide attention from the Governments and the corporate world because
of its limitless applications. It is looked upon as a panacea for treating
diseases and genetic disorders. The global demand of the biotechnological
products is on the increase. It is the science for the future with solutions to
many of the problems related to health, agriculture, environment and
industries.
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