Biotechnology Regulation Legal Aspects &

Intellectual property rights

By Shruti Gupta II Sem M.tech Marine BiotechnologyNCAAH

What is Biotechnology? Biotechnology = bios (life) + logos (study of or essence)– Literally ‘the study of tools from living things’

"any technique that uses living organisms (or parts of living organisms) to make or modify products or

to improve plants or animals, for beneficial use"

Biotechnology & the Law

Branches in Biotechnology

10

20

30

40

Legal aspects of Biotechnology

Regulatory Frame work in India

Some of the key steps taken by the State Governments includes: announcing separate Biotechnology Policy for their States. setting up of Task Forces with experts to guide them on policy issues. setting up of exclusive Biotechnology Parks with agriculture. health biotechnology as key areas.

Agriculture Biotechnology

Department of Biotechnology [DBT]

Genetic Engineering and Approval Committee[GEAC]

The Institutional Biosafety Committees (IBSC), responsible for the local implementation of guidelines.

Review Committee on Genetic Manipulations (RCGM) responsible for issuing permits.

GEAC responsible for monitoring the large scale and commercial use of transgenic materials.

The MOST important committees

IBSC

research activities involving genetic manipulation of microorganisms.

All research carried out by the applicant company shall designate a Principal Investigator [PI].

PI is required to intimate to the IBSC

PI shall seek permission of IBSC before starting the experiment. IBSC shall intimate its decision to the RCGM before execution of the experiments and RCGM shall put the information on record.

The risk involved in the experiments are considered to be of higher magnitude having the potential of polluting/endangering the environment, the biosphere, the eco system, the animals and the human beings could be conducted only after obtaining clearance from RCGM and upon being notified by the DBT.

Stage II Exp.

Stage I Exp.

Stage III Exp.

RCGM

It comprises representatives of a) DBTb) Indian Council for Medical Researchc) Indian Council for Agricultural Researchd) Council for Scientific and Industrial

Research

After reviewing the application from IBSC it recommend the application to Monitoring cum Evaluation Committee [MEC] of the DBT for agronomic benefits and evaluation.

GEAC In case of large scale field trials, deregulation and commercialization, in

addition to the DBT approval process, permission of GEAC constituted under the MoEF is also required.

Approval of the GEAC is required from the environmental angle on:

i. Import, export, transport, manufacture, process, selling of any microorganisms or genetically engineered substances or cells including food stuffs and additives that contain products derived by gene therapy.ii. Discharge of genetically engineered/classified organisms/cells from Laboratory, hospitals and related areas into environment.iii. Large scale use of genetically engineered organisms/classified microorganisms in industrial production and applications. iv. Deliberate release of genetically engineered organisms.

Pharmaceutical Biotechnology

Industrial licensing under the Industrial [Development & Regulation] Act, 1951 is compulsory for:

• bulk drugs produced by the use of recombinant DNA technology• bulk drugs requiring in-vivo use of nucleic acids• specific cell/tissue targeted formulations

Procedure

Research & Development

Imports

Manufacture

The U.S Department has created a new unit within the Animal and Plant Health Inspection service called Biotechnology regulatory services (BRS).

APHIS regulations for certain genetically engineered (GE) organisms that may pose a risk to plant health.

The Coordinated Framework for the Regulation of Biotechnology established in 1986, describes the federal system for evaluating products developed using modern biotechnology.

The three main federal agencies responsible for regulating the safe use of genetically engineered organisms are:

• APHIS (The Animal and Plant Health Inspection Service)• U.S. Environmental Protection Agency (EPA) • U.S. Department of Health and Human Services' Food and Drug

Administration (FDA)

The Regulation of Biotechnology

The Government of India has prepared a draft for public 'Biotechnology Regulatory Authority of India (BRAI) 

The Status of Biotechnology in India

Bio Agri6.95%

Bio Pharma75.24 %

Bio Services8.95%

Bio-IT2.09 %

Bio Industrial6.74%

Intellectual property rights

Intellectual property (IP) is the creation of the human mind—the intangible intellect that can translate into tangible products.

Intellectual property rights (IPR) protect the use of these human creations.

The major elements or forms of intellectual property rights today include patents, utility models, industrial designs, trademarks and service marks, geographical indications and layout of integrated circuits, copyright, and plant breeder’ rights.

There are currently two main systems of protection for biotechnology: rights in plant varieties patents:

“The right to exclusively produce, use and/or market a • Product• Process• Application”

Today, IPR plays an important role in every sector and has become an important aspect of research for Pharma and research oriented industries. The continuous efforts of the government in policy establishment, IT protection, infrastructure, IPR search portals and manpower made this Industry a step ahead.

Categories of Intellectual Property

• Industrial property, which includes inventions (patents), trademarks, industrial designs, and geographic indications of source.

• Copyright, which includes artistic works such as novels, poems and plays, films, musical works, dance, artistic works such as drawings, paintings, photographs , sculptures, and architectural designs.

• Rights related to copyright include those of performing artists in their performances, producers of phonograms in their recordings, and those of broadcasters in their radio and television programs.

References:• Keith E. Maskus, Benefiting from Intellectual Property Protection;

Development Trade and the WTO, the World Bank Handbook (2002).

• Manfield E. Intellectual property Protection, foreign direct investment,

Washington DC, International Finance Corporation, Discussion Paper No.19.

 • Sara Boettiger, Gregory D. Graff, Philip G. Pardey, Eric Van Dusen

and Br ian D . W right (2004), Intellectual Property Rights for Plant Biotechnology: International Aspects. 

• Simpson RD, Sedjo RA, Reid JW (1996). Valuing biodiversity for use in pharmaceutical research. J Pol Economy 104: 163–185.

 • UPOV Geneva (2001), International Convention for the Protection of New

Varieties of Plants of December 2, 1961 as last revised on March 19, 1991.