INTRODUCTION

The field of biotechnology has had a lot of beneficial contribution in the area of healthcare, agriculture, food production, manufacture of industrial enzymes, and appropriate environmental management. However, the advancement in this field has also lead to some concerns and controversies raised by a number of groups, NGOs etc. ELSI is the short form to represent the ethical, legal, and social implications of biotechnology. ELSI broadly covers the relationship between BIOTECHNOLOGY and SOCIETY with particular reference to ethical and legal aspects.

Concerns about the Genetically modified organisms (GMOs)

There are concerns regarding the biosafety, ethics and issues related to the release of GMOs in the environment. Many contries and NGOs have opposed the release of the GMOs due to these reasons. In order to address theses issues, the UNIDO/WHO/FAO/UNEP has built up an Informal Working Group on Biosafety. In 1991, this group prepared the “ Voluntary Code of Conduct for the release of Organisms into the Environment”. The ICGEB organizes annual workshops on biosafety and on risk assessment for the release of GMOs. It collaborates with the management of UNIDO’s BINAS (Biosafety Information Network and Advisory Service), whose aim is to monitor the global development in regulatory issues in biotechnology. An on-line bibliographic data-base on biosafety and risk assessment has also been created by ICGEB to evaluate the environmental release of GMOs.
Besides this, the ICGEB also assists its member states in developing the national biosafety framework.

The main areas of consideration for safety aspects in biotechnology are the following:

a) How to dispose off spent microbial biomass and purify the effluents from biotechnological processes?
b) The toxicity of the allergy associated with microbial production.
c) How to deal with the increase in the number of antibiotic resistant pathogenic microorganisms?
d) How to evaluate the pathogenicity of the genetically engineered microorganisms to infect humans, plants and animals?
e) How to prevent contamination, infection or mutation of the processed strains?
f) The evaluation of the interaction of the genetically engineered microbes with the elements of natural environment.

In the past, time and again, there has been public outrage against the use of genetically modified or transgenic plants and other organisms. In 1999, a British medical journal published the adverse effect of genetically modified (GM) potato (which was produced by Rowett Research Insitute). This potato was found to contain snow drop lectin which affected the small intestine of the rats and stunted the growth and damaged their immune system. This led to worldwide public concern about this issue and created a lot of controversy about the safety of GM foods.

The transgenic Bt-plants such as cotton, corn, soybean, and potato were approved for cultivation in USA. However, some countries did not allow Bt-plants in their fields e.g. Br-rice was not allowed in Philippines, Bt-cotton in France. Many Governments are also suspicious of the use of GMOs due to various reason-risks, societal beliefs, and economic concerns.

Biological Warfare?

Most of the countries of the world are signatories to the Biological Weapons Conventions of 1972. As a signatory, it is a voluntary pledge by a nation “never to produce microbial or other biological agents or toxins, whatever may be their method of production, for use in wars. However, many people have expressed their concerns about the possible use of genetic manipulations for military purposes in the near future.

Intellectual Property

With the fast pace development in the field of biotechnology, the issues related to legal characterization and the treatment of trade related biotechnological processes and products are of immense importance. These are popularly known as Intellectual Property. Intellectual Property includes Patents, trade secrets, copyrights, and trademarks. Intellectual Property Rights (IPR) is a collective term applied to a number of different types of legal rights granted by each country.
The rights to protect this property prohibits others from making, copying, using or selling the proprietary subject matter.

In biotechnology, the intellectual property covers the processes and products which result from the development of genetic engineering techniques through the use of restriction enzymes to create recombinant DNA.

Another example of intellectual property is the development of crop varieties which are protected through “plant breeder’s rights or PBRs. The PBRs ensures that the plant breeder who developed a particular variety gets the exclusive rights for marketing the variety.
Agriculture for the first time was included in the trade related intellectual property rights (TRIPS) and TRIPS is a major concern for developing countries. The following two major steps were taken in consideration of PBRs:
(a) The Food and Agriculture Organisation (FAO) has an International treaty on plant genetic resources for food and agriculture. This treaty consists of a particular classes which refers to operation of farmer’s rights.
(b) The ‘Plant Varietal Protection and Farmer’s Rights Act 2001 agrees for the right of farmers, breeders, and researchers. The protection is provided by making compulsory licensing of rights, and inhibiting the import of plant varieties consisting of ‘genetic use of restriction technology’ (GURT) e.g. terminator technology of Monsanto.

Following conditions should be fulfilled to grant protection to the new varieties:

a) the new variety must always be new i.e. it should not have ever been exploited commercially.
b) It should be biologically distinct and possess different characters.
c) The new variety of the plant must have uniform characters.
d) The distinguishing character of new variety must be stable for generations.
e) The new variety should have taxonomic validity i.e. systematic position, generic and species names etc.

Recently Utility patents for both plant and animal genetic materials, have been allowed in some countries. This forbids the use of patented material for further breeding. The farmers are allowed to use and save the seeds for cultivation only after paying a fee to the patent holder.

Some concerns have been voiced regarding the implications of IPR on the genetic diversity and the conservation of genetic resources. IPRs will directly or indirectly affect the food security and distribution around the globe, biological diversity and ecological balance, employment avenues in the poor and developing countries, and the use of new and effective agricultural practices.