This article is written by Amartya Sharan from School of law, UPES. This is an exhaustive article that covers the meaning of biotechnology and its relation with IPR and Trade laws. 

Introduction

The term biotechnology was first introduced by a Hungarian scientist “Earl Carley” in 1919. It comprises two words “bio” and “technology”. The word bio means life and technology mean to use scientific research in getting the desired result. So the word biotechnology means, using living organisms such as plants and animals with technology for getting the desired result. Under this, we modify the basic DNA that is present in a plant or animal to enhance its functions. In this, we use the biology of living organisms to solve many problems and to make useful products out of it.

The use of biotechnology can be seen in an earlier time as well, the production of bread by using yeast in it, the production of wine and beer by fermentation, and the production of cheese all these were done by using the biological structure of different organisms. But today the term Biotechnology has a completely different meaning and uses, it affects everyone and somehow we all were connected to this technology. By using this technology scientists were able to develop vaccines for many infectious diseases, many diseases have no cure earlier but, after the advancement in biotechnology scientists were able to develop some medicine and it helps them in controlling it. This technology also helps us in different sectors such as in the fuel sector and also in agriculture. It helps in developing the good quality of seeds that will lead to higher production and also by enhancing their DNA they make them stronger so that there will be less use of fertilizers in them and we will consume fewer amounts of toxins. 

Biotechnology laws in India

The main agency in our country which focuses on all the work in this industry is the Department of Biotechnology (DBT) that is made under the Ministry of Science and Technology. Another body named as Genetic Engineering and Approval Committee (GEAC) made under the Ministry of Environment and Forests, both the organizations have worked together in the development of biotechnology laws in our country. Various other organizations were set up to monitor the different activities such as manufacturing, testing, and release of such items in the market. The biological diversity Act 2002 is also there to guide us on this matter.  It ensures that everyone is sustainably using the environment and the benefits arising out of the environment should be equally distributed among everybody. The biotechnology sector in our country is experiencing growth in recent times because of the favorable policies of the government that helps in starting the industry in India. Several international companies have come forward to do business in our country seeing the potential of the biotechnology sector in our country. The Department of biotechnology along with all the other governmental organizations tries to create a favourable environment that helps companies in researching our country. It is the efforts of all these organizations that help our country in establishing its position in the global market.

International regulation of biotechnology 

The development of biotechnology in the entire world helps them in many ways. It helps the entire world in removing such diseases that have no cure before these techniques, the development of biotechnology helped the world in every sector such as health, agriculture as well as fuels. 

But with the development in it, there were also several risks attached to it. There were several risks in changing the genes of an organism. It can be proved very dangerous, we cannot know for sure beforehand what will be the outcome of the research. There is a possible risk that after the modification “the new product can be toxic or allergic to the human body”. In that case, we will face problems because the new product has new qualities which are unseen for everyone and to deal with any such problem, we have to indulge further in researching that.

This kind of incident can disturb the ecological balance of the earth and it is dangerous for everyone. So, “we need to develop an international regulation that has to be followed worldwide to ensure the effective use of biotechnology”. 

In this sector, international regulations can bring a lot of change, there were several areas unexplored in this and if two states that were working individually came together to work regarding this, then it can be very beneficial for the states and the society as well. International regulations can be placed to define the rights and obligations of different states. According to the norms set up they can authorize or prohibit a class of actions. If any states are not following the safety norms that are necessary, “then by the use of regulations they can even impose temporary or permanent constraints on countries”. 

Impact of IPR for biotechnology

Intellectual Property Rights has a very important role in this sector. IPR protects the rights of the inventor from any company that no one other than the inventor/founder can use the name of the substance or the company without the permission of the company. 

In the case of biotechnology, the IPR can help the inventor/founder to keep his name associated with that product forever. And if some other person tries to take credit for your work then the rules of IPR will restrict him from doing so. It helps the companies in retaining their patents, trademarks, and their trade secrets. 

It helps in pharma companies that if a certain company holds IPR related to a drug then that company only can sell the drugs by a specific name, no other companies have the right to sell that drug by that name. 

Such as only the company Reckitt and Colman can use the name Disprin in selling their tablets for headache, no other companies have the right to sell any medicine in that name. But other companies can use the name of the compound found in that medicine because the compound of the medicine is the same for everybody. 

So, IPR has a very important impact in this sector and without it, no companies will be able to establish their ownership. It restricts the chances of conflict between the companies and provides an equal platform for everybody to perform. 

Who regulates biotechnology research and application

There were numerous organizations and committees that kept looking at the work done in the biotechnology sector. It is an emerging sector in our country and because of that the working of these organizations is flexible in nature. They were there mainly to protect the people of the country from any possible harm by this research. There were several other organizations also present such as The Institutional Biosafety Committees (IBSC), which is mainly responsible for the local implementation of guidelines of the committee, and to look at whether the work is running smoothly or not. 

Another committee that is responsible for issuing permits to the biotechnological company is the Review Committee on Genetic Manipulations (RCGM).

There were several other statutes also present in our system which are there to be used according to their relevance, such as the Environment Protection Act, 1986, it is used when there is any conflict regarding the use of the land sustainably. Other Acts such as the Foreign Exchange Management Act, the National seeds policy, and the seeds Act all these were also used in this sector according to their uses. 

International trade law and biotechnology

This technology proved very beneficial for people around the globe. By altering the structure and DNA of organisms and plants, the scientists were able to develop good quality seeds whose yield production is higher than usual and also the new genetically modified seeds have also some characteristics that protect the attacks of weeds or insects on the crops. These seeds proved very beneficial for the world but it comes with its own set of dangers as well. One major concern of using this technology is its effect on biodiversity. The new genetically modified crops have their own set of characteristics that can pollute the land and its adverse effect can be seen in the weeds or other plants. So we need to use such things very safely and with proper precautions.

This technology is new for the entire world so no proper and uniform system can be adopted. The companies that were involved in this business have to face any problem in trading with other companies because of the confusion regarding trade laws in biotechnology. So to resolve these conflicts there were some agreements between international organizations regarding trade laws between different countries.

One of the agreements is “The Cartegena Protocol on Biosafety’‘. This agreement was adopted in Montreal, Canada on June 29, 2000. It was originally negotiated in the United Nation conference on biological diversity. It governs the transfer of living modified organisms between two states. 

There were other agreements as well that helped to regulate the trade between these companies. Such as the Agreement on the Applications of Sanitary and Phytosanitary Measures (SPS), the Agreement on Technical Barriers to Trade (TBT) and the General Agreement on Tariffs & Trade1994 (GATT).

The SPS agreements protect the companies from the protective measures of the state that they have employed. Under the technical barrier to the trade agreement, some regulations were imposed that protect the rights of humans from being violated.

Effects of stringent trade laws on biotechnology

In the biotechnology sector, trade between the two countries depends on their respective trade laws and it’s very difficult to do trade in this sector because of the nature of the substance. The genetically modified substance that a company has developed can possess a different set of characters after some time or can damage its biodiversity. So already there was a lot of confusion in the market related to this. 

The biotechnology sector is a developing sector and every country is doing its best possible research in this because of the various benefits that are associated with this industry. 

Our country has become a global market for these companies because our government provides them the best possible support in doing their research and development. If any country alters their trade laws that are not favorable to these companies, these companies will not invest their money or technology in that country. It will ultimately affect the development of the country. So to develop the infrastructure and technology in this sector the government will make such rules that will help the companies and also ensure proper safety and precaution in doing this.

Critical assessment

We can say that biotechnology is the need of every country in the world because of the constant growth of the population. The natural resources that are given to us are limited and we have to feed our population and it cannot be done only by using traditional technologies. So to meet this requirement the use of this technology in the agriculture sector is a must. The genetically modified crops have proved beneficial to all, it increases the yield production by a large amount and it also protects the crops from getting any diseases. The genetically modified seeds are also relatively cheaper than the traditional one and in these crops, we don’t have to give them any fertilizers or pesticides so the amount spent on these things was also saved by using this seed.

This technology is used in various sectors and proved beneficial for all of them so we need to develop this technology in such a way that the risk associated with it can be minimized. 

The government has to develop a proper organization that takes care of all the activities related to this sector. 

Conclusion

The biotechnology sector in our country is an emerging sector that has a very large potential to cater to the needs of the population of our country. By improving the research and development in this field we can solve the problems related to agriculture, medicine, and fuels.

In our country still, there were many areas in which the hospital facilities were not up to the mark, so if by using this technology we can develop some more vaccines that help people in preventing a class of diseases then it would be proved very beneficial.

So in total, the government has to improve the framework of the organization that was made there to implement rules in this sector and to provide support to the companies working in this industry. 

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