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Bangladesh Journal of Bioethics 2019; 10(2): 7-13 

 

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Societal Concerns with Biotechnology and Necessity of Regulations   

 

Abu Sadat Mohammad Nurunnabi1, Miliva Mozaffor2, Mariya Tabassum3, Taohidur 

Rahman Saikat4, Nahid Kabir5, Mohammad Akram Hossain6  

1. Research Assistant, Bridgepoint Collaboratory for Research and Innovation, Bridgepoint Active Healthcare, 

Toronto, ON, Canada. Email: abu.nurunnabi@sinaihealthsystem.ca  (corresponding author) 

2. Clinician Researcher, Biomedical Research Foundation (BRF), Dhaka, & Laboratory Consultant and Lecturer, 

Department of Biochemistry, Medical College for Women & Hospital, Uttara, Dhaka-1230, Bangladesh. Email: 

miliva17@yahoo.com  

3. Lecturer, Department of Biochemistry, Mugda Medical College, Dhaka-1214, Bangladesh. Email: 

drmariyatabassum@gmail.com  

4. BSc (Hons.) student, Department of Biochemistry and Molecular Biology, Tejgaon College, Dhaka-1215, 

Bangladesh. Email: taohidurrahman9@gmail.com  

5. MSc student, School of Environment and Life Sciences, Independent University, Bangladesh, Bashundhara, 

Dhaka-1212, Bangladesh. Email: nahidkabir@gmail.com  

6. Professor and Head, Department of Microbiology and Mycology, National Institute of Preventive and Social 

Medicine (NIPSOM), Dhaka-1212, Bangladesh. Email: akram.prof@gmail.com  

 

DOI: DOI: https://doi.org/10.3329/bioethics.v10i2.50660  

 

Abstract: Biotechnology is the use of living systems and organisms to develop or make products, 

or any technological application that uses biological systems, living organisms or derivatives to 

make or modify products or processes for specific use. Biotechnology is a constantly evolving 

field of modern science. New tools and products developed by biotechnologists are useful in 

research, agriculture, industry and healthcare. Although it has many benefits including lowering 

our environmental footprint, and helping in diagnosis and treatment of diseases, it comes with its 

all-possible disadvantages. The four main societal concerns revolve around are ethical, safety, 

bioterrorism and environmental issues. This paper aims to describe those societal concerns raised 

by applications of biotechnology and possible regulations related to biotech innovations and policy 

implementation.    

 

Key words: Biotechnology, societal concerns, ethical issues, laboratory safety, bioterrorism, 

environmental protection. 

 

Introduction: People have been harnessing 

biological processes to improve their quality 

of life for some 10,000 years, beginning with 

the first agricultural communities. 

Approximately 6,000 years ago, humans 

began to tap the biological processes of 

microorganisms in order to make bread, 

alcoholic beverages, and cheese and to 

preserve dairy products1. Such processes are 

not what is meant today by biotechnology. 

Moreover, today’s biotechnologies vary in 

application and complexity. The term 

‘biotechnology’ first widely applied to the 

molecular and cellular technologies that was 

emerging in the 1960s and ’70s. Genentech, 

a pharmaceutical company established in 

1976 by Swanson and Boyer to 

commercialize the recombinant DNA 



Bangladesh Journal of Bioethics 2019; 10(2): 7-13 

 

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technology, as pioneered by Boyer, Berg, and 

Cohen1. Early companies such as Genentech, 

Amgen, Biogen, Cetus, and Genex began by 

manufacturing genetically engineered 

substances primarily for medical and 

environmental uses1. Biotechnology is the 

use of living systems and organisms to 

develop or make products, or any 

technological application that uses biological 

systems, living organisms or derivatives to 

make or modify products or processes for 

specific use2. New tools and products 

developed by biotechnologists are useful in 

research, agriculture, industry and healthcare. 

Innovations through biotechnology using 

organisms or their parts or products provide 

valuable substances or processes that have 

become essential in our day-to-day life. For 

example, production of human insulin in 

bacteria to treat type I diabetes mellitus 

without causing allergic reactions is a more 

modern example of biotechnology. Two 

widely used biotechnologies that manipulate 

genes are recombinant DNA technology, 

which endows single-celled organisms with 

novel characteristics using genes from other 

organisms, and transgenic technology, which 

creates multicellular organisms that bear 

genes from other types of organisms2. Very 

recent innovations are genetically modified 

(GM) fruits and vegetables, such as a type of 

corn that manufactures a bacterial 

insecticide, are termed as “transgenic 

plants”3. Thus, biotechnology use knowledge 

of biological sciences and advanced 

technologies to generate new and useful 

products and processes for the benefit of 

society. Living standards have risen 

alongside biotech innovation and economic 

growth in so many countries. Even when it 

comes to developing countries, 

biotechnologies and innovative solutions are 

helping to combat issues such as disease, 

hunger and poverty3. Although it has many 

benefits including lowering our 

environmental footprint, and helping in 

diagnosis and treatment of diseases, it comes 

with its all possible disadvantages4. Several 

ethical concerns such as informed consent, 

confidentiality, wellbeing of the subjects for 

research, equal access to the benefits of 

research, intellectual property rights, costs 

have come into the focus4-9. Human and 

laboratory safety issues are crucial as it is 

assumed that in future insects and plant-

destroying bacteria or diseases may continue 

to evolve to give rise to superpests or 

‘superbugs’10-12. Moreover, there might be 

chances of outbreak of epidemics, due to 

faulty or erroneous handling of micro-

organisms or chemicals in the biotech 

laboratories12.13. Relating this issue, major 

emphasis is on how to control bioterrorism 

using genetically engineered super 

pathogens, drugs or chemicals4,14-17. 

Environmental issues have also come to the 

forefront as GMOs are thought to be the 

organisms actually put the entire food supply 

at risk through the homogenization of plant 

life and the death of biodiversity18-21. 

Therefore, bioethics community stands for 

the safe regulation of potential benefits of 

innovations in biotechnology and for welfare 

of mankind as well as our environment, 

which has become crucial at the moment. 

This paper aims to describe those societal 

concerns raised by applications of 

biotechnology and possible safeguards 

related to biotech innovations and policy 

implementation. 



Bangladesh Journal of Bioethics 2019; 10(2): 7-13 

 

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Societal Concerns: Today’s social 

challenges are numerous, complex, and 

urgent, from ageing societies, climate 

change, to energy efficiency and security3,4. 

There is a wide consensus that the 

disconnection between economic growth and 

wellbeing is increasing. At the same time 

research and innovation have become one of 

the main engines of growth4. However, these 

two overarching trends have not yet been 

reconciled: there is a clear lack of 

exploitation of innovative solutions to 

address these social challenges4. Besides, 

biotechnology developments are often 

controversial because of the societal issues 

they raise. They frequently become the 

subject of public debate that presents 

different viewpoints. Regarding modern 

biotech innovations, we are going to discuss 

four main societal concerns revolve around – 

ethical, public and laboratory safety, 

bioterrorism and environmental issues. 

1) Ethical issues: Uncovering the human 

genome was a tremendous step forward for 

science, but the discovery created a series of 

new concerns4. Researchers have been able to 

use the information from the Human Genome 

Project to develop the new science of 

pharmacogentics, how an individual’s genes 

affect his or her body’s ability to metabolize 

or react to a drug. Modern pharmacogentics 

aims to eliminate adverse drug events (ADE) 

and side effects by tailoring drugs specific to 

a patient’s genome. While the new 

personalized medications can eliminate side 

effects, the use of genetic information to 

create medicine contributes to the rising cost 

of drugs, and shifts attention away from 

designing affordable drugs available for mass 

population4,5. Another burning issue is stem 

cell research. Supporters argue the embryos 

used to generate stem cell lines were going to 

be destroyed, and using them for research has 

the capacity to save untold numbers of lives. 

In contrast, opponents believe creating new 

lines from embryonic stem cells is akin to 

abortion, and the destruction of any embryo 

for research purposes is an ethical violation5. 

However, both sides have come to a partial 

agreement on the use of adult stem cells over 

embryonic cells, but functionally the adult 

cells offer far fewer options and less 

promising research4-6. Besides the age-old 

debate over whether cloning genes is 

sacrilegious, innumerable ethical questions 

arise over the appropriateness of licensing 

genetic inventions and other intellectual 

property issues5,7,8. In addition, it will most 

certainly go against the ethics of a significant 

number of science and professional societies 

as well existing laws of different countries. 

There are also other ethical concerns 

including when scientists use humans as 

clinical trial subjects – informed consent, 

confidentiality, wellbeing of the subjects, 

equal access to the benefits of research, 

compensation – have come into the table of 

discussion for decades4,5,7-9. Last but not the 

least, the concept of GM foods, its efficacy, 

acceptance and associated consumer rights, 

right to food, cost also have been debated4,5. 

2) Public or laboratory safety or biosafety 

issues: Maintenance of laboratory safety or 

biosafety is a crucial point to ensure public 

safety. Human and laboratory safety issues 

are crucial as it is assumed that insects and 

plant-destroying bacteria or diseases will 

continue to evolve with the GMOs, resulting 

in superpests and superdiseases that are 



Bangladesh Journal of Bioethics 2019; 10(2): 7-13 

 

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untreatable. Similar may happen with 

overconsumption of antibiotics, which are 

also GM products, and loss of their ability to 

fight off disease will result in rise of 

‘superbugs’10-12. Some new technologies, 

usually non-biologicals such as 

nanoparticles, make commercial production 

lines before they have been sufficiently tested 

for safety12. There is also concern about 

technician safety in laboratories even under 

secure conditions when working with 

organisms of unknown virulence. The public 

health danger posed by potentially pandemic-

causing viruses or bacteria escaping from 

laboratories has become the subject of 

considerable discussion in public health 

sphere12,13. The goal of biotech experiments, 

as researchers manipulate already-dangerous 

pathogens, is to produce vaccine or other 

remedies. However, outbreak of epidemics 

have already been experienced in course of 

history, due to faulty or erroneous handling 

of micro-organisms or chemicals12.13. 

3) Bioterrorism: Biological weapons is not a 

myth anymore. In the recent past, the threat 

of a global bioterrorist attack has increased 

dramatically. In addition to the already 

existing microorganisms and techniques, the 

recent explosion in biotechnology has 

considerably added to the arsenal of the 

bioterrorist4,14. Molecular biotechnologies 

are now much available which can be used by 

committed bioterrorist groups to manipulate 

and modify microorganisms and to make 

them increasingly infectious, virulent or 

treatment resistant for causing maximum 

casualties14-17,. Apart from that, research 

involving biological or chemical weapons 

necessarily involve exposures to toxic agents 

and levels of risk higher than those that exist 

in most research4,17. Such research would 

seem to compromise the core tenet of medical 

ethics that studies should not knowingly do 

harm. Indeed, the Environmental Protection 

Agency of the U.S. now refuses to accept 

toxicity tests done on human subjects to 

determine “safe levels”4,17. 

4) Environmental issues: Environmental 

integrity remains a moral concern for 

environmentalists as they have predicted that 

biotechnology will promote the replacement 

of the natural environment with a purely 

artificial world and cause deprivation of 

healthy contact of human beings with 

nature18,19. Recent controversies about 

genetically engineered crops have 

highlighted the need for experimental 

evidence and sound scientific judgment to 

assess the risks versus benefits. This concern 

is perhaps the most widely cited by those 

opposed to genetically modified organisms 

(GMOs). It is very difficult to predict what 

will happen in an ecosystem where a new 

organism has been introduced whether 

genetically modified or not. For example, if 

farmers introduce any herbicide-resistant 

marker into a plant, there is the possibility 

those traits may be transferred to a weed, 

making it resistant to herbicides as well19. 

The backlash against GMOs has been strong 

and is growing day by day. Opponents of 

GMOs claim the organisms actually put the 

entire food supply at risk through the 

homogenization of plant life and the death of 

biodiversity18-21. They also argue that insects 

and plant-destroying bacteria or diseases will 

continue to evolve with the GMOs, resulting 

in superpests and superdiseases that are 

untreatable by modern methods18,19,21. 

Similarly, physicians, microbiologists, 



Bangladesh Journal of Bioethics 2019; 10(2): 7-13 

 

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environmental scientists argue that GMOs 

include antibiotics that make their way into 

the human body. Overconsumption of 

antibiotics is harmful, as because those drugs 

lose their ability to fight off disease19. 

 

Regulations of Biotechnology and Public 

Policy: Societal issues are inevitably 

associated with regulation and public 

policy22. Regulations and public policies are 

always fashioned in accordance with 

background assumptions or politically 

negotiated consensus about moral questions 

like “what is the public good? or who should 

make decisions and control events? or what 

are the fundamental purposes of government 

and society?”5 Even when tradition or 

consensus rules that individuals are to have 

complete discretion in exercising moral 

judgement (as is the case with respect to 

religious duties in most parts)5. The purpose 

of public policies is to find a balance between 

safety regulation and innovation22. The two 

are not necessarily at odds: innovation has the 

potential to enhance safety, e.g. by replacing 

high-risk products with newer, safer 

products. Moreover, regulatory frameworks 

that are suitably designed and implemented 

have the potential to foster innovation; for 

example, fuel economy standards have 

improved the average fuel economy of E.U. 

and U.S. vehicles23. Thus, it is incorrect to 

assume that regulation inevitably creates 

barriers to innovation. However, one valid 

area of concern is that regulations have the 

potential to impede or delay the introduction 

of innovative products to the market, if the 

regulations add substantial up-front costs and 

delays to the process of developing and 

marketing a new product23. Hence, the 

regulatory process for the use of any biotech 

product should take into account both the 

risks and benefits of implementing that 

technology as well as the consequences of 

non-implementation and the viability of 

alternative technologies. As new 

biotechnology discoveries are made, many 

western governments develop regulations, 

legislation and guidelines to minimise risks 

to people and the environment23-27. Many 

governments have created environmental risk 

management bodies that regulates and 

manages risk concerning new products or 

organisms23-27. 

 

Conclusion: Biotech innovations are 

inevitable for upcoming days. If properly 

developed, biotechnology represents an 

opportunity for developing countries to 

realize tangible health and nutritional 

benefits, sustainable agriculture, green 

energy and other possibilities to eliminate 

hunger and poverty. The regulatory agencies 

must carry out regulatory functions to protect 

public health, ensure biosafety, prevent 

bioterrorism and environmental harms. 

However, the intent of the regulatory 

guidelines should be providing mechanisms 

to assess the safety of biotechnology products 

while simultaneously offering a framework 

for advancing innovation and increasing 

transparency, coordination, efficiency, and 

predictability. Many countries are actively 

developing this technology, and their support 

for biotechnology may turn the tide in global 

public acceptance in near future. 

 

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Authors’ contribution: ASM Nurunnabi and M 

Mozaffor were involved in concept and design of the 

paper; ASM Nurunnabi, M Mozaffor, M Tabassum, 

TR Saikat, N Kabir and MA Hossain were equally 

involved in the literature search, review, compilation, 

manuscript writing and revision. 

Conflict of interest: The authors report no conflicts of 

interest in this work. 


