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Asked: July 20, 2024In: Bio-technology
What are the challenges faced by biotech companies in gaining regulatory approval for new therapies or products?
Biotechnology has been a modern-day boon to mankind and the recent advancements in the field have given desirable solutions in the food, pharmaceutical, textile, agricultural and medical industries. The fundamental principle of biotechnology is the exploitation and modification of microorganisms orRead more
Biotechnology has been a modern-day boon to mankind and the recent advancements in the field have given desirable solutions in the food, pharmaceutical, textile, agricultural and medical industries. The fundamental principle of biotechnology is the exploitation and modification of microorganisms or their by-products for human or commercial purposes. After industrialisation, research peaked in this field and companies utilise multi-disciplinary skills for inventions, however, there are many challenges faced by biotech companies globally and a few of them are listed below:
a)Patents/Trademarks: These intellectual property rights make public availability of a certain invention (eg: a drug ) less prominent, as patented products can be sold at a massive price where it’s out of means to the poor and disadvantaged. Patents also prevent the commercial sale of similar products from other companies.
b)Moral/Ethical issues: This aspect is more visible in gene therapy ( a medical treatment where a faulty human gene is replaced by an external gene thereby treating various genetic disorders) and even in ART (Assisted reproductive technologies). Ethical issues might arise as it might hurt someone’s religious sentiments and also DNA cloning can alter the human genome and a possibility of risk is present as well
c)Exploitation of biodiversity and its resources is a common concern for companies to get approval as some inventions require abundant resources.
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