Biotechnology and Life Sciences Law # MCQs Practice set

Q.1 Which international agreement regulates the trade of genetically modified organisms (GMOs)?

CITES

Cartagena Protocol

Kyoto Protocol

TRIPS Agreement

Explanation - The Cartagena Protocol on Biosafety is an international agreement which aims to ensure the safe handling, transport, and use of living modified organisms (LMOs) resulting from modern biotechnology.

Correct answer is: Cartagena Protocol

Q.2 Which of the following is a key ethical concern in biotechnology?

Patent filing process

Environmental pollution

Genetic privacy

Labor law compliance

Explanation - Genetic privacy concerns the ethical handling of individuals' genetic information, including consent, storage, and usage.

Correct answer is: Genetic privacy

Q.3 Which regulatory body in the USA oversees gene therapy clinical trials?

FDA

EPA

CDC

NIH

Explanation - The Food and Drug Administration (FDA) regulates clinical trials involving gene therapy, ensuring safety and efficacy before approval.

Correct answer is: FDA

Q.4 Intellectual property protection for biotechnological inventions is primarily covered under which law?

Trademark Law

Patent Law

Trade Secret Law

Explanation - Patent law protects inventions, including biotechnological products and processes, giving the inventor exclusive rights for a limited period.

Correct answer is: Patent Law

Q.5 Which term refers to legal rules governing the use of human tissues in research?

Bioethics Law

Tissue Law

Human Subjects Law

Genetic Engineering Law

Explanation - Human Subjects Law provides ethical and legal guidelines for conducting research involving human participants and their biological materials.

Correct answer is: Human Subjects Law

Q.6 Which act in India governs genetically modified crops?

Environment Protection Act

Seed Act

Biotechnology Regulatory Authority Act

Plant Varieties Act

Explanation - The proposed Biotechnology Regulatory Authority of India (BRAI) Act aims to regulate the research, transport, and commercialization of GMOs in India.

Correct answer is: Biotechnology Regulatory Authority Act

Q.7 Which of the following is an example of a biosafety level 4 pathogen?

E. coli K12

Influenza A virus

Ebola virus

Saccharomyces cerevisiae

Explanation - Biosafety Level 4 (BSL-4) pathogens are highly dangerous and often fatal, requiring maximum containment procedures. Ebola virus falls under this category.

Correct answer is: Ebola virus

Q.8 Which legal doctrine restricts the patenting of naturally occurring genes?

Doctrine of Equivalence

Mayo v. Prometheus

Doctrine of Patentable Subject Matter

Compulsory Licensing

Explanation - Courts have ruled that naturally occurring genes cannot be patented, but modified or isolated genes may qualify under patentable subject matter.

Correct answer is: Doctrine of Patentable Subject Matter

Q.9 Which is the main international body that sets guidelines for bioethics in research?

WHO

UNESCO

FAO

OECD

Explanation - UNESCO provides international ethical guidelines for research in life sciences, including human genetics and biotechnology.

Correct answer is: UNESCO

Q.10 Which of the following terms refers to legal liability for harm caused by biotechnology products?

Criminal liability

Product liability

Civil negligence

Regulatory noncompliance

Explanation - Product liability refers to the legal responsibility of manufacturers or developers for damages caused by defective or unsafe biotechnology products.

Correct answer is: Product liability

Q.11 The Hatch-Waxman Act in the USA primarily deals with:

Biotech patents

Drug approval and generic competition

Environmental biosafety

Stem cell research

Explanation - The Hatch-Waxman Act facilitates the approval of generic drugs while balancing patent protection for pharmaceutical innovations.

Correct answer is: Drug approval and generic competition

Q.12 Which international treaty deals with the conservation of biodiversity relevant to biotechnology?

CITES

CBD

Paris Agreement

Basel Convention

Explanation - The Convention on Biological Diversity (CBD) addresses the conservation and sustainable use of biological resources, including biotechnological applications.

Correct answer is: CBD

Q.13 Which principle ensures that new biotechnologies are not adopted until they are proven safe?

Precautionary Principle

Sustainability Principle

Principle of Utility

Equity Principle

Explanation - The Precautionary Principle states that in the absence of scientific consensus, precautionary measures should be taken to prevent potential harm from biotechnologies.

Correct answer is: Precautionary Principle

Q.14 Which law governs the ethical use of stem cells in India?

Drugs and Cosmetics Act

Biomedical Research Act

Indian Stem Cell Guidelines

Genetic Engineering Act

Explanation - The Indian Council of Medical Research has issued guidelines for ethical stem cell research, including sourcing, consent, and clinical applications.

Correct answer is: Indian Stem Cell Guidelines

Q.15 Which of the following is a key concern in synthetic biology law?

Biosecurity and dual-use research

Water pollution

Air traffic regulation

Data privacy

Explanation - Synthetic biology poses risks of misuse (dual-use research), and laws aim to regulate these biosecurity threats while promoting innovation.

Correct answer is: Biosecurity and dual-use research

Q.16 Which type of license allows use of patented biotech inventions without infringing, often for public health?

Exclusive license

Compulsory license

Open license

Voluntary license

Explanation - A compulsory license permits use of a patented invention without the consent of the patent holder, typically to address public health needs.

Correct answer is: Compulsory license

Q.17 Which of the following is considered a genetically modified organism?

Hybrid corn

CRISPR-edited bacteria

Wild-type yeast

Heirloom tomato

Explanation - Genetically modified organisms (GMOs) are organisms whose DNA has been altered using genetic engineering techniques such as CRISPR.

Correct answer is: CRISPR-edited bacteria

Q.18 Which international framework addresses the transboundary movement of LMOs?

Basel Convention

Cartagena Protocol

Nagoya Protocol

TRIPS Agreement

Explanation - The Cartagena Protocol regulates cross-border transport, handling, and use of living modified organisms to protect biodiversity.

Correct answer is: Cartagena Protocol

Q.19 Which of the following is NOT typically patentable in biotechnology?

Synthetic gene

Naturally occurring gene

Genetically modified microbe

Novel protein sequence

Explanation - Naturally occurring genes cannot be patented, but synthetic, modified, or novel sequences are eligible for patents.

Correct answer is: Naturally occurring gene

Q.20 Which agency in the European Union is responsible for biotech product approvals?

EMA

ECHA

EFSA

ECJ

Explanation - The European Medicines Agency (EMA) evaluates and supervises medicinal products, including biotechnology-derived medicines.

Correct answer is: EMA

Q.21 Which term refers to the moral obligation to protect human genetic data?

Genetic counseling

Genetic privacy

Informed consent

Biosafety

Explanation - Genetic privacy emphasizes protecting personal genetic information from unauthorized access or misuse.

Correct answer is: Genetic privacy

Q.22 The Nagoya Protocol primarily deals with:

Access to genetic resources and benefit-sharing

Clinical trials regulation

GM crop safety

Stem cell ethics

Explanation - The Nagoya Protocol sets rules for accessing genetic resources and sharing benefits fairly with the countries or communities providing them.

Correct answer is: Access to genetic resources and benefit-sharing

Q.23 Which law governs clinical research in India?

Indian Penal Code