Open Access Research Article
NEXUS BETWEEN SCIENCE TECHNOLOGY AND LAW BY: RUTVIJ RAJESH YEWALE
Published Paper
Article Details
NEXUS BETWEEN SCIENCE TECHNOLOGY AND LAWAUTHORED BY: RUTVIJ RAJESH YEWALE
Roll No. 29
Progressive Education Society’s
Modern Law College
Ganeshkhind, Shivajinagar Pune
INTRODUCTION AND MEANING
The law also plays an essential
role in the development of innovation and promoting technologies through legal doctrines and
mechanisms. The most important aspect relates to intellectual property,
by which the law gives the investors and creators a time-limited exclusive right to commercially exploit the output of the work of their
workers. The main objective of protecting
intellectual property is to promote innovation, by giving researchers, and
authors economic incentives which will aid them to create new inventions and works. New technologies cause
fundamental challenges to traditional
doctrines.
For example, digital
information might not be adequately protected by old traditional laws and it requires the copyright owner to bring
a lawsuit alleging infringement. Because unlimited copies can be made by simply uploading material on the internet
and thereafter, legislatures and courts have extended more copyright
protection for digital data.
There also exist challenges in adapting patent
law to genetic discoveries. Patenting
genes have raised
numerous scientific, legal,
ethical, and practical complexities that established patent law is not equipped
to address. Such as the traditional distinction between non-patentable products
and patentable inventions and
discoveries has been dimmed by technology.1
·
SCIENCE - TECHNOLOGY AND RELATIONSHIP WITH LAW
Law and science have a complicated
relationship. Science is the systematic approach that builds and organizes knowledge in the form of testable
explanations and predictions about the universe.
Law, on the other hand, refers to the system of rules which have been laid down
by the social institutions to regulate the actions of members and it may enforce such behaviour by the imposition of penalties. However,
with the growth
of scientific and technological advances, law, and science, the two disciplines became interdependent on
each other. The legislature of various nations
has laid down numerous laws to manage
the impacts of science and technology on society. For example, in the era of
the internet, the legislature has laid down laws and provisions which deal with cybercrimes. Law seeks to curb
the impacts of science and technology which revolve around aspects such as risks, benefits, and ethical implications.2
 |
1
https://blog.ipleaders.in/relationship-law-science-technology-modern- society/#Benefits_of_new_technologies
2
https://ijtr.nic.in/articles/art42.pdf
The judicial
system also seeks to provide remedies
to the aggrieved party that has been wronged due to the harmful implications of scientific and technological developments. Science on the flip
side has aided the legal system with modern technologies such as polygraph
tests, collection of evidence in a
scientific manner, electronic recordings which can be used as evidence before the court, etc. Science
also helps in the court proceedings with the admission of evidence, autopsy reports, etc. Therefore science and law are
codependent on each other despite
being two different disciplines in modern society with the advances in science
and technology.·
NEXUS BETWEEN SCIENCE
TECHNOLOGY AND LAW
Science and technology have substantive as well as the procedural effect
on the law. On the substantive side,
new scientific evidence and methodology can change the course of legal claims
and their outcomes,
i.e. forensic science
has opened new avenues in criminal law while creating a myriad of legal, ethical, and
social issues. And on the procedural aspect of the law, it lays down how DNA samples should be collected and stored, how
genetic information may be used, when are convicted criminals
allowed to reopen their cases, etc.
In the early twenty-first century,
digital evidence has improved the quality and availability
of trial evidence while raising concerns about tampering and fabricating
digital pieces of evidence. This led
to a massive change in the law.3
Law affects science
and technology, individuals who have been aggrieved by scientific misconduct tries to seek judicial
remedies. Advocates have even served non-party subpoenas on scientists who are doing research potentially pertinent to
the lawsuit. This exposes the scientists
to intrusive searches and they often have to disclose before the court about
their research activities.
Legislature also subjects scientists to new legal requirements, for example when any scientific project
is based on government funding
then it is important to take required
legal steps to ensure absolute protection of the scientists and the
general public. In 2000, the United States
Congress enacted the Data Quality
Act which
imposes a series
of substantive and procedural
requirements on scientific methodology. These developments indicate a trend of growing
legal intrusion on science and
technology.
|
·
PROBLEMS AND PERSPECTIVES BETWEEN LAW AND SCIENCE
In modern society, science
and technology are developing rapidly.
One of the examples of such development is Moore’s Law, which predicts
that the number
of transistors on microchips will double
every two years. The law, on the contrary, is less dynamic in nature as it has
to go through a technical statutory
process in order to keep up with the scientific developments. Statutes can easily become outdated and
case laws are also slow to adapt to the scientific and technological developments due to the binding effect of past
precedents. Therefore, it results in
the law being based on outdated scientific assumptions or fails to adapt to
recent scientific and technological
knowledge. It is essential for the law to adapt to advancing science and technology and incorporate
adaptive legal regimes to keep up with
science and technology.4
The law is the principal societal institution for
controlling these risks through the legislature
and the judiciary. Risk regulation involves two key aspects of scientific and
legal interaction. Firstly,
the part played
by law in regulating risks from science
and technology and secondly,
the use of science by law to assess risk from new and existing technologies.
The parliament of different nations
tries to reduce risk before it imposes a greater threat to society. Most industrialized nations
have comprehensive statutory
or regulatory programmes which try to reduce potential risks from
technologies such as industrial chemicals, pesticides, natural resource
extraction, pharmaceutical, etc. These legislations predict potential harms and attempts
to curb that.
In a leading
case of Daubert v. Merrell
Dow Pharmaceuticals, Inc., it was stated
by the court that federal
courts are required
to perform a gatekeeping function
to affirm that scientific testimony is relevant and reliable before
it can be admitted. This judgment has involved judges
being proactive and knowledgeable in screening prospective scientific
testimony and has also stimulated
scientific organizations to seek and educate judges and also provide experts to
aid in the proceedings
which involve science and technology.
CLINICAL TRIALS AND THE NEED PROFESSIONAL RESPONSIBILITIES AND ETHICAL
PRINCIPLES
Ethics in clinical research focuses largely on identifying and
implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit
of society at
|
4 https://blog.ipleaders.in/relationship-law-science-technology-modern-society/
large. Ethical guidelines for clinical research
were formulated only after discovery
of inhumane behaviour with participants during
research experiments.5 The Nuremberg Code was the first international code laying ethical
principles for clinical research. With increasing research all over, World Health Organization formulated
guidelines in the form of Declaration of Helsinki in 1964. The Indian Council of Medical Research has laid down
the ‘Ethical Guidelines for Biomedical
Research on Human Subjects’ in the year 2000 which were revised in 2006. It gives twelve general principles to be
followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the
researcher and the ethical guidelines
of the country. The basic responsibility of the Ethics Committee is to ensure
an independent, competent and timely
review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights,
safety and well-being of all actual
or potential research participants. A well-documented
informed consent process is the hallmark of any ethical research work. Informed consent respects individual's
autonomy, to participate or not to participate in research.The Clinical trials
are an arrangement of practices performed to confirm
and guarantee the security of a new drug molecule.
Compliant with an amendment to the Indian Patents Act 1970 in January 2005, medications can be made by following both
the item and process protecting. This
has encouraged the rise of India as a favoured and looked for after goal to direct clinical trials.
The accessibility of exceptionally prepared
doctors, attendants and specialized workforce; world class restorative offices; great IT foundation and a strong
Intellectual Property Rights administration in India have additionally
helped the reason. Rule 122 DAA of
Drugs & Cosmetics Rules, 1945 (“D & C Rules”)6 defines
clinical trials as a “systematic
study of new drug(s) in human subject(s) to generate data for discovering
and/or verifying the clinical,
pharmacological (including pharmacodynamics and pharmacokinetic) and/or adverse effects with the objective
of determining safety and / or efficacy of the new drug”.
The Drugs Controller General of India (DCGI) is in charge of administrative endorsements of clinical
trials in India.
The DCGI office relies upon outer specialists and other government organizations for exhortation.
Extra consents are required for the fare of blood tests to remote focal research centers. The ICMR has a Central
Ethics Committee on Human Research (CECHR).
This board of trustees reviews
the working of this Institutional Ethics
|
5 https://pubmed.ncbi.nlm.nih.gov/22303053/
6 https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Drugs-Rules/
Committee (IEC). The as of late revised
Schedule Y of Drugs and Cosmetic Rules
arrange the creation of the IEC according to the ICMR rules. The DCGI’s office
in a joint effort with WHO ICMR and many submitted look into
experts, has been directing preparing programs for individuals from the Ethics Committees the nation over.Clinical trials in India are controlled by Schedule Y of the Drugs and Cosmetics Rules.
The Rules are authorized by the workplace of the DCGI who is likewise in charge of observing every single clinical trial submitted to
that office for endorsement. For new medications being produced in India clinical trials must be directed in India from stage.7 For advertising endorsement of medications effectively
affirmed in different nations, a stage 3 clinical trial is required on around 100 patients in at
least three focuses, with a specific end goal to set up the medication’s effect on the Indian ethnic
populace. An application for another sign of an effectively endorsed medicate
is dealt with as an application for another medication’s endorsement. New definitions of affirmed medications might be
subjected to bioequivalence thinks
about. Till January 2005, clinical trials of new medications being created
outside India were allowed
just with a “stage slack”:
a stage 2 trial could be led in India
simply after stage
3 trials were finished
somewhere else. Stage 1 trials of outside medications were not permitted, except for medications of exceptional pertinence to India. This proviso empowered, for instance, stage
1 trials of HIV immunizations in India. Truth be told, universal multi-centre trials have been directed in India since
the mid-1990s. As of January 2005, an alteration of Schedule Y of the Drugs and Cosmetics Rules got rid of the stage
slack in worldwide clinical trials
directed by remote patrons. There are never again any confinements on
“simultaneous stage” clinical trials
in India. Stage 2 and stage 3 trials of medications found abroad may now be led in India in a similar stage and
in the meantime as they are directed in different parts of the world. The trial support
must get endorsement from the DCGI before beginning a trial. For this
endorsement, the support must submit information from pharmacokinetic and
creature thinks about furthermore,
past stage trials; data on the administrative status of the medication in different nations,
the trial convention, specialist’s leaflets and educated assent
reports. Trials can’t be begun without
leeway from the nearby morals
audit board of trustees (EC) at each site.
|
IMPACT OF SCIENCE AND TECHNOLOGY
C. G. Weeramantry, in his book, states that the spectacular advances
in science and technology that have continued unabated have
emphasized the urgency of the problems. He further states that, the urgency grows on two fronts -
the scientific and the practical - and in combination these two factors which produce an exponential growth in the
urgency and the magnitude of the problem.
8He says, the world for the betterment of the human
condition can no longer ignore
the problem since every step forward in science and technology, the
power of these forces to affect human
society for better or for worse has increased. With every passing
year that power
will increase and the need to use it in the interest of human rights
will grow correspondingly more
urgent. He further elaborates that the power of science and technology keeps
growing, and the problems
we are addressing will worsen. He illustrate it with an example, he says, given
that the right
to food and a pure environment is a recognized human right, the problems facing
us today at the beginning of the 1990s are far
more acute than they were in the
early 1980s.
Thus it becomes very important to peruse the role of
science and technology and its impact
on human rights. Science and technology is no longer the subject of a
complacent assumption that they are synonymous with progress, freedom,
and the betterment of the human
condition. Consequently, the decisions associated with their adoption
are no longer seen as neutral and
value-free. Rather, they generate strong support or opposition, provoke
emotional reactions, and, indeed, become political issues of considerable importance.
The discussions surrounding these decisions raise
sharply such issues as whether science and technology determine the course of their own development or whether society
can and should control them.
Human rights issues become inextricably interlinked with decisions regarding
suitable scientific and technological models for a given society.
Conclusion
Law and science are codependent on each other
despite being different disciplines. Law interacts
with science and technology on different levels and diverse ways. These
interactions proliferate in the
future with advancing technologies that present risks, benefits, and ethical implications on society. The field of law,
science, and technology attempt to bridge the gap between these two fields of study and also tries to tackle the challenges faced by
law, science,
8 https://blog.se.com/sustainability/2023/03/15/the-impact-of-science-and-technology-on-sustainable-future/
and technology. It also seeks to provide
a systematic treatment
of the actions and problems
that would eventually help these subjects
evolve in parallel and at pace
with subject matter.Law plays an essential part in the regulation
of science and technology and concerning the
ethical consequences of scientific research along with modern
technologies. This field of law, science,
and technology attempts to study systematically the diverse ways in which law interacts
with science and technology. It has been defined as “the discipline that deals with how our legal system can and must adjust to
accommodate the problems created by the ever more urgent and ubiquitous
impact of technology on society.”
Article Information
NEXUS BETWEEN SCIENCE TECHNOLOGY AND LAW BY: RUTVIJ RAJESH YEWALE
Authors: RUTVIJ RAJESH YEWALE
- Journal IJLRA
- ISSN 2582-6433
- Published 2024/04/24
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
- Access Open Access
- License CC 4.0
All research articles published in International Journal for Legal Research and Analysis are open access and available to read, download and share, subject to proper citation of the original work.
Disclaimer: The opinions expressed in this publication are those of the authors and do not necessarily reflect the views of International Journal for Legal Research and Analysis.