law and emerging technology notes on genetic technology

1. Genetic Technologies
(Natural Resources and
Biodiversity Act)

2. Introduction
 Research and development in modern biotechnology and gene technology
cover a broad area from stem cell research and the development of medical
genetic testing to the use of genetically modified plants, microorganisms
(including viruses) and animals.
 Modern biotechnology can provide new solutions in a number of areas such
as the health services, food production and the legal system.
 But there are some potential future risk factors relating to animal and human
health, the environment and society making the regulation of modern
biotechnology a challenge.
 Since modern biotechnology may lead to major social changes, it is argued
that people in general should be involved in the decision-making processes.
This way the authorities and those who develop the technology can obtain a
more holistic picture of the consequences the technology may have for social
development.

3. Topics
 There are many topics in which modern biotechnology and gene technology
are used. They are :
 Genetically modified organisms (GMOs)
 DNA vaccines
 Human biotechnology
 Gene therapy
 Stem cell research

4. Genetically Modified Organisms
 Gene technology today is an important part of modern biotechnology and is
used, among other things, to give bacteria, plants and animals new
properties. This is possible by inserting a gene from, for example, a
bacterium, into a plant or animal (transgenes).
 The producers develop GMOs for the purpose of giving us vaccines and
medicines, more effective aquaculture and agriculture, and cheaper food.
 Insect-resistant and pesticide-tolerant plants or plants with a combination of
these properties are the most common GM plants. Soon the market will offer
GM plants that tolerate drought, are more suitable for producing ethanol,
medicines and vaccines.
 Norway has adopted restrictive regulations concerning the use of GM
plants in agriculture.
 In the period 2007–2014, feed producers in the aquaculture industry had
authorisation to use processed GM plants in the manufacture of fish feed.
The licence was valid for one year at a time and only allowed producers to
use GM plants for feed production in emergencies.

5.  Since the producers did not use GM plants during this period, the licence was
withdrawn in 2014. By the same token, in 2015, the Norwegian authorities
recommended approval under the Gene Technology Act of GM maize for
import and processing. Before this maize can be used for food and feed it has
to be approved under the Norwegian Food Act.
 The producers of GM plants promise higher quality and greater efficiency in
agriculture, while the sceptics are concerned about unforeseen effects on
health, the environment and society. The expected consequences are short-
term benefits, while the unintended consequences (for health and the
environment) are often poorly investigated and may emerge over time.
 The Norwegian Gene Technology Act is unique in that it has five criteria
(environment, health, societal benefit, sustainability and ethics) for approval
of a GMO.
 In the EU and countries that have ratified the Cartagena Protocol, there is a
growing focus on socioeconomic effects. Little is known today about GMOs
and their relations with socioeconomics, societal benefit and sustainability.
 (The Cartagena Protocol is an international agreement aimed at regulating
the use of biotechnology in agriculture. Signed in 2000, the protocol seeks to
ensure the safe handling, transport, and use of living modified organisms
(LMOs) to avoid potential risks to biodiversity and human health.)

6. DNA Vaccines
 DNA vaccination is defined as intentional transfer of genetic material (DNA or
RNA) to somatic cells in order to influence the immune system. (Somatic cells
are non-reproductive cells in the body that are involved in the development
and maintenance of tissues and organs. They are distinct from germline cells,
which are responsible for reproduction. Somatic cells can differentiate into
various cell types, such as muscle cells, nerve cells, and epithelial cells, to
replace damaged or aged cells in the body. )
 In recent years, DNA vaccines have received a great deal of attention,
especially since they represent a novel possibility for preventing diseases
against which there are no reliable vaccines at present.
 There are many uncertainty factors with regard to what consequences DNA
vaccination may have for the organism that is vaccinated, and whether other
organisms in the surrounding environment will be affected.
 It is also unclear at present how DNA vaccines should be defined and
regulated, and whether the vaccinated organism can be defined as GMO,
which may have implications for market acceptance.

7. Human Biotechnology
In connection with humans, modern biotechnology
includes methods for producing medicines, for
detecting a genetic disposition or a disease or
disorder, methods for curing diseases, and
methods for enhancing human characteristics.
(Genetic disposition refers to an individual's
inherited genetic traits or predispositions that can
affect their health, behavior, or susceptibility to
certain diseases. It is determined by a combination
of genetic and environmental factors and can
influence everything from eye color and height to
susceptibility to certain diseases.)

8. Gene Therapy
 Gene therapy makes it possible to alter one or more genes that cause
illnesses that cannot otherwise be treated.
 A distinction is made between gene therapy on somatic cells (all the cells in a
body apart from gametes (sex cells)) and on gametes.
 In gene therapy on somatic cells, the procedure on humans aims to repair the
gene that causes disease. Gene therapy on gametes (ova (egg cells),
sperm)) or fertilised ova is most controversial, as the intervention will be
passed on to future generations.
 Recently developed technology such as CRISP/Cas9 can also alter genes,
and should therefore also be covered by the term 'gene therapy'.
 For example, PGD can be used to select gender. The same applies to the
possibility of deselecting disabilities and diseases. (Pre natal gender
screening)
 Tissue typing, for picking characteristics intended to ensure that tissue or
organs from a future child can cure its brother or sister of a serious illness, is
another example.

9.  A dilemma is that the potential latent in gene therapy can lead to expectations
and promises being linked directly to questions of access to grants, and give
rise to uncritical and unrealistic hope dynamics, with underestimation of time-
consuming innovation processes.
 This may overshadow the need for quality assurance, for prudent regulation
and for development to take place in accordance with important social needs
and accepted ethical norms.
 In a future where we may have the opportunity to cure serious diseases, it is
easy to forget that gene therapy also entails a risk of unexpected effects.
 For example, there have been reports of gene therapy having unexpected
effects such as early death and the development of rare diseases.

10. Stem Cell Research
 Today research takes place on stem cells from adults, children, umbilical cords
and cloned embryos. The most promising area, but also the most controversial, is
curing diseases like Alzheimer's and Parkinson's with the aid of stem cells from
cloned embryos. (the body's raw materials — cells from which all other cells with
specialized functions are generated)
 With stem cells from cloned embryos, the patient gets fresh cells, tissue or
organs from his or her newly produced twin.
 For many, the ethical problem associated with therapeutic cloning appears to be
the cloning itself, while for others it is the fact that in carrying out therapeutic
cloning we are also accepting the production of human life exclusively for
research purposes.
 Research ethics in the field of medicine has concentrated on protecting the
individual and preventing immoral actions from being performed in the name of
research.
 In Norway, therapeutic cloning is prohibited, and this has given rise to an
interesting debate around the questions: 1. Should we refrain from using the
potential opportunities in therapeutic cloning and research on fertilised eggs? 2.
Should we be able to use the published research results from countries where
such research is legal?
 For example, if treatment of Parkinson's disease becomes possible in Denmark,
it will hardly be possible to prevent Norwegian patients from going there for
treatment.

11. Biodiversity Act, 2002
 The dependence of human beings on biological diversity is beyond challenge,
as evident in everyday life. The food, fibre, fuel, fodder, shelter, health and
other needs of the growing world population are dependent on various
components of biodiversity. Plant genetic resources for food and agriculture
are a common concern of all countries and most countries depend largely on
plant genetic resources that have originated elsewhere.
 Therefore, the sustainable use of biological diversity at the national as well as
international level is of critical importance. For this reason, the access to and
sharing of both genetic resources and technologies for their sustainable use
among nations are essential.
 A legally binding agreement, Convention on Biological Diversity (CBD),
was adopted by the United Nations Conference on Environment and
Development, held at Rio de Janeiro in June 1992.
 The main objectives of the CBD are ‘the conservation of biological diversity,
the sustainable use of its components and the fair and equitable sharing of
the benefits arising out of the utilization of genetic resources.

12.  The Convention reaffirmed that country have sovereign rights over their biological
resources and that the countries are responsible for conserving these resources and using
them in a sustainable manner.
 The contracting parties to the CBD (which included India) was, therefore, required to
integrate considerations of conservation and sustainable use of biological diversity
into its country level programmes and polices.
 In India, access to biological resources for research, and for commercial utilisation
including Intellectual Property Rights (IPR) was an unregulated domain until the Biological
Diversity Act, 2002 was passed by the two houses of Parliament.
 With rising bio-piracy and bio-based trade it was felt that serious checks were needed, and
that these should have the force of law.
 It was also becoming clearer that legislation should be crafted so that the conservation of
biodiversity is considered as a whole, and not only through the lens of sector-specific laws
of forest, wildlife, water and pollution.
 Further, there was also a need to check the illegal access to natural resources and also the
'theft' of traditional knowledge based on these resources.
 All of these pointed to the need for comprehensive legislation around the principles of
sovereignty and decentralisation for a more people-based conservation.
 Also, access to India’s biodiversity and/or associated traditional knowledge for research
and commercial utilisation, especially by foreign entities needed legal regulation and
monitoring.

13. Brief on Biological Diversity Act
 “Biological Diversity Act 2002” (hereafter referred as BD Act) was passed by the
Lok Sabha on 2nd December, 2002 and by the Rajya Sabha on 11th December
2002.
Some salient features of the act are:
 to regulate access to biological resources of the country with equitable share in
benefits
 arising out of the use of biological resources.
 to conserve and sustainable use of biological diversity.
 to set up National Biodiversity Authority (NBA), State Biodiversity Board (SBB)
and
 Biodiversity Management Committees (BMCs).
 to create National, State and Local Biodiversity Fund and its use for conservation
of biodiversity.
 to respect and protect knowledge of local communities traditional knowledge
related to biodiversity.
 to conserve and develop the areas of importance from the standpoint of
biological diversity by declaring them as biological diversity heritage sites.

14. Case Study:
Traditional Knowledge of Kani Tribe in
Kerala
 The subject of this case study is the role of intellectual property rights in the
benefit sharing arrangements concerning the “Jeevani” drug, which was
developed by scientists at the Tropical Botanic Garden and Research Institute
(TBGRI), based on the tribal medicinal knowledge of the Kani tribe in Kerala,
South India. “Jeevani” is a restorative, immune-enhancing, anti-stress and anti-
fatigue agent, based on the herbal medicinal plant arogyapaacha, used by the
Kani tribal in their traditional medicine. Within the Kani tribe the customary rights
to transfer and practice certain traditional medicinal knowledge are held by tribal
healers, known as Plathis. The knowledge was divulged by three Kani tribal
members to the Indian scientists who isolated 12 active compounds from
arogyapaacha, developed the drug “Jevaani”, and filed two patent applications on
the drug (and another patent based on the same plant but for different use). The
technology was then licensed to the Arya Vaidya Pharmacy, Ltd., an Indian
pharmaceutical manufacturer pursuing the commercialization of Ayurvedic herbal
formulations. A Trust Fund was established to share the benefits arising from the
commercialization of the TK-based drug “Jevaani”. The operations of the Fund
with the involvement of all relevant stakeholders, as well as the sustainable
harvesting of the arogyapaacha plant, have posed certain problems which offer
lessons on the role of intellectual property rights in benefit-sharing over medicinal
plant genetic resources and traditional medicinal knowledge.

15.  The need for multi-stakeholder frameworks for discussing the scope of
access, value addition and benefit-sharing was brought to light by this case
study. If the Forest Department has jurisdiction over a territory, then the
Department must be included in the stakeholder discussions while
establishing benefit-sharing mechanisms. Further, the rights of informants
and that of the community need to be distinguished in the benefit-sharing
arrangements. The informants were the first to receive payment from the
amount deposited in the community trust. Actually they should have been
paid from the resources that scientists and research institution (in this case,
TBGRI) received. By not doing so, an avoidable impression was created
among the Kani tribals that the trust was supposed to benefit only a few
community members. The real intention of the scientists was to help the
community to manage resources through their own volition and institutions. It
is important to note that the Trust Fund came into existence only because
patent applications were filed for the value-added processes developed from
local knowledge and licensed to a commercial entrepreneur.

16.  The fact that scientists did not claim any share from the license fee goes to
prove that their values and motivations, as reflected in the benefit-sharing
arrangements, were focused on equity and the fair sharing of benefits. The
patent applications filed on drugs based on arogyapaacha were all national
process patent applications, none had been granted, and yet licensing of the
technology had already yielded a very good amount, fifty percent of which
was shared with the community. This is an important indicator of the potential
which the effective use of intellectual property rights might have to generate
benefits which can be shared with the communities. As this case illustrates,
the use of intellectual property rights can in some cases help to generate
benefits, even before exclusive rights over the TK-based invention are
granted.

17.  The scope of benefits to be shared could have been much wider if international
patent applications had been filed under the Patent Cooperation Treaty
administered by WIPO, to protect the formulation in countries other than India;
product patents were available in India for pharmaceutical products, not only
process patents, and trademarks had been registered to protect the distinctive
signs distinguishing this product from those of other undertakings. At the same
time, these intellectual property rights would not have restricted the rights of local
communities. The case highlights the possibility of third party Trademark
protection as done by NutriScience Innovations, LLC, USA which owns Jeevani
Trademark in the United States of America. This in turn would have generated a
much higher share of funds to be shared with the Kani tribe and also to fund
future research.
 The degree of involvement of various tribal settlements and groups could have
been increased. The rights of informants vis-à-vis the communities requires more
discussion among the communities themselves. The role of the Plathis as an
informal association of healers which hold rights to the use of certain traditional
medicinal knowledge was not recognized by the benefit-sharing arrangements in
this case. The Forest Department had not permitted the cultivation and collection
of the arogyapaacha plant. This was so in spite of the fact that the plant could be
easily cultivated and many tribal had actually done so. The tribal informants were
not named as co-inventors in the patent application.

18. Conclusion
 With the introduction of the Biological Diversity Act, which curtails availability
of genetic material from India to the rest of the world is bound to influence the
free scientific exchange of valuable research.
 The NBA, whose main objective is equitable sharing of benefits, even after
several years of its establishment, is neither known to have delivered any
benefit to the stakeholders of biodiversity in the country nor have contributed
to the conservation of biodiversity.
 Further, from the case study of Kani tribal, we can easily deduce the
importance of knowledge sharing and joint scientific developments.
Intellectual Property Rights and Patents are vital instruments for securing
economic benefits, which can lead to the sustainable development of the
local community and also towards the sustainability of the bio resource. BD
Act 2002, is counter productive to India’s position on IPRs and Patents Bill.

19.  India’s position on CBD in Rio de Janeiro in 1992 seems to be based on little
scientific input and can easily turn out to be counter-productive and self-
defeating. As India (every other country too) heavily depends on global
biodiversity for sustenance, we should ideally have argued for open access and
free exchange of genetic resources in Rio de Janeiro. But perhaps the lure for
benefit sharing blinkered us to overlook our high dependency of food industry,
agro sector, and many other sectors on the import of exotic gene plasms.
 The BD Act differentiates between domestic companies and the MNCs, although
the provisions of TRIPS demand that MNCs be treated at par with domestic
companies. The Act may also adversely affect research, because the researchers
from abroad may need approval of NBA and the domestic researchers may need
to register with SSB for using the biological resources for research purposes.
Further, the Act does not seem to have an overall riding effect on the existing
laws on wildlife and forests, and it is not clear which law will prevail, in case of a
dispute. BD Act should make provisions or exemptions in the law for biodiversity
research because the cost and time to get permits is very prohibitive and many
amateur, self-financed researchers might not be able to carry on with their
research. It can be seen that although the Act aimed at important issues, the
fulfilment of the goals can be a problem if the weaknesses pointed out are not
sorted out quickly.

20. END