NIMBB UP DILIMAN

CYNTHIA T. HEDREYDA, Ph.D

National Institute of Molecular Biology and
Biotechnology
University of the Philippines Diliman
 Emerging Issues in Biotech Law
1. Privacy and confidentiality Genetic data

2. Regulation
Genetically Modified Organisms (GMO’s)

3.Liability
Malpractice cases related to genetic testing

4. Forensic evidence

5. Intellectual property
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 National Policies
Article II of the 1987 RP Constitution
Section 15 -Protection and promotion
of right to health
Section 16 – Protection and advancement
of right of people to a balanced
and healthful ecology in accord
with the rhythm and harmony of
nature
Section 17 – Priority to education, science
and technology…
Science and Technology
Article XIV 1987 Constitution

Sec. 10 – S&T are essential for national

development and progress. The State
shall give priority to research and
development, invention, innovation and
their utilization…
National Policy on Biotech

The State shall promote the safe and

responsible use of modern biotechnology
and its products as one of the several means
to achieve and sustain food security,
equitable access to health services,
sustainable and safe environment and
industry development.
Philippine Laws On Biosafety
EXECUTIVE ORDER NO. 430 (1990)
CONSTITUTING THE NATIONAL COMMITTEE ON
BIOSAFETY OF THE PHILIPPINES (NCBP) AND
FOR OTHER PURPOSES
NCBP shall
Undertake the study and evaluation of existing
laws, policies and guidelines on biotechnology
and its related matters
Recommend such measures for its effective
utilization and prevention of possible pernicious
effects in the environment
National Committee on Biosafety
of the Philippines
Coverage:
work involving genetic
engineering

activities requiring the importation,

introduction, filed release and
breeding of potentially harmful
organisms
National Committee on Biosafety
of the Philippines
Identify and evaluate potential hazards
involved in :
initiating genetic engineering
experiments or the introduction of new
species and genetically engineered
organisms
Recommend measures to minimize
risks
Philippine National Policies on
Biosafety
“shall not engage in any activity related to
chemical and biological warfare”

“Guidelines shall apply to all research,

production and manufacturing work and/or
institutions in the country, whether public or
private, national or international, engaged in
genetic engineering work”
 Composition of the NCBP
Chairperson: DOST Undersecretary for R&D
Members:
1 biological scientist
1 environmental scientist
1 physical scientist
1 social scientist
2 respected members of the community
1 representative each from the DA, DENR, and
DOH to be designated by the respective Heads
of Offices
 Important Definitions in Appraising
Hazards Due to Biotechnology

Hazard: “a characteristic that, in particular

circumstances, can lead to harm”

Risk: “the chance, in quantitative terms, of

harm occurring from a defined hazard,
and the expression “risk of (a specific
event or set of events)” must refer to the
hazard
Important Definitions in Appraising
Hazards Due to Biotechnology

Harm: “occurs when a hazard is realized

and damage is done to a human being
(or other organisms or to the
environment)”
Damage: “loss of inherent quality
suffered by an entity (physical or
biological)
Specific Biosafety Concerns in
Biotechnology
A. Environmental Safety:
containment policy appropriate for the
biohazard level of the organism used
B. Product Safety:
adherence to
a. Good Laboratory Practice (GLP) and
b. Good Manufacturing Practice (GMP)
c. Toxicity and potential adverse effects of
therapy shedding of viral vector used
 Specific Biosafety Concerns
in Biotechnology

C. Use of selectable markers in production

of GMOs
Features of selectable markers to be
considered in assessing their hazards a. a.
a. Toxicity of the gene used as marker
b. Toxicity of the gene product
c. Transfer of the marker gene to
pathogens in the environment
d. Potential damage to the environment
due to the marker gene
 Specific Biosafety Concerns in
Biotechnology
d. Horizontal gene transfer
- spread of genes from a plant to microorganisms through
non-sexual processes
- residues of genetically modified crops are a potential
source of genetic pollution which may lead to antibiotic
resistance in pathogens or microorganisms
- estimated contribution due to GM crops is
- 5.4 x 10-6, which is comparable to the natural frequency of
mutation
Specific Biosafety Concerns in
Biotechnology:
e. Breakdown Products
f. Non-specific Catalytic Activity
Marker gene e.g. kanamycin resistance gene
(phosphotransferase) may act on other products of
the GMO (e.g. plant), which may result in
pharmacologically active substances
Gene products involved in phosphorylation reactions
g. Crop Management
 Bioprospecting/Biopiracy
EXECUTIVE ORDER NO. 247 (1995) Prescribing
Guidelines and Establishing a Regulatory Network
for the PROSPECTING OF BIOLOGICAL AND
GENETIC RESOURCES, THEIR BY-PRODUCTS AND
DERIVATIVES, FOR SCIENTIFIC AND COMMERCIAL
PURPOSES
• It shall be the policy of the State to regulate the
prospecting of biological and genetic resources so that
these resources are protected and conserved, are
developed and put to the sustainable use and benefit of
the national interest.
• Provides for Commercial Research Agreements
• Academic Research Agreements
 EO 247 Key Aspects
• Prior informed consent of indigenous
cultural communities if prospecting biological
and genetic resources within their ancestral
lands and domains

• Prior informed consent of concerned local

communities
 EO 247 Minimum Terms
• There must be a limit on samples that may be
obtained and exported
• Complete set of all specimens collected shall be
deposited with the National Museum or other
government entity
• Access to collected specimens and relevant
data deposited abroad shall be allowed to all
Filipino citizens and Philippine governmental
entities
 EO 247Minimum Terms
• Collector must inform the Philippine
government and affected local and
indigenous cultural communities of all
discoveries from the activity conducted in
the Philippines if a commercial product is
derived from such activity
• Royalties shall be paid to the National
Government, local or indigenous
community in case commercial use is
derived from the biological and genetic
resources taken
 EO 247Minimum Terms
If Collector is a foreign person or entity,
scientists who are Filipino citizens must
be actively involved in the research and
collection process, and where
applicable or appropriate, in the
technological development of a product
Such involvement shall be at the cost of
the Collector
 EO 247Minimum Terms
• Collector shall be encouraged to avail
of services of Philippine universities
and academic institutions
• Where applicable and appropriate,
Collector shall be required to transfer
equipment to a Philippine institution or
entity
 Bioprospecting/Biopiracy
REPUBLIC ACT NO. 9147 (2001) Wildlife Resources
Conservation and Protection Act
Bioprospecting: research, collection and utilization of
biological and genetic resources for purposes of
applying the knowledge derived therefrom solely for
commercial purposes

Bioprospecting shall be allowed upon execution of an

undertaking by any proponent, stipulating therein its
compliance with and commitment(s) to reasonable
terms and conditions that may be imposed by the
Secretary (of the DENR) which are necessary to protect
biological diversity
 DAO No. 8
Department of Agriculture
ADMINISTRATIVE ORDER No. 8
Series of 2002 Rules and Regulations for
the Importation and Release of Plants
and Plant Products Derived from the
Use of Modern Biotechnology
 DAO No. 8
Scope
The importation or release into the
environment of:
Any plant which has been altered or produced
through the use of modern biotechnology
if the donor organism, host organism, or
vector or vector agent belongs to any of the
genera or taxa classified by BPI as meeting
the definition of plant pest or is a medium
for the introduction of noxious weeds
 DAO No. 8

Any plant or plant product altered

or produced through the use of
modern biotechnology
which may pose significant risks to
human health and the environment
based on available scientific and
technical information.
 Cartagena Biosafety Protocol
Ensures adequate level of protection in the
field of the safe transfer handling and use
of living modified organisms resulting
from modern biotechnology that may
have adverse effects on the conservation
and sustainable use of biological
diversity taking also into account risks to
human health and specifically focusing
on transboundary movements