Alphonse Kambu - UNU-IAS

21 st Pacific Science Congress
Strengthening Linkages between
Science and Policy
Issues and Concerns about Biomedical
Research involving Indigenous and Local
Communities: Hagahai of Papua New Guinea
Alphonse Kambu

Overview
1. Merits of Biomedical
Research
2. Issues and Concerns
3. Hagahai Case
4. Lessons for the Future
Source: PNG IMR

1. Merits of Biomedical Research
• Finding solutions to medical
problems, curbing chronic
diseases (HIV/AIDS, malaria,
etc) and improving health care.
• Drug discovery.
• Contribution to knowledge base.
• Sharing of results for academic
and educational purposes.
• Achievement of UN Millennium
Development Goals.
• Intentions of biomedical
research are good.
Source: PNG IMR

2. Issues and Concerns
• Sensitivity of the nature of research
– Deals with humans
• Ethical dimensions
– Embarks upon issues such as life
• Religious reasons
– What are the religious views and are they considered in biomedical
research?
• Social and cultural aspects
– What do the social and cultural norms say and are they being
consulted?
• Information Strategy
– Prior Informed Consent
– Privacy
– Ownership of information
• Policy and legal grounds
– Do the right kind of laws and policies exist and are they being
consulted?

3. Hagahai Case
• Background
– Hagahai Tribe of Papua New
Guinea (PNG).
– PNG Institute of Medical
Research (IMR): Dr. Carol
Jenkins.
– 1995 US Patent No. 5,397,696
involving the “human t-
lymphotropic virus” (HTLV-I).
– Patent listed Dr. Jenkins and 4
other US Government
researchers for the “invention” .
– Patent revoked after global and
domestic controversies, but the
cell is being still kept alive in the
library at NIH despite request
from Dr. Jenkins to destroy it.
Source: PNG IMR

3. Hagahai Case, cont’d
• Why the controversy
– Communication strategy
– Policy and legal grounds
– Social and cultural reasons
– Religious and ethical reasons

3. Hagahai Case, cont’d
• Communication Strategy
– Prior Informed Consent
• Purpose and process should be
CLEAR, SIMPLE and
UNDERSTANDABLE to subjects of
research
– Contents of communication: nature
of activities, process, pros and cons,
– Wider consultation, discussion and
dialogue among stakeholders
– Right of stakeholders and duty of
researchers, research institutions, etc.
– Duty of researchers and research
institutions to inform should not be
perceived as a burden, but a positive
step
• Helps educate others about oneself
and the nature of activities and
clarifies doubts
• Helps secure public approval and trust
– Ownership of information
• Patents
Source: PNG IMR

3. Hagahai Case, cont’d
• Lack of realistic understanding of
direct benefits of gene patenting on
drug and other benefits for the
majority
– Public versus private interests in
research
– Drugs on the market are
prohibitively priced and cannot be
afforded by many (40 million people
in the world living with HIV/AIDS;
closing down of health centers due
to lack of essential drugs for malaria,
typhoid, pneumonia, etc in rural
areas of PNG)
– Can another patent evolving from
biomedical research being
conducted on poor indigenous
communities really help solve their
health problems and the broader
majority when 85 % of people in
PNG are poor subsistence farmers
who are not able to afford basic
drugs?
– Good intentions of biomedical
research is put to test
Source: PNG IMR

3. Hagahai Case, cont’d
• Why the controversy
– Communication strategy
– Policy and legal grounds
– Social and cultural reasons
– Religious and ethical reasons

3. Hagahai Case, cont’d
• Policy and legal grounds
– Were there concrete and clear policies and laws on the issue? Have
the laws and policies been considered?
– Non-existent of specific laws and policies
• Constitution of PNG
– Fundamental Human Rights and Freedom
• Right to Life and the enjoyment of it and not to deprive it (Section 35).
• Patenting of information derived from genes, the building blocks of life,
is an issue that can be directly linked with the right to life and its
deprivation.
• The very act of taking patents on information derived from genes can
interfere with the right to life in that patents have a potential to hinder
the free use of the information and its source (genes and DNA)
– Exploitation of the silence or ambiguity of PNG laws
• Institute of Medical Research Act (1967) establishes the PNG IMR and
provides for the conduct of research in any field of medical science or
biology, anthropological and sociological aspects of health and illhealth
and public health in general.
• Silent on a case such as the Hagahai Patent Case or patenting of
results in general

3. Hagahai Case, cont’d
• Why the controversy
– Communication strategy
– Policy and legal grounds
– Social and cultural reasons
– Religious and ethical reasons

3. Hagahai Case, cont’d
• Social and cultural reason
– Do cultural practices and ideologies allow for
ownership of genes, life, DNA? Have cultural and
social norms and practices of the indigenous
community been observed?
• Customary Laws and Practices (Kastam)
– Norms, principles, values, wisdom and processes in
both formal and informal institutions, and observed
by 85% of the PNG population
– Do not speak directly of life patents, but very
important to consult when determining matters of
public interest or common concern such as patenting
of information associated with a gene which is a
common heritage of mankind
– Rule or Principle of Communitarianism
– Consultation
– Transparency
– Consensus
– PNG Ways (Preamble of the Constitution)
• National affairs or development to be conducted
through PNG Ways
– Patenting of information derived from the common
good should have involved wider stakeholder
consultation through PNG Ways
– The Hagahai Patent Case failed to consider the reality
of the socio-cultural practices and laws in PNG and as
such was inconsistent with Kastam and the spirit of
the Constitution
Source: PNG IMR

3. Hagahai Case, cont’d
• Why the controversy
– Communication strategy
– Policy and legal grounds
– Social and cultural reasons
– Religious and ethical reasons

3. Hagahai Case, cont’d
• Religious and ethical reasons
– Have the religious principles and
practices in the country being considered?
– Can human genes, the building blocks of
life be owned under these principles?
• Disregard for Christian faith
• PNG Constitution declares the itself a
Christian country
• 90% of the population in PNG upholds
the faith
• The Christian faith preaches that humans
and body parts (including genes) are ends
in themselves and not means to ends;
humans and their body parts in their
entirety are God’s creation and therefore
sacred, and should not be meddled with
or commodified
Source: PNG IMR

3. Hagahai Case, cont’d
• Latest developments in PNG
• Patents and Industrial Designs Act (2000) Section 2
– “…“invention” means an idea of an inventor, which permits in
practice the solution of a specific problem in the field of technology
and may be, or may relate to, a product or process, but does not
include – (a) a discovery, scientific theory or mathematical
method; or (b) a scheme, rule or method for …”
• Explanatory Notes and Guide on Filing New Patent and
Industrial Designs Application
– “…It should be noted also that the essentially biological
processes cannot be patented. Microbiological processes,
however, are patentable. This means that an invention that has very
little “human input” but which generally allows natural biological
processes cannot be protected. Essentially biological processes would
include the art of cloning or simply nurturing plants or animals.
Similarly human genes (occurring naturally) cannot be
patented.”

4. Lessons for the Future
• Significant lessons
– Emphasis on a holistic approach in undertaking biomedical R&D
(moral, ethical, legal and socio-cultural dimensions).
– Communication strategy that facilitates free flow of information
that is adequate, simple and comprehensible among all
stakeholders to enhance understanding and elicit trust and
minimize controversy
• PIC Procedures to be followed
– Looking beyond the immediate and direct laws, principles and
norms and policies associated with biomedical R&D
– Observing socio-cultural norms and practices of the land and
people when conducting biomedical research
– Application of the precautionary principle to weigh the costs and
benefits
– Strengthening the link between science, policy and other disciplines

THANK YOU
Source: PNG IMR