Framework for Access Benefit Sharing in PNG: Implementation of the

Convention on Biological Diversity

Teatulohi Matainaho

School of Medicine and Health Sciences

University of Papua New Guinea

Oceania Biodiscovery Forum

November 19-23, Brisbane, Australia

Papua New Guinea’s Biodiversity

• 70% covered by tropical rainforest

• Covers less than 1% world land mass but contains more 5 % biodiversity

• probably represent 400, 000 species of life forms (fungi, plants, animals)

• Native flora contains 15, 000 to 20, 000 species of vascular plants

• Has more than 3, 000 orchid species

• 242 mammals, 762 species of birds, 305 species of reptiles, 200 species of

amphibians

• 329 or more freshwater fish species

• Invertebrate diversity is about 400 species

• 3000 species of marine fish

• 300 species of coral species

• 43 species of bird of paradise: 39 endemic

The Need for Integrated Environmental &Biological Strategy

• Support biodiversity conservation

• Explore bio-economic options for development

– Current policies do not recognize the sustainable economic benefits from the use of biological resources

• To carry out an economic, medicinal and commercial evaluation of biological resources

– Assessment vital for continuous utilization and diversification of biodiversity use to drive conservation

• Biodiversity severely threatened by unsustainable activities with short-term economic gain

– Rapid loss of biodiversity

• Biodiversity can provide materials / basis for biodiscovery process, product research & development- education and training

– Promote research, management and development of the biodiversity

• Develop a definition for ownership and Intellectual Property Rights

• Support the environment and reduce impact of climate change

PINBio (PNG BioNET) Establishment: Policy

and Legal Update

• 1998: PINBio Policy Approved by Government

• 2004: Legislative review of existing laws and policies on

biodiversity

• 2004: Access Benefit Sharing (ABS) workshop, Lae

• 2005: PINBio awareness workshop, Bougainville

• 2005: PINBio awareness seminar, Lae

• 2006: Study of cultural, social and economic issues that impact

on ABS

• 2007: Biodiversity draft legislation for Access Benefit Sharing-

pending

PNG Biodiversity Research and Development Programs

• Biodiversity Inventory/ Survey and Collection, including documentation of Indigenous Knowledge [FRI]

• Biodiscovery/ Drug Discovery, Herbal Medicine, Venoms and Toxins, and Aromatics [UPNG]

• Agrobiodiversity/ Agricultural Plant Genetics Resources, Agro-chemicals, and Horticulture [NARI]

• Biotechnology Applications [PNG UOT]

• Biodiversity Conservation/ Carbon Offset Sinks [UPNG & DEC]

• Biodiversity Database and Management/ Information Sharing

[PINBio/ DEC]

• Policy and Legislation/ Intellectual Property Rights Development/ Collaborative Arrangements [UPNG & Attorney General]

• Training and Infrastructure Development/ Capacity Building/ Technology Transfer [All]

• Education and Awareness [PINBio]

Integrated Goals for Environmental Sustainable Strategy

1. Biodiversity Conservation

2. Product (Value) Discovery

3. Economic Development

4. Infrastructure Development & Technology

Transfer

Key Objectives of Strategy

• Documentation and inventory of biological diversity

• Assess conservation status of biological resources and develop effective strategies for their preservation

• Develop safe and effective herbal remedies

• Discover and evaluate bio-active compounds to treat human diseases

• Discover and evaluate natural products as agrochemicals and improve crop production and generate economic benefits

• Discover and evaluate potential uses of genetic materials

• Discover and develop alternative renewable energy sources

• Conserve biodiversity and facilitate benefits through carbon trading mechanisms – in promoting carbon sinks

• Develop, share and manage information/ database relating to biodiversity

• Develop capacity building and facilitate technology transfer

• Protect biological resources through patent or Intellectual Property Laws.

• Create a public awareness for action on environmental protection and climate change

• Identify short-term programs with achievable outcomes

• Assess the extent of industrial output and assess

investment in domestically generated products

• Assess extent of IP in the definition of sovereignty and

ownership of raw biological products

• Define ownership and IPR in the context of indigenous

knowledge

• Assess the implications of IP as defined by WTO, on

traditional value systems

• Assess and evaluate the position of the country’s

resources and its value systems

• Define access in the context of CBD, UNCLOS etc. and as it

means to ensure a bioaccess policy

• Develop a biodiscovery fund to promote innovation in

research and development of new commercial products

Biodiversity Strategy

Biodiversity

Conservation

Knowledge

Economics

Translating Biodiversity into Knowledge and into Economics

“An Integrated Environmental Conservation- Biodiscovery-

Economic Development Strategy”

To Create Environmentally Sustainable Industries through Research,

Innovation and Development Our environmental/ biological resources are untapped, underutilized and losing very fast- and

greatly impacted by Climate Change

Environmentally Sustainable Option

Wealth Generation

Natural Form

Human Capital

Institutional Capital

Products

&

Services

Translating and Transforming Natural Wealth into Human Capital

and Institutional Capital and into Products and Services

Mutually Beneficial Collaboration

Biologically Rich Countries

Biotechnologically Rich Countries

Materials in Exchange for Biotechnology and Training

Bio-inventory

Biodiscovery Research

Medicines TB

HIV/AIDS

MALARIA

CANCER

Bio fuel Coconut Oil

Jatropha Oil

Herbal Products Coconut Oil

Noni Juice

Bio-innovation

Bio Industry Biodiversity Conservation

FROM ACCESS TO BENEFITS

The UPNG-UU ICBG Collaboration

• Our ICBG collaboration involves an integrated set of programs linking biological resource survey and conservation, drug discovery, technology transfer and education

• We built on active PNG programs and them linked with USA capabilities to build capacity for independent research

• This required coordinated development and acceptance of protocols for prior informed consent and access to biodiversity and equitable benefit sharing, while observing and implementing DEC and FIC guidelines and COBD goals

• The successful activities of our program have provided technology transfer including an equipped and active Biodiscovery Laboratory, and training opportunities for UPNG students having supported over 65 PNG students and contributing to more than 39 degrees so far. Two currently in Ph.D. programs in Australia.

• Elements of this UPNG/UU collaboration illustrates prototypic components of future research collaborations between UPNG faculty and foreign institutions.

Including: 1) infrastructure building, 2) training opportunities, 3)

inclusion and co-publishing, 4) faculty development, 5) community benefits,

6) intellectual property right agreements, and 7) real products.

Prior-Informed Consent: Meeting the Community

Goodenough Island Plant Collection

Bougainville Island Plant Collection

ICBG: Partnership Support Scheme (PASS)

ICBG: Facilitating medical services in remote community/ plant collection site

Providing

small water

tanks for small

village

Providing

appreciation

fee to

community

school

Team Work is Community Interaction and Partnership

Technology Transfer and Training Opportunities

• Established

and equipped a

Biodiscovery

laboratory

• Support for

>65 PNG

Students, >46

diplomas

• Technical

training for

Professional

Faculty and Staff

• Support for

~20 US Trainees

• 6 UPNG

Graduates have

Served as

Lecturers at

UPNG, 2 at

UNDP & NGO, 2

going on for

Ph.D.s

Biodiversity Survey

• Sustains

Herbarium

Activities, Led by

Trained Botanists,

underfunded since

~1990.

• Promotes

National Survey of

Endemic and

Indigenous

Species.

• Implements

Reconnaissance,

PIC, Outreach and

Benefit Sharing.

• Establishes

Partnerships with

Local Communities,

guaranteeing

Inclusion and

Feedback.

Dr. Osia Gideon

Pius Piskaut

Roy Banka

Robert Kiapranis

CNA 1992

Biodiversity Survey

• Led by Trained

Botanists Gideon and

Piskaut

• Identified Novel

Species Range and

New Species in Papua

New Guinea

• 1,700 Type Specimen

Vouchers Specimens

have been

Disseminated to Major

Herbaria World Wide

• Approximately 5%

Flowering Plants of

PNG Collected,

Approximately 480

Species Indigenous

and Endemic species

and Approximately 370

Species of Medicinal

Plants

CNA 1992

Janet Gagul

Extraction, Prefractionation, Screening and

Chemistry for Drug Discovery

20 g

sample

material

Extract

with

150 mL

MeOH

24 hrs

30 mL onto 150

mg HP20

Dry sample in

SpeedVac

Dry load column

Prefractionation –

each methanol

extract into 4

fractions

Dissolve in DMSO Extract Plates

1 mg for HIV, TB, other microbes & cytotoxicity

Structure

Determination

Thanks T. Bugni, M.K. Harper, and M. Dindi LCMS fractionation

21277CMI2005:L H3

m/z200 400 600 800 1000 1200 1400

%

0

100

PNH05-3-056-F2_lib 162 (5.308) Cm (154:179) 1: TOF MS ES+ 3.93e4711.2581

709.2602

113.0738

338.3413186.9391 631.3493

391.2806

429.2381

712.2651

731.2449

734.2484

743.2240

819.18301097.3514823.1785 1421.6121

NMR

Dereplication

& Prioritization Dereplication

Evodia (Melicope) elleryana

Student Project

CYTOTOXIC

ASSAY TB-MTT ASAY

50ug/ml

5ug/

ml

50ug/

ml

5ug/

ml

B-H A I A I

B-E I I A I

B-M A I I I

L-H A I +/-

L-E I I I I

L-M +/- I I I

S-H A I +/-

S-E +/- I I I

S-M I I I I

L.R. Barrows, E. Powan, C.D. Pond and T. Matainaho Anti-TB activity of Evodia elleryana bark

extract Fitoterapia 78, pg 250-252, 2007 Thanks E. Powan

• Used traditionally in

Kurti region of Manus

Island

• Locally called Sehit

• Water extract of bark

used for cough and fever

• Documented anti-TB

activity

Cassia alata

Medicinal Plant Surveys

Dr. Prem Rai

Thanks T. Matainaho & P. Rai

• Database set up by Rai and Matainaho in 2001 with WHO and Ministry of Health support

• Survey training & travel for >25 pharmacy and M.D. students • Provides documentation and preservation of traditional knowledge on >1,500 medicines, now

includes collection of samples for validation studies • Medicinal plant development now

promoted within PNG National DoH. The

global herbal supplements and remedies

market is forecast to reach US $107 billion

by the year 2017

Dr. M. Linge

COLLECT_ID

ASSAY_

CATEGORY

FAMILY ORDER GENUS SPECIES

TRADITIONAL USES

U20211 Anti-tuberculosis, HIV

CONVOLVUL-ACEAE

POLEMONIALES

IPOMEA PRES-CAPPRE

fever, headache, joint pains, swelling of the body; gonorrhoea, used as a uterine cleanser after child birth

U29012 Anti-HIV, malaria, tuberculosis

STERCULIACEAE

MALVALES

KLEINHOFFIA

HOSPITA

cough, dyspnoea & asthma

CASSIA ALATA

Anti-HIV, tuberculosis

FABACEAE ROSALES CASSIA ALATA fungal infection (tinea/grille)

U20536 Anti-HIV, tuberculosis

COMBRETACEAE

MYRTALES

TERMINALIA

CATAPPA

shortness of breath, cough, weight loss, loss of appetite; shortness of breath in asthma,

U20524 Anti-tuberculosis

RUBIACEAE RUBIALES

MORINDA

CITRIFOLIA

cough, shortness of breath, fever, productive cough, malaria symptoms (fever, vomiting, chills) ; TB

U20532 Anti-HIV, tuberculosis

APOCYNACEAE

GENTIANALES

CERBERA

FLORIBUNDA

malaria, pneumonia

U20525 Anti-HIV, malaria

GUTTIFERAE

THEALES CALLOPHYLLUM

INOPHYLLUM

enlarged spleen;

U29041 Anti-tuberculosis, HIV, Malaria

ANNONACEAE

MAGNOLIALES

CANANGA

ODORATA

cough; malaria symptoms (fever, headache, chills, vomiting)

U20555 Anti-tuberculosis malaria, HIV

APOCYNACEAE

GENTIANALES

ALSTONIA

SPECTABILIS

asthma; severe headache; cold & flu, malaria, asthma, cough (simple & strong)

• 407 biologically active plant fractions,

identified to species in ICBG collection.

• The active plants from the ICBG

collection were searched against the

Traditional Medicines database list of ~400

identified to species.

• This work had several limitations, e.g., in

the NAPIS data different parts of the plant

may have been analyzed pharmacologically

than is used traditionally, etc.

• 54 plants were found to have bioactivity

in our assays while at the same time are

used medicinally.

• Many have multiple pharmacological

activities, often including cytotoxicy

(36/54).

• 9 plants have activities in ICBG assays

that were consistent with the traditional

use.

• The Traditional Medicines Taskforce will

use these data, to inform healers regarding

their use, particularly the use of toxic

plants in high concentration.

Database Analysis

Minnie Bates’ Story, Herbal Medicines & Cosmetics

• Extraction of an analgesic/anti-inflammatory lichen

preparation with hexanes atranorin and chloroatranorin as

suitable marker compounds that accounted for >90% of

the extract (NMR and HRMS)

• Atranorin has been shown to block lipid peroxidation

while exhibiting little cytotoxicity and have COX 1

inhibitory activity at high concentrations

• Based on the published findings, Ms. Bate empirically

adjusted the strength of her preparations to improve

efficacy and reformulated her products using more

cosmetically attractive ingredients including coconut oil

• Ms. Bate won first place at a new entrepreneur fair and

has used ICBG data to support her marketing, she now

distributes her product to outlets in Japan

0

0.5

1

1.5

2

2.5

3

190

210

230

250

270

290

310

330

350

370

390

410

430

450

Wav elength (nm)

AU

LichenPreparation

Atranorin

Chloroatranorin

Lichen HexaneExtract

Atranorin and Chloroatranorin Bugni, T.S.; Andjelic, C.D.; Pole, A.R.; Rai, P.; Ireland, C.M.; Barrows, L.R. Fitoterapia. 2009; 80(5):270-3

Thanks M. Bate, S. Louwhoff

Building Infrastructure - Solid Products

• Honors and Masters work of Owen Paiva, with David Williams of the

AVRU (University of Melbourne) and Dr. Matainaho (UPNG). The

work was presented at the 2009 PNG Medical Symposium is now

published: PLoS Neglected Tropical Diseases: “Prelinical evaluation

of caprylic acid-fractionated IgG antivenom for the treatment of tiapan

(Oxyuranus scutellatus) envenoming in Papua New Guinea”

• Their work has generated a new equine whole IgG

monovalent Papuan taipan antivenom that is

Currently in GMP production at Instituto Clodomiro

Picado, Costa Rica (projected cost of ~$250

USD per vial, less than 25% of current antivenom)

• The lyophyllized product shows superior potency

it has passed preclinical assessment and is

ready for clinical testing

• Rosemary Benjamin completed her Honors project

studying snake venom phospholipase A2.

• Owen Paiva and Rosanne Power now employed by

$1.2M AusD AVRU development program to Dr.

Matainaho and Dr. Willams Anti-Venom!

Hemiasterlin, HTI-286, and Wyeth

Cytotoxins from Cymbastella

• Roberge showed that hemiasterlin was a

potent microtubule depolymerizing agent – Cancer Chemotherapy and Pharmacology 1997, 39,

223

• Completed total synthesis of hemiasterlin – Tetrahedron Lett. 1997, 38, 317

HTI-286: Taltobulin

• Synthesized a library of ≈ 50 hemiasterlin analogs (Hemiasterlin Tubulin Inhibitors)

• HTI-286 synthesized in 1998: IC50 ≈ 0.3 ng/mL

• Licensed to Wyeth - NCI - NCDDG program

• Advanced to Phase II clinical trials against non-small cell lung cancer

• Small number of positive responses

• Significant percentage of stable disease

J. Nat. Prod. 2003, 66, 183: Cancer Research 2003, 63, 1838

HTI-286 -Revenue Return to PNG

• “.. will allow the refurbishment of a dilapidated student residence into a

series of properly equipped student research laboratories (about 15).”

• “… will house PhD and MSc research students working on relevant

research projects.”

• “For UPNG it will be quite a spectacular infrastructural provision … and

more than sufficient to ignite UPNG's research potential in the area.”

Aquinox: Development of SHIP1 Activators

• UBC Spinoff Founded in 2006 • Raised ≈ $40,000,000 in venture capital

– J&J; Pfizer; Baker Brothers Investments; Lions Capital;Ventures West • AQX1125 - pharmacophore analogue of marine natural product pelorol • AQX-1125 is a potent allosteric activator of SHIP1 • Developed for the treatment of blood and immune disorders • Many desirable drug attributes

– it is highly selective for SHIP1 – it is a small molecule (<500 daltons) – it has a scalable synthesis – it has shown potent anti-inflammatory activity both in vitro and in vivo – it can be dosed once-a-day orally – it has excellent pharmaceutical properties

• Completed Phase I in Q2, 2011 • Completed successful Phase IIa against asthma in Q1, 2012 • Second Phase IIa is ongoing – complete in June 2012

Biodiversity Compensation & Financing

A. UPNG/PINBio’s inventions revenue sharing – 5% Ownership of resources by the State and the customary resource

owners

– 5% Traditional knowledge-where there exists prior knowledge of uses of biological materials

– 5% Added value to be shared between PINBio and the people where;

» materials are used for the discovery of a new product or technology which is novel’

» materials are used by traditional owners, but its other properties are yet to be discovered.

– 5% Negative impacts on carbon emissions/carbon offset trade within PINBio

– 5% Environmental protection and rehabilitation

– 75% Institutional support, of which 25% will be shared by the inventors, while the rest will be similar to that shown in Part B below.

Biodiversity Compensation & Financing

B. UPNG/PINBio shared inventions through Collaborations

• 25% PINBio/State/traditional owners

• 75% UPNG: – 10% Inventors or staff recognition/compensation

– 5% UPNG Administration for Management purposes

– 25% Biological Laboratory

– 15% Chemistry Laboratory

– 30% Pharmacology Laboratory

– 5% Policy and IP

– 10% Postgraduate Scholarships

• Device a common policy approach that clearly sets national

goals in the use of biological resources to improve level of

education, health services, traditional agriculture, protect

the environment and sustain rural/ village based lifestyle

• Determine the extent of biological (genetic) resources base

of the country

• Ascertain the progressive (negative) impact of changes

(and development) on the environment and biodiversity

• Identify strategies and mechanisms that would add value

and diversity the use of resources

• Identify current institutional (universities) and government

agencies with capabilities in managing resources

• Create and develop mechanisms for partnership

arrangements with industries and communities

• Identify and create essential manpower and skills that are

still lacking

• Identify international support through various agreements

and conventions

Biodiversity Strategy

R D

Biodiversity

&

Human Health

Care

Agricultural

Goods

Industrial

Applications

Chemical &

Environmental

Translating Biodiversity into Benefits

Ownership Scheme

Biological Resources Product

Sovereignty Resource Owners

Research and Development

Ownership of Intellectual Input/ Ideas Original Final

• Use of Materials

• Use of IK

• Intellectual Input

• Technology Input

• Economic Products • Industrial Products • Health Products

• Human Res. Dev

Ownership of Material/ IK

Raw Materials to Knowledge and Products

Ownership of Products

•Raw Materials

•IK

Intellectual Property Rights Scheme

Biological Resources Product

Sovereignty Resource Owners

Research and Development

IP Policy Original Final

• Human Resources Training

• Infrastructures

• Technology Transfer & Dev

• Discovery/ Value Addition

• Standards / Quality

• Protection

• GMP

• Certification • Marketing

• Trade

Protection Policy

Materials to Knowledge and Products

Patent/ Market Protection

• PIC

• ABS

Access Benefit Sharing Scheme

Biological Resources

Product FEES • Access • Admin • Collection • Dive • Tour • Village Projects

Biotechnology

Biotechnology Policy

Original Final

• Fair and equitable sharing of benefits: Monetary/ Non-monetary

• Access to training/ technology- based on mutually agreed terms

• Information Sharing

• Joint IP/ Milestone/ Royalties

• Bio-industry • Market Access • Green Label

• Bilateral/

• Multilateral Trade

• Royalties

Access Policy

PIC

GMP- Policy

Material Access to Economic Wealth

Access Benefit Sharing Issues

Ownership of Biological Resources and IPR

Development/Utilization of Biological Resources

Development of Human Resources

Development of Infrastructure

Product Development

Economic Benefit

Sustainability of Resources

Access Benefit Sharing Issues

Biodiversity Benefits & Ecosystems Services Bioinventory

Biodiscovery

Agrobiodiversity

Biotechnology

Biodiversity

Conservation/Carbon

Sinks

Biodiversity Database

Biodiversity Policy and

Legislation

Training and Infrastructure

Education Awareness

Stock

Medicines

Agriculture

Application

Conservation

Knowledge

Law & IP

Skills &

Expertise

Stewardship

Species value

Health

Food Security

New Systems

Environment & Carbon

Credit & Energy

Information

Protection

Manpower

Responsibility