The Network of the Indigenous Peoples – Solomons (NIPS)

C/o-PO Box 1751, Honiara

Solomon Islands
Contact email addresses: dmxplain@solomon.com.sb or grammie_vahia@hotmail.com

Information Kit:
Taiwan Government Must Prevent
Violations of Free and Prior Informed Consent
Against Indigenous Peoples
Co-signed by
1. Network for Indigenous Peoples Solomons (Contact: Grammie Vahia e-mail:
grammie_vahia@hotmail.com)

2. Atayal Nation's Council of Taiwan (Contact: Mr. Urux Lbak phone 0910-297-012)

3. Atayal People Sustainable Development Association of Taoyuan County (Contact: Mr. Omi
Wilang, phone 0985-072-926

4. Atayal Presbyterian Church of Central Taiwan

(Contact: Rev. Yumin Hayung, phone 0920-619-793

5. Taiwan Association for Atayal People Sustainable Development

(Contact: Mr. Pagung Tomi, phone 0937-155-214)

6. Taiwan Indigenous Peoples Social Development Association

(Contact: Mr. Atong Yupas, phone 0921-608735)

7. Taiwan Association for Rights Advancement of Pingpu Plains Aborigine Peoples (Contact:
Jason Pan, E-mail: jasonpan@mail2000.com.tw ).

CONTENTS:
RELEVANT DECLARATIONS AND LAWS.......................................2
WHAT IS A PATENT?...........................................................................3
HOW KO SAYS HE OBTAINED
THE INDIGENOUS PEOPLES SAMPLES...........................................4
WHY FILE PATENT APPLICATIONS ON
GENETIC RESEARCH ON INDIGENOUS PEOPLES?.....................5
NEWS ARTICLES..................................................................................7.
US AND TAIWAN PATENT APPLICATIONS..................................11
RELEVANT LINKS..............................................................................11
 Information Kit: Taiwan Government Must Prevent FPIC Violations Page 2 of 11

RELEVANT DECLARATIONS AND LAWS

“Free, prior and informed consent recognizes Indigenous peoples’ inherent and prior rights to
their lands and resources and respects their legitimate authority to require that third parties enter
into an equal and respectful relationship with them, based on the principle of informed consent”
(as defined by the Working Group on Indigenous Populations, Twenty-second session, 19 -13
July 2004).

1) United Nations Declaration on the Rights of Indigenous Peoples

Article 31 states:
“1. Indigenous peoples have the right to maintain, control, protect and develop their cultural
heritage, traditional knowledge and traditional cultural expressions, as well as the manifestations
of their sciences, technologies and cultures, including human and genetic resources, seeds,
medicines, knowledge of the properties of fauna and flora, oral traditions, literatures, designs,
sports and traditional games and visual and performing arts. They also have the right to maintain,
control, protect and develop their intellectual property over such cultural heritage, traditional
knowledge, and traditional cultural expressions.
2. In conjunction with indigenous peoples, States shall take effective measures to recognize and
protect the exercise of these rights.”

Comment: this UN declaration clearly asserts that Indigenous peoples have a central role in any
genetic research involving them.

2) World Medical Association Declaration of Helsinki - Ethical Principles for Medical

Research Involving Human Subjects
Articles 24 and 25 state:
24. In medical research involving competent human subjects, each potential subject must be
adequately informed of the aims, methods, sources of funding, any possible conflicts of interest,
institutional affiliations of the researcher, the anticipated benefits and potential risks of the study
and the discomfort it may entail, and any other relevant aspects of the study. The potential subject
must be informed of the right to refuse to participate in the study or to withdraw consent to
participate at any time without reprisal. Special attention should be given to the specific
information needs of individual potential subjects as well as to the methods used to deliver the
information. After ensuring that the potential subject has understood the information, the
physician or another appropriately qualified individual must then seek the potential subject's
freely-given informed consent, preferably in writing. If the consent cannot be expressed in
writing, the non-written consent must be formally documented and witnessed.

25. For medical research using identifiable human material or data, physicians must normally
seek consent for the collection, analysis, storage and/or reuse. There may be situations where
consent would be impossible or impractical to obtain for such research or would pose a threat to
the validity of the research. In such situations the research may be done only after consideration
and approval of a research ethics committee.

Comment: Ko Ying-chin and his colleagues violated these provisions because they did not
reveal their interest in patent applications.
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3) Taiwan’s Indigenous Peoples Basic Law

Taiwan’s own laws assert that Indigenous peoples be consulted in advance of research. Article 21
of the Taiwan Indigenous Peoples Basic Law passed by the Taiwan Parliament in 2005 states:

“The government or private party shall consult indigenous peoples and obtain their consent or
participation, and share with indigenous peoples benefits generated from land development,
resource utilization, ecology conservation and academic researches in indigenous people’s
regions.

In the event that the government, laws or regulations impose restrictions on indigenous peoples’
utilization of their land and natural resources, the government shall first consult with indigenous
peoples or indigenous persons and obtain their consent.

A fixed proportion of revenues generated in accordance with the preceding two paragraphs shall
be allocated to the indigenous peoples’ development fund to serve as returns or compensations.”
(Indigenous Peoples Basic Law, 2005).
From:
http://www.apc.gov.tw/portal/docDetail.html?CID=74DD1F415708044A&DID=3E651750B400
6467D4B40DD3AC1D7378

Comment: Ko also violated these provisions because he did not consult with the involved Atayal
Aborigines before filing the US and Taiwan patent applications.

WHAT IS A PATENT?

A patent is a form of intellectual property right. When a patent is granted according to the United
States Patent and Trademark Office:
“The right conferred by the patent grant is, in the language of the statute and of the grant itself,
“the right to exclude others from making, using, offering for sale, or selling” the invention in the
United States or “importing” the invention into the United States. What is granted is not the right
to make, use, offer for sale, sell or import, but the right to exclude others from making, using,
offering for sale, selling or importing the invention. Once a patent is issued, the patentee must
enforce the patent without aid of the USPTO.”
From: http://www.uspto.gov/patents/resources/general_info_concerning_patents.jsp

Comment: Basically, a patent is a legal right that protects an invention by excluding or stopping
others from making, importing or offering the same invention for sale.
 Information Kit: Taiwan Government Must Prevent FPIC Violations Page 4 of 11

HOW KO SAYS HE OBTAINED THE INDIGENOUS PEOPLES SAMPLES

In US patent application 200900098056, Ko and Tsai state:

“[130] A population-based epidemiology survey in Dayan [Atayal] tribe communities in Taiwan
was conducted during 2004-2007. All 1522 subjects including 917 male (422 gout cases and 495
controls) and female 605 (126 gout cases and 479 controls), responded to questionnaires on the
information, such as demographic information (age, gender, and ethnicity), alcohol consumption
(the frequency of intake of alcoholic beverages), general and detailed medical history including
current/past medications, during the survey conducted at the local health stations in Taiwan, with
the aim of health education and disease prevention.”

“[131] The diagnosis of gout was confirmed by a rheumatologist based on the preliminary
criteria for the classification of the acute arthritis of primary gout (Wallace et al., Arthritis Rheum
20: 895-900 (1977)). The study was approved by the Human Ethical Committee of Kaohsiung
Medical University and National Health Research Institutes in Taiwan. Blood was drawn by
trained medical technologists. Routine blood tests were conducted using automated analyzer
(Beckman LX-20, Palo Alto, Calif.) to measure biochemical indexes, such as plasma total
cholesterol, triglyceride, creatine and uric acid for the study subjects. Total genomic DNA was
obtained from white blood cells using a genomic DNA extraction kit (PureGene DNA
Purification Kit) (Gentra Systems, Minneapolis, Minn.) and stored at −20° C. until genotyping.
Informed consent for collecting blood samples, anthropometric measurements and the survey
questionnaires was obtained for each study subject before the study.”

Comment: Paragraphs 130 and 131 above describe how Atayal research subjects were classified
by whether they had gout or not. Ethics oversight requires some sort of real separation but this
patent application involves serious conflicts of interest because it was approved by Kaohsiung
Medical University where Ko is the vice-president and by the Taiwan National Health Research
Institutes which was the assignee of both the US and Taiwan patent application.

In US Patent Application 20100248253 Dr. Ko and three colleagues have filed a US patent
application some of the SNP data that is included in the fourth patent application is also is
included in a June 2010 article entitled, “The SLC22A12 gene is associated with gout in Han
Chinese and Solomon Islanders” in the journal, Annals of the Rheumatic Diseases. This article
states that:

“We further enrolled 54 male gouty cases (age 49.4±11.2) (22 tophi) and 138 controls (age
46.0±14.0) from the National Referral Hospital of Honiara and 2 provincial minihospitals of
Southeastern Guadalcanal in the Solomon Islands. The institutional review boards at each
participating hospital approved this study” (Tu et al, 2010:1252).

As well the article states:

“Ethics approval: This study was conducted with the approval of the Institutional Review Boards
of Kaohsiung Medical University, Kaohsiung Chang-Gung Memorial Hospital, the National
Health Research Institutes (KMU-IRB:93-063 and NHRIEC: 0940102) and Ethics and Research
Committee of the Ministry of Health and Medical Services in the Solomon Islands in September
2006” (Tu et al, 2010:1253)
 Information Kit: Taiwan Government Must Prevent FPIC Violations Page 5 of 11

Comment: Dr. Ko discussed the informed consent practices used during his trip to the Solomon
Islands in an October 12 2007 bioethics lecture to students at Kaohsiung Medical University (see
links at end of article). One of Ko’s 2007 lecture slides features an excerpt from the informed
consent form signed by the research subjects which gives the research subjects very strong rights:
“I [the research subject] can withdraw my consent at any time and have the rights of the
participation returned to me, removed from the experimental records, or destroyed.” The
informed consent form makes it appear that the research subjects retain control over their samples
and they need only telephone Dr. Ko to withdraw their consent. Therefore, it would appear that
the ethical standards were very high. However, involved participants cannot withdraw their
consent, if their data is included in a patent application.

In another conflict of interest, Kaohsiung Medical University where Ko is the vice-president, is

also the assignee of US patent application 20100248253.

WHY FILE PATENT APPLICATIONS ON

GENETIC RESEARCH ON INDIGENOUS PEOPLES?

Genetic researchers assume that Indigenous peoples are geographically and socially isolated
populations who because of lack of marriage outside group have less genetic variation as a group,
so it will be easier to find genes that are correlated or linked with diseases. Hyperuricemia
involves high levels of uric acid in the blood because the kidneys do not excrete enough uric acid.
When someone has hyperuricemia, they can develop gout, which is the painful build-up of uric
acid crystals in the joints, particularly of the big toe and the hands. Ko’s patent applications focus
on what are called “SNPs,” which stands for single nucleotide polymorphisms. Here the SNPs are
variations in the sequence of DNA in a particular gene. In patent application 200900098056,
different versions SNPs related to a gene called ALPK1 were supposed to useful to predict if
someone had an increased risk of developing gout and hyperuricemia. The table below shows
how the US patent application 20100248253 incorporates SNP related genetic research findings
from Solomon Islanders. Here the SNPs are variations in the sequence of DNA in a particular
gene called URAT1 (also known as SLC22A12). The URAT1 gene encodes a protein that affects
how the kidneys process a chemical called uric acid. Certain SNPs (variations) of the URAT1
gene are associated with higher levels of uric acid in the blood that may lead to hyperuricemia
and gout.
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NEWS ARTICLES

Source: Solomon Times Online

Title: Doctor Abandons US Patent Application
Source: Solomon Times Online
Date: Monday, April 11, 2011 8:05 AM

This patent application entitled "Method and Kit for Assessing Risk of Gout and Hyperuricemia,"
uses samples from 192 Solomon Islanders.

The Network of the Indigenous Peoples-Solomons, NIPS, welcomes the abandonment of a US

patent application that uses genetic samples from Solomon Islanders, in a case that raises major
ethical questions.

The patent application was launched by US based lawyers on behalf of Taiwanese scientist, Dr
Ko Ying-Chin.

According to the US Patent Application Information Retrieval system, US based lawyers

representing Taiwanese scientist, Dr Ko Ying-Chin, have since filed an express abandonment
application on the first of this month for the patent application number.

NIPS says the express abandonment was subsequently processed by the US body on Monday this
week and now the status of the US patent application is listed as "expressly abandoned.

Effectively, the patent application is now stopped.

This patent application entitled "Method and Kit for Assessing Risk of Gout and Hyperuricemia,"
uses samples from 192 Solomon Islanders, collected at the National Referral Hospital and two
clinics in Guadalcanal Province during a research trip led by Dr Ko in September 2006.

Dr Ko and his colleagues only abandoned the patent application after NIPS, along with other
non-governmental organizations in the Solomon Islands, began to publicly challenge it.

The basis of this challenge was Dr Ko's failure to obtain proper informed consent from the blood
donors for such commercialization.

From: http://www.solomontimes.com/news.aspx?nwID=6035
 Information Kit: Taiwan Government Must Prevent FPIC Violations Page 8 of 11

The following are three 2010 articles from the Taiwan Government Information Office
concerning Dr. Ying-chin Ko’s violations of informed consent involving Taiwan Atayal
Aboriginal peoples.

1) Title: Researcher accused of misuse of gene resources

Publication Date：03/22/2010
Source： United Daily News

A research team leader from Taiwan’s National Health Research Institute has been accused of
biopiracy in gene research on aboriginal people, sources familiar with the matter said March 22.

The NHRI research team, led by Ko Ying-chin, vice president of Kaohsiung Medical University,
located a genomewide linkage for high prevalence of gout among the island’s indigenous people
after having sampled blood from 1,500 residents from Atayal villages in Hsinchu County since
the research project began in 2003.

Ko and the NHRI filed patent applications in 2005 and 2007 in the United States for their
findings involving aborigines. The first application was rejected, while the second one is still
under review.
Last year, Ko’s team and the NHRI were reported by a Canadian researcher to the Canadian-
based international advocacy organization, ETC Group, for having committed ethics violations
by not having informed the Atayal aborigines of the patent applications.

“We started to investigate the case because we feel the patent applications involve potentially
huge commercial profits, which should go to the aboriginal research subjects,” Neth Dano, an
ETC program manager said. Other members of the research team expressed surprise that Ko had
made patent applications without their knowledge.

After conducting interviews with several local aboriginal communities, ETC decided that Ko and
the NHRI should cancel the patent applications and make apologies to the Atayal since they were
not consulted about the application move.

In response, Ko said they had received permission for blood sampling for academic research. He
added that there was no violation of law since the country’s Indigenous Peoples Basic Act does
not cover patent rights.

The NHRI rejected the necessity to make apologies. “There are no business profits involved,”
NHRI Secretary-General Chiang Hong-che said.

According to sources, Ko testified in Kaohsiung District Court Jan. 8 that any commercial
benefits associated with the discovery would go to aboriginal foundations. The NHRI also
expressed willingness to the Cabinet-level Council of Indigenous Peoples to cancel patent
applications. But sources said as of March 17 the applications had not yet been withdrawn.
 Information Kit: Taiwan Government Must Prevent FPIC Violations Page 9 of 11

Ko’s findings had been lauded by the NHRI as a “gift from Taiwan to the world” when they were
first made public in July 2004. He is regarded as one of the most prominent researchers in
Taiwan on aboriginal health. (PCT-THN)

From: http://www.taiwantoday.tw/fp.asp?xItem=96424&CtNode=413

2) Title: Patent application withdrawn in biopiracy dispute

Publication Date：03/24/2010

Taiwan’s National Health Research Institute and research team leader Ko Ying-chin have
withdrawn a U.S. patent application following allegations by an international organization of
misuse of aboriginal genetic materials.
The Canadian-based international advocacy organization ETC Group had accused the NHRI and
Ko of ethics violations for not informing the Atayal aborigines from villages in Hsinchu County
of the patent application with findings based on their blood samples.

The NHRI started the research project and sampling procedure in 2003, aiming to determine the
genome linkage for the high prevalence of gout among the island’s indigenous peoples.

ETC confirmed March 23 that the United States Patent and Trademark Office has received the
proposal to withdraw the application.

“We are glad to learn of the move and hope that this case will help protect the aboriginal people’s
rights regarding the use of genetic materials from their aboriginal community,” Neth Dano, an
ETC program manager said.

Meanwhile, local human rights groups and aboriginal communities issued a joint statement
criticizing the lack of legal protection for human research subjects in the country. “Current
research on humans is regulated only by a notice of points for attention, which is not even an
administrative order,” the statement said.

These civic groups called on the Department of Health to set out clear regulations in its draft bill
of the Human Research Act.

In addition, to better protect the country’s aborigines, they urged the Council of Indigenous
Peoples to beef up Taiwan’s Indigenous Peoples Basic Act of 2005 by speeding up the drafting of
implementation rules, the absence of which renders the basic act ineffectual. (PCT-THN)
From: http://taiwantoday.tw/fp.asp?xItem=96692&CtNode=413

3) Title: Unauthorized human experiments to be banned

Publication Date：06/04/2010

The Executive Yuan approved a draft bill on research on human subjects June 3 that would
require researchers to obtain the informed written consent of their study subjects.
 Information Kit: Taiwan Government Must Prevent FPIC Violations Page 10 of 11

The bill stipulates that researchers in seeking consent must first explain to the subjects the risks
involved in the research, their rights and interests, as well as the purpose of the research. The
research organizations would also be required to gain the approval of an ethics committee for the
planned studies.

Violators would be subject to fines of between NT$100,000(US$3,125) and NT$1 million.

The Department of Health, which mapped out the draft bill, said it is aimed at promoting the
development of scientific study concerning humans. It would also give legal status to policy
guidelines on research on human subjects announced in July 2007.

The bill to guarantee the rights of study subjects is also in line with stipulations contained within
the Indigenous Peoples Basic Act.

It states that coercion, enticement through promises of material gain, or other irregular methods
should not be used in conducting research on human subjects.

As for research on fetuses or cadavers, the consent of the closest relatives must first be obtained,
with violators to be fined between NT$50,000 and NT$500,000.

In addition, the draft bill prohibits the use of prisoners as research subjects, with the restriction
being waived only in instances when they cannot be replaced with other subjects.

Human rights groups said formulation of the draft bill was accelerated by the recent case
involving a research team led by Ko Ying-chin, vice president of Kaohsiung Medical University.
Ko applied for patents in the United States for gout research findings allegedly obtained by using
blood samples from aboriginal citizens without gaining their prior consent. This case gave rise to
a storm of controversy regarding medical ethics. The National Health Research Institutes’
subsequent decision to cancel the patent applications was heralded as a “great step forward for
human rights” by the rights activist groups. (SB)

From: http://www.taiwantoday.tw/fp.asp?xItem=105803&CtNode=413

Chinese Language Articles:

1) Taiwan scholars again violate Indigenous peoples’ genetic property rights, Taiwan Association
for Human Rights calls on agency in charge to step up and curb this serious problem. 2010, April
6. Taiwan Association for Human Rights website. From:
http://www.tahr.org.tw/index.php/article/2011/04/06/1663/

2) A series of Chinese language articles published on March 22 2010 in the United Daily News
on the 20090098056 controversy are available at:
http://city.udn.com/62960/3913587?tpno=8&cate_no=0

3) "Genes become Patent - Human rights groups Disagree"

http://www.cna.com.tw/SearchNews/doDetail.aspx?id=201104090046&q=%E9%95%B7%E5%
BA%9A
 Information Kit: Taiwan Government Must Prevent FPIC Violations Page 11 of 11

4) Genetic Research Patent, Academic Sinica KMU controversy. Liberty Times: April 10 2011
http://www.libertytimes.com.tw/2011/new/apr/10/today-life4.htm

US PATENT APPLICATIONS

Ko Ying-chin and Tsai Shih-feng. USPTO Patent Application 20090098056: ALPK1 gene
variants in diagnosis of risk of gout. Published April 16 2009 by the USPTO Patent and
Trademark Office. From: http://www.uspto.gov
Ko Ying-Chin and Cheng Li Shu-Chuan. United States Patent Application 20050170387, Gout
related genetic locus. Published by US Patent and Trademark Office. From: www.uspto.gov

Ko Ying-chin. United States Patent Application Publication 20100035255: Method and kit for
assessing risk of gout and hyperurcemia. Published by US Patent and Trademark Office,
February 11 2010. Accessed: April 30 2010 http://www.uspto.gov

Ko Ying-chin, Chang Shun-jen, Wang Shu-jung and Chiang Shang-lun. US patent application
20100248253: Method and kit for assessing risk of gout and hyperurcemia. Published September
30 2010 by the US Patent and Trademark Office. From: http://www.uspto.gov

TAIWAN PATENT APPLICATIONS

Ko Ying-Chin and Cheng Li Shu-Chuan. Taiwan Patent Application, Publication number
200521132: Gout related genetic locus. Published by Taiwan Intellectual Property Office. From:
http://twpat.tipo.gov.tw

Ko Ying-chin and Tsai Shih-feng. Taiwan Patent Application, Publication number 200923103:
ALPK1 gene variants in diagnosis risk of gout. Published July 1 2009 by the Taiwan Intellectual
Property Office, July 1. From: http://twpat.tipo.gov.tw

Ko Ying-chin. Taiwan Patent Application, Publication number 201006498: Method and kit for
assessing risk of gout and hyperurcemia. Published February 16 2010 by Taiwan Intellectual
Property Office. From: http://twpat.tipo.gov.tw

RELEVANT LINKS
For further information please check the following links:
1) Ko Ying-chin. Transnational medical research ethics, the example of the Solomon Islands.
October 12, 2007 Powerpoint presentation on Medical and Humanistic Cyberspaces website at
Kaohsiung Medical University. The beginning slides are in Chinese but the Solomon Islands
slides are in English: http://ehumed.kmu.edu.tw/images/papers/ethics/9601/1012-1.ppt

2) Aroha Mead and Dr Steven Ratuva. Pacific indigenous experiences & analysis of the
commodification & ownership of life (2007). United Nations University:
http://www.ias.unu.edu/resource_centre/Pacific_Genes_and_Life_Patents.pdf

3) Munsterhjelm, Mark and Gilbert, Frederick (2010) How do researcher duties conflict with
Aboriginal rights?: Genetics research and biobank problems in Taiwan. Dilemata: Journal of
Applied Ethics, 4:33-56.
http://www.dilemata.net/revista/index.php/dilemata/article/viewFile/53/67