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Asian Journal of Healthy and Science
p-ISSN: 2980-4302
e-ISSN: 2980-4310
Vol. 2 No. 11 November 2023
PROTECTION OF GENETIC DATA IN HEALTH SERVICES
BASED ON GENOMICS TECHNOLOGY IN INDONESIA
Shinta Susanti, Handar Subhandi Bakhtiar, Handoyo Prasetyo
Universitas Pembangunan Nasional Veteran Jakarta, Indonesia
Email: 0820shinta@gmail.com, handoyoprasetyo@upnvj.ac.id
Abstract
Indonesia is developing precision medicine by integrating genomic capacity into
health services. Currently, there is no comprehensive regulation governing these
services, resulting in legal uncertainty regarding the regulation of personal data
protection (genetic data) based on Indonesian statutory provisions. The purpose of
this research is to immediately form implementing regulations to regulate in detail
Personal Data Protection in genomics-based health services in Indonesia. The
research method used is normative juridical (Legal Research) which is descriptive
analytical in nature using a statutory approach and using secondary data types. The
results of this study explain that broadly speaking, genetic data generated from
genomics-based technology is one of the data that should be protected by the State
with provisions, rights and obligations and sanctions that should be obeyed by all
interested parties. The establishment of an independent Data Controller is needed in
an effort to implement personal data protection. The conclusion obtained by the
author is that the PDP Law has not been implemented clearly and completely so that
it requires derivative regulations that ensure the implementation of the protection of
personal data of the community.
Keywords: Genomics, Personal Data Protection, Health
INTRODUCTION
Human beings have inherent rights that are obtained not from the gift of others
or the state. One of them is the right to health services obtained since humans are still
in the womb. This right is part of human rights known as human rights (Marif et al.,
2021). The concept of the welfare state as a modern state concept gives greater power
to the government to promote and achieve respect for human rights. The government
no longer simply guarantees that a person's rights are not harmed or violated, but
must strive to uphold those rights. Similarly, with the right to health, governments
have an obligation to fulfil and respect that right (Perwira, 2014).
Along with the development of technology that occurs at this time, the human
mindset is also developing. Technology develops in many aspects, including the
health aspect (Azzuri & Prasetyo, 2021). Precision medicine and genomics are the
latest revolutionary healthcare technologies that have brought about profound
changes in the treatment of diseases. In precision medicine, treatment is based on the
patient's individual characteristics, including genetics, environment, and lifestyle, so
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therapy can be tailored to achieve optimal results. One of the key technologies
underpinning precision medicine is genomics, which involves analyzing a patient's
genome to understand how genetic differences affect response to treatment. This
allows doctors to prescribe more effective treatment and minimize side effects.
Currently, genomic treatment has been carried out sporadically in Indonesia (Ariani
et al., 2017).
The Biomedical and Genome Science Initiative (BGSi) is Indonesia's first
nationally integrated biomedical initiative established to bring Indonesia into the era
of precision medicine by integrating genomic capacity into healthcare. Launched by
the Ministry of Health of the Republic of Indonesia on August 14, 2022 (Indonesia,
2017). This program is designed to develop more accurate treatments for the
community through the use of technology in collecting genetic information (genome)
from humans called whole genome sequencing (WGS).
Indonesia does not yet have a comprehensive legal framework on genomics,
apart from the Decree of the Minister of Health of the Republic of Indonesia Number
Hk.01.07/Menkes/1141/2022 concerning the Implementation of the Biomedical
Genome-Based Science Initiative for Precision Medicines and the Development of
Genomics-Based Health Services for Certain Diseases. The regulation stipulates that
BGSi carries out registry activities for patients with certain diseases, regulates
specimen storage (biobanking), organizes the management of human Whole
Genome Sequencing (hWGS) examinations in Indonesia, and organizes the
development of precision medicine (Indonesia, 2017).. The regulation also regulates
biobanking operations, which are essential for storing biological samples used in
genomic research.
Legal issues that arise are regarding the protection of personal data in genomic-
based health services. Personal data protection is mandated by Article 28G paragraph
(1) of the Constitution of the Republic of Indonesia Year 1945 which states that:
"everyone has the right to protection of himself, family, honor, dignity, and property
under his control, and has the right to a sense of security and protection from threats
of fear to do or not do something that is a human right".
Based on the background as described above, the problem that needs to get an
answer in this study is that there is legal uncertainty regarding personal data
protection arrangements in this case genetic data based on the provisions of
Indonesian legislation.
In this study, the author uses several theoretical foundations to answer the
problem, namely: Legal Protection Theory, according to Satjipto Rahardjo defines
legal protection as an effort to protect one's interests by allocating a human right
power to him to act in the framework of these interests (Rahardjo, 2003).
It can be concluded that protection in general means protecting something from
something harmful or more negative, which can be in the form of benefits, objects,
or property. In addition, protection also means one's protection against someone who
is weaker. Thus, legal protection means that the government seeks to create legal
certainty to protect citizens so that their rights are not violated and violators are
punished according to applicable regulations.
RESEARCH METHODS
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The type of research used is normative juridical (Legal Research) which is
descriptive analytical using a statutory approach (statute approach) that prioritizes
legal materials in the form of laws and regulations as basic reference material in
conducting research (Schotel, 2013). The data used in normative research is a type of
secondary data, consisting of 3 (three) sources of legal materials:
Source of Primary Legal Material, which is legal material consisting of
hierarchical laws and regulations and court decisions. In this study, it consists of:
1. Law Number 27 of 2022 concerning Personal Data Protection (PDP Law)
2. Law Number 17 of 2023 concerning Health (Law 17/2023)
3. Law Number 19 of 2016 concerning Electronic Information and Transactions
(ITE Law)
4. Sources of Secondary Legal Materials, namely legal materials consisting of
textbooks, legal journals, expert opinions, research results, and others legal
materials outside of primary legal materials, related to the issue being studied,
namely about personal data protection related to genomic-based health services in
Indonesia.
Tertiary Law sources, namely data that includes dictionaries, encyclopedias,
the internet and mass media related to writing topics that can be used as information
for this study.
RESULTS AND DISCUSSION
Genomics-Based Health Services in Indonesia according to Law Number 17 of
2023 concerning Health
Genomics is the branch of biology that studies the genome of an organism or
virus. Genomics can be said to be a branch of genetics when viewed historically,
although in genomics many methods derived from other branches of biology are
used, such as bioinformatics and molecular biologyer (Konczal, 2013).
Whole genome sequencing (WGS) is a technology of mapping the entire DNA
sequence of an organism, WGS presents many benefits as well as challenges in its
application. The most influential application of WGS lies in its ability to
revolutionize personalized medicine. By decoding a person's genetic blueprint, WGS
allows healthcare providers to offer more accurate care to individuals as well as
communities. For example, it can identify genetic variants associated with specific
diseases, enabling early intervention and targeted therapies (Nadon et al., 2017). In
addition, genomic research has helped in identifying the genetic causes of various
diseases including hereditary diseases such as thalassemia and phenylketonuria that
support early diagnosis, counseling and development of better therapies.
The Indonesian Ministry of Health in collaboration with East Ventures
supports the strengthening of innovation in the Indonesian health sector by launching
the Biomedical & Genome Science Initiative (BGSi). This program is designed to develop
more accurate treatments for the community through the use of technology in
collecting genetic information (genome) from humans and pathogens such as viruses
and bacteria or can also be called whole genome sequencing (Yuana et al., 2017).
Previously, the WGS method itself has been used and plays an important role in
preventing COVID-19 in Indonesia, by helping to track the spread of the disease and
inform intervention strategies that allow researchers around the world to start
developing vaccines.
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The WGS method will be used for research and development of treatments in
six major disease categories, namely: cancer, infectious diseases, brain and
neurodegenerative diseases, metabolic diseases, genetic disorders, and aging. In its
implementation, BGSi was carried out in seven vertical hospitals, namely Cipto
Mangunkusumo Central General Hospital, National Brain Center Hospital (PON
Hospital), Sulianto Saroso Hospital, Friendship Center General Hospital, Dharmais
Cancer Hospital, Sardjito Hospital, and Prof. IGNG Ngoerah Hospital.
In addition to providing preventive care and appropriate treatment solutions,
clinicians can plan therapies that are more tailored to a patient's genetic profile,
allowing for more effective treatment and reducing side effects and can also help
lower overall health care costs due to early detection and targeted treatment.
These benefits not only impact an individual's health, but can also have a huge
social and economic impact. However, it is important to ensure that research and use
of genomic technology in Indonesia is carried out with strict ethical and legal
standards in the collection, use, and storage of genomic data. In addition, there needs
to be an adequate legal and regulatory framework to protect the privacy and rights of
individuals in the context of genomics and public education and awareness about
genomics is also important so that the benefits can be widely felt.
In Law number 17 of 2023 (Law 17/2023) concerning Health, there are
regulations on the use of health technology, including biomedical technology which
includes genomic technology.
Article 338 (1) in order to support Health Services, the Central Government and Local
Governments encourage the use of Health Technology, including biomedical technology. (2)
The use of biomedical technology as referred to in paragraph (1) includes genomic,
transcriptomics, proteomics, and metabolomics technologies related to organisms, tissues, cells,
biomolecules, and other biomedical technologies (Kesuma, 2023).
Meanwhile, the storage and management arrangements are contained in article
339 as follows:
Article 339 (1) Storage and management of materials in the form of clinical specimens
and biological materials, information loads, and data for the long term shall be carried out by
biobanks and I or biorepositories. (2) Biobanks and/or biorepositories as referred to in
paragraph (1) are organized by Health Service Facilities, educational institutions, and/or
Health research and development institutions, whether owned by the Central Government,
Regional Governments, or the private sector.
The passage of the new Law 17/2023 on Health aims to address gaps or
vagueness in the existing legal framework, provide better clarity and direction, and
meet the unique considerations required by genomics.
Article 338 of Law 17/2023 paragraphs 1 and 2 explicitly recognizes genomics
as part of biomedical technology that is important to support health services in
Indonesia. The law outlines the various stages at which genomics can play a role,
from initial specimen collection to long-term specimen storage and even further afield
to the management and utilization of specimens and related genomic data. The
process aims to advance scientific knowledge and develop health technologies and
health services, including precision medicine.
Article 339 of Law 17/2023 paragraphs 1 and 2 explicitly outline provisions
relating to the establishment and operation of biobanks or biorepositories, which are
essential for genomic studies as they are responsible for storing and managing
biological samples safely in Indonesia. Health Facilities, Educational institutions,
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Research institutes, both public and private sectors, can establish these biobanks or
biorepositories, with approval from the government and under regulatory
supervision. This requirement is a very important protective measure to address
international access or exploitation issues.
Meanwhile, Article 339 paragraphs 4 and 5 of Law 17/2023 states as
follows:
(4) The collection, long-term storage, and management and utilization of materials in the
form of clinical specimens and biological materials, information content, and related data in
the context of utilizing biomedical technology must obtain approval from the patient and /
or donor.
(5) The obligation to obtain approval from the patient and/or donor in the management
and utilization of materials in the form of clinical specimens and biological materials,
information content, and related data as referred to in paragraph (4) is excluded if:
1. Material in the form of clinical specimens and biological materials, information content,
and data that cannot be traced or in the form of aggregate data;
2. Material in the form of clinical specimens and biological materials, information content,
and data for legal purposes; and/or material in the form of clinical specimens and
biological materials, information content, and data for public interest in accordance with
the provisions of laws and regulations
Genetic data captured through genomic technology is a clinical tool that
supports clinical genetics, oncology, obstetrics, neurology, pediatrics, and others.
When health facilities and other organizations pursuant to article 339 of Law
17/2023 obtain, collect, store, use, and disclose more genetic information, there is a
greater likelihood of invasion of privacy, confidentiality, and security.
Some of the scenarios in which such breaches may occur are: (1) genetic data
disclosed to or accessed by health care providers without authorization or lawful need
to view it; (2) the scope of genetic data obtained and disclosed beyond that required
for legitimate health care purposes; and (3) genetic data used for purposes unrelated
to disclosure of health and other issues (Clayton et al., 2019).
Therefore, informed consent is very important as regulated in Permenkes RI
Number 585 / MEN. KES / PER / X / 1989 informed consent is consent given by
the patient or his family on the basis of an explanation of the medical action to be
carried out on the patient. In the case of genomics-based health services, informed
consent/consent of the data subject should also include confidentiality, access,
management (including sharing) and storage.
In response to another issue arising in the Human Genome Project, namely
genetic discrimination in insurance, especially health insurance. Where insurance
companies can deny coverage to individuals who are genetically at risk of a particular
disease whose disease is excluded from underwriting by the insurance. Law 17/2023
Article 342 states that everyone is prohibited from discriminating against the results
of a person's genetic examination and analysis (1), and may be subject to
administrative sanctions in the form of administrative fines up to license revocation
(2).
Separately, Law No. 17 of 2023 concerning Health has not clearly regulated
genomic-based health services. Technically, one of the requirements for health
facilities or institutions such as what is allowed to take and store specimens, as well
as medical personnel and health workers who can take and send specimens only
those who have the expertise and authority obtained from licenses and / or
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certifications from certain institutions. It is also unclear what the form of the cross-
border data transfer agreement in Law 17/2023 related to the PDP Law requires
ensuring that the country where the Personal Data Controller and/or Personal Data
Processor receiving the transfer of Personal Data has a level of Personal Data
Protection that is equal to or higher than that provided for in this Act.
Legal protection of genetic data in genomics-based health services based on Law
Number 27 of 2022 concerning Personal Data Protection
Regulation of Whole Genomic Sequences (WGS) varies across countries and is
subject to ongoing scientific, technological, and ethical considerations. Some key
aspects of WGS-related regulation are related to Ethics and Privacy concerns in terms
of the protection of individual privacy and the ethical use of genetic information.
Many countries have regulations that require informed consent from individuals
before their genomes are sequenced. In addition, there are strict rules regarding
storage, sharing, and access to genomic data including genetic data to prevent misuse
or unauthorized access.
The data security aspect requires regulations that can require entities
performing WGS to implement strong security measures to protect the data they
generate and store. Individuals should also be fully informed about the potential risks
and benefits of genome sequencing, how their data will be used, and who will have
access to it. If genomic data is to be shared with other researchers or organizations,
it must be done in accordance with regulations and with the consent of the
individuals involved. The data sharing agreement should also specify how the data
will be used and protected.
According to Chander & Land, 2014; Djafar & Santoso, (2019), reminded the
many surveillance practices and interception of communications carried out
arbitrarily and unlawfully, including arbitrary collection of personal data, which is a
form of violation of privacy rights. Effective measures should be taken by the state to
ensure that information regarding a person's private life does not reach the hands of
persons not permitted by law to receive, process and use it Chander & Land, 2014;
Djafar & Santoso, (2019).
Personal data is basically a person's privacy, which is included as a basic right
protected under the Constitution of the Republic of Indonesia Year 1945, as
explained by Article 28G paragraph (1): Everyone has the right to the protection of
himself, family, honor, dignity, and property under his control, and the right to a sense of
security and protection from threats of fear to do or not do something that is a human right.
This is in line with the role of the state in this case the government in an effort to
protect the rights of its people related to personal data protection.
The role of law in ensuring the protection of personal data for users of
information and communication technology, through laws and regulations is
contained in Article 26 paragraph (1) of Law Number 11 of 2008 concerning
Electronic Information and Transactions as amended by Law Number 19 of 2016
(ITE Law), regulated as follows:
"Unless otherwise stipulated by laws and regulations, the use of any information through
electronic media that concerns a person's personal data must be carried out with the consent of
the Person concerned”
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Based on the explanation of Article 26 paragraph (1) of the ITE Law above,
personal data protection is one part of privacy rights, which contains the following
definitions:
1. Personal rights are the right to enjoy a private life and be free from all kinds of
interference;
2. Personal rights are the right to be able to communicate with others without spying;
and
3. Privacy rights are the right to monitor access to information about a person's
private life and data
Law Number 11 of 2008 concerning Electronic Information and Transactions
(ITE Law) generally regulates the use of electronic data and information. This ITE
Law contains provisions related to privacy and data protection including sanctions
for privacy violations.
Government Regulation in Lieu of Law Number 2 of 2017 concerning
amendments to Law number 11 of 2008 concerning ITE regulates personal data
protection and requires the processing of personal data to meet a number of principles
including the principle of consent and the principle of reasonable necessity.
In addition, personal data protection is specifically regulated through Law
Number 27 of 2022 concerning Personal Data Protection (PDP Law), in order to
guarantee the constitutional rights of personal data subjects. This law states that
personal data is data about natural persons who are identified or can be identified
separately or combined with other information, either directly or indirectly through
electronic or non-electronic systems.
Referring to Article 4 of the PDP Law, there are at least two types of personal
data. First, specific data, then general data. Specific personal data include (Calzada,
2022) :
1. health data and information;
2. data biometrik;
3. data, genetics;
4. criminal record;
5. child data;
6. personal financial data; and/or
7. Other data in accordance with the provisions of laws and regulations.
Meanwhile, personal data of a general nature in the form of:
1. full name;
2. jenis kelamin;
3. Citizenship;
4. religion;
5. marital status; and/or
6. Personal data combined to identify an individual.
Therefore, based on article 4 of the PDP Law, genetic data produced from
genomic-based technology is one of the data that should be protected by the State
with provisions, rights and obligations and sanctions that should be complied with
by all interested parties.
If its application follows this principle, then the processing of personal data will
be carried out after fulfilling legal reasons, such as the consent of the data owner;
ascertaining the processing requirements related to the contract concluded with the
data owner; comply with the law with its obligations; protect the vital interests of the
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data owner; carry out tasks in the public interest assigned to the data controller; or
the exercise of legitimate interest) by the data controller or third party.
The main requirement of personal data protection not only prioritizes the
application of such principles but also respects the rights of the data subject and the
obligations of the data controller. The data owner has rights, among others:
1. Obtain information about the clarity of identity, the basis of legal interest, the
purpose of requesting and using personal data, and the accountability of the party
requesting Personal Data (Article 5)
2. Complete, update and/or correct errors and/or inaccuracies in personal data
about him in accordance with the purpose of personal data disclosure, (article 6)
3. Obtain access and obtain a copy of Personal Data about him in accordance with
the provisions of laws and regulations. (Article 7)
4. End processing, delete and/or destroy Personal Data about him in accordance
with the provisions of laws and regulations. (Articles 8, 42, 43, 44.45)
5. Withdraw the consent to the processing of Personal Data about him that has been
given to the Personal Data Controller (articles 9, 40)
6. Object to decision-making actions based solely on automated processing,
including profiling, that have legal consequences or have a significant impact on
Personal Data Subjects (regulated in Government Regulations) article 10
paragraph 1
7. Suspend or restrict the processing of Personal Data in accordance with the purpose
of processing the Personal Data. (Articles 11, 41)
8. Sue and receive compensation for violations of processing personal data about him
in accordance with statutory provisions. (Article 12 paragraph 1)
9. Obtain and/or use Personal Data about him from the Personal Data Controller in
a form that is appropriate to the structure and/or format commonly used or
readable by electronic systems. (Article 13 paragraph 1)
10. Use and transmit personal data about himself to the personal data controller
about him to other personal data controllers as long as the systems used can
communicate with each other securely in accordance with the principles of
personal data protection under the law (stipulated in Government Regulations).
Article 13 paragraph 2
11. The exercise of the rights of the Personal Data Subject is submitted through a
registered request submitted electronically or nonelectronically to the Personal
Data Controller (Article 14)
Meanwhile, the obligation of the Personal Data Controller must provide
organizational and technical measures to demonstrate that the data processing has
been carried out in accordance with applicable legal principles. The specific
explanation of its obligations includes: providing an audit of the latest data;
comprehensive provisions and procedures related to personal data protection;
Privacy by design &; by default; Data Protection Officer; clear procedures for data
subjects; data protection assessment; human resource capacity building; strong data
security technicalities; procedures regarding Personal Data Protection breaches and
failures; as well as evaluation procedures for steps that have been implemented.
Data including personal data moving across borders poses significant and
complex jurisdictional issues, including possible conflicts of laws between one
country and another. Data protection law should put individuals at the centre: this
means ensuring that individuals' personal data is protected, regardless of whether
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their data is processed within or outside the region in which they are located. This
protection can be achieved in a variety of ways, including by establishing that the
law:
1. Applies to controllers and processors established in that country, even if the
processing takes place outside the jurisdiction of the country.
2. Applies to the processing of personal data by controllers and processors
established outside the jurisdiction of the country in which the individual is located
(Mattoo & Meltzer, 2018).
Article 340 paragraph 1 of Law 17/2023 states that data can be transferred
outside Indonesia with the requirements listed in paragraph 2 as follows: :
1. The transfer and use of materials in the form of clinical specimens and biological
materials, information content, and/or data outside the territory of Indonesia is
carried out by taking into account the principles of maintaining the wealth of
biological resources and genetics of Indonesia.
2. Transfer and use of materials in the form of clinical specimens and biological
materials, information content, and/or data outside the territory of Indonesia as
referred to in paragraph (1) can only be carried out if:
3. how to achieve the purpose and purpose of the examination cannot be carried out
in Indonesia;
4. examinations can be carried out in Indonesia but to achieve the main objectives
of research, it is necessary to conduct examinations outside the territory of
Indonesia; and/or.
For the benefit of quality control in order to update the accuracy of diagnostic
and therapeutic standard capabilities.
In this regard, article 56 of the PDP Law states that:
1. The Personal Data Controller may transfer Personal Data to the Personal Data
Controller and/or Personal Data Processor outside the jurisdiction of the Republic
of Indonesia in accordance with the provisions stipulated in this Law.
2. In carrying out the transfer of Personal Data as referred to in paragraph (l), the
Personal Data Controller must ascertain the country where the Personal Data
Controller and/or Personal Data Processor is located. receiving transfers of
Personal Data has a level of Personal Data Protection equivalent to or higher than
that stipulated in this Law.
3. In the event that the provisions referred to in paragraph (2) are not fulfilled, the
Personal Data Controller shall ensure that there is adequate and binding Personal
Data Protection.
4. In the event that the conditions referred to in paragraph (2) and paragraph (3) are
not fulfilled, the Personal Data Controller shall obtain the Personal Data Subject's
dispute.
5. Further provisions regarding the transfer of Personal Data are regulated in
Government Regulations
The data controller is the party responsible for the implementation of personal
data protection indicating compliance with the principles of personal data processing.
The law should therefore regulate the data controller's liability. This liability refers to
liability supported by legal sanctions and codes of ethics. Personal data shall be
processed in a fair manner, based on the consent of the data subject and the best
interests of the data subject (Krzysztofek, 2018).
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Law No. 27 of 2022 concerning Personal Data Protection has also not been
comprehensively able to provide protection for personal data (genetic data). This can
be seen in the absence of an independent Data Controller who serves as the executor
of the formulation, determination of policies and efforts to protect personal data,
conduct supervision, become an administrative law enforcer against court violators
socialization of arrangements for personal data protection activities, monitoring its
implementation, handling administrative disputes, mediating, and adjudication of
non-litigation related to problems Personal Data Protection. Even until now there
has been no competency certification based on laws and regulations for the position.
CONCLUSION
From the above research, the author concludes that a comprehensive and
harmonious regulatory framework is the first step towards genomic-based health
services. Many aspects need to be considered in making regulations for genomic
development. Among them are related to service, consent, protection of personal
data and ethical use of data as well as about the management, sharing, storage, right
of access and processing of data.
With several interrelated regulations and becoming a legal umbrella for
genomics-based health services, there should be no differences in interpretation in
their implementation, causing legal uncertainty. Therefore, it is necessary to
immediately formulate specific derivative regulations to regulate genetic data
protection so that all existing laws and regulations can be implemented effectively
and efficiently and function to provide protection to the community.
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Copyright holders:
Shinta Susanti, Handar Subhandi Bakhtiar, Handoyo Prasetyo (2023)
First publication right:
AJHS - Asian Journal of Healthy and Science
This article is licensed under a Creative Commons Attribution-ShareAlike 4.0
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