Urgensi Pembentukan Undang Undang Terhad
The Urgency of the Legislative Regulatory Formulation on Traditional Knowledge and
Genetic Resources in Indonesia
▨ Muhammad Tizar Adhiyatma* 47)
전통지식 및 이와 관련된 유전자원에 관한 다양한 문제가 인도네시아 또는 그밖의 국가에서 국ⅱ적으로 발생하고 있다. 이러한 문제는 생물다양성협약 (Convention on Biological Diversity : CBD) 당사국ⅲ의 회의와 지적재산권, 유 전자원, 전통지식의 보호에 관한 정부간회의와 같은 국제적 포럼 속에서 다양 한 구성원의 주의를 끌고 있다. 이 논문은 인도네시아에서의 토착민ⅲ의 전통 적 창작으로서 전통지식】 유전자원의 적극적 보호를 보장하기 위한 성문입법 의 급박한 필요성에 촛점을 둘 것이다. 성문입법을 통한 규제는 법규 ⅱ 형벌 적 조항】 함께 법적 확실성을 제고할 수 있는 정보로써 기능할 것이다. 특히 다국적 기업을 포함하여 외국 당사자에 의하여 자행될 수도 있는 유전자원의 생물학적 해적행위(biopiracy) 그(고인도네시아의 전통지식】 관련된 해적행위 로부터 인도네시아국민을 적극적으로 보호할 수 있을 것이다. 이 법은외국당 사자에 의한 인도네시아 유전자원 및 전통지식 등에 대한 착취와 해적행위에 대항하기 위한 지역토착민의 공동의 권(를 제공해 줄 것이며, 나아가 인도네 시아의 지속가능한 경제 및 사회복지를 위한 초석이 될 것이라 생각한다.
* Consultation and Legal Aid Unit of Hasanuddin University
Ⅰ. Introduction 2. The Kingdom of Norway
3. India
Ⅱ. Traditional Knowledge and Genetic
4. Brazil
Resources Ⅴ. Sui Generis for The Protection of Ⅲ. International Instrument for Traditional
Traditional Knowledge associated Knowledge and Genetic Resources
with Genetic Resources in Indonesia 1. C o n v e n tio n o n B io lo g ic a l
1. Perception Gap between Deve- Diversity(CBD)
loped Countries and Developing 2. Nagoya Protocol
Countries for The Protection of 3. International Treaty on Plant Genetic
Traditional Knowledge Resources for Food and Agriculture
2. Public Domain and Communal Right
Ⅳ. Protection Model for Traditional
3. Analysis
Knowledge and Genetic Resources in Indonesia and other Countries
Ⅵ. Conclusion
1. Indonesia
Ⅰ. Introduction
Issue of traditional knowledge protection (hereinafter referred to as TK) has drawn serious attention in some international forums such as WIPO Intergovernmental Committee on Intellectual Property Right and Genetic Resources, Traditional Knowledge, and Folklore (hereinafter referred to as WIPO IGC). This forum is a committee established to negotiate texts of an international law instrument particularly the one that guarantees protection of genetic resources (hereinafter referred to as GRs), TK, and Folklore. 1) The latest meeting of this forum discussing TK and associated with GRs was held from 28 November to 2 December 2016 as thirty-second session of the WIPO IGC and the thirty-fourth session was planned from 12 June to 16 June 2017 with topic covering traditional
1) J. Janewa OseiTutu, “Emerging Scholars Series: A Sui Generis Regime for Traditional Knowledge: The Cultural Divide in Intellectual Property Law”, Intellectual Property Law Rev. No. 1 Vol. 15 (2011), p. 147
The Urgency of the Legislative Regulatory Formulation on Traditional Knowledge and Genetic Resources in Indonesia / Muhammad Tizar Adhiyatma 269
cultural expressions and stocktaking session. In this forum, panel of indigenous people and local community has been established. The panel delivered presentation with topics covering protection, promotion and preservation of TK, traditional cultural expression, as well as GRs. 2) Issue of TK protection is also discussed in Conference of The Parties of Convention on Biological Diversity (hereinafter referred to as COP). COP holds the highest authority among countries parties that ratified Convention on Biological Diversity (hereinafter referred to as CBD) which is held once in two years to discuss unresolved problems concerning biological diversity, set priorities and be committed to work plan, agree on various international issues in order to reach the goal of CBD which is conservation, sustainable utilization of biological diversity and profit sharing for the utilization of GRs. The latest meeting of this conference was held on 4-17 December 2016 in Cancun, Mexico. Those should bring awareness to Indonesia, as a country that does not only have abundant GRs but also traditional heritages which many are found in the society and still well preserved and inherited by local communities and even by indigenous people, to immediately formulate strong law to protect those traditional heritages mainly for TK and associated with GRs.
WIPO IGC has given recommendation in WIPO/GRTKF/IC/7/5 suggesting that
2) As for example, a presentation delivered in 2013 by Australia represented by Mr. Robert Leslie Malezer as Co-Chair National Congress of Australia's First Peoplesentitled ‘...the right to maintain, control, protect and develop their intellectual property over....traditional knowledge...’ . Mr. R. L. Delivered his presentation by emphasizing the rights of indigenous people mainly by comparing the rights of indigenous people stated in Article 31 UN Declaration on the Rights of Indigenous Peoples (hereinafter referred to as UNDRIP) to the rights of all people stated in Article 29 Universal Declaration on Human Rights (hereinafter referred to as UDHR). He explained that in Article 29, it is the right of indigenous people to preserve, control, protect, and develop their cultural heritage, traditional and cultural knowledge including human and GRs and so forth. Furthermore, Mr. R. L. Malezer said that according to Article 29 UDHR the right to preserve, control, protect and develop cultural heritage, TK and traditional cultural expression and so forth should belong to not only indigenous people, as stated in Article 31, but also all people. Therefore, all people have right to preserve, control, protect and develop their intellectual property of cultural heritage, TK and traditional cultural expression. In WIPO/GRTKF/IC/24/REF/GRTKF/24/INDIGENOUS PANEL/LES MALEZER, can be accessed in http://www.wipo.int/meetings/en/doc_details. jsp?doc_id=235882, accessed on 28 th March 2017. See also presentation by Mr. Yanuar
Nugroho as the representative of Indonesian Traditional Wisdom Network from Indonesia entitled Experience from Indonesia.
all participants in the committee implement either national or regional approach for the protection of TK. Moreover, in the 13 th meeting, COP set agenda of reporting
The Ad-hoc Open-ended Inter-sessional Working Group for Article 8(j) and
associated provisions related to CBD in the 9 th meeting in Montreal, Canada 4 –7 th November 2015 that has adopted 5 recommendations regarding of voluntary
th
guidance for mechanism development, law or other precise initiatives to ensurethe [free] prior informed consentor [approval and involvement] of indigenous people and local communities to access their knowledge, innovation and practice, fair profit sharing as a result of the use and the application of those knowledge, relevant innovation and practice for conservation and sustainable utilization of biological diversity, and for the report and prevention of a deprivation that violates the Law of TK. Accordingly, Indonesia should have easily formulated national act in order to prevent Indonesian TK from misappropriation or any form of biopiracy for its GRs. For example, the case of the utilization of Indonesian GRs associated with TK has been done by Shiseido Cosmetic Company Japan. This company proposed a patent for some of efficacy of herbal formula as cosmetic potion to make anti-agents and hair tonic. They succeeded in getting some patent rights with register number 10316541 for product from Indonesian plants that are
KayuRapet( ParameriaLaevigata ), Kemukus( Pipercubeba ), Tempuyang ( SonchusArvensis ), Belantas( PlucheaIndica L ), Mesoyi( Massoia Aromatic Becc ), Pule
( AlstoniaScholaris ), Pulowaras( AlyciaReindwartii BI ), and Sintok ( Cinnamomumsintoc BI ). 3) This is possible because the existing regulation, and even until today, is still very weak to guarantee these TK to be protected properly.
In addition, protection (either in the form of positive protection or defensive protection) will halt developed countries to accuse developing countries as the violators of intellectual property right. Like when United States accused developing countries of various piracy of intellectual property that made them suffer the loss of royalty as much as $202 million a year. Nevertheless, in terms of GRs associated with TK, it is in fact developing countries which would have suffered the loss.
3) Henk ten Have, Global Bioethics: An Introduction, Routledge, (2016).
The Urgency of the Legislative Regulatory Formulation on Traditional Knowledge and Genetic Resources in Indonesia / Muhammad Tizar Adhiyatma 271
United States owes $302 million for agricultural royalty and $5.1 billion for medication. 4) In addition, this protection is also useful to avoid unnecessary lawsuits from developed countries like in the case of Yellow Bean ( Phaseolus Vulgaris ) from Mexico that has been patented by POD_Ners. Plc, Amerika (US Patent No. 5,984,479). This patent right was then used as the basis of lawsuit to Mexico company. Another case happened in 1991 involving a craftsman from Bali (Indonesia) who was sued in TheNew York District Court for using Borobudur motif. Moreover, local people do not know that TK that they have got hereditarily conveys economical advantages especially TK about medications. Therefore, government has to provide protection for indigenous people and local communities and also guarantee the moral right of the ownership of TK associated with GRs from the practice of misappropriation and biopiracy.
This paper focuses on the urgency of formulating Indonesian national legislation in order to guarantee the protection of TK and GRs as the form of traditional creativity belonging to indigenous people. The study in this paper will be supported with The Black Box Theory 5) by David Easton whose scope is limited only to TK, particularly the one closely related to GRs and will be elaborated by examining gap perception between developed and developing countries in terms of TK protection as well as in terms of differences between the concept of public domain and the concept of communal right. This study is necessary in order to convince government that protection through the system of intellectual property right is no longer appropriate so that stronger protection in the form of national legislation with sui generis model which isactis needed.
4) Vandana Shiva, The Vandana Shiva Reader, The University Press of Kentucky (2014), p. 169 5) Black Box theory will provide clear description that a policy can be well implemented and
reached its goal if the policy is positive, meaning that it is responsive to input or as what it is expected by the people and is protective against any negative interest of elite businessmen group or pressure from other countries which have interest in the policy, thus in the input and output process, there will be balance between people interest and government interest, meaning that it suits the ideal expected in terms of direction, the goal of the policy formulation, and the implementation of the policy.
Ⅱ. Traditional Knowledge and Genetic Resources
Sometimes international public is mistakenly considered TK as folklore. In fact, those two terms are substantially different. Michael Blakeney explained that folklore is discussed more in copyright or copyright plus or, in other words, it includes in domain which protection is covered in copyright law. 6) The definition of TK is developed by The International Council for Science (ICSU) by developing the characteristics of TK itself. Here is the definition:
”Traditional knowledge is a cumulative body of knowledge, know-how, practices and representations maintained and developed by peoples with extended histories of interaction with the natural environment. These sophisticated sets of understandings, interpretations and meanings are part and parcel of a cultural complex that encompasses language, naming and classification system, resource use practices and ritual, spirituality and worldview.” 7)
In addition, CBD defines TK as original knowledge, innovation and practice from local people. Therefore, based on the definitions aforementioned, TK covers creative expressions, information, knowhow which particularly has its own characteristics and can identify social units.
Meanwhile, GRs itself is a common term used in international policies related to agriculture, environment, intellectual property right, and trade. 8) GRs, for the first time, bring its influence to the food and agriculture organization commission on plant GRs. In CBD forum itself in 1992, GRs became a hot issue discussed at that time and was an issue that was thoroughly brought to international stage. 9)
6) Michael Blackeney, The Protection of Traditional Knowledge under Intellectual Property Law (2000), EIPR 22(6) 251-261 in Suyud Margono, Hukum Kekayaan Intelektual (HKI): Mencari Konstruksi Hukum Kepemilikan Komunal terhadap Pengetahuan dan Seni Tradisional dalam Sistem Hak Kekayaan Intelektual (HKI) di Indonesia, Pustaka Reka Cipta (2015), p. 180
7) ICSU and UNESCO, Science, Traditional Knowledge and Sustainable Development (ICSU Series on Science for Sustainable Development No. 4, ICSU, Paris 2002) in Tobias Kiene, The Legal Protection of Traditional Knowledge in The Pharmaceutical Field, Waxmann (2011), p. 25
8) Kent Nnadozie, Robert Lettington, etc, Africa Perspective on Genetic Resources: A Handbook on Laws, Policies and Institutions, Environmental Law Institute (2003), p. 9 9) Ibid.
The Urgency of the Legislative Regulatory Formulation on Traditional Knowledge and Genetic Resources in Indonesia / Muhammad Tizar Adhiyatma 273
Article 2 CBD defines GRs as a genetic material that is actual or has potential value. Genetic material itself is a material derived from plants, animals, microbes or others containing heredity functional units. FAO defines GRs in a narrower sense. According to FAO, GRs is specially intended for plants, food and agriculture. Still according to FAO, GRs is a genetic material coming from plants and having potential value for food and agriculture. Genetic materials in FAO define as any materials coming from plants, including reproductive and vegetative propagation materials containing heredity functional units. 10)
Ⅲ. International Instrument for Traditional
Knowledge and Genetic Resources
TK and GRs have been regulated both in international area, as international legal instrument, and in Indonesia area. As international legal instrument, both TK and GRs have been formulated in CBD, Nagoya Protocol, FAO and International Treaty for food and Agriculture 11) .
10) Gerald Moore and Witold Tymowski, Explanatory Guide to The International Treaty on Plant Genetic Resources for Food and Agriculture,IUCN(2005), p. 341. In addition, Morten Walloe Tvedt and Peter Johan Schei defined genetic resourcesas access and benefit sharingthat is very essential because it defines the object that is searched to be managed, Morten Walloe Tvedt and Peter Johan Schei,”The Term ‘Genetic Resources’ Flexible and Dynamic While Providing Legal Certainty?”, in Sebastian Oberthur and G.Kristin Rosendal (eds.), Global Governance of Genetic Resources: Access and Benefit Sharing after the Nagoya Protocol, Routledge (2014), p. 18. See also Bevis Fedder, Marine Genetic Resources, Access and Benefit Sharing: Legal and Biological Perspective, Routledge (2013), Manuel Ruiz Muller, Genetic Resources as Natural Information: Implication for The Convention on Biological Diversity and Nagoya Protocol,Routledge (2015), Lyle Glowka, A Guide to Designing Legal Frameworks to Determine Access to Genetic Resources, IUCN (1998), p._
11) International Treaty for Food and Agriculture, popularly known as the International Seed Treaty, is a comprehensive international agreement in harmony with the Convention on Biological Diversity, which aims at guaranteeing food security through the conservation, exchange and sustainable use of the world's plant genetic resources for food and agriculture (PGRFA), as well as the fair and equitable benefit sharing arising from its use. It also recognises Farmers' Rights, subject to national laws to: a) the protection of TK relevant to plant GRs for food and agriculture; b) the right to equitably participate in sharing benefits arising from the utilisation of plant GRs for food and agriculture; and c) the right to participate in making decisions, at the national level, on matters related to the conservation and sustainable use of plant GRs for food and agriculture. The Treaty establishes the Multilateral System of Access and Benefit-sharing to facilitate plant germplasm exchanges and
1. Convention on Biological Diversity(CBD)
CBD is established as a reaction to an issue on the extinction of biological resources used as drug raw material. 12) CBD is a convention that specially discusses preservation of natural resources. CBD expands the scope of its discussion by recognizing the existence of the rights of indigenous people and local people who live around the environment that is rich of natural resources. This convention has created a new standard for justice. It requires the countries members of ratification to act fairly and morally when they intend to access natural resources of a sovereign country by respecting indigenous people and also local people in the research object country. The fair treatment is in the form of profit sharing 13) between the researcher and people who live where the natural resources are from. A decent fair treatment is realized by having priorinformed consent 14) from people living where the research object exists.
This convention requires participant countries, in one of its provisions, to preserve nature, respect, protect and maintain knowledge, innovation and practices
benefit sharing through
Transfer Agreement(SMTA)in https://en.wikipedia.org/wiki/International_Treaty_on_Plant_Genetic_Resources_for_Food_and_Agr iculture#cite_note-1, accessed on 6 th April 2017
Standard
Material
12) Agus Sardjono showed in his book a research conducted by Steven R. King stating that 74% of raw material of pharmacy industry is derived from physic or medicinal plants used by traditional people or local people who mostly live in developing countries. Curtis M. Horton, “Protecting Biodiversity and Cultural Diversity Under Intellectual Property Law: Toward a New International System”, Journal of Environmental Law and Litigation, Vol. 10 (1995), p. 5 in Agus Sardjono’s book, Hak Kekayaan Intelektual dan Pengetahuan Tradisional, PT Alumni (2010),p. 65
13) The mechanism of profit sharing was assigned to the participants of the convention, Article 19 paragraph (2) CBD stated that “Each Contracting Party shall take all practicable measures to promote and advance priority access on a fair and equitable basis by Contracting Parties, especially developing countries, to thе results and benefits arising from biotechnologies based upon GRs provided by those Contracting Parties. Such access shall be on mutually agreed terms.”
14) One of the weakness of the protection through CBD is the term of prior informed consent. Chris World emphasized thatthe parties must also interpret “prior informed consent” to define the groups that must to be informed and allowed to participate in the negotiations regarding access and benefit sharing. Although the Biodiversity Convention applies only among States, it is clearly meant to bring others, particularly indigenous peoples, into the decision-making process. Because of the parties’ lack of experience in this area, simple resolution of these issues is likely to be long and difficult.in Agus Sardjono, supra note12,pp. 67-68
The Urgency of the Legislative Regulatory Formulation on Traditional Knowledge and Genetic Resources in Indonesia / Muhammad Tizar Adhiyatma 275
of indigenous and local people that reflect life style with traditional characteristic s. 15) This formulation is stated in Article 8(j) and is the main provision of CBD related to indigenous people and local people. In addition, Article 10(c) of the convention requires the participants’ countries to protect and encourage the utilization of natural resources based on the practices of traditional culture. 16) This provision is a particular protection given by each country participant of the convention to indigenous people and local communities. Moreover, this convention also demands its participants to initially obtain first information from the party who provides the natural resources before accessing the natural resources. 17)
2. Nagoya Protocol
Nagoya Protocol is protocol under CBD, and as guidelines for the implementation of CBD itself, CBD is established in order to manage access to genetic resources and fair profit sharing of its utilization. Therefore, as a formulation of the implementation of CBD regulation regarding the granting of access and its profit sharing, this protocol is aimed at giving access and profit sharing for the utilization of GRs and TK, including the utilization of its derivative products. Another aim is to prevent the stealing of GRs, or usually called biopiracy. Principally, the intent and purpose of Nagoya Protocol is to manage: access to GRs and TK associated with GRs; fair and balanced profit sharing of the utilization of GRs and TK associated with GRs; and to prevent GRs stealing (biopiracy). The main objects regulated in Nagoya Protocol are:
15) Article 8(j) CBD states that subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices.”
16) Article 10 (c) CBD states that protect and encourage customary use of biological resources in accordance with traditional cultural practices that are compatible with conservation or sustainable use requirements
17) Article 15 paragraph (5) CBD states that access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party.
Fair and balanced profit sharing of utilization of GRsand TK given based on Mutually Agreed Terms/ MAT. 18) Profit sharing can be in the form of monetary and non monetary; 19)
Access to GRs and TK associated with GRs which is conducted through Prior Informed Concern/PIC involving the owner or the supplier of GRs; 20)
Simplification of steps to access for non-commercial researchers and special consideration in emergent situation in health, environment, and food; 21) Cross-countries Mechanism of global multilateral benefit sharing of GRs and T K; 22)
The authorized institution has to be appointed as National Competent Authority (NCA). NCA is an institution which authorizes to give written access permit and also to assign National Focal Point as a liaison of CBD Secretariat. 23)
Providing Clearing House as a place of information exchange mechanism and data basis regarding GRs; 24) Structuring national regulation acts in relation to GRs; 25) Establishment of checkpoint for the purpose of monitoring; 26) Structuring and model of mutually agreed clause contract; 27) Code of ethics, guidelines and the best practice, and/or standard; 28) and Improvement of capacity, technology transfer, and partnership. 29) This protocol gives a country a mandate to make efforts to ensure that TK
associated with GRs owned by indigenous people and local communities is accessed through prior inform consent that involves associated indigenous people
18) Article 5 paragraph (1) Nagoya Protocol 19) Article 5 paragraph (4) Nagoya Protocol 20) Article 6 paragraph (1) Nagoya Protocol see also Article 7 in the protocol 21) Article 8 paragraph (1) Nagoya Protocol 22) Article 10 Nagoya Protocol 23) Article 13 Nagoya Protocol 24) Article 14 Nagoya Protocol 25) Article 15 and Article 16 Nagoya Protocol 26) Article 17 Nagoya Protocol 27) Article 19 Nagoya Protocol 28) Article 20 Nagoya Protocol 29) Article 22 and Article 23 Nagoya Protocol
The Urgency of the Legislative Regulatory Formulation on Traditional Knowledge and Genetic Resources in Indonesia / Muhammad Tizar Adhiyatma 277
and local communities and mutual agreement that has been established. 30) The implementation of this protocol in national law must take into account adat law or custom law, a protocol and procedure concerning with TK in relation to GRs that applies in the society. 31)
3. International Treaty on Plant Genetic Resources for Food and Agriculture
This Treaty is in harmony with CBD. It has similar goal to CBD, however, the issue exposed in this treaty is focused more on the problems of food and agriculture. Object of this treaty is in the form of conservation and sustainable use of GRs plants for food and agriculture as well as “fair and equitable sharing of benefits” arising from its utilization. Regarding indigenous people, this treaty states that in order to support the efforts of indigenous people and local communities, in situ conservation of relatively wild plants and wild plants to produce food should be promoted. This treaty is similar to CBD. Both do not specifically refer to indigenous people. This treaty even gives very limited portion to discuss indigenous people. The main topic is farmers’ rights instead.
Ⅳ. Protection Model for Traditional Knowledge and Genetic Resources in Indonesia and other Countries
1. Indonesia
TK protection in Indonesia also takes into account the protection of GRs. Unfortunately, the existing protection is less sufficient to protect TK associated with GRs. As for example, on the issues on GRs, the transport of wild animals and plants into and out of Indonesia is managed by ministry of environment and forestry as an authorized management in Indonesia. Minister of environment and forestry
30) Article 7 Nagoya Protocol 31) Article 12 Nagoya Protocol
will give the release of wild plants and animals after getting permission from LIPI as a scientific authority in Indonesia. Before foreign researchers bring Indonesian plants and animals, first they must sign a MTA. MTAdepends on the type of GRs. As for example for agriculture GRs, the MTA must be issued by the ministry of agriculture. If biological sample is related to health, the MTA must be issued by the minister of health and must fulfill the requirements of Kepmenkes (Health ministerial decree) No. 732/Menkes/SK/VII/2009. If the sample is a wild plant and/or a wild animal, the MTA must consider ministerial decree 447/Kpts-II/2003. MTA itself is regulated in Peraturan Pemerintah (Government Regulation) No. 41/2006 on MTA.
GRs-basis TK in Indonesia is only protected by giving access permit and utilization permit and through contract instrument. The utilization of GRs which is also integrated with TK in Indonesia begins by applying permit to access information about the resources desired. Access permit is differentiated between access for common interest such as for educational purpose and access for commercial interest in the form of a research for products development for an industry. For information access related to GRs and/or TK for the purpose of holding the right of intellectual property and commercialization, the next step is to get utilization permit. To get utilization permit, benefit sharing for the utilization of GRs and/or TK is required. Utilization permit is given after the applicant accesses the information about GRs and/or TK. After that, a utilization agreement is made. This agreement is an integral contract instrument in access and utilization permit application procedure. This utilization agreement must formulate clauses about diversion of biological material and any matter arising from the diversion. This contract instrument is what we call utilization agreement. Utilization agreement involves at least three parties concerned consisting of user party (researcher or industry), supplier country (represented by competent national authority) and local people as the holder of rights of GRs and TK. To make decision, local people associated with the asset must be involved in order to participate in the negotiation of their interest during the formulation of the utilization agreement. Therefore, to
The Urgency of the Legislative Regulatory Formulation on Traditional Knowledge and Genetic Resources in Indonesia / Muhammad Tizar Adhiyatma 279
apply for utilization permit, utilization agreement is required. This agreement is made between user party and the resources community with the help of an associated government institution. This utilization agreement must be enclosed in the application of utilization permit as a document. In utilization agreement, particularly the one related to access and utilization permit, PIC can include in the agreement. Application of access permit followed up with registration of intellectual property or commercialization requires PIC to communicate the interest of the resources community and supplier country to the interest of the user.
<Flow Chart 1> Flow of the utilization protection of genetic resources and traditional knowledge associated with genetic resources in Indonesia.
TK and GRs in Indonesian legal context is not protected using a proper system and tends to be prone to biopiracy, however, Indonesian indigenous people has been recognized in Article 18B paragraph (2) Indonesian Constitution 32) and some other regulations. 33)
There some issues which still come up in operational level regarding procedure and mechanism of obedience to “good scientific practices”. Synergy among researchers, research institutions, authorized parties and partners (national and international) does not run well because of the various levels of understandings
32) Article 18B Indonesian Constitution states, “The State recognizes the existence of indigenous people along with their rights and traditional” 33) See also Article 1, paragraph 32,33,34, and 35 Act of The Management of Coastal Area and Act of Protection and Management of Indonesian Environment.
and other factors such as rules, institution capacity, and so forth. Manual book to guide the implementation of profit sharing system can be used as general platform.
Abundance of GRs owned by Indonesia as well as property of TK is in contrast to the lack of acts that have capacity to provide proper legal protection. Indonesia needs to protect them whether by issuing national legislation (positive protection) or establishing a new institution and/or even immediately setting up a project to inventory all GRs associated to TK owned by Indonesia (defensive protection).
Protection of TK and TK associated with GRs should be based on protection system offered in WIPO IGC, TRIPS Agreement and CBD as well as Nagoya Protocol. Those agreements provide solution and are an ideal integrated protection to be applied in Indonesia especially in terms of Indonesian local wisdom. As
a member of WTO, Indonesia has harmonized its regulations; one of them is TRIPs agreement. Adopting intellectual property rights and launching sui generis system are the best ways to protect TK and TK associated with GRs in Indonesia. It is necessary to have fair access and fair benefit sharing. The holder of a patent needs to mention home country where an invention is from (in this case an invention deriving from plants and associated with TK) and developed. Furthermore, Indonesia also needs to be concerned with the inventory of GRs associated with TK, like in India, they have “Traditional Knowledge Digital Library” (hereinafter referred to as TKDL) or in Korea, they have database system called “Korean Traditional Knowledge Portal” (hereinafter referred to as KTKP). It is important to note that strict permit issuance, whether animals and/or plants are allowed to
be brought out of Indonesia, is also necessary, like Brazil’s protection system. Although Indonesia has had some sectorial regulations for the issuance of permit, those regulations are still weak considering the hierarchy of Indonesian laws and regulations. 34) Ministerial regulation is on the lower level of the hierarchy, for
34) Drafting procedure of laws and regulations in Indonesia is regulated in Act No. 12 of 2011 on Legislation Drafting Procedure in Article 7 paragraph (1) stating that Types and hierarchy of legislations consisting of :
a. The 1945 Constitution of The Republic of Indonesia
The Urgency of the Legislative Regulatory Formulation on Traditional Knowledge and Genetic Resources in Indonesia / Muhammad Tizar Adhiyatma 281
example Regulation of Minister of Health No. 657/Menkes/per/VIII/2009 on the shipment and the utilization of clinic specimen, Biological Material and its information content. Indonesia needs a national regulation in the form of Act that has strong protection like in India. The regulation must also be based on the balance of interest, like what Peru and Philippines have. In these countries, the states recognize the interest of their indigenous people. Therefore, the regulation must be in the form of legal regulation which applies criminal sanction as for example acts, provincial ordinance and district or municipal ordinance. 35)
2. The Kingdom of Norway
Norway gives serious attention for the protection of not only biological diversity but also indigenous people, especially Sami indigenous people 36) . The Nature Diversity Act, The Sami Act and Section 110A Constitution form the basis for general policy related to Sami and work to preserve and expand TK of Sami people. Those three regulations are the form of positive protection of Norway to protect TK and TK associated with GRs of Norway’s indigenous and local people. The first section
b. Tap MPR (People Consultative Assembly Resolution); c. Acts/ Government Regulation in Lieu of Law; d. Government Regulation; e. Presidential Regulation; f. Provincial Ordinance; g. Municipal/ District Ordinance.
35) Article 15 Act No. 12 of 2011 on Procedure of Laws and Ragulations Formulation states that matters of crime provisions contained only in the following: a. Acts; b. Provincial Ordinance; or c. Municipal Ordinance.
36) Sami People is indigenous people that populate the northern part of Fenno-Scandinavia and Peninsula city. Sami indigenous people is spread across four countries (with total population reaching around 137,477 people). However, they still share the same identity. Sami
indigenous people also have their own flag, national anthem, and national day on the 6 th of February as means of their unification. One of countries that recognized the existence of
Sami indigenous people is Norway. Norway government realized this step by enacting Sami Act about Sameting (Sami Parliament) and other legal issues on Sami. This act has been promulgated on the 12 th of June 1987 in Norway.In Norway, it is predicted that the number of
37,890 - 60,000, see https://en.wikipedia.org/wiki/Sami_people accessed on 4 th April 2017
Sami indigenous
people
is
approximately
of Norway’s Nature Diversity Act states that this act is aimed at protecting biological, geological and other diversity and ecological process through conservation and sustainable utilization. According to this act, environment provides the basis of human activities, culture, health, and welfare, for the present and the future, including basis for Sami culture. 37) Norway’s Nature Diversity Act indicates that this act is formulated by taking into account Sami Culture that comes with the relation of Sami people with their nature. This Act mandates an authorized institution in Norway to prioritize knowledge based on multiple generations that experience the utilization and interaction with nature, including the utilization of Traditional Sami. 38) Genetic material obtained from natural environment is communal resources owned by Norway’s people in general and is managed by the state. This genetic material will be used optimally for the sake of environment and human both in national and international context, particularly in taking the right step for the sharing of the benefit arising from the utilization of genetic material. This is necessary in order to protect the interest of indigenous people and local community. 39) Based on Norway’s Nature Diversity Act, King can make regulation about application containing information about the utilization of knowledge of indigenous or local people. The regulation made by the king should explain how the interest of the landowner and indigenous people as well as local community can be properly protected. 40) Furthermore, based on this act, any individual who get genetic material from public collection must hold him/herself not to claim the intellectual property right or other rights of the material. The claim of intellectual property right may limit the use of the material, such as its use as food and in agriculture, either in Norway or abroad. 41) The individual can claim the right only if the claim is modified that in turn will also alter the substance of the material. If the individual still claims the genetic material, a competent
37) Section 1 Nature Diversity Act of Norway 38) Section 8 Nature Diversity Act of Norway 39) Section 57 Nature Diversity Act of Norway 40) Section 58 Nature Diversity Act of Norway 41) Section 59 Nature Diversity Act of Norway
The Urgency of the Legislative Regulatory Formulation on Traditional Knowledge and Genetic Resources in Indonesia / Muhammad Tizar Adhiyatma 283
authority must take legal actions.
3. India 42)
India has established Traditional Knowledge Digital Library/TKDL containing 34 million pages that consist of 2.26 million medical formulations in some languages. 43) In 2003, India issued an Act of Biological Diversity aimed at conducting conservation of biological resources associated with knowledge and facilitating its access sustainably. Then, through Act of Biological Diversity, Authority of Biological Diversity is formed. This authority is in charge of approving or refusing applications proposed by an individual who wishes to have biological resources or associated knowledge for the need of a research or for the need of commercialization or for bio-survey and bio-utilization existing in India. 44) According to India’s Biological Diversity Act, no one, including every non-resident Indian or Indian who does not live in India or Corporation or organization body that is not registered in India or that has non-Indian capital share or non-Indian management, can transfer the result of a research concerning biological resources that is in India or that is obtained from India for monetary purpose without granting permission from Indian National Biological Diversity Authority, as defined in Section 30 sub-section 2 of The 1961 Income-Tax Act. 45) Biological Diversity Act of India also prohibits anyone to have intellectual property right inside or outside India without initially granting permission from Indian National Biological Diversity Authority. 46)
TKDL is designed as sources of information for patent office in providing the information for prior art test. Through TKDL, India presents information about their
42) India recognizes the existence of indigenous people in their Constitution in Section 161 Sub-section (1). This Section requires that minister be in charge of tribe welfare. In addition, Section 131states that custom as one of laws that is recognized by the constitution, in
http://lawmin.nic.in/coi/coiason29july08.pdf, accessed on 4 th April 2017 43) Indian Traditional Knowledge Protection in www.wipo.int/wipo_magazine/en/2011/03/article_
0002.html, accessed on 4 th April 2017 44) Section 3 sub-section 1 Biological Diversity Act of India. 45) Section 4 Biological Diversity Act of India. 46) Section 6 sub-section 1 Biological Diversity Act of India
TK and prevents misuse by third party using the GRs and then patenting it. Sui generis legislation also facilitates patent examiners in patent offices to search for prior art in medical formulation proposed to be patented in their offices. Therefore, the system facilitates the examiners in determining whether the applicants who propose patent application for an invention that is considered new or that is in the form of “discovery”. 47)
4. Brazil 48)
Brazil is one of countries that have focused on biological diversity since 1933. It can be seen from the fact that there are many decrees and acts concerning biological diversity applied. After becoming the member of CBD, Brazil then gives
a very serious attention for the existing issues. 49) Responding to CBD, Brazil issued MedidaProvisoria 2186-16/2001 (hereinafter referred to as M.P. 2186). One of its provisions claims that TK is supposed to be protected by this act in order to avoid illegal use, exploitation and other dangerous or unauthorized actions. M.P. 2186 recognizes the rights of indigenous people and local community to decide the review of the utilization of their TK as GRs. 50) In addition, M.P. 2186 emphasized that indigenous people and local community who create, develop, hold or preserve TK associated with GRs is guaranteed a right to be recognized as the source of all TK accesses in all publication, utilization, exploitation and spread, and prevents third party who is not authorized to utilize, test, research or use commercially their TK or spread, transmit or forward the data or information of the TK. They
47) There are some views regarding the granting of patent for biopiracy and bioprospecting invention. The first view considers that any invention, including things associated to GRs and TK, can always be patented as long as it fulfill all the requirements that are general standard stated in TRIPS Agreement that is novel, inventive and useful. The second view sees basic argument in novelty requirement for the invention associated with GRs or TK cannot be patented because the novelty requirement is not fulfilled.
48) Brazil Federal Constitution in Article 231 states that protection of indigenous people as a legal entity that can fight for their rights and interests in court. 49) Antonio C. Gueder and Maria Jose Sampaio, Genetic Resources and Traditional Knowledge in Brazil, at UNCTAD expert meeting on systems and national experiences for protecting traditional knowledge, innovation, and practices, (Geneva, 30 October-1 November 2000), p. 2
50) Article 8 M.P. 2186
The Urgency of the Legislative Regulatory Formulation on Traditional Knowledge and Genetic Resources in Indonesia / Muhammad Tizar Adhiyatma 285
also receive benefit of economy utilization by third party directly or indirectly for they who hold the right. 51) Article 31 M.P. 2186 also emphasizes that the granting of industrial property right for process of product that is from or is derived from GRs needs to be conditioned in this law. For those who apply for intellectual property right, whether a person or an institution, must inform the source of the GRs and GRs associated with TK as it is supposed to. Brazil also has 3945/2001 Decree that is meant to formulate laws and regulations related to the establishment of
de GestaodoPatrimonroGenetico (hereinafter referred to as CGEN), that has been mentioned in Article 10 M.P. 2186. M.P 2186 functions to create and maintain database of TK that is relevant for conservation of biological diversity as well as to establish procedure and approve the process for genetic access agreement. The issuance of regulation and policy of intellectual property in Brazil, such as sui generis , is necessary because Policy of National Biological Diversity states requires to build sui generis legal system for the protection of collective rights of intellectual property associated with TK and biological diversity. The entity that has authority for the Policy of National Biological Diversity is National Biological Diversity Commission. There is also 5092/2004 Decree that is meant for issues on conservation priorities, sustainable utilization and fair benefit sharing of biological diversity. 52)
Genetic Resources
Board
of
Management/ Conselho