Monday, September 23, 2013

National measures on access to genetic resources and benefit sharing- the case of The Philippines.(Working Draft)

National measures on access to genetic resources and benefit sharing- the case of The Philippines.
The Philippines is one of the richest countries in Southeast Asia in terms of biodiversity. It signed the CBD in June, 1992 and ratified it in October, 1993.[1] Prior to the ratification of CBD, there were no significant legislations regulating access and benefit sharing relating/derived from biogenetic resources and associated traditional knowledge. “The Guidelines for the Collection of Biological Specimens in the Philippines”, which was adopted in 1990 by government agencies and academic institutions was the only legal document dealing with issues related to bio prospecting in the Philippines.[2] Rather than being a regulatory framework for bio prospecting, these guidelines were mainly an administrative coordination and permit system.[3]

1.1)            The Presidential Executive order 247, 1995
The Presidential Executive order 247 (EO 247) Prescribing Guidelines and Establishing a Regulatory Framework for the Prospecting of Biological and Genetic Resources, their By-products and Derivatives, for scientific and Commercial Purposes[4] was the first national legislation on ABS ever to be introduced.[5] In accordance with the provision of section 15[6] of the EO 247, the document was further clarified by the Implementing Rules and Regulations on the Prospecting of Biological and Genetic Resources (Implementing Regulations)[7]. Together, the EO 247 and the Implementing Regulations established the first detailed legal framework for bio prospecting and access to biogenetic resources.

The preamble of the EO 247 reasserts the mandate of article 16 of the CBD and reaffirms the rights of indigenous cultural communities to preserve their knowledge and practices and use them directly or indirectly for commercial use.[8]


1.1.1)       Scope
The EO 247 governs all biological and genetic resources in public domain, including natural growth in private lands owned by state that can be utilized by both foreign and local individuals, and government as well as private entities and organisation.[9] Furthermore, it covers all the activities related to bio prospecting aimed at discovering, exploring, or using biogenetic resources for pharmaceutical development, agricultural, and commercial applications.[10] It however excludes traditional uses from its scope.[11]

1.1.2)      The prior informed consent
The Implementing Rules and Regulations define PIC as, ‘the consent obtained before undertaking any bioprospecting activity by the applicant from the Local Community, including Indigenous Peoples, concerned individuals and government agency after disclosing full scope and intention of the bioprospecting activity, in a language and process understandable to the community.’[12]

The Regulations requires that biological and genetic resources bioprospecting must be done only after obtaining PIC from the concerned Indigenous Peoples, Communities, Individuals and concerned government agencies.[13] In cases where PIC is to be obtained of indigenous cultural communities, the consent of the concerned communities must be obtained in accordance with their customary laws.[14] Once the PIC has been obtained and the application for carrying out bioprospecting activities [15][Citation needed, see section 7 of the Regulation] has been accepted, the contracting parties depending upon on the nature of the activities envisaged must sign either an academic research agreement (ARA)[16] or a commercial research agreement (CRA)[17].[18] Only after fulfilling the aforementioned procedures bioprospecting activities may be conducted.


1.1.3)      The Inter-Agency Committee
The Inter-Agency Committee is a body established by the EO as the regulatory body to ensure that the provisions of the EO are enforced and properly implemented.[19] The committee is located within the Department of Environment and Natural Resources and supported by a technical secretariat.[20]

In formation of the committee to ensure the participation of all the relevant agencies and concerned communities a multi- stake holder approach was chosen. As a result the committee is comprised of representatives from all concerned stake holders including, Indigenous communities, nongovernment organisation and government agencies.[21]

The committee processes application for research agreements and depending on the nature and character of the prospecting activity, if deemed appropriate, recommends for approval to the concerned government agencies.[22] It also works on ensuring the rights of indigenous and local communities in regard to right over biological resources, use of traditional knowledge associated with genetic resources etc as stated in section 3 and 4 of the executive order.[23] The committee holds power to issue necessary rules and regulations in order to effectively implement the provisions of the EO[24], ‘Implementing Rules and Regulations’ which was formulated in 1996 can be an example in this context. The Committee also functions as the national focal point for all the access and benefit sharing procedures.

The EO further specifies that all bioprospecting activities should not in anyways, harm biodiversity, ecological balances or affect the inhabitants where such activity is being carried out. An Environment Impact Assessment must be done in order to determine the possibility or feasibility of such activities. Bioprospecting without an agreement are considered criminal offence and any act that comes in contrast with the agreement can result in cancellation or revocation of the agreement, confiscation of collected material, forfeit of bond and perpetual ban from prospecting activities in the Philippines.

2.1) The Wildlife Resources Conservation and Protection Act 2001.
The Wildlife Resources Conservation and Protection Act[25] entered into force in 2001 with an objective of conserving and ensuring the sustainability of all wildlife resources habitats in the Philippines.[26] The Act together with its Implementing Rules and Regulations[27]and Draft Guidelines for Bio prospecting Activities in Philippines[28]provides an elaborated framework specifically for bioprospecting and benefit sharing.[29]

The Act defines bioprospecting as, research, collection and utilization of biological and genetic resources for purposes of applying the knowledge derived there from solely for commercial purposes[30]; and considers such activities as legal once the proponent formally declares, compliance with and commitment(s) to reasonable terms and conditions that may be imposed by the concerned agency, which are necessary to protect biological diversity.[31]


2.1.1.) Draft Guidelines for Bioprospecting Activities in the Philippines: -
In terms of Access and Benefit Sharing legislations, Draft Guidelines for Bio prospecting Activities in the Philippines has introduced detailed benefit sharing provisions which were lacking in previous laws. The Guidelines form an attempt to streamline the access and benefit sharing procedure in the Philippines, facilitate compliance, and establish a cost-effective, transparent, and standardised system.  It also provides guidelines for obtaining PIC of resource providers, and in negotiations for fair and equitable sharing of benefits arising from bioprospecting with relevant parties.[32]

It applies to all biological and genetic resources such as wildlife, private lands, ex situ collections, protected areas, and ancestral domains found within the Philippines.[33] However, collection of resources for application in traditional field along with other exceptions[34] falls beyond the scope of the law.

The procedure of obtaining PIC is almost identical to the EO 24 except for some changes in procedure of publishing notifications and public consultations. As per the guidelines the applicants should inform interested parties of their intention to carry out bioprospecting activities through a letter of intent. A summary of the research proposal must be made available to the concerned communities in a language that is comprehendible to them; this requirement was missing from the EO 247.  Instead of 60 days as mandated by EO 247, now the concerned agencies or private owners have 30 days to issue the PIC making the procedure more practical. It is also mandatory to obtain the free and prior informed consent (FPIC) from the indigenous people and communities as determined by their customary laws.

In regard to benefit access and benefit sharing, the draft guidelines significantly limit the freedom of parties of bioprospecting agreements with regards to the benefits to be shared.  Chapter VI of the Draft Guidelines deals about the benefit sharing derived from bioprospecting. It specifies every single detail of the process, including the kinds of benefits that can be shared, who can be the beneficiaries, the provisions for minimum upfront payment, royalties, bioprospecting fees, non monetary payments etc.[35] In addition, it put in a place a mechanism for monitoring the principles of fairness and equity in benefit sharing, with a checklist of suggested indicators.[36]

The new legal framework contained in the draft guidelines covers the inadequacies of previous laws and responds to the loopholes and drawbacks by introducing new provisions. It is noteworthy that the draft guidelines set a uniform procedure for accessing genetic resources used for commercial purposes and clarifies previous overlaps between the different legislative instruments. However, at the moment the draft only have status of a code of conduct and does not bind or supersedes any existing laws.
The EO 247 together with its Implementing Regulations has established a detailed access and benefit sharing legal framework based on the principles of CBD, which regulates the bioprospecting to a much higher level. However, it does not regulate the subsequent use of these benefits or ensure that the benefits would reach the source communities or that the benefits would be used to foster conservation, as required by the CBD. When it was first implemented, it received negative responses from academics and other research bodies about its long and tedious approval process for concluding research agreements. Many concluded that its regulatory measures were discouraging to advancement of research on biological resources.[37]
In order to cover the deficiency of the EO 247 and other laws, the draft guidelines were introduced in joint initiation of Protected Areas Wildlife Bureau (PAWB) and DENR as a part of project called, “support to the implementation of EO 247 in the Philippines” funded by GTZ. The draft guidelines introduced detail provision for benefit sharing which was lacking in the previous laws. It also widened its application by including Ex Situ collections under its scope for the first time. Even the provision of CBD does not apply to Ex Situ collections. The draft guide is expected to give the bioprospecting measures of the Philippines a new height after it comes to force. The draft guidelines have reaffirmed the rights of the Indigenous peoples and communities over biogenetic resources and made it mandatory for the proponents to obtain PIC as well as FPIC from them before conducting any activities of bioprospecting. Furthermore, it also regulates the benefits derived from the bio genetic resources and ensures that the benefits are received by the providing and affected communities.

Apart from the above mentioned legal instruments, the use of biological resources in the Philippines is governed by a number of other legislations, including the Indigenous Peoples’ Rights Act[38], the Traditional and Alternative Healthcare Act[39], and the National Museum Act[40]. The provisions of these laws are in conformity to the EO 247, however, they could; in some cases influence the legal force or interpretation of the primary ABS laws.[41]

In this way the Philippines has undertaken the national implementation of ABS measures.

References: -

[1] List of parties, retrieved from https://www.cbd.int/convention/parties/list/ (Accessed on 17th September 2013).
[2] A. Smagadi, ‘National Measures on Access to Genetic Resources and Benefit Sharing – The case of the Philippines’, Law, Environment and Development Journal (2005), P. 60
[3] Ibid.
[4] Executive order no 247, 18 May 1995.
[5] K. Swiderska et al., Developing the Philippines’ Executive Order no 247 on Access to Genetic Resources, Participation in Access and Benefit- Sharing Policy, International Institute for Environment and Development, (2001).
[6] Section 15 of the Executive order 247 states, “The implementing rules and regulations shall be formulated by the Inter-Agency Committee and signed by the Secretary of Department of Environment and Natural Resources not later than three months after the effectively of the Executive Order.”
[7]  Administrative Order no 96- 20, Inter- Agency Committee and Department of Environment and Natural Resources, 1996.
[8] Preamble of the Executive Order 247, 1995.
[9] Section 3.1(a), Implementing Rules and Regulations on the Prospecting of Biological and Genetic Resources, Administrative Order No. 96-20, 2004.
[10] Section 3.1(b), Implementing Rules and Regulations, 2004.
[11] Ibid.
[12] Section 2(1) w, Implementing Rules and Regulations, 2004.
[13] Section 7, Implementing Rules and Regulations, 2004.
[14] Section 7.1.2, Implementing Rules and Regulations, 2004.
[15] As per section 7 of Implementing Rules ..............................
[16] Academic research agreement deals with the prospecting of biogenetic resources for purely academic purpose and only duly recognised Universities and academic institutions of the Philippines and domestic governmental and intergovernmental entities can apply for this type of agreements.

[17] As per section 3 of the EO 247, “If the research and collection of biological and genetic resources is intended, directly or indirectly, for commercial purposes, the agreement must be a Commercial Research Agreement.”
[18] Section 3, EO 247, 1995.
[19] Section 6, EO 247, 1995.
[20] Section 10 & 11, Implementing Rules and Regulations, 2004.
[21] Section 6, EO 247, 1995.
[22] Section 7(a), EO 247, 1995.
[23] Section 7 (e), EO 247, 1995.
[24] Section 7(j), EO 247, 1995.
[25] Wildlife Resource Conservation and Protection Act, Republic Act No. 9147 of the year 2001.
[26] Ibid, Section 2.
[27] Implementing Rules and Regulations on the Prospecting of Biological and Genetic Resources, Administrative Order No. 96-20, 2004.
[28] The Draft Guidelines were issued according to section 14 of the Wildlife Act and Rule 14(1) of the Implementing Rules to Wildlife Act. Which states that, “The Department of Agriculture and the Palawan Council for Sustainable Development must issue joint guidelines specific for bioprospecting.”
[29] A. Smagadi, ‘National Measures on Access to Genetic Resources and Benefit Sharing – The case of the Philippines’, Law, Environment and Development Journal (2005), P. 60
[30] Section 5(a), Wildlife Resource Conservation and Protection Act, Republic Act No. 9147 of the year 2001.
[31] Section 14, Wildlife Resource Conservation and Protection Act, Republic Act No. 9147 of the year 2001.
[32] Section 4, Draft Guidelines for Bioprospecting Activities in the Philippines.
[33] Section 2, Draft Guidelines for Bioprospecting Activities in the Philippines.
[34] As per section 3 of the Guidelines, it does not apply to the following uses of biological resources:
·         Traditional Use
·         Subsistence consumption
·         Conventional Commercial consumption for direct use such as logging or fishing
·         Scientific research on wildlife under section 15 of the Wildlife Act
·         Scientific research on agro diversity
·         Existing Procedures of collection and transport of wildlife species exclusively for commercial or conservation breeding or propagation under sections 17 and 24 of the Wildlife act; and
·         Ex-situ collections currently accessed under international agreements where the Philippines is a party.
[35] See Chapter VI of the Draft Guidelines for Bioprospecting Activities in the Philippines for more details.
[36] Section 23 and Annex V, Draft Guidelines for Bioprospecting Activities in the Philippines.
[37] K. Liebig et al., “Governing Biodiversity- Access to Genetic Resources and Approaches to Obtaining Benefits from their Use: The Case of the Philippines “, Reports and Working Papers, German Development Institute (2002), P. 1- 107.
[38] Republic Act 8371 of the year 1997.
[39] Republic Act 7586 of the year 1992.
[40] Republic Act 8492 of the year 1998.
[41] Perry S. Ong, ‘Access and Benefit Sharing: Experiences from the Philippines, A Mega diverse Developing Country’, Wildlife Conservation Society of the Philippines (2005)

Convention on Biological Diversity and Access and Benefit Sharing in India.(Working Draft)

India is one of the world’s most biodiversity rich regions, with approximately 8% (over 89,000 species of animals and 46,000 species of plants) of the world’s total variety of plants and animals.[1]Many policies, Acts, and Rules have been formulated by the Government of India with an aim to safeguard the forest, wildlife and habitats that per se cover the default biodiversity by direct and indirect means. Such government legislations prior to Biological Diversity Act 2002 are as follows:
1. Indian Forest Act, 1927
2. Indian Wildlife Protection Act, 1972
3. Forest Conservation Act, 1980
Basically, Indian Forest Act deals with overall protection & management of forests. Similarly, Indian wildlife protection Act aims to conserve the biodiversity with specific focus of wildlife (both animals and plants) with in situ and ex situ measures and Forest Conservation Act is focused on conservation of biodiversity through habitat protection. These Acts are very important for the protection of biodiversity in India. However, they hardly regulate the access to biogenetic resources or about sharing the benefits arising from such use.
India signed the CBD on 5th June 1992 and ratified it on 18th February 1994 and as per the mandate of the CBD, India is bound to make a concerted effort to ensure that the broad objectives of the CBD and other associated relevant instruments are addressed at a domestic level and proper guidelines for ABS mechanism are in place. Prior to the ratification of CBD by India, there were no specific legislations or policies dealing with the issues related to biodiversity and ABS. Even after the CBD entered into force in late 1993, it took India almost a decade to introduce the biodiversity legislation. After a very extensive and long consultations and discussions at different level, the government of India finally adopted the Biological Diversity Act (BDA) in May 2002.
The BDA aims to provide for conservation of biological diversity, sustainable use of its components and equitable sharing of the benefits arising out of the use of biological resources.[2] The BDA outlines a framework and process by which resources can be accessed, and details the procedural hierarchy that exist for those parties interested in doing so.[3] It also outlines measures for sharing of benefits from the use of biodiversity, including transfer of technology, monetary returns, joint research & development etc.[4] Furthermore it provides measures to conserve and sustainably use biological resources, including habitat and species protection, environmental impact assessments (EIAs) of projects, integration of biodiversity into the plans, programmes, and policies of various departments/sectors.[5]
Scope:
The Act extends to the whole of India[6] and regulates the issues relating to biological resources. The Act defines biological resources as, plants, animals and micro organisms and parts thereof, and their genetic material and by-products, with actual or potential use or value, but does not include human genetic materials.[7]
Regulating Authorities
To oversee the conservation, sustainable use and sharing of the benefits from the use of biological resources and traditional knowledge associated thereto, the Act has established different regulating authorities at different level. At the national level, National Biodiversity Authority (NBA) has been established.[8] It is mandatory to get approval from the NBA prior to conduct any activities related to biological resources.[9] At the state level, State Biodiversity Board (SBB) has been established[10] and it performs functions similar to that of NBA (but in state level). Finally, the Act establishes Biodiversity Management Committees (BMC)[11], within every local body and they shall be governed by existing village level political mechanism.
 ABS provisions in Biological Diversity Act: -
The underlying principle of ABS is to ensure that access to biological resources and/or associated traditional knowledge is based on a set of principles, terms and conditions that include prior informed consent (PIC), mutually agreed terms (MAT) and ensuring fair and equitable sharing of benefits. In the following section we shall examine the provisions of the BDA in regard to ABS.
Access: -
Any parties interested in accessing the biological resources and/or traditional knowledge associated thereto for research or for commercial utilization or bio-survey and bio-utilization must obtain approval from the NBA prior to conducting such activities.[12] This provision applies only to the persons as specified by section 3 (2) of the Act[13] and exempts Indian citizens and institutions. However, Indians and Indian institutions need to inform the SBB prior to undertaking any research with the intent of commercialization.[14]
The applicants interested in seeking access to biological resources and/or associated traditional knowledge must fill application form for access to biological resources and/or associated traditional knowledge (form I) under the Act.[15] Application processing fee of ten thousand Indian currencies is levied on the applicants at the time of submitting the application.[16] All applications are reviewed in terms of nature and quantity of material to be accessed, the timing, geographical location and other related issues.[17] The application are approved only after extensive consultation is made with an expert committee[18] and local bodies from whose jurisdiction the biological resources and associated traditional knowledge will be accessed.[19]
Access to biological resources by local people and communities of the area, including growers and cultivators of biodiversity, and vaids and hakims, who have been practising indigenous medicine are exempted from the purview of this Act.[20] Furthermore, normally traded commodities (NTCs) (Currently 190 species are designated as NTCs) are also exempted provided they are used as commodities.
The NBA shall give public notice of every approval granted for access to biological resources.[21]
Benefit Sharing: -
The NBA is responsible for securing equitable sharing of benefits arising out of the use of accessed biological resources, their by-products, innovations and practise associated with their use and applications and knowledge relating thereto in accordance with MATs at the time of granting approval to the applicants.[22] The terms or manner of benefit sharing must be determined by the NBA as provided in section 21 (2) [23]of the Act.
It is mandatory to obtain prior approval of the NBA if anyone wishes to apply for intellectual property rights (IPR) based on any research information on a biological resources obtained from India[24] and at the time of granting such approval the NBA may impose benefit sharing fee or royalty or both or impose conditions including the sharing of financial benefits arising out of the commercial utilisation of such rights.[25]
The Act has established National Biodiversity Fund (NBF)[26] with a purpose of channelling benefits, to the conservers of biological resources and creators and holders of knowledge, for the conservation of areas from where such biological resources of knowledge associated thereto has been accessed and for the socio-economic development of such areas in consultation with the local bodies concerned.[27] All the grants and loans made by the central government as per section 26[28] and monetary benefits arising from the benefit sharing shall be deposited to the NBF unless otherwise directed by the NBA.[29] However, in cases where biological resources was a result of access from a specific individuals or group of individuals organisations, the NBA may direct the benefit procured to be paid directly to such parties in accordance with the terms of any agreements.[30]
In the state level there is a State Biodiversity Fund (SBF), which is administered by the SBB. The main aim behind establishing this fund is to provide for the management and conservation of heritage sites and biological resources as well as helping in socio-economic development of areas from where biological resources or knowledge associated thereto has been accessed.[31] A similar mechanism is designated to exist at the village level[32]; this Local Biodiversity Fund (LBF) shall be used for “conservation of biodiversity in the areas falling within the jurisdiction of the concerned local body and for the benefit of the community in so far such use is consistent with the conservation of biodiversity.”[33]
Observation: -[34]
The BDA in its preamble explicitly acknowledges the obligation under the CBD and states that this very Act has been enacted to provide for conservation, sustainable utilisation and equitable sharing of benefits arising out of utilisation of genetic resources and also to give effect to the CBD. The objectives of the CBD have been addressed somehow in the BDA and it can be said that India’s engagement with ABS issues has been progressive and noteworthy. However, there are many things that is lacking in the BDA in comparison with the provisions of CBD. The BDA vests absolute authority to the NBA for granting PIC, concluding MTAs, regulating the sharing of benefits etc. Article 8 (j) of the CBD has been blatantly ignored by this Act as it does not give any rights to the Indigenous people and communities relating to the granting of PIC, negotiating the benefit sharing via MTAs etc. The provision of consulting the local bodies before granting PIC is present but is not very exclusive.
The BDA imposes restriction not only to access but also to the transfer of results of such research relating to any biological resources occurring or obtained from India to non Indian individuals and institutions without previous approval of the NBA. Furthermore, the Act makes it mandatory for obtaining prior approval from the NBA if anyone wishes to apply for IPRs based on any research or information on a biological resource obtained from India.[35]




References: -
[1]
[2] The Biodiversity Bill, 2002.
[3] J.R. Ghose, “Access and Benefit Sharing Systems: An Overview of the Issues and the Regulation”, 2003, P. 19.
[4] Sutar & Swain, Implementation of Biological Diversity Act in India: An Overview with Case Studies, Regional Centre for Development Cooperation, 2011, P. 20- 32
[5] Ibid.
[6] The Biological Diversity Act (2002), section 1 (2),
[7] Ibid, section 2 (c)
[8] Ibid, section 8 (1)
[9] Ibid, section 3
[10] Ibid, section 22.
[11] Ibid, section 41
[12] The Biological Diversity Act (2002), Section 3 (1).
[13] Section 3 (2) of the Act provides the list of persons who shall be required to take the approval of the National Biodiversity Authority which are as follows: -
a)       a person who is not a citizen of India;
b)       a citizen of India, who is a non-resident as defined in clause (30) of section 2 of the Income-tax Act, 1961;
c)       a body corporate, association or organisation-
i)         not incorporated or registered in India; or
ii)       Incorporated or registered in India under any law for the time being in force which has any non-Indian participation in its share capital or management.
[14] The Biological Diversity Act (2002), Section 23 (b).
[15] Ibid, section 19 (1).
[16] Access and Benefit Sharing Experiences from India, National Biodiversity Authority, this document can be found at http://nbaindia.org/uploaded/pdf/ABS_Factsheets_1.pdf ( accessed in 19th September 2013).
[17] Ibid.
[18] The Biological Diversity Act (2002), Section 41(2).
[19] Ibid.
[20] Ibid. Section 7.
[21] Ibid, section 19 (4).
[22] Ibid, section 21 (1).
[23] As per section 21 (2) the benefit sharing must be determined in all or any of the following manner, namely: -
a)       grant of joint ownership of intellectual property rights to the National Biodiversity Authority, or where benefit claimers are identified, to such benefit claimers,
b)       transfer of technology;
c)        location of production, research and development units in such areas which will facilitate better living standards to the benefit claimers;
d)       association of Indian scientists, benefit claimers and the local people with research and development in biological resources and bio-survey and bio-utilisation;
e)       setting up of venture capital fund for aiding the cause of benefit claimers;
f)        payment of monetary compensation and other non- monetary benefits to the benefit claimers as the National Biodiversity Authority may deem fit.

[24] The Biological Diversity Act (2002), section 6 (1).
[25] Ibid, section 6 (2).
[26] Ibid, section 27.
[27] Ibid, section 27 (2).
[28] As per section 26, the central government may provide the NBA grants or loans to be utilised for the purpose of achieving the objectives of the Act.
[29] The Biological Diversity Act (2002), section 21 (3).
[30] Ibid.
[31] Ibid, section 32.
[32] Ibid, section 43.
[33] Ibid, section 44.
[34] Ibid, section 4.
[35] Ibid, section 6.