Developments on Emerging Intellectual Property Rights in the Philippines DEVELOPMENTS ON EMERGING INTELLECTUAL PROPERTY RIGHTS IN THE PHILIPPINES Bienvenido I. Somera, Jr. and Jade A. Andaman Introduction Further to the Philippine Report submitted last year in the Asian Patent Attorneys Association Council Meeting in Fukuoka, Japan on emerging intellectual property rights in the Philippines, hereunder is an update on the status of the laws and regulations on the matter, together with a discussion on Traditional and Alternative Medicines Act of 1997 which was not included in last year’s report. I. THE TRADITIONAL AND ALTERNATIVE MEDICINES ACT Republic Act No 8423 otherwise known as the “Traditional and Alternative Medicines Act (TAMA) of 1997” provides for the acceleration of the development of traditional and aItemative health care in the Philippines. TAMA declares it a state policy to seek a legally workable basis by which indigenous societies would own their knowledge of traditional medicine. When such knowledge is used by outsiders, the indigenous societies can require the permitted users to acknowledge its source and can demand a share of any financial return that may come from its authorized commercial use.1 Senior Partner, Villaraza & Angangco Law Offices, Philippines Junior Associate, Villaraza & Angangco Law Offices, Philippines 1 Article I, Section 2 paragraph two of TAMA 1 Developments on Emerging Intellectual Property Rights in the Philippines In this regard, TAMA defines intellectual property rights as the legal basis by which the indigenous communities exercise their rights to have access to protect, control over their cultural knowledge and product, including but not limited to, traditional medicines, and includes the right to receive compensation for it.2 Hence, among TAMA’s objectives is to formulate policies for the protection of indigenous and natural health resources and technology from unwarranted exploitation, for approval and adoption by the appropriate government agencies.3 To implement TAMA, the Philippine Institute of Traditional and Alternative Health Care (PITAHC) has been established and functions as an attached agency of the Department of Health.4 Pursuant to its Section 19, the Department of Health-Traditional Health Unit formulated the rules and regulations (“IRR”) necessary for the implementation of TAMA. The IRR recognizes the existence of community intellectual rights, and defines the same as a sui generis or unique set of rights which provides the legal basis for the indigenous and local communities to control, protect, and regulate access to their knowledge systems concerning plants and biological resources used in traditional and alternative health care practices and includes the right to receive benefits from its sustainable utilization as well as the commercialization of products that may be derive from it.5 2 Article II, Section 4(j) of TAMA Article I, Section 3 (e) of TAMA 4 Article III, Section 5 5 Rule II, Section 1(10) of the IRR 3 2 Developments on Emerging Intellectual Property Rights in the Philippines In order to protect the biological and genetic resources including indigenous knowledge systems associated herein, their exploration and utilization shall be done with the free and prior informed consent of the communities possessing these knowledge systems and living where these resources may be found.6 For this purpose, the Board of Trustees of the Philippine Institute of Traditional and Alternative Health Care (PITAHC) shall endeavor to develop workable mechanisms, in accordance with the customary practices of the place, for the identification and documentation of indigenous knowledge systems relevant to the utilization of biological and generic resources that re applied in traditional and alternative health care practices of the community.7 In addition, the PITAHC shall endeavor to monitor and inventory Philippine natural health products that have been inappropriately applied for intellectual property rights protection in the Philippines and abroad without complying with applicable laws and regulations and shall make representations with the appropriate international institutions and agencies of the Government of the Philippines, to cancel this rights or to renegotiate the terms and conditions thereof that are favorable to Philippine interest.8 Moreover, the application of existing forms of intellectual property rights on biological and genetic resources as well as indigenous knowledge systems shall be without prejudice to the application of whatever sui generis rights that may be provided by law to the appropriate local and indigenous communities. The Board or other appropriate governmental bodies shall also intervene, whenever it becomes necessary for the protection of the general welfare of the communities involved, to protect and ensure the rights of the communities during the negotiations for benefit sharing.9 6 Rule IX, Section 1 of the IRR Rule IX, Section 3 of the IRR 8 Rule IX, Section 4, paragraph 3 9 Rule IX, Section 4, paragraph 4 7 3 Developments on Emerging Intellectual Property Rights in the Philippines II. DEVELOPMENTS ON EXECUTIVE ORDER NO. 247 AN THE WILDLIFE RESOURCES AND CONSERVATION PROTECTION ACT On 12 January 2005, the Joint DENR-DA-PCSD-NCIP Administrative Order No. 1, Series of 2005, also known as the Guidelines for Bioprospecting Activities in the Philippines (the “Guidelines”) was approved. The Guidelines was jointly signed by the Secretaries of the Department of Environment and Natural Resources (DENR) and the Department of Agriculture (DA), and the Chairmen of the Palawan Council for Sustainable Development (PCSD) and the National Commission on Indigenous People (NCIP).10 The Guidelines was formulated and approved pursuant to the obligations of the Philippines under the Convention on Biological Diversity and other relevant international agreements, the provisions of Executive Order No. 247 as amended by Section 14 of the Wildlife Act and Section 35 of the Indigenous Peoples’ Rights Act and the TAMA, among others. The Guidelines provides that the State shall ensure that the prior informed consent is obtained from resource providers11 before allowing any bioprospecting12 activity. The State shall also ensure the fair and equitable sharing with the resource providers of benefits derived from the utilization of biological resources. With respect to its scope, the Guidelines shall apply to bioprospecting activities conducted by resource users,13 including government agencies, on 10 www.pchrd.dost.gov.ph In Section 5 of the Guidelines, resource provider refers to the local community, indigenous peoples, Protected Area Management Board, private land owner from where the biological resources were collected. 12 In Section 5 of the Guidelines, bioprospecting means the research, collection and utilization of biological and generic resources for purposes of applying the knowledge derived therefrom solely for commercial purposes. 13 In Section 5 of the Guidelines resource user refers to the local or foreign individual, company, organization, institution, or entity, either public or private that will utilize biological resource; a given area in the Philippines for bioprospecting purpose on the basis of a Bioprospecting Undertaking it entered with appropriate agencies. 11 4 Developments on Emerging Intellectual Property Rights in the Philippines any biological resources found in the Philippines, including wildlife, microorganism, domesticated or propagated species and exotic species.14 The Guidelines shall also apply to all ex-situ collections of biological resources sourced from the Philippines, except for collections currently accessed under international agreements where the Philippines is a party.15 Under 3.2 of the Guidelines, scientific studies conducted by researchers with no commercial interests and purely for academic purposes, using biological resources for taxonomy or solely for the characterization of biological, chemical or physical properties of the biological resources, shall not be covered by the Guidelines but by Section 15 of the Wildlife Act provided that subsequent transfer of these biological resources and use of research findings for commercial purposes, shall be considered bioprospecting and subject to the requirements or the Guidelines. Under Section 6.1 of the Guidelines, bioprospecting shall be allowed only upon execution of a Bioprospecting Undertaking (BU) between the resource user and the Secretary of the DA and/or DENR, and the Chairperson of the PCSD when the bioprospecting activity is to be conducted in the Province of Palawan. The Guidelines also provides that the Protected Areas and Wildlife Bureau of the DENR, the Bureau of Fisheries and Aquatic Resources or other concerned regulatory agencies of DA shall provide separate assistance to resource providers in evaluating proposals for purposes of prior informed consent and in effectively negotiating for benefit-sharing.16 On the other hand, the NCIP shall lead in assisting indigenous peoples who are resource 14 Section 2.1 of the Guidelines. Section 2.1 of the Guidelines. 16 Section 7.3 of the Guidelines 15 5 Developments on Emerging Intellectual Property Rights in the Philippines providers in documenting free and prior informed consent and in negotiating for benefits under the BU.17 The Guidelines also provides for the general procedure for securing a BU,18 guidelines for prior informed consent19 and provisions for benefitsharing arrangement.20 The resource provider shall designate a representative to negotiate with the resource user provided that only one BU containing the negotiated terms with all provider-groups shall be executed between the resource user and the appropriate signatories. The resource user and providers shall come to an agreement regarding payments of monetary and non-monetary benefits in accordance with the following: a. The Bioprospecting fee21 shall accrue to the national government, payable to the implementing agencies; b. Up-front payments shall accrue to the resource between the national providers; c. Royalties shall be shared government and the resource providers; and 17 Section 7.4 of the Guidelines Chapter III, Section 8 of the Guidelines 19 Under Section 13.2 of the Guidelines, the prior informed consent shall be secured from the concerned resource providers through the following procedures: (1) notification; (2) sectoral consultation; and (3) issuance of the prior informed consent Certificate. 20 Chapter VI of the new guidelines 21 In accordance with Section 15 of the new guidelines, the minimum bioprospecting fee shall be US$3,000.00 for each BU and the maximum bioprospecting fee shall be three times the minimum and will depend on the following criteria: 18 a. b. c. d. e. That the sampling method involves the killing or destruction of wildlife; That the species collected is rare, or reproduces/recovers slowly; That the species to be collected is known to have a better than average commercial potential based on previous researches; That the species to be collected is a pest or vector of diseases, ad that the research is geared towards controlling the pest or vector; and That the bioprospecting involves access to traditional knowledge. 6 Developments on Emerging Intellectual Property Rights in the Philippines d. Local governments shall share in the amounts received by the national government, consistent with the provisions of the Local Government Code. To monitor whether the benefit sharing agreement can be considered fair and equitable, a checklist of process and content indicators can be used by the contracting parties and other stakeholders.22 With respect to sanctions and penalties under Section 31 of the new guidelines, non-compliance with the provisions in the BU shall result in the automatic cancellation/revocation of the said agreement and confiscation of collected materials in favor of the government, forfeiture of bond and imposition of a perpetual ban on access to biological resources in the Philippines by the violator. Such breach is considered a violation of the Wildlife Act and shall be subject to the imposition of administrative and criminal sanctions under existing laws. Any person who shall conduct bioprospecting without a BU shall be subject to penalties for collection without permit. III. APPLICATION Pilot projects promoting implementation of legislation on access and benefit-sharing have been undertaken since 1999. For instance, the nongovernmental organization South East Asia Regional Institute for Community Empowerment (SEARICE) worked with indigenous and local communities to prevent illegal bioprospecting and to conclude equitable bioprospecting contracts.23 This enabled the Talaandig indigenous community in Mt. Kitanglad to assert their ownership over their resources by developing their own prior informed consent mechanisms, taking as legal 22 23 Section 24.1 of the new guidelines www.gtz.de/biodiv/english/genres.htm 7 Developments on Emerging Intellectual Property Rights in the Philippines basis the provisions of the IPRA on free and prior informed consent and its legal command to indigenous communities to formulate these in consonance with existing community rules and practices.24 A Cultural Impact Assessment (CIA) Framework, within which to evaluate any application for any developmental activity, has been established by the Talaandig indigenous community within the Mt. Kitanglad Protected Area in addition to their community’s free and prior informed consent procedures under IPRA.25 In the province of Palawan, the Palawan NGO Network (“PNNI”) successfully lobbied for the adoption of the city ordinance in the local implementation of the Executive Order 247 in Puerto Princesa City, the capital city of Palawan.26 The same is true with the local government of Lantapan in Bukidnon.27 Update on emerging IP rts@IP14/JAA 24 www.biodiv.org/programmes/socio-eco/benefit/project.aspx www.biodiv.org/programmes/socio-eco/benefit/project.aspx 26 www.biodiv.org/programmes/socio-eco/benefit/project.aspx 27 www.biodiv.org/programmes/socio-eco/benefit/project.aspx 25 8