Issues in Chemistry

Marilou G. Nicolas, Ph.D.

University of the Philippines Manila

Introduction
Science is a social structure

It relies on the interactions, behaviors and expectations of individuals in order to function It has a code of practices that constitutes its behavioral norms and/or moral philosophy

Chemistry is a science that involves human processes that rely on many decisions and produce various outcomes

Dependent on:
Honesty Trustworthines

Where ethical decisions are needed

Experimental design Gathering of data Interpretation and reporting of data Interactions between collaborators and subjects Evaluation of colleagues

Some major categories of scientific misconduct

Falsification of data Plagiarism Impropriety of authorship

Giving or not giving credit in published materials Publishing/presenting the same results/ paper in more than one fora Listing as authors individuals who have not made a definite contribution to the work published Submission of multi-authored manuscripts to publishers without the agreement of all authors on the content of the material

Some major categories of scientific misconduct (2)

Misappropriation of the ideas or intellectual property of others Violation of ethical research practices and compliance with existing laws pertaining to:

Use/misappropriation of funds or other resources Care of animals and human subjects Research personnel and community welfare (biosafety and biosecurity issues) Use of biological resources or chemical materials

Intellectual Properties are

IDEAS!

Can ideas be protected?

Yes

If transformed to tangible form If new or novel

Tangible forms of ideas

Written materials Words or phrase Computer software Symbols Invention Industrial design Biotechnology innovation New plant variety

Ways to protect ideas

Copyright Patents Trade secrets Trade marks Plant variety protection Traditional knowledge Geographical indication

What is the protection?

The right to prevent or stop anyone or any organization from using the intellectual property. This right, when granted by a government body, is referred to as Intellectual Property Rights or IPR

Erbisch, Fred. (2004). Introduction to IP, IPR and course

What rights are given after granting permission to use IP and/or IPR
Establish a contractual arrangement Sell the intellectual property and/or intellectual property rights License the intellectual property and/or intellectual property rights Give away the intellectual property and/or intellectual property rights

Erbisch, Fred. (2004). Introduction to IP, IPR and course

What is a copyright
It is the protection given to published and unpublished literary, scientific and artistic or creative works that have been transformed into a tangible form Includes: literary works, movie, songs, dance moves, computer graphics, source codes

Berne Convention
Grants to creator/author the exclusive right to reproduce modify, distribute, perform and display the work publicly Protection is given for the life of the author and 25-50 years after death.

IPR Issues in Research

Information Innovations and inventions

Industrial design for machines and other devices Synthetics

Biological resources

Information
Ideas of others

Written notes Verbal communications Published information

Citations

Innovations and inventions

Issues

Acceptable innovation Patents

Biological resources
Genetic material - any material of plant, animal, microbial or other origin containing functional units of heredity, i.e. DNA Genetic resources - genetic material of actual or potential commercial value

Issues and concerns

Public domain or common heritage vs. breeders rights Biological diversity and sustainability development Biotechnology/ recombinant technology Bioprospecting and natural products research Country of origin Traditional knowledge

Genetic Resources, Intellectual property rights and international treaties

FAOs International Undertaking (IU) Convention on Biological Diversity (CBD) ITPGRFA

The CBD adopted in 1993 with the Philippines as one of the signatories declares that countries have national patrimony rights to all biological and genetic materials within their territories and can enforce laws and regulations on access and utilization of resources

World Trade Organization TRIPS

Articles in CBD concerned with IPR

Benefit-sharing (Art. 8(j)), Access to Genetic Resources (Article 15), Access to and Transfer of Technology (Art. 16), Exchange of Information (Art. 17), Handling of Biotechnology and Distribution of its Benefits (Art.19).

WTO-TRIPS
TRIPs requires that countries should provide intellectual property protection for plant varieties, either through patents or an effective sui generis regime

Important provisions that impacts on intellectual property protection

Formal protection and patentable subject matter (particularly Art. 27.3(b) regarding plants), Anticompetitive Practice (Article 40), Geographical Indications (Article 22-24), Exchange of Information (Art. 17), Copyright (especially, Art. 9, 10, 12), Trademarks, (Section 2, Art 15-21), Trade Secrets (Art. 39).

How would this affect research and practices in developing countries?

Evolution of Legal systems Agreements

Evolution of Legal systems

Bioprospecting

The business of bioprospecting

Need for drugs either to cure currently incurable diseases that affect increasing numbers of the world population (AIDS, Alzheimers, TB, cancer) Need to replace drugs that are becoming increasingly ineffective to treat health problems (such as pathogens resistant to antibiotics)

Bioprospecting industries
Pharmaceuticals, including natural products Agribusiness and Agrochemical industries, Cosmetics, health and beauty aids industries, and the Biosafety sector

Bioprospecting is also inextricably linked to sustainable economic development, biodiversity conservation and equitable use and stewardship of global natural resources

Terrestrial resources
The Philippines, the worlds second largest archipelago after Indonesia, covers a land area of about 300,000 km2. It is one of the 17 megadiversity countries, which between themselves contain 70 to 80 percent of global biodiversity Philippine rainforest is home to more than 1130 terrestrial wildlife species and between 10,000-13,000 species of plants so far recorded, of which more than half are found nowhere else in the world. Philippines has also been described as Galapagos times ten.

Marine Resources
The countrys marine waters cover 2.21 M km2 with a coastline of 22,450 km and an estimated27,000 km2 of coral reefs. This contains exceptional marine biodiversity, among which are: (a) nearly 500 coral species of the more than 800 known coral species worldwide; (b) more than 2,000 species of fish and (c) more than 40 species of mangrove plants making the country one of the richest concentrations of marine life in the world although these and seagrass beds have been reduced to 120,000 ha from 500,000 ha and only 5% of coral reefs in excellent condition, making the Philippines among the worlds Marine biodiversity hotspots.

Example of a biodiversity area

Some of Isarogs waterfalls, flora and fauna

Philippines Biodiversity Strategy and Action Plan: pre-CBD era

The national parks system in the Philippines was established way back in 1932 through Republic Act (R. A) 3915 The creation of the Protected Areas and Wildlife Bureau (PAWB) in 1987 when the Department of Environment and Natural Resources (DENR) was re-organized through Executive Order No. 192. The enactment of R.A. 7586 or the National Integrated Protected Areas System Act (NIPAS) in June 1992

Problems
Lack of a national land use policy Implementation of the NIPAS vis a vis contradictory laws

Local Government Code of 1992, the Mining Act of 1995, Indigenous Peoples Rights Act (IPRA) of 1997, Agriculture and Modernization Act of 1997

Incoherent biodiversity conservation policies and rules; lack of personnel and academic training programs

Management Policies and Strategies: Post-CBD

The completion of the Philippine Biodiversity Conservation Priority-setting Program (PBCPP), December 2001 The holding of the First National Protected Areas Congress last November, 2001

Bioprospecting laws
The passage of the Wildlife Resources Conservation and Protection Act of 2001 (RA 9147) which repealed DENR Department AO 9620, the implementing rules and guidelines of EO 247 otherwise known as 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

Bioprospecting Rules
Approval of the new Philippine guidelines on bioprospecting otherwise known as Guidelines for Bioprospecting Activities in the Philippines (Joint DENR-DA-PCSDNCIP Administrative Order No. 1 Series of 2005) Signed on January 12, 2005

Joint DENR-DA-PCSD-NCIP AO 1 (2005)

Harmonized provisions of EO 247 and RA 9147 (Wildlife Act) Redefined bioprospecting as the research, collection and utilization of biological and genetic resources solely for commercial purposes only and requires a Bioprospecting Undertaking (BU) before the user is allowed access to biological and genetic resources for bioprospecting/commercial purposes Scientific research (with no commercial purpose) shall be allowed after the signing of a MOA and the issuance of a gratuitous permit

Joint DENR-DA-PCSD-NCIP AO 1 (2005)

Set rules governing the implementation of EO 247, Wildlife Act (RA 9147) and other relevant laws that will protect indigenous and local communities with regard to collection, use of biological and genetic resources and equitable sharing from these resources Bioprospecting is the search for useful application, process or product in nature; search for useful organic compounds in microorganisms, fungi and plants that grow in extreme environments; search for new chemicals in living things that will have some medical or commercial use.

Guidelines for the Collection of Biological Specimen in the Philippines

Section 1: The state shall promote the common good, conserve and develop the patrimony of the nation for the present and future generations. Consequently the protection of our natural resources, which include biological specimen should be the primary concern of all Filipinos

Restriction and control mechanisms in the entry and exit of biological specimen must be established in coordination with various agencies to prevent the technical smuggling of biological specimen under the guise of education and scientific research; and Enforcement of the Convention on International Trade of Endangered Species of Wild Fauna and Flora (CITES) should be strictly observed

AGENCIES INVOLVED
National Museum of the Philippines (NMP) Protected Areas and Wildlife Bureau (PAWB) in cases falling under the coverage of CITES Bureau of Fisheries and Aquatic Resources (BFAR) and UP Marine Science Institute in cases of marine organisms Bureau of Plant Industry (BPI) and UP in cases of plants Bureau of Animal Industry (BAI) and UP in cases of animals

Agreements
Between researchers Between agencies or researchers and agencies Between researchers and the community Between researchers and industry

Why have agreements?

Allows all parties to specify and know conditions (e.g. length of time, cost, specific uses) of collaboration/ undertaking Prevents misunderstanding, fights (legal and extra-legal), reserves ownership, etc Provides basis for legal actions for not following conditions of agreement
Erbisch, Fred. 2004. Agreements (slide presentation

Why have agreements?

Protect intellectual properties especially those not protected by government or where protection is limited.

Retain ownership Define how the intellectual property is to be used; Commercialization restrictions

What type of agreements should be used?

Handshake Verbal agreement Written and properly executed agreement or signed document

Some types of agreements

Confidential Disclosure Agreement

allows researchers to exchange information under defined terms allows researchers to exchange research materials under defined terms

Material Transfer Agreement

Research Agreement (Commercial Research Agreement or Academic Research Agreement) Cooperative/ inter-institutional agreement (MOU/MOA) License Agreement

Researches involving genetic resources in the wild: requirements

Protected areas

Memorandum of Agreement (with local DENR-PAWB and PAMB) Gratuitous permit If site is within ancestral domains permit from NCIP Prior informed consent (PIC) from community

References
http://www.chemistryexplained.com/Di-Fa/Ethics.html Magboo, CE and Nicolas, MG (2004). Genetic resources and intellectual property rights: procedures, issues and concerns in the Philippines (country report-2004) Genetic Resources and Intellectual Property Rights, Svalov, Sweden Intellectual Property Management in Health and Agricultural Innovations: A Handbook of Best Practices (2007). Krattiger A et. al. (eds), MIHR and PIPRA, Oxford, UK (www.ipHandbook.org) http://sunsite.nus.edu.sg/apcel/dbase/filipino/primary/phobio.html House of Representatives and Senate (2001). RA 9147 An Act Providing for the Conservation and Protection of Wildlife Resources and their Habitats, Appropriating Funds Therefor and for other Purposes http://www.pchrd.dost.gov.ph/index.php/news-archive/70 Benavidez PJ II. The Challenges in the Implementatin of the Philippine ABS Regulations: Monitoring and Enforcement of Bioprospecting Activities in the Philippines International Expert Workshop on Access to Genetic Resources and Benefic Sharing I. Identificatin of Outstanding ABS Issues: National Access Laws