Biological materials and biotech research:

1. Biological materials and biotechresearch: Challenges, opportunities and the role of Material Transfer Agreements Harry Herkutanto

2. Ministry of Health Republic of IndonesiaNational Institute of Health Research and Development Harry Herkutanto • Chairman of MTA Review Team • advocatingresearchers to negotiate and drafting research contract, both at the individual and the institutional level • Formulating policies at the national level.

4. To Foster Cooperation in biotech and research, and embrace the biodiversity and bioinformatics resources • To exchange views on how to implement the cooperation and avoid unnecessary disputes World Pharma Trials 2011

5. Cooperation and Agreement in biotech and research • Focus on Asian Excellencein biodiversity and resources • Indonesia as an example World Pharma Trials 2011

6. Introduction • Challenges and opportunities to cooperate • Material transfer agreement and international instruments World Pharma Trials 2011

7. Shifting of technological cycle from IT to biotech era • Capacity differences in technology and bioinformatics resources amongst countries • Raising demands for cooperation to fill in the gap in knowledge, technology, and bioinformatics resources amongst countries

9. Challenges and opportunities TO COOPERATE

10. Potential of Bioinformatics Resources

11. Population: Indonesia 240 Mio (Asean:600 Mio) • to be one of the 17“megadiverse”countries • Indonesia is the second largest country in biodiversity resources after Brazil, including resources for vaccine development. http://www.cbd.int/countries/profile/default.shtml?country=id#facts

12. Wide variations of disease • a large patient pool • Low cost (compared to the US-Europe: HK and South Korea 20% lower, Singapore 30%, Malaysia 40%, Taiwan -Thailand – The Philipinesand India 50%, Vietnam and Indonesia 55%). • Asia:overall 30% cheaper • Support from regulatory bodies are getting better http:// Sofia Arborelius, Karolinska Institutet, 2006

13. huge potential and opportunities: • The number of residents to the world's 4th largest • Disease patterns represent most of the world • Support from regulatory bodies are getting better http:// Sofia Arborelius, Karolinska Institutet, 2006

14. Dedicated authorities: Ministry of Research and Technologies • Credible institutions: the Institute of Sciences; Research Universities, Eijkman Institutes • Excellent resources: International and National Accredited Teaching and Research Hospitals

15. Asia (China and ASEAN) is home to 60% of the world population, and is currently the most potential for the market place drug • Asian Excellence: large populations, low cost, fast execution, focus on science and education; rapid growth; rapid change World Pharma Trials 2011

17. Material Transfer Agreements (MTAs) are legal documents that outline the transfer of material between institutions. • Purpose: To avoid Future misunderstandings or disputes  http://www.ehow.com/about_6404562_material-transfer-agreement_.html

18. A Material Transfer Agreement (MTA) is a document that can be used when a researcher wants to either send materials to an outside party or receive materials from an outside party.  • MTAs define the rights and responsibilities of both the providing and receiving party regarding issues such as permitted use, ownership, publication, intellectual property, and liability. • All incoming and outgoing MTAs must be evaluated and signed by an authorized representative from Your Institution Office. Even if you have been provided a signature line, you can’t sign. A Material transfer agreement (MTA) is a contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. Biological materials, such as reagents, cell lines, plasmids, and vectors, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds and even some types of software. The Ohio State University

19. The purpose for which consent was given • Tissue must be used according to the protocol • Ownership of the tissue – retained or transferred • Ownership of IP arising from use of the tissue • Identification of samples – anonymised or linked • What will happen to the tissue at the end of the agreement • Terms pertaining the equipment http://www.crncc.nihr.ac.uk/about_us/ccrn/gm/industry/research-contracts/equipment.htm

20. Academic Purposes • The use of speciments for educational purposes • Medical service Purposes • The use of speciments for medical treatment purposes • Research Purposes • The use of speciments for research including commercial purposes http://www.ehow.com/about_6404562_material-transfer-agreement_.html

21. The MTA is designed to prevent • misunderstandings between the parties,and • liabilities resulting from the misuse of material transferred http://www.ehow.com/about_6404562_material-transfer-agreement_.html

22. It protects the rights from claims relating to the use, handling, storage and disposal of the materials. • It defines the duties of the recipients and their institutions, including the responsibility to properly handle, use and dispose of the materials according to applicable laws and regulations. atcc.custhelp.com/app/answers/detail/a_id/1227/~/importance-of-material-transfer-agreement

23. It protects the rights of the recipients by offering the terms of a warranty, which guarantees that if the received materials are not viable, the recipient is entitled to a refund or replacement • It prevents uncontrolled distribution of Biological Materials atcc.custhelp.com/app/answers/detail/a_id/1227/~/importance-of-material-transfer-agreement

24. INTERNATIONAL INSTRUMENTS was agreed on 29 October 2010 in Nagoya, Japan  • ACCESS TO GENETIC RESOURCES AND THE FAIR AND EQUITABLE SHARING OF BENEFITS ARISING FROM THEIR UTILIZATION TO THE CONVENTION ON BIOLOGICAL DIVERSITY www.cbd.int/abs/about/

25. The Nagoya Protocol is intended to create greater legal certainty and transparency for both provider and users o genetic resources by: • Establishing more predictable conditions for access to genetic resources • Helping to ensure benefit-sharing for both parties www.cbd.int/abs/about/

26. Monetary benefits Non-monetary benefits Sharing of research and development results; Collaboration, cooperation and contribution in scientific research anddevelopment programmes, particularly biotechnological research activities,where possible in the Party providing genetic resources; Participation in product development; Collaboration, cooperation and contribution in education and training; Admittance to ex situ facilities of genetic resources and to databases; Transfer to the provider of the genetic resources of knowledge andtechnology under fair and most favourable terms, including on concessionaland preferential terms where agreed, in particular, knowledge and technology that make use of genetic resources, including biotechnology, orthat are relevant to the conservation and sustainable utilization of biological diversity; Strengthening capacities for technology transfer; Institutional capacity-building; • Access fees/fee per sample collected orotherwise acquired; • Up-front payments; • Milestone payments; • Payment of royalties; • Licencefees in case of commercialization; • Special fees to be paid to trust fundssupporting conservation and www.cbd.int/abs/about/

27. Monetary benefits Non-monetary benefits Human and material resources to strengthen the capacities for theadministration and enforcement of access regulations; Training related to genetic resources with the full participation of countriesproviding genetic resources, and where possible, in such countries; Access to scientific information relevant to conservation and sustainableuse of biological diversity, including biological inventories and taxonomic studies; Contributions to the local economy; Research directed towards priority needs, such as health and food security,taking into account domestic uses of genetic resources in the Party providing genetic resources; Institutional and professional relationships that can arise from an accessand benefit-sharing agreement and subsequent collaborative activities; Food and livelihood security benefits; Social recognition; Joint ownership of relevant intellectual property rights. • sustainable use of biodiversity; • Salaries and preferential terms where mutually agreed; • Research funding; • Joint ventures; • Joint ownership of relevant intellectual property rights. www.cbd.int/abs/about/

28. Capacity differences amongst countries opens opportunity to cooperate and share the benefits of biodiversity • The MTA’s and other International Instruments protects the right of parties enjoying the benefeit sharing and avoid unnecessary disputes

29. Thank you