Regulatory Framework of Material Transfer Agreement (MTA) Under Indonesian Laws

The MTA provides for a contractual agreement between a provider and recipient of the material which content the rights and obligations of all parties, including third parties. In international law, the Convention on Biological Diversity (CBD) and FAO International Treaty on Plant Genetic Resources for Food and Agriculture (ITPRFA) provides mandate to Contracting Parties have to enact laws and adopt policies regarding the MTA for negotiation between the recipient and provider of access to genetic resources based on profit-sharing agreement. Regulation MTA in Indonesia is covered in the Regulation of the Minister of Agriculture under Regulation of the Minister of Agriculture No. 15/Permentan/OT.140/3/2009 on Guidelines for Preparation of Material Transfer Agreement and Regulation of the Minister of Health No. 657/Menkes/Per/VIII/2009 on Delivery and Use of Clinical Specimens, Biological Materials and Content the information. This article aims to examine the provisions of MTA under international laws and Indonesian law, it will analyze to what extent MTA set out in Regulation of the Indonesian Minister of Agriculture No. 15/Permentan/OT.140/3/2009 and Indonesian Minister of Health No. 657/Menkes/Per/VIII/2009. Then this study will also give suggestion for additional terms due to any weaknesses of MTA regulations in Indonesia. MTA regulations provides many benefits for Indonesia as a state provider, especially in terms of the protection of intellectual property rights. Provider can cooperate to research and development on food, agriculture and health, with domestic or foreign researcher, providers gain benefit sharing on the sale or lisence of products produced from the contracted material. For local communities also gain profit from its commercialization of the collection or invention of material obtained in the region owned by local communities. Yet, the MTA regulations is considered can inhibit the development of research and invention, costly. MTA provision that allow the recipient to distribute the genetic material and its derivates to other parties raises possibility violation by the recipient and also will arise conflict on the third party. According to MTA regulations, the provider difficult to monitor and control the implementation of the agreement. Thus, It needs to be more detailed arrangements regarding intellectual property protection to limit the use of the transferred material, also need to be set separated on benefit sharing when both parties negotiate of MTA.

Correction to: South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation

An amendment to this paper has been published and can be accessed via the original article.

South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation

Background Whenever South African (SA) research institutions share human biological material and associated data for health research or clinical trials they are legally compelled to have a material transfer agreement (MTA) in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health (SA MTA). Main body The article offers a legal analysis of the SA MTA and focuses on its substantive fit with the broader legal environment in South Africa, and the clarity and practicality of its terms. The following problematic aspects of the SA MTA are highlighted: (a) Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; (b) Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; (c) the SA MTA’s consent provisions are not aligned with extant law; and, similarly, (d) its provision on donor ownership is misaligned with extant law; (e) its creation of fictitious performance can only cause frustration on the part of an injured party; (f) its benefit-sharing provision is vague and will have little practical effect; (g) its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; (h) it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, (i) its data privacy provision is insufficiently specific, is overbroad, and fails to provide terms that in general would facilitate the international sharing of human biological material and associated data in terms of existing privacy law. Conclusions While some of the problematic aspects of the SA MTA are intricate and require consultative processes with stakeholders and others, to develop comprehensive solutions, most of the problematic aspects can be resolved immediately through amendments by the South African Minister of Health. The formulation of such amendments is proposed and, where possible, interim measures are suggested that may ameliorate the problems presented by the SA MTA.

New ECCO model documents for Material Deposit and Transfer Agreements in compliance with the Nagoya Protocol

ABSTRACT The European Culture Collections’ Organisation presents two new model documents for Material Deposit Agreement (MDA) and Material Transfer Agreement (MTA) designed to enable microbial culture collection leaders to draft appropriate agreement documents for, respectively, deposit and supply of materials from a public collection. These tools provide guidance to collections seeking to draft an MDA and MTA, and are available in open access to be used, modified, and shared. The MDA model consists of a set of core fields typically included in a ‘deposit form’ to collect relevant information to facilitate assessment of the status of the material under access and benefit sharing (ABS) legislation. It also includes a set of exemplary clauses to be included in ‘terms and conditions of use’ for culture collection management and third parties. The MTA model addresses key issues including intellectual property rights, quality, safety, security and traceability. Reference is made to other important tools such as best practices and code of conduct related to ABS issues. Besides public collections, the MDA and MTA model documents can also be useful for individual researchers and microbial laboratories that collect or receive microbial cultures, keep a working collection, and wish to share their material with others.

Seed Banking as Future Insurance Against Crop Collapses

Food security is dependent on the work of plant scientists and breeders who develop new varieties of crops that are high yielding, nutritious, and tolerate a range of biotic and abiotic stresses. These scientists and breeders need access to novel genetic material to evaluate and to use in their breeding programs; seed- (gene-)banks are the main source of novel genetic material. There are more than 1,750 genebanks around the world that are storing the orthodox (desiccation tolerant) seeds of crops and their wild relatives. These seeds are stored at low moisture content and low temperature to extend their longevity and ensure that seeds with high viability can be distributed to end-users. Thus, seed genebanks serve two purposes: the long-term conservation of plant genetic resources, and the distribution of seed samples. Globally, there are more than 7,400,000 accessions held in genebanks; an accession is a supposedly distinct, uniquely identifiable germplasm sample which represents a particular landrace, variety, breeding line, or population. Genebank staff manage their collections to ensure that suitable material is available and that the viability of the seeds remains high. Accessions are regenerated if viability declines or if stocks run low due to distribution. Many crops come under the auspices of the International Treaty on Plant Genetic Resources for Food and Agriculture and germplasm is shared using the Standard Material Transfer Agreement. The Treaty collates information on the sharing of germplasm with a view to ensuring that farmers ultimately benefit from making their agrobiodiversity available. Ongoing research related to genebanks covers a range of disciplines, including botany, seed and plant physiology, genetics, geographic information science, and law.

Pathogens collections, biobanks and related-data in a One Health legal and ethical perspective

SUMMARYResearch on emerging infectious diseases calls for a work on collections of pathogens (including hosts or vectors from which the pathogens were isolated), related to human and animal health, to wildlife or on the environmental material. In this respect, the adoption of a One Health perspective is determined by the need for a common approach to consider the collection, storage and use of pathogens coming from human or non-human sources, and particularly when the same pathogen is taken from different environments. In response to this development, our purpose is to delineate a flexible regulation framework concerning collections of pathogens from various origins or hosts and their associated data in order to facilitate scientific work and research partnerships. The legal and ethical cutting-edge research on Biomedical Big Data is particularly stimulating when it comes to address challenges related to collections or biobanks of pathogens such as prior informed consent and accessibility, Material Transfer Agreement or benefit sharing.

MATERIAL TRANSFER AGREEMENT SEBAGAI SARANA PERLINDUNGAN HUKUM PARA PIHAK DALAM PERJANJIAN PENGALIHAN MATERI BIOLOGI

Biological material is largely a free component, but the development of these materials can be objects that have commercial high value. Thus, the biological material is also associated with the ownership and control should be regulated by the misuse of biological materials hukum. According to the characteristics of MTA as a civil agreement, the parties will be decisive in the formulation of the agreement, but the characteristics of biological materials, including viruses, which can endanger the safety and threaten public health requires the use of surveillance capabilities sampled by the competent authority. Thus, the protection of the right to material biologidan implementation monitoring system redirects biological materials need to be studied in detail for the purpose of sharing microbiological material for the benefit of mankind could reached . Indonesia's cases refusal to carry through the mechanism of virus sharing GISN (Global Influenza Surveillance Network) in the system of the World Health Organization (wHO) in 2007, the result of a lack of regulations concerning the transfer of biological material not truly perfect

The use of Biotechnology in the Characterization, Evaluation, and Utilization of Indonesian Rice Germplasm

<p>Penggunaan Bioteknologi dalam Karakterisasi, Evaluasi,<br />dan Pemanfaatan Plasma Nutfah Padi Indonesia. Tiur S.<br />Silitonga. Beras merupakan makanan pokok penduduk<br />Indonesia yang terus meningkat kebutuhannya. Untuk memenuhi<br />kebutuhan beras nasional, peningkatan produktivitas<br />varietas padi terus diupayakan melalui peningkatan potensi<br />hasil dengan cara merakit varietas tipe baru dan padi<br />hibrida yang berdaya hasil tinggi dan genjah, tahan terhadap<br />cekaman biotik dan abiotik. Sejak tahun 2006 sampai saat<br />ini jumlah varietas yang dihasilkan sebanyak 31 varietas.<br />Perakitan varietas itu semua dilakukan dengan menggunakan<br />plasma nutfah. Sampai saat ini plasma nutfah yang dilestarikan<br />di Bank Gen Balai Besar Penelitian dan Pengembangan<br />Bioteknologi dan Sumberdaya Genetik Pertanian<br />(BB-Biogen) berjumlah sekitar 4.000 aksesi yang terdiri atas<br />varietas padi lokal, varietas padi unggul lama, varietas unggul<br />tipe baru, galur-galur elit, dan kerabat spesies padi liar.<br />Untuk menjaga keselamatan koleksi, sebanyak 2.500 aksesi<br />dilestarikan di Balai Besar Penelitian Padi sebagai koleksi<br />duplikat. Di samping itu, sebagai mitra kerja sama internasional,<br />koleksi ini juga disimpan di pusat pelestarian plasma<br />nutfah padi International Rice Research Institute (IRRI) sebanyak<br />lebih dari 8.900 aksesi. Plasma nutfah ini memiliki<br />peranan yang sangat besar sebagai sumber gen dalam<br />program pemuliaan padi. Untuk mempermudah pemanfaatannya,<br />koleksi ini telah di karakterisasi, dievaluasi, dan didokumentasikan<br />di dalam database. Karena plasma nutfah<br />memiliki nilai potensial dan nilai aktual bagi kehidupan manusia,<br />maka sangat penting untuk melestarikannya baik<br />secara in situ, ex situ, dan lekat lahan (on farm). Pada tulisan<br />ini diuraikan status koleksi plasma nutfah, bagaimana dikoleksi,<br />karakterisasi, evaluasi, dan didokumentasikan dalam<br />database dan dimanfaatkan dalam program pemuliaan<br />padi serta dalam pertukaran plasma nutfah padi. Dalam pemanfaatan<br />dan pertukaran plasma nutfah, Indonesia telah<br />meratifikasi perjanjian pertukaran sumber daya genetik dan<br />mengimplementasikannya dengan menggunakan Standard<br />Material Transfer Agreement (sMTA) melalui UU No. 4 Tahun<br />2006.</p>