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

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Donrich W. Thaldar ◽  
Marietjie Botes ◽  
Annelize Nienaber
Keyword(s):  
Intellectual Property ◽  
South African ◽  
Health Research ◽  
Biological Material ◽  
Research Institutions ◽  
The South ◽  
Material Transfer ◽  
Material Transfer Agreement ◽  
Associated Data ◽  
Human Biological Material

Abstract 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.

scholarly journals Protecting participants in health research: The South African Material Transfer Agreement

2019 ◽  
Vol 109 (5) ◽  
pp. 353 ◽  
Author(s):  
M Labuschaigne ◽  
A Dhai ◽  
S Mahomed ◽  
K Behrens ◽  
A Nienaber ◽  
...  
Keyword(s):  
South African ◽  
Health Research ◽  
The South ◽  
Material Transfer ◽  
Material Transfer Agreement

LICENSING AGRICULTURAL INTELLECTUAL PROPERTY: HOW SHOULD PUBLIC R&D INSTITUTIONS IN DEVELOPING COUNTRIES RESPOND?

2012 ◽  
Vol 09 (04) ◽  
pp. 1250028 ◽  
Author(s):  
JANE G. PAYUMO ◽  
HOWARD D. GRIMES ◽  
KEITH J. JONES
Keyword(s):  
Developing Countries ◽  
Technology Transfer ◽  
Intellectual Property ◽  
Agricultural Biotechnology ◽  
Strong Association ◽  
Research Institutions ◽  
Material Transfer ◽  
Case Examples ◽  
Starting Point ◽  
Agricultural Innovations

In the 21st century, licensing is the most common vehicle by which Intellectual Property Rights (IPR), especially for agricultural biotechnology, are transferred from inventors to users. In this paper, we argue that due to the strong association between IPR and agricultural biotechnology, technology transfer (e.g., licensing), needs to be conducted differently for agricultural biotechnology products. We examine two important licensing mechanisms: the patent license and material transfer agreements, and their unique features, and issues associated with their use. And yet, it's important to note that these legal instruments for agricultural biotechnology are contextual, case-specific, and may even be country-specific. We hope that this paper can serve as a starting point for discussion, and/or a guide for public research institutions in developing countries to more effectively use these technology transfer tools. We also present a few case examples that highlight the experiences of other national research institutions in handling these legal mechanisms. Learning from these experiences may help other institutions maximize benefits while minimizing cost and risk under the new context of technology transfer for agricultural innovations.

scholarly journals Drafting Biological Material Transfer Agreement: A Ready-To-Sign Model for Biobanks and Biorepositories

2016 ◽  
Vol 31 (2) ◽  
pp. 211-217 ◽  
Author(s):  
Silvia Cervo ◽  
Paolo De Paoli ◽  
Ermes Mestroni ◽  
Tiziana Perin ◽  
Luca Escoffier ◽  
...  
Keyword(s):  
National Cancer Institute ◽  
Biological Material ◽  
Material Transfer ◽  
Appropriate Use ◽  
Whole Process ◽  
Material Transfer Agreement ◽  
Essential Components ◽  
New Models ◽  
Theoretical Issues ◽  
Model Agreement

Purpose Due to the scarcity of publications, guidelines, and harmonization among national regulations, biobanks and institutions face practical and theoretical issues when drafting a material transfer agreement (MTA), the fundamental tool to regulate the successful exchange of biosamples and information. Frequently researchers do not execute MTAs because of a general lack of knowledge about this topic. It is thus critical to develop new models to prevent loss of traceability and opportunities both for researchers and biobanks, their exposure to various risks, and delays in transferring biomaterials. Methods Through the involvement of institutional groups and professionals with multidisciplinary expertise, we have drawn up a ready-to-sign MTA for the CRO-Biobank (the biobank of the National Cancer Institute, CRO, Aviano), a standardized template that can be employed as a ready-to-use model agreement. Results The team identified the essential components to be included in the MTA, which comprise i) permissions, liability and representations; ii) custodianship and distribution limitations; iii) appropriate use of materials, including biosafety concerns; iv) confidentiality, non-disclosure, and publications; v) intellectual property protection for both the provider and recipient. Conclusions This paper aims to be an unabridged report (among the few works in the existing literature) providing a description of the whole process related to the formation of an MTA. Biobanks and institutions may consider adopting our ready-to-sign form as a standard model. The article discusses the most important issues tackled during the drafting of the document, thus proposing an operative approach for other institutions that face the same problems.

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

Yuridika ◽  
2017 ◽  
Vol 31 (2) ◽  
pp. 321
Author(s):  
Sogar Simamora ◽  
Agung Sudjatmiko ◽  
Ria Setyawati
Keyword(s):  
Biological Material ◽  
Competent Authority ◽  
Biological Materials ◽  
World Health ◽  
Influenza Surveillance ◽  
Material Transfer ◽  
Surveillance Network ◽  
Material Transfer Agreement ◽  
Health Organization ◽  
The Right

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

scholarly journals The contribution of copyright-based industries to the South African economy

2017 ◽  
Vol 113 (11/12) ◽  
Author(s):  
Anastassios Pouris ◽  
Roula Inglesi-Lotz
Keyword(s):  
South Africa ◽  
Intellectual Property ◽  
South African ◽  
World Intellectual Property Organization ◽  
The South ◽  
The World ◽  
Agriculture And Food

We report the results of an effort to measure the contribution of copyright-based industries to the South African economy. Following the methodology of the World Intellectual Property Organization, we identify the copyright industry’s contribution to GDP, employment, imports and exports in South Africa for the period 1970–2009. It was estimated that the sector contributed 4.1% to GDP – more than the contributions of other sectors such as agriculture and food, beverages and tobacco. Because of this quantified importance of the copyright-based industries, we recommend that relevant South African policy authorities and policymakers should monitor and publicise regularly the performance of the copyright-based industries as well as promote programmes for their development and growth.

scholarly journals The role of community advisory boards in health research: Divergent views in the South African experience

2010 ◽  
Vol 7 (3) ◽  
pp. 2-8 ◽  
Author(s):  
Priscilla Reddy ◽  
David Buchanan ◽  
Sibusiso Sifunda ◽  
Shamagonam James ◽  
Nasheen Naidoo
Keyword(s):  
South African ◽  
Health Research ◽  
The South ◽  
Advisory Boards ◽  
African Experience ◽  
Community Advisory Boards
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