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Volume 8 Journal of Biotechnology & Biomaterials
ISSN: 2155-952X Adv.Biotech 2018
November 15-17, 2018
Page 49
Notes:
conferenceseries.com
November 15-17, 2018 | Berlin, Germany
4th International Conference on
Advances in Biotechnology and Bioscience
Marietjie Botes, J Biotechnol Biomater 2018, Volume 8
DOI: 10.4172/2155-952X-C6-102
Material transfer agreements for human biological material: Successful sample and data sharing
in the framework of European and South African privacy laws
Insurance companies in South Africa are increasingly developing insurance products which will enable patients to afford genetic
testing for purposes of personalized medicine, specifically in the oncology fields. But because South Africa does not currently
possess sufficient local capacity to sequence and/or test genetic samples, these services will have to be outsourced to laboratories in
foreign countries. SouthAfrica is also home to the San, an indigenous populationwith the oldest living genes on earth, whichmake
this population highly sought after for GWAS and other genomic research. It is thus clear that South Africa scientists and medical
practitioners will increasingly engage with their foreign counter parts by means of Material Transfer Agreements, as these are only
two examples of areas where the cross border transfer of human biological material will be imminent. In July 2018 South Africa
has adopted its first formal Material Transfer Agreement for Human Biological Materials in terms of its National Health Act 61 of
2003 which, amongst others, addresses issues such as benefit sharing, informed consent, publications and publicity. However, this
agreement sorely lacks substance when it comes to the management of intellectual property, which often constitutes the lifeline of
biotechnology companies. It also does not deal with material ownership, as opposed to possession, or privacy, further considering
that genetic material and genetic sequences resulting there from cannot really be de-identified to comply with the recently enacted
European GDPR and the South African Protection of Personal Information Act 4 of 2013. Further considering the vulnerability
of both sick patients and an indigenous minority group, coupled with the sensitivity of the medical and population data that may
be gathered from the genetic testing and/or sequencing of these persons, the value of Material Transfer Agreements (MTA) and
the ethics and legal issues surrounding it is of critical importance to ensure a balance between the rights and protection of patients
or research participants and easy access to biotechnological services, samples and data by scientists and medical practitioners to
aid biomedical innovation.
Biography
Marietjie Botes is the Founder and Managing Director of Biolawgic, a private company focusing on the promotion of Bioethics and Director at Dyason Inc in Pretoria where
she specializes in Health-tech, Fin-tech and Bio-tech Contracts, Biotechnology Law, Health Care and Life Sciences Law and Insurance Litigation. She is particularly
interested in and passionate about genetic, genomic and stem cell research and has published numerous articles in both national and international journals on these topics.
Marietjie Botes
Dyason Inc, Republic of South Africa