You know that your DNA is your own unique genetic fingerprint. But can you say you really own it when biobanks across South Africa collect and store thousands of biospecimens such as blood, saliva, plasma, and purified DNA?
Unisa’s College of Law (CLAW) held a seminar on the ethical and legal issues around biobanking, on 26 August 2013, to look at some of the controversial issues that are raised by the practice, such as the privacy of individuals who store their biomaterial with these banks or volunteer to assist with research.
Concerns about communicating research findings, dealing with the tissues that remain, the rights of family members, and the thorny questions of payment and benefit sharing were also considered.
Professor Omphemetse Sibanda, Director: School of Law, explained that CLAW was looking to provide legal solutions to the topic, to benefit stakeholders and influence policy development. “This discussion has a national and international context and includes arenas such as stem cell and genome research.”
Blood donors are biobankers
Many people are loyal blood donors and yet, perhaps, are unaware that the South African National Blood Service (SANBS) can be considered as one of the country’s largest biobanks, storing and collecting blood on a daily basis. Organisations such as SANBS, while adhering to legislative policies, are mostly self regulating. Dr Loyiso Mpuntsha, CEO: SANBS, says that private biobanks must adhere to strict self-regulating guidelines such as considering all stakeholders, collaboration on a local and international level, and supplying quality bio specimens. She believes that biobanks are becoming a viable alternative for researchers and medical professionals. “Biobanks are attracting the attention with the government and pharmaceutical industry and funding of contractual agreements.”
International perspectives on biobanking
From an international perspective, some countries have already instituted far-reaching legislation and laws that deal with biobanking including private networks. Iceland and Sweden have introduced laws and the United Kingdom has a human tissue act. Ma’n Zawati, Academic Associate Lawyer, Centre of Genomics and Policy, McGill University Canada, dealt with the regulation of biobanks from an international perspective, pointing out that the public are voluntarily coming forward to donate their human specimens to help research, in, for instance, clinical trials. “There is an ethical imperative attached to this because people are handing over their data but they expect biobanks to do something with this. They need to see progress or they won’t continue.”
Zawati believes that it is impossible to harmonise international law but that it is possible to harmonise the tools for biobanks by providing generic documents that countries can use, citing that they were formulated using international standards.
Establishing a public biobank in South Africa
The situation in South Africa is vastly different from its international counterparts. Currently, there is no public biobank in the country as the field comprises private companies. Professor Michael Pepper, Director: Institute for Cellular and Molecular Medicine, University of Pretoria, says they have conducted research with the Department of Health to possibly establish a public bank. “The response has been overwhelmingly positive after trials to establish a public biobank. This also speaks to the fact that the private sector has spent 150 million rand to store blood, units, stem cells and other material for several years which has not been used. There is no point in storing these cells and not using them.”
Pepper revealed that there are gaps in terms of policies as well as norms and standards but noted that more and more groups involved in human tissues have begun to self regulate and have professional bodies to ensure international standards are met. “Legislation must protect individuals from harmful or unethical practices. It must be uppermost in our minds that we make provisions for all South Africans and allow the public to benefit from advances in medical science.”
*Article by Rajiv Kamal