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Meeting The Standard: an Overview of European Biobank Regulation and a Comparison to the Current South African Position

Document Cited authorities 13 Cited in Related
Vincent
Date01 February 2015
Published date01 February 2015
Pages54-73
AuthorLarisse Prinsen
DOI10.3366/ajicl.2015.0110
INTRODUCTION

Due to fascinating new developments in biomedicine, such as stem cell therapy and tissue engineering, contemporary medicine is moving away from being a reactionary process to being a process focused on the maintenance of health by being personal, predictive, preventative and participatory.1

Also referred to as ‘4 medicine’. See L. Hood, L. Rowen, D. Galas and J. Aitchison, ‘Systems Biology at the Institute for Systems Biology’, Briefings in Functional Genomics and Proteomics (2008): 239–48 and J. Loscalo and A. Barabasi, ‘Systems Biology and the Future of Medicine’, 3(6) Wiley Interdisciplinary Review of Systems Biology Medicine (2011): 619–27.

This means that medicine is moving away from traditional forms of treatment, to a point where treatment and experimentation almost merge, and thus it is moving away from the known forms of regulatory frameworks and mechanisms. In fact, the best method of regulating biomedicine is uncertain and will be subject to a process of trial and error for many years. This is true on a global scale and also on a local South African one. This regulatory process has stalled to some extent while each role player, whether an authority, institution, practitioner, researcher or even country, attempts to solve all the issues individually since this leads to a nonconformist and confusing mass of incoherent binding and nonbinding legal and ethical documents, guidelines and rules. This in turn hinders sharing of information, data and ultimately knowledge and subsequent development.2

An example of this may be found in the contradictory Regulations published in the Government Gazette, no. 29526, 5 January 2007, namely the Regulations regarding the Use of Human DNA, RNA, Cultured Cells, Stem Cells, Blastomeres, Polar Bodies Embryos Embryonic Tissue and Small Tissue Biopsies for Diagnostic Testing, Health Research and Therapeutics and the Regulations regarding Artificial Fertilisation and Related Matters. Two independent working groups had been working on the Regulations unaware of the other. The groups only became aware of one another when their Regulations appeared in the same Gazette. The two Regulations obviously do not conform and lead to confusion.

 A uniform system would encourage and facilitate sharing and would lead to collaboration and better and faster development of biomedicine

South Africa is the African leader in biomedicine and must set an example.3

J. Kassah, ‘Stem cell legislation in South Africa’, available at http://embrybros.wordpress.com/2011/03/16/stem-cell-legislation-in-south-africa/ (accessed 7 September 2013).

But where should South African biomedical legislators and regulators turn and on what example should the South African model be based? The European model is preferred as it encompasses a wide variety of jurisdictions with different legal traditions, which somewhat resembles the hybrid system of law in South Africa that forms a single system. Also, the parallel of the European and African Unions and in future South African and other AU members will be in the same position as the EU members in finding a common outlook on health matters. Lastly, the European community has been active in both the scientific biomedical field and the regulatory since the 1970s4

Biomedicine in the United States of America suffered under the Bush administration and only recovered under the Obama administration and could perhaps be described as being on a similar path of discovery, regulation wise, as South Africa.

 with the birth of the first test tube baby, Louise Brown in 1978. The first regulatory model was developed during the 1980s by the Committee of Inquiry into Human Fertilisation and Embryology chaired by Mary Warnock from 1982 to 1984, which ultimately gave rise to the Human Fertilisation and Embryology Act of 1990. The aim of this paper is therefore to provide an overview of the European regime of Regulation of Biobanks and a comparison thereof to the South African instruments and position. This encourages understanding of the regulatory environment in order to direct development in South Africa towards one that is in unison, or at least on par, with European development. This overview attempts to clarify what might be a complex system to grasp as an outsider and hopes to ease replication. Ultimately, this article attempts to illustrate aspects addressed by European instruments and that are lacking in the South African system. Due to various social, economic and political reasons, South Africa is not yet able to contend with European countries regarding biomedical science but an aspect of biomedicine that has been practised in South Africa for a number of years now is that of banking biological material.5

See, in general, B. Lindeque, A. Lindeque, H. Hausner and T. Le Roux, ‘Tissue Banking in South Africa: A 19-year History’, 6(11) Cell Tissue Bank (2005): 65–70.

 This paper thus focuses on a single aspect of biomedicine, namely Biobanks and some attention must be given to this concept Biobanks

Biomedicine itself relies on research and research requires research subjects. In biomedicine, the subject is biological material and biological material in some quantity is therefore necessary as well as a place to store such material. This place is none other than a bank and more specifically, a biobank.

The term ‘biobank’ may be understood as an umbrella term that includes ‘human genetic research databases’, ‘biorepositories’, ‘population genetic databases’ or ‘tissue banks’ as used in South Africa. The term ‘biobank’ will be used in this paper. Biobanks may be characterised based on various grounds6

These include: size, research design, types of biological collected sample, the collection methods employed by the bank, storage of samples and any relevant disease or research focus. On this basis a distinction could be made between population-based biobanks, disease- orientated biobanks, case-control biobanks and tissue banks.

that influence the scope of activities undertaken by the biobank7

For example, donor recruiting, consent procedures, the scale of support required, governmental infrastructures necessary and the potential for commercial exploitation.

 and vice versa. Some common traits do however exist that apply to all Biobanks. They are:8

European Commission Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research, Biobanks for Europe: A Challenge for Governance, Publications Office of the EU (2012), p. 1.

the collection of biological samples;

Biobanks are not static projects and continuously and on a long-term basis collect samples;

the banks are associated with a purpose;9

This could include currently defined or future, not yet specified research.

some form of data coding is used to de-identify the sample and ensure data privacy but the data is also be re-identifiable; and

governance structures and procedures are in place to ensure ethical and legal operation of the bank.

For the purpose of this paper, a biobank must be understood as a facility that, in accordance to its existential purpose, procures and distributes10

Collects and supplies.

biological materials or samples and associated data in an organised manner and is subject to governance structures and procedures

In order to compare the European and South African systems, an understanding of the systems is necessary and so the current South African regulatory tool regarding Biobanks should be discussed.

 SOUTH AFRICAN REGULATIONS RELATING TO TISSUE BANKS

There are two Regulations in South Africa dealing with Tissue Banks. The first appeared in the Government Gazette on the 1 April 2001 and the second on the 2 March 2012. Both the 2011 and 2012 Regulations will be briefly discussed here. The purpose of this discussion is to outline the current position in South Africa to illustrate areas in need of development. Once the shortcomings of the South African instruments have been identified, it becomes simpler to determine where South Africa stands developmentally and which aspects of the European regulatory tools should be replicated. The Regulations relating to Tissue Banks were created under the National Health Act11

National Health Act, Act 61 of 2003. For more on the National Health Act, see L. Prinsen, ‘An Analysis of the Proposed Regulatory Framework for the Procurement and Distribution of Stem Cell’, LLM thesis, University of Pretoria (2010), available at http://upetd.up.ac.za/thesis/available/etd-07122011-115208/unrestricted/dissertation.pdf (accessed 17 September 2013).

and are first-of-its-kind in the South African health law context.

The 2011 Regulations relating to Tissue Banks12

‘The Regulations Relating to Tissue Banks of 1 April 2011’, Government Gazette, no. 34159.

define a tissue bank as a registered organisation, institution or person. The Regulations consist of four chapters that provide for the registration of an organisation, institution or person as a tissue bank. An organisation, institution or person must register where it or they acquire or import human tissue; preserve, screen, test, process, store, label, separate, pack, supply or dispose of human tissue; or produce, pack, seal and label any tissue product.13

Ibid., at Regulation 2.

 Registration is not required where the tissue product is used for educational or scientific purposes, only or where the tissue is transported in the normal course of business.14

Ibid., at Regulation 2(2).

 The Regulations provide for the application procedure for registration15

Ibid., at Regulation 3.

 and provisions for the suspension and revocation of registration.16

Ibid., at Regulation 4.

Chapter 2 of the 2011 Regulation deals with the duties of a tissue bank17

Ibid., at Regulation 6(1).

including inter alia keeping a register of tissue donors; keeping a record and a record of statistics of tissue donations and a record of untoward reactions. Chapter 3 handles quality and safety matters. A...

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