THE APPLICATION OF RESPONSIVE REGULATORY THEORY IN THE CONTEXT OF HESC RESEARCH

The thesis is informed by these two pyramids in the context of regulating HESC research in Malaysia. Both pyramids are complementary. ‗Pyramid design is a creative, deliberative activity‘119

and ‗regulators that think responsively tend to design very different kinds of pyramids for different kinds of problems ...‘120

The first pyramid of regulatory strategies designed in this thesis is illustrated in Figure 3 below.

117

In interview with Brownsword, 18 November 2009, London

118 _{See Brownsword R, Rights, Regulation and Technological Revolution at 137}

119 _{Braithwaite J, ‗Responsive Regulation and Developing Economies‘ (2006) 43 World}

Development 888

120

Figure 3: A possible approach of a pyramid of regulatory strategies to regulate HESC research

At the base of the pyramid is education. Through education, awareness is created amongst the scientific community about the importance of observing high ethical standards whilst conducting HESC research and the consequences of breaching the regulation. It will be seen later in this thesis that the Australian regulatory framework includes this important component.121 It is based on a model of ‗cooperative compliance‘ where licence holders are encouraged to cooperate with the NHMRC to comply with the legislation. Emphasis is placed on education and communication, as these promote awareness of the responsibilities of both licence- holders and inspectors. A key mechanism for raising such awareness is through information exchange visits, which were made to researchers, licence-holders, human research ethics committee members and other interested organisations. In addition, information is made available through seminars, workshops, websites and publications. In this way, researchers are deterred from breaching the law.

On the next rung of the pyramid is professional Code of Practice/ industry self regulation, the aim being to provide guidance as well as support and advice to

121

See Chapter 6.6 of this thesis

Statut ory Licensi ng Schem e Guidelines

Professional Code of Practice

Education

Statutory Licensing Scheme

scientists. Professional bodies and institutions should adopt industry self-regulation. This practice is encouraged as it sets industry standards for compliance. However, it is noted that a reservation of the model of self-regulation is that it may be seen as a licence for self-interested regulatory activity, that is, an industry may act in ways that suit its own interests and sets regulatory standards as long as it is happy to comply with those standards.

Further up the pyramid is the Guidelines scheme, also known as soft law/ under legislation, made by government agencies.122 Guidelines are advantageous in the regulation of new technologies. They are flexible and can be amended as needed. Amendments can be made slowly, focusing directly on issues that arise as new discoveries are made.123

Finally, at the apex of the pyramid is statutory licensing scheme where restrictive research on embryos is permitted by statute and criminal offences apply where the activity is carried out without a valid licence.124

With the strengths-based pyramid model (Figure 2), scientists are motivated to be compliant with regulations. At the base of the pyramid, through education, scientists are informed and motivated to conduct research whilst observing high ethical standards. On the next rung is receiving an informal praise and not everyone is singled out for a special praise. This is followed by receiving prize/ research grant and again not everyone will receive the grant. The next rung is ‗escalated‘ prize/ grant and few will receive, for instance, a $1m dollar grant. Finally at the peak of the pyramid, even fewer will receive an award such as the Nobel prize or being conferred knighthood or being named as the ‗Person of The Year‘ and receiving cash prize.

A regulatory model which includes both regulatory and strengths-based pyramids, comprises of the two pyramids, is effective as it has a combination of instruments

122

For instance, the NHMRC guidelines in Australia

123 _{Countries that have adopted national guidelines scheme as their regulatory model include}

USA, Japan, India, China, Spain and Malaysia

124

UK, Sweden, New Zealand, Canada, Finland, Greece, Israel, the Netherlands, Singapore, South Korea, the American states of California and New Jersey

that promote the regulatory purposes with a spectre of punishment in the background. Thus they have the effect of channelling/ controlling the conduct of scientists. In the words of Braithwaite, ‗It‘s very important to have a mix of support and sanctions.‘125

It may be argued that the theory of responsive regulation might not be appropriate in some regulatory arenas and it is acknowledged that the theory of responsive regulation is an approach designed in wealthy developed countries. As Ayres and Braithwaite explain, the theory is ‗not a clearly defined program or a set of prescriptions concerning the best way to regulate‘ and therefore, it should not be mechanically applied as the appropriate strategy to be adopted would ‗depend on the context, regulatory culture and history.‘126

It is recognised that a limitation that the developing world faces is the lack of capacities necessary to make responsive regulation work effectively compared to wealthy societies. In Malaysia, the potential challenges include the high costs that are likely to be incurred and the need for well-organised extensive training as well as broad public education and engagement.127 It is conceivable that these difficulties are particularly acute in developing nations. But this does not mean that responsive regulation is any less desirable in poorer countries. Rather, it should be of universal application. As Braithwaite explains :

Responsive regulation deals with the fact that no government has the capacity to enforce all laws. It is useful for thinking about regulation in developing countries with weak enforcement capabilities.128

As such, Braithwaite‘s theory of responsive regulation is as relevant to Malaysia as to any other country. The potential challenges that Malaysia regulators might encounter as identified above could be effectively addressed with assistance from the ISSCR and by adopting model regulatory frameworks that have already been successfully implemented in countries like Australia, moulded to local needs. In this

125 _{In an interview with Braithwaite, 19 October 2009, Canberra} 126 _{See Braithwaite J, Responsive Regulation at 5}

127 _{In Part II (Chapters 4-6) of this thesis, these factors are explored in the analysis of the}

Australian regulatory regime

128

See Braithwaite J, Responsive Regulation and Developing Economies at 888. On the relevance and applicability of his theory in the developing world, Braithwaite refers to various examples such as the resolution of the 2006 East Timorese crisis, see Braithwaite J, Regulatory Capitalism at 100-108

regard, the regulatory regime adopted in Singapore, a close neighbouring country which has similar culture and political and legal institutions, is pertinent.129 Today, this nation has one of the world‘s most permissive and progressive regimes for the regulation of HESC research alongside with UK and Israel.