Regulation

Download a PDF of Chapter 8 – Regulation (15 pages)

Emerging biotechnologies require a regulatory approach that shows commitment to the broad interests of society.

As with many technologies, the regulation of emerging biotechnologies is often led by concepts of risk and harm (including safety and security) and the likelihood of benefits. However, as emerging biotechnologies are characterised by uncertainty and ambiguity (see page 5), the risks and benefits associated with them are hard to determine or agree. Risk-benefit models of regulation are therefore not appropriate to emerging
biotechnologies.

Organisation of regulatory systems

We identify some key features of regulatory systems that influence emerging biotechnologies and give rise to problems of control, coordination, evasion and accountability:

  • National organisation – while biotechnology innovation is a global enterprise, the organisation of regulation and key institutions remains embedded in particular countries. For example, universities remain culturally, politically and financially dependent on nation states.
  • National preoccupations – each country has their own attitudes and laws regarding safety and ethical permissibility. For example, genetically modified crops are widely accepted in some countries but have been rejected by others.
  • Extra-national organisation – regulation is set within multiple layers of international organisation. For example, the European Union has a strong influence on the development of regulation for emerging biotechnologies in the UK.
  • Public and private co-operation – regulation requires a partnership between public regulators and private institutions. This is especially important in regulation of emerging biotechnologies where many leaders of innovation are private corporations [Chapter 8].

The solution to the challenges they present is not to be found in the design of regulatory systems. Regulatory design will always involve dilemmas (such as between surveillance and control, consistency and precision, ‘soft’ and ‘hard’ regulation). Instead, there is a need for continuous broad reflection, engagement and adaptation to mitigate against undesirable crowding out or locking in.

Previous work

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