Is Risk Regulation A Strategic Influence On Decision Making In The Biotechnology Industry? Joanna Chataway and Joyce Tait II II I Illll Joanna Chataway is a Research Fellow at the Centre for Technology Strategy at the Open University. She has carried out extensive research on the emergence of biotechnology. Recent work includes research on the management of biotechnology, factors influencing the rate and direction of innovation and biotechnology policy in industrially developing countries. Joyce Tait is Deputy Director, Research and Advisory Services, Scottish Natural Heritage (SNH) and is also a visiting professor at the Centre for Technology Strategy, Open University. SNH is a public body charged with the conservation of the natural environment in Scotland. Prior to taking up these recent appointments she was a professor in Strathclyde Graduate Business School, teaching Environmental and Technology Management, following from a senior lectureship in the Systems Department of the Open University. At the Open University and at Strathclyde University she has directed three major research projects-- "Strategies and R & D Decision Making in Biotechnology Companies", "Risk Regulation of Biotechnology", and "Public Attitudes to Biotechnology," resulting in an integrated analysis of the interactions between industry, government, and the public in the development of this new technology. ABSTRACT This paper discusses strategic decision making in firms pursuing biotechnology innovation and the influence of risk regulation on firm strategy. Data from three research projects1, involving interviews with over 60 managers from agricultural and food related biotechnology companies and also over 60 key participants in the regulatory process in the UK and EC, shows a diversity of strategy and opinion. While some industry representatives identified new risk regulations governing the release of genetically manipulated organisms (GMOs) as the primary constraint on biotechnology innovation, thefindings of the study painted a more complex picture. The controversies surrounding the issue of risk regulation and its impact on innovation are best understood if viewed in the context of other political and economic factors. We conclude that the actual impact of risk regulation on industry strategies is probably less than the rhetoric of industry lobbyists would suggest. At the same time, the very act of lobbying so forcefully could lead to a public backlash against industry that would be much more damaging than the regulation itself. 1. Introduction Biotechnology has been seen by some theorists as the harbinger of the next long wave economic cycle, follow- ing on from information and communications technol- ogy (Freeman et al., 1982; Thompson, 1986). In the EC context it has been described as "... a powerful tool for the renewal of the economic base of contemporary soci- ety" (Commission of the European Communities, 1984). However, this early promise of biotechnology has not materialized as fast as was initially expected (Tait etal., 1990). This paper examines some of the complex issues and interactions that influence the decisions of managers involved with agriculture-related biotechnology devel- opments. The research has concentratedon the following 60 key factors: the level of investment by industry in differ- ent types of innovation; the nature and level of govern- ment and EC support policies for agriculture; the evolu- tion of national and international risk regulatory re- gimes, particularly as regards the release of GMOs; and the favorability or otherwise of public attitudes to bio- technology (Tait, 1990). We discuss the proactive nature of risk regulation of biotechnology, the changes in- volved in new regulatory codes, and the implications for industry of a return to more reactive approaches to risk regulation. The conclusion discusses aspects of continu- ity and change in techno-economic systems, and social and political aspects of innovation. Risk regulation is widely perceived as the major factor inhibiting innovation in biotechnology. However,