Abstract: The Establishment of Sanofi Pasteur Japon: Overcoming Japanese Entry Barriers in a New Era of Globalization for the Vaccine Industry
This paper will examine the impact of regulatory policy on the growth, innovative capabilities, and globalization strategies of the vaccine industry over two phases: the late 1960s to the early 1980s and the mid-1980s to the present. The mid-1980s marked a watershed for the vaccine industry. With the exodus of half the vaccine producers in the United States during the first phase, public health policy-makers began to consider measures to ensure vaccine supply while also making vaccine development and production more attractive to corporate investment. Conversely, the withdrawal of American manufacturers provided an opportunity to the French vaccine industry to expand globally and develop new products. The purpose of this paper will be to provide an overview of the major trends in vaccine production, while focusing specifically on the French industry's expansion into a new market, Japan, where policy also had a marked impact on domestic production. Non-tariff barriers in the form of higher quality standards caused delays in the launch of one of the French industry's most novel products, the ACTHib vaccine. Despite these obstacles, the French did succeed, and since then, the Japanese government's stance toward the vaccine industry and vaccination has evolved considerably. The implications of the launch of ACTHib in Japan are important to governments, because this case illustrates the significance of policy choices on the competitiveness of industries as well as on their capacity to innovate.