Biotechnology Regulation: Views of the Authorities, Investors, and Product Developers in Finland

Abstract

This study addresses regulatory issues and problems associated with product development of biotechnological medical products and devices. Data were collected from interviews with Finnish companies, including: (1) recent startup companies and more established companies that develop biopharmaceuticals and devices; (2) primary public and private investors in Finland, including venture and corporate capitalists; (3) private Finnish insurance companies; and (4) representatives of the Finnish national authorities. Two United States biotechnology companies, and European Agency for the Evaluation of Medicinal Products and U.S. Food and Drug Administration representatives were also interviewed.Results show that, in Finland, developers, regulators, and investors have strong confidence in the success of Finnish biotechnology. However, according to this study, the regulatory definition of product categories of new biotechnological products is still evolving. This may lead to difficulties in achieving a definitive und...