Secrecy in drug regulation

Abstract

The objective of this paper is to describe secrecy in drug regulation in Finland, by recording and reporting our experience in obtaining Norplant^® licensing documentation. The materials used are the documents, phone calls and other contacts recorded in a research diary that were produced while relevant authorities considered our application to obtain the documents and the publication of our manuscript. The application process was complicated, and it took three years to obtain the licensing documentation and two years to try, unsuccessfully, to get permission to publish the manuscript. In the course of these procedures we made 188 active contacts, and the authorities wrote several memoranda. The drug regulatory authority and the manufacturer wanted to categorise the whole licensing process as a trade secret, and to have the manufacturer define what a trade secret is and when trade secrets could be released, while the Ministry for Social Affairs and Health valued more open regulation. The process is still not complete because the manufacturer has sued the ministry in court about their decision to grant dispensation. It can be concluded that to enable independent research on drugs and drug regulation, the publicity status of documents must be clear, and trade secrecy must be defined narrowly. Decisions on dispensation to give access to classified documents should consider the interests of public health and should be made by authorities other than the drug regulatory authority.