Abstract
Objective
The objective of this study is to assess public attitudes toward pharmaceutical companies’ secondary uses of patient records and public preferences regarding consent approaches.
Method
3000 responses to an online survey were collected from adults in Japan. The questionnaire included 32 items related to (1) awareness of “clinical trials”; (2) awareness of the processes of drug development, such as cost, time, and the number of candidate substances in a new drug; (3) knowledge of the laws and regulations for use of patient records in Japan; (4) assessment of the public benefit of the secondary use of patient records; (5) preferences for consent for the secondary use of patient records; and (6) basic characteristics of the respondents.
Results
The public benefit from secondary use of records by academic institutions for scientific research was rated highest. All of the activities by pharmaceutical companies were rated higher than those by governmental institutions and other for-profit companies. Regarding consent approaches, 37.9% preferred an “opt-in” approach for new drug development by pharmaceutical companies, 79.7% of whom would change their preference to an “opt-out” approach under specific conditions, such as ensuring intended uses only.
Conclusion
Our respondents consider the “public benefit” as dependent on the relative distance from “promoting public health” when assessing the secondary purpose of patient record use. Pharmaceutical companies should include the beneficial purposes when using patient records with “opt-out” approach. Policy makers should pay more attention to the purposes of use when develo** personal information protection policies.
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Nakada, H., Inoue, Y., Yamamoto, K. et al. Public Attitudes Toward the Secondary Uses of Patient Records for Pharmaceutical Companies’ Activities in Japan. Ther Innov Regul Sci 54, 701–708 (2020). https://doi.org/10.1007/s43441-019-00105-2
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DOI: https://doi.org/10.1007/s43441-019-00105-2