A Study on Ethical Considerations in Post-Marketing Surveillance

Abstract

Background Post-marketing surveillance (PMS) in Japan is conducted under the Good Post-marketing Study Practice (GPSP) ordinance, which does not specify requirements for informed consent (IC) or ethical review. As PMS increasingly involves data collection beyond routine clinical practice and wider dissemination of results, ethical considerations have become more important. This study aimed to compare perceptions of IC, ethical review, survey content, and survey-related cost between hospitals and pharmaceutical companies.

Methods A nationwide anonymous self-administered questionnaire survey was distributed to 1,270 hospitals and 89 pharmaceutical companies.

Results Responses from 188 hospitals and 64 companies were analyzed. IC was considered mandatory by 14.9% of hospitals and 40.6% of companies, with significantly higher recognition among foreign-affiliated companies (p<0.05). Ethical review was conducted or requested for all PMS in 59.6% of hospitals but only 10.9% of companies (p<0.05). Survey content concerns were reported by 56.4% of hospitals, and 60.6% of hospitals and 45.3% of companies experienced survey content beyond routine clinical practice. Regarding costs, 53.2% of hospitals considered payments insufficient, often due to CRC involvement and survey content beyond routine care.

Conclusions Although IC and ethical review are partially implemented in PMS at certain institutions, the lack of uniform regulatory requirements leads to considerable variability and may result in insufficient ethical oversight. When surveillance includes procedures beyond routine care or research-oriented use of data, ethical frameworks comparable to clinical research and alignment with global standards are warranted. Multistakeholder collaboration is needed to establish standardized rules for IC and ethical review.