Lay summary
Currently, in Aotearoa New Zealand, natural health products (NHPs) are only minimally regulated: there is no regulatory pre-market assessment of product quality, safety or efficacy, and no mandatory requirements for manufacturers of NHPs to undertake pharmacovigilance (safety monitoring) activities for their NHPs (unless such products have a formal medicines approval, which few have). The proposed study will (a) explore consumers’ views on and experiences with the NHPs industry and its contribution towards pharmacovigilance for NHPs in NZ, and (b) seek consumer input into the development of a new, active surveillance (safety monitoring) method that could be used to collect more comprehensive data on the patterns of use and benefit-harm profiles for NHPs marketed in NZ. The proposed activity involves: priority setting; expert panel and stakeholder engagement (Māori and Pacific peoples, NHPs consumers, NHP industry, NHPs/medicines regulators, policymakers, pharmacovigilance professionals), and designing, pre-testing and administering a bespoke questionnaire to NHP consumers on this topic.