title: Manufacturing risk: reframing the discourse of safety of commodified potent substances.
abstract: BACKGROUND
  The rapid commodification of plant-based medicines has led to the development of regulatory guidelines and standards by the World Health Organization to ensure the safety of these products. However, these standards have been identified to be selectively implemented, if implemented at all, in many contexts. A primary concern for proving the safety of intrinsic factors of plant-based medicines, may result in less attention paid to the often more problematic extrinsic factors of mass production. This article critically examines the normative global discourse of safety concerning plant-based medicines and problematises many of the assumptions identified in this discourse.
  
  
  METHODS
  This qualitative research was conducted in the Traditional Medicine Unit of the Western Pacific Regional Office of the World Health Organization (WHO) and in field work in the rural Philippines. Data was collected through archival research, analysis of WHO data sets, semi-structured and structured interviews and surveys, participant observation concerning local plant-based medicine use in the Philippines and participant observation in WHO meetings regarding future strategies for traditional Asian medicines.
  
  
  RESULTS
  Although informants reported concerns of safety for every aspect of the production, marketing and sales of plant-based medicines, this research has identified that the implementation (WHO guidelines) has been uneven and inconsistent over the past ten years in the Western Pacific Region of the WHO. Differences in local contexts that are not consistent with global guidelines and standards were reported by informants. Issues have also been identified in the inconsistent regulation of plant-based medicines as pharmaceuticals within only certain, rather than all, processes of production.
  
  
  CONCLUSIONS
  It is imperative to understand plant-based medicines as the potent substances they are, whose rapid global commodification may affect both their potency and safety. The WHO discourse of the need for safety in the use of plant-based medicines has justified the need for biomedical oversight through processes of commodification. Yet, it is often through these very processes of commodification and mass production that safety may be compromised. This research suggests that the discourse concerning the safety of the plant-based medicines needs to be reframed from a primary focus on the intrinsic factors of plant-based medicines to a greater focus on the extrinsic factors of global commodification.
authors.affiliation: Xi׳an Jiaotong-Liverpool University, 111 Ren׳ai Road, Public Building Room 516A, Dushu Lake Higher Education Town, Suzhou Industrial Park Suzhou, Jiangsu, 215123 People׳s Republic of China. Electronic address: paulkadetz@gmail.com.
authors.forename: Paul
authors.initials: P
authors.lastname: Kadetz
mesh_terms: D032821:Commodification; D006801:Humans; D066192:Manufacturing Industry / Q000592:standards; D008519:Medicine, Traditional / Q000009:adverse effects / Q000592:standards; D010946:Plants, Medicinal / Q000009:adverse effects; D012306:Risk; D014944:World Health Organization
keywords: Commodification; Global health policy; Plant-based medicines; Safety; World Health Organization