Table 1

Political contextual factors identified affecting PTTSs; no data were retrieved for Ethiopia, Hong Kong, Pakistan, Taiwan and the UK

CountryGovernment supportLegislation and regulation
TurkeyGovernmental support and action, thanks to a political sense of urgency because of widespread reimbursement fraud.9Legislation and regulation were well defined.9
DenmarkLegislation was becoming increasingly extensive and complex.29
GermanySpecific legislation and increased requirements of drug safety. Pharmaceutical companies that did not comply face fines and charges.30
IndiaGovernment started to realise the extent of the problem32… resulting in more extensive regulation.32
IranA general lack of concern about the topic.33Little regulation was in place.33
PolandRequirements mainly regarding banning the marketing of SFMP.34
USAThe government was aware of the SFMP problem and recommended measures,37 but the use of PTTS had not been mandated.42A framework for the guidance of PTTS efforts had been released, but states were developing their own laws.38 The standards were often inconsistent among states, which may impede the adoption of PTTSs across the national supply chain.39
  • PTTS, pharmaceutical track-and-trace system; SFMP, substandard and falsified medical product.