Table 1 Summary of analytic framework linking provisions, pathways, and potential impacts
Provisions | Pathways | Potential impacts on core pharmaceutical policy objectives |
|---|---|---|
TRIPS-Plus intellectual property protection | • Extended periods of exclusivity for patented medicines and obstacles to market entry for generic and biosimilar medicines can reduce competition and lead governments and consumers to pay monopoly prices for longer periods of time | • Access to affordable medicines may be reduced |
Investment protection: investor-state dispute settlement mechanism; investment chapter with IP covered in definition of investment | • Disputes, or the threat of a dispute, may cause reversal of pharmaceutical policy decisions or regulatory chill—possibly resulting in extended exclusivity periods, relaxation of regulatory standards or inability to support local producers | • Access to affordable medicines may be reduced • Rational use of medicines may be compromised • Local production and health security may be compromised |
Procedural requirements for national pharmaceutical pricing and reimbursement programs | • Industry objectives and values may be given priority over public health and access to medicines • Pharmaceutical companies may be given additional opportunities to provide input to, or to contest, decision-making regarding pricing and/or reimbursement • Flexibility regarding prioritization and timing of listing drugs for reimbursement may decrease • Scarce health resources may be diverted towards implementing procedural requirements with no public benefit • Pharmaceutical policy-making may come under pressure from trade partners with large pharmaceutical industries • Excessive prices may not reflect clinical value of medicines | • Access to affordable medicines may be reduced • Rational use of medicines may be compromised |
Provisions with implications for regulation of pharmaceutical marketing | • Attempts to prohibit or restrict pharmaceutical promotion to health professionals (to encourage better prescribing) or consumers (to encourage better use of medicines) may be reversed or chilled • Restrictions on pharmaceutical marketing may be difficult to enforce (for cross-border advertising services) | • Rational use of medicines may be compromised |
Regulatory requirements for assessing safety, efficacy and quality | • Standards may be lowered through harmonization to the lowest common denominator, pressure from trade partners to adopt lower standards or greater involvement of the pharmaceutical industry in standard-setting • Pressure to speed up regulatory approval processes may result in increase in safety risks • Constraints on public information about pharmaceutical inspections may compromise safety and quality • Cooperation on pharmaceutical inspection issues may improve the quality of medicines thereby improving consumer safety | • Safety, efficacy and quality of medicines may be compromised • Manufacturing quality of medicines may be lowered or improved |
Reduction/elimination of tariffs on pharmaceuticals or their ingredients | • Prices of imported pharmaceuticals may fall, in some circumstances (if additional mark-ups are not applied at other points in the supply chain) • Viability of local generic pharmaceutical industry in question if there is greater competition—potentially reducing supply and compromising health security | • Access to affordable medicines may increase • Local production and health security may be compromised |
Rules applying to government procurement of pharmaceuticals | • Governments/hospitals may pay lower prices as a result of open tendering, depending on the nature of the procurement process and institutions • Viability of fledgling domestic pharmaceutical industries may be reduced if government and hospital purchasing cannot preference local suppliers | • Access to affordable medicines may increase • Local production and health security may be compromised |
Rules applying to state-owned enterprises and designated monopolies | • Viability of domestic pharmaceutical industry in developing countries may be affected if state-owned pharmaceutical companies are required to operate as commercial entities and cannot be given financial support or preferential treatment, or cannot give preference to local suppliers • Pressure for reform of state owned enterprises may result in greater competition and lower prices | • Local production and health security may be compromised, or improved |
Procedural requirements for customs administration and trade facilitation | • Movement of generic pharmaceuticals across borders may be impeded, or facilitated, in cases of suspected breaches of IP laws | • Access to affordable medicines may be reduced, or improved |
Rules applying to regulatory practices, cooperation and coherence | • Pharmaceutical industry may have additional levers to provide input to, or contest pharmaceutical policy • Potential for industry representation on or input to expert advisory groups may compromise optimal pharmaceutical policy outcomes | • Access to affordable medicines may be reduced • Safety, efficacy and quality of medicines may be compromised • Rational use of medicines may be compromised • Local production and health security may be compromised |