This greater use of OTC pharmaceuticals is consistent with the policy of many governments to increase the role of patients in their own health, improve access to medications where consistent with safety, and to reduce costs to health systems.
This study looks at an important impediment to continued growth of the sector: an inconsistent regulatory environment. Although different aspects of the issue have been addressed at multilateral and regional levels, progress has been limited and slow – despite the possible benefits to health and economic outcomes a more coherent market could bring.
Drawing on substantial desk research and in-depth interviews with 15 experts from industry bodies, regulators, academia and patient groups, this study looks at efforts at regulatory harmonisation, the barriers they have encountered, and prospects for the future. Its key findings include:
- Non-prescription drugs face regulation across a wide range of areas, in many of which the costs and benefits remain poorly understood.
- Regulatory regimes are highly inconsistent between countries, but research on the impact of the resultant market fragmentation is lacking.
- Regulatory harmonisation efforts have tended to be tangentially and partially relevant for non-prescription pharmaceuticals rather than directly focused on them.
- Effective harmonisation requires a holistic approach, a similar level of regulatory capacity and an understanding of the role of professionals and patients in care.
- There is little interest in greater regulatory harmonisation in this area probably because there is little agreement on what harmonisation should mean.
