OTC
Handbook
Building Smarter Health Systems Through Self-Care
Self-care is a proven catalyst for stronger, more sustainable health systems. Research shows that self-care currently saves $120 billion annually and estimated $179 billion annually by 2030, frees up billions of productive days, and improves quality of life worldwide. These benefits create a win-win scenario: individuals gain autonomy and faster access to care, while health systems reduce costs and free up resources.
The OTC Handbook is designed for policy makers, civil servants and stakeholders, as a guide to the implementation of selfcare policy. It addresses critical areas such as risk-appropriate regulatory frameworks, reliance, Rx-to-OTC switches, and digital innovations, which are essential for embedding self-care into health policy. By enabling modern, agile frameworks, we can unlock the full economic and social value of self-care in achieving universal health coverage.
Global health challenges, from antimicrobial resistance to climate change, demand collaborative solutions. Harmonization and regulatory convergence are key to ensuring consistency, efficiency, and equitable access to self-care products globally. This handbook is a call to action for collective progress: when self-care thrives, health systems and societies thrive too.
Greg Perry I Director General, Global Self-Care Federation
Driving Innovation Through Harmonization and Convergence
For industry, self-care is more than a growth opportunity. It is a responsibility to deliver safe, effective solutions that empower consumers and strengthen health systems. Its impact is evident: billions in cost savings, improved productivity, and better health outcomes globally. These benefits extend to companies as well: harmonized and convergent regulatory frameworks reduce duplication, streamlined regulatory processes accelerate approvals, and create environments favourable to innovation.
The OTC Handbook provides practical frameworks for regulators wanting to enable progress change or transformation. Topics such as reliance models, regulatory modernization, and real-world evidence are critical to building systems that support innovation, while safeguarding quality. Through creating global alignment, we can ensure faster access to self-care solutions, improve efficiency, and deliver consistent standards across markets globally.
Andrew Wilson I Vice President, Global Product Stewardship, R&D, Personal Health Care P&G, Industry Co-Chair, Regulatory Affairs Committee