Quality-assured, safe and effective medicines, vaccines and medical devices are fundamental to a functioning health system. Unlike many other commodities, though, patients, consumers and health professionals are not in a position to judge their quality, safety and appropriate use.
Regulatory authorities responsible for the oversight of medical products are entrusted by governments to ensure that products on the market are legally authorized, safe and perform as claimed when used according to directions. The reality, however, is that many countries around the world do not have the capacity to provide effective regulatory oversight, a situation that represents a threat to global public health and can delay access to essential medical products. Helping regulatory authorities fulfill their mandate in an effective, efficient, predictable, and transparent manner is therefore of critical importance in an increasingly complex global environment.
WHO mandated by Resolution WHA 67.20, plays a pivotal role in supporting countries to strengthen regulatory systems by:
- building regulatory capacity in Member States consistent with good regulatory practices, and
- promoting regulatory cooperation, convergence and transparency through networking, work-sharing, and reliance.
Towards this end, the WHO Regulatory Systems Strengthening (RSS) programme has over the last several decades developed, implemented and refined a robust model of support that involves the assessment of a regulatory system and functions using a standardized tool (the Global Benchmarking Tool or GBT) and the formulation of institutional development plans (IDP) designed to assist countries in implementing effective regulatory oversight. IDPs, as such, provide a blueprint for government investment and technical assistance by WHO and other development partners working within a framework of Coalition of Interested Parties (CIP). Coupled with GBT indicators, IDPs also provide an objective baseline for monitoring progress.
An ongoing WHO initiative aims at establishing a globally recognized, evidence-based framework for evaluating and publicly listing authorities – WHO-Listed Authorities (WLAs) - operating at an advanced level of performance and continuous improvement with the goal of promoting regulatory reliance and the international supply of safe and quality-assured medical products.
Impact
A well-functioning regulatory system for medical products is vital to a country’s public health goals, creating an environment in which medical products are appropriately manufactured, stored, distributed, and dispensed. It ensures that the quality, safety and efficacy of marketed products have been properly evaluated, that health professionals and patients have the information they need to use medical products rationally, that promotion and advertising is fair and balanced, and that quality or safety issues associated with a medical product are detected and acted upon.
Weak or inefficient regulatory systems, on the other hand, can act as a barrier to access, innovation and investment, encourage the circulation of substandard and falsified medical products and contribute to avoidable adverse events, antimicrobial resistance, morbidity and mortality, healthcare costs and lost productivity. As disease and falsified medical products know no boundaries in an increasingly inter-connected world, this can also have significant negative consequences in other countries.
Simply put, helping countries improve their ability to provide effective regulatory oversight of medical products benefits patients, health systems, and economies. Upon the request of Member States, the WHO has played a leading role in strengthening regulatory systems using a well-established and objective process, guided by the principles of ‘smart regulation’ – working cooperatively to better confront common issues, reduce unnecessary regulatory divergence and enable the effective use of resources by leveraging the work of other trusted regulators and regulatory networks. As a consequence, the WHO regulatory system strengthening programme has contributed to improved worldwide access to safe, effective and quality assured medical products. In the area of vaccines, for example, over 95% of globally available doses used in national immunization programmes are quality assured through effective regulatory oversight - a dramatic increase from the start of the RSS programme.