The Global Smart Pharmacovigilance Strategy

This document is the official strategy published by the World Health Organization (WHO) to provide a practical and adaptable framework for countries, particularly Low- and Middle-Income Countries (LMICs), to build, strengthen, and sustain their Pharmacovigilance (PV) systems for medicines and vaccines.

The core problem it addresses is the critical gap between the increasing access to medicines/vaccines in LMICs and their underdeveloped capacity to monitor their safety. This leaves populations vulnerable to avoidable harm and can undermine public trust in health systems. The strategy is “smart” because it advocates for a strategic, efficient, and resource-conscious approach, focusing efforts where they are most needed and leveraging global collaboration to avoid duplication of work.

---

Key Points and Detailed Breakdown

Here is a detailed breakdown of the strategy’s main components:

1. The Core Problem and Rationale

• Imbalance in Access vs. Safety Monitoring: While access to medicines and vaccines has improved in LMICs, their PV systems have not kept pace. For example, LMICs contribute over 70% of WHO Member States but only about 18% of the safety reports in the global database, VigiBase.
• The LMIC Challenge: LMICs often lack the resources, infrastructure, and capacity to routinely analyze safety data, detect signals, and implement risk-minimization measures. This is especially dangerous for products used exclusively in LMICs (e.g., for neglected tropical diseases) or for new products launched simultaneously worldwide, where LMICs cannot rely on data from High-Income Countries (HICs).
• The COVID-19 Lesson: The pandemic acted as a “global stress test,” brutally exposing the vulnerabilities of fragmented and underfunded PV systems and underscoring the urgent need for resilient, agile safety monitoring.

2. The Four Foundational Pillars (Underlying Principles)

The entire strategy is built on four interconnected pillars:

Pillar 1: Build on Previous Efforts and Existing Resources

• Concept: Don’t start from scratch. Leverage decades of global investment in PV.
• Examples: Use established systems like the WHO Programme for International Drug Monitoring, global databases (VigiBase), data management tools (VigiFlow, VigiMobile), standardized reporting formats (ICH E2B), and training curricula (WHO-ISoP PV Curriculum).

Pillar 2: Apply a Risk-Based Approach and Prioritization

• Concept: In a resource-constrained environment, countries cannot monitor everything. They must strategically focus their PV efforts on products with the highest potential risk or relevance to their population.
• Priority Products Include:
  1. Products exclusive to a country/region (e.g., for sleeping sickness).
  2. Products with limited clinical data or accelerated approval (e.g., new vaccines launched globally).
  3. Older products with known but poorly managed risks (e.g., a teratogenic medicine).

Pillar 3: Embrace Work-Sharing and Reliance

• Concept: Countries do not need to perform every regulatory function independently. They can share work and rely on the assessments of trusted, mature regulatory authorities.
• Reliance: A country’s National Regulatory Authority (NRA) can accept and use the decisions (e.g., marketing authorization, risk management plans) of a reference authority like the European Medicines Agency (EMA) or the WHO Prequalification Programme, while remaining accountable for the final decision.
• Work-Sharing: NRAs from multiple jurisdictions can collaborate on tasks like joint assessments, joint inspections, or joint signal analysis (e.g., the VigiCarib system in the Caribbean), saving resources for all.

Pillar 4: Anchor PV in Overall Regulatory System Strengthening

• Concept: For PV to be sustainable, it must be integrated into the national regulatory framework, not operate as a standalone project.
• Key Tool: The WHO Global Benchmarking Tool (GBT): This tool is used to assess the maturity level (ML1-ML4) of a country’s regulatory system, including its PV function. The results are used to create a tailored Institutional Development Plan (IDP) with short, medium, and long-term goals for systematic improvement.

3. Implementation: From Theory to Practice

The strategy provides practical guidance on how to apply these principles:

• Supporting Networks: Implementation will be driven through existing global and regional networks like the WHO Programme for International Drug Monitoring, the African Medicines Regulatory Harmonization (AMRH), the South-East Asia Regulatory Network (SEARN), and the Coalition of Interested Parties (CIP).
• Implementation Scenarios: The document outlines hypothetical scenarios with detailed IDPs for countries at different maturity levels, showing how they can introduce a new vaccine, rely on a reference authority for a new medicine, or manage a known risk from an older product.
• Real-World Case Studies: The strategy is illustrated with concrete examples from countries:
  • Brazil: Rapid detection and management of an anaphylaxis signal with a new dengue vaccine.
  • Egypt: Digitalizing the AEFI reporting system by adapting existing infrastructure (VigiFlow).
  • Ethiopia & Indonesia: Using the introduction of new TB and malaria medicines (e.g., bedaquiline) as a catalyst to strengthen entire PV systems and integrate them with public health programmes.
  • Japan: Promoting work-sharing and reliance in the Asia-Pacific region.

4. Enhanced Safety Communication

The strategy highlights safety communication as a critical, cross-cutting element. It aims to:

• Build public trust and combat misinformation.
• Provide clear, timely messages during safety crises.
• Train healthcare workers in risk communication.
• Leverage networks like the WHO Vaccine Safety Net (VSN) to direct the public to reliable, science-based information.

5. Monitoring and Measurement

The strategy proposes specific indicators to measure its uptake and impact, such as:

• Number of countries adopting the strategy and using priority product lists.
• Participation in regional work-sharing platforms.
• Improvements in PV maturity levels (as per the GBT).
• Increases in the quantity and quality of safety reporting.

Summary

In essence, this WHO strategy is a pragmatic and sustainable blueprint for making medicine and vaccine safety monitoring accessible, effective, and efficient for all countries, regardless of their resources. It moves away from a one-size-fits-all model and instead promotes a flexible, intelligent approach where countries can prioritize, collaborate, and rely on each other to ensure that the benefits of medicines and vaccines outweigh their risks, thereby protecting patients and building stronger, more resilient health systems worldwide.

---