Access to safe, effective and quality-assured health products and technologies

Roadmap for WHO action 2025-2030

Executive summary

Access to safe, effective and quality-assured health products and technologies is crucial for achieving universal health coverage and primary health care goals. The continued growth of the aging population; increasing burden of noncommunicable diseases; growing burden of mental health issues; climate change; shifting patterns of vector borne diseases, fungal disease and waterborne diseases; antimicrobial resistance; and new infectious hazards create an ongoing need for equitable access to safe, effective and quality-assured health products and technologies, and renewed investments in research and development for innovative health products and technologies.

The coronavirus pandemic exposed the inequalities in access to health products, highlighting the need for longer-term strategies to strengthen access to health products and technologies outside of and in emergency situations. While technological and scientific advances present an opportunity to increase access to health products and technologies, the risk of increasing inequality due to higher prices for new health products and technologies; the persisting problem of substandard and falsified medical products; a lack of skilled workforce in many low- and middle-income countries; and a lack of data for decisionmaking and for measuring progress present significant challenges.

In 2019, WHO underwent reform to better meet the United Nations Sustainable Development Goals and its own “triple billion” targets as described in the 13th General Programme of Work. A new structure was established and the Access to Medicines and Health Products Division was recognized as the leading division in Headquarters in supporting Member States to improve access to safe, effective and qualityassured health products and technologies. Certain roles such as the establishment of priority or essential lists, technical specifications, regulatory guidance and standards, regulatory strengthening, the issuance of nonproprietary names, and prequalification are unique to the Division.

The Access to safe, effective and quality-assured health products and technologies: roadmap for WHO action 2025–2030 outlines to Member States, and other stakeholders WHO’s unique role and approach for increasing access to safe, effective and quality-assured health products and technologies in order to reach Sustainable Development Goal targets for achieving universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all. WHO’s expertise and leadership are essential for delivering the complex and wide-ranging support needed to address the many challenges in the health product and technology ecosystem.

The roadmap highlights how the work of WHO aligns with and contributes to WHO’s 14th General Programme of Work, particularly Strategic objective 3: Advance the primary health care approach and essential health system capacities for universal health coverage. The roadmap outlines WHO’s 5 programmatic priority areas for access to safe, effective and quality-assured health products and technologies and elaborates the priorities within each area:

Programmatic area 1 • Research, development and production; viii

Programmatic area 2 • Safety, efficacy, and quality assurance;

Programmatic area 3 • Policy and prioritization;

Programmatic area 4 • Procurement and supply chain management, provision and use; and

Programmatic area 5 • Cross-cutting.

This year marks the 50th anniversary of the first mention of the concept of essential medicines by the World Health Assembly, a well-recognized and transformational public health concept. The anniversary offers an opportunity to reaffirm and renew political commitment to accelerate the implementation of the 2030 Agenda for Sustainable Development including enhancing efforts to ensure access to safe, effective, quality-assured essential medicines and other health products and technologies.

Improving the affordability, availability, accessibility, acceptability and assured quality of health products and technologies requires the collaboration of stakeholders; strong, effective, and reliable regulatory, legal and policy frameworks; adequate health-care financing; and a trained and capable health workforce. Going forward WHO will continue to adapt approaches to keep pace with the ever-evolving health landscape and to address new challenges and to make the most of new opportunities.