Having considered the report by the Director-General,

Recognizing the Declaration of Alma-Ata (1978), which identified primary health care as “essential health care based on practical, scientifically sound and socially acceptable methods and technology […] at a cost that the community and country can afford to maintain at every stage of their development in the spirit of self-reliance and self-determination”, and the Declaration of Astana (2018) on building sustainable primary health care in accordance with the call of the 2030 Agenda for Sustainable Development to achieve universal health coverage and the health-related Sustainable Development Goals, and that diagnostics are important to ensure quality, comprehensive and integrated primary health care and health services everywhere and for everyone;

Recognizing that diagnostic services are vital for the prevention, diagnosis, case management, monitoring and treatment of communicable, noncommunicable, neglected tropical and rare diseases, injuries and disabilities;

Noting that the WHO Constitution upholds the enjoyment of the highest attainable standard of health as one of the fundamental rights of every human being, without distinction of race, religion, political belief, economic or social condition, and recognizing that the achievement of any state in the promotion and protection of health is of value to all, and that governments have a responsibility for the health of their peoples that can be fulfilled only by the provision of adequate health and social measures;

Recognizing that access to diagnostics in many countries may be reduced for households living in remote and rural areas, hard-to-reach and pastoral communities, low-income householdsand people in vulnerable situations, as well as those at higher risk of disease, and that equitable access to diagnostics, in particular diagnostic imaging in developing countries, is particularly deficient and that targeted efforts are needed to lift these barriers;

Recognizing that increasing access to diagnostics from current levels could reduce annual premature deaths, including for people living in developing countries;

Noting that equitable access to safe, effective and quality assured diagnostics requires a comprehensive health-systems approach that addresses all stages of the value chain;

Recallingthe Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) as amended, and also recalling the Doha Declaration on the TRIPS Agreement and Public Health, which affirms that the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of the right of Member States to protect public health and, in particular, to promote access to medicines for all, and which recognizes that intellectual property protection is important for the development of new medicines while also recognizing the concerns about its effects on prices;

Resolution WHA74.6. Strengthening local production of medicines and other health technologies to improve access. In: Seventy-fourth World Health Assembly, Geneva, 24 May–1 June 2021. Geneva: World Health Organization; 2021  (https://apps.who.int/gb/ebwha/pdf_files/WHA74/A74_R6-en.pdf, accessed 1 February 2023).

Recalling resolution WHA67.20 (2014) on regulatory system strengthening for medical products, requesting the Director-General to prioritize support for “strengthening areas of regulation of health products that are the least developed, such as regulation of medical devices, including diagnostics”;

Resolution WHA67.20. Regulatory system strengthening for medical products. In: Sixty-seventh World Health Assembly, Geneva, 19–24 May 2014. Geneva: World Health Organization; 2014  (https://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R20-en.pdf, accessed 17 October 2022).

Recalling resolution WHA67.23 (2014) on health intervention and technology assessment in support of universal health coverage;

Resolution WHA67.23. Health intervention and technology assessment in support of universal health coverage. In: Sixth-seventh World Health Assembly, Geneva,19–24 May 2014. Geneva: World Health Organization; 2014  (https://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R23-en.pdf, accessed 5 January 2022).

Noting regional resolutions and initiatives on the regulation, assessment and/or management of medical devices, including in vitro diagnostics, and on strengthening public health laboratories;

Strengthening Public Health Laboratories in the WHO African Region: A Critical Need for Disease Control. Geneva: World Health Organization; 2008  (https://www.afro.who.int/sites/default/files/sessions/resolutions/AFR-RC58-6.pdf, accessed 4 January 2023).

Noting the publication of the First WHO Model List of Essential In Vitro Diagnostics,

First WHO Model List of Essential In Vitro Diagnostics. Geneva: World Health Organization; 2019 (WHO Technical Report Series, No. 1017; https://apps.who.int/iris/bitstream/handle/10665/311567/9789241210263-eng.pdf?ua=1, accessed 4 January 2023).

Recalling resolution WHA60.29 (2007) on health technologies, which covers issues arising from the deployment and use of health technologiesand the need to establish priorities in the selection and management of health technologies, in particular medical devices;

Resolution WHA60.29. Health technologies. In: Sixtieth World Health Assembly, Geneva, 14–23 May 2007. Geneva: Word Health Organization; 2007  (https://apps.who.int/iris/bitstream/handle/10665/22609/A60_R29-en.pdf?sequence=1&isAllowed=y, accessed 4 January 2023).

Recognizing the development of the Universal Health Coverage Compendium

UHC Compendium: Health interventions for universal health coverage [website].Geneva: World Health Organization; (n.d.)  (https://www.who.int/universal-health-coverage/compendium, accessed 30 October 2022).

Recognizing that some of the barriers to improving equitable access to medicines are similar to those for diagnostics and that the regulation, selection, process, training for proper use, maintenance and – where appropriate – infrastructure support are different and in some instances even more complex, but nevertheless recognizing that synergies can be used wherever possible when addressingthe barriers to access to medicines and diagnostics;

Recognizing the need to establish priorities in the management of diagnostics, considering procurement,

Considering alternative procurement mechanisms, including pooled procurement, bundled procurement – including reagents and accessories – public-private partnerships (PPP), leasing, etcetera.

Recognizing the critical role of rapid and accurate diagnostics to combat antimicrobial resistance by guiding the correct management of infections, and the appropriate use of new and existing antimicrobials through improved antimicrobial stewardship and surveillance;

Recognizing the lack of equitable access to basic diagnostics in many parts of the world for priority pathogens, which have been identified by WHO as having the greatest outbreak potential;

Recognizing that appropriate diagnostics are needed to inform prediction, prevention, detection, monitoring and control of outbreaks and pandemic diseases; and noting that diagnostics capacity at national and subnational levels is essential;

Noting the emphasis of the Access to COVID-19 Tools Accelerator

The Access to COVID-19 Tools (ACT) Accelerator [website]. Geneva: World Health Organization; (n.d.)  (https://www.who.int/initiatives/act-accelerator, accessed 1 February 2023).

Noting the learnings derived from the Access to COVID-19 Tools Accelerator1 (ACT-A),including its diagnostics pillar, regarding the strengths and weaknesses of ACT-A;

Noting that during the COVID-19 pandemic response, despite the sharing of the genome sequence of the novel coronavirus that paved the way for the rapid development of diagnostic tests, the lack of access for developing countries in particular to diagnostic tests created inequities in the public health response;

Noting that the benefit of diagnostics can be maximized by a suitable health system (including laboratories), which enables the selection/regulation and use of them in a proper way, with a skilled and licensed workforce operating in safe and operational facilities with the appropriate infrastructure and adequate financing;

Recalling resolution WHA74.7 (2021) on strengthening WHO preparedness for and response to health emergencies, which underscores that timely, fair and equitable access to health products is a global priority and that the availability, accessibility, acceptability and affordability of health products are fundamental to tackling global public health emergencies;

Resolution WHA 74.7. Strengthening WHO preparedness for and response to health emergencies. In: Seventy‑fourth World Health Assembly, Geneva, 24 May–1 June 2021. Geneva: World Health Organization; 2021  (https://apps.who.int/gb/ebwha/pdf_files/WHA74/A74_R7-en.pdf, accessed 22 December 2022).

Recognizing the increasing burden of noncommunicable diseases

Including those that affect eye, ear and oral health.

Recognizing the need to ensure the integrated and coordinated provision of high-quality, affordable, accessible, age and gender sensitiveand evidence-based diagnostic interventions, for all individuals without discrimination, with a view to achieving universal health coverage;

Noting the importance of point-of-care tests at the primary health care level as well as at the community level, including self-testing, to increase access to and the affordability and use of diagnostics;

Noting the opportunities for improved diagnostics including, but not limited to, the research and development of simple, affordable tests for diseases currently lacking good quality tests, digitalization, telediagnosis and clinical decision support and improved information management,

Recommendations on digital interventions for health system strengthening–Executive summary. Geneva: World Health Organization; 2019(document WHO/RHR/19.8).

Noting resolution WHA72.8 (2019) on improving the transparency of markets for medicines, vaccines and other health products;

Measuring medicine prices, availability, affordability and price components, 2nd edition. Geneva: World Health Organization; 2008  (https://apps.who.int/iris/bitstream/handle/10665/70013/WHO_PSM_PAR_2008.3_eng.pdf?sequence=1&isAllowed=y, accessed 25 November 2022).

Noting the challenges associated with the cost of diagnostic tests in developing countries that affect access;

Recalling resolution WHA74.6 (2021) on strengthening local production of medicines and other health technologies to improve access, which recalls “resolution WHA61.21 (2008), decision WHA71(9) (2018) and document A71/12 (2018), insofar as they address the role of technology transfer and local production of medicines and other health technologies in improving access;”

Resolution WHA74.6. Strengthening local production of medicines and other health technologies to improve access. In: Seventy-fourth World Health Assembly, Geneva, 24 May–1 June 2021. Geneva: World Health Organization; 2021  (https://apps.who.int/gb/ebwha/pdf_files/WHA74-REC1/A74_REC1-en.pdf#page=27, accessed 9 February 2022).

Noting that although high-burden infectious diseases persist globally, considerable efforts over the last decade by Member States, WHO, donors and other stakeholders have expanded laboratory diagnostic services and access to in vitro diagnostics for several high-burden infectious diseases,

Global technical strategy for malaria 2016–2030, 2021 update. Geneva: World Health Organization; 2021  (https://www.who.int/publications/i/item/9789240031357, accessed 1 February 2023).