Bull World Health Organ 2022;100:467–467A | doi: http://dx.doi.org/10.2471/BLT.22.288313 Editorials 467 In vitro diagnostic tests are essential tools in the fight against the coronavirus disease 2019 (COVID-19) pandemic and other infectious disease outbreaks.1 However, access to effective and low-cost tests in many low- and middle-income countries is suboptimal. Improving such access depends on factors at country level such as health priorities, public procurement, research capacity, local innovation and local production. Diagnostics research and development in low- and middle-income countries is one of the most neglected top- ics in global health.2 Technology sharing models are criti- cal to promoting technological catch-up based on public interest.3 A good example is the World Health Organization’s (WHO) COVID-19 Technology Access Pool, an initiative that aims to expand equitable access to COVID-19 health products, pro- viding a global platform for developers to share knowledge, intellectual property and data. In November 2021, the technology access pool and the Medicines Patent Pool announced a licence with the Spanish Na- tional Research Council for a COVID-19 serological antibody technology. This global agreement is transparent, royalty-free and non-exclusive; it covers all the necessary patents, biological material and know-how for production on a global scale.4 Some countries have demonstrated technological dynamism, that is, an ability to generate and incorporate in- novations, through the development and production of tests. For example, in India, the National Institute of Virology, part of the Indian Council of Medical Research, developed the COVID KAVACH ELISA kit. The technology allows the detection of immunoglobulin G antibodies in patients who present with symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. A technology transfer agreement was signed with the company Zydus Lifesciences Ltd (Ahmedabad, India), which supplied the product free of cost to the Indian Council of Medical Research.5 Fiocruz, a public biomedical research institution based in Brazil, has recently developed two reverse transcriptase poly- merase chain reaction (RT–PCR) tests: one that differentiates between influenza viruses A and B and SARS-CoV-2, and a second one that allows the detection and screening of variants of SARS-CoV-2. These technologies add to Fiocruz’s efforts to locally produce tests for SARS-CoV-2. In early 2022, Fiocruz had already supplied more than 20 million RT–PCR tests and 45 million rapid antigen tests to the coun- try’s unified health system. Additionally, the Fiocruz COVID-19 Biobank was created to supply biological materials enabling the de- velopment of new tests, vaccines and other inputs, improving self-reliance and building resilience in the national health system.6,7 The Indian and Brazilian initiatives are examples of efforts to reduce the de- pendence on international supply chains. Moreover, these investments also contrib- ute to strengthening national laboratories and preparing them to join international networks in new public health challenges. Nonetheless, some challenges re- main unaddressed. The poorer countries experience underinvestment in research and development, limited cooperation opportunities, and difficulties accessing data, biological materials and technol- ogy transfer. Another recurrent point is the drain of researchers to high-income countries. Such factors hinder a more regular and vigorous involvement of low- and middle-income countries in develop- ment of diagnostics and its global market. The pandemic has taught us that with- out autonomy in technological production, the most vulnerable will have to wait for vaccine doses and diagnostic tests, and pay more for them. Low- and middle-income countries should be co-participants, not only recipients of technological solutions.8,9 Fair and equitable access will be promoted with the inclusion in international and global initiatives of local development capacity in those countries that are now poorly represented. The participation of these countries in technological and industrial cooperation for diagnostics has been a priority issue in WHO debates for at least a decade.10 Such participation would enable reduction of the dependence of these countries on importation of inputs, tests, equipment and devices associated with tests and would contribute to the development of high-quality, cost-effective tests adapted to local needs.1 In addition, the world’s health security depends on countries’ capacities – including diagnostic capacity – to deal with health crises. Thus, technological capabilities in diagnostics in low- and middle-income countries should be a global priority, demanding global collec- tive action within and among countries.11 To address the gaps in diagnostics and other health tools – both in terms of new developments and access frame- works – implementing structural changes in the innovation system will be neces- sary. The sharing of intellectual property and know-how should be coupled with finance and network coordination, hu- man resources training, public policies for innovation and capacity strength- ening, aligning public health priorities with mobilization of State capacities and public–private partnerships. ■ Innovation in diagnostics: addressing gaps in low- and middle-income countries Claudia Chamas,a Mady Malheiros Barbeitas,b Marilena Correa,c Koichi Kameda,d Ana Claudia Dias de Oliveirae & Luiz Villarinhob References Available at: http://www.who.int/publications/ journals/bulletin a Oswaldo Cruz Foundation and National Institute of Science and Technology for Innovation on Diseases of Neglected Populations, Avenida Brasil, 4036, Sala 814, Rio de Janeiro RJ Brazil 21040-36, Brazil. b École des Hautes Études en Sciences Sociales (EHESS, Cermes3), Villejuif, France. c Social Medicine Institute, University of the State of Rio de Janeiro, Rio de Janeiro, Brazil. d Centre Population et Développement, Institut de Recherche pour le Développement (CEPED, IRD), Paris, France. e Innovation Department, University of the State of Rio de Janeiro, Rio de Janeiro, Brazil. Correspondence to Claudia Chamas (email: claudia.chamas@ fiocruz .br). Editorials 467A Bull World Health Organ 2022;100:467–467A | doi: http://dx.doi.org/10.2471/BLT.22.288313 References 1. Fleming KA, Horton S, Wilson ML, Atun R, DeStigter K, Flanigan J, et al. The Lancet Commission on diagnostics: transforming access to diagnostics. Lancet. 2021 Nov 27;398(10315):1997–2050. doi: http:// dx .doi .org/ 10 .1016/ S0140 -6736(21)00673 -5 PMID: 34626542 2. Local diagnostics to meet local health needs. Paris: Médecins Sans Frontieres, Access Campaign; 2022. Available from: https:// msfaccess .org/ improve -local -production -diagnostics [cited 2022 Jul 5]. 3. Swaminathan S, Pécoul B, Abdullah H, Christou C, Gray G, IJsselmuiden C, et al. Reboot biomedical R&D in the global public interest. Nature. 2022 Feb;602(7896):207–10. doi: http:// dx .doi .org/ 10 .1038/ d41586 -022 -00324 -y PMID: 35140380 4. WHO and MPP announce the first transparent, global, non-exclusive licence for a COVID-19 technology. Geneva: World Health Organization; 2021. Available from: https:// www .who .int/ news/ item/ 23 -11 -2021 -who -and -mpp -announce -the -first -transparent -global -non -exclusive -licence -for -a -covid -19 -technology [cited 2022 Jun 27]. 5. Rao V, Kannan S, Kumar J, Arakeri G, Subash A, Batra HV, et al. COVID-19: an insight into the developments in diagnostics and therapeutics in India. Indian J Med Sci. 2020 Aug 21;72(2):77–82. doi: http:// dx .doi .org/ 10 .25259/ IJMS _152 _2020 6. Fiocruz desenvolve dois novos testes RT-PCR Covid-19. Brasília: Ministério da Saúde; 2022. Portuguese. Available from: https:// www .gov .br/ saude/ pt -br/ assuntos/ noticias/ 2022/ janeiro/ fiocruz -desenvolve -dois -novos -testes -rt -pcr -covid -19 [cited 2022 Jun 27]. 7. Boar C. Fiocruz inaugurates COVID-19 Biobank. Rio de Janeiro: Oswaldo Cruz Foundation; 2022. Available from: https:// portal .fiocruz .br/ en/ news/ fiocruz -inaugurates -covid -19 -biobank [cited 2022 Jun 27]. 8. Kelly A, Lezaun J, Street A. Global health, accelerated: rapid diagnostics and the fragile solidarities of ‘emergency R&D’. Econ Soc. 2022;51(2):187–210. doi: http:// dx .doi .org/ 10 .1080/ 03085147 .2021 .2014730 9. Kameda K. Molecular sovereignty: building a blood screening test for the Brazilian nation. Med Anthropol Theory. 2021 Nov 3;8(2):1–25. doi: http:// dx .doi .org/ 10 .17157/ mat .8 .2 .5122 10. Increasing access to diagnostics through technology transfer and local production. Geneva: World Health Organization; 2011. Available from: https:// www .who .int/ publications/ i/ item/ 9789241502375 [cited 2022 Jun 27]. 11. Local diagnostics to meet local health needs. Geneva: Médecins Sans Frontières Access Campaign; 2021. Available from: https:// msfaccess .org/ improve -local -production -diagnostics [cited 2022 Jun 27].
Bull World Health Organ 2022;100:467–467A | doi: http://dx.doi.org/10.2471/BLT.22.288313 Editorials 467 In vitro diagnostic tests are essential tools in the fight against the coronavirus disease 2019 (COVID-19) pandemic and other infectious disease outbreaks.1 However, access to effective and low-cost tests in many low- and middle-income countries is suboptimal. Improving such access depends on factors at country level such as health priorities, public procurement, research capacity, local innovation and local production. Diagnostics research and development in low- and middle-income countries is one of the most neglected top- ics in global health.2 Technology sharing models are criti- cal to promoting technological catch-up based on public interest.3 A good example is the World Health Organization’s (WHO) COVID-19 Technology Access Pool, an initiative that aims to expand equitable access to COVID-19 health products, pro- viding a global platform for developers to share knowledge, intellectual property and data. In November 2021, the technology access pool and the Medicines Patent Pool announced a licence with the Spanish Na- tional Research Council for a COVID-19 serological antibody technology. This global agreement is transparent, royalty-free and non-exclusive; it covers all the necessary patents, biological material and know-how for production on a global scale.4 Some countries have demonstrated technological dynamism, that is, an ability to generate and incorporate in- novations, through the development and production of tests. For example, in India, the National Institute of Virology, part of the Indian Council of Medical Research, developed the COVID KAVACH ELISA kit. The technology allows the detection of immunoglobulin G antibodies in patients who present with symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. A technology transfer agreement was signed with the company Zydus Lifesciences Ltd (Ahmedabad, India), which supplied the product free of cost to the Indian Council of Medical Research.5 Fiocruz, a public biomedical research institution based in Brazil, has recently developed two reverse transcriptase poly- merase chain reaction (RT–PCR) tests: one that differentiates between influenza viruses A and B and SARS-CoV-2, and a second one that allows the detection and screening of variants of SARS-CoV-2. These technologies add to Fiocruz’s efforts to locally produce tests for SARS-CoV-2. In early 2022, Fiocruz had already supplied more than 20 million RT–PCR tests and 45 million rapid antigen tests to the coun- try’s unified health system. Additionally, the Fiocruz COVID-19 Biobank was created to supply biological materials enabling the de- velopment of new tests, vaccines and other inputs, improving self-reliance and building resilience in the national health system.6,7 The Indian and Brazilian initiatives are examples of efforts to reduce the de- pendence on international supply chains. Moreover, these investments also contrib- ute to strengthening national laboratories and preparing them to join international networks in new public health challenges. Nonetheless, some challenges re- main unaddressed. The poorer countries experience underinvestment in research and development, limited cooperation opportunities, and difficulties accessing data, biological materials and technol- ogy transfer. Another recurrent point is the drain of researchers to high-income countries. Such factors hinder a more regular and vigorous involvement of low- and middle-income countries in develop- ment of diagnostics and its global market. The pandemic has taught us that with- out autonomy in technological production, the most vulnerable will have to wait for vaccine doses and diagnostic tests, and pay more for them. Low- and middle-income countries should be co-participants, not only recipients of technological solutions.8,9 Fair and equitable access will be promoted with the inclusion in international and global initiatives of local development capacity in those countries that are now poorly represented. The participation of these countries in technological and industrial cooperation for diagnostics has been a priority issue in WHO debates for at least a decade.10 Such participation would enable reduction of the dependence of these countries on importation of inputs, tests, equipment and devices associated with tests and would contribute to the development of high-quality, cost-effective tests adapted to local needs.1 In addition, the world’s health security depends on countries’ capacities – including diagnostic capacity – to deal with health crises. Thus, technological capabilities in diagnostics in low- and middle-income countries should be a global priority, demanding global collec- tive action within and among countries.11 To address the gaps in diagnostics and other health tools – both in terms of new developments and access frame- works – implementing structural changes in the innovation system will be neces- sary. The sharing of intellectual property and know-how should be coupled with finance and network coordination, hu- man resources training, public policies for innovation and capacity strength- ening, aligning public health priorities with mobilization of State capacities and public–private partnerships. ■ Innovation in diagnostics: addressing gaps in low- and middle-income countries Claudia Chamas,a Mady Malheiros Barbeitas,b Marilena Correa,c Koichi Kameda,d Ana Claudia Dias de Oliveirae & Luiz Villarinhob References Available at: http://www.who.int/publications/ journals/bulletin a Oswaldo Cruz Foundation and National Institute of Science and Technology for Innovation on Diseases of Neglected Populations, Avenida Brasil, 4036, Sala 814, Rio de Janeiro RJ Brazil 21040-36, Brazil. b École des Hautes Études en Sciences Sociales (EHESS, Cermes3), Villejuif, France. c Social Medicine Institute, University of the State of Rio de Janeiro, Rio de Janeiro, Brazil. d Centre Population et Développement, Institut de Recherche pour le Développement (CEPED, IRD), Paris, France. e Innovation Department, University of the State of Rio de Janeiro, Rio de Janeiro, Brazil. Correspondence to Claudia Chamas (email: claudia.chamas@ fiocruz .br). Editorials 467A Bull World Health Organ 2022;100:467–467A | doi: http://dx.doi.org/10.2471/BLT.22.288313 References 1. Fleming KA, Horton S, Wilson ML, Atun R, DeStigter K, Flanigan J, et al. The Lancet Commission on diagnostics: transforming access to diagnostics. Lancet. 2021 Nov 27;398(10315):1997–2050. doi: http:// dx .doi .org/ 10 .1016/ S0140 -6736(21)00673 -5 PMID: 34626542 2. Local diagnostics to meet local health needs. Paris: Médecins Sans Frontieres, Access Campaign; 2022. Available from: https:// msfaccess .org/ improve -local -production -diagnostics [cited 2022 Jul 5]. 3. Swaminathan S, Pécoul B, Abdullah H, Christou C, Gray G, IJsselmuiden C, et al. Reboot biomedical R&D in the global public interest. Nature. 2022 Feb;602(7896):207–10. doi: http:// dx .doi .org/ 10 .1038/ d41586 -022 -00324 -y PMID: 35140380 4. WHO and MPP announce the first transparent, global, non-exclusive licence for a COVID-19 technology. Geneva: World Health Organization; 2021. Available from: https:// www .who .int/ news/ item/ 23 -11 -2021 -who -and -mpp -announce -the -first -transparent -global -non -exclusive -licence -for -a -covid -19 -technology [cited 2022 Jun 27]. 5. Rao V, Kannan S, Kumar J, Arakeri G, Subash A, Batra HV, et al. COVID-19: an insight into the developments in diagnostics and therapeutics in India. Indian J Med Sci. 2020 Aug 21;72(2):77–82. doi: http:// dx .doi .org/ 10 .25259/ IJMS _152 _2020 6. Fiocruz desenvolve dois novos testes RT-PCR Covid-19. Brasília: Ministério da Saúde; 2022. Portuguese. Available from: https:// www .gov .br/ saude/ pt -br/ assuntos/ noticias/ 2022/ janeiro/ fiocruz -desenvolve -dois -novos -testes -rt -pcr -covid -19 [cited 2022 Jun 27]. 7. Boar C. Fiocruz inaugurates COVID-19 Biobank. Rio de Janeiro: Oswaldo Cruz Foundation; 2022. Available from: https:// portal .fiocruz .br/ en/ news/ fiocruz -inaugurates -covid -19 -biobank [cited 2022 Jun 27]. 8. Kelly A, Lezaun J, Street A. Global health, accelerated: rapid diagnostics and the fragile solidarities of ‘emergency R&D’. Econ Soc. 2022;51(2):187–210. doi: http:// dx .doi .org/ 10 .1080/ 03085147 .2021 .2014730 9. Kameda K. Molecular sovereignty: building a blood screening test for the Brazilian nation. Med Anthropol Theory. 2021 Nov 3;8(2):1–25. doi: http:// dx .doi .org/ 10 .17157/ mat .8 .2 .5122 10. Increasing access to diagnostics through technology transfer and local production. Geneva: World Health Organization; 2011. Available from: https:// www .who .int/ publications/ i/ item/ 9789241502375 [cited 2022 Jun 27]. 11. Local diagnostics to meet local health needs. Geneva: Médecins Sans Frontières Access Campaign; 2021. Available from: https:// msfaccess .org/ improve -local -production -diagnostics [cited 2022 Jun 27].