Comment
Improving global access to medicines for non-communicable diseases WHO’s Global Action Plan for tackling non-communicable diseases (NCDs) aims for 80% availability and affordability of essential medicines for NCDs in both public and private facilities,1 but in low-income and middle-income countries these medicines remain both poorly available (particularly in the public sector) and inordinately expensive.2,3 Access to medicines plays a vital part in achieving universal health-care coverage and many of the barriers to expanding universal health-care coverage relate to how medicines are purchased and used.4 The challenges of access to essential medicines for NCDs fall into four distinct categories: generic oral medicines available cheaply on the international market but intermittently available in countries and of uneven quality; asthma inhalers and insulin available at high cost, and quality assessment being highly challenging; NCD medicines still under patent and accessible only through expanded access programmes; and opioid analgesics for palliative care often limited by excessive regulation. Global initiatives have shown that it is possible to deliver care and medicines for a complex chronic disease in low-income and middle-income countries.5 The Global Fund to Fight AIDS, TB and Malaria (GFATM) and the Clinton Foundation HIV/AIDS Initiative use pooled procurement and negotiate prices with suppliers. Issues about quality of medicines have been addressed through the WHO prequalification scheme that assesses both the product dossier and related manufacturing site, which helps UN agencies, the GFATM, and countries purchase medicines of guaranteed quality, safety, and effectiveness.6 Like other initiatives, such as UNITAID and GAVI, these disease-oriented supply mechanisms have been well funded. By contrast, initiatives for NCDs have relied on donations or restricted tiered pricing and have been limited in terms of scope and sustainability. Two NCD schemes might provide pointers for future directions. The Global Task Force on Expanded Access to Cancer Care and Control helps with delivery of affordable cancer drugs, vaccines, and services through assistance with finance and procurement.7 The Asthma Drug Facility8 established and run by International Union Against Tuberculosis and Lung Disease has assisted low-income and middle-income countries to reduce by www.thelancet.com/lancetgh Vol 2 October 2014
half the cost of quality-assured asthma inhalers through a quality assurance system based on WHO standards and a transparent tendering process. Combining these initiatives as a basis for an NCD Drug Facility might offer an attractive route to improve the international availability and affordability of quality generic medicines for NCDs. This Facility would need to assist countries in tackling other barriers, such as selection, tendering, purchasing, distribution, prescription, and use, through health system strengthening. There are also potential dangers of creating parallel, vertical programmes that require substantial international financial support. Creating an NCD Drug Information Facility may address many of the barriers that exist with fewer challenges and lower costs by obtaining information on different medicines, their suppliers, prices, and quality, with the dossier of each manufacturer being assessed by independent and qualified experts. Countries would be able to access the information to enable them to obtain medicines from the best source. Provision of this information might also foster competition, as different suppliers would be able to see the overall market for their competitor’s products. The NCD Drug Information Facility would help develop and implement proper training and evidence-based guidelines for people in the medicine supply chain, pharmacists and clinicians, and support countries in doing monitoring surveys to measure and report the availability, price, affordability, and use of essential NCD medicines with established methods.9,10 Given the nature of the NCD Drug Information Facility’s proposed role and the need for independence, its natural home would be within WHO. The expertise is also present at WHO, with regional offices, for example PAHO, being able to pilot such an initiative in-country. The aim of the NCD Drug Information Facility would be to support WHO in providing a channel for all Member States to attain the globally agreed target of 80% availability and affordability of generic essential medicines for major NCDs. This target from the Global Action Plan is the only one related to health systems and should serve as an opportunity for WHO, Member States, and other partners active in NCDs. A WHO-led e561
Comment
multistakeholder meeting backed by a resolution at the World Health Assembly would be the natural next steps to move forwards with a health system approach to NCDs to contribute to reducing premature mortality1 and the wider aim of universal health-care coverage.
1
*David Beran, Christophe Perrin, Nils Billo, John S Yudkin
4
Division of Tropical and Humanitarian Medicine, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 6, CH-1211 Geneva 14, Switzerland (DB); International Insulin Foundation, London, UK (DB, JSY); Paris, France (CP); International Union Against Tuberculosis and Lung Disease, Paris, France (NB); and University College London, London, UK (JSY) [email protected] DB has done work for WHO on the issue of access to medicines for NCDs; DB and JSY are active within the International Insulin Foundation, an organisation campaigning to improve access to medicines for people with diabetes in low-income settings. Copyright © Beran et al. Open Access article distributed under the terms of CC BY-NC-SA.
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6 7
8 9
10
WHO. Global action plan for the prevention and control of noncommunicable diseases 2013–2020. Revised draft (version dated Feb 11, 2013). Geneva: World Health Organization, 2013. Cameron A, Roubos I, Ewen M, et al. Differences in the availability of medicines for chronic and acute conditions in the public and private sectors of developing countries. Bull World Health Org 2011; 89: 412–21. Mendis S, Fukino K, Cameron A, et al. The availability and affordability of selected essential medicines for chronic diseases in six low- and middle-income countries. Bull World Health Org 2007; 85: 279–88. WHO. The world health report 2010. Health system financing: the path to universal coverage. Geneva: World Health Organization, 2010. Hogerzeil HV, Liberman J, Wirtz VJ, et al. Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration. Lancet 2013; 381: 680–89. The important world of drug prequalification. Lancet 2004; 364: 1830. Farmer P, Frenk J, Knaul FM, et al. Expansion of cancer care and control in countries of low and middle income: a call to action. Lancet 2010; 376: 1186–93. Billo N. Asthma drug facility: from concept to reality. Int J Tuberc Lung Dis 2006; 10: 709. WHO, HAI. Measuring medicine prices, availability, affordability and price components. Geneva and Amsterdam: World Health Organization and Health Action International, 2008. Beran D, Higuchi M. How to investigate access to care for chronic noncommunicable diseases (NCDs) in low- and middle-income countries. Draft for field testing. Geneva: World Health Organization, 2012.
www.thelancet.com/lancetgh Vol 2 October 2014
Improving global access to medicines for non-communicable diseases WHO’s Global Action Plan for tackling non-communicable diseases (NCDs) aims for 80% availability and affordability of essential medicines for NCDs in both public and private facilities,1 but in low-income and middle-income countries these medicines remain both poorly available (particularly in the public sector) and inordinately expensive.2,3 Access to medicines plays a vital part in achieving universal health-care coverage and many of the barriers to expanding universal health-care coverage relate to how medicines are purchased and used.4 The challenges of access to essential medicines for NCDs fall into four distinct categories: generic oral medicines available cheaply on the international market but intermittently available in countries and of uneven quality; asthma inhalers and insulin available at high cost, and quality assessment being highly challenging; NCD medicines still under patent and accessible only through expanded access programmes; and opioid analgesics for palliative care often limited by excessive regulation. Global initiatives have shown that it is possible to deliver care and medicines for a complex chronic disease in low-income and middle-income countries.5 The Global Fund to Fight AIDS, TB and Malaria (GFATM) and the Clinton Foundation HIV/AIDS Initiative use pooled procurement and negotiate prices with suppliers. Issues about quality of medicines have been addressed through the WHO prequalification scheme that assesses both the product dossier and related manufacturing site, which helps UN agencies, the GFATM, and countries purchase medicines of guaranteed quality, safety, and effectiveness.6 Like other initiatives, such as UNITAID and GAVI, these disease-oriented supply mechanisms have been well funded. By contrast, initiatives for NCDs have relied on donations or restricted tiered pricing and have been limited in terms of scope and sustainability. Two NCD schemes might provide pointers for future directions. The Global Task Force on Expanded Access to Cancer Care and Control helps with delivery of affordable cancer drugs, vaccines, and services through assistance with finance and procurement.7 The Asthma Drug Facility8 established and run by International Union Against Tuberculosis and Lung Disease has assisted low-income and middle-income countries to reduce by www.thelancet.com/lancetgh Vol 2 October 2014
half the cost of quality-assured asthma inhalers through a quality assurance system based on WHO standards and a transparent tendering process. Combining these initiatives as a basis for an NCD Drug Facility might offer an attractive route to improve the international availability and affordability of quality generic medicines for NCDs. This Facility would need to assist countries in tackling other barriers, such as selection, tendering, purchasing, distribution, prescription, and use, through health system strengthening. There are also potential dangers of creating parallel, vertical programmes that require substantial international financial support. Creating an NCD Drug Information Facility may address many of the barriers that exist with fewer challenges and lower costs by obtaining information on different medicines, their suppliers, prices, and quality, with the dossier of each manufacturer being assessed by independent and qualified experts. Countries would be able to access the information to enable them to obtain medicines from the best source. Provision of this information might also foster competition, as different suppliers would be able to see the overall market for their competitor’s products. The NCD Drug Information Facility would help develop and implement proper training and evidence-based guidelines for people in the medicine supply chain, pharmacists and clinicians, and support countries in doing monitoring surveys to measure and report the availability, price, affordability, and use of essential NCD medicines with established methods.9,10 Given the nature of the NCD Drug Information Facility’s proposed role and the need for independence, its natural home would be within WHO. The expertise is also present at WHO, with regional offices, for example PAHO, being able to pilot such an initiative in-country. The aim of the NCD Drug Information Facility would be to support WHO in providing a channel for all Member States to attain the globally agreed target of 80% availability and affordability of generic essential medicines for major NCDs. This target from the Global Action Plan is the only one related to health systems and should serve as an opportunity for WHO, Member States, and other partners active in NCDs. A WHO-led e561
Comment
multistakeholder meeting backed by a resolution at the World Health Assembly would be the natural next steps to move forwards with a health system approach to NCDs to contribute to reducing premature mortality1 and the wider aim of universal health-care coverage.
1
*David Beran, Christophe Perrin, Nils Billo, John S Yudkin
4
Division of Tropical and Humanitarian Medicine, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 6, CH-1211 Geneva 14, Switzerland (DB); International Insulin Foundation, London, UK (DB, JSY); Paris, France (CP); International Union Against Tuberculosis and Lung Disease, Paris, France (NB); and University College London, London, UK (JSY) [email protected] DB has done work for WHO on the issue of access to medicines for NCDs; DB and JSY are active within the International Insulin Foundation, an organisation campaigning to improve access to medicines for people with diabetes in low-income settings. Copyright © Beran et al. Open Access article distributed under the terms of CC BY-NC-SA.
e562
2
3
5
6 7
8 9
10
WHO. Global action plan for the prevention and control of noncommunicable diseases 2013–2020. Revised draft (version dated Feb 11, 2013). Geneva: World Health Organization, 2013. Cameron A, Roubos I, Ewen M, et al. Differences in the availability of medicines for chronic and acute conditions in the public and private sectors of developing countries. Bull World Health Org 2011; 89: 412–21. Mendis S, Fukino K, Cameron A, et al. The availability and affordability of selected essential medicines for chronic diseases in six low- and middle-income countries. Bull World Health Org 2007; 85: 279–88. WHO. The world health report 2010. Health system financing: the path to universal coverage. Geneva: World Health Organization, 2010. Hogerzeil HV, Liberman J, Wirtz VJ, et al. Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration. Lancet 2013; 381: 680–89. The important world of drug prequalification. Lancet 2004; 364: 1830. Farmer P, Frenk J, Knaul FM, et al. Expansion of cancer care and control in countries of low and middle income: a call to action. Lancet 2010; 376: 1186–93. Billo N. Asthma drug facility: from concept to reality. Int J Tuberc Lung Dis 2006; 10: 709. WHO, HAI. Measuring medicine prices, availability, affordability and price components. Geneva and Amsterdam: World Health Organization and Health Action International, 2008. Beran D, Higuchi M. How to investigate access to care for chronic noncommunicable diseases (NCDs) in low- and middle-income countries. Draft for field testing. Geneva: World Health Organization, 2012.
www.thelancet.com/lancetgh Vol 2 October 2014
