{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,13]],"date-time":"2026-11-13T01:06:46Z","timestamp":1794532006573,"version":"4.9.1"},"reference-count":111,"publisher":"BMJ","issue":"3","funder":[{"name":"the European Union\u2019s Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Glob Health"],"accepted":{"date-parts":[[2018,4,13]]},"published-print":{"date-parts":[[2018,5]]},"abstract":"<jats:p>Miltefosine, the only oral drug approved for the treatment of leishmaniasis\u2014a parasitic disease transmitted by sandflies\u2014is considered as a success story of research and development (R&amp;D) by a public-private partnership (PPP). It epitomises the multiple market failures faced by a neglected disease drug: patients with low ability to pay, neglect by authorities and uncertain market size. Originally developed as an anticancer agent in the 1990s, the drug was registered in India in 2002 to treat the fatal visceral leishmaniasis. At the time, miltefosine was considered a breakthrough in the treatment, making it feasible to eliminate a regional disease. Today, access to miltefosine remains far from secure. The initial PPP agreement which includes access to the public sector is not enforced. The reality on the ground has been challenging: shortages due to inefficient supply chains, and use of a substandard product which led to a high number of treatment failures and deaths. Miltefosine received orphan drug status in the USA; when it was registered there in 2014, a priority review voucher (PRV) was awarded. The PRV, meant to facilitate drug development for neglected disease, was subsequently sold to another company for US$125\u2009million without, to date, any apparent impact on drug access. At the heart of these concerns are questions on how to protect societal benefit of a drug developed with public investment, while clinicians worldwide struggle with its lack of affordability, limited availability and sustainability of access. This article analyses the reasons behind the postregistration access failure of miltefosine and provides the lessons learnt.<\/jats:p>","DOI":"10.1136\/bmjgh-2018-000709","type":"journal-article","created":{"date-parts":[[2018,5,3]],"date-time":"2018-05-03T13:08:40Z","timestamp":1525352920000},"page":"e000709","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":142,"title":["Why miltefosine\u2014a life-saving drug for leishmaniasis\u2014is unavailable to people who need it the most"],"prefix":"10.1136","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0369-8830","authenticated-orcid":false,"given":"Temmy","family":"Sunyoto","sequence":"first","affiliation":[{"name":"Department of Public Health, Institute of Tropical Medicine (ITM), Antwerp, Belgium"},{"name":"Policy Department, M\u00e9decins Sans Fronti\u00e8res- Campaign for Access to Medicines, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julien","family":"Potet","sequence":"additional","affiliation":[{"name":"Policy Department, M\u00e9decins Sans Fronti\u00e8res- Campaign for Access to Medicines, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marleen","family":"Boelaert","sequence":"additional","affiliation":[{"name":"Department of Public Health, Institute of Tropical Medicine (ITM), Antwerp, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2018,5,3]]},"reference":[{"key":"2025073013270572000_3.3.e000709.1","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0035671","article-title":"Leishmaniasis worldwide and global estimates of its incidence","volume":"7","author":"Alvar","year":"2012","journal-title":"PLoS One"},{"key":"2025073013270572000_3.3.e000709.2","first-page":"557","article-title":"Global leishmaniasis update, 2006\u20132015: a turning point in leishmaniasis surveillance","volume":"92","author":"World Health Organization","year":"2017","journal-title":"Wkly Epidemiol Rec"},{"key":"2025073013270572000_3.3.e000709.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)67629-5"},{"key":"2025073013270572000_3.3.e000709.4","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0002869"},{"key":"2025073013270572000_3.3.e000709.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.pt.2006.09.004"},{"key":"2025073013270572000_3.3.e000709.6","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.2011.10-0321"},{"key":"2025073013270572000_3.3.e000709.7","unstructured":"WHO. 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