{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,24]],"date-time":"2025-12-24T18:18:02Z","timestamp":1766600282428,"version":"3.48.0"},"reference-count":27,"publisher":"BMJ","issue":"9","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,9,10]]},"published-print":{"date-parts":[[2019,9]]},"abstract":"\n Objectives<\/jats:title>\n Challenges remain in ensuring universal access to affordable essential medicines. We previously estimated the expected generic prices based on cost of production for medicines in solid oral formulations (ie, capsules or tablets) on the WHO Model List of Essential Medicines (EML). The objectives of this analysis were to estimate cost-based prices for injectable medicines on the EML and to compare these to lowest current prices in England, South Africa, and India.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n \n Data on the cost of active pharmaceutical ingredients (APIs) exported from India were extracted from an online database of customs declarations (\n www.infodriveindia.com<\/jats:ext-link>\n ). A formula was designed to use API price data to estimate a cost-based price, by adding the costs of converting API to a finished pharmaceutical product, including the cost of formulation in vials or ampoules, transportation and an average profit margin.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n For injectable formulations on the WHO EML, medicines had prices above the estimated cost-based price in 77% of comparisons in England (median ratio 2.54), and 62% in South Africa (median ratio 1.48), while 85% of medicines in India had prices below estimated cost-based price (median ratio 0.30). 19% of injectable medicines in England, 9% in South Africa, and 5% in India had prices more than 10 times the estimated cost-based price. Medicines that appeared in the top 20 by ratio of lowest current price to estimated cost-based price for more than one country included numerous oncology medicines\u2014irinotecan, leuprorelin, ifosfamide, daunorubicin, filgrastim and mesna\u2014as well as valproic acid and ciclosporin.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Estimating manufacturing costs can identify cases in which profit margins for medicines may be set significantly higher than average.<\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-027780","type":"journal-article","created":{"date-parts":[[2019,10,1]],"date-time":"2019-10-01T08:15:13Z","timestamp":1569917713000},"page":"e027780","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":17,"title":["Estimation of cost-based prices for injectable medicines in the WHO Essential Medicines List"],"prefix":"10.1136","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0359-1259","authenticated-orcid":false,"given":"Dzintars","family":"Gotham","sequence":"first","affiliation":[{"name":"Independent researcher, Independent, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melissa Joy","family":"Barber","sequence":"additional","affiliation":[{"name":"Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew M","family":"Hill","sequence":"additional","affiliation":[{"name":"University of Liverpool, Liverpool, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2019,9,30]]},"reference":[{"key":"2025121515200211000_9.9.e027780.1","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1016\/S0140-6736(16)31599-9","article-title":"Essential medicines for universal health coverage","volume":"389","author":"Wirtz","year":"2017","journal-title":"The Lancet"},{"key":"2025121515200211000_9.9.e027780.2","unstructured":"World Health Organization . Revised procedure for updating WHO\u2019s Model List of Essential Drugs, 2001. Available: http:\/\/apps.who.int\/medicinedocs\/documents\/s22165en\/s22165en.pdf [Accessed 8 Mar 2018]."},{"key":"2025121515200211000_9.9.e027780.3","doi-asserted-by":"crossref","DOI":"10.1136\/bmjgh-2017-000571","article-title":"Estimated costs of production and potential prices for the who essential medicines list","volume":"3","author":"Hill","year":"2018","journal-title":"BMJ Glob Health"},{"key":"2025121515200211000_9.9.e027780.4","unstructured":"Kenber B . Drug firm is facing fine of \u00a3220m for hiking prices. In: The Times, 2017. https:\/\/www.thetimes.co.uk\/article\/drug-firm-faces-fine-of-220m-for-hiking-prices-gf0ssclqk"},{"key":"2025121515200211000_9.9.e027780.5","unstructured":"Competition and Markets Authority . CMA fines pfizer and Flynn \u00a390 million for drug price hike to NHS. Available: https:\/\/www.gov.uk\/government\/news\/cma-fines-pfizer-and-flynn-90-million-for-drug-price-hike-to-nhs [Accessed 28 Oct 2018]."},{"key":"2025121515200211000_9.9.e027780.6","doi-asserted-by":"crossref","DOI":"10.1136\/bmjgh-2018-000850","article-title":"Production costs and potential prices for biosimilars of human insulin and insulin analogues","volume":"3","author":"Gotham","year":"2018","journal-title":"BMJ Glob Health"},{"key":"2025121515200211000_9.9.e027780.7","unstructured":"World Health Organization . 19Th who model list of essential medicines, 2015. Available: http:\/\/www.who.int\/medicines\/publications\/essentialmedicines\/EML2015_8-May-15.pdf?ua=1 [Accessed 28 Jan 2016]."},{"key":"2025121515200211000_9.9.e027780.8","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1016\/S2055-6640(20)30484-2","article-title":"Analysis of minimum target prices for production of entecavir to treat hepatitis B in high- and low-income countries","volume":"1","author":"Hill","year":"2015","journal-title":"J Virus Erad"},{"key":"2025121515200211000_9.9.e027780.9","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2015-009586","article-title":"Target prices for mass production of tyrosine kinase inhibitors for global cancer treatment","volume":"6","author":"Hill","year":"2016","journal-title":"BMJ Open"},{"key":"2025121515200211000_9.9.e027780.10","doi-asserted-by":"crossref","first-page":"28","DOI":"10.1016\/S2055-6640(20)30691-9","article-title":"Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C","volume":"2","author":"Hill","year":"2016","journal-title":"J Virus Erad"},{"key":"2025121515200211000_9.9.e027780.11","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2016-011965","article-title":"Estimated generic prices of cancer medicines deemed cost-ineffective in England: a cost estimation analysis","volume":"7","author":"Hill","year":"2017","journal-title":"BMJ Open"},{"key":"2025121515200211000_9.9.e027780.12","doi-asserted-by":"crossref","unstructured":"Gotham D , Fortunak J , Pozniak A , et al . Estimated generic prices for novel treatments for drug-resistant tuberculosis. J Antimicrob Chemother 2017;72. dkw522.doi:10.1093\/jac\/dkw522","DOI":"10.1093\/jac\/dkw522"},{"key":"2025121515200211000_9.9.e027780.13","doi-asserted-by":"crossref","first-page":"1700","DOI":"10.1016\/j.vaccine.2018.01.011","article-title":"Cost of goods sold and total cost of delivery for oral and parenteral vaccine packaging formats","volume":"36","author":"Sedita","year":"2018","journal-title":"Vaccine"},{"key":"2025121515200211000_9.9.e027780.14","doi-asserted-by":"crossref","first-page":"286","DOI":"10.5455\/msm.2013.25.286-290","article-title":"Financial aspects and the future of the pharmaceutical industry in the United States of America","volume":"25","author":"Karamehic","year":"2013","journal-title":"Mater Sociomed"},{"key":"2025121515200211000_9.9.e027780.15","unstructured":"IMS Institute for Healthcare Informatics . Understanding the pharmaceutical value chain, 2014. Available: https:\/\/www.ifpma.org\/wp-content\/uploads\/2016\/02\/IIHI_Report_Pharma_Value.pdf"},{"key":"2025121515200211000_9.9.e027780.16","unstructured":"Medicines Patent Pool . MedsPaL. Available: http:\/\/www.medspal.org\/ [Accessed 28 Feb 2018]."},{"key":"2025121515200211000_9.9.e027780.17","unstructured":"Murphy H . \"Teva and other generic drugmakers inflated prices up to 1000%, State Prosecutors say\". In: The New York Times, 2019. https:\/\/www.nytimes.com\/2019\/05\/11\/health\/teva-price-fixing-lawsuit.html. (11 May 2019)."},{"key":"2025121515200211000_9.9.e027780.18","unstructured":"Digital NHS . Prescribing costs in hospitals and the community, England 2016\/17: NICE data. 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In: The supply and delivery of solid dosage forms to the Department of health for the period up to 31 July 2018, 2017. http:\/\/www.health.gov.za\/tender\/docs\/contructs\/HP092016SD01ContractCircular.pdf"},{"key":"2025121515200211000_9.9.e027780.23","unstructured":"Central Board of Excise and Customs . Notification No. 140\/2016. Available: https:\/\/www.seair.co.in\/custom-notifications\/notifications-issued-in-the-year-2016-notification-no-1402016-dated-25th-nov-2016-268128.aspx [Accessed 4 Apr 2017]."},{"key":"2025121515200211000_9.9.e027780.24","unstructured":"World Health Organization . Medicines shortages: global approaches to addressing shortages of essential medicines in health systems. WHO Drug Inf 2016;30."},{"key":"2025121515200211000_9.9.e027780.25","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.11.101303"},{"key":"2025121515200211000_9.9.e027780.26","doi-asserted-by":"crossref","DOI":"10.1186\/s12916-016-0674-7","article-title":"Medicine shortages: a commentary on causes and mitigation strategies","volume":"14","author":"Iyengar","year":"2016","journal-title":"BMC Med"},{"key":"2025121515200211000_9.9.e027780.27","unstructured":"Hill A , Barber M , Gotham D , et al . Generic treatments for HIV, HBV, HCV, TB could be mass produced for <$90 per patient. In: 9Th IAS conference on HIV science. Paris, 2017. http:\/\/programme.ias2017.org\/Abstract\/Abstract\/1978"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2018-027780","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T23:20:08Z","timestamp":1765840808000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2018-027780"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,9]]},"references-count":27,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2019,9,30]]},"published-print":{"date-parts":[[2019,9]]}},"alternative-id":["10.1136\/bmjopen-2018-027780"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2018-027780","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2019,9]]}}}