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Global barriers to access to insulin

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Global Barriers to Access to Insulin Co-authors M. Ewen1, D. Beran2, M. Lepeska1, R. Laing3. 1Health Action International, Amsterdam, The Netherlands. 2. University of Geneva, Geneva, Switzerland 3Boston University School of Public Health, Boston, USA. Background Insulin for Type 1 diabetes is a rare example of an absolute need for a given medicine. Although global disease burden data is lacking it is estimated that 490,100 children aged 0-14 have Type 1 diabetes. Type 1 diabetes may represent 5% of the total diabetes burden (estimated at 347 million) or 17.4 million people. Use of insulin in the management of Type 2 diabetes is required for better control and its use is dependent on a variety of health system factors. Barriers to access to insulin in many contexts leads to high morbidity and mortality. Aim The aim of this study is to identify how global factors impact access to insulin at a country level. Method A variety of data sources were analyzed and combined in order to develop a better overview of the global insulin market. To identify insulin manufacturers a literature review of the insulin market using a variety of databases and Google searches was carried out. For product registration, available websites for the medicine regulatory authorities and ministries of health for each country were searched. A systematic literature review was carried out looking at use of insulin in Type 2 diabetes. The UN Commodity Trade Statistics database was used to extract insulin related trade data. Using the term “insulin”, the United States Food and Drug Administration’s Orange Book and the Canadian Online Drug Product Database Online Query and its Patent Register were searched for patents on insulin. Results Forty independent insulin manufacturers were identified in 17 countries. A total of 55 countries had 1,985 insulin products registered. Of these 58% were human insulin, 38% were analogues, 3% were animal insulin, and 1% was unknown. Novo Nordisk had the highest number of registered products (719) followed by Eli Lilly (470) and Sanofi (361). Together these companies represent 88% of total product registrations globally. Only two countries did not list any insulin on their National Essential Medicines List. In looking at insulin use in people with Type 2 diabetes, the literature showed a range from 2.4% in Taiwan to 23.5% in the US. No patents were found for human insulin. For analogue insulins, 61 patents were found in the US Food and Drug Administration’s Orange Book and 8 patents were listed in the Canadian Online Drug Product Database. For insulin exports between 2003 and 2013, 10 countries made up 98% to 99% of the global value of retail insulin exports. Over this period, Denmark, France, and Germany collectively exported between 85% to 96% of global retail insulin by value. Fifty percent of global imports were to the US, UK, Germany and Japan. Around 60 countries (mostly low- and middle income countries) imported insulin from only one country for making then vulnerable to disruptions in supply. Discussion This data provides a unique addition to the knowledge about the global insulin market from different angles. It confirms from the dominance of Eli Lilly, Novo Nordisk and Sanofi with regards to the global insulin market. Although other insulin manufacturers have been identified, their size and market penetration seem to be low. Intellectual Property is not an issue for insulin itself. These global barriers result in high prices of insulin. In the public sector for individuals were US$7.64 for human insulin and US$45.03 for analogues. In the private sector analogues were higher priced (US$39.35) than human insulins (US$16.65). This translates to mean affordability in the public sector was 2.5 days’ wages for human insulins, and 7.5 day’s wages for analogues. In the private sector, it was 3.5 and 9.5 days’ wages for human and analogues insulins, respectively. For other medicines, generic competition has been able to lower prices and improve access, however this has not happened for insulin despite no patents on human insulin. The reasons for this may be linked to a variety of factors, such as the marketing strength of these 3 multi-national companies, push for analogue versus human insulin, the complexity of manufacturing a biological product, lack of government funding for purchasing insulin and lack of civil society mobilisation around the issue of access to insulin. In order to address these global barriers global mechanisms are needed as has been seen for HIV/AIDS and other communicable diseases.

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