Lead Authors: Margaret Ewen and David Beran
Organization: Health Action International; Geneva University Hospitals and University of Geneva
Country: Netherlands and Switzerland
Abstract
Ensuring access to medicines is an essential priority of the WHO Global Action Plan on non-communicable diseases, key to achieving the health target of the Sustainable Development Goals, and contributes to the strengthening of health systems and Universal Health Coverage. However, access to essential medicines for diabetes, especially insulin, has had insufficient attention despite evidence of its low availability and poor affordability in many countries across the globe. The reasons for poor affordability of insulin appear to be multifaceted. Firstly, three companies dominate the market which limits competition. Unlike other medicines, the production of biosimilar (generic) insulin by others has had minimal impact on the global insulin market. Nationally, mark-ups (often uncontrolled in low- and middle-income countries), taxes, duties and other costs in the pharmaceutical supply chain add to the manufacturers’ price and push prices up to often unaffordable levels. Factors contributing to poor insulin availability include inadequate quantification at the national level, inequitable in-country distribution, and poor determination of needs at lower levels of the health system. These barriers contribute to the stark reality that of the 100 million people who need insulin, only one in two can rely on regular and affordable access.
In this contribution, we outline why current initiatives are insufficient to significantly improve access to insulin, and the work underway by the Addressing the Challenge and Constraints of Insulin Sources and Supply (ACCISS) Study group to develop interventions that provide sustainable solutions. These include allocating a small proportion of the existing diabetes funding for innovation in the delivery of insulin, creating a regulatory framework for biosimilars, and instigating a global compact with industry to ensure more affordable human insulins in vials are not be taken off the market.
Submission
Access to insulin: current status and global policy implications
Insulin was first discovered in 1921 and has been on the WHO Essential Medicines List since 1977, yet on World Diabetes Day in 2013, UN Secretary General Ban Ki Moon had to re-highlight that “nearly 100 years after insulin was first used to save the life of a diabetic patient, people around the world still die because they cannot access this hormone”. Insulin is essential for survival for type 1 diabetes patients and without it individuals face death within a matter of weeks. It is also used for the management of 10-30% of cases of type 2 diabetes.1 Worldwide, 100 million people need access to the insulin, yet currently one in two of these people cannot rely on an adequate supply due to a multitude of barriers to affordability and availability. These barriers have a devastating impact; currently, the most common cause of death for a child with type 1 diabetes is due to lack of insulin. Poor access to insulin can translate into a life expectancy for a child with type 1 diabetes in sub-Saharan Africa as low as one year, in comparison to close to a full life expectancy for a child born in a high-income country. Issues around insulin affordability and availability do not just affect low- and middle-income countries. In a study of diabetes in a US inner city setting, the leading cause of diabetic ketoacidosis was insulin discontinuation, with 27% of patients reporting no money to buy insulin.2 The issue of access and affordability has also become a problem for European countries dealing with and rising health budgets.
Over the past few decades, several declarations on tackling diabetes have been made by international organisations and societies e.g. from the St Vincent Declaration (1989) between the European branches of WHO and International Diabetes Federation (IDF), the Kos Declaration of the International Society for Pediatric and Adolescent Diabetes (1993) to ensure access to insulin, and the IDF Melbourne Declaration (2013) also on access to medicines. However, these statements have not yielded a definitive response to adequately address the complexities of access to insulin. Until the UN General Assembly on NCDs in 2011, little attention was given to access to medicines for NCDs. Moreover, despite being the main cause of mortality worldwide, with 63% of total deaths, NCDs remained off the global development agenda until the recent 2015 Sustainable Development Goals.
The WHO’s Global Action Plan on Non-Communicable Diseases 2013-2020 provides a clear target on access to medicines for chronic conditions: “80% of availability of the affordable basic technologies and essential medicines, including generics, required to treat major NCDs in both public and private facilities” In addition, WHO guidelines on insulin are under development, making this an opportune time to focus on eliminating barriers to accessing insulin. The benefits of improving access to insulin are clear i.e. longer life expectancies for people living with type 1 diabetes, and a decrease in blindness, amputations and kidney failures and premature mortality for people with type 1 or type 2 diabetes. Furthermore, barriers to access to medicines impede the achievement of Universal Health Coverage. The Director General of the WHO stated in 2013 that achieving Universal Health Coverage was essential to avoid individuals having to face “catastrophic health expenditures that drive households into poverty”.3 From a human rights perspective, access to insulin is a fundamental component of a strong health system that upholds the right to health, equality and non-discrimination, development and living a life in dignity.
This contribution to the UN Secretary General Panel on Access to Medicines will address current issues and barriers to access, the work underway in the ACCISS Study, and some initial solutions for tackling the problem.
Barriers impacting availability and affordability of insulin
Studies have identified a variety of barriers to accessing insulin, at both international and national levels. But two key barriers stand out i.e. low availability in outlets and high prices.
Insulin is different to most other medicines in that the market is dominated by three companies, currently accounting for about 90% of the global insulin market in terms of value and volume.1 This restricts price competition and enables the three companies to shape the market, including the promotion of higher priced analogue insulins rather than lower priced human insulins. An insulin price survey, to be released on World Health Day 2016 by the ACCISS Study, shows patients were paying about $7 versus $42 for 10ml of human and analogue insulin respectively in the public sector, and $17 versus $40 in the private sector.4 In parallel to an increase in insulin usage, analogue insulin is taking increasingly larger shares of the market.
Intellectual property is not a barrier to accessing the insulin molecule, but shifts to use of insulin delivered in pen devices, which are patented, is likely to be a barrier in many settings.
Unlike antiretrovirals (ARVs) and other medicines, the production of biosimilar insulin is complex both in terms of the process of creating an exact biological copy and in ensuring quality. Because of this, regulatory requirements are more complex for biosimilar insulin compared to generic small molecules, which adds a further barrier to competition.
Many barriers to access are also due to how insulin is purchased and used at the national level. Firstly, insulin is often subject to import duties (ranging from 0-15%) and taxes (0% to 25%).5 Then mark-ups (often uncontrolled in low and middle-income countries) and other charges are applied in the supply system, which drive up patient prices even further.
Purchasing insulin places a large financial burden on people with diabetes and their families, especially in low- and middle-income countries. Affordability to the individual is an issue, even when buying in the public sector. For example, the lowest paid unskilled government worker in Burundi has to work six days to pay for 10ml human insulin in the public sector. In the public sector in Indonesia, 3 days’ wages are needed to by human insulin and 6 days’ wages to buy analogue insulin.4
The limited number of suppliers can impact government procurement, and hence insulin availability, in some countries. For example, in Mali a minimum of three bids are required as part of the tender process which is challenging when there are so few suppliers. In some countries, governments prioritise other medicines when purchasing or difficulties are encountered when distributing medicines particularly to rural areas. Transportation and storage costs of insulin movement from urban to rural areas can result in higher patient prices.
In early 2015, Health Action International in collaboration with Boston University School of Public Health, the Geneva University Hospitals, and University of Geneva Division of Tropical and Humanitarian Medicine launched its three year ACCISS Study. The aim is to provide a comprehensive, pioneering, evidence-base on the global insulin market, in particular on the type, extent, and effect of barriers to global insulin access. Based on the first year of the study, the main innovation will not come from new formulations of insulin, but rather innovative models of supply and interventions. These interventions will be developed as the study progresses. That said, some actions are already apparent as outlined in the call to action.
Call to action
Many diabetes organisations and pharmaceutical companies have worked towards providing insulin for those in need, through donations programmes such as IDF’s Life for a Child and differential pricing schemes. However, these approaches are small-scale, do not provide long-term solutions, and rarely tackle the barriers to access in the first place. For example, the selection of countries for differential pricing schemes is usually based on a country’s income, therefore often excludes middle-income countries, where large segments of the population can be poor.
Although the approach to tackling access to insulin is different to that of ensuring access to ARVs, certain lessons can be learnt. Firstly, while international financing schemes tend to fund ARVs, insulin is purchased from national budgets with no external funding. In 2000, Yudkin estimated that for highly indebted poor countries, $3-5 million would be sufficient to provide insulin for all needing this medicine. This is a small amount compared to the funding allocated to researching a cure for type 1 diabetes by foundations, governments and the private sector. The US National Institute for Health designated more than one billion dollars for diabetes research in 2015 alone. We call for a small portion of this funding, such as 5%, to be allocated to improving access to insulin for patients, and for improving health systems.
Secondly, in the fight for affordability of ARVs, the market was reshaped by the promotion of generic competition, including prequalification, transparency in reporting government procurement prices, and product quality testing. In order to ensure that the quality of generics met national and international standards, WHO developed a prequalification scheme for medicines for HIV/AIDS, malaria and tuberculosis, and has since expanded the programme to other diseases. Insulin is not included in this prequalification scheme. Biosimilar insulins have not impacted the insulin market in the same way that generic ARVs have, a key factor of which is the complexity of proving similarity with the originator. Dealing with this issue is important in improving access to insulin. We call on WHO to investigate the inclusion of insulin in its prequalification scheme, to develop a regulatory framework for biosimilar insulin, and to support governments to procure quality-assured, safe, efficacious and cost-effective insulin products.
To tackle the issue of rising prices due to incremental technology innovations, we also suggest the development of a global compact with the insulin industry; to guarantee that human insulin and insulin in vial form will not be removed from the market.
Innovation in the supply of insulin, active civil society involvement, and funding will be necessary to achieve the Global Action Plan’s target of 80% availability of affordable medicines to treat NCDs, or the more pioneering target of the 100 Campaign of “100% of people living with type 1 diabetes having access to insulin by 2022.”
Challenges lie ahead in developing and implementing these solutions, especially where stakeholders see the existing solutions, such as differential pricing and donations, as sufficient. However, with the newly announced Sustainable Development Goals and work on Universal Health Coverage, now is the time for action to address inequalities in access to insulin.
Bibliography and References
1. Wirtz V. Insulin market profile. To be published 7 April 2016 by HAI as part of the ACCISS Study.
2. Randall L, Begovic J, Hudson M, Smiley D, Peng L, Pitre N, et al. Recurrent diabetic ketoacidosis in inner-city minority patients: behavioral, socioeconomic, and psychosocial factors. Diabetes Care.2011 Sep;34(9):1891-6. PubMedPMID: 21775761. PMCID: 3161256.Epub 2011/07/22. eng.
3. Opening remarks at a WHO/World Bank ministerial-level meeting on universal health coverage Geneva, Switzerland 18 February 2013 http://www.who.int/dg/speeches/2013/universal_health_coverage/en/
4. Ewen M, Joosse H-J, Ashigbie P, Beran D, Laing R. Insulin prices. To be published 7 April 2016 by HAI as part of the ACCISS Study.
5. Kaplan W. Import tariffs and taxes on insulin. To be published 7 April 2016 by HAI as part of the ACCISS Study.