A list of articles, reports, case studies and other updated publications is presented alphabetically by the ACCISS Study project.

A

A GLOBAL PERSPECTIVE ON THE ISSUE OF ACCESS TO INSULIN | Article

D. Beran, M. Lazo-Porras, C. Mba, and J. Mbanya

A PERSPECTIVE ON GLOBAL ACCESS TO INSULIN: A DESCRIPTIVE STUDY OF THE MARKET, TRADE FLOWS AND PRICES | Article

D. Beran, R. Laing, W. Kaplan, R. Knox, A. Sharma, V. Wirtz, J. Frye, and M. Ewen.

ACCESS TO INSULIN: CHALLENGES AND CONSTRAINTS |  Report

The ACCISS Study has completed its first phase of work, which aimed to gain an overall understanding of the insulin market through different profiles. These included profiles on the insulin market, intellectual property, insulin trade, prices, and taxes and tariffs. The main lessons from this work are presented in this report.

Access to INSULIN 100 Years On | Leaving No One Behind | Video

To mark the centenary of the discovery of insulin, the Addressing the Challenge and Constraints of Insulin Sources and Supply (ACCISS) Study teamed up with Cloud9Media to shine a spotlight on the current realities of access to insulin from both a global and national perspective. The result is a moving account of not only the challenges that people using insulin face, but also the opportunities for change through the concerted efforts of civil society, governments, and people most affected by diabetes:

Alternative funding sources to improve insulin access: a briefing document for low- and middle-income countries | Tool

J. Luo

B

BEYOND ACCESS TO INSULIN: A HEALTH SYSTEMS APPROACH TO MANAGING TYPE 1 DIABETES |  Report

L. Favez, K. Jungo, and D. Beran

BIOSIMILAR INSULIN REGULATORY PROFILE | Report | Fact Sheet

The Biosimilar Insulin Regulatory Profile discusses the regulatory pathways and challenges faced by companies seeking marketing authorisation for insulin biosimilars, particularly in highly-regulated markets such as the European Union (EU) and the United States (US).  It also includes a case study of two manufacturers who sought marketing authorisation from the European Medicines Agency (EMA) for insulin products.

C

CHALLENGES CONSTRAINING ACCESS TO INSULIN IN THE PRIVATE SECTOR MARKET OF DELHI, INDIA | Article | Appendix

A. Sharma, W. Kaplan

COMPANY AND COMPANY SUPPORTED PROGRAMMES WITH A COMPONENT OF DONATED INSULIN IN LMICs  || Report

The report looks at the supply of donated insulin through corporate social responsibility and other programmes by the three main insulin-producing companies.

CONSTRAINTS AND CHALLENGES IN ACCESS TO INSULIN: A GLOBAL PERSPECTIVE | Article

D. Beran, M. Ewen, R. Laing

D

DIABETES AND THE WHO MODEL LIST OF ESSENTIAL MEDICINES | Article

D. Beran, S. Besançon, M. Ewen, E. Gale, M. Lazo-Porras, M. Lepeska, K. Lipska, J. Zafra-Tanaka, A. Zhaparova, and J. Yudkin

E

ESTIMATION OF GLOBAL INSULIN USE FOR TYPE 2 DIABETES, 2018-30: A MICROSIMULATION ANALYSIS | Article

S. Basu, J. Yudkin, S. Kehlenbrink, J. Davies, S. Wild, K. Lipska, J. Sussman, D. Beran

F

FAILING TO ADDRESS ACCESS TO INSULIN IN ITS CENTENARY YEAR WOULD BE A CATASTROPHICMORAL FAILURE | Comment 

D. Beran et al.

G

GUIDELINES FOR INSULIN USE: REVIEW OF THE EVIDENCE ON INUSLIN AND ITS USE IN DIABETES | Tool | Summary

S. Kehlenbrink, M. McDonnell, J. Luo, and R. Laing

GUIDELINES FOR PROCUREMENT OF INSULINS AND ASSOCIATED SUPPLIES | Article

C. Macé, C. Perrin

H

HEALTH SYSTEM REPONSES FOR TYPE 1 DIABETES: A SCOPING REVIEW | Article

J. Zafra-Tanaka, D. Beran, and A. Bernabe-Ortiz

I

INSULIN MARKET PROFILE | Fact Sheet | Report

This profile identifies insulin manufacturers and countries where their products are registered and/or sold,  the inclusion of insulin in national essential medicines lists, insulin product registration data, recent studies on the efficacy and safety of analogue and human insulin, and an estimate of the rate of insulin consumption for people with type 2 diabetes.

INSULIN PATENT PROFILE | Fact Sheet | Report | Article

This profile uses data from various sources, including the United States Food and Drug Administration’s Orange Book and Health Canada, to determine the patent status of analogue and human insulins, and whether patents are a barrier to accessing insulin.

INSULIN PRICE COMPONENTS: CASE STUDIES IN SIX LOW/MIDDLE-INCOME COUNTRIES | Article

D. Ball, M. Ewen,  R. Laing, D. Beran

INSULIN PRICES, AVAILABILITY AND AFFORDABILITY IN 13 LOW-INCOME AND MIDDLE-INCOME COUNTRIES | Article

M. Ewen, H-J. Joosse, D. Beran, R. Laing

Insulin Prices Profile | Fact Sheet | Report

This profile analyses government procurement prices for insulin, patient prices and affordability of insulin in the public and private sectors, and insulin reimbursement prices. A time-series analysis of insulin prices listed in Management Sciences for Health International Drug Price Indicator Guide is also provided.

Insulin products and patents in the USA in 2004, 2014, and 2020: a cross-sectional study | Article

This correspondence in the Lancet sheds light to the fact that the amount of patents on insulin in the US has greatly increased since 2004, but the majority of these patents are now on delivery devices for existing insulins.

Insulin Tariffs and Taxes Profile | Fact Sheet | Report

This profile describes import tariffs on retail insulin and bulk insulin over time, and identifies countries that continue to apply high tariff levels. It also identifies countries that apply value-added tax on insulin.

Insulin Trade Profile | Fact Sheet | Report | Annexes: 3 | 4 | 5 | 6 | 7 | 8

From available trade databases and published literature, this profile maps the global trade of retail insulin and bulk insulin to show importing and exporting countries and their importance in global insulin trade. Countries that import insulin from only one country, making them vulnerable to possible disruptions in supply, are also identified.

Insulin Users’ Perspective Profile | Report | Infographics: 1 | 2 | 3 | 4 | 5 | 6

This report focuses on the issues and complexities of insulin use and access to insulin from the perspective of those living with diabetes. For this profile, 36 people who use insulin were interviewed in 11 countries, including the United States, Thailand, Mali and Tanzania.

INTERCHANGEABILITY OF BIOSIMILARS IN THE EUROPEAN UNION | Report

T. Giezen

J

K

L

M

MANAGEMENT OF TYPE 1 DIABETES IN LOW- AND MIDDLE-INCOME COUNTRIES: COMPARATIVE HEALTH SYSTEM ASSESSMENTS IN KYRGYZSTAN, MALI, PERU AND TANZANIA | Article

Abdraimova et al.

Market Report: Diabetes self-monitoring devices in LMICs | Report| Factsheet

Clinton Health Access Initiative (CHAI)

N

O

P

POOLED PROCUREMENT OF INSULIN AND ASSOCIATED SUPPLIES | Report

C. Macé

PRODUCTION COSTS AND POTENTIAL PRICES FOR BIOSIMILARS OF HUMAN INSULIN AND INSULIN ANALOGUES | Article

D. Gotham, M. Barber, A. Hill

PRICES PEOPLE PAY FOR GLARGINE INSULIN | Briefing Note

A global snapshot in 2023, covering 47 countries, of the prices people currently pay for glargine insulin and its affordability

Q

R

Regulatory Profile: Glucose self-monitoring tools | Profile

R. Meurant

S

T

THE DEVELOPMENT OF A NATIONAL DIABETES PROGRAMME IN TANZANIA | Report

This report traces the development of the National Diabetes Programmes from its beginnings.

THE IMPORTANCE OF INSULIN DONATIONS FOR CHILDREN IN 43 LOW- AND MIDDLE-INCOME COUNTRIES | Article

H. Hogerzeil, S. Recourt

THE INSULIN MARKET REACHES 100 | Article

D. Beran, E. Gale, and J. Yudkin

The Road to Free Insulin: Ecuador Case Study

G. Alarçon

The Road to Free Insulin: Guyana Case Study

E. Klatman, K. Singh, G. Ogle

The Road to Free Insulin: Kyrgyzstan Case Study

A. Abdraimova, A. Dunganova, A. Zurdinova

The Road to Free Insulin: Lebanon Case Study

R. Karam, M. Watfa

The Road to Free Insulin: Thailand Case Study

S. Khunsri, V. Tantayotai, T. Vannapruegs

THE ROLE OF BIOSIMILAR MANUFACTURERS IN IMPROVING ACCESS TO INSULIN GLOBALLY | Article

C. Perrin, M. Ewen, D. Beran

TRANSITION FROM A DONOR-SUPPORTED PROJECT TO A NATIONAL DIABETES PROGRAMME: LESSONS FROM TANZANIA | Policy Brief

Despite some remaining challenges, development of the diabetes programme in Tanzania can in many ways be considered successful and may serve as an example for other countries. In this policy brief an analysis is presented of the factors contributing to its achievements, and a few lessons learnt in the transition.

TYPE 1 DIABETES IN 2017: GLOBAL ESTIMATES OF INCIDENT AND PREVALENT CASES IN CHILDREN AND ADULTS | Article

A. Green, S. Hede, C. Patterson, S. Wild, G. Imperatore, G. Roglic, D. Beran

U

USER REQUIREMENTS FOR NON-INVASIVE AND MINIMALLY INVASIVE GLUCOSE SELF-MONITORING DEVICES IN LOW-INCOME AND MIDDLE-INCOME COUNTRIES: A QUALITATIVE STUDY IN KYRGYZSTAN, MALI, PERU AND TANZANIA | Article

E. Safary, D. Beran, B. Vetter, M. Lepeska, A. Abdraimova, A. Dunganova, S. Besançon, M. Lazo-Porras, J. Portocarrero Mazanett, S. Pérez-León, M. Maixenchs, H.Nchimbi, K. Ramaiya, C. Munishi, G. Z Martínez-Pérez

(ULTRA-)LONG-ACTING INSULIN ANALOGUES FOR PEOPLE WITH TYPE 1 DIABETES MELLITUS| Article

B. Hemmingsen, M. Metzendorf, B. Richter

V

Value of insulin: The cost-effectiveness of analogue and human insulin – a systematic review  | Tool | Summary

J. Luo

W

WHY ARE WE FAILING TO ADDRESS THE ISSUE OF ACCESS TO INSULIN? A NATIONAL AND GLOBAL PERSPECTIVE | Article

D. Beran, I. Hirsch, J. Yudkin

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Y

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