A new WHO report shows barriers to insulin availability and suggests actions to promote universal access

“Scientists who discovered insulin 100 years ago refused to profit from its discovery and sold the patent for just one dollar,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. “Unfortunately, this gesture of solidarity was surpassed by a multi-billion dollar deal that created huge gaps in access. The WHO is working with countries and manufacturers to close these gaps and expand access to this life-saving medicine for all who need it. ”

Insulin is the cornerstone of diabetes treatment – it makes a deadly disease feasible for nine million people with type 1[i] diabetes. For more than 60 million people living with type 2 diabetes, insulin is essential to reduce the risk of kidney failure, blindness, and limb amputation.

However, not every other person who needs insulin because of type 2 diabetes gets it. Diabetes is on the rise in low- and middle-income countries, and yet their insulin consumption has not accompanied the growing burden of the disease. The report points out that although three out of four people affected by type 2 diabetes live in countries outside of North America and Europe, they account for less than 40% of insulin sales revenue.

Keeping the 100-year promise – to make access to insulin universal, published today in memory of 100^th anniversary of the discovery of insulin, highlights the main causes of deficiencies in the global approach to insulin as:

• The transition to a global market from human insulin, which can be produced at a relatively low cost, to more expensive analogues (synthetic insulin) imposes an unsustainable financial burden on lower-income countries. In general, human insulin is just as effective as analogs, but analogs are at least 1.5 times more expensive than human insulins, and in some countries three times more expensive;
• Three multinational companies control more than 90% of the insulin market, leaving little room for smaller companies to compete to sell insulin;
• Non-optimal regulation and policy, including suboptimal approaches to drug pricing, poor supply and supply chain management, insufficient funding to cover demand, and generally poor management affect access to insulin and related devices, such as monitoring and delivery devices, in all countries;
• Insufficient health system capacities and infrastructure, including lack of integration of services at the primary health care level, inadequate capacities to provide diabetes care and ensure continuity of supply and infrastructure for information management, supply management and local insulin production are widespread challenges for lower income people. countries;
• Research focuses on rich markets, ignoring public health needs in low- and middle-income countries, which account for 80% of the burden of diabetes.

The tubular landscape is also uneven and reveals a lack of transparency in the way prices are set, the report said. For example, biosimilar insulins (essentially generic versions) could be more than 25% cheaper than the original product, but many countries, including those with lower incomes, do not benefit from this potential savings.

The report suggests several actions to improve access to insulin and related products, including:

• Encouraging the production and supply of human insulin and diversifying the production base for biosimilar analogue insulins in order to create competition and reduce prices;
• Improve accessibility by regulating prices and brands, using pooled procurement and improving the transparency of how prices are set;
• Promote local production capacities in regions with a lack of services;
• Promote research and development focused on the needs of low and middle income countries;
• Ensure that increased insulin access is accompanied by rapid diagnosis and access to accessible blood sugar monitoring and insulin injection devices;
• Use health resources wisely by selecting human insulin where possible and allocate appropriate resources to provide a comprehensive care package.

The WHO has accelerated efforts to address some of the barriers to the availability of insulin and related drugs and health technologies through a series of dialogues with business associations and manufacturers of these products.

A few months after the first dialogue, the industry committed to a range of actions, including:

• Development of draft policies to improve access to biosimilar insulins;
• Participation in the WHO pre-qualification program for insulin, glucose meters, test strips and diagnostic tools;
• Participation in international / UN joint procurement mechanisms or aggregate demand, once established;
• Providing data on insulin thermostability to the WHO; and
• Participate in the reporting mechanism that the WHO will use to register and publish contributions from the pharmaceutical and health technology industries.

The extension of the WHO prequalification program is expected to include glucose monitoring devices, test strips and diagnostic tools, and the inclusion of additional forms of insulin and other diabetes drugs in the latest update of the WHO Essential Medicines Inventory Model will lead to improved access to countries where demand is currently not met.

Efforts to increase access to life-saving diabetes drugs are just one of the workflows of the Global Diabetes Agreement, launched in April 2021. The Compact brings together national governments, UN organizations, NGOs, private sector entities, academic institutions, philanthropists. foundations, people living with diabetes and international donors to work in a world where all people at risk of diabetes or living with diabetes can access the care they need.

[i] For definitions of type 1 and 2 diabetes, see WHO data on diabetes