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Dr. Gojka Roglic, Technical Officer for the Diabetes Unit at WHO Geneva and Emer Cooke, WHO’s Head of Regulation of Medicines and Health Technologies, unveiled the start of a pilot programme to prequalify human insulin last month on November 13th.  With dozens of press reports covering the announcement, most people learned that the objective of WHO’s new Prequalification Programme is to increase access to human insulin in low- and middle-income countries. WHO’s decision addresses the high cost of insulin and barriers to access and affordability. According to WHO only half of people requiring insulin are able to access it worldwide, largely due to high prices. Access is not just a problem in resource poor countries. In the United States, the price of a vial has risen to $300 from $20-30 dollars which has led people to ration whatever they can afford or to buy insulin on the black market which has led to preventable death.

WHO’s two-year pilot project involves the evaluation of insulin developed by manufacturers to ensure their quality, safety, efficacy and affordability. Human insulin has been on WHO’s Essential Medicines List since the first list was published in 1977. The approval process will permit United Nations agencies and medical charities to buy approved generic versions of insulin. It will also help to ensure the confidence of countries without strong regulatory agencies that these insulins are safe to purchase.

In the midst of the crisis, and WHO’s new pilot programme for increased access to human insulin, Dr. Roglic generously agreed to answer a few questions.  She joined WHO in 1999 and is the medical officer responsible for WHO activities on diabetes management and individual level prevention, within the Department of Noncommunicable Diseases in Geneva, Switzerland. She has received training as a physician and epidemiologist at the University of Zagreb, Croatia, and the London School of Hygiene and Tropical Medicine in London, UK. In addition, Dr Roglic provides technical advice to member states on public health aspects of diabetes and is responsible for the development and update of WHO norms and standards related to diabetes diagnosis and management.

The cost of insulin has been steadily increasing for almost two decades, and global access and availability has been at a crisis level for many people in low- and middle-income countries. What was the tipping point for the World Health Organization in making the decision to test and approve generic versions of human insulin (aka “prequalification”)?

GR:  It is difficult to say that there was an actual tipping point. Pressure to tackle access to insulin has been rising, with more and more countries voicing their difficulties, and mounting scientific evidence documenting the size of the problem, going beyond anecdotal reports and personal stories. Political commitments through Sustainable Development Goals and UN High Level Political Meetings on Noncommunicable Diseases provide a strong mandate for WHO and member states to take action. There is also increasing interest from the civil society to financially and technically support a range of initiatives related to access to insulin, including activities around approval of insulin biosimilars.

Other than the United States, where people (with both type 1 and type 2 diabetes) have rationed their insulin and suffered complications and death, what country or population today is at the greatest risk for not being able to afford or get access to insulin? 

GR: There are insufficient data to single out a specific country. The countries with most difficulties are countries with lower income, countries without universal health coverage or other measures that ensure that those who cannot afford insulin can access it. However, all poor populations who have to pay out of pocket are at risk, regardless of which country they live in.

Can you please discuss what happens to people with diabetes when they can’t access prescribed insulin?

GR: All people with type 1 insulin die within a short period of time if they are deprived of insulin. People with type 1 diabetes are generally aware of this. When insulin is unaffordable, the most likely strategy adopted by patients is its rationing, i.e. taking enough to stay alive, but not enough for controlling blood glucose values. In the long-term, this leads to debilitating complications and ultimately shortens lives. Some 15% of people with type 2 diabetes require insulin for controlling blood glucose. They are not in immediate danger of death if they do not receive it, but are more likely to suffer microvascular complications such as blindness and kidney failure in the longer term.

Gojka Roglic
Dr. Gojka Roglic

Does WHO currently partner with the insulin manufacturers who sell insulin for profit today? Eli Lilly, Novo Nordisk and Sanofi are making profits from a medicine whose active ingredient has not changed since 1923.  Back then it was sold for $1, because “insulin belongs to the world” said the discoverers. Their intention was to ensure people with diabetes would not have to suffer or struggle to get their insulin. Please discuss.

GR: There is no formal partnership between WHO and the insulin manufacturers. Unlike some other medicines, patents on insulins are not a major obstacle to access. One has to acknowledge that insulin manufacturers are not charities, they work to make profit. But how big a profit, that should be discussed. There is need to engage in discussions to elaborate a business model that improves access for poor populations and that also allows companies to make some return on investment. Access to human insulin should be a global priority given that currently the evidence is lacking on the benefits of analogue insulin and that their prices are significantly higher.

Corruption is often pointed to as the cause for insulin inaccessibility in low-and middle-income countries.  In some regions, like sub-Saharan Africa, countries may receive thousands of vials of insulin, but it may get “stuck” at customs and never get to the people it was intended for.  Additionally, insulin intended either for charity or for National Health Departments often gets “lost” but resurfaces at a much higher cost on either the black market or in pharmacies.  Do you agree corruption is a part of the barrier?  If yes, how do you hope to avoid corruption in a generic market?

GR: It is difficult to quantify, but it is possible that corruption has a role, albeit small, in the complex landscape of the overall insulin market. Corruption is an overall challenge within some contexts and WHO has recently launched a report which aims to advance a more coherent approach towards mainstreaming anti-corruption efforts into work to strengthen and repurpose health systems towards universal health coverage. The goal of this work is to support the efforts of WHO Member States to prevent corruption through greater transparency and reinforced accountability mechanisms in their health systems. Re-shaping the insulin market by opening it to more manufacturers could reduce the opportunities for gross financial gain.

How long do you think the prequalification process for generic insulin will take to get to the people who so desperately require insulin now?

GR: The process can take from three months to two years, depending on how quickly manufacturers can provide all the required information.

In the meantime, what can people with diabetes who require insulin do?

GR: Get organised and advocate vigorously for better access, not only to insulin, but to diabetes care. Although a step in the right direction, availability of biosimilar insulin alone is unlikely to be the ultimate solution and other mechanisms to improve access will be explored as well.


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