India currently represents 49 percent of the world’s diabetes burden, with an estimated 422 million cases, a figure expected to almost double to 134 million by 2025. Diabetes is a chronic autoimmune disease, characterized by the inability of the pancreas in the human body to either produce sufficient insulin or to use it efficiently. Insulin is a hormone made by the pancreas, that acts like a key to let glucose from the food we eat pass from the blood stream into the cells in the body to produce energy.
All carbohydrate foods are broken down into glucose in the blood. Insulin helps glucose get into the cells. The absence of insulin leads to an increased concentration of glucose in the blood, termed as hyperglycaemia- increased sugar in the blood. While type 1 diabetes (insulin-dependent or childhood-onset diabetes) is caused by a lack of insulin production, Type 2 diabetes (non-insulin-dependent or adult-onset diabetes) is caused by the body’s ineffective use of insulin. The only treatment available is through injection of synthetic insulin. Since, insulin is like oxygen to diabetics, it qualifies to be called a life-saving drug.
Lack of insulin is a major cause of cardiovascular diseases, amputation, kidney failure, nerve damage, also lowering the body’s immunity to fight back other syndromes, making the body vulnerable. It is also noted to be a leading cause of deaths, 2.2 million per year.
So, what is the Insulin Crisis?
The insulin crisis started a decade ago in America. The price of insulin has skyrocketed by 1200%. Interestingly, a vial of insulin by Novo Nordisk, sold in Canada costs around $35-40, whereas the exact same vial is sold for $350-400 in America, the diabetic capital of the world, precisely 10 times costlier. Resultantly, one in every four Americans admits to rationing their insulin dosages, because they can’t afford it. This is the typical aspect of insulin crisis – people die because insulin is simply out of access.
So, what is going on in the Pharmaceutical Economy?
The ‘big three’ insulin producers – Eli Lilly, Novo Nordisk and Sanofi – dominate more than 90% of the world insulin market by value. Often only one of these companies supplies insulin in a country, which means they hold a monopoly there i.e. they exclusively possess and control the supply and trade of insulin, implying can set prices as they wish. They enjoy collective pool all over the world, and coincidently as it seems, they increase their prices at about the same rate at the same time. Put simply, a diabetic consumer is left with no option but to purchase this life granting drug from these selected manufacturers, at exorbitantly venal price. What is it, if not exploitation?
Adjacently, a ‘Pay for delay’ agreement, i.e. a patent dispute settlement in which a generic manufacturer acknowledges the original patent of a pharmaceutical company and agrees to refrain from marketing its product for a specific period of time. In return, the company receives a payment from the patent-holder. This means it is actually legal for one insulin producer to pay another one not to enter the market. A few years ago the company Merck announced plans to sell a biosimilar version of Sanofi’s Lantus insulin. Sanofi Sued and eventually Merck announced that it was no longer pursuing its biosimilar, presumably due to payments from Sanofi to stay away. If Pay for delay schemes don’t work, the ‘big three’ can still sue other players, prolonging processes and pushing players out of the market because of legal fees and time-wasting. All of these are win-wins for companies, and lose-lose for patients, signifying a very clever and strong control of the insulin market.
Why aren’t we seeing more companies making Insulin?
There are many reasons for this, but patent evergreening is a big one. Patents give a person or organization a monopoly on a particular invention for a specific period of time. In the USA, it is generally 20 years. Humalog, Lantus and other previous generation insulins are now off patent, as are even older animal-based insulins. So, what’s going on? Pharmaceutical companies take advantage of loopholes in the patent system to build thickets of patents around their drugs which will make them last much longer (evergreening). This prevents competition and can keep prices high for decades. Sanofi, the maker of Lantus, is no exception. Sanofi has filed 74 patent applications on Lantus alone, which means Sanofi has created the potential for a competition-free monopoly for 37 years.
Also, companies are not in the habit of throwing money away, and they are not in the habit of staying out of politics. Eli Lilly, Novo Nordisk, and Sanofi collectively rake in several billions of dollars in profits. That’s not millions, but billions. We know they spend millions on marketing, but they also spend millions on lobbying politicians and donating to decision-makers so that they keep quiet about price gouging. How horrific it is to know that the government itself pillars this system of profiteering.
Business, in its purest definitions stands synonymous to profit generation. But as it seems here, the bacon is brought home at the cost of people’s lives. It is collusion. It is corruption. And it is greed. As a formal solution, the government of certain western powers provides compulsory insurance upto the age of 21 years. After that, the medical bills are bound to choke a patient. For the rest of the world, the government chooses to remain silent on grounds of any possible medical help, reimbursement or subsidized rates.
These are lives, not just numbers. Without major improvements in access, insulin will be beyond the reach of around half of the 79 million adults with diabetes who will need it in 2030, with African, Asian, and Oceania regions predicted to have the largest unmet insulin need if access remains at current levels. This is why independent patient voices are so important. The victimized group together has to mirror the greedy notion of the world insulin economy, and stand up against the malfeasance. Coming in terms with the brutal reality – insulin is what diabetics need to stay alive, and insulin is what they’re barred from, simply stealing their right to live a healthy life. This simply generates a degraded and huge question mark on the right to live, and to live well. The diabetic community still yearns for revolutionary changes in the economic graph manipulation by the manufacturers, with urgent need of regulation by government to allow them a fair chance of survival.