 Diabetes is a chronic disease and requires attention throughout the life of the patient. Type 1 diabetes mainly affects children, adolescents and young adults. Insulin is a must for their survival. Type 2 diabetes develops at a later stage and nearly 10% of the patients are dependent on insulin. However, even after 100 years of discovery, insulin remains out of reach for half the people requiring it. Patients in low and middle income countries are worst affected. We've had this as a drug for over 100 years but still less than half of people who need insulin globally have access and that of course is worse in low resource settings. And this is for a range of reasons but a cost is certainly in there with very few governments being able to provide insulin within the public sector in any kind of reliable way. But also the complexity of using insulin, both in terms of our healthcare workers' knowledge on the ground of how to prescribe it, how to monitor it, but also the investment that we've made as a global community to provide people with living with diabetes, the tools but also the most important kind of education they need to be able to self-manage their disease. So it is complex but we've had this drug for 100 years so really why aren't we doing better? We generally associate diabetes with obesity and lifestyle problems but the context of low and middle income countries makes things worse. For example, lean diabetes which occurs amongst the poor and malnourished people. We know that in rural India or rural India, I'm talking about rural central India first the marginalised part of India. Almost 40% of all the adult diabetes, the typical type 2 diabetes are a different form of diabetes than the one that we see in cities and we would like to call that a diabetes of the poor which also otherwise would be called as lean diabetes. People who are under nourished and are diabetic. So as I would say that 70% of people in the areas that we work in in central India have diabetes which is associated with normal or under nutrition situation as opposed to in US where 95% of people who have diabetes are obese. So and these type of these diabetes that we see among the poor not only pose a problem in their diet control but also the fact that 50% of them require insulin very early in their disease progress. So therefore the challenge to provide insulin for people who are type 1 diabetes and those with type 2 or lean diabetes who require insulin are large and one of the largest problems is the fact that these are injections that have to be given and they have to be given at least twice daily if not three or four times daily which poses a problem in terms of first teaching people and monitoring their diabetes that is a challenge that it throws up otherwise you cannot use a drug which can otherwise cause more problems than diabetes itself which is that it can cause low sugar and then you can die because of that. So that poses the challenges to the system of you know having trained people to teach how to use insulin how to monitor use of diabetes insulin and the second problem is of the fact that it is a drug which is thermo labile. So it is temperature sensitive. So ideally the temperature should be at less than eight degrees Celsius for insulin that the skept but it can survive to some extent if it is below 25 degrees Celsius that is a temperature which is not easily possible among the summer months in India and I would set some at almost six months in a year the day temperatures would often go beyond 25 in most places in India. So therefore one of the most important technologies that can help insulin survive and people who require insulin thrive is refrigeration which can which is not easy because it requires power the usual public health systems are not they don't respect noncommunicable diseases of which diabetes is one and if at all they start paying it any attention they are focusing on type two diabetes the type which does not require insulin and those children who require in all the type one diabetes who require insulin and the ones who are type two diabetes and require insulin are not under the radar of public health systems and they often die of premature death so it would not be it would be the commonest many commonest scenario that people with type one diabetes children would die by the age of 20 or 15 because of under current intercurrent infections and they may not be labeled as even as diabetes no one diagnosis no one treats them so these are the so called the hidden deaths that we see in our public health system because of complete neglect of you know problems which require some amount of challenges technological advances like a refrigerator or a drug like insulin so insulin is also not a cheap drug that is another problem I would say insulin is a drug which the cheapest insulin that I know cost for about over 100 rupees for 400 units and you require insulin syringes which are not so cheap also again but 400 units would cost over 100 rupees that means cost of so you know you only get only four units of insulin per rupee of you know per rupee and often people require I think the expenses that people make on only insulin for a one month's treatment is over a thousand rupees per month inaccessibility to insulin is not limited to low and middle income countries the business practices of big pharmaceutical companies are making even the US citizens run for their lives literally but what the companies have done is they have filed for various patents on the devices the pens the injector pens and that is what has actually blocked a lot of biosimilar competition so for example if we look at what's happened in the United States which is what I'm more familiar with because of the work that we've done here it's the pen devices have been used in litigation and they've actually delayed biosimilary I think only recently my land broke through that barrier after various years of litigation they challenged some formulation patents which Lantus was holding and then they challenged advice patents and so you know one other thing that's worth noting is in the United States as a the regulatory system the FDA only approves a product once you clear the patent hurdle it's called the linkage of patents and regulatory approval and what what companies were doing the three main companies were actually listing on the orange book which is a book that lists the patents related to the product that the FDA has approved the originated product they were listing device patterns in order to stall biosimilar entry and this was a gray area there wasn't any real sort of practice of guidelines as to whether these patterns should be listed or not so they found a loophole a bit of the ambiguity and they played on it and so that has actually been one of the reasons why we haven't seen biosimilar entries being caught up in litigation even companies that have litigated a settled Merc actually was going to come up with his own biosimilar products he was sued by Lantus and eventually they settled and they didn't come to market so we still technically have three companies that are actually a sort of an oligopoly in the United States and actually globally you know you think about that these three companies Novo Nordisk, Sanofi and Eli Lilly represent sort of 90% of the global market and if you think that only I think the figure is is like US companies only 50% of the global insulin market but yet they they account for 50% of the revenue so the US is really in a dire situation when you compare it to other OECD countries and elsewhere because we've heard stories where people are crossing borders in the United States to get insulin they're rationing their insulin and people have died as a result so this is this is the situation so I think it's actually a mixture of patterns it's a mixture of very poor anti-trust laws, anti-competition laws to kind of break these kind of cartels and the ability for these companies because they have so much power to shadow price you know usually you think in a healthy competitive market you have three players they'll bring the prices down of each other in fact they've gone lockstep up in terms of shadow pricing you know and and that is actually what's played out and then there's a big there's a big inquiry going on here in the United States that's why this is happening but yet we have not seen any real solutions if we take the US public spending programs which we call Medicare so this is this is for whether the US government actually spends for people who are entitled because you know they're either elderly or they're they don't have the means to receive their dedication and we think about how much that's being spent like for example I mean these are some figures that I've got here like Lantus which is the Novus product this Medicare alone spends 27 billion on the product Novalog which is normal Nordisk some 17 billion was spent on that Humalog which is Eli Lilly that's a 12 billion so we know we're talking a significant dollars and and and so you know the companies are saying well you know the list prices are not what the payers are paying there's a discount and so forth but that really still is not making a big enough debt in the profit margins and the amounts that people are having to pay or public payers are having to pay in terms of anecdotes I mean the stories are the patients we spoke to and I alluded to those in my last slightly longer answer was the people are traveling to Mexico to get their entity stories we spoke to there's a story here which where I think it was a mother's son was literally couldn't afford to buy his incident so he was rationing it and as a result of rationing he died and this is a common story that you know if you just spend time on people we've been in touch with in the US the stories you hear of people the price tax that are put on like some two thousand three thousand dollars to get their insulin for a month and it's quite shocking that we in the richest country in the world you have people who are rationing their sort of life-saving medication that they it's there's not like it's not it's not a choice this is something that they have to take and and and the fact that that people have to say well I can't afford it I'm gonna I'm gonna use whatever vial I have and use it into not in it's not the way I should be using it into injecting it into myself and it's in its full form I'm gonna save a little bit so that I've got enough because I can't afford to buy the next one I think I think it just shows the the severe drug pricing problem that the United States is facing and and as a result of the the intellectual property laws the patent system you know many people talk about well how is it that three companies are controlling the market and patents really are an issue I think they are an issue they still perform part of an issue at least in the United States and and that's because the system allows it in the in the name of innovation and I think the the one thing I've learned as I'm not it I'm not it I'm not a US from the US I'm from England I grew up in a national healthcare system what have you but I think the United States has what I don't call it a healthcare system I call it an economic system all the incentives appointed to driving economics and I think until the United States can realize that another country is realizing that this is not a good model that we we're going to continue to have this problem because of the large influence that the companies have and they pressure the United States government and Western country governments that these are the models that they think are best for the for patients but only enhance the private market of private power the issue of lack of access to insulin has become so serious that governments realize they had to intervene in some manner thus in this year's world health assembly they passed a resolution on insulin to address some of these issues but we will need to wait and see if they are committed to change the ground reality and this year at the wealth health and health assembly member states governments endorsed a resolution on diabetes and we really welcome several key points in that resolution one of which was around developing web based tool so that we get some transparency around these insulin prices and for member states to be able to kind of benchmark the prices when doing tenders so this we feel is a really positive step forward but it needs to be implemented it needs to be utilized by the member states that have endorsed this resolution a second really important point in the resolution was linked to the ability for companies generic companies that make insulin to enter the market currently they face really complex regulatory processes to get their products approved and so we hope that the through the resolution that WHO can really start to work with some of the generic producers of insulin to help bring their products to market and increase competition by doing this we hope that this will drive prices down the other really important point we see and we see this in our projects we see people not only rationing insulin but we see people rationing the tools they need to inject insulin and the tools they need to monitor insulin so that's needles and syringes that's glucose strips to monitor the blood sugar blood sugars throughout the resolution it talks about not just the drug but it talks about diagnostics and it talks about health technologies to monitor so it's really important that we work as a global community to make sure that a bundle of tools that is needed to use insulin is budgeted for forecast for and procured because insulin alone it really is not enough we need to make sure people living in diabetes have the tools to inject insulin and monitor it's used so that it's used safely