Diabetes and the Insulin Crisis
The International Diabetes Federation reports that in 2019 approximately 463 million adults worldwide were living with, and 4.2 million deaths were caused by, diabetes.
Diabetes has no cure. It is a disease where the body is unable to properly regulate its blood glucose levels because of an inability to produce (type 1), or deficiency in producing and using (type 2), the hormone which allows the body to absorbglucose, insulin. For both types of diabetes, the only treatment is by the manual injection of insulin, when and measured as needed, in order to keep one’s blood glucose levels within a safe range. If insufficient insulin is administered, the body enters a state of diabetic ketoacidosis, which, if left untreated, is fatal. People with type 1 diabetes need insulin every day in order to stay alive.
There is, at present, a crisis in access to insulin. Earlier this year, news outlets reported the death of a young man living in the United States (“US”) by the name of Jesimya David Scherer-Radcliff. Mr Scherer-Radcliff had diabetes. He died because he could not afford enough insulin and, consequently, had to ration his supply. This is but one of an increasing number of cases where people, unable to afford increasingly prohibitively priced insulin, are forced to dangerously risk rationing that insulin against medical advice, causing their tragic death.
Insulin in the US is too expensive. The problem lies in access, not supply. In 1996, one vial of insulin cost around $25. Now, one vial can cost around $275 to $300 – a price increase of more than 1000%. In a country where the federal minimum wage is $7.25 an hour, insulin treatment can cost almost $3,000 a month for the uninsured. It is said that 1 in 4 people with diabetes in the US ration their insulin. This is why.
This short article proposes to begin to identify and explore the normative content of international law on the right to health, and how it might be operationalised to address the insulin crisis, which is most prevalently reported in the US, but is occurring around the world. The article focusses upon an analysis of the right to health enshrined in art 12 of the International Covenant on Economic, Social and Cultural Rights (“ICESCR”) and the Committee on Economic, Social and Cultural Rights’ (“CESCR”) interpretation of it in General Comment No. 14 (“GC14”) (but see also art 25.1 of the Universal Declaration of Human Rights). Former Special Rapporteur on the right to health, Professor Paul Hunt, has argued that article 12 has a critical role to play in realising the wider human right to health.
A Human Right: art 12 ICESCR
Article 12 of ICESCR enshrines erga omnes partes, in these terms, the right to health:
1. The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
2. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for:
a. The provision for the reduction of the still-birth rate and of infant mortality and for the healthy development of the child;
b. The improvement of all aspects of environmental and industrial hygiene;
c. The prevention, treatment and control of epidemic, endemic, occupational and other diseases;
d. The creation of conditions which would assure to all medical service and medical attention in the event of sickness.
The article is unambiguous. By its operation, the 170 State parties to ICESCR covenant to ensure the right of everyone to the “highest attainable standard” of health. The Optional Protocol to ICESCR, which allows individuals whose rights under ICESCR have been violated to present complaints at the international level,was opened for signature in 2009 and, to date, has 24 State parties. Article 12(2) sets out, non-exhaustively, steps to be taken to realise the right. In particular, article 12(2)(c) requires the treatment of disease, and article 12(2)(d) requires that conditions be created that assure medical service and attention for sick people.
In addition to ICESCR’s text,CESCR, the authoritative interpreter of the Covenant, has produced GC14, which provides valuable guidance as to the intended purpose, meaning and operation of article 12. Part I of GC14 interprets the normative content of article 12. Part II interprets States parties’ obligations under the article. When Part I is applied to Part II “a dynamic process is set in motion which facilitates identification of violations of the right to health”: GC14 . Three points bear emphasis.
First, article 12 includes the right to a health system which provides equality of opportunity for people to enjoy the highest attainable level of health. Such a health system comprises the facilities, goods, services and conditions necessary for the highest attainable level of health to be realised and extends to the provision of equal and timely access to “appropriate treatment of prevalent diseases”: GC14 -; .
Second, GC14 makes clear that an essential element of the right to health is the accessibility of those facilities, goods and services. Importantly, one dimension of accessibility is economic accessibility, that is, equity and affordability. Whether privately or publicly provided, poorer households must not be “disproportionately burdened” by the cost of healthcare: GC14 (b). In fact, States have a “special obligation” to provide those without sufficient means with necessary healthcare: GC14 (b); -; . Another relevant, interrelated, dimension of accessibility is non-discrimination in access to healthcare on grounds of, inter alia, social or other status. This is also reflected in article 2(2) of ICESCR.
Third, GC14 reiterates that the right to health, like all human rights, imposes three levels of obligations on States, being to respect, protect and fulfil the right. These, in essence, are obligations to refrain from obstructing, to prevent third parties from obstructing, and to adopt appropriate legislative, administrative and other measures as necessary to fulfil the right, respectively: GC14 ; see Estaiteyeh at p 5. It is the State’sobligation (cf. private entities) to ensure the right to health.
GC14 affirms and expands upon what is already apparent from the text of ICESCR itself. Article 12 requires making accessible and affordable the appropriate treatment for diseases; in this case, insulin for diabetes. Prohibitive pricing violates international law.
Progressive Realisation and Limitations
It might be said that, by articles 2 and 4 of ICESCR, the right to health, and the obligation to fulfil it, is not absolute. Article 2 qualifies and moderates article 12 by stating that State parties only undertake to take steps to the “maximum of [their] available resources” to “progressively realise” the rights within the Covenant. However, this qualification does not leave obligations without “meaningful content” – States must still use their maximum available resources and move as expeditiously and effectively as possible towards the full realisation of the rights within the Covenant. There is also a strong presumption against retrogressive measures: GC14 ; . This being so, it is difficult to understand how resourceful first world countries such as the US could ever, by the operation of article 2, excuse failing to make insulin accessible to people with diabetes.
Article 4 is the limitations device of ICESCR. It provides that the rights in the Covenant may be limited only by law, compatibly with the nature of the rights within the Covenant and for the exclusive purpose of promoting general welfare in a democratic society. GC14 elaborates that any such limitation must be necessary in the interest of a legitimate aim, and proportional to it; where a number of alternatives are available the least restrictive form of limitation must be adopted: GC14 ; . Again, it is difficult to conceive of a legitimate aim, or greater good, that could be served by dangerously limiting access to insulin.
Contrary to International Law: The United States
The simple answer is that, as long as people continue to suffer or die because they cannot afford enough insulin, whatever the actual price one pays for it, the conduct of the US will stand contrary to article 12. It should be said that the US has signed, but is yet to ratify, ICESCR. It is therefore not bound by it simpliciter. It has only an interim obligation to not defeat its object and purpose under article 18 of the Vienna Convention on the Law of Treaties. Of course, not being bound by a treaty does not mean that a State’s conduct is not contrary to the principles and ideals existing within it. Leaving aside the question of a customary international law right to health, a State’s conduct can still be analysed and held against the standard that a treaty creates and, therefore (in the case of one with 170 State parties), the morality of the international community, whether it is bound by that treaty or not. That analysis can then be applied to States that are bound by ICESCR. The insulin crisis is widely reported and best understood in the context of the US, so it is useful to use the US as a case study. It is also powerful because the US is a global superpower and a prosperous libertarian democracy and yet, there, the insulin crisis prevails.
The cause of the insulin crisis, in short, is a confluence of free market domination, insufficient government regulation, the complexity involved with emulating a biological product (cf. antiretrovirals and many other drugs) and patenting. Change will require compromise. The friction that attends the transmogrification of human rights into domestic legal systems has been described as one between “universal deontological principles” and “deeply contextuali[s]ed political realities”.
There are, however, some positive signs. A law called “Kevin’s Law”, named after a young man who died after he could not fill an expired insulin prescription, has been passed in Ohio and at least 17 other states. The law allows pharmacists to provide insulin without a prescription in emergency situations. Ohio lawmakers have also recently introduced a proposal to cap the cost of insulin at $100 per month. The Alec Smith Emergency Insulin Act was passed in Minnesota in April 2019 this year. The Act establishes a program to financially assist people who struggle to afford insulin by charging the large insulin companies a manufacturer’s fee. Such initiatives are encouraging but, without more, insufficient to address the crisis.
In 1923, the researchers who discovered insulin sold its patent for $1 each. They did this because they understood that insulin was a lifesaving drug that must be available to those who need it. Sadly, this noble, foundational ideal has not been realised.
This short article has sought to identify and explore the international law framework, specifically article 12 ICESCR, that might be brought to bear upon the insulin crisis. It should be appreciated, though, that the confluence of factors causing the insulincrisis, could arise vis-à-vis any lifesaving medication. This analysis therefore has wider application. The article establishes that the prohibitive pricing of insulin –causing the deaths of people with diabetes – is clearly, and perhaps unsurprisingly, contrary to international law and the right to health, as contained in article 12 of the ICESCR. Yet, the insulin crisis, with its tragic consequences, is unacceptably ongoing in some of the most developed parts of the world.
Benjamin Teng (BCom/LLB, Hons. I) is a Judge’s Associate.