Material Principles of Distributive Justice

All theories of justice include the formal principle of justice that equals should be treated equally, and unequals should be treated unequally. This principle is formal, since it neither offers criteria to decide whether individuals are considered equals nor instructs in which respects equals should be treated equally (Beauchamp and Childress 2019, 268). In contrast, material principles of justice “identify morally relevant properties that persons must possess to qualify for particular distributions” (Beauchamp and Childress 2019, 269). In the present empirical study, at least three theories of justice, each expressing a general material principle of distributive justice, emerged during the data analysis: egalitarianism, utilitarianism, and libertarianism. According to Beauchamp and Childress, the material principle of distributive justice for egalitarianism is: “To each person an equal measure of liberty and equal access to the goods in life that every rational person values” (Beauchamp and Childress 2019, 271); for utilitarianism, it is: “To each person according to rules and actions that maximize social utility” (Beauchamp and Childress 2019, 271); while for libertarianism, it is: “To each person a maximum of liberty and property resulting from the exercise of liberty rights and participation in fair free-market exchanges” (Beauchamp and Childress 2019, 271). These material principles of distributive justice are essential in healthcare prioritization (Beauchamp and Childress 2019, 270–271), and all three principles emerged in the interviews during the data analysis.

The present study investigated the process of prioritizing access to expensive biological treatments in Denmark. The respondents generally focused on their perception of a fair allocation of expensive medicine to patients and fair medicine prices, but they also reflected upon abstract topics related to distributive justice, such as their perception of fair partitioning of the total national social budget and fair allocation within the target healthcare budget. In short, the four themes related to distributive justice that emerged during the data analysis were: 1) partitioning the total national social budget, 2) allocation within the target healthcare budget, 3) allocation of scarce treatments for patients (Beauchamp and Childress 2019, 300–301), and 4) the capitalist market economy and medicine prices. The data analysis below presents these four themes related to distributive justice.

Theme 1: Partitioning the Total National Social Budget

Governments establish total national social budgets containing allocations for social goods such as healthcare, education, culture, and defence. Since resources are not limitless, expenses for healthcare compete with expenses for other social goods (Beauchamp and Childress 2019, 300). The respondents in the present study agreed that expenditure for medicine in Danish hospitals could not be considered isolated from partitioning the total national social budget. The Researcher stated that socio-economic implications of expensive medicine have to be considered but added that patients might have another opinion: “… I think we focus too little on socio-economic considerations in that discussion. And I say this, because I am not sick. If I was sick, I would have a different opinion” (Researcher).

From the perspective of the national social budget, the Patient found it fair that major groups of patients suffering from common diseases are prioritized and allocated more resources than minor groups of patients suffering from rare diseases.

Since resources are not limitless, the Politician argued that prioritization is essential, and medicine should be given appropriately. The Politician also specifically said that the number of chronically ill patients will increase in Denmark in the coming years in an aging population, so that expenses for healthcare will increase correspondingly.

Theme 2: Allocation Within the Target Healthcare Budget

When the government has allocated money for segments such as healthcare, education, and so on, it must then allocate resources within each segment. In the segment of healthcare, politicians decide which diseases should be given the highest priority in terms of resources allocated (Beauchamp and Childress 2019, 301).

Policymakers will examine various diseases in terms of their communicability, frequency, cost, associated pain and suffering, and impact on length of life and quality of life, among other factors. Under some circumstances, for example, it might be justified, as a matter of priority ranking, to concentrate less on fatal diseases, such as some forms of cancer, and more on widespread disabling diseases, such as arthritis. (Beauchamp and Childress 2019, 301)

This is in line with the statement by the Researcher, who expressed the utilitarian view that more resources should be allocated to treatment and research into chronic diseases than to diseases with a low expected survival rate. The Researcher argued that cancer-related research receives a priority ranking regarding external funding compared to research into rheumatoid arthritis, which is not a fatal disease (table 3).

Table 3. Allocation within the target health care budget (Theme 2). Theories of justice as expressed by the respondents (in italics)Cancer Patients Receive High Priority Ranking Versus Equal Access

The Patient expressed two different opinions regarding prioritization depending on the perspective from which prioritization was considered. From the perspective of theme 1 (partitioning the total national social budget), the Patient found it fair that major groups of patients suffering from common diseases are prioritized and allocated more resources than minor groups of patients suffering from rare diseases. From the perspective of theme 2 (allocation within the target healthcare budget), the Patient agreed that cancer patients receive the highest priority ranking regarding allocation of resources in the Danish healthcare system. However, the Patient maintained the egalitarian view by emphasizing that from the patient’s perspective, it is not fair that minor groups of patients suffering from rare diseases receive low priority ranking regarding medical examinations and treatments compared to the major group of cancer patients. The Patient stated that patients suffering from rare diseases should be given higher priority than they currently have. The Politician also maintained the egalitarian view by emphasizing that politicians should ensure patients suffering from rare diseases are prioritized regarding the allocation of resources for research and implementation.

The Patient said that there is a lack of human resources in neurological departments in Danish hospitals. The MS Association Representative agreed and added that the disease course in patients suffering from MS entails that medical treatment is not possible in some cases. Often, these patients are left without contact with neurologists. The MS Association Representative expressed the MS Association’s egalitarian view promoting access for the minor group of MS patients to medicine, care, support, and so on. The Physician Involved in Drug Regulation agreed that patients suffering from cancer and cancer-related research receive a high priority ranking regarding resource allocation in the Danish healthcare system and expressed the egalitarian view by emphasizing that such inequalities are problematic. The DMC Representative also adhered to the egalitarian material principle of distributive justice: equal access to healthcare is an essential ethical principle, and uniform treatments and equal access to treatments across the Regions of Denmark might be possible using the guidelines from the DMC (text box 1, table 2). The Researcher agreed and expressed the egalitarian view by stating that, compared to the American healthcare system (which approximates a libertarian commitment), the Danish healthcare system is fair. The Danish system ensures the best treatment for the largest possible number of patients paid by taxes. The Researcher was willing to pay more in taxes to avoid reductions in healthcare financed by the government:

Generally, I think that the Danish healthcare system is the right way to go compared to the American system. I think it is good that we, as a society, ensure that as many patients as possible can get the best treatment. I am willing to pay more in tax to avoid reductions in healthcare financed by the government. Self-financed healthcare entails that there will be groups in society that simply cannot afford it. (Researcher)

The Treating Physician also maintained the egalitarian view by stating that patients should have access to the best evidence-based treatments regardless of medicine prices. In contrast, the Pharmaceutical Industry Representative supported a utilitarian view by saying that it is essential to get as much benefit as possible from the money available in healthcare. In healthcare economics, cost-benefit analysis is commonly used to compare cost-benefit ratios in different areas of healthcare by using QALYs. However, the Pharmaceutical Industry Representative said that the Danish government (which approximates an egalitarian commitment) does not want to use the method of cost-benefit analysis by using QALYs, because this entails a value placed on human life:

… that is the whole way of thinking also with this health economic approach to it, it is of course … utilitarianism, as you point out, that we … it is about getting as much benefit as possible …. (Pharmaceutical Industry Representative)

According to the Politician, prioritization in the Danish healthcare system is based on health professional assessment combined with financial assessment. The Politician stood up for the egalitarian view by strongly opposing basing prioritization in healthcare solely on cost-benefit analyses and in this way excluding treatments that are not cost-effective (table 3):

… there is no way to make it cheaper. There are ways to discuss whether you can finance it differently, and there are financial ways in which you can slice some off and say, it was a pity they could not afford it. That is how you keep costs down by slicing some off. We do not do that in Denmark. So, the expenditure on health, i.e., real growth, must necessarily increase in the coming years. (Politician)

Theme 3: Allocation of Scarce Treatments for Patients

Beauchamp and Childress write: “Because health needs and desires are virtually limitless, every healthcare system faces some form of scarcity, and not everyone in need of a particular form of healthcare can gain adequate access to it” (Beauchamp and Childress 2019, 301), so politicians must set priorities. Setting priorities in healthcare includes allocating medical resources to specific classes of patients (Beauchamp and Childress 2019, 301). In Denmark, the DMC decides which patient groups should have free and equal access to every standard medicine.

Priority Setting Influenced by Size of Patient Group, Alternative Treatment Options, and Severity of Disease

The Patient expressed the egalitarian view by stating that patients suffering from rare and not self-inflicted diseases should receive a high priority ranking regarding access to medicine, even though the expense for medicine per patient suffering from rare diseases is relatively high. The Politician also held the egalitarian view. He emphasized that the DMC prepares assessments according to principles stating that patients suffering from rare diseases should be given as high priority as patients suffering from common diseases such as cancer. The MS Association Representative argued the egalitarian view by stressing that in assessments of whether new expensive medicine should be recommended as standard treatment, consideration should be given to whether the patient target group has alternative treatment options. If not, the new medicine should receive high priority despite its price. The Politician agreed, adhering to the egalitarian principle of distributive justice. It is fair to pay a high price for medicine for a group of patients that previously did not have treatment options:

… if it is effective enough, and it really makes a difference. For instance, that you can help someone that you could not help before, and you can help them in a way that makes a difference. Well, then we are willing to pay a high price … there must be scientific evidence that it has a real good effect. (Politician)

The DMC Representative stated that the assessments by the Council adhere to the principle of severity, noting that serious diseases receive high priority ranking (table 4).

Table 4. Allocation of scarce treatments for patients (Theme 3). Theories of justice as expressed by the respondents (in italics).Access to the Best Evidence-Based Medicine

The DMC Representative maintained the utilitarian view by emphasizing that the Council prepares cost-effectiveness and cost-benefit analyses of new medicines to be recommended (or not) as standard treatment in Danish hospitals. There are methodological requirements for documentation of the effect of medicines in the assessment process. According to the DMC Representative, if the Council’s guidelines are rightly implemented in Danish hospitals, there is room for assessment by the individual physician. This agrees with the statement by the Politician that in particular individual cases, health professional assessments can be made that other medication than the standard therapy should be given. However, the Treating Physician strongly disagreed that these guidelines leave room to deviate from the standard treatment, stating that the guidelines restrict, rather than just guide, physicians. Physicians are forced to follow the guidelines because failure to adhere to them has financial consequences for the hospital department:

Guideline means that it guides you, without being obligatory. But it is a slightly different situation here, because if we have a guideline, they expect that you really should follow the guideline, and this is mainly for economic reasons. For example, in the MS field, when they introduced the two latest oral treatments, it was teriflunomide, which is Aubagio, and dimethyl fumarate, which is Tecfidera. Then the guidelines suggested that in Denmark about 70 per cent of the patients, who are newly diagnosed and start the treatment should be treated with Aubagio. And this was partly based on economic reasons, and our hospital here enforced this very much for economic reasons. Because Aubagio is cheaper than Tecfidera, so we were really forced to use Aubagio … This immediately limits your choice and your precision medicine. And then it is not a guideline, it is literally not a guideline … if you must follow it. (Treating Physician)

The Treating Physician and the Physician Involved in Drug Regulation maintained the egalitarian view that patients should have equal access to the best evidence-based medicine irrespective of the price. The Physician Involved in Drug Regulation added that patients should be confident that the healthcare system offers the best treatment available:

I am a medical doctor; I do not consider economics. Maybe it is wrong, but I don’t think it is my task to consider that. I would be happy if I was free to give patients the optimal treatment … we are already controlled … Because obviously, my aim is that I would like to be free … to treat the patients according to the best evidence and according to the patient’s needs. (Treating Physician)

The MS Association Representative also maintained the egalitarian view that patients should have equal access to the best medicine available and added that fair medicine prices should be negotiated. The DMC Representative emphasized that the issue for the Council is not whether patients should be treated or not treated. The point is instead to negotiate favourable medicine prices. This agrees with the Physician Involved in Drug Regulation, who stressed that the authorities do not reject effective medicine as standard treatment because it is too expensive. A budget is set for medicine consumption in Danish hospitals. If this budget is exceeded, more resources are allocated, that is, precisely the resources needed for medicine are allocated. However, according to the Politician, expensive medicine which is only marginally more effective than the standard therapy is not implemented. This agrees with the statement by the Researcher that, previously, patients had access to the best treatment available regardless of price (which approximates to an egalitarian commitment), whereas nowadays the effect of the medicine is evaluated using its cost (which approximates to a utilitarian commitment) (table 4).

Cost-Effectiveness and Cost-Benefit Analyses Combined with a More Holistic Perspective

The MS Association Representative and the Patient believed that the DMC should take a holistic perspective when deciding whether new medicine should be accepted as standard treatment in Danish hospitals. Cost-effectiveness and cost-benefit analyses should compare new medicine to the standard therapy and include a more holistic consideration at the societal level:

We should consider what the expenditures would be, if the medicine was not available, not so much what it would cost the individual hospital or the individual region, but more broadly what the socio-economic costs would be, if an individual did not receive the medicine. In relation to the fact that the person in question might be able to work, there might be lost hours at work, there might be more sick days, there might be all sorts of expenses for aids, which the person in question would not need either … you have to consider more broadly what you get for the money. (MS Association Representative)

The Politician agreed that broader perspectives should be included in cost-effectiveness and cost-benefit analyses, contribution to the labour market, and so on. The MS Association Representative thought it essential to include patient perspectives and needs and, most importantly, the life quality of the individual patient when deciding whether new medicine should be implemented as standard treatment in Danish hospitals but argued that it is difficult to quantify the quality of life, so it is problematic to use QALYs to value human life. The Drug Industry Representative emphasized that health economists and patients have different perspectives. Health economists maintain a utilitarian approach focusing on cost-benefit analyses and QALYs, while patients emphasize that these analyses should be supplemented with reflections regarding life quality for the individual patient. According to the Politician, the DMC was established without using QALYs and that the use of QALYs meant healthcare prioritization would be based on financial assessments only. The Politician emphasized that healthcare prioritization should be based on health professional assessment combined with financial review (table 4).

Theme 4: The Capitalist Market Economy and Medicine Prices

In the present study, the respondents generally acknowledged that prices for medicine are high because of high costs for pharmaceutical companies for research, development, trials, etc., but they also believed that medicine prices tend to increase rapidly and that it is fair that Danish authorities should regulate medicine prices to a reasonable level. The DMC Representative specifically pointed out that while expenditures for medicine are high and increasing, departments in Danish hospitals lack resources for nurses and care in general, so it is important to both prioritize and negotiate favourable medicine prices. According to the Pharmaceutical Industry Representative, Denmark is unique in having price negotiations and agreements that set fixed upper prices for medicine:

Considered worldwide, it is unique that we have these price agreements in Denmark. This is our contribution to the expenses not running wild. Prices are rising, they may well rise … for instance, we see prices for hospital medicines are rising. With the price cap, however, we ensure that the pharmaceutical industry does not raise prices, so that only the volumes of medicine increase because a larger number of patients are treated. (Pharmaceutical Industry Representative)

However, the Physician Involved in Drug Regulation emphasized that when authorities push down medicine prices, there is a risk that pharmaceutical companies will not want to enter the Danish market. For instance, this is the case in Norway, where some medicines are unavailable for Norwegian patients:

The Medicines Council has just said no to Spinraza. And then we can ask, well, is the company interested in doing something regarding the price? This is the first time someone is trying to push down prices in this country. If enough countries say no, then it will probably change … However, there is a … we have seen in Norway, where they have said no for a long time. There are drugs that do not enter Norway … that the Norwegians simply do not get. These drugs do not enter the market in Norway, because they say no. So, obviously, this is a risk. (Physician Involved in Drug Regulation).

According to the Treating Physician, negotiating medicine prices is complicated, because multiple interests are involved: pharmaceutical companies demand profit, and society wants medicine available for patients. According to the Politician, when the patent period of a drug expires, it means free-market competition. When the patent period for an original drug has expired, biosimilars enter the market, leading to meagre prices for medicine. The Politician stated that this shows that the pharmaceutical industry is lucrative. According to the Researcher, since biosimilars undergo reduced clinical trials, the biosimilar price is lower than the original product price. Reduced clinical trials enrol fewer subjects and aim only to test the toxicity, not the drug’s effect, so the price of a biosimilar is approximately half of the original product price. However, the Treating Physician cautioned against prescribing biosimilars, because one does not know whether the biosimilar is similar to the original product because of the reduced clinical trials.