In the mid 2010s, breakthrough medicines that promised to cure hepatitis C came onto the market. The catch was, the pharmaceutical company Gilead set the price of up to £70 000 for a 3-month course of treatment. No government would pay that much given the number of people with hepatitis C. In the UK alone, it was estimated that there were around 214,000 people with the disease in 2015, which would bring the cost of treating them all to about £15 billion. Concern about the pricing of these medicines led the US Senate to conduct an 18-month investigation into Gilead’s pricing strategy.
A concerned physician who treated people with hepatitis C brought this entire episode to my attention. He told me about the FixHepC buyer club set up by the Australian doctor James Freeman that sourced generic copies from abroad at a discount of up to 99%. The medicines seemed to work just as well as the brand name products, however, they were not approved by the Australian regulator – the Therapeutic Goods Administration or TGA. When the Australian government finally struck a deal to subsidize hepatitis C medicines the TGA issued a letter to the FixHepC buyer club warning that they were illegally promoting a medicine. The FixHepC buyer club subsequently moved offshore and continued operating as usual.
This situation highlights an important question. When the primary barrier to accessing a medicine is cost, what responsibilities do doctors have to help patients source a more affordable product? Most new medicines entering the market are high-cost specialty medicines. By high-cost I mean medicines that can cost tens to hundreds of thousands for a course of treatment. This suggests that the latest treatments will be out of reach for all but the wealthiest unless the government steps in to subsidize them, or buyer clubs step in to bridge this access gap.
There are laws that set limits around personal importation. However, if governments fail to address the legitimate healthcare needs of their citizens, it seems somewhat unfair if they then prosecute patients who attempt to service their own needs. For instance, in Australia doctors can get an exemption to use unapproved medicines, but only for clinical reasons. If the reason is because patients can’t afford the medication, doctors cannot get an exemption, and patients are left to their own devices. They must import the medicine themselves.
Since doctors are the only profession that has a duty to put the patient’s interest first, surely this should include a duty to help patients access the treatments they need? In fact, doctors do this already by lobbying for compassionate access to drugs, enrolling patients in trials, and prescribing drugs off-label when no on-label treatment is available or affordable. However, helping patients to access and the use entirely unapproved products that are imported from overseas introduces new legal risks. In this situation, doctors’ decisions may be motivated by fear of being prosecuted.
Can doctors argue that their job is purely clinical and issues of cost and access are beyond the scope of their professional practice? I say no, because income or rather lack of it, is a major social determinant of health. A large body of research shows that inability to afford medications is a major cause of not taking prescribed medications, with subsequent impact on health outcomes. Therefore, in my article I argue that doctors have a responsibility to help patients import medicines if the risk of not getting treatment at all outweighs the risks associated with importing them. I also believe that there needs to be clear guidance for doctors to remove any legal uncertainty and thereby empower them to help patients who find themselves in this difficult situation.
What I find fascinating about this entire scenario is the irony. On the one hand, a distorted free market ideology in health care has forced many patients into a miserable situation where their health depends on the amount of money they have in their pockets. On the other hand, this same ideology has driven patients and their advocates to find creative solutions to the access problem and thereby potentially undermine the institutional structures that price them out of the market. The FixHepC buyer club and Cystic fibrosis buyer club are good examples of such initiatives. They have set a precedent for how manufacturing and supply chains can be disrupted to serve the patient interest. I predict that the unprecedented globalisation we enjoy in the 21st century will lead to a rise of such initiatives, challenging everything from intellectual property regimes, the authority of regulators, the power of pharmaceutical companies, and the nature of the patient-physician relationship.
Originally published in: https://blogs.bmj.com/medical-ethics/2022/03/17/should-doctors-help-patients-import-medicines/