Safe HIV Drugs Should Not Require Financial Desperation -By Fransiscus Nanga Roka

A health insurance program that requires patients to use questionable sources of drugs, in order to contain costs, is confusing cost control with patient care. However, even if there was a major win for the drug industry to protect its supply chain, this alone will not solve the affordability issue that is causing patients to find such supply chains appealing.

On August 13, 2026, the U.S. Court of Appeals for the Fourth Circuit affirmed a preliminary injunction against Meritain Health, ProAct, Rx Valet, and other defendants, which prohibited them from importing or helping to facilitate importation of Gilead’s products that are sold outside of the United States. While this was a major temporary trademark decision, it was not a final order on every issue raised in the case, a patent decision, or a nationwide ban on all other types of funding programs.

An employer-sponsored plan allowed a Maryland patient to receive Turkish market Biktarvy, packaged with Turkish-language packaging and patient information. Most importantly, tests proved that the Gilead tablets were real. According to the court, the patient notified his doctor of the problem in February 2024, and filed a lawsuit in December. This matter is more than just counterfeit pills; it is about keeping track of the timeline of events.

The legal definition of “chemically identical” is important. A chemically identical drug may be different from each other in several ways such as labeling, and/or quality control protection. The court found that Gilead was likely to succeed in its claim under the Lanham Act which included a claim for contributory infringement against the intermediary. Even if a product was manufactured authentically, this does not mean it is authentic according to U.S. trademark law.

The reasoning behind this is worthy of consideration. There are several aspects to a prescription beyond the active ingredient (molecule). This includes clear warning labels, accurate dispensing practices and appropriate distribution of drugs. Patients do not need to research the global drug supply chain to determine how much of their health care costs will be covered by their insurance.

Precision is required in how corporations express themselves. There is no reason to believe that all medications sold in Turkey are either fake or substandard. Just because there may be some risk in the way that drugs are distributed does not mean that every shipment of drugs is contaminated, has been affected by extreme temperatures, or is clinically ineffective. Corporations should provide evidence when defending their protective measures rather than making vague allegations against other nations.

The wider indictment reaches both sides of America’s pharmaceutical economy.

Intermediaries should not use patients as tools for international price arbitrage. Similarly, manufacturers should not view successful trademark enforcement as evidence of the fairness of their domestic pricing. A judgment upholding a brand does not demonstrate that patients will be able to purchase the product at a reasonable cost.

The policy response must close both gaps.

Employers first need to assess each specialty drug contract they have in place. They must identify who provides the medication, where it is dispensed from (which pharmacy), what types of authorizations are required for use of the specialty drugs, and how the employer will guarantee that employees continue receiving these specialty drugs. Additionally, employers need to ensure that their contracts require disclosure of all intermediaries involved in obtaining the specialty drugs, as well as the compensation those intermediaries receive. If employers find that the process of obtaining specialty drugs is not being followed properly by the provider of the specialty drugs, the employer should take steps to correct the problem.

Second, the Labor Department and state regulatory agencies with authority over benefits will need to investigate if the design of a benefit shifts access burden to patients in an unacceptable manner. If they determine that such shifts occur, then those agencies will need to use their investigatory authority and relevant evidence to address those concerns. No matter how much of its administrative responsibilities a company contracts out, it can never abandon its oversight role.

Thirdly, the FDA and each state’s board of pharmacy should work together to enforce rules regarding product tracking (traceability), product labeling, and accountability for how products are dispensed. If a person wants to propose that they legally import products from outside the U.S., then that person needs to prove that their importing practices provide the same level of safety as what exists today; simply saying that the products will cost less is not enough.

Fourth, health insurance plans and Gilead need to develop an open and long-term arrangement for providing access to its products. Additionally, policy makers must consider the cost of pharmaceuticals, including those imported without authorization, with the same urgency as they do unauthorized imports.

Finally, each time an enforcement action occurs, a funded transition of care from treatment to maintenance should occur. Individuals receiving services from the state should receive adequate replacement supplies and ongoing care provided by a medical professional during the period that states are litigating.

Courts have the ability to block an illegal supply chain, however, they do not have the power to create a cheap prescription option for each individual who will be left without medication once the supply chain closes. The true success of this ruling is determined if patients are able to find safe and continuous access to affordable treatments after being blocked from receiving them via the illegal supply chain or if they find that the only way to obtain treatment is through the legal supply chain at a price that is prohibitively expensive.

Fransiscus Nanga Roka

Faculty of Law University 17 August 1945 Surabaya and Managing Partner Law Firm Victorious Indonesia