Shefali Luthra, Kaiser Health News and Victoria Knight
On the presidential major marketing campaign path in Iowa, Sen. Elizabeth Warren (D-Mass.) introduced out a favourite speaking level: methods the president can deliver down drug costs with out ready for Congress.
It’s not the primary time Warren and different candidates have referenced this alleged energy. In this case, she pointed to insulin, EpiPens and HIV/AIDS medication as attainable targets.
We requested the Warren marketing campaign for the idea of her declare they usually directed us to her “Medicare for All” transition plan. It identifies two authorized mechanisms ― “compulsory licensing” as outlined in 28 U.S. Code Section 1498 and the so-called march-in rights provision of the 1980 Bayh-Dole Act.
We spoke to authorized and pharmaceutical coverage consultants about whether or not these mechanisms may very well be used to deliver down drug costs, as Warren described. The reply? Yes. But it’s sophisticated and controversial.
The Legal Mechanisms
Of the 2 authorized levers, Section 1498 is probably extra easy.
The regulation says the federal government can intervene to take over patents with out a firm’s permission if the worth is just too excessive. The authorities can then create competitors to deliver down costs by importing these merchandise from overseas or manufacturing them. The unique producer can sue for damages however can not cease Washington from breaking the patent.
“What they would do is announce they are taking other bids from other companies to supply the product” to authorities packages reminiscent of Medicare, mentioned Aaron Kesselheim, a professor of medication at Harvard Medical School, who researches drug pricing legal guidelines and has written extensively about Section 1498.
The provision has been used earlier than ― within the 1960s to obtain low-cost generic medication ― and was invoked as lately as 2001 as a menace to get a greater value on Ciprofloxacin, a high-powered antibiotic used to deal with anthrax. It additionally was utilized in 2014 in non-pharmaceutical contexts, reminiscent of by the Defense Department to accumulate lead-free bullets.
Invoking this a part of the U.S. code wouldn’t essentially apply to all medication, mentioned Jacob Sherkow, a professor at New York Law School. But merchandise reminiscent of those Warren talked about ― insulin and EpiPens, as an illustration, that are patented within the United States and overseas and value far much less in different nations ― would qualify. And that would ship a message to different drug producers.
“If you’re a particularly aggressive president, you can find some low-hanging fruit, and use 1498 to show other pharmaceutical companies you’re damn serious,” Sherkow mentioned.
There are different caveats. Sherkow famous that licensing a competing drug is simply a part of the equation; competitors typically brings down drug costs, however not at all times. In addition, not all medication have equal patents right here and overseas, which complicates importation. But lots of the technical obstacles are surmountable, argued Amy Kapczynski, a professor at Yale Law School.
The march-in rights authority is a bit of trickier. Bayh-Dole, the regulation that created march-in rights, suggests the federal government can “march in” when a drug isn’t obtainable amid considerations over public well being, reminiscent of an epidemic. It applies solely to prescription drugs for which the federal government holds all of the patents as a result of it funded the analysis that led to their growth. An instance may very well be Truvada for PrEP, the HIV prevention capsule, Kesselheim mentioned.
Unlike Section 1498, march-in rights have by no means been used to barter a cheaper price ― regardless of a number of petitions to the National Institutes of Health, the federal company that will approve and oversee the method.
The query is whether or not excessive costs can represent each a barrier and a public well being concern having rendered a drug unavailable. Sherkow, for one, expressed skepticism.
NIH has traditionally opted towards making this willpower. For one, its administrators have sometimes argued that value isn’t inside their space of experience. And, for an additional, they’ve prompt that “marching in” would discourage pharmaceutical corporations from utilizing government-funded analysis ― finally resulting in fewer breakthrough medication being developed.
“That is a matter of culture, and I think a president could alter that perspective,” Kesselheim mentioned.
Doing so, although, would require political capital. Even although Congress isn’t required to vote on the matter, the president must, as an illustration, appoint officers keen to vary the NIH perspective ― and people leaders do require Senate affirmation. “You’d probably have to defend it in court,” Kesselheim added.
Finally, these mechanisms would additionally draw sharp pushback from the pharmaceutical business. Given the fervor over the drug pricing debate, neither Section 1498 nor march-in rights needs to be used ubiquitously, Kesselheim mentioned.
“It is a complicated enough and politically charged enough procedure, that it’s something that should be reserved as a safety net for real public health emergencies,” he mentioned. “I think Sen. Warren is identifying some of those cases.”
They’re All Talking About It
Warren’s proposals are half of a bigger sample: Democratic presidential candidates, together with Vermont Sen. Bernie Sanders and former South Bend, Indiana, Mayor Pete Buttigieg, have talked about methods to deliver down drug costs with out congressional motion.
Minnesota Sen. Amy Klobuchar additionally referenced such motion through the January presidential major debate.
“I have a plan of 137 things I found that a president can do herself in the first 100 days without Congress that are legal. And one of those things is that you can start bringing in less expensive drugs from other parties,” she mentioned.
According to Klobuchar’s marketing campaign, she was referring to a list she revealed on Medium in June by which she wrote that she would use “existing Food and Drug Administration authority to grant a waiver that allows people to import safe prescription drugs for personal use from countries like Canada to decrease drug costs for seniors and all Americans.”
Sherkow mentioned that is certainly one other instance. Section 804 of the Federal Food, Drug and Cosmetic Act authorizes the HHS secretary to order the importation of particular medication if it might impose no extra threat to the general public’s well being and security and would lead to a major value discount. But this instance additionally highlights the complexities concerned and why it’s not essentially quick or straightforward.
He identified that the president must nominate a candidate for secretary, get that individual confirmed, then have the secretary make this order in respect to particular medication, certify that the medication are secure and would lead to value discount ― then have the importation happen.
”Kudos to anybody for making an attempt that within the first 100 days,” Sherkow mentioned.
Our Ruling
Warren mentioned, “The president of the United States already has the legal authority to reduce the price of many commonly used prescription drugs.” Multiple presidential candidates have talked about methods to deliver down drug costs with out new laws.
We targeted on Warren’s argument: that the president already has this authorized authority for a lot of medication, and that the facility stems from Section 1498 and the march-in rights provision of a 1980 regulation. On these factors, she is on agency floor.
Legal consultants agreed that legal guidelines on the books do, in some circumstances, give the president that government energy ― and the circumstances Warren outlined are viable candidates, particularly for “compulsory licensing.” The identical consultants additionally identified that even with this authority, the politics and logistics may very well be difficult, and that utilizing these mechanisms wouldn’t handle your entire drug pricing challenge.
We charge this assertion True.
Kaiser Health News (KHN) is a nationwide well being coverage information service. It is an editorially unbiased program of the Henry J. Kaiser Family Foundation which isn’t affiliated with Kaiser Permanente.