Nov 1, 2019

How 2020 Democrats plan to take on pharma — alone

Illustration: Eniola Odetunde/Axios

One of the Democratic presidential candidates' leading ideas to lower drug prices would come with intense legal battles and thus an uncertain fate.

Why it matters: Democrats' plans to seize drugmakers' patents could give patients some relief from high drug costs, if they work, but they'd be testing the boundaries of the law in order to get there.

What they're saying: Sens. Kamala Harris, Elizabeth Warren and Bernie Sanders have said they'd use "march-in rights" to take away the patents on expensive drugs. South Bend, Ind. Mayor Pete Buttigieg has also said he'd rely on similar tools.

How it works: "March-in rights" come from a decades-old, bipartisan law that allows the government to award a generic competitor the rights to make and sell a patented drug that was developed using public funding, in certain circumstances.

  • They've never been used before.
  • A second method, referred to as "Section 1498," applies to every patent regardless of funding. It's been used in the past, but not recently for prescription drugs.

Yes, but: There's a formal process to challenge individual uses of the authority, and it would also be vulnerable to challenges about whether it should exist at all in this context.

  • The biggest question regarding march-in rights is whether a drug's price can be used to trigger them.
  • "Some have argued that the law was not intended to be used for high-priced drugs, and that the law isn't available for use on high-price drugs, but that hasn't been tested in court," Washington University law professor Rachel Sachs said.
  • Section 1498 may be easier to use than march-in rights, Sachs said, but could still be challenged.

The other side: The use of march-in rights "will only jeopardize our country's ability to deliver new medicines to address our most costly and challenging diseases," said Tom Wilbur, a PhRMA spokesperson.

Go deeper

2020 Democrats' new drug pricing bill

Sens. Bernie Sanders and Cory Booker. Photo: Tom Williams/CQ Roll Call

Sens. Cory Booker, Bernie Sanders and Kamala Harris — who are all running for president in 2020 — are announcing legislation Friday that would create an independent agency to determine list prices of prescription drugs.

Why it matters: This is further mainstreaming of Democrats' leftward shift on drug prices.

Go deeperArrowNov 15, 2019

Federal lawsuit against Gilead puts patent rights on trial

Truvada generated $3 billion of sales in 2018. Photo: Justin Sullivan/Getty Images

The Trump administration's decision to sue Gilead Sciences — the maker of HIV prevention pills known as pre-exposure prophylaxis, or PrEP — pours gasoline on the debate about how patents and prices should work when important drugs are developed by both public institutions and private companies.

Yes, but: "None of this will address drug pricing more generally or the unique circumstances of the HIV drug market," Jen Kates, an HIV policy expert at the Kaiser Family Foundation, said in a thread on Twitter. "And ultimately, the stakes are quite high given that PrEP can save lives."

A drug pricing method that values the price of a life gets new attention

Illustration: Eniola Odetunde/Axios

A drug pricing model used by other countries but long opposed by drugmakers in the U.S. is getting new attention amid the political debate over drug prices, the Wall Street Journal reports.

How it works: The method, pushed by the Institute for Clinical and Economic Review, "puts a dollar figure on a year of healthy life, calculates how much health a drug restores to a sick patient, then prices drugs accordingly," per the Journal.

Go deeperArrowNov 5, 2019