from the drug-prices-are-a-patent-problem dept
As Democrats struggle to bring together 50 votes to pass the Build Back Better Act, a major sticking point with the legislation has emerged. That is, whether it should include provisions changing the law to allow Medicare to negotiate drug prices, with caps on payments set based on prices paid by other wealthy nations.
Concerns about such an extensive, centralized program are not unreasonable. On the other hand, patent reform is a market-friendly approach that embraces the benefits of competition and free entry to cut costs and better align the incentives for new drug development.
Negotiation would indeed take a bite out of drug prices. Analyses of proposed drug price negotiation plans find savings around half a trillion dollars over ten years. That’s serious money needed for the bill to pass reconciliation. But there’s more than one way to achieve this and bring down drug costs. To that end, patent reform would be a much more worthwhile endeavor.
The savings needed don’t have to come from drug price negotiation. For that matter, the popularity of such a provision doesn’t come from the specific policy. Rather, it’s popular because it means lower drug prices. Drug price negotiation is a policy with potential (though melodramatically overstated) harms. Well-designed patent reform, on the other hand, can trim prices while better orienting drug development.
Drug price negotiation isn’t a riskless proposition. The Congressional Budget Office estimated that a significant reduction in revenue would reduce new drug discovery by 3-5 percent (8 to 15 fewer drugs out of an estimated 300 approved). Market size and the potential return inform the decision to invest (or not) in R&D. As the largest prescription drug market in the world, the U.S. isn’t just the arsenal of democracy; it’s also the medicine cabinet. Negotiation will bring down prices and the return on investment for new drug discovery without the benefits of a competitive market created by patent reform.
If savings is the goal, going after drug patents is the best way to achieve that. Dean Baker found that patent protections added over $300 billion per year to the price of pharmaceuticals in 2018. According to the FDA, the entry of one generic competitor reduces drug prices by 40 percent, increasing to a whopping 95 percent of the original price when there are six or more generic competitors.
But aren’t patents necessary to ensure a return on the enormous investments needed to develop a new drug? Generally yes, even if the costs of such investments are overstated. But it’s possible to have too much of a good thing and, unfortunately, that’s where we are today. Analysis by the Initiative for Medicines, Access, and Knowledge (I-MAK) reveals that the effective patent terms for the top-selling drugs in the U.S. are nearly twice as long as the 20 years patents are supposed to last. Drugmakers pull this off by loading up dozens of patents per drug, including ones for therapeutically trivial changes (like going from two pills to one pill a day). As a result, they can continue to charge sky-high prices long past the point when they should be facing real competition. Reforms are needed to change the incentive structure that makes extending monopolies more profitable than developing new treatments.
Raising the bar for patent eligibility is a structural reform to ensure quality. But what if the holders of good patents still abuse their exclusivity? In these cases, there are tools available to the federal government to license the patents needed to legally manufacture drugs (that is, allow competitors into the market).
The first is march-in rights under the 1980 Bayh-Dole Act, which helps “subject inventions”–those made under a government contract–to be licensed. Since this power has never been utilized, its usefulness in fighting high prices is technically an open legal question. Still, there’s no time like the present to find out. Even without march-in rights, the government can use other compulsory licensing powers to pay a reasonable royalty while reaping the benefits of low costs under free-market competition.
There are two ways to fight monopoly power: with the bargaining power of a large, centralized buyer like the federal government or with increased market competition. Drug price negotiation takes the former approach, and there’s a place for it. But whenever an opportunity to pursue the latter is possible, we should take it. Making sure the incentives created by the patent system don’t turn into excesses will cut costs and ensure the rewards of a patent go to innovative activity.
Daniel Takash is the Niskanen Center’s regulatory policy fellow.