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Drug Price Negotiation Is A Second-Best Fix. Here's What Will Really Work

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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.

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posted at: 12:00am on 12-Nov-2021
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DRM Breaking Games Again, This Time Due To New Intel Chip Architecture

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We were just discussing how Denuvo's inability to renew one of its domains suddenly prevented lots of paying customers from playing several of their paid-for video games. While we can laugh at Denuvo's ineptitude, the real point in all of that is once again how DRM in video games tends to prevent nothing when it comes to piracy, yet paying customers tend to get impacted for a variety of reasons. DRM, in other words, almost universally functions to punish paying customers, which is stupid.And now here we are again, with DRM suddenly preventing paying customers from playing their games, albeit for a completely different reason. Intel released a list of something like 50 games where DRM breaks playability as a result of Intel's new chip architecture. While the reason this occurs on these chips is somewhat technical, ArsTechnica has a writeup that includes a reasonable summary.

We've already covered how Alder Lake's hybrid "big.little" design splits the CPU's workload into high-powered "performance" (P) cores and low-powered "efficiency" (E) cores. But after hinting at the potential issue in a developer FAQ last month, Intel is now confirming that some games contain DRM that Intel says "may incorrectly recognize 12th Generation Intel Core Processors efficient-cores (E-cores) as another system." That issue can lead to games that "may crash during launch or gameplay or unexpectedly shut down," Intel says.PC Mag's Chris Stobing explained that the issue arises from the DRM middleware treating the two different types of cores as two distinct systems. "Once it detects that some portion of the load has been split between the P- and E-cores, it sees the new cores as a new license holder (a separate system) and force-quits the game to prevent what it believes is two PCs trying to play one game on the same key,” he said.
That makes technical sense. What doesn't make sense is why this DRM is used in the first place. Again, I can just about promise you that all or a majority of these games are being pirated anyway, despite the DRM. So here again we have the classic DRM scenario: pirates going to pirate, while the paying customer finds out the game they bought suddenly isn't operable any longer.Now, Intel has indicated that it will be patching this issue out and is working directly with game developers to do that. In addition, it has provided workarounds, such as:
Intel says users can get around the problem by upgrading to Windows 11 (in some cases) or launching into the BIOS setup and turning on Legacy Game Compatibility Mode, then activating it with the Scroll Lock key. But an Intel spokesperson told PC Mag that this mode isn't yet available on at least some Alder Lake CPUs and "should be included in a future BIOS update."
But when viewed through the lens of the average PC gamer, this is mostly absurd. Upgrade the entire OS to play a game you already bought? Making changes in the BIOS? Come on.DRM needs to die. It's almost entirely useless at everything other than screwing things up for game companies' actual customers. How can all of this be worth it?

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posted at: 12:00am on 12-Nov-2021
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