I think patent reform is a great way to get to lower drug prices but this means an update to objective rules. Selective enforcement and playing favorites by wagging your finger telling execs to be nice doesn't work. Not only does it not work but it invites corruption and political targeting. Having govt dictate price (ie price controls) aren't a new idea and have failed time and time again
It is essentially impossible for the Democrats to pass serious drug patent reform. Even if the senate Republicans don't filibuster just to prevent Democrats from appearing effective, there's enough Democrats that don't support it that it would be dead.
I'd much rather spotting and dodgy executive action than nothing.
If Republicans are voting against it too they are also to blame though? If some Republicans would vote for it then it could pass. I'm an Australian so maybe there is nuance here I'm missing about how the US of A's legislative process works, but I don't understand why you think they don't deserve some culpability and a mention?
* Doesn't have enough votes in congress, even though 95% of a single caucus that makes up 50% supports it because 10% of votes have to come from another caucus.
If 49% votes consistently binary; and another party has 5% on a gradient depending on policy; and 60% of consensus + executive signing is required then no, you can't ignore the issue of having 2 parties.
> The administration did not immediately release details about how the process will work and how it will deem a drug costly enough to act. White House officials would not name drugs that might potentially be targeted.
> There will be a 60-day public comment period. If the plan is enacted, drugmakers are almost certain to challenge it in court.
It isn't even the role of the executive branch to address this area. It's the job of the legislative branch (ie actual patent reform). Thus, this announcement is election year posturing which will not result in meaningful change. It's not even a real threat toward pharma corps because they already know it's toothless and it's dishonest from the white house because they know the pharmas know this.
The entire point of patents is to create a limited-time monopoly which increases profits. The key to less costly drugs is real patent reform that increases free market price competition paired with streamlining onerous FDA regulations making it faster, less costly and less uncertain to develop new drugs. Pharmas are by far the largest political lobbyists/donors. They wouldn't keep spending all that money in Washington if it didn't work, thus the lack of any meaningful political lobbying reform is an upstream enabler of this problem. Legislative term limits would also help.
Even before partisanship made Congress functionally useless, they were deferring a lot of rule-making power to executive branch agencies. That was a reasonable thing to do. There are only a few hundred Congresspeople; they have neither the time nor the expertise to determine every detail of every regulation. So they set up agencies that are supposed to hire experts to provide those details.
The Patent Office is one of those agencies, and that gives the Executive Branch a fair bit of power to nudge the rules without Congress' help. It would be great if Congress weren't fundamentally useless, but it's just not the case, and so government governs with what power it has.
That comes down to a billion details by a billion different players (most notably the 800 pound SCOTUS gorilla). But it is entirely possible that the Patent Office could say, "See this rule here? Turns out we shouldn't have granted you that patent in the first place." That is very much a power they have.
They'd rather not do it that way. It's bad policy. So they're starting gently, by pointing to what weight they do have to throw around, and hoping that the pharma execs do the right thing. It might even work; we've already seen similar effects bring down the price of insulin (even if it's still three times the price of any first-world country).
It would be even better if Congress were to sit down and write decent legislation instead. But my unicorn and I won't be holding our breaths on that.
I think you overstate the power of Patent Office. I don't think they can just say "Turns out we shouldn't have granted you that patent in the first place." Without providing evidence such as prior art. I don't think the courts would tolerate they are making too much money" argument from the patent office.
There are so many things that receive patents where prior art exists. I wouldn't be surprised if someone looked just a little bit, they could find prior art for just about any drug and rule that it is close enough to invalidate the patent. All it takes is someone challenging it.
Yes, came to say this. There are mechanisms and some economic incentives for third parties to challenge issued patents leading to invalidation. Whether there is enough economic incentive is a case by case.
The risk capital funding drug development can go elsewhere. If you break the spreadsheet math of drug development, you won’t get cheaper drugs. You just won’t get drugs.
Why break the only system in the world consistently delivering 30–40 new drugs year after year?
Because absolute opinions on this are stupid. For every cutting edge cancer treatment we get, there’s another pharma company abusing their position to overprice specific drugs. Since the free market explicitly can’t rectify the situation (patents grant artificial monopolies, sick people have very little option to shop around) there should be some system to review and police the worst abuses. One can argue about whether this type of political review is the best, or if we should have a more structured approach (I would like that, tell Congress.) But just shouting that the current system is perfect and should be unrestricted is also a bad approach.
There is nothing free market about enforcing patent on parties that aren't signatory to it, nor the high regulatory impositions that choke out those who aren't suitably connected to regulatory capture apparatus.
Almost all of the research for these drugs was funded by taxpayer dollars. Taxpayer dollars are increasingly used to pay for early rounds of safety trials. Private capital now only pays for the late-round efficacy trials, which is the last step before commercial sales.
So we'll still get the drugs. We'd just have fewer rich pharma bros with multiple condos and yachts.
https://health-policy-systems.biomedcentral.com/articles/10.... ("The largest funder was the United States National Institutes of Health ($26.1 billion), followed by the European Commission ($3.7 billion), and the United Kingdom Medical Research Council ($1.3 billion).")
58% were funded in some fraction. I wonder what percent of approved drug cost is publically funded, and what percent is fulfilling regulatory requirements. The high cost is in large part government induced, so it's kind of hilarious to regulate this massive cost and then brag about helping to fund some fractional number.
I’d ask what is driving the high cost induced by government? There are Large rigorous studies required to support efficacy and safety, and rigorous manufacturing requirements to ensure consistent drug supply for example. For sure, Pharma needs to drop the DRC advertising crap, and rely more on data than the current level of marketing to physicians/patients . Making safe and innovative drugs is expensive. The drugs should go generic gracefully, and then become cheap after a reasonable time. That isn’t happening and Pharma also needs to drop the BS patent extensions.
All clinical studies are not equal so some nuance on the objective of the studies is probably important. My impression is that grant funded clinical studies tend to be earlier in development and more exploratory if interventional, or observational if larger (eg framingham study). This isn’t absolute, but the funding required to cover large definitive pivotal studies, and all pharm/tox and manufacturing needed for a drug approval is large and I believe is very unlikely to be covered by grants.
I agree NIH is essential and Pharma has some large issues, but I don’t believe NIH is teeing up loads of approvable drugs for industry to exploit.
Even though this is only funding for trials and not research, I have to admit that I didn’t expect that and I will concede that it would be on me now to prove that research funding is differently distributed.
I would say the NIH is probably the biggest funder, and those of us coming out of universities earlier in our career - that is where most of us think of asking for money first; mostly as that is the "standard" model of getting into academia (i.e. K grants, R grants, etc). That being said, it seems like there's a decent amount of patents from the private sector as well
Because those drugs are worthless if people can't afford them. It's also a bit silly to ignore the entire rest of the world's pharmaceutical R&D. Lots of people would gladly give up bragging rights on production metrics if it means they can live healthier lives.
The divide in US (and I suspect elsewhere) politics is not Left v Right, it's Stasis vs Dynamism. In this case the "progressives" are proposing a plan that will cause Stasis or even decline...
This is a much better plan than their prior plan of pursuing parallel frivelous felony charges against the players of the game who legally raise prices (Shkreli).
Shkreli wasn’t convicted on raising drug prices. He was running multiple organizations and was using left-pocket right-pocket accounting to fund one organization with the investor funds from the other. That iwas not legit and illegal.
I'm sure the fact the government suddenly was interested in a guy who made his investors gobs of money, none of whom approached as victims (although did testify they would invest again) was absolutely totally unrelated to the fact they prosecuted him in close chronology to the price debacle.
When the state finds it's target, they're not bothered they find an unrelated technicality to really punish something else. What they clearly were actually punishing was legal behavior raising price.
