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Pharmaceuticals: understanding your solution set

30 Jan 2008 08:21 am

There's an old adage variously attributed to chefs and engineers: "Good. Fast. Cheap. Pick two."

This does not hold all the time, of course; strawberries in season are fast, cheap, and divine. On the other hand, if it doesn't happy to be July, you have to wait months. So usually, the adage holds: you cannot have everything. You have to choose.

A lot of people in my comment threads on pharma are saying "Well, okay, maybe if we forced the drug prices so far down, that would kill off innovation. But it's not fair that Europe is free riding. We need to find some way to force them to Pay Their Fair Share." Interestingly, many of them seem to be conservatives, the same people who applaud when I say, in re other policy issues, that the fact that there is a problem does not automatically imply that there is also a solution.

No one who is a serious policy wonk on this stuff has any sort of workable proposal whereby America persuades Europe to pay more for its drugs. We have no leverage to do so. European governments have extraordinarily strong financial and political incentives to keep the costs of drugs down. Our trade relationship is not exactly harmonious right now. And we cannot forbid pharmaceutical companies to sell into those nations at discount prices, because those countries can break the patents and license generic manufacturers to manufacture the drugs. All we would end up doing is removing a small source of profit from the pharma company's books. This threat seems to be the most plausible reason that Pharma is still selling to Canada at heavily discounted prices, even though this costs them a fair amount of money in the US market. We have the legal ability to force American prices down to European levels. We do not have any way to force their prices up to ours. The fact that you are animated by an angry passion does not magically conjure up a solution out of nowhere.

As your mother repeatedly told you, the only person whose behavior you can control is your own. Screwing up our pharmaceutical industry because it's so damn unfair that Europe gets the benefit too is cutting off our noses to spite our faces, as long as we're still getting good value for money. As anyone, including me, who is taking a newly invented drug will tell you, we're getting pretty good value for money. (And if you're not getting good value for money, you can just not take the drug! Problem solved.)

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Comments (39)

On the other hand, what would happen if Europe actually broke the existing framework on patent protection? Just as a hypothetical. The retaliation -- and it would not even BE a retaliation, just acceptance of the new status quo -- would likely involve not only pharmacological patents (unless there would be a LOT of good will in Senate and Congress to contain the breach). Any and all European patents would become fair game in the US, and, reciprocally, US patents in Europe. The companies would overwhelmingly switch to trade secret protection instead of relying on patents, with attendant security. Name's Bond... James Bond... with Glaxo-Smith-Kline.

Isn't this an interesting discussion topic?

Why can't we threaten to retaliate against Canadian and European drug companies that profit from selling in our markets? How is that not leverage?

Countries have an incentive to fund research when the private benefits for their country exceed costs, and an incentive to free-ride when there are benefits but they do not exceed costs. The richer and the larger population a country is, the more incentive they have to fund the drugs and not free-ride. They can split the cost over more citizens, and the value of the benefits increases.

The only ways that I see to get other countries to pay more for drugs are:

1) Have the EU set drug prices and fund research solely at a EU-wide level, so that they are more like a single country with an economic and population similar to the US and their incentive to free-ride is somewhat decreased.
2) Have China, India, Brazil, Mexico, and the other large population countries catch up to the US in per capita income, so that their incentive to free-ride is somewhat decreased.
3) Have Canada join the US in a North American Union.
4) In a similar vein to 3, worldwide treaties and negotiations determining every country's "fair share" of drug research, with some enforcement methods. Something like a world government.

Not saying that I necessarily favor any of these, but I can't think of other methods that would succeed.

The incentives to free-ride are the same across different markets, although the pressure to set price controls is stronger in pharmaceuticals. That's why, e.g., the US has led in public goods like GPS as well, and why European space research has been encouraged by it being Europe-wide funding.

In Brasil, the government gave American pharmaceutical companies an ultimatum. Provide AIDS drugs for a lot cheaper, or swiftly lose the largest market in Latin America. The drug companies folded. Brasil may be the only country in the world now with a negative AIDS rate.

Maybe we can't force Europeans to pay more, the least we can do is analyze the negatives and positives that more affordable, accessible drug care is having on society at large. It may not be fair, from a corporate perspective, but the policy is exceptionally pragmatic in addressing the issue of high drug prices.

Also consider this: European and Canadian-produced drugs suffer considerable barriers to entry when it comes to the U.S. market, at least partially because of protectionist trade policies. Maybe it evens itself out...

Max,

Keeping trade secrets is tough when your goal is to sell the products. What is often easier to keep secret is the best process by which the product is made.

In the case of pharmaceuticals, identifying and copying the product exactly is trivial in almost every case. The best process for doing so can be kept secret for a while, but not forever, and in the case of chemical compounds, a good process chemistry department will find your optimal route (or a better one) pretty rapidly (this is one reason why pharmaceutical companies patent the processes, as well, rather than try to keep them secret).

Fred,

The leverage, unfortunately, nets out on the European side, not the US side.

We could stop contributing to international agencies that Europe likes such as the UN, World Bank and IMF and give the savings to U.S. pharmaceutical companies.

Yancey: as I mentioned, once the process has begun it won't stop with pharma. It'll be a free for all. Very hard to say where the leverage will net out.

Even in pharma, it's not too hard to imagine some possible pro-active tactics against copycats. E.g. planting on them a failed molecule with known nasty side effects as an "improvement" (via a high-placed mole in the R&D dept). THAT would play havoc with their marketing strategy even if People's Republic of Europe is the sole buyer.

I never said I propose this path as a SOLUTION, just as an interesting hypothetical...

As your mother repeatedly told you, the only person whose behavior you can control is your own.

Actually, I think a lot of mothers did not tell their children this. I'm not even sure mine did; I think I had to figure it out on my own, or from books and movies. I suspect this has a lot to do with the tiny population of libertarians. I know quite a few people who genuinely do not feel or believe the sentence that you quoted above.

I know people who do not feel that they are in control of their own behavior, and I certainly know plenty of people who feel a strong need to control the behavior of others.

We could stop contributing to international agencies that Europe likes such as the UN, World Bank and IMF and give the savings to U.S. pharmaceutical companies.

Or we could return the savings back to the taxpayers, who could spend it on pharmaceuticals. Or cigarettes.

Seems to me that we could just either allow wholesale reimporting or pass a law that said that US customers must get the same deal offered on the world market.

Would this lower inovation, yes probably, but it would also lower cost in the US and raise cost in Europe.

The quesion for us is what is the cost of lost inovation vs cheaper drugs.

Also, sometimes you have to be willing to hurt yourself a little to punish a free rider (it is a dynamic not a static game). Europeans are not paying thier fair share. If we threaten pain on both sides of the Atlantic maybe they will come to us with a workable solution that will solve the issue and be more fair.

Seems to me that we could just either allow wholesale reimporting or pass a law that said that US customers must get the same deal offered on the world market.

Would this lower inovation, yes probably, but it would also lower cost in the US and raise cost in Europe.

The quesion for us is what is the cost of lost inovation vs cheaper drugs.

Also, sometimes you have to be willing to hurt yourself a little to punish a free rider (it is a dynamic not a static game). Europeans are not paying thier fair share. If we threaten pain on both sides of the Atlantic maybe they will come to us with a workable solution that will solve the issue and be more fair.

What about locating the factories where the EU starts to make the generic form of our drugs and blowing them up. Surely we could make it look like some form of Islamic terrorism. Win-win.

As I understand it, drugs typically have only about ten years of patent protection after clearing clinical trials. So what's the big deal? Is it really that much of a problem that drug companies can command a premium for cutting-edge technology, when just about every drug that's been on the market for ten years or more is available at cost plus a competitive profit margin?

"And we cannot forbid pharmaceutical companies to sell into those nations at discount prices, because those countries can break the patents and license generic manufacturers to manufacture the drugs. All we would end up doing is removing a small source of profit from the pharma company's books."

First, a question: Does anybody know what percentage of profit is actually coming from regulated markets? And a related question: What percentage of the actual drugs is going to those markets in unit terms? Seems you can't really estimate the effect of any trade action without knowing those two variables.

Having said that, we should make sure that there aren't ways to force regulated markets to de-regulate with appropriate trade policies. After all, this is basically the same as busting a union, a skill with which Americans have no small amount of experience. The fact that the Union is European is merely a matter of scale.

The issue of whether these countries would break our patents is key. Also note that, as Yancey points out above, trade secrets won't work--drugs are easy to reverse-engineer. However, I'm having a hard time imagining the EU or any other regulated market starting a trade war over this. The consequences of destroying the international intellectual property framework are too terrible to imagine. Call me a cockeyed optimist--I don't think it would happen.

Given that, how would you proceed to destroy the regulated markets, or at least make them buy at closer to fair market value? Some ideas (none of them without serious flaws):

1) Similar to cccdogg, you can massively reimport. This will induce shortages in the regulated markets, forcing them either to raise their prices or do without. Two problems with this: First, the pharma companies have to be willing to take the hit on domestic profits for as long as it takes to make the shortages critical. Second, it's easy for the regulated market to make exporting the drugs illegal.

2) Subsidize domestic pharma companies to reduce or withold supply from the regulated markets. Again, shortages mean higher prices. Beside the obvious domestic political problems with this, I suspect that this would run afoul of WTO treaty obligations, but you could cause an awful lot of trouble before the legal process took its course.

3) Simply embargo drugs to regulated markets. The obvious problem with this is that's its pretty close to an act of war and would certainly result in breaking the patents.

4) Negotiate. The regulated markets have as much or more to lose than we do. Maybe if you get them to import at no less that x% of US fair market value, you can dramtically reduce the problem. As shown above, we have a certain number of sticks to bring to such a negotiation. Finding a few carrots shouldn't be very hard.

5) This is a half-baked idea: It occurs to me that the real problem here is that drugs are effectively pure intellectual property. They cost very little to manufacture but their R&D costs are huge. I wonder if there's a way to set up royalty pools for drug export. We do this all the time for other forms of technology. In effect, you get a license under which you agree to pay a certain cost per unit into the pool for the intellectual property and you have the right to manufacture as much as you want. Seems to me that you could, per treaty, come up with a formula where pharma companies could establish a royalty pool to generate an appropriate return on investment and then license the manufacturing of their products in the regulated markets. As I said, this is half-baked at best, but it certainly would change the paradigm. At the very least, it exposes the true cost of bringing the drug to market.

As I said at the beginning of this (now incredibly long) comment, a lot of what you can do is dependent on how big the regulated markets really are. But you ultimately can't have a market with some free-riders and some market consumers--it's unstable. This is a really scary problem because, as Megan has pointed out, you only have to change the economics a little bit to make the return on investment unattractive and stifle all innovation. And once you've done that, un-stifling it is very difficult. Once the R&D apparatus is disassembled, it's hard to but Humpty-Dumpty together again.

It's not even a matter of threatening retaliation. There are international patent agreements with real teeth. Failing to respect a foreign country's patents under TRIPS can lead the WTO to authorize cross-sectoral trade sanctions. That means tariffs and embargoes on all goods, not just foreign IP.

As your mother repeatedly told you, the only person whose behavior you can control is your own.

Your mother was bad at game theory. Your behavior changes the incentives of others around you. This would not be the first time Megan has accused people of being irrational when they've simply thought things ahead further than she did.

No, it isn't possible that Europeans will ever pay American prices for drugs. But yes, it is definitely the case that they could pay a bit more than they do now if we played a bit rougher. Just make the supplies in Europe a bit tighter, and it would be more in Europe's interest to pay a bit more than it would be to start a trade war. We can't make things fair, but we could make things more fair--and probably make research of new drugs more profitable while we're at it.

Pharma is special because there's a humanitarian exemption for compulsory licensing . . .

pass a law that said that US customers must get the same deal offered on the world market.

Exactly.

Megan may or may not be correct that the US as a country has no leverage against Europe/Canada with respect to increasing the amounts they pay for drugs. But we can increase the leverage that the drug companies have vis-a-vis Europe/Canada.

In essence, the law would be the equivalent of a "most favored nation" clause in a contract.

Rad Mod,

In addition to your list why not pass a law forbiding price discrimination in the US vs socialized systems?

Put a cap of 5% (to allow for potential cost differences) above the best price offered world wide on what you can sell drugs for wholesale in the US.

Drug companies then have a choice they can charge US consumers the same price, raise their prices to other countries, or stop selling in the US (unlikely).

The most likely occurance would be that they would raise prices world wide but lower them in the US. This might impede inovation as their profits would likely fall but it could still be better for US consumers because the prices have fallen.

However it is undoubtedly worse for European consumers because they now get higher prices and less inovation. Hopefully they would then come to the table with the US to work out a solution beneficial to all.

Can someone explain to me what would happen if we use our power to:

We have the legal ability to force American prices down to European levels.???

It seems to me that it would massively hurt innovation which would be bad for the entire world.

Then the rich countries of the world would decide that they would rather have somewhat higher drug prices for somewhat more innovation.

The net effect of our actions would be to force up prices in Europe, Canada, and Japan and bring prices down here. It might reduce innovation but it would hurt other countries far more than it would hurt America.

Pharma is special because there's a humanitarian exemption for compulsory licensing . . .

Yes, but it's (deliberately) a very hard standard to meet. The sort of thing that prevents Brazil from breaking patents on AIDS drugs, let alone wealthy European nations from pirating Lipitor. You certainly couldn't apply it across the board to all US pharma.

Pardon me, but afaik what stopped Brazil was the pharmaceutical companies caving in and selling the drugs very cheaply, not the WTO.

No one knows what will happen if the drug companies stop selling to Europe/Canada. I am very, very skeptical that the WTO will stand up to every one of its members except the US on the question. And it's pretty clear that the implicit threat to break the patent is being wielded with great force to lower prices.

If I give up my wallet to the knife-wielding mugger without a fight, did the knife play no role in the mugging?

love the little adage you started the piece with. similar to one i've heard about dating: beauty, brains, availability. pick two.

If I give up my wallet to the knife-wielding mugger without a fight, did the knife play no role in the mugging?

No, no, it's just that the proper solution is to criminalize giving up your wallet, so as to give you leverage to negotiate with the mugger, thereby reducing mugging overall.

If the markup on new, patent-protected prescription drugs in the EU is so low, then the resulting profits can have virtually no impact on pharmaceutical profitability, nor can they really impact the incentives for private R&D.

IF that is indeed the case, then in practical terms, why should a pharmaceutical care if, say, the Czech Republic manufactures their drug for local consumption?

But the Czech Republic pretty well HAS to care about respecting the patents on the drug company if it wishes to survive in the global economy, as Trevor was kind enough to point out.

I guess I don't see a contradiction in the Brazil case. They weren't on the verge of getting a humanitarian exemption, they were threatening to ignore the rules and essentially say "sue me." They drove a hard bargain, and more power to them. That doesn't really make it more likely that Europe could get compulsory licensing under the current rules.

Of course you're right that if it really becomes the US vs. the world, all the treaties in the world aren't doing anyone any good. The rules change.

"As anyone, including me, who is taking a newly invented drug will tell you, we're getting pretty good value for money. (And if you're not getting good value for money, you can just not take the drug! Problem solved.)"

By this logic we should completely deregulate your local power utility too. After all if you don't like the much higher new prices they will charge you can just not use the electricity! Problem solved.

Run a screen of high return-on-equity companies and it will immediately be apparent that big pharma is the only industry with consistently off the charts return-on-equity. In a capitalist system this shouldn't happen. New competitors should come in and compete away the high returns. They can't because of the patents. The fact that returns in the industry as a whole are so high is an indicator that the terms of the patents are too generous to the pharma companies.

The approach in electricity regulation is usually to target a the RoE, so the consumer gets a fair deal but capitalists still want to invest in the industry.

Re: And we cannot forbid pharmaceutical companies to sell into those nations at discount prices, because those countries can break the patents and license generic manufacturers to manufacture the drugs.

Are you sure? They *can* do that. But would they dare, knowing that it would start a trade war fought with massive patent infringement on both sides? We are (I assume) talking about Europe here, and it's not as if Europe doesn't generate a fair amount of intellectual property they dearly need to protect too.

Re: We have the legal ability to force American prices down to European levels.

You seem to suggest that market forces are inoperative. History has shown (see: Soviet Union) that even a truly totalitarian government bent of forcing a market to its will cannot accomplish that act of circle squaring. So there are two possible conclusions here: either the there is somek everage that would force prices in Europe up to market levels, or they are already at market levels in Europe and it is the US consummer who is being shamelessly gouged.

Re: As your mother repeatedly told you, the only person whose behavior you can control is your own.

I don't know about your mother, but mine strove mightily (and often effectively) control my behavior when I was a child. Your silly bromide suggests that laws and diplomacy of any sort of useless efforts.

Run a screen of high return-on-equity companies and it will immediately be apparent that big pharma is the only industry with consistently off the charts return-on-equity.

Run a screen of those who win the lottery and the winners are off the charts, too. Biotech startups, have a _much_ higher than average failure rate and generally make poor investments. There's a tendency by some observers to cherry pick the high-performing companies in the pharma industry to create a skewed picture of that industry.

Also, as others have mentioned, you'd have to have a pretty tremendous return on your investment to justify staying in any industry with such a protracted and uncertain R&D cycle.

The obvious question for anyone who thinks that pharmaceutical companies make money hand over fist for no good reason is why there aren't more of them. If making pharmaceuticals is so far superior to other ways of making money, then talent and capital should be flooding in and bringing expected profits down to the levels they're at in other idustries.

Some hypotheses:

1. Expected profits aren't extraordinary after all.
2. They are, but this is super-secret information known only to leftists and pharmaceutical industry insiders.
3. Extraordinary profits are a new phenomenon, and new entries into the market will soon erode them.
4. There are barriers to entry.

So which is it?

Run a screen of high return-on-equity companies and it will immediately be apparent that big pharma is the only industry with consistently off the charts return-on-equity.

Ryan gave one explanation for this above. Here's another: It's not true. I ran Yahoo's stock screener, and of the 100 highest-ROE large companies (market cap >= 10B), only 2 were pharmaceuticals (GSK and Astrazeneca, though Wyeth was close).

As a whole, the pharmaceutical industry has an ROE of 23% (see here for the top and bottom ten). That's above average, but it's neither "off the charts" nor unique.

Brandon
Running a screen using only one year's ROE is meaningless because it is going to include those cyclicals that happen to be at the top of the cycle.
If you run a screen (I used MSN) of those with highest 5 year ROE and market cap > 10B then GSK, Alcon, Merck, Wyeth, Astra-Zeneca, Akza-Nobel and Bayer appear.

As for your first question the answer is obvious. There are barriers to entry and its called a patent. You may have noticed that once drugs go off-patent the price (and margins) tend to fall drastically.
The terms of the patents are determined by government legislation not by the free market.
And the excess ROE of the big-pharma (the small start-ups are a different story) indicates to me that government has been excessively generous to big pharma in a way that they have not been to regulated utilities.

"By this logic we should completely deregulate your local power utility too."

Only if we allow competition between several power providers, but that has been considered impractical because it's not efficient to build more than one grid. Plus there are the large costs to building a power plant, and the enormous opportunity costs to not having a sufficient supply of power, which makes excess capacity desirable (did you happen to visit Manila in 1992 or 1993? I did, the frequent blackouts were extremely disruptive and costly to the Phillipine economy).

There is free competition to develop new drugs. Granted, once the discovery is made, property rights are awarded in the form of patents, for a limited amount of time. But if people choose to use the drugs, then presumably (using a revealed preference argument) they are being made better off by them, even given the cost. If they don't feel that a drug is worth the cost, then they shouldn't take it, as Megan said.

NYT:
Thanks. I stand corrected regarding ROE. This doesn't diminish Ryan's point about survivor bias, though.

Regarding barriers to entry, patent protection isn't a barrier to entering the pharmaceutical industry. It's a barrier to selling one particular drug. Obviously once you have a patent on a frequently-prescribed drug, expected profits are high. Several people have already pointed out that this is a feature and not a bug; large rewards are needed to induce people to undertake the staggering risk and expense of developing new drugs and bringing them to market.

The question is whether pharmaceutical companies make lots of money for no good reason, i.e., whether expected profits are extraordinarily high at the point when you start development. What are the barriers to entry that allegedly keep the pharmaceutical industry so lucrative even ex ante?

If the US is doing such a vastly disproportionate level of pharmaceutical R&D, such that other wealthy and advanced nations are free riding, we must consider the very real possibility that we are spending too much on it. Innovation in drugs is wonderful, but what are the opportunity costs? You don't get something for nothing...unless some other nation over invests in an easily stolen piece of intellectual property. Then you do.

I think we need to examine why we spend so much on this. It may be irrational cultural beliefs, poorly designed tax codes, over (or under) regulation. Maybe we are right and other countries are foolish and immoral. Maybe we have genuinely different priorities than people in other countries with esentially equivalent wealth and technology. I doubt those last two though.

Despite being a "single payer" adherent, I don't think nationalizing big pharma is the way to go. However, I do think we need to look at reformulating the patent protection laws. They are terribly abused by pharmaceutical companies in ways that were almost certainly not intended by the writers of the original legislation. Stricter adherence to the original intent of patent laws would cost big pharma a lot of money. The idea that reducing profits for pharmaceutical companies would cause them to reduce R&D is not sufficient by itself when you accept that there might be too much of it.

"Only if we allow competition between several power providers, but that has been considered impractical because it's not efficient to build more than one grid."

On the contrary, we do allow competition between several power providers. If you want to build some power plants to compete with Mid-American you are free to do so. But since new entrants are reluctant to do that (for the reasons you mention), the government intervenes and restricts the returns of the incumbents to an ROE range, usually in the low to mid-teens.

The drug industry is not a free market. The government prevents you from competing directly with a patented drug. So since the returns of big pharma are dependent on government intervention, the government should ensure that those returns are not out of line. But very clearly, they are. No other industry has multiple major participants earn ROEs of 25% and more for decades.


"But if people choose to use the drugs, then presumably (using a revealed preference argument) they are being made better off by them, even given the cost. If they don't feel that a drug is worth the cost, then they shouldn't take it, as Megan said"
Well why not apply your logic to the power industry then? Allow the generators to charge whatever you will bear.


It's interesting how much this problem (and the circularity of the discussion) resembles the problem of stopping genocidal dictators (just the most virulent form of the economic free rider)--because in our current social arrangements, we always find it close to impossible to negotiate the claims of the same old opposing forces (what a coincidence!), namely liberty versus equality.

If people insist on keeping their wonderful nation-states regardless, then they might at least want to look at the ingenious market-based proposals of Ronald Dworkin (especially in his book Sovereign Virtue, which offers some brilliant palliatives for these problems); but for my money, we ought to just cut the Gordian Knot! The nation-state is going to die a well-deserved death eventually, so why don't we just get ahead of its impossibility, write the new, improved Federalist Papers, save millions of lives, and form a world government?

Oh, yes, I know--that's impossible! "Human nature is such that....the UN proves that....I'd rather die than give up my sovereignty!"

Ok, then, forget it! But it seems tragic that so many intelligent people still insist on dragging the peaceful humans down into the pit in the name of such wretched, long-superseded metaphysics.

Good luck to us all, but discussions like this one hardly give much grounds for optimism...

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