Generics Drive Down Drug Prices In India, TPP Trying To Stop That
from the really-sick dept
Back in March, we wrote about an important development in India, where a compulsory license for Bayer's Nexavar anti-cancer drug was granted. Bayer, of course, is fighting back:
in its 37-page appeal to the Intellectual Property Appellate Board, Bayer has "demanded the withdrawal of the country’s first compulsory license given to Natco Pharma, arguing that a three-fourths reduction in the price of the anti-cancer drug by another Indian firm has made the permit redundant and its patent itself is vulnerable to being revoked," the Economic Times, India’s leading business newspaper, reported on 19 May. Bayer says CIPLA’s new price "will render Natco’s price unreasonable and defeat the purpose of compulsory licensing," according to the newspaper.
As that shows, there's been an interesting twist in this story. Cipla, another Indian manufacturer of generics, has announced that it too is coming out with a version of Nexavar, pricing it at $125 for 120 tablets. That's even cheaper than Natco's price of $163, to say nothing of Bayer's $5,128 for the same course. A key difference is that India's Patent Controller has granted a compulsory licence to Natco, but not to Cipla. In fact, Bayer has said that it is taking Cipla to court over its production of a cheap version of Nexavar.
Bayer is employing some very strange logic here. On the one hand, it is saying that Cipla's cheaper version of Nexavar means that Natco's licence is no longer needed, and should be revoked. On the other, Bayer is suing Cipla because it has produced Nexavar without the compulsory license that Natco has. Clearly, Bayer hopes to get the best of both worlds -- the revocation of Natco's compulsory licence, and a court ruling against Cipla, which would leave Bayer once more as the only supplier of Nexavar.
Bayer seems to be trying to make that outcome more palatable by emphasizing that it has already reduced the price of Nexavar for some people:
Bayer stresses that to facilitate access for patients to innovative treatments, it has had a Patient Access Programme in place since the launch of Nexavar in India in 2008. Bayer says that this programme, last expanded in April 2012, reduces the price for the monthly treatment with Nexavar for qualified persons to about a tenth of the regular pharmacy price (Rs 280,000 or $5,128) for the complete duration of treatment.
But it's not clear how many patients have actually benefited from this program. And in any case, the reduced price of $512 per 120 tablets is still three times higher than Natco's pricing, which would put it out of the reach of many poorer patients. Compulsory licensing, by contrast, has driven down the price to $163, and maybe even to $125 if Cipla is allowed to offer it too. In other words, the availability of indigenous alternatives has caused the price to drop from completely unaffordable levels to ones that are more realistic for the India market -- exactly as generics are supposed to do:
Health advocates and cancer patients are happy that the fight between the big brand-name pharmaceutical producers and local generic drug makers is making cancer drugs cheaper. The vast majority of Indians don’t have any form of health insurance and out of pocket payments continue to be among the highest in the world. Cancer has also become one of the ten leading causes of death in India today. It is estimated that there are nearly 2 – 2.5 million cancer cases at any given point in time in the country.
Against that background, provisions in TPP that will make it much harder for local manufacturers to produce low-cost generics legally are troubling. They represent a clear attempt by the US to prevent the kind of access to vital patented drugs that India's compulsory licensing has permitted. Western pharmaceutical companies and their shareholders may rejoice if that happens, but many of those in emerging economies who are unable to afford life-saving medicines will die as a result.
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Filed Under: access to medicine, drugs, generics, india, tpp
Companies: bayer, cipla, natco
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So what? If they can't afford the drug, it's not like we're losing any customers...
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Despicable.
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Business woman on plane: Are there a lot of these kinds of accidents?
Narrator: You wouldn't believe.
Business woman on plane: Which car company do you work for?
Narrator: A major one.
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It's easy to get the impression that Bayer hasn't considered it, because $5K+ compared to the generic prices appear to be a gouge. And trying to thwart access, even through legal process, is at best a dubious endeavor.
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I suppose the rest of world would catch on and demand the same. We can't expect an established company to change its ways can we? We can only hope that the Indian compulsory licensing system spreads to the rest of the world.
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That also assumes that Indian officials care more about a foreign companies profits than their own country's health. I'm willing to bet that their own country's health comes before foreign companies, and before you throw a fit over that, ask yourself if the situation were reversed, if it were the US in need and, say, a Chinese company with the patents, would the US side with the foreign company or our local population?
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The obvious answer is that the US government would side with whichever side made the most campaign contributions, which would most likely be the Chinese company.
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Except that's almost never the case. These days the major pharmas swoop in at as late a date as possible, after all the key research is done (often using federally funded grants).
Why are you commenting on a subject you don't appear to know much about?
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Thanks to US/EU regulations, testing on humans (you want your medical procedure/drugs tested, don't you?) is prohibitively expensive.
Academics do a research, but don't do enough tests to qualify drugs for mass usage. That cost must be recouped somehow. Generic drugs don't have this cost - it's already paid by original manufacturer.
So, how original manufacturer, (evil Big Pharma) should recoup those costs? Until today it's going through limited exclusivity period - patents. How long should it be - that's debatable.
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I think there's three questions rather than one though:
Are Patents the best way of promoting progress?
If so how long should the patent be?
and, most importantly,
Is recouping a company's costs more important than saving lives?
The obvious rejoinder is that if the companies can't recoup their costs then they wouldn't be making any drugs at all, hence it becomes a tricky question.
But to get back to the case in point, a quick shufti at google gives me a figure of about $8000 for an average yearly wage in India. So a drug costing 2/3rds of a annual salary probably isn't going to sell that many treatments, so I'm not sure how much they would have recouped on this in India anyway?
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No, but this is irrelevant question. Companies use patents to recoup huge certification costs. Don't like this process - fight to lower qualification barriers first.
>> Is recouping a company's costs more important than saving lives?
Yes. Welcome to real world, not all lives are equally valuable.
Don't like it - why not start your own pharma company and we'll see how that will work?
>> so I'm not sure how much they would have recouped on this in India anyway?
You're so smart! Call Bayer's CEO immediately and give your valuable advise. Hint for you: annual salary is irrelevant here. What's relevant is annual salary _of target population_. If annual salary here (doesn't matter where) is ~$3000/month, does it mean that BMW should close the shop?
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Please tell me you're applying Poe's Law.
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That is why I will support anyone who breaks those patents.
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*for a psychological/social level of true.
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You do know that most drugs produced today bear a striking resemblance to the cooking process right?
What happens when people discover that they actually can produce their own medicine?
I know what it happens, the reasoning for all that patent stuff gets out the window and people get educated on how it is produced and how quality control works, prices go down and monopolies grumble.
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Actually that is a very good idea, I can see a future where everybody produce their own medicine or the very least the precursors of the drugs, is not like is different from cooking rice or having an aquarium, you go there feed the bacteria the reproduce and produce the compounds needed and you test it to see if there are any problems with it, how hard can it be?
Modern penicillin production started with brewing technology adapted to drug manufacturing, there are many little stills capable of doing it today, what is lacking is knowledge and QA but the technology is there to start in your own home production of drugs for a variety of problems many of them are not even under patents anymore, so that is actually not a bad idea at all.
If people want to drive the cost down they will need to start doing it themselves.
Can you imagine when you go to a shop and buy a new brewing machine that will produce all the medicine you can take and it does it all including the quality control check just like the big machines do it?
About life, well for some that is true, not all life is equal, for me all life is precious it doesn't matter who's life it is.
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Please share stuff you're smoking. Did you produced it by yourself?
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Balderdash!
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Source: http://blog.ginkgobioworks.com/2009/01/26/diy-bioengineering-recap-of-the-recent-mit-soapbox-session -on-diybio/
Quote:
Source: http://www.fastcoexist.com/1679356/diy-bioengineering-make-your-own-antidepressant-yogurt
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Youtube: Tuur van Balen - Hacking Yoghurt
There was a time that you needed a million dollars to do that.
Today you go to PartsRegistry choose the DNA parts you want and ask a lab to synthesize the organism for you.
OMG! Oh the horror!
People can do that today!
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Youtube: Tuur van Balen - Hacking Yoghurt
There was a time that you needed a million dollars to do that.
Today you go to PartsRegistry choose the DNA parts you want and ask a lab to synthesize the organism for you.
OMG! Oh the horror!
People can do that today!
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I was thinking about the patent system and how generous it is, you can refile ad infinitum until you get it right, there are no penalties for getting it wrong, but if you try to do something else and get it wrong you get instant punishment to discourage you from ever doing it again. There is something wrong with that, it should be the exact opposite, where people trying to do something for themselves get all the leniency and information needed to get it right and people trying to enact monopolies gets punished if they get it wrong so they be very careful when claiming something.
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No, but this is irrelevant question. Companies use patents to recoup huge certification costs. Don't like this process - fight to lower qualification barriers first."
My understanding was that this post was about how US uses mechanisms like the TPP to export its IP laws (that are developed by vested interests), the IP in this question is a patent, hence it seems relevant to the discussion.
">> Is recouping a company's costs more important than saving lives?
Yes. Welcome to real world, not all lives are equally valuable.
Don't like it - why not start your own pharma company and we'll see how that will work?"
"Real world" is a variable thing though isn't it? Do you give to charity? If so you're implicitly deciding that a proportion of your profit is worth less than the lives that it might save. The Indian government obviously made a decision that they considered the lives of their populace more important than Bayer's profits. Something that potentially affects over a billion people seems fairly real world to me.
Besides which, isn't starting their own pharma company exactly what Cipla and Natco have done?
">> so I'm not sure how much they would have recouped on this in India anyway?
You're so smart! Call Bayer's CEO immediately and give your valuable advise. Hint for you: annual salary is irrelevant here. What's relevant is annual salary _of target population_. If annual salary here (doesn't matter where) is ~$3000/month, does it mean that BMW should close the shop?"
You're very aggressive this morning, have I offended you? Apologies if so. The BMW analogy isn't really a very good one though is it? Manufacturing costs of a BMW compared to a Tata are very different. Research and licensing are sunk costs, Bayer might find that if they reduced their profit-per-course to something that competes with the generic market they might have an target population of around a billion people rather than just the tiny percentage at the top of the salary scale. They might not of course, I'm sure they've done the maths, so they've decided to pay some lawyers instead and people will die if they win.
All of which does tend to reinforce the idea of the whole Evil Big Pharma thing.
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No. Does it make me evil? Of cause not, but you seems to think so.
>> The Indian government obviously made a decision that they considered the lives of their populace more important than Bayer's profits.
Oh, how cute of them. Since Bayer's profits are going to US, it's easy choice, isn't it? Will you excuse me if I value profits of my $company (not US-based, don't worry) more that lives of entire Africa?
>> Research and licensing are sunk costs
Did you already offered your services to Bayer as genius economist? If they refused, that's probably because your explanation makes no sense. How is your business doing?
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No. Does it make me evil? Of cause not, but you seems to think so."
Not at all, just giving an example of where people in the real world put profit second. No evil was implied in the writing of this post.
">> The Indian government obviously made a decision that they considered the lives of their populace more important than Bayer's profits.
Oh, how cute of them. Since Bayer's profits are going to US, it's easy choice, isn't it? Will you excuse me if I value profits of my $company (not US-based, don't worry) more that lives of entire Africa?"
Yes, yes it is an easy choice. I'm afraid you'll have to clarify your point for me though. As for valuing your company profits over all the lives in africa, actually I won't excuse you for that, it feels horrifically inhumane to me.
">> Research and licensing are sunk costs
Did you already offered your services to Bayer as genius economist? If they refused, that's probably because your explanation makes no sense. How is your business doing?"
My business is doing fine thanks, if you'd like to explain why you think my statement about those being sunk costs is wrong we can continue the discussion. Or you can continue to make petty insults instead of coherent arguments.
Either way is good with me.
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No. Does it make me evil? Of cause not, but you seems to think so.
Yes. That's the definition of evil.
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Nope.
This makes you evil.
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It's one of the most relevant questions, as promoting progress is the sole Constitutional purpose of the patent system.
A can't imagine a purer expression of sociopathy than this.
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Do you have any data on that please?
Quote:
Source: http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050001
Article about the same study elsewhere.
http://www.sciencedaily.com/releases/2008/01/080105140107.htm
Are you sure those companies don't spend money on advertizing?
By their own estimates according to IML something near 50% of all the spending done by those companies is directed at marketing that means at the very least half the price of medicine is because of marketing and the study also points out failings and inconsistencies in the way those numbers are presented to the public, so where do your information come from exactly?
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Quote:
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Source: http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050001
If by dodge you mean IMS trying to hide the total expenditure in advertisement by big companies yes that is exactly what they did, the researchers on the other hand aware of the problems with that took care to look beyond that and found some numbers.
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At the same time, I am intimately familiar with all the various sources of government funding, ranging from contracts to grants to cooperative agreements, as well as the statements of work performed under such funding instruments.
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speaking of...can we get a follow up on the facebook IPO post.
ty, tyvm.
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In doing so they should specifically take note of the rights granted to the USG for "subject inventions" as to which the private entity elects to take title, including march-in rights.
As for the pharma industry itself, I do seem to recall stating I have represented individual companies over the years, starting with the pursuit of an idea through market introduction, including the law as it pertains to patents nearing the end of their terms and orphan drugs.
Of course, I have no information concerning you personally that permits me to make pejorative statements such as yours above.
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The "pharma companies don't do key research, they just swoop in" argument is one of the key signs of a crank who doesn't understand drugs at all.
If it's so easy and cheap to produce a working drug from the basic research, why don't the government labs, or the generics to make a drug? Why is it so difficult to replicate the results of published in academic work, as industry has constantly found?
To the extent that funded research makes drugs research easier, that definitely increases the number of drugs. But there are always drugs on the margin that might or might not make sense to research, once you take into account the chance of failure. The risk of failure, even when a drug reaches Stage III trials, is so great that any successful drug must pay for itself many, many times over in order to pay for all the failures.
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I seem to remember they often enjoy rolling their marketing budgets for the drugs into "research" costs.
I seem to remember they like to try to change up the drug in some minor way as the patent is about to expire to lock it up again.
I seem to remember some of them are handed the rights to drugs already "discovered" and then cranking up the costs to recoup what that research cost them. Because something deemed to toxic for chemo became a huge cash cow for them. So what if people died around the globe, they were owed obscene profits for a drug they didn't fund the discovery of weren't they?
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Health care is fast becoming something exclusively for the rich.
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If, for example, Smith-And-Wesson are making people-killing devices, it's government's job to regulate who can buy such. Or Ford doesn't create over-polluting trucks. Or Boeing's plane doesn't fall from the sky. And so on.
>> Health care is fast becoming something exclusively for the rich.
Some health care IS exclusivity for the rich. That's one of reasons people want to be rich in a first place. Again, it's up to your government to determine limits of such exclusivity.
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Yes but the pharmaceutical corps' pricing is well beyond excessive.
"Some health care IS exclusivity for the rich. That's one of reasons people want to be rich in a first place. Again, it's up to your government to determine limits of such exclusivity."
Yet if you look at what's being done, they're working in tandem with the pharm. corps to drive prices through the roof and maintain a monopoly on potentially life-saving drugs. It's more important to them that the pharm. corps maintain astronomical fixed costs than it is to have alteratives at much lower cost. That's why they're cracking down on imported drugs from Canada. We're able to import goods such as foreign movies, games, music, etc. etc., just not anything which can undercut their overly expensive drugs.
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Do you believe in the concept of right and wrong - that some things should not be done, even if they're profitable because they might hurt people, or that some things that aren't profitable should be done anyway because they make life better for everyone?
The current economic system and the opportunities it affords the selfish doesn't make it okay for anyone to be a dirtbag.
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True some healthcare is the domain of the rich, nobody today would be able to afford anything if they weren't insured, that is the problem with the system today, if the government doesn't care well then they can't complain when others(countries or their own people) find ways around those monopolies, it will harm the companies more than if they competed fairly in the market in the first place.
The very thing you seem not to realize is that, people will find a way to go around restrictions if they are motivated to do so and I so highly motivated people once they face death.
When the options are die or rob someone, I believe most people will rob others no matter what, it is not prudent or in the interest long term of any company to put others in that position, they will lose, because they are few that is reality for you.
Screw people and they will find a way to screw you back a thousand times over since every single individual will do it to you what you did to them and they vastly outnumber the people who believe are better than others.
That is exactly why governments everywhere subsidize food production and take great care to not let it go down because if it does shortly after riots break out and chaos comes in, is a matter of national security and so is health, no matter what the companies say, no matter what it costs them if it is only for a few the other large part of the population left behind will find a way to counter that and achieve the same results and there is no law that is going to stop people from doing it, they will not die so others can have a monopoly on anything and if you believe people will just roll over and die you are mistaken.
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True, and also very few people can afford treatment for really serious injury or illness even when they do have insurance.
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No it isn't. Not hurting others is everyone's responsibility.
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All valid points. The American people are the ones footing the bill for medical expenses, so it's to the pharm. corps' benefit to keep jacking up prices.
This all reminds me of all those 'donate to help find a cure for X' or other such things. The thing is, there's more money in the disease/ailment than in the cure, so it's in their best interests to prevent cures from ever taking shape. A healthy public is anathema to the medical/pharm industries.
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People need to realize that they are responsible for the quality of care that they receive and taking away the decision to do so, does more harm than good, subsidizing healthcare does more harm than good because than you exclude the need to improve things, the urgency to find solutions and so forth at the expense of the retirement funds that the government was responsible of overseeing and it uses for other purposes.
America is apparently at a breaking point today and I don't know about you, but I am sure not leaving my future in the hands of others to decide I am an acceptable casualty of circumstances.
This is why anything I can produce I will do it myself, food, medicine, cloths, it seems post apocalyptic but I don't see it that way, what I see is a means to reduce the cost of living by learning to do things by myself, since in the future I may need that knowledge, if for nothing else just to have the peace of mind of knowing I will be able to live comfortably if the need arises, it takes away the fear and uncertainty.
If you go to a hospital today they won't let you in for an aspirin if you are not insured that is not good, people should take away the responsibilities for producing the simple things they can and let only the real hard stuff in control of others.
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heres hoping they get it instead.
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So, which part of this system you suggest we should chop? Clinical trials? Make it smaller? Stop paying doctors to run those trials, hoping that they have pure hearts and will work for free? Stop using the qualified facilities to manufacture drugs that use 2-3x safety checks to ensure that what you take is what was prescribed? Yeah, we can make the stuff on the cheap in China, mix it with chalk and sell it to you for a penny. But don't complain if one day your aspirin will fry your stomach and liver. Who's fault that would be?
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Patientslikeme just proved they can do equally or better than traditional means, open source software for that exact purpose is appearing at staggering rates, so could we please make the trials less costly?
I am sure, many people would volunteer to do all the trials that people need if they it was for their own good.
Humanity would greatly appreciate that.
Quality checks today are mostly automated, there is nothing technologically barring people from producing drugs in their own homes, the technical hurdles have been overcome, it is a matter of policy not technology. Distributed production of drugs could greatly improve availability and cost. Basic research is done already with government funding so there would be no radical changes in that area.
About aspirin, did you know that it was a home medicine extracted from the bark of trees?
Mostly the effects you refer too about acetylsalicylic acid comes down to dosage not impurities, how is that an insurmountable problem in any way form or shape?
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Seems about as fair as saying that if the Indian companies continue to be allowed to produce these drugs that "Indian pharmaceutical companies and their shareholders may rejoice if that happens, but many of those who suffer from diseases whose cures are not invented will die as a result."
You can compare company profits to company profits if you want, but the real argument is about saving people now versus saving people later. It may be that the patents don't spur innovation, but if so, that's where the argument should go.
My inclination is that pharma patents do spur research in a way that software patents or various silly obvious patents don't. I could be wrong. But please convince me on that basis.
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And we all know just how poor a lot of these people are in a lot of these Nations.Of all the nerve charging over 5 Grand for Meds while others do it for $163.Like a villager in a village who might make $100 US every month or even a year can go right out and afford.
TPP You are a piece of shit ! Medicines are meant to save lives but our Government has no morals except their moral of taking large Corporate Cash.
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Is Bayer behind Cipla
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$5,128.00
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Bayer should burn
Bayer has made more than enough on this drug already to recoup their cost of development (which probably consists of buying someone else's work at a deep discount, doing some testing, and then marketing it). If they deserved to call themselves human they would be selling it at cost by now.
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