Brazil Voids Merck Patent On AIDS Drug
JoeBackward writes "Merck has this useful anti-AIDS drug Elfavirenz, and Brazil has lots of poor people with AIDS. So, after trying really hard to get Merck to cooperate on pricing, the Brazilian government has decided to take a 'compulsory license' to the patent, and get the drug from a factory in India. This compulsory license is basically a way to take the patent by eminent domain." This move gives Brazil one more thing in common with Thailand, both of which have blocked YouTube. Thailand's compulsory licensing of Elfavirenz and Plavix has landed the country on the US's watch list for piracy.
it s nice to see humanity win one for a change
who can really put a price on that?
back in the day we didnt have no old school
you know what else Brazil and Thailand have in common? A boisterous tourism industry and hot girls. Seriously, what does youtube have to do with this story?
this is not about humanity. the only reason this drug even exists is becuase money was able to be spent on R&D to create or discover the compound. Brazil has just put another nail in the coffin of innovation by this move: if a company cannot make money from a discovery or invention the amount of both will decline.
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I wonder what the endgame might be out of situations like this.
Right now, my understanding is that to produce and get approval for a drug, you need to release its chemical formula and other information about it.
But I wonder if at some point in the future, if the drug companies get too worried about their profits due to genericization in countries like Thailand and Brazil, that they might try to implement some sort of "drug DRM." Rather than making the composition of the drug open, don't release what's actually in it, and just test it as a 'black box,' show empirically through tests that it's effective and reasonably safe, but dope the actual pills with a lot of random substances that make it difficult to reverse-engineer (or have the actual drug only be something that's produced in the body through subtle combinations of various things in the pill, or keep the methods of producing the various chemicals in the pills a secret). I'm sure there are lots of bizarre ways that the drug companies could think up to protect the compositions.
Now, I'm not saying that any of these schemes would be effective at protecting the composition -- if the market for a generic drug is big enough, the labs in Thailand can probably afford to spend a lot of time with a mass spectrometer/gas chromatograph and unravel it, but that doesn't mean the drug companies wouldn't try, and waste a lot of time and effort in the process.
As we've seen in the battles over digital IP, there are a whole lot of things that can end up as collateral damage in the fights between rightsholders who see the gravy train slowing down, and people who want their products at a lower price than is being offered.
"Ladies and gentlemen, my killbot features Lotus Notes and a machine gun. It is the finest available."
what happened was this: merck had the AIDS drug and Brazil tried to negotiate it at what they could afford, merck declined, Brazil then told merck to screw themselves and got the drug anyway. it isn't so much an attack on merck's ability to make money off its own research as it is the idiot practice of denying DYING people medical treatment for the sake of said profit. moral of story: better to negotiate then to be bypassed.
Sigs are too short to say anything truly profound so read the above post instead.
I remember seeing that "Brazil blocks Youtube" thing on slashdot, but seriously, I tested it back then, and there was no block, I talked to everyone I know, and they also noted no block. Not that one wasn't issued though, it probably was never enforced.
It was a BS case anyway, it was a public beach, everyone was there to see them having sex. If anyone was breaking the law, they were. Of course, with the justice system here as corrupt and moronic as it is, those kinds of rulings aren't surprising. Believe me though, 100% of the Brazilian people would be against any sort of ban.
Because they're too busy farming your coffee and sewing your clothes for $3 a month?
Idiot.
As they say: necessity is the mother of innovation. As long as we have a need for medicine, someone's going to do the research to look for it. It may become less easy to justify spending millions in funding and make millions in profits off of discoveries, but that doesn't mean that innovation will stop.
This move gives Brazil one more thing in common with Thailand, both of which have blocked YouTube.
This is a warped comparison... AIDS will hill hundreds of millions of people in our lifetime. YouTube is a floofy website. AIDS will still be a problem in 20 years. YouTube probably won't exist.
How are these two situations related, exactly? Are you trying to make some comparison because both involve "Intellectual Property"? If so, you failed.
Besides, even though they're not White Anglo-Saxon American Protestants, most Brazilians are people (some, of course, are special haircuts in your no-no zone), and if I have to choose between a lot of people dying and a bunch of lying thieves (converting gov't research money into private intellectual property for mega-corporations is evil in my opinion) getting richer, well, I'm going to pick the people (some of whom are always also going to be lying thieves), because I'm like that.
Honestly, though, it's the 21st century. As a race, humanity can do so much more for each other than this. Shrill cries of, "Let's give Merck our cash!" or "Pure capitalism would have fixed this!" just bother me. Capitalism is a good system, but it isn't magical, and we should try to avoid using it to price out a human life, or its span. Can we always avoid that? No, we're not on Star Trek. But it's nice to occasionally give it a try.
These countries are treading on a slippery slope. At what point is it OK now to not pay for the hard work of other people, or to begin to directly steal from them? If this happens enough the company will go bankrupt as correctly pointed out by the parent comment. There will always be someone else who can justify why their need is to get/steal/borrow what they need to a greater and greater extent.
Yes I know that giant pharm firms spend a lot on advertising, but it also costs approximately one Billion dollars to get a single new drug to the marketplace (that's $1,000,000,000 !!)
Pricing is a problem for the third world countries, probably because it takes so many resources to make that product.
Now please pay attention - I'm not saying that Brazil is unjustified in it's taking of the drug and helping those people, but rather that there needs to be some limits so that this behavior is not abused, and ruins it for everyone. This sounds like a good problem for the U.N.
..........FULL STOP.
Won't happen, because the companies will spend a lot of money on lobbying against it. If it was created, it would mean the end of them, so they'd do whatever in their power to prevent it.
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Year 2001: 5 (five) US citizens die in Anthrax scare. US government immediately starts proceedings for compulsory license for Cipro, wrestling the patent rights away from foreign company and competitor Bayer. This stance is widely praised as proactive and protecting the precious lives of US citizens.
Year 2007: Tens of thousand of people die in Brazil each year from AIDS because they cannot afford patented medication. Action from Brazil to force compulsory licensing is widely denounced as destroying the worldwide pharma industry, especially by US commentators.
Well...
Stop believing big pharma's FUD.
There are several significant factors undercutting this supposed billion dollar price tag. The first is that AIDS research has received significant public funding, and second is that antiretroviral drugs have the shortest time to approval of any class of drugs, approximately half the time of normal clinical trials (the mean time for antiretrovirals is 44.6 months, compared to an industry average of 87.4 months).
See this report from Doctors Without Boarders for more information.
The people who did the work got paid. Its the corporation who is getting ripped off, not any people.
Reality has a liberal bias
A-haha, haha... [tear] I would like some of that stuff you are smoking.
Mentioning stealing is just a troll. And it is perfectly OK not to pay people when they do not work for you. I live in US, and even here I believe that these people do not work for me. I'll pay them for the research results when I can tell them what to do. Why should Brazil or anyone else suffer if they think that medical patents are stupid? If medical patents are as awesome as you think, shouldn't we just wait a few years and see the Brazilian economy shatter? Oh, wait, you say, patents do not work this way. Americans will actually be in a crippling disadvantage if they have patents and no one else does. Well, duh. That is because sharing knowledge is more productive than creating scarcity where there is none.
Patents are government-granted monopolies. It is not an absolute right and has to be balanced against the need of the People.
Reading this news as a fight between corporate greed and governmental greed is the wrong way to look at that. Right or wrong, you try to choose the lesser evil. Everyday the little citizen get crushed for reason of State, for once it is a big pharma that pays the price.
BTW, the pharma spammer are quick on the button today. Disgraceful.
ID: the nose did not occur naturally, how would we wear glasses otherwise? (apologies to Voltaire)
If drug companies invested a significant percentage of their revenue on research. They don't (about 5%). It's *far* more efficient to give the money that would be spend on non-generic drugs to university research programs.
Indeed. And when we're bankrupt we can go back to the rest of the world for help, right?
Right?
I have nothing against capitalism as a rule, and I'm not naive enough to believe in some twee fantasy World where life-saving medications are free for everyone all around the World. That said, setting a price point on what is an ESSENTIAL medication of $1.59 per pill when the same company already sells the same product to another country at $0.65 per pill is disgusting. Merck are (or were) essentially holding the Brazilian peoples lives to ransom.
If Merck can afford to sell the product to Thailand for $0.65 and still make a profit (clearly as an Indian company can sell it for $0.45 and turn a profit themselves) then there is no reason whatsoever other than pure capitalistic greed why they could not have given the same offer to the Brazilian government. Don't forget we're not talking about the variable domain costs of marketing and staffing, the government is the customer - how the Brazilian government then choose to distribute/market the treatment is their decision and at their cost.
There are a great many products around the World that are sold for different prices to different regions, but in practically all cases you can permit the corporations involved some latitude simply because the products they're selling are luxury or otherwise non-essential. Gouging a customer with a 300%+ markup on a life-saving drug when you know the customer/market HAS to have it is disgusting.
Let's not forget that the research dollars that went into developing this particular drug came from U.S citizens.
I don't think this is a sign of "erosion of respect in American patents", this is after all the first time the Brazilian government has even invoked the power of "eminent domain".
From the Article:
Other countries, including Canada and Italy, have also used a clause in World Trade Organization rules to flout drug patents in the name of public health.
Under WTO rules, countries can issue a "compulsory license" to manufacture or buy generic versions of patented drugs deemed critical to public health.
the Brazilian government has decided to take a 'compulsory license' to the patent, and get the drug from a factory in India. This compulsory license is basically a way to take the patent by eminent domain.
A "compulsory license" is not the same as "taking a patent", it's a compulsory license, as the name implies.
Furthermore, the term "eminent domain" simply doesn't apply to patents because patents aren't "private property". Patents are temporary monopolies granted by the government for a specific purpose, and revoking that grant when the patent doesn't accomplish its purpose is not the same as taking away "private property". The only thing the government is ultimately obligated to observe in the granting and revocation of patents is that it is done non-discriminatorily.
Trying to equate a patent grant with private property is ideological bullshit; don't fall for it.
The only company that could make it under license could only make a certain amount per year, and had no capacity to ramp up. They screwed around, claiming they could (but did nothing in particular). If they'd stepped forward and produced enough for the need, the US government would have happily paid the price.
The compulsory license wasn't about cost. It was about capacity. And the US DID pay a license fee to the company, instead of outright theft, as Brazil is doing.
On the other hand, with the amounts involved, if it was just a matter of a billion dollars to develop an AIDs drug, why didn't Brazil create their own and license it for free?
Oh, yeah - that billion dollars was for a SUCCESSFUL drug. They kinda left out the other hundred compounds they looked at, and the ten to twelve they actually tested, before the drug companies found that one drug that worked.
Then you get the ones that work, but turn up side effects when they get past trials. Vioxx, for example. major drug, well-liked by 99% of its users, and it wasn't until after they got it out into the open market that the (theoretical) side effects were noticed - and they were, truly, minor for pretty much everyone (tiny increases in health risks, and no actual deaths or injuries tied to the drug). And it was banned. Huge loss for the company.
Total actual cost to find a high-quality, high RISK new drug for a major disease, with full trials and liability coverage? Closer to five or TEN billion dollars...
Cost to produce some of these drug combinations? That's another story. Some of these chemicals take huge investments in machinery to even make, and the precursor chemicals alone put the price at ten to twenty cents per pill. Actual manufacturing can push the cost to simply produce one pill for some drugs into the multi-dollar range.
The drug's name is Efavirenz not Elfavirenz. The stupid troll couldn't even get the name right.
- Sales revenue: 22,636.0
So where does the money go?- Manufacturing costs: 6,001.1
- Marketing & adminstrative costs: 8,165.4
- R&D: 4,782.9
Only 20% of the price of each pill goes toward future research and development... Marketing & administrative costs are double that. Ouch.This is really total bull shit. Drug companies spend very little on R&D and most of their expenses are marketing, legal, insurance, and obscene bonuses for executives.
Eminent domain is needed for cases like this where the need of the people outweigh the need for a ceo to trim his jet interior in pure gold.
Good for Brazil
* Carthago Delenda Est *
Here's a Kaiser study - the$ billion dollar amount is only the R&D /FDA trial costs. What about when companies get sued by lawyers for billions of dollars for crap lawsuits - I.E. Dow chemical for silicone breast implants - bankrupted for no definite scientific evidence, and now people are using them again.
d ex.cfm?DR_ID=17747
The Vioxx lawsuit is costing Merck between 4 and 30 billion$ for some shaky scientific evidence. There were perhaps 300-400 people who doctors though had deaths DIRECTLY contributable to Vioxx - now remind you , many of these patients had crippling arthritis, pre-existing cardiac conditions, were over 70 years of age. I've had patients tell me that they take up to 4-5 times the recommended doses of pain medicine sometimes. Do you think the lawyers, or clients mention that - of course not - they want their easy money. Do you think many of those people would have died anyway? - probably.
IF you are involved in medicine, and have some money, you will get sued. Every doctor and pharmaceutical company does, and the cost gets passed on to everyone else in the form of a 65 cent pill, as opposed to a 30 cent pill. THese class action lawsuits make multi millions for many law firms, because enough people in menial jobs don't want to work anymore , and are "injured, or think they are" (actual line I heard from an ambulance chaser commercial).
Link to Kaiser/Tufts study supporting the billion dollar R&D/FDA cost per new drug below.
http://www.kaisernetwork.org/daily_reports/rep_in
..........FULL STOP.