Ben, the black market is the answer to your question. Differential pricing really doesn’t work. You cannot sell a lot of a medication in South Africa for a tiny price, and realistically expect none of those subsidized pills to appear in southeastern Europe, which is able to pay five times the amount, or in the UK, which able to pay ten times the amount.

If the price in the developing world is less expensive than creating a manufacturing facility to make generic version, the developing world simply gets all of its pills “stolen” by drug traffickers — traffickers that operate exactly like the meth makers in the developed world, who find that hiring someone to buy two boxes of Sudafed from each pharmacy in town is a perfectly profitable model. There will always be some poor woman who thinks that this week’s supply of pills is less important than this week’s supply of food for her children. Various schemes are being attempted to reduce this (including only dispensing a single day’s pills at a time, or marking the pills to look different), but it still happens.

I’m on a medication that runs US$10 per day. The “affordable”, “patent-free” price in most of the developing world would be much closer to ten cents. Don’t you think, that for a gross profit of US$9.90, you could figure out how to get a half a gram of pills from South Africa or India to the US?

Your article has been picked up over at Techdirt, where they claim that those figures have been “widely debunked”:
http://www.techdirt.com/articles/20090909/0412576143.shtml

Of course, they are as guilty as anyone else of readily believing “facts” that support their opinions and discounting those that don’t, so it would be interesting to get a feel for how authoritative/unbiased/reliable the figures are.

I guess the real answer is going to be “a lot”, regardless…

Yes completely unreasonable!¹ – and not actually the (sole) ‘reason’ given for any of the numerous term extensions since the Statute of Anne anyway AFAIK.

“I am not aware of any good alternatives.”

As far as pharma is concerned, nor am I, but I know other people have been thinking about it² and we certainly shouldn’t assume that we are getting a good deal the way things are now³.

¹ James Boyle’s book: http://www.thepublicdomain.org/ very good on copyright and copyright folly, poor on patents and patent folly.

² http://www.sanger.ac.uk/Users/th/
³ http://www.dklevine.com/general/intellectual/againstfinal.htm (Chapter 9. Sobering.)

Copyright and Patents are completely different things. Copyright is a right not to have a specific work you have produced copied by anyone else. The term was decided upon so as to allow the right to be transferred to your grandchildren (as it was believed any heirs who actually knew you should be allowed to benefit from your work). Arbitrary I know, but not completely unreasonable. Patents on the other hand are a monopoly right. That’s not just copying. Even if someone else comes up with something independently which is within the scope of your patent they still infringe. I don’t know where the term for patents comes from but it may have something to do with the likely period you could keep an industrial secret for or the pace of innovation perhaps. Whatever it is, the breadth of the monopoly right means that it should always have a
much shorter term than copyright.

Second point, I feel I must challenge the “millions of deaths due to the patent system” comments made above. Overpricing of medicines is surely a reason why some people die in the developing world but it’s not everything. It would be difficult for the poorest countries to by even generics. This is a common problem when people talk about the world’s poor, a single problem is singled out and its impact is overemphasised. If we all feel so strongly about the 96% of the population of the earth who are poorer than us (no reference, might be made
up) then we need more general action to make the world fairer.

Incidentally, surely we have a valid argument in the UK against the price of certain medicines? We have the NHS, which has a finite amount of money, and big pharma, who are accused here of making money hand over fist from the same NHS. So when NICE has to decide which of two medicines to make available because they are both expensive, shouldn’t we blame the patentees? It seems to me that the general problem people have is that big pharma are making lots of money. If we want to stop them profiteering in healthcare in general then we should say so, but we should also suggest a genuine alternative to profit for stimulating innovation. I am not aware
of any good alternatives.

Look at the problem like this: I, as an academic, have discovered what may be a revolutionary treatment for AIDS. In order to turn that into a drug that can be given safely to patients and to prove that it actually does work I need to go through the preclinical, and Phase I, II and III clinical trials. I have to find a way of producing a drugable substance from my initial material i.e. one that can be ingested/injected and will ensure that the active ingredient gets to the target site. I also need to develop a manufacturing route of appropriate quality and consistency and then go through the long bureaucratic process of gettin gthe drug approved for sale.

I ask the bank for a loan (I will need about $500 to 800m for about 5 to ten years). The bank asks for the business plan, I tell them that if successful the product will sell $1b per annum whilst under patent (max 10 years)at possibly 15% margin but if unsuccessful (which might happen at any point in the development chain) all the money will be lost (every single $).

Currently there are investors out there that will take that risk. Now change the plan slightly and add – “Oh, by the way we may actually have to give the drug away at cost price for ethical reasons, or our patent may only last for 2 years not ten, or an Indian generic company may decide to break the patent and flood the market with cheap copies. The investors will drain away like water into the desert sand.

Remember that these costs & risks apply to any new drug regardless of who is involved academic, government or private company.

Volvo did not patent the three-point seat belt because they felt it would be invidious to do so. The transnational drugs companies come out of this looking like the bad guys – but I guess that is nothing new to them.

Even the most misguided (but not completely ignorant and irrational) defenders of the patent system I’ve come across haven’t been foolish enough to try to argue that the appalling folly of copyright term extension makes or has made a greater case for (general) patent term extension.

“I have to say that there is something completely nuts about patents being limited to, what?, twenty years, while copyrights are easily extended for more than ninety. Doesn’t Disney hold rights to what is essentially public domain fairytales by now (H.C. Andersen for instance)?”

I made this point in a previous blog post. Unfortunately, as copyright terms are extended perennially, it makes a greater and greater case for potentialy extension of patent laws. After all, what is Congress supposed to say to the pharma company who brings up the point that Britney Spears’s work is protected for for 120 years from release – 12 x longer term than a lifesaving drug?

I know that most people think that because drugs are so important, laws would never be passed to extend the patent because it could hurt people. But what kind of ground is it to stand on to say that “we punish the scientists (relative to the musicians) because their work is so important”? It’s almost enough to make me throw The Fountainhead at somebody.

“Someone might steal the drug” ..

When in FACT .. ? .. all it is is a .. ? .. phytol .. ?

” m-chlorocres-ol ”

They tested one of the drugs which is very good in malaria and found
almost ALL of its’ efficacy was due TO .. ? .. the preservative they
added.

Out of TWELVE substances IN the drug what did they find .. ?

“Virtually all activity was m-chlorocresol included as a
preservative”

Antileishmanial activity of sodium stibogluconate fractions.
Antimicrob Agents Chemother. 1993 Sep ;37 (9):1842-6 8239593
(P,S,G,E,B)
W L Roberts, P M Rainey
Department of Laboratory Medicine, Yale University, New Haven,
Connecticut 06510.

Sodium stibogluconate, a pentavalent antimony derivative produced by
the reaction of stibonic and gluconic acids, is the drug of choice
for
the treatment of leishmaniasis.
It has been reported to be a complex mixture rather than a single
compound.
We separated sodium stibogluconate into 12 fractions by anion-
exchange
chromatography.
One fraction accounted for virtually all the leishmanicidal activity
of the fractionated material against Leishmania panamensis
promastigotes, with a 50% inhibitory concentration (IC50) of 12
micrograms of Sb per ml; that of unfractionated sodium stibogluconate
was 154 micrograms of Sb per ml.
Further analysis of this active fraction revealed that a major
component was m-chlorocresol, which had been included in the sodium
stibogluconate formulation as a preservative.
The IC50 of pure m-chlorocresol was 1.6 micrograms/ml, a
concentration
equivalent to that present in unfractionated sodium stibogluconate at
a concentration of 160 micrograms of Sb per ml. After ether
extraction
to remove m-chlorocresol, the IC50 of sodium stibogluconate was >
4,000 micrograms of Sb per ml.
In contrast, when L. panamensis amastigotes were grown in
macrophages,
the IC50 of ether-extracted sodium stibogluconate was 10.3 micrograms
of Sb per ml.
The 12 fractions of ether-extracted sodium stibogluconate obtained by
anion-exchange chromatography had IC50s of 10.1 to 15.4 micrograms of
Sb per ml.
We conclude that preservative-free sodium stibogluconate has little
activity against L. panamensis promastigotes but is highly active
against L. panamensis amastigotes in macrophages.
This activity is associated with multiple chemical species.

Mesh-terms: Animals; Antimony Sodium Gluconate :: chemistry; Antimony
Sodium Gluconate :: pharmacology; Antiprotozoal Agents ::
pharmacology; Cell Line; Chromatography, Ion Exchange; Cresols ::
pharmacology; Leishmania :: drug effects; Leishmania :: growth &
development; Leishmania :: metabolism; Macrophages :: drug effects;
Macrophages :: microbiology; Mice; Microbial Sensitivity Tests;
Spectrophotometry, Ultraviolet; Support, Non-U.S. Gov’t; Support,
U.S.
Gov’t, P.H.S.; Uracil :: metabolism

Ben, there seems to be a rash of Guardian articles about the swine flu vaccination that are bringing up the whole GBS thing again. Even Dr Crippen is referring to the vaccination as ‘untested’, when it’s simply a slight variation on the standard flu vaccination issued every year. I have nurses using these articles as justification for not having the vaccine, putting patients in my emergency department at serious risk.

I know it’s rehashing old territory, but any chance you would consider a rebuttal to this crap? i am running out of patience and I’m going to start screaming soon…

Currently investors put money into drug development because, although it is a risky business (only 1 in 100 potential drugs actually makes it to the market) there are considerable rewards to be made from the few successful drugs in their first 10 years of sales. After 10 years all drugs are patent free and relatively cheap.

If there is no patent protection there is no incentive to invest (that was Ben’s point). My point was that if patent protection is not global, then for easily exportable high value products like pharmaceuticals, patents are almost worthless.

The system is by no means perfect and alternative mechanisms are needed to ensure maximum availability of new medicines whilst preserving appropriate rewards for those who risk the necessary finance. I don’t think governments would be willing to take the risks.

The situation w.r.t. parallel imports is largely orthogonal to the question of patent protection in the third world. Patenting cannot stop legal arbitrage. It’s also a rather more complex situation in other ways:

http://www.wipo.int/about-ip/en/studies/pdf/ssa_maskus_pi.pdf