IP law and bird flu

by Henry on February 7, 2007

When I saw this story yesterday in the FT, my first reaction was to wonder what Tyler Cowen would think of it (not only does my mental model of Tyler often sit on my shoulder while I blog, making polite and well reasoned libertarian criticisms of my arguments, but the man has a direct interest in the topic at hand).

Indonesia, the country worst hit by the deadly H5N1 bird flu virus, has stopped sharing human genetic samples of the highly pathogenic illness with foreign laboratories, raising fears it could slow international efforts to prepare for a pandemic. … Officials say Indonesia stopped providing samples internationally last month, hindering efforts to confirm whether the virus killing its citizens is H5N1 and limiting production of vaccines to help prevent its spread. … “all will be revealed” on Wednesday, when Indonesian officials are due to announce they are collaborating with Baxter International, the world’s biggest maker of blood-disease products, on a vaccine.

The answer is that Tyler doesn’t like it much. More generally, I think this is a pretty tough case for people (among whom I don’t count Tyler) who make overly strong claims about the benefits of intellectual property law for the spread of information, the production of drugs and the protection of human well being. At the least, it suggests that there are important instances where these arguments don’t work very well. It also presents some difficulties for those on the left who argue on behalf of giving intellectual property over drugs produced, say, from indigenous plants, to governments in the developing world; while there are still good equity arguments for doing this, there’s no necessary reason to think that these governments will use these rights more wisely or selflessly than big pharma (they’re more likely to be subject to popular pressure, but will often have material incentives that point the wrong way).

{ 1 trackback }

Crooked Timber » » Models of Bloggers
02.08.07 at 3:16 am

{ 33 comments }

1

DC Tax Wonk 02.07.07 at 9:21 pm

Very much off of the topic of avian flu, but entirely on the topic of “overly strong claims about the benefits of intellectual property:” a very recent development in U.S. patent law involves tax practitioners obtaining “business method patents” on “tax strategies.”

(For instance, an estate planner devlopes a structure involving the use of trusts to minimize estate taxes, and then patents it, so that anybody else using the same planning structure either has to pay a royalty to the “inventor” or else is subject to a possible lawsuit for infringement.)

The House Ways & Means Committee held a hearing on this last summer; the Joint Committee on Taxation did a decent overview of the policy issues involved, located on their website here.

2

anon 02.07.07 at 9:23 pm

Interestingly, this particular problem isn’t solved by replacing patents with bounties as an incentive to drug development.

3

abb1 02.07.07 at 9:44 pm

…there’s no necessary reason to think that these governments will use these rights more wisely…

Naturally these governments would have to assume some obligations in exchange for getting these rights.

4

abb1 02.07.07 at 9:47 pm

…for example, the obligation to share human genetic samples of highly pathogenic illnesses with foreign laboratories.

5

Tracy 02.07.07 at 11:08 pm

Abb1, in my experience “naturally” doesn’t have much to do with government policy.

I haven’t noticed those governments arguing for such rights stating that they would take on any obligations in exchange.

6

Peter 02.07.07 at 11:19 pm

Naturally these governments would have to assume some obligations in exchange for getting these rights.

There is a lot of history with pharma and seed companies collecting samples of indigenous species, patenting some portion of the genetic material of those species, then selling them back to those countries for vast mark ups.

BigPharma is going to make big money off any H5N1 vaccine, while expecting countries like Indonesia to selflessly supply the resources needed to make those profits for someone else.

It isn’t just other countries that this happens to. You could look up a court case here in the US about some guy who had hairy cell leukemia, the doctor/hospital who cut the cells out, grew them, then sold the cell strain for several hundred thousand dollars. The patient these came from wanted his share, after all, he paid for the medical treatment in the first place. But the courts disagreed, giving total ownership of this and derivative works to the doctor/hospital involved.

Collectivized costs, privatized profits.

In some countries, it is illegal to export biological samples. They’ve decided they don’t want to be the free source of billions of dollars of profit for big pharma.

7

patent 02.07.07 at 11:40 pm

The patent law is not the problem, it includes already the solution. Or at least in the european patent right, but I believe it is the same in other country too.
Every governement can refuse /suspend a patent/ command a licensing at their condition when it is for the common good.
So they can gently explain baxter and Indonesia they will never make a cent with the patent of the vaccine if they don´t let the scientific community take part to the sweepstake. Right.Now.

The problem is the lobbying of the big companies for distorting the IP laws, and the willingness of the goverment to abide to it.

8

derrida derider 02.07.07 at 11:50 pm

AS for giving IP on indigenous plant based drugs to governments, you don’t have to be a raving small government person to see that this is most unlikely to help any indigenous people. The right is wrong on many things, but not about the general incompetence and often active malevolence of Third World governments.

9

Michael B Sullivan 02.08.07 at 12:48 am

This is the first I’ve heard of this issue, so it’s likely that I’m missing some nuance. However, from just what I read above, there seems like there’s a weird underlying assumption: that the Indonesian government has some kind of monopoly on all infected tissues of its citizens.

That’s pretty wack.

I mean, shouldn’t it be the case that anyone who’s interested in getting these kind of samples can negotiate directly with the infected individuals or their families? If we presume that right exists, doesn’t that make the entire problem go away? I would think that we’d get a situation where the supply outstrips the demand, and thus even the WHO or whatever interntional altruist organization is referenced above would have the means to obtain all the samples they want.

10

anonymous 02.08.07 at 2:19 am

[highly offensive comment removed]

11

eudoxis 02.08.07 at 4:53 am

Does IP law cover naturally occuring viruses? I thought not, but governments act in their self-interest anyway. China withheld viral seed samples for a while, too, insisting on proper credit for their researchers. For sharing information, however, as the WHO claims, only sequence data is necessary, not a live seed sample.

12

RS 02.08.07 at 2:36 pm

IP law covers your genome, the virus has no chance.

13

eudoxis 02.08.07 at 2:49 pm

The point is that governments do what they want to do without the help of IP protection. You see, it’s companies that need IP protection, not countries. The issue here, it seems to me, is that Indonesia sees its strains of the H5N1 as a valuable resource and this would be the case without the involvement of IP law. The WHO can’t compel a country to freely share its resources and it may end up having to pay for it. Other countries may follow suit. It’s not that Baxter stands to make a profit from a functional vaccine (even it will do so), it’s that Indonesia stands to make a profit because it has a resource that the rest of the world wants.

14

RS 02.08.07 at 2:59 pm

eudoxis, surely it is only one more step to biological warfare + vaccine of the evil mastermind variety?

15

v-tach 02.08.07 at 4:02 pm

Oh, come on! Who in Indonesia stands to make a profit from this policy? The infected patients? The “indigenous peoples” of Indonesia? The Ministry of Health? Or…Someone in the Indonesian government who got a kickback from Baxter?

16

abb1 02.08.07 at 6:11 pm

It’s not that Baxter stands to make a profit from a functional vaccine (even it will do so), it’s that Indonesia stands to make a profit because it has a resource that the rest of the world wants.

It’s not that Baxter stands to make a profit, it’s that Baxter stands to make Incredibly Huge profit.

17

Michael B Sullivan 02.08.07 at 6:44 pm

Seriously. Does anyone know why the WHO can’t just go to individual people affected by the bird flu and get/buy samples from them directly? Anyone?

I don’t think that you can meaningfully talk about anything else on this issue until you have an answer to that question.

18

RS 02.08.07 at 7:46 pm

Because they are very very sick and it is impractical let alone unethical?

19

abb1 02.08.07 at 7:48 pm

Because they are in hospitals? Quarantined, perhaps?

20

Michael B Sullivan 02.08.07 at 8:54 pm

rs: It’s “unethical” to get disease samples from sick people? That’s just a baffling sentiment.

As to rs’s “because it’s impractical,” and abb1’s “in hospitals/quarantined,” a few comments.

1. Do you know this, or are you guessing? I mean, I could guess, too, but obviously you just confirm your own biases.

2. The shared hypothesis that you seem to be advancing is “there is no one stopping the WHO (or whomever else) from obtaining disease samples, it’s just that there are practical/logistical difficulties with doing that.” Let us assume for the sake of argument that this is true.

If that is the case, then it seems to me that the cause of this failure is that our international medical institutions can’t get a few doctors on the ground in a less-developed country to do their fieldwork. I submit that people being in a hospital somewhere (or even in quarantine) should not pose an insurmountable obstacle to sample collection on behalf of a multi-national first-world effort to get samples. If it currently is an insurmountable obstacle, we should change the WHO until it is not. How hard could this possibly be? Get them a few dozen permenant staff with medical training? Some biohazard suits? Facilitate volunteer doctors (and don’t tell me that there aren’t some altruistic doctors in Indonesia who would be willing to do sample collection for the WHO) hooking up with the organization so that it can use their expertise? Whatever the problem is, it MUST be solveable, and it’s doubtless solveable via a great deal less effort than changing IP laws or altering drug markets or whatever.

Let me throw out a few other possible causes for the WHO’s inability to deal with individual patients:

1. Their ability to do so is being actively obstructed by the Indonesian government, at the urging of Baxter, which stands to profit from having a monopoly.

In this case, the proximate cause of the failure is that a government is interfering with some basic liberties of its citizens. First world democracies should be pressuring Indonesia not to do this via diplomatic and economic means. The second-order cause of the failure is that a corporation is trafficking in human misery. It should be illegal for corporations to attempt to obstruct data collection by international altruistic organizations.

2. Some kind of wacky IP laws means that the WHO can get the physical samples, but is legally barred from using them because Baxter now owns the copyright or something like that.

In this case, the solution is straightforward: reform the IP laws which allow this. (It’s simply inane to suggest that there’s any benefit to allowing someone to own a genome that they didn’t create, anyhow).

3. There are so few people infected that really there are only enough physical samples for one organization to use.

In this case, we’d have to question whether there definitely is a failure. I mean, if only one organization can get samples, on what basis do we say, “this is the one that ought to get them”?

21

abb1 02.08.07 at 9:50 pm

Michael, I’m pretty sure WHO normally doesn’t even have its own field staff, they operate via local governments.

Now, there are international organizations that do have field offices all over the world, but they certainly don’t go around on their own collecting samples or doing anything the local government doesn’t want them to do. Their work is based on cooperation with local governments, that’s Rule Number One. All it takes to stop them is one phone call.

22

Michael B Sullivan 02.08.07 at 10:15 pm

abb1 writes:

Michael, I’m pretty sure WHO normally doesn’t even have its own field staff, they operate via local governments.

And doesn’t that strike you as a criminal failure? I mean, let’s ignore the perfidy of many local governments, and just concentrate on their incompetence. Who strikes you as more likely to have the organizational expertise to gather disease samples: the WHO, or the Indonesian government? Or the Chad government, or the Somali (cough) “government”?

I mean, not to pick on the WHO in particular. Maybe they aren’t the organization for this, but it seems to me that relying on local governments as the sole point of access for anything international health related is just stupid.

Now, there are international organizations that do have field offices all over the world, but they certainly don’t go around on their own collecting samples or doing anything the local government doesn’t want them to do. Their work is based on cooperation with local governments, that’s Rule Number One. All it takes to stop them is one phone call.

Yeah, this is the scenario that I judge most likely, too. Someone in the Indonesian government stands to profit from Baxter having a monopoly on disease samples, and so they deny anyone else access.

And this should be handled as a human rights violation, and an egregious one. No government has any business telling its citizens “you can’t voluntarily participate in an international search for a cure to a deadly epidemic.” Frankly, no government has any business telling its citizens that they can’t sell samples of their own blood or whatever to anyone for any reason. It’s an issue of having control over your own bodily integrity, and, in this case, a high-stakes issue.

If it is the case that the Indonesian government is blocking sample collection, then governments of industrialized nations should be saying, “This is bullshit,” and pushing hard in the diplomatic sphere to get the Indonesian government to reverse its course.

Secondarily, it would be a good idea to try to prevent corporations like Baxter from inciting governments to this kind of malfeasance. But that’s secondary because, a.) it’s going to be difficult to do in a universal way, or to catch people at it, and b.) the corporate actions are not in and of themselves sufficient to cause the problem. The governmental actions are.

23

jeremyb 02.09.07 at 11:38 am

Michael, the central issue here is not kickbacks but access to medicines in the event of a pandemic. If all things remain equal, Indonesia and other countries on the front line will continue to provide crucial samples to the WHO, but will never see any of the vaccines that result.

Developing countries have been trying the ‘good faith’ approach to resolving this over the last couple of years, and a crucial point was reached at the World Health Assembly last June when Thailand proposed an amendment to the international sample-sharing agreement on influenza viruses, saying they could be used for non-commercial purposes only. This was an attempt to separate out the international pooling of scientific information from the business of profiting from unequal distribution of vaccines. But it failed. There’s a report on that meeting here: http://www.twnside.org.sg/title2/health.info/twninfohealth024.htm. As it says, Thailand believed the final compromise…

“was a win-lose solution where the winner was developed countries which can produce vaccines and the loser was developing countries which cannot access the vaccine, whereas it is the developing countries that are submitting the flu strains to the WHO collaborating centers.

Thailand however said it did not want a lose-lose situation where no one has the vaccine and everyone dies.”

In this context, Indonesia’s move, while short-termist, may actually have a positive effect for its citizens if it strengthens the hand of developing countries in future negotiations. That’s not corruption, that’s defending its national interest.

24

jeremyb 02.09.07 at 11:39 am

25

Michael B Sullivan 02.09.07 at 5:58 pm

Jeremy writes: Michael, the central issue here is not kickbacks but access to medicines in the event of a pandemic. If all things remain equal, Indonesia and other countries on the front line will continue to provide crucial samples to the WHO, but will never see any of the vaccines that result.

Actually, the central issue of the article under discussion did very much seem to be providing the samples, not who gets the eventual medicines or vaccines.

In this context, Indonesia’s move, while short-termist, may actually have a positive effect for its citizens if it strengthens the hand of developing countries in future negotiations. That’s not corruption, that’s defending its national interest.

So your argument is that by selling its samples to a private corporation rather than giving them to the WHO, Indonesia will place itself in a better bargaining position for getting the eventual fruits of the research (if any)? I’m not sure how that follows.

26

RS 02.09.07 at 6:36 pm

Michael, all this talk of special WHO teams on the ground is just silly – an elite international team of capitalist phlebotomists storming through the hospitals of a hostile government wearing bio suits and respirators is not a rational fantasy.

H5N1 is an airborne droplet transmitted illness with a 50% mortality rate and potential for a pandemic – of course patients will be in quarantine and informed consent will be very difficult to obtain from such sick people, let alone permission from the clinicians to go harrassing their isolated patient. Once they’re better the viral load will be low to non-existent (or they’ll be dead).

A fairly small number of people worldwide have been affected by the virus, only 81 in Indonesia (~50 last year), and confirmation that it is H5N1 requires antigen testing in a suitable lab – therefore the most practical way to obtain samples is retrospectively from the treating physicians or normally you’d send samples off to the WHO reference labs who are tracking the epidemiology worldwide (as they do with many other disease, including normal flu).

27

RS 02.09.07 at 6:43 pm

It is pretty unlikely that the WHO data would be in any way proprietary – for instance, currently the seasonal flu data is made available to commercial concerns to make vaccines, but it is not marketed as a commodity in and of itself.

So Indonesia’s position is that it couldn’t afford to buy any vaccine (because supply would initially be limited, and thus the price high) but if it prevents the WHO getting the samples and sells it to a commercial concern then that concern will give them preferential access to the vaccine (although probably at the risk of reduced production capacity for the rest of the world because the vaccine would be proprietary). So it seems very much like a win-lose situation.

28

Michael B Sullivan 02.09.07 at 7:14 pm

rs: “Michael, all this talk of special WHO teams on the ground is just silly – an elite international team of capitalist phlebotomists storming through the hospitals of a hostile government wearing bio suits and respirators is not a rational fantasy.

You are seriously trying to make the argument that the entirety of the concerned industrialized world is simply incapable of getting tissue samples from sick people, but that Indonesia apparently has no difficulty with doing so?

That’s just insane.

29

RS 02.09.07 at 9:01 pm

How about an experiment. Go into your nearest hospital and try and get a blood sample off someone with miliary TB (legally) without getting yourself banned or in court. That should be much easier, they aren’t that contagious and the government hasn’t just declared itself hostile to your actions.

30

RS 02.09.07 at 9:08 pm

Sorry Michael, I shouldn’t be goading you, but seriously, you have no idea what you’re talking about here. Medicine does not work the way you seem to think. Indonesia has no trouble getting the samples because they run the country and have access to them, the WHO does not because the health care sector (fortunately) is not some crazy free for all where you can track down ITU patients and harrass them for samples, without government and by extension hospital cooperation you cannot carry out a surveillance programme.

31

eudoxis 02.09.07 at 9:36 pm

IP law covers your genome, the virus has no chance.

The virus is free to mutate or infect any fowl or mammal it can. Irrespective of IP law.

As it stands, there isn’t a single H5N1 strain out there today that can trigger a human avian flu pandemic. Until a reassortment or other mutation event occurs that allows the H5N1 to be transmitted between humans, there is no avian flu pandemic. And, there is no indication that this event will occur in Indonesia. The primary concern is that with the large epizootic infections concentrated in countries where people keep birds for food, the probability of such an event occuring is very high.

Indonesia has done this sort of thing before. Last year it withheld both avian and human samples from the WHO for many months and then ended up giving the WHO 91 samples for sequencing. The WHO passed some of those strains to other entities, including an Australian pharmaceutical company that produced a vaccine with one of them. Indonesia is trying to recover money(not vaccine rights) from that company.

Delays in sample and information sharing have been an ongoing problem with the avian flu samples and sequences.

There are numerous companies making avian flu vaccines. In the end, however, there will not be a vaccine specific for the strain that causes a human pandemic and a wild scramble would most likely ensue. Containment and antivirals will be effective strategies at that time.

32

RS 02.09.07 at 9:56 pm

We don’t know that the vaccines made with H5N1 avian strains will not protect against a human H5N1 variant should it arise – on the other hand we don’t know that it will either, the possibility remains that the H5N1 pathogenicity may be transferred without the antigens (say through antigenic shift).

I wouldn’t depend on anti-virals, there’s already evidence for H5N1 resistance in Vietnam.

33

RS 02.09.07 at 10:41 pm

That should be: “…there’s already evidence for H5N1 resistance to oseltamivir in Vietnam.”

Comments on this entry are closed.