Why TPP Threatens To Undermine One Of The Fundamental Principles Of Science

from the and-that's-a-fact dept

Mon, Aug 10th 2015 11:03pm — Glyn Moody

Last week, we wrote that among the final obstacles to completing the TPP agreement was the issue of enhanced protection for drugs. More specifically, the fight is over an important new class of medicines called "biologics," which are produced from living organisms, and tend to be more complex and expensive to devise. The Conversation has a good feature looking at this issue in more detail. The central problem with biologics in TPP is "data exclusivity," which the article explains as follows:

Data exclusivity refers to the protection of clinical trial data submitted to regulatory agencies from use by competitors. It's a different type of monopoly protection to patents. While a product is covered by data exclusivity, manufacturers of cheaper follow-on versions of the product can't rely on the clinical trial data produced by the originator of the drug to support the marketing approval of their product.

Section 25a of Australia's Therapeutic Goods Act provides for five years of data exclusivity for all medicines. It makes no distinction between biologics and other drugs. Data exclusivity provides an absolute monopoly that, unlike a patent, can't be revoked or challenged in court.

As that makes clear, data exclusivity is a kind of super-patent in that it can't be challenged or revoked: if a drug company has run clinical trials to establish the safety of its new drug, it has an absolute and irrevocable monopoly on the use of that data -- for five years in the case of Australia, Chile, Singapore and New Zealand. This is obviously an incredibly powerful form of monopoly, so perhaps it's no surprise that US pharmaceutical companies want TPP to require signatories to grant an even longer period -- 12 years of data exclusivity -- for biologics.

That's useful for them, because even after drug patents have expired, and generic manufacturers can theoretically offer the same products without paying licensing fees, there remains the barrier of clinical testing. If the generic manufacturers can't point to the original clinical trials as proof that the drug is safe, they will need to carry out their own, which will take time and cost money. In practice, they are more likely to wait until the period of data exclusivity is over, effectively extending the original manufacturer's monopoly beyond that provided by patents alone.

So what? You might ask. Surely it's only fair that generic manufacturers cannot piggy-back on the work of the original drug companies? Although that argument sounds plausible, it overlooks the fact that what clinical trials produce is safety data about a drug, which is simply a certain kind of scientific fact concerning a particular complex compound, as unchanging as all its other features. It is not something that depends on the ingenuity of the person measuring it, because it represents intrinsic information about a substance. Granting data exclusivity is thus nothing less than giving a monopoly on knowledge itself, since it forbids any other company from being able to use that newly-established scientific fact.

That is a profoundly retrogressive step. Although dressed up in terms of fairness and recouping investments, the very notion of data exclusivity is an attack on the key idea that no one can own a scientific fact, and that science advances by building on existing knowledge. Arguments about whether the length of that monopoly should be five, eight or even twelve years, are not just pointless, they are pernicious, because any of them would lock the TPP countries into a system that allows basic facts to be owned, and would forbid them from exiting from it. The only acceptable length for data exclusivity is zero years; anything longer turns TPP into an attack on science itself.

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Filed Under: biologics, data, data exclusivity, science, sharing, tpp

23 Comments

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That One Guy (profile), 10 Aug 2015 @ 10:27pm

Re-inventing the wheel. Again, and again, and again...
Safety data should never be locked up. If something is unsafe, or conversely has been proven to be safe, then that information should be disseminated as widely as possible, not locked up for any amount of time.

If something is found during testing to cause harm, locking the results up means that anyone who wants to duplicate the same testing will almost certainly run into the same problems, causing harm needlessly when it could have been easily avoided. Similarly, if something is found to flat out not work, rather than allowing future research to bypass the failed section, locking up research will force everyone to run the exact same tests, to get the exact same results, multiple times.

Society, culture, and especially science builds upon what has been discovered, invented, and created before, any attempt to lock up knowledge like this is ultimately harmful to everyone, as it undermines that core requirement for advancement, and forces people and companies to wastefully re-do what has been done before to get to the same result.
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Sheogorath (profile), 10 Aug 2015 @ 11:13pm

The only acceptable length for data exclusivity is zero seconds.
FTFY, Glyn. Had to or somebody would propose a data exclusivity length of 364/5 days, 23 hours, 59 minutes and 59 seconds, which, of course, would still be zero years.
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That One Guy (profile), 10 Aug 2015 @ 11:17pm

Re:
I'd say you were being overly cynical, but we've got idiots who argue that copyright lasting decades after death is still 'limited', so it's hard to argue against the idea that they would try exactly what you describe if they thought they could get away with it.
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JoeCool (profile), 10 Aug 2015 @ 11:41pm

Even worse
If one branch of technology can demand data exclusivity, how long will it be until they ALL demand the same privilege?
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Anonymous Coward, 10 Aug 2015 @ 11:42pm

Nothing like making a drug that has a hazard to it revealed in testing. So a drug company covers that little part up, you can't get the data to prove it is any other than the drug company says it is, mostly like after the statue of limitations has run out.

How convenient to not only have a locked in, guaranteed lock down on generics but to also have a way out of court liability.
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David, 11 Aug 2015 @ 12:06am

Well, there is a point to data exclusivity
A number of studies and trials performed by a corporation do not constitute "science" as such. They are not independent, and there is no particular interest in large redundancy. If data has been found to be falsified, one can sue the company which controlled the trials. But you can hardly sue the company for damages by other drug producers.

So data exclusivity is one tool that leads to a larger test base under control of separate parties. Of course, those parties all have a vested interest. But they still work with different test labs and different test persons and different statistics. Or, if you want to be pessimistic, at least are liable for their own data tampering.
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Steve, 11 Aug 2015 @ 1:14am

Clinical trials
Does this all not also conflict with the push in the EU and the US for more open reporting of clinical trials? Or have the regulatory bodies for such matters been dragging their heals hoping for things like TPP to take away thatrequirement?
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Anonymous Coward, 11 Aug 2015 @ 1:36am

Re: Well, there is a point to data exclusivity
So they can all have different stories?
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Anonymous Coward, 11 Aug 2015 @ 2:06am

agree with the final statement that data exclusivity should be zero years, but am extremely surprised that the desired length by the USA pharma companies isn't even longer than 12 years. in fact, i find it strange that those companies haven't gone for the 'Life + 70 years'. we give that length of time for something as pathetic as music and movies, yet, because it can cost lives there is still a time frame wanted to be used! the whole idea of TPP and every other 'Agreement' is to make the USA stronger by making every other country in the world, bit by bit, agreement by agreement, worse off. these agreements actually show the USA for what it really is, nothing other than a selfish, self-preserving virus that destroys or at least tries to, anyone that gets in it's way or disagrees with what it wants to do. the even bigger problem is that after it gets what it wants, it turns everything in on itself and becomes so paranoid that no one is then trusted, not even it's own government members! the 'reds under the bed' comes back into play!
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Michael, 11 Aug 2015 @ 3:10am

It is not something that depends on the ingenuity of the person measuring it

Based on the information we have found out about many drugs years later, I think this could be in dispute.
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Richard (profile), 11 Aug 2015 @ 4:12am

Re:
somebody would propose a data exclusivity length of 364/5 days, 23 hours, 59 minutes and 59 seconds, which, of course, would still be zero years.

No - it would be 0.99999996829020801623541349568747 years
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Anonymous Howard, Cowering, 11 Aug 2015 @ 4:17am

David #6 - Re: Well, there is a point to data exclusivity
Wrong. There is NO point to data exclusivity. The studies and trials DO constitute science. Even if, as you claim, the concept forces duplicate clinical trials, each of those will also be locked up and there will be no useful "larger test base." There is no upside to the idea.

Perhaps you are thinking of the polished report that is eventually issued describing in glowing terms how this drug will be the salvation of mankind. That is PR, not science. But the data IS science and a manufacturer should have no claim to exclusivity.
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David, 11 Aug 2015 @ 4:38am

Re: David #6 - Re: Well, there is a point to data exclusivity
Uh, the data exclusivity does not mean that the data stays hidden or unpublished or otherwise "locked up". It just means that competitors may not use the data to substitute for their own clinical trials when marketing medication.

So if some trials determine that a drug is generally a bad idea, this result will, even with data exclusivity, mean that competitors are saved from doing their own trials before deciding not to market.

It only makes a difference when competitors decide to go to market with an identical substance. Then the marketing license is tied to having either independent or older test results to show. When your test results come out positive while the tests of a competitor showed a problem, that does not mean you can ignore the bad test results while data exclusivity is ongoing.

The science is not affected. Just the tick mark for being allowed to market.
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David, 11 Aug 2015 @ 4:40am

Re: Clinical trials
I don't think the idea is to stop the open reporting of clinical trials. Just who may claim to have dispersed himself of his duty to perform trials.
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Ambrellite, 11 Aug 2015 @ 6:55am

Re: Re: David #6 - Re: Well, there is a point to data exclusivity
But aren't the hypothetical medicines we're talking about already being sold and marketed? If the original trials weren't enough to establish safety, why approve the drug in the first place?

That's what the "more data is necessary" argument boils down to, isn't it?

There are other, much better ways to get more data than adding more IP restrictions to an industry already overloaded with them.
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Chronno S. Trigger (profile), 11 Aug 2015 @ 7:19am

I agree that this is a stupid idea, but isn't this even more stupid than you give it credit for? Patents last 20 years, this idiocy would last for 5 (or 12). What are they going to do, patent the drug and not do the clinical trials required to sell the drug until the patent is almost up?

If anything, this is a ploy. Sneak something in that can easily be shrugged off and they can extend quietly in the future. The TPP negotiators are being played (or played with depending on if they know or not.)
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DerekCurrie (profile), 11 Aug 2015 @ 7:23am

#MyStupidCorporatocracy
This is insane. TPP, TTIP and CISPA are insane.

The level of demanded lunacy in 'data exclusivity' points out that the LAST entities that should be ruling the world are corporations. They represent a GAMING SYSTEM called 'finance', NOT real life.

No thank you to allowing game players to run anything IRL. Stick to playing your game, corporate kiddies! Stay Out of my REAL life please.
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Sheogorath (profile), 11 Aug 2015 @ 10:30am

Re: Re:
I was right the first time. It would be put in human readable terms for the people in Congress, the majority of whom wouldn't get what that bunch of numbers means. ;)
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FamilyManFirst (profile), 11 Aug 2015 @ 12:02pm

It was paid for, so it should be available
Surely it's only fair that generic manufacturers cannot piggy-back on the work of the original drug companies? (/rhetorical question)

No, it's not fair. The manufacturer was paid for that work, among other things, by the patent that they were granted. If they don't want that data used by other companies, don't file for a patent.
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Uriel-238 (profile), 11 Aug 2015 @ 1:17pm

I can't imagine these rules being able to be enforced.
When a drug is released, the data showing it works / it's safe is published as well. No data, no drug.

You can't state what that data can or cannot be used for. Well, you can, but that's not going to stop others from using it anyway.

This not only couldn't be enforced, but will drive end users of pharma underground.
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Nop (profile), 13 Aug 2015 @ 12:53am

Re: Well, there is a point to data exclusivity
"A number of studies and trials performed by a corporation do not constitute "science" as such."

If they aren't science, then they aren't supposed to be accepted by the FDA, that being the entire point of clinical trials.
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Nop (profile), 13 Aug 2015 @ 12:56am

Re: Re: David #6 - Re: Well, there is a point to data exclusivity
The science is not affected. Just the tick mark for being allowed to market.

Which is effectively a patent extension, as pointed out in the article. Duh.
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John Fenderson (profile), 13 Aug 2015 @ 7:51am

Re: Re: David #6 - Re: Well, there is a point to data exclusivity
"The science is not affected. Just the tick mark for being allowed to market."

So, what you're saying here is that it's all BS?
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