EU To Open Up Secret Clinical Trial Data; TPP Looking Even More Retrogressive

from the openness-strikes-again dept

Wed, Jul 18th 2012 11:34pm — Glyn Moody

Openness is really beginning to sweep through the European Union at all levels. Yesterday we wrote about the European Commission's ambitious plans to make the results of publicly-funded research freely available as open access; now comes news of a major opening up in the world of pharmaceutical data:

Europe's medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information.

The change is a landmark in transparency that puts Europe ahead of the United States, according to critics of the $1 trillion-a-year global drugs industry, who have long argued for full access to trial data.

Such information is a treasure trove for scientists wanting to test drug company claims and potentially expose product deficiencies.

Pharma companies are keen to keep that data locked away for another reason: it acts as a very effective barrier to manufacturers of generics, who are unable to use existing clinical results in order to get approval for their drugs. Indeed, extending drug data exclusivity is one of the key proposals of the TPP agreement, as this analysis of two leaked US documents explains: If pharmaceutical companies can get substantially longer data exclusivity, especially if it contains mechanisms for evergreening exclusivity such as that involving biologics, they won’t have to rely on patent protections to obtain marketing monopolies. Data monopolies of sufficient length will be superior to patents from the perspective of pharmaceutical firms because data monopolies give the same or higher level of monopoly protection without the need and expenses of proving that the product meets the relatively high standards for patentability.
That makes the EU's planned move even more significant, since it would signal that TPP's proposal to extend data exclusivity is not the only approach when it comes to regulating medicines, and that greater openness is also an option.

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Filed Under: clinical trials, eu, open access, pharma, tpp

16 Comments

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Chargone (profile), 18 Jul 2012 @ 11:51pm

*ponders* wasn't part of the point in patents to AVOID the whole 'trade secret' idea on important stuff like this?

eesh.
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- Anonymous Coward, 19 Jul 2012 @ 1:03am
  
  Re:
  This reminds me when I was a kid and saw for the first time an advert saying "free course" I didn't know at the time that the "free course" didn't mean free, but that you had to buy the books from the training company, my father laughed at my inexperience.
  
  I see those claims that patents are to help spread knowledge the same way, just lies, damn lies.
  
  :)
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- Anonymous Coward, 19 Jul 2012 @ 1:06am
  
  Re:
  This is exactly why I prefer the DIY approach, if you want it done correctly we shouldn't let others do it for us.
  
  This is the same reason countries strive to not get dependent on others, it is a mistake to give up something and have nothing to leverage after, pharma companies have no competitors besides themselves and that is starting to become a problem to everyone.
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- Mason Wheeler, 19 Jul 2012 @ 8:06am
  
  Re:
  Yes, that was exactly the point of patents. Destroy the trade secret, put an end to the loss of useful information when a skilled craftsman died without passing it on that has held the progress of mankind back for millennia, by requiring inventors to publish the details of things they invented. And when it's been used correctly instead of abused, it's been an incredibly successful system. Unfortunately, today we've got the tail wagging the dog.
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Anonymous Coward, 19 Jul 2012 @ 2:28am

"Openness is really beginning to sweep through the European Union at all levels."

Sort of wishful thinking. There are proposals, but there aren't many passed laws. Lots of talk, but any action? Not really. Europe and the European Union is just way to tied in knots for anything to happen.
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- The eejit (profile), 19 Jul 2012 @ 2:51am
  
  Re:
  Maybe...
  
  I'm more inclined to consdier the possibility that people are actually seeing the possibilities of openness.
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  - Anonymous Coward, 19 Jul 2012 @ 3:16am
    
    Re: Re:
    I just think that if this was somewhere else besides Europe, it might have legs. But the European Union and all it's parts don't work together well at all, and in fact they seem to be at odds with each other at every turn.
    
    One group proposes openness as another group passes a privacy law, if you know what I mean.
    
    They have spent so long chasing their tails on almost every issue that it's hard to take them seriously. It's also hard to see who (if anyone) has the power, clearly the EU doesn't seem to have all that much influence on member states.
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    - Anonymous Coward, 19 Jul 2012 @ 4:38am
      
      Re: Re: Re:
      This is however, coming out of the commission, a more direct line to the governments of the member nations rather than the Parliament which is elected by the people and therefore accountable to them and not to the member governments.
      Given the commission's support of ACTA etc, it's interesting that they are even talking about openness in anything.
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    - abc gum, 19 Jul 2012 @ 5:19am
      
      Re: Re: Re:
      "I just think that if this was somewhere else besides Europe, it might have legs. But the European Union and all it's parts don't work together well at all, and in fact they seem to be at odds with each other at every turn."
      
      Yes, because things work so smoothly elsewhere. For example, the US congress over the past four years has been the most productive congress ever - right?
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      - Anonymous Coward, 19 Jul 2012 @ 5:36am
        
        Re: Re: Re: Re:
        I wasn't talking about inefficiency, rather that the European system currently has way too many heads, way too many ruling bodies, way too many overlapping and contradictory laws and rulings. It's hard to imagine if something IS passed that any of the member countries would actually follow.
        
        Did I do a better job of explain it?
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        abc gum, 19 Jul 2012 @ 6:43am
        
        Re: Re: Re: Re: Re:
        Good explanation of your comment, however - I remain unconvinced that the EU has more heads, ruling bodies, overlapping and contradictory laws than any other country, republic, kingdom, whatever. Not sure why Eurobashing is so chic these days.
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- John Fenderson (profile), 19 Jul 2012 @ 9:35am
  
  Re:
  There are proposals, but there aren't many passed laws. Lots of talk, but any action?
  
  But all laws start with proposals. At least Europe is getting that far. It's better than the US is doing.
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Anonymous Coward, 19 Jul 2012 @ 3:30am

when the main reason for all of these type of 'trade agreements' (SOPA, ACTA, TPP etc) is to protect the monopolies of US companies and industries, benefiting the rest of the world very little, i understand this move by the EU. i am a bit surprised that they have shown some balls though but it's about time the US was stood up to and made to realise it is not the only nation on the planet and it is certainly not always the best, not by a long chalk!
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- abc gum, 19 Jul 2012 @ 5:25am
  
  Re:
  But ... american exceptionalism says we are the greatest ever!
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Modplan (profile), 19 Jul 2012 @ 4:59am

I remember a story a long time ago about a trade agreement between the EU and South Korea:

http://www.techdirt.com/articles/20110221/02392413184/eu-follows-us-steps-signs-free-trade -agreement-with-korea-thats-all-about-ip-protectionism.shtml

It stated that such data cannot be used, with no distinction between public or private data, so I wander how that'll be affected. Only reason I remember is because I wrote about it /selfpromotion.
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Andrew F (profile), 19 Jul 2012 @ 2:51pm

Lives
Reminds me of this: http://www.techdirt.com/articles/20120625/19574119473/protected-to-death-how-medical-privacy-laws-he lped-kill-25000-people.shtml

Having lots of data available is crucial to evaluating, for example, if an anti-inflammatory drug is really giving people heart attacks.
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