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EU To Open Up Secret Clinical Trial Data; TPP Looking Even More Retrogressive
from the openness-strikes-again dept
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.
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:
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.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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eesh.
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I see those claims that patents are to help spread knowledge the same way, just lies, damn lies.
:)
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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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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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I'm more inclined to consdier the possibility that people are actually seeing the possibilities of openness.
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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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Given the commission's support of ACTA etc, it's interesting that they are even talking about openness in anything.
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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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Did I do a better job of explain it?
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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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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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Lives
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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