European Court Puts Release Of Drug Safety Data On Hold

from the regrettable dept

Wed, May 8th 2013 12:22am — Glyn Moody

Last month Techdirt wrote about the case of the giant pharma company AbbVie seeking to prevent the European Medicines Agency from releasing basic health safety data that AbbVie claims contains commercially sensitive information. Unfortunately, an interim injunction has just been granted to that effect:

The European Medicines Agency (EMA) has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court. These interim rulings were made as part of court cases brought by two pharmaceutical companies, AbbVie and InterMune. The companies are challenging the Agency's decisions to grant access to non-clinical and clinical information (including clinical study reports) submitted by companies as part of marketing-authorisation applications in accordance with its 2010 access-to-documents policy.

As the EMA notes, it's not as if the release of this data is unprecedented: Since November 2010, the Agency has released over 1.9 million pages in response to such requests. This is the first time that the policy has been legally challenged.
That obviously raises the question of why AbbVie and InterMune have problems with drug safety data being released when other companies don't. Fortunately, there is very broad support for the EMA's attempt to make this important information available for other researchers to check and analyze: Since the two pharmaceutical companies filed these legal actions, the EMA has received more than 30 statements of support from various stakeholders, including the European Ombudsman, national competent authorities, members of the Agency's Management Board, Members of the European Parliament, academic institutions, non-governmental organisations, citizens' initiatives and scientific journals, some of whom have also applied to formally intervene in defence of the EMA at the Court.
There's a crucially important principle here, that public safety must outweigh any claims of commercial confidentiality. Let's hope that the General Court of the European Union recognizes that in its final judgment, which will have a major impact on health and safety not just in Europe but, as a knock-on effect, around the world too.

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Filed Under: clinical trials, drug safety, europe, health, information, safety
Companies: abbvie

7 Comments

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Anonymous Coward, 8 May 2013 @ 1:40am

this is not the General Court of the European Union agreeing with the drug companies- the standard for interim injunctions is lower than for permanent ones. The point of an interim injunction is to prevent the lawsuit becoming moot. (if the safety information was released, you cannot then prevent the release of the information) So the interim injunction is probably justified on the grounds that it prevents the court's verdict being pre-empted by the release of the information.

I DO, however, think that the court should allow the release of the information. I can't see why clinical studies should be confidential.
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Anonymous Coward, 8 May 2013 @ 2:20am

It is unfortunate, but kind of expected. If the court thinks there is any chance of the druggies winning, this is how to do it.
Now we just have to wait for the real ruling.
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Anonymous Coward, 8 May 2013 @ 2:31am

if there is money involved, everyone knows the court will rule towards that and public safety will be kicked into touch!
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Anonymous Coward, 8 May 2013 @ 3:20am

I, for one, am happy to see a proper hearing being held where policy may harm business. I may not like the business itself but we've got laws and it encourages me to see them being followed by world governments.

It's got to be better than arbitrarily shutting down companies without trial (and by so doing threatening entire industries) as the US seems to like doing.
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Anonymous Coward, 8 May 2013 @ 3:20am

Re:
actually, the EU tends to rule in favor of rights. Note the drawn-out process that is the Quatada deportation. ( no-one denies he's an absolutely foul human being, but the court seems to never be satisfied that he'll get a fair trial in Jordan. Despite guarantees thus far that he will get a new trial on some charges he had been convicted on in absentia, with evidence obtained by torture having been thrown out.) Plus, the EU takes a dim view of drugs not proven to be safe. ( The US generally uses a system of 'prove it's not safe' while the EU generally uses 'prove it is safe')
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Anonymous Coward, 8 May 2013 @ 5:03am

What are the possible side effects?
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Anonymous Coward, 8 May 2013 @ 8:09am

Re:
A reduction of publicly accessible information. It is probably relatively limited what direct implications it will have since it is rather few and specific sources using it, but the indirect impact of lesser openness in administration, might make companies strategies to get a positive outcome less desirable.
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