Giant Pharma Company Claims Releasing Data On Drug Safety Is Illegal As It’s Confidential And ‘Commercially Sensitive’


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By Glyn Moody
Tech Dirt
March 19, 2013

One of the initiatives gaining momentum around the world is open data — the idea that, for example, non-personal data affecting the public should be made freely available.

That’s partly to improve transparency, so that citizens are more informed about what is happening, and partly to stimulate new kinds of business that build products and services based on that data.

An important category of open data that boosts transparency concerns basic drug safety information. Last month, Techdirt wrote about the AllTrials initiative that seeks to have key information about clinical trials placed in the public domain. As part of a wider move towards greater openness, the European Medicines Agency, the main body that licenses drugs in Europe, is starting to make available information that has hitherto been withheld.

Although doctors and patients are rejoicing at this greater transparency, not everyone is pleased by the move. AbbVie, the pharma company spun out of the Abbott Laboratories at the beginning of this year, for example, is taking legal action to stop it:

AbbVie, a pharmaceutical company has sought an injunction to block Europe’s medicines regulator from releasing “confidential” and “commercially-sensitive” information on its blockbuster rheumatoid arthritis drug, a spokeswoman for the U.S. drugmaker confirmed on Sunday.

The Chicago-based company had taken legal action against the European Medicines Agency to stop it from releasing data on the effects in individual patients in clinical trials for its drug Humira, the Financial Times reported earlier on Sunday.

Except, of course, this isn’t “confidential” and “commercially-sensitive” information: it’s just basic data about its safety and efficacy. Doctors and patients surely have a right to know this before using products that could potentially have serious, even fatal, side-effects.

Another EU body, the European Food Safety Authority (EFSA), is also opening up:

The project is part of EFSA’s continuing commitment to openness and addresses recommendations made by an independent evaluation report of the Authority’s performance to further enhance transparency in its decision-making processes. EFSA’s Science Strategy also highlights the importance of the Authority playing a leading role in making relevant scientific data more accessible to all interested parties.

Here’s one particular set of data that it has now released:

Given the level of public interest, EFSA will make all data on genetically modified (GM) maize NK603 publicly available on its website today (14 January).

Once more, that seems reasonable, since the public ought to be able to find about what is going into the food chain whose end-products it will consume. But some disagree: according to a story on, Monsanto is threatening to sue the EFSA over the release of this data.

What makes this a little confusing is that the company is quoted in that article as saying that it “firmly supports transparency” — and yet here it is fighting tooth and nail against precisely that. Apparently, Monsanto also wants the regulatory environment in Europe to be “science-based”. Modern science requires experimental data to be made available so that anyone can check the validity of the conclusions that have been drawn from it. If it can’t be scrutinized, the conclusions can’t be confirmed, and it’s not science. So, given its call for “science-based” regulation, why does the company want to keep that data hidden? A cynic might almost suspect that Monsanto and AbbVie have something to hide.

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