Tuesday, February 7, 2012

A Difficult Balance: How Much Drug Information Should Be "Trade Secret"?

I am very late in pointing the readership to this fine article by Ed Silverman over at Pharmalot, but it asks a very important -- and difficult -- question. And, as luck would have it, the question involves Merck's Canadian operations.

Do go straight over and read Ed's piece, from stem to stern, but here is a bit of the flavor:

. . . .In a ruling that has repercussions for the pharmaceutical industry, the Supreme Court of Canada late last week issued what is being called a landmark ruling on what constitutes a corporate trade secret under the Access to Information Act. The decision involved a decade-old dispute between Merck and Health Canada over the release of information about the Singular asthma drug.

The 6-to-3 decision is seen as a victory for advocates of open government and is expected to stiffen requirements for companies that rely on exemptions to the law in order to block the release of documents they argue contain confidential or sensitive business information, otherwise known as trade secrets. . . .

[Quoting the court, now:]". . .It is particularly important to allow broad access to this sort of information in the context of the pharmaceutical industry. As the respondent points out, Health Canada systematically posts on its website reports about undesirable effects of all drugs sold in Canada. In addition, the Food and Drug Regulations require pharmaceutical companies to report adverse reactions of their drugs to Health Canada. Information about those reactions is publicly available. It is therefore difficult to see how release of such reports through an access to information request could result in harm to the third party. . . ."

As I say, it is a great, and rapidly-evolving debate: how much of the drug-innovator's "know how", processes and plans should be protectible (i.e., exempt for public release -- which of course means not available to competitors, including generic reformulators) -- balanced against the prescriber's (and public's) need to know exactly how the drug works (to the extent such a thing is knowable, at all) -- and to know what might be best for a given patient.

We should also be well-aware -- in the web-enabled age -- that whichever local jurisdiction ultimately sets the lowest bar to release of putatively "secret" drug information. . . in effect, sets the standard for the entire globe. And that is a daunting thought -- as information made available in Canada flies, without friction, and almost instantly, to India (the home to many generic manufacturers), for example.

Do go read all about it. Kudos to Ed -- for noticing it.

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