Open Medicine EU

HARD TALK ON SOFT LAW

Are you aware you are working in a health care industry with patients and human beings?” It Is not often you hear a regulator putting this question to a speaker from the pharmaceutical industry but this happened (twice) at a meeting I attended a couple of weeks ago.

The speaker was Neal Parker, a lawyer from AbbVie, and the occasion was the presentation of the principles on transparency agreed by EFPIA, the European Federation of Pharmaceutical Industry Associations, and their American counterparts. If the purpose was to present the EFPIA project in the best possible light, Mr Parker did not help.

Broadly, the EFPIA principles are a voluntary code of transparency under which a company would make clinical trial data available to suitable independent researchers under the condition, among others, that they should not share the data with the company’s competitors. You can read the Code here.

Mr Parker stressed the importance of commercially confidential information (CCI) and made it clear that his company would not release such information except under the most limited and conditional of circumstances. Furthermore, it was for the company to decide what was and was not confidential and what to release or withhold in any given case. In response to a question from me he said that the company’s judgement on CCI could be challenged – in the courts. I doubt if we will find many independent researchers with the resources to take on a pharmaceutical company in the courts.

Mr Parker showed a slide. The blue information is information that would normally be disclosed when a medicine is put on the market – it is not CCI. The information in yellow is generally CCI but may be released in a specific case and on the company’s terms to independent researchers. The information in white was a company asset, the ”intellectual output of our scientists”. It was commercially confidential and generally would not be released.

It was this analysis that provoked the question from the Dutch regulator. (A representative of the European Medicines Agency added that he was “flabbergasted” by Mr Parker’s presentation.) The admission that adverse effects might sometimes be considered confidential may have contributed to the vehemence of the regulators, but I think they were reacting also, as I would, to his key point that “..each company needs to be allowed to decide what they don’t want to release..” This is a long way from a commitment to abide by a set of key principles.

You can see and hear Mr Parker here . His presentation begins 11 minutes, 31 seconds into the video, the regulators intervene at 20’58”, and you can even see me at 39’30” onward.

American lawyers are often more adversarial in their presentations than their European counterparts. A European lawyer might have been “softer” in his or her presentation but we would have been less wise as a result.

I will look more closely at the EFPIA Principles in a future blog.END

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