Thursday, 26 July 2007

Delighted to engage GSK shareholders...

Welcome back, gentle reader (I'm in Aesop mode). People often ask me where I get the ideas for my stories. I always answer as truthfully as I am able: that my inspiration tends to be the people whom I meet and the events that I witness. It was only the other day... (that's enough Aesop. Ed.)

It was way back in February, this year, when the most recent Panorama expose, Secrets of the Drugs Trials, aired that GSK took to contacting MPs of constituencies in which GSK had premises (as I understand it) and asked them to not sign the Motions for Early Day ("EDMs") of a certain MP, Paul Flynn, who has been known to be critical of Big Pharma. I have to say, I took a dim view of GSK, which does not vote as a member of the electorate, influencing the democratic process, in this way. So, I took to copying The Four, as they're probably not known, on my correspondence with the MHRA, by way of reprise - a state of affairs that I was sure to communicate to them. The Four are the four MPs who identify themselves in the Register of Interests as being shareholders of GSK.

Some time ago, I had cause to write to the MHRA concerning an incident in Russia, whereby GSK were being investigated over some alleged research transgressions involving vaccinations of children. I was delighted to have one of The Four seek clarification of the MHRA's powers from the then Secretary of State for Health, Patricia Hewitt. The upshot was that the MHRA is under no obligation to take any interest in any allegations of wrongdoing made in other jurisdictions.

I wrote back to the one of the Four expressing my disappointment. I pointed out that in Compliance circles, it is well known that those who are up to no good will target territories with weak controls. This was not to say that I was pre-judging GSK's conduct. God forbid that I should be so precipitous. No, I was merely pointing out that as a matter of due diligence, it was my opinion that a good regulator would regard an incident such as that in Russia as a flag, and would undertake an investigation.

Today, I received another letter from the One, where he expressed the belief that legislation would be required to permit that kind of multi-jurisdictional authority. I fear I was a little scathing in response, as I pointed out that one does not need legislation to pick up the phone and ask one's Russian counterpart what the story is. Nor does one need legislation to call the UK HQ of one's member company and cordially invite it to have a discussion about the incident at one's offices.

I was quite blunt in owning up that I regard the MHRA as a non-regulator. I have no idea what it's doing, to be honest, but I'm quite convinced that it's not regulating. I wonder what it thinks it's doing?

I have to say, it's a bit worrying that the MHRA is regarded as a world leader in this regulatory field. What are everybody else's regulators like, I wonder? Of course, while those of a generous nature might point out that people are flocking to the UK to do their research and get their drugs licensed, which validates the claim of the MHRA's excellence, I think I might be inclined to reiterate my observation to the One and suggest that the UK has actually got the weakest controls, which would also explain it's popularity.


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