"Promptly" or "Reasonably Practical"? MHRA Semantics

I have in my possession a letter sent to The Rt. Hon. Alan Johnson MP, Secretary of State, from Jim Dobbin MP for Heywood & Middleton.

Dobbin clearly highlights the frustrations when dealing with the semantics of the UK Medicine Regulator [MHRA]

It's well worth a read as it focuses on the MHRA investigation into GlaxoSmithKline regarding the suppression of important data that, in essence, could have saved lives.

As you may recall, GlaxoSmithKline were investigated by the MHRA, an investigation that took over 4 years to complete. Basically, the MHRA concluded that GlaxoSmithKline could not be prosecuted because of a weakness in the law. Instead, Jean Pierre Garnier, the then CEO of Glaxo, was issued with a schoolboy reprimand from the CEO of the MHRA, Kent Woods.

Personally, and they already know my thoughts on this, I believe the investigation was pretty abysmal. Arrests should have been made regardless of whether Glaxo employees would have chosen to talk to MHRA investigators. Glaxo have once again been let off the hook.

Dobbin, now believes the MHRA are playing around with words such as 'Reasonably Practical' and 'Promptly'

I have a pdf copy of the letter should any of you wish to view it [click on mailbox, right hand side of this blog]

Here is the letter:

The Rt. Hon. Alan Johnson MP
Secretary of State
Department of Health
Richmond House
79 Whitehall
London
SW1A 2NS

Tuesday 12th May 2009

Dear Alan,

Further to my previous unanswered correspondence of 28/04/09, I would like to bring your attention to matters arising from my P.Q. 264951 and the subsequent clarifications provided by the Department of Health and the MHRA.

The MHRA investigated the Pharmaceutical Company Glaxo Smith Kline for withholding safety information concerning their product SEROXAT; specifically Glaxo Smith Kline concealed increased rates of suicide in children given SEROXAT. The MHRA concluded that Glaxo Smith Kline should not be prosecuted because of a weakness in the law.

The Health Minister Dawn Primarolo M.P. announced that the law would be strengthened to make sure this could not happen again. On the 3rd of April 2008 Dawn Primarolo M.P. stated, in answer to a Parliamentary Question by myself:

The MHRA plans further stringent regulations to place obligations on companies to report safety issues timeously.

The MHRA produced a draft amendment to the law which used the word “promptly.” After a consultation process the amendment was altered to “reasonably practicable.”

My Parliamentary Questions 261391 and 264951 were intended to establish the wording of the amendment and the meaning of these words. When I asked the Department of Health for further clarification of the answers I was given I was put in touch with Dr Julie Williams of the MHRA and then Beryl Keeley of the MHRA.

There was then an additional complication, in order to place the words “reasonably practicable” in their full context it was necessary to obtain and juxtapose three separate documents.

i) The Medicines for Human Use (Marketing Authorisations etc) Regulations 1994.
ii) Medicines (Codifications Amendments etc) Regulations 2002.
iii) SI 2008 Amendment Regulations (3097)

According to Beryl Keeley ‘consolidated regulations’ do exist but they are not available to M.P.’s. This is the first point I want to bring to your attention; that the most complete and up to date copy of legislation should be available to M.P.’s, so that they can carry out their work.

In response to my main question, the meaning of the words “reasonably practicable”, Beryl Keeley directed me to an MHRA Explanatory Memorandum on the 2008 Amendments. Paragraph 8.5 states:

On balance, use of “as soon as reasonably practicable” can be argued to give those required to comply a clearer understanding than the insertion of the word promptly. There is more case law around use of this phrase and it is more commonly used in offence-creating legislation.”

However, when I asked Beryl Keeley for the reference to the case law to which the memorandum refers she was “unable to identify any.” In other words there is no pharmaceutical case law on which to base the introduction of the words “as soon as reasonably practicable” or which could clarify the meaning of these words.

“Reasonably practicable” is in my opinion a vague and subjective phrase. It could easily be interpreted by a pharmaceutical company to mean a long process which could extend into years.

In my opinion the wording suggested by MIND in response to the consultation would have been appropriate. MIND suggested “quickly, as soon as it comes to light”, also “urgently”, or a defined period of time.

There have been no prosecutions of pharmaceutical companies for withholding safety information since 1992, according to a recent answer to a parliamentary question. To the best of my knowledge there were no prosecutions prior to 1992 either.

In my opinion the withholding of safety information by pharmaceutical manufacturers has been widespread and has resulted in thousands of deaths and drug injuries. A clear example is the benzodiazepine tranquillisers such as Valium and Ativan which were claimed by the manufacturers to be safe and non-addictive.

The 2008 amendments were an opportunity to have closed at least one loophole in the regulations and provide some improved protection to the public. My second point is that this amendment was introduced by the MHRA on the basis of case law that does not exist, and that the amendment is weak and should be corrected.

Thirdly, I would like to point out that in my opinion the MHRA have not handled this matter effectively. The MHRA was heavily criticised by the Health Select Committee enquiry 2004-5, “The Influence of the Pharmaceutical Industry,” the MHRA was seen as too closely connected to the pharmaceutical industry. My third point is that this connection remains the case and that this change to the law should have been carried out by Parliament, not the MHRA.

I would appreciate it if you could answer this letter personally.

Yours sincerely,

Jim Dobbin MP
Chair of the All-Party Parliamentary Group on Involuntary Tranquilliser Addiction

cc. Phil Woolas MP
MIND

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Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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