Regulation in the UK – the MHRA

Here are some more ‘did you know’ moments.

It’s a surprise to many that regulation of drugs in the UK is not governed by the Department of Health. It was effectively ‘privatised’ and handed over to a body now named the MHRA which is entirely financed by the Pharmas. Its present chief executive worked for 27 years at GlaxoSmithKline, while its current Director of Licensing was Glaxo’s Worldwide Director of Safety in his last job. Regulators and industry are intimately intertwined.

The MHRA investigation into Seroxat has been heavily criticised for delays and lack of scientific rigour. Embarrassingly, the initial committee set up to look at the safety of Seroxat was force to disband after months of work. Half the ‘independent experts’ on the committee had links with GSK. Significantly and courageously Richard Brook, the mental health charity Mind’s Chief Executive at the time, resigned from the MHRA expert group on SSRIs. He said that continued membership was incompatible with Mind’s remit to represent the interests of mental health service users. He revealed that the MHRA had delayed publishing for ten years data they possessed of the dangers of Seroxat for children.

Mind has a distinguished record of tackling the might of the Pharmas. They take no money from the industry. The integrity of other charities may have been compromised; Depression Alliance admits to taking more than 80% of their funding from Pharmas in the recent past. Their mouths have been bandaged into silence throughout the exposure of the Seroxat scandal – Depression Alliance’s sole contribution to the debate was an attack on the accuracy of programmes on the subject made by the BBC’s Panorama .

Charities and patients’ groups depend on Pharmas’ cash. In a survey conducted, 18 charities involved in parliamentary lobbying said that they took donations; six refuse. Young Minds charity stated, “It is Young Minds’ policy not to enter into financial partnerships with Pharmaceutical companies. This enables the organisation to maintain its independence and avoid any possible instances of compromise.”

Many of these groups provide support for Commons All-Party. No declarations of interests are currently required. The groups may be used as Trojan Horses to wield influence in parliament. Full transparency is being sought.

7 Responses to “Regulation in the UK – the MHRA”

  1. Gary Says:

    I’m afraid there are several incorrect statements in this post. The Department of Health (DH) still regulates drugs in the UK. The MHRA is part of DH and its staff are both employees of and paid by DH. As part of the civil service it has certainly not been privatised nor is it entirely financed by Pharma. Whilst some staff members may have been previously employed in the industry, this is hardly surprising. How else would they have the knowledge and experience necessary to perform their regulatory duties? From what I understand staff are forbidden to own shares in medical companies in any case.

  2. Bob Fiddaman Says:

    Extracts of The House of Commons Select Committee Report of March 2005 on the Pharmaceutical Industry

    Page 30:

    The MHRA is unusual in being one of few European agencies where the operation of the medicines regulatory system is funded entirely by fees derived from services to industry

  3. admin Says:

    Gary – I can’t agree with your comment at all – and neither do others who know much more than me about the whole issue.

    The following is an early day motion from Paul Flynn MP, prompted by the report on the drugs trial which went so tragically wrong at Northwick Park.

    EDM 438
    DRUG TRIALS AND THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY 07.12.2006
    Flynn, Paul
    That this House believes that Professor Duff’s report on the TGN 1214 drugs trials proves the failures of the regulatory body the Medicines and Healthcare products Regulatory Agency (MHRA), which is funded by the pharmaceutical industry; welcomes the exposure that the MHRA’s initial report was a whitewash in claiming that there were `no errors in the administration of the drugs to trial participants’; recalls the Health Select Committee’s judgement that `the MHRA’s organisation, process and techniques are focused on bringing drugs to market fast’ and that the MHRA `has been too close to the industry’; and calls for the Committee’s recommendation for fundamental review of the MHRA because of its many failings to be implemented.

    Mr Flynn continues:
    The self-serving MHRA have been exposed by Professor Duff’s report as the Provisional Wing of the ABPI.

    The Commons Health Committee nailed the regulatory body in their report in 2005. Most people believe that our drugs are reguated by an independent body. The MHRA is financed and greatly influenced by the drugs industry. Their first reaction when this dreadful event happenned was to defend their own profits. They wrongly claimed that nothing has gone wrong.

    Adverse reactions to drugs are a major killer. We need rigour and independence from the regulator. That’s not what we have here. The drug Vioxx was blamed in the USA for 144,000 heart attacks and strokes. The MHRA noticed no problems here.

  4. Gary Says:

    Checking out the latest MHRA annual report (see link below), page 51 reveals they received a hefty £10m from the Department of Health last year. I admit this is a fraction of their total income but to state they are entirely financed by Pharma is wrong. Even the House of Commons gets it wrong sometimes!
    http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2025135&ssTargetNodeId=382

  5. admin Says:

    I have to stand corrected on this one Gary – you’re not going to let it lie, are you?.

    However, I think we need look a little deeper still.

    Note 5 on page 58 (Segmental Analysis) gives us the breakdown of the income figures and you’ll see that the figures are broken down into ‘Devices’ and ‘Medicines’. For the ‘Medicines’ figure we see that £52,819m out of £53,047 income comes from the Pharmaceutical industry for licensing drugs.

    For ‘Devices’ £10,447m out of £10,819m income comes from the Department of Health for devices operations.

    So what this tells us is that it is actually only the drug licensing part of the part of the MHRA business that is almost completely (99.5%) funded by Big Pharma fees…

    I notice another tiny, but important detail here as well.

    This note talks about ‘Trading Income’ and ‘Department of Health Funding’. I only mention this, as in his statement, the Chairman, Professor Breckenridge, uses somewhat different terminology – he talks about the Department of Health being the MHRA’s “main customer for our devices operations.”

    So, to be correct this note should read “Trading income: Pharmaceutical Industry” and “Trading Income: Department of Health.”

    or, maybe it could read:

    “Industry Funding” and “Department of Health Funding”

  6. Gary Says:

    A fair point! However you may want to look a little deeper into these accounts, as despite the best efforts of the accountants they suggest the MHRA is teetering on bankruptcy! On page 38 “Income and Expenditure” income is down by 7%, the main reason given is “problems associated with the introduction of new systems”. Costs increased by a whopping 10%, due to higher staff pay and numbers and grade inflation. The net result being a deficit of £10.9M.

    More interesting reading on page 48: “Significant internal control issues… key financial controls were neither adequate nor effective during the course of the year… the most significant of these areas was the interaction of the Sentinel case folder on the recognition of income”.

    Despite the attempts to gloss over this in the rest of the report, it looks like the MHRA is on course for meltdown through its own financial incompetence. It will be interesting to see what spin is put on the next annual report.

  7. admin Says:

    You’ve been away for a while! – good to hear from again, Gary.


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