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After a great deal of consideration, written and verbal consultation with the Mr Simon Gregor the Medicines and Healthcare products Regulatory Agency (MHRA) Director of Communications – I am publishing the following correspondence between him and myself.
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The Patient and Public Engagement Strategy (PPES) is - as its title states – an official contrivance to engage Patients and the Public – therefore of Patient and Public interest.
Without passing any judgement on Simon Gregor or the MHRA, I still don’t really see how the PPES - a public relations (PR) exercise - is going to improve the areas of medicines control and the efficacy and safety of the drugs being licensed.
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However, as Simon Gregor has eloquently stated in his correspondence, he see’s the function of the MHRA communication department as much about listening, as it is about disseminating information;
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in theory this is commendable, but I feel some apprehension insofar as – unless there is a major shift in the industry devised regulatory paradigm the MHRA work under at present –
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and changes in Government legislated regulations which facilitate the MHRA - and therefore the industry it self-regulates, free reign without any official checks and balances, and answerable to no one –
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there will be little improvement in the service and protection it affords patients, in prescription drug safety and efficacy monitoring, and no protection or channel for recourse or recompense when things go wrong - and things do go wrong.
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This is a fact NICE(1), the MHRA, NHS and Government are acutely aware of and freely admit to - as all medicines are registered, licensed and monitored for efficacy and safety on the merit of risk-benefit profile ratios.
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There are several areas where there appear to be opportunities for improvement in the current system, unless these are explored and avenues opened to facilitate change the situation will stagnate and patients will remain in the same vulnerable circumstance.
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As Simon Gregor has offered the opportunity for discourse I have -- after deliberation -- written and accepted his invitation to discuss these issues with him, however, due to my health limitations and time restrictions meeting on a personal basis will not be possible at this time;
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so am doing so on the understanding that current discussions will be carried out through the written medium or by telephone, and all correspondence and transcripts of telephone calls / discussions will be published here for open public record.
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This will raise public awareness to areas of concern within the medicine regulatory system, give a record of the level of commitment to involving Patients and the Public and hopefully show that those areas of concern can and will be improved -– or not as the case may be.
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Publishing this correspondence will also offset others unnecessarily engaging the MHRA FoI (Freedom of Information) department with requests for information, stop erroneous speculation or resulting replies and items being quoted out of context, misinterpreted and otherwise exploited.
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Having discussed with Simon Gregor publishing our informal introductory basis correspondence thus far, I would like to make point that they are only being published to put the records straight with regard the current circumstance;
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whereby the contemptuous, disrespectful activities of Mr Bob Fiddaman of the fiddaman.blogspot continues – along with his stalking and harassment, in an attempt to undermine, intimidate and discredit me - for some warped perverse reason known only to himself.
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Whilst eager to involve Patients and the Public, the MHRA being aware that the situation has arisen in part due to their involvement, appear to have done nothing to assuage the situation, despite that involvement being used as ammunition in the unfounded, vitriolic if fanciful, venomous attacks.
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In taking up this opportunity for discussions with the MHRA I am under no illusions - but feel it would be prudent for other Patients and members of the Public to approach any PPES(2), PPIP(3) with caution and consideration to a lack of concern by and support - if need arises - from the lead organisations.
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Acronyms:
1 The National Institute for Clinical Excellence
2 Patient and Public Engagement Strategy
3 Patient and Public Involvement Program
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