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MHRA’s point-blank refusal to investigate misleading BBC pro-vaccine documentary


MANY have expressed profound concerns about the BBC documentary Unvaccinated,  first broadcast on July 20 this year.

I joined other clinicians and scientists to write to the BBC to complain about its lack of balance, factual inaccuracies and failure to be transparent about potential conflicts of interest. This complaint is still progressing through the BBC’s arcane complaints procedure but thanks only to the persistence of the doctors and scientists pursuing it, as reported by Kathy Gyngell in TCW yesterday. 

In addition to concerns about BBC editorial standards, there were perhaps even more worrying questions about whether this programme broke laws relating to the promotion of medicines. My immediate reaction to viewing the programme was that it did.

For general commodities or services there is a requirement that advertising should be of a high standard. It should not, for example, include anything which creates unrealistic expectations in the consumer or is misleading. There is also recognition in British law that risks associated with medicines are greater than those associated with general commodities. Furthermore, concerns that potentially vulnerable, sick people and their carers could be affected, or even targeted, by promotional activities mean additional legal restrictions are placed on the promotion of medicines. 

As the programme appeared to transgress these requirements in a number of ways, the body to turn to was the Medicines and Health products Regulatory Agency (MHRA), who are responsible for monitoring and enforcement of laws relating to the advertising of medicines, laws set out in the Human Medicines Regulations (Part 14).

These are helpfully translated and interpreted by the MHRA in their document ‘The Blue Guide’. It was this that my colleagues and I consulted to check whether the people responsible for Unvaccinated had, as we suspected, breached numerous requirements of these advertising regulations. 

Do these laws apply only to pharmaceutical companies, colleagues had asked me. No, I replied. The Blue Guide makes it abundantly clear that UK legislation ‘makes it the responsibility of any person who promotes a medicine, including the licence holder, a private individual or any third party such as journalists, publishers or public relations agencies, to ensure compliance with the legislation’. It couldn’t be plainer.

What is meant by ‘promotion’ was the next question they raised: did the BBC programme count as journalism (or entertainment), not promotion?Once again, the MHRA’s Blue Guide proved very helpful, clearly defining advertising as any thing or any activity which is intended to encourage prescription, supply, sale or consumption of medicinal products. Thus the scope of the legislation is wide-reaching (deliberately so as the potential adverse health outcomes, both personal and public, of misleading promotion of medicines are so great).

In conclusion, yes, Unvaccinated had broken the law by promoting the vaccines.

It was incumbent on us to alert the MHRA to this, setting out the numerous ways in which the programme constituted promotion of the Covid-19 vaccines, so we wrote accordingly. In our letter we also listed numerous ways in which it failed to meet the quality standards for such promotion as set out in the Advertising Regulations. In particular we felt that, as well as ignoring the fundamental requirement not to promote prescription-only medicines to the general public, none of the other requirements – to ensure balance, to present data objectively, not to exaggerate and not to mislead – had been met.

Numerous breaches of the regulations which we identified in the programme included:

·         Inaccurate data for the numbers of people unvaccinated in the UK;

·         Misleading and unbalanced statements about the immunogenicity of Covid-19 vaccines;

·         Describing Covid-19 vaccines as ‘safe’ (this is a specific prohibition listed in the Blue Guide – see below).

The MHRA responded very quickly, but I am sad to say dismissively. You can read all the correspondence here. They refused to engage with any of our numerous detailed complaints about the content as they did not accept that the programme was promotional. This was despite the fact that they did accept that the intention of the programme was to encourage people to be vaccinated and that specific vaccines were indeed referred to in the programme. 

They described the content as ‘factual and informative’. One of the most risible reasons they gave for deciding that that no promotion was taking place was that no ‘product claims’were made. Yet a number of such claims had been listed in our initial complaint letter! 

We wrote again to ask them to reconsider their decision and included a list of additional product claims such as:

·         the vaccine is very good at preventing illness;

·         vaccine immunity is more consistent and usually stronger than infection immunity;

·         if you catch Covid whilst pregnant, your risk of losing your baby to stillbirth is 15 per cent lower if you are vaccinated.

Whether you think these statements are true or not (and there is sufficient evidence in the public domain to suggest that they are not) it is very difficult to deny that they highlight qualities of the medicine and therefore meet the legal definition of a product claim. Nevertheless, deny is exactly what the MHRA chose to do in their next response. 

In this letter their assertion that these statements are actually not product claims at all but ‘factual statements’would be laughable if it were not so chillingly Orwellian. What makes them ‘factual statements’ rather than product claims? The MHRA do not say.

Surely their ‘factual statement’ assertion cannot just be based on the fact that they were broadcast by the BBC? Some of them are not even statements of fact. However, this does indeed appear to be the foundation on which the MHRA have doubled down on their original decision not to investigate our complaint.

Perhaps we should not be surprised at the lengths to which the MHRA are apparently prepared to go to avoid dealing with the details of this complaint properly. When, last year, I wrote to them about a government advertisement describing Covid-19 vaccines for children as ‘incredibly safe’ (the Blue Guide says ‘Advertising which states or implies that a product is “safe” is unacceptable . . . no medicine is completely risk free’) I was initially told that they would not investigate as this was not an advertisement but part of a government public health campaign. When I pointed out that the material was actually labelled as an advertisement, they told me that an advertisement which forms part of a government public health campaign is exempt from the advertising regulations. I asked where in the legislation I could find this exemption. They did not reply. 

Doubts about the competence and independence of the MHRA have increased over the past few years, particularly with regard to their role in the licensing and post-marketing surveillance of medicines. Unfortunately their role in the monitoring and enforcement of compliance with the law relating to the promotion of those medicines must now be suspect also. In particular, when it comes to Covid-19 vaccines, rather than enforcing the law and protecting the public, they appear to be prepared to perform the most extreme semantic gymnastics to protect compliant media, their government bosses and the pharmaceutical industry from proper scrutiny of the way information is provided.

Disappointingly, there is no route of appeal for us short of taking to the courts to challenge the MHRA’s interpretation of the regulations. This is a risky and expensive thing to do therefore I doubt that it will happen unless a philanthropic donor with deep pockets is prepared to take up the cause. Is it the end of the road for this particular complaint?  

The MHRA suggest we take it to the Advertising Standards Authority (ASA); indeed they are so keen to get it out of their in-tray that they have volunteered to send it for us. I think this would be a mistake. The ASA do have some responsibility for the regulation of over-the-counter medicines advertisements but this is not a mild analgesic or cold relief we are dealing with. Our complaint is a very serious one concerning promotion of prescription-only medicines with potentially great public health consequences. As such, it is the responsibility of the MHRA, as the UK’s principal medicines regulatory authority, to deal with it. Their decision not to investigate is now on the record and hopefully they will be called to account for it one day.

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Dr Alan Black
Dr Alan Black
Dr Alan Black is a retired pharmaceutical physician.

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