I’ve already asked if the the decision to market the Polypill as an unlicensed medicine on the internet was really the forward for this potentially useful medicine, and Adam Jacobs has asked if it is conventional medicine or quackery. However, what is the legal position on advertising an unlicenced medication to the public? Remember the Polypill has taken the unlicenced route because, as the inventor of the pill Prof Wald states, “You need randomised trials that demonstrate efficacy and safety for each component and in combination. It’s so difficult that for practical purposes it’s impossible”.
Advertising of medicines in the UK is controlled by statutory regulations, enforced by the MHRA, and a system of self-regulation run by the pharmceutical industry. Since the Polypill is manufactured by a specials manufacturer, who most certainly do not advertise direct to the public for reasons that will become clear, it is hard to see how the Polypill site is regulated by the self-regulation applied to licenced products, so the MHRA would appear to have the ball in their court.
In the UK advertising of medicines directly to the public is restricted to medicines you would normally obtain from a pharmacy (P meds) or those you could buy in a normal shop (General Sales List – GSL). We do not have Direct to Consumer Advertising (DTCA) of prescription only medicines in the UK or the EU. The MHRA website sets out the legal basis for the regulation of advertising medicines quite clearly in The Blue Guide. In short, Part 14 of the UK’s Human Medicines Regulations 2012 implements Title VIII of Directive 2001/83/EC [PDF] on the advertising of medicines for human use.
Regulation 279 states that there is a general prohibition on the advertising of unlicensed medicines to the public.
It is in breach of the Regulations to issue any promotional material for a licensable medicine until the licence has been granted.
This regulation is the one that stops companies promoting unlicensed indications of medicines, although it does allow factual answerrs to unsolicited questions, but equally applies to the suppliers of unlicensed medicines. That’s why specials manufacturers have to be very careful about advertising and the information they provide.
Section 5.7 of the Blue Guide also states that advertisements to the general public should “not contain material which refers to recommendations by scientists or healthcare professionals, or which refers to recommendations by celebrities who, because of their celebrity, could encourage consumption of products.” It’s not clear to me if this would capture the “as featured in” graphic citing several newspapers on the frontpage of the PolyPill website, or the quote from the BMJ.
Section 5.10 of The Blue Guidemakes it clear that websites are included in the regulations:
The internet is used widely to provide information to both consumers and healthcare professionals. Website providers should ensure that materials posted on the internet do not contravene the Regulations. Material posted on UK websites and/or aimed at the UK audience is subject to UK medicines advertising legislation.
So, if someone had asked me if it was possible to set up a website like the Polypill site legally, which has patient orientated material and an offer to have a consultation for suitability of the Polypill, my response would have been no. To clarify the position of the Polypill site, I have sent a complaint to the MHRA, specifically about regulation 279, and hope to hear back from them shortly.
In the interim, I do wonder about the primary purpose of the Polypill site. The site has brighter more intelligent people than me behind it, who are surely aware of the potential of breeching the regulations. So, is the Polypill site more of a political statement about the difficulties of getting licensing for the Polypill? A rather extravagent protest site?
If that is the purpose, then on what basis can different standards apply to people who think they are on the side of the angels? The history of drug regulation is littered with examples of potentially good things that ultimately caused harm. Such instances have driven the development of the very regulations that Wald says prevent his Polypill obtaining a licence. Over the past few months the Alltrials campaign has been arguing that hidden data is unacceptable, marketing a product in the abscence of data that would allow one to obtain a marketing licence isn’t much of an improvement.