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Business as usual

MHRA explains that its emphasis will remain firmly on vetting when it comes to pharma advertising

Business as usual

Rather exciting times” was how June Raine of the Medicines & Healthcare products Regulatory Agency (MHRA) described the current raft of new regulations, products and media facing the pharmaceutical sector today. Speaking at the recent MHRA 'Hot Topics in Advertising' seminar, Raine, the agency's director of vigilance and risk management of medicines, told delegates that the emphasis remains firmly on vetting.

In presenting the MHRA 2015 review of the year, Raine said that the agency has 'much to celebrate', and paid tribute to her 'small but perfectly-formed team'.

Last year 53 innovative products were reviewed, she said, compared with 48 in 2014. The agency hit its five-day response target in 98% of cases, despite reviewing 35% more items in 2015. No advertising complaints were upheld by the Prescription Medicines Code of Practice Authority (PMCPA) - three were upheld in 2014, Raine explained. The number of complaint investigations dropped significantly, from 188 cases in 2014 to 167 in 2015. There was no recourse to statutory procedures and only one corrective statement was issued in 2015. New active substances, excluding orphans, accounted for the bulk of new products vetted, at 27%. Orphans accounted for a further 11%.

Raine flagged up the work of Operation Pangea, the Interpol-coordinated initiative targeting the online sale of counterfeit and illicit medicines. The UK leads the way, she reported, having seized £15.8 million worth of illegal products. “The UK operation also resulted in 1,380 websites being closed down, 339 of which were domestic sites”, she added.

Two companies opted out of the PMCPA complaint procedure in 2014, although both continue to comply with the Association of the British Pharmaceutical Industry (ABPI)'s requirements for advertising. The MHRA still monitors the companies' training and practice, and continues to vet all advertising for one of them.

The number of complaint investigations dropped significantly... in 2015

Raine told delegates that the MHRA 'greatly welcomed' changes to the new ABPI Code of Practice, which took effect on 1 January 2016. She highlighted two areas of particular interest covered by the Code: collecting transparency data and examining the details of international meetings.

The latter has been in the news in the past year - and again in the week preceding the seminar - courtesy of an investigation by the Telegraph newspaper into the payment of NHS officials by drugs companies. Beryl Keeley, advertising standards and outreach unit manager, VRMM, spoke of it further in her presentation.

Beryl outlined the legal position before giving some examples of breaches of the ABPI Code. She highlighted a number of factors that organisers of advisory boards should consider. Among these are the balance of the agenda (the focus should be on participants giving the organisers advice on clinical matters), whether information about products can be published as pre-work, and the numbers and expertise of the attendees.

In the case of advisory boards meeting in Europe, she said, companies would need to justify the location. They should also ascertain whether the event fell under UK or corporate control. If it is the latter, Beryl stressed that companies still needed to ensure that the meeting complied with UK law and ABPI requirements. Meetings arranged by someone else should be treated with particular caution, she added.

Beryl also highlighted the need for transparency in reports produced after such events. She said: “Healthcare professionals get very upset when they start reading something only to read in the small print at the end that a particular company chose the people and the questions, and wrote it up with their own slant.”

She encouraged companies to state clearly if an event is promotional, suggesting an explanation along the lines of: 'Please note that no honorarium will be offered to attend this meeting. This meeting will include promotional content.'

VRMM medical assessor Rafe Suvarna talked delegates through MHRA complaint and scrutiny cases in 2015, explaining that 80% of the 167 complaints received concerned the promotion of botulinum toxin and other prescription-only medicines to the public. Eight such complaints were upheld in 2015.  He stressed that although MHRA has statutory powers when it comes to dealing with these infringements, it is expected that in most cases companies will work with the agency to issue acceptable advertising, without the need to resort to formal procedures.

Suvarna also highlighted potential hazards. These included misleading statements and unfair comparisons, promotion of prescription-only medicines to the public, the promotion of unlicensed medicines and use of the word 'safe'.

He also cautioned delegates over 'dual use', describing a situation where ferric citrate was promoted at a kidney disease symposium. It was described as being FDA-approved - which it is, but not for the treatment of kidney disease. Following a warning, the presentation was changed.

Suvarna also described an example of an unfair comparison, where a claim of equivalency was incorrect, as the two products were not available in the same dosage.

He also spoke of an incident where a product in the early stages of development was mentioned in a newspaper supplement. It was agreed that this could be regarded as an advert, and the online version of the piece was withdrawn.

Suvarna flagged up the threat posed by social media. He described a situation where an account manager at a pharmaceutical firm commented on a customer's LinkedIn post. The information then appeared in the account manager's feed, meaning that they had unintentionally promoted a prescription-only medicine to the public.

Future proofing
MHRA's Jan MacDonald focused on whether prescribing information is suitable for the future, sharing the results of a survey carried out among a small group of nurses, doctors and pharmacists. Those surveyed were asked about the contents and structure of adverts, and what they considered 'essential information'.

Responses varied between the professions. A nurse said: “I only look at adverts if the medicine is relevant to my practice”, a doctor stated: “I either need to take the snappy tag line at face value or assumed it's over-hyped - neither is good for my patient”, and a pharmacist replied: “Small print is not enough - I often need to find the references”. MacDonald said, in summing up the results of the survey, that while healthcare professionals do read adverts, they tend to only look at relevant products. She stressed that there is a need to understand the balance of risks and benefits, and a clear appetite for engagement.

Looking ahead
A delegate asked about disclosures. He noted that these are required under the Code but are not a legal requirement, and asked whether this was likely to become the case.

PMCPA director Heather Simmonds told him: “The ABPI wanted a central database because of how it might develop in the future. The UK wanted to continue to rely on self-regulation. Part of the thinking is that this could potentially be expanded.”

Beryl pointed out that the ABPI code has 'been going much longer than statutory regulations on advertising'. This is a good illustration of the strengths of self-regulation, she added.

“Law is a blunt instrument and not half as open to change as self-regulation”, she stressed.

In the conclusion to her review of the year, June Raine told delegates that MHRA will continue to work in partnership to maintain its high standards. It will continue to encourage self-regulation through its own flexibility to respond underpinned by its statutory role, and will co-operate with Europe in doing so. It will work with the industry to issue and deliver clear guidance and advice, while at the same time facilitating company responsibility. 

Article by
Tara Craig

is a freelance journalist and editor

4th May 2016

Article by
Tara Craig

is a freelance journalist and editor

4th May 2016

From: Marketing, Regulatory



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