“An ounce of prevention is better than a pound of cure,” said American founding father Benjamin Franklin. It’s probably safe to say that he wasn’t talking about medicines, but his quote was used at the recent Medicines and Healthcare Products Regulatory event in the UK, and the sentiment echoed throughout.
While MHRA director of vigilance and risk management of medicines June Raine made much of the number of advertising infringements investigated in 2013, she stressed that her organisation would, this year, continue to focus on pre-vetting of both products and advertising materials.
Raine’s point was reinforced by colleague Jan MacDonald, who told the audience that the MHRA wanted companies and their representatives to take responsibility for their own products and materials.
Far fewer complaints were received, Raine noted, from sectors where self-regulation is established. There has been a marked increased, however, of complaints concerning homeopathic products, whose makers have yet to really engage in self-regulation.
Training and education
MacDonald, the MHRA’s head of patient information, told delegates that it is worth putting processes in place at the outset. She – along with several subsequent speakers – underlined the need for effective staff training.
Staff need not only to understand the products, but also to know what they can say in advertisements. They need to stay within the law and, stressed MacDonald, their training needs to be updated regularly, in order to stay abreast of regulatory developments. All training should be documented, in case of audit.
Sales representatives in particular need to be trained on an ongoing basis, emphasised MHRA pharmacovigilance inspector Sophie Keddle, with Heather Simmonds – director of the PMCPA, which administers the ABPI Code of Practice – suggesting that compliance be discussed regularly and staff encouraged to take personal responsibility for their work.
Written procedures should be in line with EU legislation, delegates heard. They should be updated and distributed in a timely fashion – in other words, as soon as possible after the introduction of new legislation.
Keddle also stressed the importance of timely updates of materials not directly aimed at suppliers of medicines, for example the pharma company’s website. Companies should also ensure that updated patient information leaflets are included in product packs.
External factors
While training should ensure that staff are on message and armed with the latest regulatory information, third party agencies also need to be not only brought on board, but kept in check. A number of the Code of Practice breaches seen in 2013 were due to PR agencies, for example, sending out messages unbeknown to the pharma companies they work for.
Press releases, said Simmonds, should always be checked. Where new product launches are concerned, press releases must be factual, balanced and non-promotional in content. Similarly, patient materials must be consistent with the patient information leaflet, and free from promotional claims. Simmonds also questioned the degree to which those who develop the medicines are involved in marketing campaigns, suggesting that they increase their input in order to ensure accuracy.
Social media – threats and opportunities
Social media in particular has the potential for advertising pitfalls, said the MHRA, partly because it is often the responsibility of external agencies, but also because it is relatively new and its capacity for breaching advertising codes still largely misunderstood.
Camelia Mihaescu, advertising and regulatory affairs manager at the Proprietary Association of Great Britain (PAGB), explained how, for instance, Twitter advertisements have already been seen to break over-the-counter advertising rules because the 140-character limit means that essential information (EI) can rarely be fitted into a single tweet. To solve this, the MHRA and PAGB have agreed, said Mihaescu, that the EI can be broadcast via separate, sequential tweets, although at least part of it must be included in the initial tweet. The subsequent tweets must be numbered and sent shortly after the first.
Another example given involved an events company tweeting invitations to an event promoting prescription only medicines – a marketing activity their clients remained unaware of, at least until complaints were made.
Twitter isn’t the only tricky channel in this area. A tenth of the advertising complaints received by the MHRA in 2013 were social media-related, June Raines said, with the bulk involving Facebook. Common breaches include using Facebook to promote clinics and prescription only medicines, with Botox-type medicines being the worst offenders.
It’s clear, then, that the training and understanding not only needs to extend to all stakeholders, but also needs to be updated as and when new technologies and means of communication become available.
Audience concerns
The seminar’s Q&A session threw up a number of interesting points, and showed the delegates to be particularly concerned about audits. They were keen to hear not only how to avoid them, but also how to deal with them, should the worst come to the worst.
Asked about the main pitfalls in audits, the PMCPA’s Simmonds urged companies to look at materials with fresh eyes, and to keep job bags in good order, particularly where materials had gone through a number of incarnations before final sign-off. Different sizes and different formats of the main material also need to be scrutinised in their own right. Delegates were keen to hear how long they should keep advertising materials, on the off-chance that their company would be audited. MHRA advertising standards unit manager Beryl Keeley suggested three years after the advert’s final appearance.
Materials for auditing and pre-vetting will be accepted in electronic format, as long as all of the wording is legible, delegates were reassured, having asked whether they needed to provide examples of larger marketing materials such as cardboard cut-outs or display stands. They must also be able to show how the material was used.
Where websites are being offered up for pre-vetting, Keeley said, text-only material could be submitted in the first instance. She added that the MHRA is pre-vetting an increasing amount of materials designed for iPad use.
What is the MHRA doing to help?
With the industry increasingly aware of the parameters within which it must operate, and the emphasis very much on getting materials and messages right – and legally watertight – before they enter the public domain, it is in everyone’s interest that the MHRA helps make the process as easy as possible for the pharma companies. The organisation is working towards a five day response target in pre-vetting cases. Raine told the audience that it achieved this 98 per cent of the time last year, up from 93 per cent in 2012.
Significant strides are also being made in the cutting of red tape. The MHRA is in the process of assessing feedback from a consultation that ran from February to April and covered simplifying the information requirements for advertising to prescribers and suppliers of medicines. Its outcome will determine whether use of the abbreviated format is extended to include advertisements for over the counter medicines.
As the nature and range of complaints develops, the MHRA is continuing to review its guidance and codes, among them The Blue Guide, which provides comprehensive guidance on the advertising and promotion of medicines in the UK. The Guide will need to be updated if the abbreviated advertisement changes are agreed, and the MHRA has worked with the PAGB to develop guidance on advertising through social media.
Compliance should be discussed regularly and staff encouraged to take personal responsibility for their work
In her opening presentation, Raine mentioned that one of the three key pillars of the MHRA’s work is collaboration. Ongoing work with other, similarly minded, organisations is helping drive home the MHRA’s messages while enabling it to extend its reach.
The MHRA is working with the Advertising Standards Authority (ASA), for instance, to underline the latter’s work to combat the illegal advertising of Botox. Meanwhile its membership of the European body FOAM (the Forum on Advertising Medicines) is allowing the MHRA to tackle a number of issues, including transparency, social media and enforcement.
The new ABPI Code of Practice, which came into effect on January 1, has been ‘very much welcomed’ by the MHRA, said Raine, for three key reasons and she pointed to the transparency provisions of the EFPIA Code, the information on ADR (adverse drug reaction) reporting for patient materials and the widened certification for pharmacists.
Looking ahead – what’s next for the MHRA?
“We’re not standing still,” said June Raine. The coming year will see more of the same, she stressed, adding that the MHRA’s message is ‘robust’. The organisation’s activities will continue to focus on pre-vetting, cutting red tape and collaborating with like-minded agencies.
“We’re not standing still,” said June Raine. The coming year will see more of the same, she stressed, adding that the MHRA’s message is ‘robust’. The organisation’s activities will continue to focus on pre-vetting, cutting red tape and collaborating with like-minded agencies.
The MHRA will continue to listen to the industry, she said. And while long-standing areas of concern will still be addressed, new areas – among others, social media, advertising of prescription only medicines, and promotion of unlicensed homeopathic remedies – will receive particular attention.