Brand management, Pharma/Healthcare

The cost of non-compliance in pharmaceutical marketing 

All companies are held to strict rules that govern what they can and cannot do. Organizations in the pharmaceutical industry are no exception.

As suppliers of potentially life-saving medicine, pharma companies have a responsibility to not only produce safe pharmaceutical products, but to market these drugs to healthcare professionals (HCPs) and the general public honestly and transparently. 

Meeting these rigorous standards is essential. However, when you consider the immense challenges your marketing departments already face – such as growing content demands and ever-evolving brand guidelines – delivering compelling, compliant pharma content is no simple feat.

To help your marketing teams build trust, increase sales and ensure compliance, here we explore the regulatory hurdles your campaigns have to overcome, the potential ramifications of non-compliant marketing efforts on your brand, and a handful of helpful strategies you can use to produce content that is compliant and successful.

What is non-compliant pharma marketing?

Whether your brand works closely with HCPs to get prescription-only medicine (POM) into the hands of pharmacies, or promotes over the counter (OTC) products to target audiences online, your pharmaceutical marketing must meet a series of stringent, self-regulated standards in the UK. 

These strict rules are outlined and enforced by several regulatory agencies. For prescription medicine, PMCPA administers the ABPI Code of Practice. For marketing plans that involve OTC drugs, PAGB works to make sure all marketing activity falls in line with their own advertising code. 

[Papirfly blog] Regulations of UK pharmaceutical marketing and promoting medicines - Infographic - Source: Gov.uk

While there are different guidelines for promoting over-the-counter products and prescription medicine, at its core, compliant pharmaceutical marketing should be ethical, accurate and patient-focused. These principles should not only apply to your social media posts and email campaigns, but also to product packaging, clinical trial data and post-marketing surveillance.

With all of that in mind, what does pharma marketing actually look like when it steps outside of these regulations? While non-compliant content can take practically any form, it’s common to see regulatory bodies step in when elements like side effects are absent on promotional material, usage instructions are unclear, or the trial data used in a campaign was deliberately skewed.

[Papirfly blog] Examples of non-compliant pharma marketing - Papirfly infographic

What are the consequences of non-compliant pharmaceutical marketing?

According to a recent research conducted by University of Bath and Lund University academics, there were more than 1,100 cases where pharmaceutical companies fell short of advertising standards in the UK between 2004 and 2021. 

These instances do more than simply jeopardize the health and wellbeing of end users. A lack of compliance in pharma marketing poses significant risks to your brand’s reputation and long-term success.

Your brand’s reputation can decline

Reputation is important for any brand, especially one relied on by HCPs and customers to save lives and cure ailments.

Whether your medicine fell short of a patient’s expectations, or news of a compliance breach found its way into headlines, few things can undermine the credibility of your brand more than a damaged reputation. When healthcare professionals, existing customers and your wider public feel they can no longer trust you, they won’t hesitate to look elsewhere to get their pharmaceutical products.

This is all to say that breaching pharmaceutical marketing compliance can quickly erode public opinion in your company, directly affect your market share and undermine your business’s bottom line.

[Papirfly blog] Importance of brand trust - 71% of customers stop buying from brands that break trust - Source: MarketingWeek

It’s also important to acknowledge the effect a bad reputation can have on your employer brand. If prospective candidates don’t feel able to trust your company due to a poor track record of compliance, it’s likely that your talent acquisition efforts will become less effective.

Your company can face financial penalties

Falling foul of PAGB’s advertising standards or ABPI’s Code of Practice influences more than just your organization’s reputation. In many cases, sub-standard pharma marketing can lead to substantial fines.

While the specific amount varies depending on the type and severity of your collateral’s breach, findings suggest these penalties often reach six figures.

[Papirfly blog] Financial impact of UK pharmaceutical marketing non-compliance averages a £630,000 penalty cost - Source: The Pharmaceutical Journal

In very rare and serious cases, there have been cases known to cross into the billions. You only have to look back to 2009, when Pfizer pleaded guilty to misbranding Bextra in the US, which landed them a historic fine of $2.3 billion (over €2.1 billion).

When you consider that regional audience expectations continue to grow as marketing budgets shrink, it’s easy to imagine the impact a substantial fine could have on your marketing and overall business operations. 

Your products can be recalled

Another notable consequence of non-compliant promotional activities is product recalls.

If your marketing materials or product packaging fails to meet the high bar for compliance in the UK, authorities such as the MHRA may step in to pull your medicine from pharmacies and store shelves. Needless to say, this can have disastrous consequences for your campaigns.

Not only will you have to forfeit any resources you have invested; chances are you’ll need to devote more time and money to rectifying these mistakes, producing entirely new collateral that meets your legal requirements.

[Papirfly blog] Pharma industry advertising marketing spend was £54 billion in 2022 - Source: Kantar

3 strategies to deliver successful, compliant pharmaceutical marketing

Now you understand the regulatory hurdles your pharma marketing must overcome, and the consequences of falling short, what steps can you and your marketing team take to deliver captivating, compliant pharma marketing?

1. Invest in ongoing training for your campaign teams

As regulations around pharmaceutical advertising evolve and the marketing landscape shifts, laying the foundation for success in your marketing team starts with the right training.

After all, if your creatives, sales representatives and marketing executives don’t understand the rules their content must abide by, or the best approach to compel HCPs and other customers – achieving true marketing success becomes significantly harder.

However, before you plow ahead and invest in training, it’s first important to gauge the current capabilities of your team. To do this, it is wise to carry out a thorough audit.

[Papirfly blog] The 6 steps of an internal skills audit for pharmaceutical company marketing teams

Once you have a clear understanding of what gaps exist in your marketing department’s understanding, the next step is to plug in the right training. There are plenty of approaches your pharma company can take here, such as:

  • Holding compliance workshops when rules change, mapping out how new legislation affects your upcoming and existing campaigns
  • Investing in online training platforms to make it as easy as possible for individuals across your teams to take on new skills at their own pace
  • Inviting external experts in to provide talks or guidance about best pharma marketing practices
  • Creating compliance toolkits your teams can refer to when producing marketing materials 

With the right steps, you can upskill your teams efficiently, and create a foundation from which to launch compliant, successful marketing campaigns now and in the future.

2. Regularly engage third-party compliance auditors

Whether your team is in a rush to meet the launch of a new OTC medicine, or prepare materials in time for an upcoming HCP event – the urge to push full steam ahead with your promotional materials can be strong.

However, when your department is ‘all heads down’ and racing toward a deadline, this can leave room for costly mistakes. From inadequate warning labels on boxes to unsubstantiated testimonials on TV adverts, these errors can quickly draw the ire of regulators.

As a result, it can be helpful to consult with third-party specialists before rolling out a new campaign:

[Papirfly blog] Best practice tips for consulting third-party pharma compliance auditors - Papirfly infographic

When you consider the risks of non-compliance in the pharmaceutical industry, such as reputational damage and financial losses, gaining complete peace of mind before going live can be a wise investment.

3. Adopt the right marketing tools

In the world of pharmaceutical marketing, it isn’t enough to produce compelling marketing materials. You have to navigate strict rules, all while keeping your brand modern, your global audiences engaged, and your efforts on budget.

To help you overcome these obstacles and meet the standards required by UK compliance organizations, brand templating tools can be a game changer.

Instead of requiring your content creators to manually produce the dozens (if not hundreds) of print adverts, social graphics, videos and more that shape your campaigns, on-brand content creation software helps reduce the time, effort and resources involved through the use of smart, customizable templates.

How does this work in practice? While different platforms will vary in features, the core principle is simple – aspects such as imagery, copy and colors can be switched out in a matter of clicks, without altering core brand elements, like logo placement and mandatory disclaimers. 

For example, if you needed to produce a wide range of different posters for GP surgeries, pharmacies and retail stores, these tools can empower anyone on your team to put these materials together in a matter of minutes – all with the assurance they’ve followed every regulatory requirement and brand guideline along the way.

[Papirfly blog] Compliant pharmaceutical marketing assets – easy task with Papirfly!

Having software that upholds compliance and consistency across your content creation pipeline is a powerful asset for any organization. However, to ensure your marketing materials remain compliant in every campaign, a dedicated Digital Asset Management (DAM) solution is another essential investment for pharmaceutical marketers.

Able to integrate with on-brand content tools and other must-have martech, these platforms act as a centralized library for your digital files and assets, keeping everything orderly and readily accessible at all times. 

This functionality makes it seamless to ensure the right content is published at the right time, in the right places. On top of this, incorporating a DAM for compliance reduces the stress associated with finding content that has to be updated in line with post-marketing surveillance.

Additionally, in the UK, regulatory agencies can request copies of advertising materials. Thankfully, with a DAM platform’s robust search functionality, finding relevant assets and fulfilling these requests can become an effortless formality.

[Papirfly blog] Find your marketing assets easily with a DAM solution from Papirfly.

Deliver compelling, compliant pharma marketing

If you’re a pharmaceutical company marketing products in the UK, the promotional materials you publish are held to a strict standard of ethics, accuracy and patient wellbeing.

It doesn’t matter if you are promoting OTC medicine to the public, or prescription-only products to HCPs, meeting these stringent codes of conduct are non-negotiable.

With substantial fines, legal action and reputational damage hanging in the balance, navigating this landscape – all while making sales and meeting budgets – demands a considered approach. 

We hope the tips and brand management solutions we’ve covered today – from upskilling your digital marketers and sales representatives to incorporating on-brand content creation tools – can help your campaigns enter a new era of compliant, consistent success. 

[Papirfly blog] Meet Papirfly – the #1 solution to create and manage content. On-brand. At scale.