Please login to the form below

Not currently logged in

Creative marketing and compliance

The challenge of addressing this fine balancing act

Creative marketing

Readers hardly need a reminder about just how tough marketing is in the pharmaceutical industry: regulation and compliance requirements that have to be a part of the launch and campaign materials for any new drug often make creativity a real challenge. Additional challenges include the increasing array of marketing channels available (such as social media) and direct marketing to consumers, plus a growing volume of visually-based brand communications.

No wonder pharmaceutical companies are finding it difficult to keep track of how and where their marketing materials are being used (and more importantly, if it's within 'the rules'). A pharmaceutical company might have hundreds of thousands of these kinds of 'assets' across packaging, social media, PR, literature, web and other channels.

The cost of getting it wrong is high: there have been cases of pharmaceutical firms being fined over one billion dollars for incorrect promotion of a prescription drug. Fines are just the tip of the iceberg though: loss of reputation and market confidence can have a devastating effect on a company's future. The tragedy is that mistakes like this can happen very easily if the right measures are not in place. Sales people can be using marketing content in good faith, without realising that it is 'off label' and unapproved.

No longer fit-for-purpose
Surely the pharmaceutical companies have a handle on this? The reality is that in many cases, they are getting by with processes and systems that were built before the digital economy, but which struggle to keep up in today's always-on world, with high volumes of content being pushed out, in an ever-increasingly regulation-centric environment.

Of course, departmental 'gates' already exist - there are the legal or marketing departments but not the global end-to-end view. How many of us have seen several files of ostensibly the same content, all with the word 'final' on them? In common with other industries, marketing assets can become siloed into shared drives, email approval chains or other processes. Digital asset management (DAM) systems may exist, but they are often specific to one function and not interconnected. Accountability may be there on a departmental level, but not enterprise-wide.

The catalyst for change often only happens when something goes wrong and marketing or brand asset management suddenly becomes a board-level issue. Not only is this a dangerous strategy, it is an approach that is missing a major opportunity to reap the benefits of better asset management.  Adherence to compliance and regulation is essential, but other advantages can include better re-use of content, quicker and more streamlined approval from regulatory authorities and faster response time to market opportunities.

Life of an asset
Before we look at what 'best practices' might look like, let's quickly remind ourselves of the typical life of a marketing asset in the pharmaceutical industry.

Much of the creation of marketing content is usually around the launch of a new drug or device, but those materials are going to have to have a long life cycle, as they trickle out into the field, into the hands of doctors and other audiences. Even before that happens, there are a whole host of tasks: each department internally will review and hopefully sign off those assets, then they are packaged up and sent to the relevant authority - for instance, the FDA - for approval before hitting the market, a process that can easily take upwards of 18-24 months.

Let's also think about what those assets typically are: rigour around text-based communications is pretty well understood, but we're operating in an increasingly visual world of still images, audio, video and other graphic-based content. It's all too easy to lose sight of how these assets are used, which is very important. Get it wrong and not only is there the risk of being 'off brand' (it could even be a matter of life or death), but local regulations might be contravened. While many nations of the world may generally follow the FDA, they are not the only authority; the European Medicines Agency for the EU and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK are also influential.

Digital asset management systems may exist, but they are often specific to one function and not interconnected

Also, demand for access to these assets is happening faster and faster. Years ago, communications to target audiences were largely print-based, with maybe a little bit of TV or radio advertising. In today's digital world, the pressure is on pharmaceutical marketers 24/7. It's easy to see how something might slip through the cracks if content isn't being managed properly, risking future litigation. Then of course there is the constant need to have 'track and trace' for the use of all assets in case of external auditing.

Best practice - six steps
The net result of all this is that an increasing number of pharmaceutical organisations are implementing digital asset management (DAM) strategies and supporting IT systems. As well as assisting with compliance, these systems have other benefits, which are often the catalyst for implementation, such as better accessibility and re-use of assets (thus preventing wasted budget). DAM systems are also often a pivotal part of digital transformation projects, helping to bring all the different elements together.

However, there is a huge gap between a great DAM concept and successful execution. So which steps should pharmaceutical companies be considering?

Create champions and act stepwise 
Start with a few stakeholder groups, such as sales, marketing, R&D and legal. Work closely with them to build workflows that fit their individual processes. Demonstrate how it works and get their buy-in so that they become ambassadors for the DAM project, and then start rolling it out to other functions. An environment of 'quick wins' is essential to keep up momentum.

Create a single lens 
Have one single system that says 'this is the final asset that is approved and safe for re-use', together with associated regulatory information and rights management for each asset. In this way, staff can be confident that they are using the right assets in the right way.

Consider local requirements In the pharmaceutical market, the more sophisticated regulatory markets - such as the US, UK and France - largely set the tone for the rest of the world, meaning that more remote and less regulated countries can be sure that the necessary due diligence has been performed. However, there will be instances where local rules apply, including cultural uses (for example, some images are not appropriate for use in some Arabic and Asian countries).

Build digital asset management (DAM) around people, not technology 
Fact: people will only use technology if it's easy to use. Otherwise, they will find a workaround. This is why it is essential to put in the time to make sure that the workflows and features within the system are built around people and existing processes, rather than imposing a new way of working. Above all, finding the right content must be easy, with a delicate balance between having enough parameters to give people choice without overwhelming them with too many options. This means investing in defining the correct taxonomy and vocabulary because although tagging is essential, it is not the most exciting task.

Automate as much as possible As approving agencies update their submission processes and go digital, the ability to automate the process becomes possible, even essential. With all the checks and balances in place from the implementation of DAM and workflow systems, the automation of regulatory submission makes sense. It ensures that the right content gets to where it needs to be with all supporting materials and that submissions only happen when everything is in place and ready to go.

But don't stifle creativity 
Rules are important, but so is the ability to be creative and that means having a system and set of processes that enable some flexibility and encourage individual inspiration, while giving people the confidence that they are working within approved guidelines. The trick is to provide tools - such as a DAM that is user-focused rather than just a stick to beat people with - that supports creativity while still ensuring compliance. As we have seen within our own customer base, it is not impossible to have the best of both worlds.

And that really is the bottom line here: while no-one is denying the scale of the challenges facing marketers in the pharmaceutical industry, a variety of techniques and tools are available that between them can go a long way towards achieving that delicate balance between compliance and creativity.

Article by
Jason Arena

 is CMO at North Plains Systems

23rd November 2016

Article by
Jason Arena

 is CMO at North Plains Systems

23rd November 2016

From: Marketing



Career advice

No results were found

Subscribe to our email news alerts

Featured jobs


Add my company
JPA Health

JPA Health is an award-winning public relations, marketing and advocacy firm known for sharing our clients’ commitment to making people...