Play at your own risk

‘Agile’ content approvals in the pharmaceutical industry

In this article, the first in a series of ‘how-to’ guides for the pharmaceutical industry, Paul Grant explains the premise of ‘agile approvals’ and gives us a challenge on how we can apply existing engagement protocols to real-time or social conversations.

Why “we can’t…” – the perceived obstacles to agility

Compliance; pharmacovigilance; industry reputation; our complex regulatory environment; protocols; resources: these are just some of the common phrases heard when it comes to innovative attempts to re-think the way in which the pharmaceutical industry engages in public social media.

By comparison, how inspirational are alternate phrases such as: social pharma; agile approvals; pharmaceutical engagement; real-time communication; patient-centricity.

In fairness, all of us within the industry are generally trying to do the ‘right’ thing. We understand the importance of ensuring the correct information is available to patients and healthcare professionals. We understand that we should not inappropriately promote treatments to the public, nor do we want to bring the industry into disrepute. On a personal level, very few of us want to jeopardize our own careers by being the ‘one’ that causes a non-compliant situation for our company.

It is also true that each pharmaceutical company adopts, implements and even interprets regulation in keeping with their own culture of risk versus innovation, from which protocols and standard operating procedures govern future actions.

With this understood, our challenge is to not allow such matters stifle innovative thinking.

Why “we can…” – constraints as a catalyst for innovation

In my experience, constraints (whether regulatory or otherwise) are the very best catalyst for innovation.

A little mantra that I carry within me, adapted from another quote I once heard but is now long forgotten: “…innovation is born from adversity.

Consider the following hypothetical situation:
You have been invited to create a picture for which you will be paid any price you believe the picture is worth. You have free choice of medium, of materials, of subject – even dimensions – and not only that you are allowed to take as long as you like to complete the picture until you are satisfied that it is perfect.

For many, such ‘freedom’ would be the root of paralysis. This is a quandary faced by many a novelist, finding themselves staring perpetually at a blank piece of paper with “writer’s block”.

Now consider an alternative situation:
You have less than five minutes to draw a picture of a cat on the back of the nearest piece of paper using the first writing implement you can lay your hands on. Any of us could do such a task, to varying degrees of complexity and with varying degrees of aesthetic appeal. Yet, I am confident all would rise to the task. Furthermore, we may even see some really interesting interpretations and creative expressions!

So too with constraints and regulations in the pharmaceutical industry – I personally find great joy navigating within these boundaries to find innovative and appropriate ways to communicate.

They are a cause for creativity, for stimulating action – not inaction.

Why “we already do…” – nothing is new under the sun

Within our companies, we already understand the balance of regulated messages and human connection, within the culture of our organizations.

For example, when a field force representative visits a health care professional to talk about a product or therapeutic option, they may spend the first few minutes in an unscripted and ‘unapproved’ dialogue – very human, hopefully engaging, and built on developing a relationship between two people.

Certainly, at some point, the conversation turns to the detail of the product and data questions. Here, there exists specific guidance about what is or is not permissible, and the representative will endeavor to remain within company protocols for appropriate communication.

The same is true if a journalist contacts the press office or communications department of a pharmaceutical company. Firstly, some human interaction – unscripted – followed by an official position or statement relevant to the question at hand.

Medical information and drug safety colleagues also engage with the public and respond to unsolicited enquiries, supporting questions and concerns about products and other related health matters.

My point here is that we inherently know and understand that some parts of our conversation are covered by guidance, and other parts are common sense human engagement.

Applying agile approval principles

This delineation between approved content and engagement is the concept behind so-called ‘agile approvals’. Some content produced by a pharmaceutical company will through necessity require full legal and/or medical scrutiny, and will ultimately require an authorized individual to approve that the content is suitable for release.

Typically, content requiring approval contains:

  • a health or referenced factual claim, or
  • is soliciting information from the public, or
  • mentions a regulated treatment, or
  • contains some other potentially litigious concept such as terms of use or privacy agreements.

Naturally, these are subject to industry and company-specific guidance.

The opportunity however, lies in all other forms of communication.

For example, a large portion of social media dialogue is actually quite ‘human’ or ‘conversational’ and may consist of pleasantries, gratitude, salutations, ‘sign-posting’ to other approved resources, or providing general support to questions relating to online resources such as websites.

With this in mind, consider whether certain authorized individuals within your organization could be empowered to better represent the company in real-time social channels – using their own discretion to respond and engage with others in a conversational way, unless the conversation turns to an topic requiring approval as identified above.

Some content may also be eligible for a ‘fast-track’ approval, not requiring all of the usual signatories – if for instance it only contains content that may be best addressed through another approved resource such as a press release.

Moving towards an agile approvals model starts with understanding how to plan for conversational scenarios – the topic of our next article in this series.

In the following articles within this series, we will look at other tools and techniques for achieving ‘agility’ in the pharmaceutical industry.

Image source: http://www.sxc.hu/profile/nosheep

Paul Grant

Paul Grant is Healthcare Engagement Strategist with global consultancy Creation Healthcare, where he leads digital behaviour research studies and advises healthcare clients on engagement strategies. He has been providing strategic insight solutions and professional services to the world's leading biopharmaceutical and healthcare organizations, helping them to find appropriate pathways to engagement within regulatory frameworks.