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23.03.2011

Healthcare engagement in the absence of regulatory guidance

In early March 2011, at a pharmaceutical marketing conference in Munich, Heather Simmonds of the PMCPA gave very much the same perspective on UK and European regulatory guidelines that she has for the past few years. There were some murmurings amongst the crowd from those who had heard it all before.

Refreshingly, at the same conference, Ray Chepesiuk of Canada’s Pharmaceutical Advertising Advisory Board presented a somewhat enlightened and progressive approach to emerging channels such as social media and forums – explaining how his organization established guidance on two-way engagement dating back to 2005.

Having attended and presented at many pharmaceutical marketing conferences throughout Europe, Asia, and the United States (see where we’ll be in the coming months here), Creation Healthcare very often hears delegate concerns and frustration about the lack of guidance from regulators and industry bodies. The organisations that provide guidance to the industry are currently under a lot of pressure to understand the implications of something which is in a constant state of flux, and in which they themselves have very little experience or expertise.

We understand that according to the FDA, they are currently researching issues such as:

  • Responding to unsolicited requests
  • Fulfilling regulatory requirements when using tools associated with space limitations
  • Fulfilling post-marketing submission requirements
  • On-line communications for which manufacturers, packers, or distributors are accountable
  • Use of links on the Internet
  • Correcting misinformation

Their statement goes on to say that they only expect to have draft guidance on “at least one of these topics during the first quarter of 2011”.

Meanwhile, the capabilities of the Internet and the expectations of the people who are increasingly seeking health information and engagement online are exponentially changing.

What if we actually had guidance?

What would really happen if the PMCPA or FDA were to say “these are the new rules of engagement for social media and emerging channels”. In actual fact it may not be as beneficial as everyone expects; indeed it could be crippling to the daily innovation which already exists amongst pharmaceutical and healthcare companies.

Certainly at the current time, many appropriate and interesting decisions are being made by individual pharmaceutical companies in response to the changing landscape – all within the existing rules and regulations and based on learning from what has been done before.

Another point about producing guidelines is that a company actually needs to acquire experience for itself over time to best understand how to use emerging channels. Simply specifying guidelines might open the possibility that a newcomer to this form of communication may badly interpret the guidance and create the first ‘alarming’ example – which then hinders other ‘good’ practice initiatives.

What is potentially ‘right’ for one company isn’t necessarily a rule for everybody – if they are not also in an appropriate place to understand and implement with sufficient resource and process.

Rather, if a regulatory or industry body was to actually survey and collate the many intelligent solutions and precedents which have already been developed amongst pharmaceutical brands; they would immediately have a non-technology specific guidance which would be light-years ahead of anything that they would be likely to conceive themselves.

This is why Creation Healthcare has repeatedly called for regulatory leadership in bringing together global knowledge and to help form useful guidance.

Specific ‘Social Media’ guidance cannot keep pace with change

There is a well-worn expression that says, “The only certainty is change itself”; quite fitting when observing the platforms and technologies that are evolving into ‘normal’ life. To illustrate how guidance cannot sufficiently address specific technology challenges, consider that Facebook this month made several new changes to their system which affect the way ‘Pages’ operate.

On one hand this has created some welcome new opportunities for pharmaceutical companies to choose how conversations are managed.

On the other hand, these changes could have easily been for the worse.

The point is that they could have provided a new feature which suddenly added functionality – perhaps welcomed by other industry sectors – but which creates a regulatory compliance or pharmacovigilance issue for the pharmaceutical industry. This would immediately have ramifications for all of the companies that are using Facebook for corporate communications, health awareness or patient safety campaigns.

Guidance simply cannot keep pace if it is only aligned to specific technology or functionality.

The challenge for a regulated pharmaceutical company online is that when Facebook, Google, or another web-based software company produces an ‘update’, it potentially introduces a new piece of functionality which was not considered or approved when any pharmaceutical sponsored initiatives were conceived and developed; potentially creating brand new project parameters without the pharmaceutical company having any opportunity to consider or approve this.

Such is the nature of this changing landscape, and something that we have to get used to.

Planning for change

When Creation Healthcare considers the various platforms available for a project it is based on a careful evaluation of the constraints, opportunities, and risks which exist for that solution. We also know that the Internet changes quickly, and that the solution which was successful in one campaign will not automatically be the most appropriate solution for the next campaign, even if very similar in principle.

In thinking about the ‘certainty of change’, here are just a few key principles for creating successful long-term engagement using the Internet, and in the absence of specific regulatory guidance:

  1. Plan for change within the development period of your initiative – and more importantly ongoing after the release. What will the process be for evaluating the impact of new changes and for making updates to internal approvals?
  2. Carefully consider who and how administrators are set up for 3rd party websites such as Facebook – if a user is blocked or deleted, or no longer has access, what are the implications for your initiative?
  3. You do not have control over 3rd party websites – they can and will change things without your permission. Expect it, and be ready to escalate to the appropriate level depending on the implication of the change.
  4. At any point, your 3rd party website initiative can be removed, irrecoverably lost or be unavailable – in such cases the process or access to customer support is often not guaranteed. What will the company response be, and through which alternate channels?
  5. Consider that you do not usually own the rights to content on 3rd party websites – they may remove or reject your content at any time, and may be able to retain rights to content for longer than the duration of your initiative.
  6. Whether an internal resource or an external trusted consultancy like Creation Healthcare – someone needs to watch and document relevant industry changes on your behalf and build a repository of knowledge about your company initiatives
  7. Take a view on the landscape around you, the experience you have to date, and choose engagement initiatives in keeping with your own resources and risk profile – do not attempt to do something just because it is possible or because another company is doing it
  8. With best intent, always clearly demonstrate compliance with existing code and regulations – increase efficiency by establishing a repository of precedents and lessons learned within your company, to be reused and adapted for future initiatives

Creation Healthcare is a specialist in healthcare engagement for pharmaceutical companies. For assistance in developing best practice change response processes, or to better understand guiding engagement strategy principles, contact us on +44 (0)207 849 3167 to arrange a confidential meeting.

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