A Practical Guide to Interpreting PMCPA guidance

It was ironically only a couple of weeks ago that Creation Healthcare published a piece about “Healthcare engagement in the absence of regulatory guidance”. In that article, I made the point that “specific social media guidance cannot keep pace with change”, and more importantly that when using 3rd party engagement platforms like Facebook, Flickr or Twitter, a pharmaceutical company needs to ‘plan for change’.

In what I perceive as a positive step, the PMCPA recently issued guidance on ‘Digital Communications’. I was pleasantly surprised to see a certain level of clarity and an attempt to be non-technology specific. I still felt that in some cases it was too specific, which I will explain as you read on.

Even so, the inevitable ‘What does it mean for me?’ has me once again turning to interpretation and best intent, rather than an exact rule of law that some have called for.

A ‘forum’ for debate

For pharmaceutical companies, the most significant lines in the new guidance, in my opinion, can be found in Guidance 4 (p 6) where we see the words “Can companies run discussion forums?” and:

“Before undertaking such an activity the company must be confident that it can moderate the site such that the only content to appear complies with the Code”.

You may at first think, “Well that is fine; we are not running a forum”.

Yet so many 3rd party platforms are perhaps not technically described as a ‘forum’, yet have the characteristics of one. Consider Facebook, Twitter, Flickr, or indeed any place where it is possible to submit user-generated content in some form or another. The main difference between them is the speed of response between participants.

Some platforms may not even be designed with two-way conversation in mind – instead to merely provide a means for a person to comment – yet when used in a particular way can certainly become conversational, albeit not in real-time.

The real issue here is not whether it is a forum or not, but the fact that people can enter free-text.

Free text creates the possibility for a range of potentially problematic content, such as: mentions of brand names which might be construed as promotional content (intentional or otherwise); discussions about off-label use of medicines; or spontaneous Adverse Event reports.

I would suggest as a general thought that the PMCPA might want to change some of the technology specific terminology like ‘forum’ to a broader description around a ‘text submission’. By all means, they may wish to illustrate the point with examples of specific technologies (like Twitter, Facebook etc.) however the guidance itself should ideally not be so tightly defined.

That said, let’s now consider the second part of Guidance 4 “…the only content to appear complies with the Code”.

Reading the guidance here (in the ‘spirit of the code’) has major implications for current and future Pharmaceutical communications activities. Here is the gist in my interpretation:

Content MUST be pre-moderated.

‘Pre’ versus ‘Post’ versus ‘Both’

Until now, some pharmaceutical companies have used ‘best intent’ and ‘due diligence’ to implement strategies and processes that accommodate the constraints of some 3rd party platforms such as inability to pre-moderate user generated content.

If the new guidance really does clarify that all content must be pre-moderated, I predict that in the place of some currently innovative pharmaceutical communication initiatives, you will see a return to company controlled dedicated websites with built-in functionality for moderation. You may even see many companies move away from social media altogether.

It may well be a step backwards from ‘fishing where the fish are’, but will also call for new ‘innovation born from adversity’. I’ve always believed that the very best creativity comes when there are constraints. Like the artist with only three colours in her palette, or the architect with a limited material selection, there is always a solution. Conversely, give an artist unlimited budget and unlimited time, and you don’t often see something of artistic merit.

So, moderation is the one big element of the guidance which has me really thinking. From my perspective the moderation issue is not quite ‘black and white’. There is quite a bit of ‘grey’.

The extent of this issue

Let’s consider some examples of this ‘greyness’ in context:

Have you created a Facebook page? Perhaps you decided not to open the wall for comments, to prevent user-generated content. Well, let’s say someone has gone ahead and ‘Liked’ your page and thanks to Facebook’s new image gallery on pages (launched March 11), decides to click on an image. There they discover that they can add comments to the images within the gallery. If your pharmaceutical company is monitoring this, any non-code compliant comments may be deleted; yet this would be a post-moderated step that only happens at the point of awareness of the comment.

Facebook has and is likely to continue to move its platform away from simply ‘hosting’ product or awareness pages, forcing conversational features on page owners.

Perhaps you have enabled Facebook’s new word filter and listed all of your product names in there to avoid any unwanted brand mentions? Yet let’s assume that someone enters a comment on your wall and has not spelled your product name correctly. It has made it through the moderation filter and you now need to delete it. Once again, post-moderation is required.

What about the clever pre-populated sharing tools that are on a website? If a pharmaceutical company provides a means for a user to share a website or content about a campaign, that user can modify the final submission in keeping with their own message; yet the pharmaceutical company cannot moderate this. Whether the company is responsible or not is likely to depend on a number of factors including whether such shared comments appear on any platforms hosted, managed or endorsed by them. Of course a person can also share content of their own accord, using their own preferred sharing tool.

Responsibility

In many ways, it is the ‘responsibility of ownership’ which truly defines what is or isn’t possible.

What is made very clear through the new guidance is the extent to which a pharmaceutical company is responsible for content when on 3rd party websites, and indeed on sponsored websites (See Guidance 5, pg 7). The definition of “arm’s length” and ‘unrestricted grant’ really does show that the only way that a company is not responsible for the ongoing activities of a sponsored website is if it does not ‘initiate the material, or the concept for it’; that is has no ‘influence’ on the material, and that it does not ‘promote the social media site in anyway unless all of the content complies with the Code’.

I’m not saying that any pharmaceutical company would knowingly sponsor a site which promotes prescription-only products. However, by sponsoring a site it appears to me that the Code requires the pharmaceutical company to indefinitely be aware of the content on that site; even if the recipient of the grant or sponsorship has breached the Code at a much later date.

This raises one of the evolving considerations for pharmaceutical companies in digital communication. What is the true cost of ownership of a social media campaign? At what point in time is it no longer an obligation? Are we forever committed if we engage with the public?

This new guidance is likely to accelerate the pace of change within pharmaceutical brand and communications teams, as they look to increase capacity and skillsets for keeping abreast of all that is happening in the digital space across multiple digital properties.

Where to from here?

Certainly, we are all navigating in uncharted territory. I believe that as an industry we really want to do the ‘right’ and ‘best’ thing for our customers. Yes, I did say ‘customers’.

The PMCPA, the ABPI, the FDA, and the many Pharmaceutical companies who are trying to meet the customer on their ground, still have a long way to go before the customer receives anything like the level of engagement which they are used to from other industries and which they expect in regard to their own personal health information needs.

I can’t help feeling that the various attempts to understand, describe, and provide boundaries for changing communication platforms is making this all much more complicated than it need be. I also wonder if the guidance could instead be summed up in one sentence:

If you are a pharmaceutical company in Europe, don’t inappropriately promote your prescription-only products through digital, or any other channels.

In the world of emerging digital channels, pharmaceutical companies would then be free to adapt to the changing landscape and innovate in a regulatory-compliant manner.

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.