The fact that the pharmaceutical sector is one of the most heavily regulated industries in Australia is just one reason why it is important for pharmaceutical marketers – and their agencies – to have a good solid working knowledge of the various marketing codes.

With the 16th Edition of the Medicines Australia Code of Conduct under review, I thought it timely to review the provisions that relate to direct to consumer communications and tease out the implications for PR.

Much is made of the apparent "one bite of the PR cherry" for "a new product, indication or PBS listing" (12.4.1).

I suspect in its original form the provision was intended to cover nothing more than a confirmation in the public domain that a new compound had now been registered for marketing or that its indication had changed significantly (ie, it was now approved for use in an area that it had not previously been used in). No doubt these announcements were occasionally leveraged into more substantial news opportunities.

In recent years this provision has been misinterpreted by some as representing an opportunity for a promotional free-for-all. But there are strict provisions in the code about how this media relations process should be managed. The over-arching guidance is that any promotion to the general public "must be educational" (12.3) "and not include promotional statements or claims" (12.4.1).

Some people question why different versions of the media release are often prepared for healthcare professional and consumer media. Part of the reason is that there are some important differences between what can be included in your healthcare professional media release and what can be used in the consumer release. For example, your consumer media release must not include "quotes from experts, opinion leaders or patients that are promotional" (12.4.1) whereas this provision is more lenient when healthcare professionals are the target audience.

What if you decide to restrict your media releases and communications program to healthcare professional media only, but the process of implementing that program attracts the attention of a consumer news journalist?

Well surely the independent actions of the journalist are a matter for them and not covered by the code?

Interestingly the Medicines Australia complaints committee recently found a breach of the Code had occurred exactly along these lines – because the member and its agencies had not done enough to ensure that a consumer story (originally triggered by some healthcare professional PR activity) was accurate and balanced. They ruled a breach had been committed even though they accepted the manufacturer and its PR agency had not proactively attempted to promote the story to consumer news outlets.

The Complaints Committee ruled that the company knew a consumer journalist was interested in reporting on their development and the Committee therefore believed the company had "made no attempt to prevent the [consumer coverage] occurring".

So the onus is very much on the manufacturer and its agencies to keep the implementation of the healthcare professional and consumer streams quite separate.

In my experience the main areas of internal conflict (usually between the medical/regulatory team on the one hand and the marketing/corporate affairs team on the other) are around (1) the interpretation of "promotional" and (2) in relation to pack shots for consumer media.

First the issue of promotions. Of course one man's promotion is sometimes another man's education program. But let's not forget that the media release is actually about what (we all presume) the company and the regulators think is a positive development. Aren't we trying to educate people on the benefits?

Second, the code is clear in its position on pack shots ("media release must not include pack shots..."). But it is "acceptable to respond to media enquiries..." (12.4.2). So where a journalist is trying to distinguish in their story exactly which product they are referring to by showing a visual in it, and have specifically requested that visual, then a manufacturer would be able to argue it is responding to a request in a responsible way as a tactic for minimising the risk of "incorrect information" (12.4.2).

The manufacturers that handle these processes best are the ones that have policies and positions agreed in advance. What does the company regard as promotional? How does the company agree to respond to pack shot requests? What role do we agree external commentators and medical specialists can play in these processes?

Planning for code compliance with prescription-only launches is all part of diligent marketing and effective PR.

Because companies who continue to see the "one bite of the cherry" provision as a promotional free for all are clearly heading for regulatory trouble.