The 20 years since 1992 may – or may not – seem a long time to you. It will depend on what has happened in your life and how events have changed you. It is reasonable to say that as far as ethics and best practice in the pharma industry are concerned, the two decades have been a very long time indeed.

The self-regulatory Codes have always operated within a framework of legislation, with the balance between the two varying over time, and from country to country.

Generally, legislation has become a much more significant force, spectacularly so in US, with several recent fines levying billions of dollars. 

The Foreign Corrupt Practices Act extends the potential reach of US legislation to pharma activities anywhere in the world. The UK Bribery Act is arguably as stringent, and may also apply to activities outside the UK. In the UK, the Code is the cornerstone of regulation, but the Medicines and Healthcare products Regulatory Aency (MHRA) has greater involvement these days, dealing directly with complaints about advertising. Also, all materials associated with the launch of a new product must be submitted to the MHRA for pre-vetting – a significant requirement which needs to be factored in to launch timescales.

EFPIA Steps Things Up

In 1992, there was a European Code of Practice, but it was rudimentary compared to the current EFPIA Code. Any strength in terms of detailed requirements and, crucially, of implementation, was to be found in the national Codes. The UK Code's reputation as the 'strictest' Code probably stems from this era – but this is now far from being the case. 

The EFPIA Code has become much more demanding in principle – in its detailed requirements and in its implementation at country level. This has been driven by a much greater commitment from industry leaders, at international and national level, towards ethics and integrity, and the recognition that building trust is essential for the industry as a whole and for each individual company. Key elements in this are the drive towards transparency in all activities, and the re-balancing of the relationship between pharma and its stakeholders to one of partnership. 

Since 1992, the UK Code has had to respond to these internal drivers, and to the various external influences, by means of revisions every two to three years, although the most significant changes have occurred over the last few years. 

One part of the Code that has changed very little is the clauses dealing with advertising claims. Some new, specific requirements have appeared over the years, eg, in relation to discussing risk or including figures, but the main requirements are unchanged – the claims must be accurate, balanced, substantiated and of course, not misleading. 

The key test for any piece of advertising is still that you should step back from it, put yourself in the position of being one of your intended audience and ask 'Does this enable me to make an informed decision about this medicine?'.

Audience Hunger for Information

What has changed is the nature or style of advertising. Target audiences have become more demanding, requiring often very detailed information about medicines, rather than simply headline claims. 

Arguably, simple product branding has become less effective, at least in the way it was done in the past, with logos, livery and the long established 'giveaways'. Branded items were made unacceptable in UK in 2011, not because of concern that a doctor would be unduly influenced by being given a free mug, but because dishing out 'goodies' was seen as a barrier to establishing a relationship between doctors and industry that is based on equal partnership. Given that very similar aspirations are being voiced at European level, it seems likely that other countries will follow suit before too long.

Perhaps the most significant change over the past 20 years is the role of the internet in all our lives. This now presents pharma with the tantalising opportunity to engage directly with patients and the general public. However one thing that shows no sign of changing is the ban throughout Europe on advertising medicines to the public – direct to consumer and direct to consumer advertising is not on the horizon. 

The creative challenge therefore is how industry can engage with patients and the general public in ways that do not amount to advertising. Perhaps the most significant obstacle here is that there is a body of opinion, particularly at European level, which considers that any pharma company activity directed towards the public can only be advertising. 

The UK Code is arguably more pragmatic, acknowledging that the public now demands a greater say in its healthcare and therefore requires greater access to information about medicines, health and disease. It is therefore acceptable for information about medicines to be placed on the internet as a resource for the public to 'pull' from – but this is a long, long way from allowing companies to 'push' information out, or to take full advantage of all the possibilities offered by social media. 

Pharma use of social media over the next few years will result not from any changes to legislation or Codes, but from creative and innovative ideas for working within the current framework.