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Know your limits

A guide to ABPI compliance for online healthcare communications

A looped ribbonIf you're focusing on the regulatory problems and high-risk challenges involved in producing online communications that comply with the ABPI Code of Practice, then take a second look at the online opportunities you may be missing. What options already exist using the internet and digital media? What is the best practice for online content that is UK code-compliant? According to Heather Simmonds, director, Prescription Medicines Code of Practice Authority (PMCPA), the Code provides much guidance regarding online communications but the 'devil is in the detail'. It's up to the industry to capitalise on these options.

Start with intent
While the revised ABPI Code (2008) includes a clause regarding the use of the internet, the key difference between promotion and information online still remains a rather grey area. The difference depends on intent, explains Joan Barnard, managing director, Code in Practice Ltd: "Companies must decide whether an online activity is promotional or non-promotional from the outset, as this determines how it should be handled to ensure that it compliant. Is the intent to provide factual information or is it to encourage use of a specific medicine?"

According to the Code, like all other types of pharmaceutical communications, digital and online material is divided into 'sponsored independent content, produced at arm's length' or 'commissioned content, produced with the client's input'. 

Sponsored independent content
Sponsorship of medical education on the web is an important way for the pharmaceutical industry to demonstrate its commitment to a particular therapy area, and educate HCPs and patients about medications (plural) and disease areas. According to the Code, all sponsored independent content must be non-promotional and the content cannot be product branded. This content does not require prescribing Information and is generally peer-reviewed. As a sponsor, the pharmaceutical company's input should be focused on the suggested disease area only. This means companies have no input into the scope of independent educational content.

However, hands off does not mean hands-free. If an online module is supported by a pharmaceutical company – even at arm's length, it still needs to ensure that the content is Code compliant, and that there is total transparency about the company's involvement. The sponsor's medical advisers should still check the content for balance and accuracy, and ensure that it is non-promotional towards any product, be it the clients' or their competitors.

Commissioned content
Commissioned content for pharmaceutical communications – online or offline – can be either promotional or non-promotional, and must comply with the ABPI Code. Company input is allowed, and the content may be product-branded but doctor participation cannot be incentivised.

With regards to incentives, Aisling O'Keeffe, senior medical writer at Doctors.net.uk, says: "Incentives, for example eSR points or gifts, cannot be offered to view sponsored online campaigns as they may be seen as an inducement to prescribe a particular drug."

In 2008, the Code clarified that promotional websites do not need to be password-protected for HCPs, as long as they are clearly labelled for the intended audience, and there is a separate section for the public. It is also important to note that while global teams often develop dot.com websites, all content for the UK market needs to be compliant with both the UK code and UK law. Companies also need to be careful about data protection, and remember the Disability Discrimination Act, which is relevant to web design.

Increased transparency
PMPCA's Heather Simmonds also emphasises that the 2008 Code reflects an overall objective to increase transparency, with a clear shift towards regulating industry communications with a broader range of stakeholders. The code no longer simply governs promotion to HCPs but also looks at interactions with them.

Full author disclosure
Full author disclosure, stating his/her involvement and any potential conflict of interest should, ideally,  be included in any online content for both sponsored independent or commissioned activities.

Novartis recently sponsored an eCME education module focusing on age-related macular degeneration. The sponsor's involvement was indicated on the first page of the eCME and reads: "This educational module is sponsored by Novartis. An author was suggested by Novartis and Doctors.net.uk commissioned an independent peer reviewer. Novartis has reviewed the content for factual accuracy and compliance with the ABPI code. Final approval of the content rested with Doctors.net.uk".

Other online opportunities
Pharma companies currently have a broad number of options online to support the use of their products yet the sector is still some years behind the consumer and financial industry.

Doctors.net.uk's Aisling O'Keeffe continued: "Disease awareness campaigns and reference information for doctors and patients are great ways for companies to raise the profile of a particular disease, yet many healthcare communicators are overlooking these Code-compliant opportunities."

"Digital and online media are just one part of the communications mix and not a standalone activity – a balance of various media and sales representative is required for effective campaigns."

The ABPI is one of the few codes in Europe that allows pharmaceutical companies to produce websites focused at patients; however, this non-promotional information cannot encourage patients to ask HCPs to prescribe a specific prescription-only medicine.

Clause 22.2 of the Code indicates that non-promotional internet content that can be provided for patients includes the summary of product characteristics, the assessment report, registration studies and HTA information. This reference information can also include medicine guides, clinical studies, published and unpublished, and information about diseases and specific medications.

In summary, while the pharmaceutical communications industry tries to pre-empt future ABPI regulation in online media, now is an optimal time for forward-thinking companies to seek out, review and invest in tried and tested current online opportunities for effective, code-compliant campaigns.

The Author
Carwyn Jones is head of pharma at Doctors.net.uk
He can be contacted at carwyn.jones@mess.doctors.org.uk 

To comment on this article, email editor@pmlive.com

23rd August 2010

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