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Setting parameters

For pharma to break the social media barrier, regulators must give a clear definition of what separates information from promotion

A clown dressed in black and white pushing his hands against an imaginary objectOver the course of more than 50 years of the ABPI Code of Practice, the UK industry has become well-accustomed to the terms of engagement permitted when communicating with its stakeholders (both patients and HCPs). But as media evolves and new channels to market emerge, the grey areas have conspired to leave marketers either vulnerable to breaching legislation or in danger of missing an opportunity. A proliferation of tools and technologies – blogs, microblogs, social networking sites, podcasts, widgets and wikis – has opened up new models of communication and taken the accessibility and sharing of information to an unprecedented level. Within the information/promotion conundrum, the clichéd challenges and opportunities for the pharmaceutical industry are vast in equal measure.

Defining the boundaries of medical information, and indeed regulating its provision to patients and health professionals, is currently a hot topic for lawmakers on both sides of the Atlantic. Last December, the European Commission published proposals to amend aspects of Directive 2001/83/EC relating to the provision of information on medicinal products to the general public. The proposals, part of the EU's Pharmaceuticals Package, sought to define certain forms of information as 'not advertising' and to allow manufacturers to interact with patients about the supply of certain information about their products. They remain before the European Parliament for consideration, but are highly unlikely to be passed in their current form. One criticism is that the proposals make no distinction between information and advertising, and therefore, do not provide sufficient guarantee that the prohibition of advertising prescription only medicines (POMs) to the general public will not be circumvented.

In the US this November, the Food and Drug Administration (FDA) will hold a public hearing to discuss issues related to the promotion of FDA-regulated medical products using the internet and social media tools. The FDA says that the evolving nature of the internet, including the development of web 2.0 and social media tools, has raised 'questions and concerns' over how to apply existing regulations to promotion in these newer media. The internet's ability to facilitate communication, information exchange and user-generated content has, it said, driven a need to evaluate how the statutory provisions, regulations and policies concerning advertising and promotional labelling should be applied to product-related information on the web. "Although the agency believes that many issues can be addressed through existing FDA regulations, special characteristics of web 2.0 and other emerging technologies may require the agency to provide additional guidance to the industry on how the regulations should be applied," it said.

The eventual findings of the FDA will not only have far-reaching consequences for the global pharmaceutical industry, but will also provide a fascinating case study for professionals in Europe, where specific guidelines for using the digital channel have long been craved. The EFPIA (European Federation of Pharmaceutical Industries and Associations) Code, issued in late 2007, makes no specific provisions for the internet, though it does offer some guidelines on websites for HCPs, patients and the public through Annex B. It does not, however, define advertising and non-promotional information. The revised ABPI Code (2008) includes a clause related to the use of the internet, but generally speaking, guidelines for the web are wrapped up in the broader provisions made for promotion – much to the chagrin of digital evangelists. In the process, the internet, which promises an accessibility and interactivity beyond virtually all other traditional media channels, becomes another victim of the grey areas that blur the lines between promotion and information. So how does the industry distinguish between the two? Where does information cross the line to become advertising?

The answer, it seems, boils down to intent. "The key difference is purpose," says Joan Barnard, managing director, Code in Practice Ltd. "Is the purpose of a communication genuinely to provide factual information or is it to encourage use of a specific medicine? According to Clause 22.2 of the ABPI Code, statements must not be made for the purpose of encouraging members of the public to ask their health professional to prescribe a specific POM."

The definition of promotion is provided in Clause 1.2 of the ABPI Code and it goes to the very nub of the issue. "The term promotion means any activity undertaken by a pharmaceutical company, or with its authority, which promotes the prescription, supply, sale or administration of its medicines."

Steven Gray, managing director, Steven Gray Consulting, says that, taken at face value, the terms of Clause 1.2 could be considered emphatic. But, as with most of the Code, it is open to interpretation. "In effect, Clause 1.2 means that the Code regards any proactive communication about medicines or diseases as potentially promotional, and the vast majority of communications about medicines as actually promotional. However, it is not as clear-cut as that. To control the situation within the UK, everything released proactively that includes information about medicines or diseases must be certified by registered company signatories before release."

The requirement for company certification by registered signatories – the essence of self-regulation – is often held up as a barrier to the kinds of engagement facilitated by the advance of web 2.0. The sheer impracticality of authorising every nuance of online conversation has led most companies towards a blanket ban on communication via social media sites. But aside from the practical implications of resourcing the moderating of conversations – which itself goes against the spirit of interactive communication – items such as blogs and chatrooms present other problems for pharma.

"A chatroom is a great place for answering questions, but is a chatroom a med-info-style Q&A session, or does the fact that it is visible to a wider audience make it promotional?" says Steven Gray. "If the conversation stays visible a week later, does that make it reference information or promotion? If the Q&A is with HCPs, then what happens if the questions are about off-licence products? Does the pharma company have to remove them? Should a Q&A forum be interpreted as a meeting, a scientific exchange or is it promotion?"

Likewise, blogs generate similar challenges. Web 2.0 is built around the principles of debate and interactivity, but with an emphasis on user-generated content, there is a risk that products could get mentioned by the end-user, making drug companies vulnerable as they can't guarantee compliance with the Code. "The PMCPA has issued guidance discouraging industry sponsorship of blogs," says Ian Dodds-Smith, partner and co-head of global law firm Arnold & Porter's Food, Drug and Medical Devices Practice Group. "The companies cannot be in control of content and, therefore, if they are sponsoring a blog, it is likely they will be viewed as distributing the information. Furthermore, any discussion of the properties of a product is likely to be viewed as advertising."

So if dialogue through blogging and chatrooms is considered too risky and likely to drive interaction that falls on the wrong side of the information/promotion divide, what can the industry do – online or otherwise – that enables it to fulfil its duty to provide balanced and useful information where appropriate? One answer is disease awareness. "Disease awareness campaigns are a good example of how the distinction between promotion and information can be defined by your purpose or intention," says Joan Barnard. "By definition, the purpose behind these initiatives should be to raise awareness about a disease, how best to manage it and the options for management. These options will include medicines – plural – and lifestyle. However, if the purpose is to raise awareness of an individual product, this is unacceptable."

The internet is, of course, a perfect home for patient information such as disease awareness. What's more, the web can be used to provide reference information that is available at a time to suit the reader – the immediacy of the medium means that it can go beyond the restrictive constraints of traditional media, which are often dictated by time and controlled delivery mechanisms. The vagaries of European law, however, prohibit promoting the availability of such information, as proactively raising awareness of the information is considered to be advertising. "If you have information on the Internet and are drawing people towards it, you are in effect promoting it," says Joan Barnard. "But if you don't publicise it, and you just wait for people to come to you – that's reference information."

Clause 22.2 of the ABPI Code sets out the details of non-promotional reference materials that can be provided on the web for patients. These include the summary of product characteristics, the assessment report, registration studies and HTA information. "This goes just about as far as any member state, but the MHRA, which endorses the Code, is comfortable with it, provided the information published is compliant with the over-riding obligation to be factual, balanced and doesn't raise unfounded hopes of success. Critically, it must not appear to be there to encourage members of the public to ask their doctor to prescribe the product," says Ian Dodds-Smith.

The provision of information to patients lies at the heart of the European Commission's proposals. One of the central suggestions is to mirror the ABPI model and allow publication of approved summary product characteristics, the patient leaflet and certain other materials and the assessment report for the medicine. Providing this is all presented accurately, the proposals say that it will be deemed 'information' rather than promotion. Yet most member states seem determined to reject these proposals.

"The Commission has put forward proposals that try to draw a bigger distinction between information and advertising, but the majority of member states' governments do not believe it is clear enough," says Ian Dodds-Smith. "They also don't think that the information one might get from a pharmaceutical manufacturer is likely to be as unbiased as is necessary. Fundamentally, they are worried that any information from manufacturers will lead to increased patient demand."

The UK is one of the most liberal environments in Europe, says Ian Dodds-Smith. "The ABPI Code makes general allowance for, for instance, press releases on new trial results and of medicines being launched. In some member states, such as Germany, there is the view that press releases may raise interest and lead to patients requesting specific products and, therefore, the accusation that they are a vehicle to increase sales. The majority of member states are terrified that anything that is seen as a foot in the door for drug companies to engage directly with patients will increase the drug bill."

Rumours abound that the EC proposals regarding information to patients are likely to be sidelined – with the Commission disregarding them and turning attention to other aspects of the pharmaceutical package. UK commentators believe this to be no bad thing, with the suggestion that a harmonised approach across Europe would more likely restrict, rather than enhance, what is already possible in the UK.

It is clear that social media is already redefining boundaries and that pharma must focus on making progress in this important area of communication. "We must hope that some of the definitions and rules surrounding the online information exchange can be redefined going forward so that more forums and websites can legitimately be hosted by pharma as genuine sources of information," says Steven Gray. "This will be affected by the EU consumer information legislation, the forthcoming FDA digital media consultation and, hopefully, by the PM Society's Digital Working Group as we share our feedback to inform the next ABPI Code."

The Code will, of course, evolve and it is hoped that the internet will begin to assume a greater presence within it. But, if nothing else, the current grey areas do provide both problem and opportunity. "People need to explore the opportunities, but that cannot be done without some risk," says Joan Barnard. "The purpose of the internet is to enable communication. The industry needs to take a good look at how it relates to this, because if the industry, through its Code, unnecessarily inhibits communication with HCPs or members of the public who require information, that cannot be a good thing."

The Author
Chris Ross is a freelance journalist

18th November 2009

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