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Never wasted

Developing patient information expertise is invaluable, however legislation changes

An empty litter binChanging regulation in Europe is unlikely to produce an explosion in consumer communication opportunities for the pharmaceutical industry. The most radical suggestions contained in the consultation proposal centre on the contents of the patient information leaflet (PIL) and how it could be distributed proactively. Given that, under the provisions of freedom of information legislation, the PIL is already available to anyone who asks for it, this may not be seen as a fundamental step forward. Plus, given the strength of opposition across Europe, even this proposal is likely to struggle to reach the statute books.

One more probable outcome, however, is formalisation over which disease awareness campaigns are allowed, together with educational content on treatment options and specific drug information available on request.

The industry's role in this information provision remains controversial, but some companies have already made significant moves to provide responsible and high quality information of this type. Building on this base and expanding disease awareness, treatment education and compliance programmes will demonstrate the value that the industry can bring to improve patients' understanding of their conditions and the treatments themselves.

Those of us hoping that the proposal would at least harmonise what is allowed across Europe are likely to be disappointed, as the responsibility for policing and sanctioning any new legislation stands firmly with national regulatory bodies. Therefore, the wide variation in what is allowed in individual states is likely to continue.

However, building expertise in patient communications now will still bring significant benefits, even after any changes in legislation.

Current environment
The key to successful implementation in the present environment is to understand fully the regulatory environment. Experience shows that you cannot rely solely on internal legal and regulatory groups, as what is possible often falls outside the standard pharmaceutical promotion and industry regulatory guidelines.

It is important to be aware that the regulatory environment surrounding patient activities is often unclear. In the absence of transparent and extensive legislation, many decisions on what is allowed are based on interpretation of what legislation or voluntary regulation there is and/or on precedent.

Branded promotion (use of brand name in association with a clinical claim/indication for use) is, of course, forbidden everywhere, except in the US and New Zealand, and this will continue to be the case in Europe.

However, disease awareness campaigns to educate consumers about particular conditions, with the aim of improving diagnosis or treatment rates, are allowed in almost every market. As long as these campaigns do not breach advertising standards and contain no drug information, they are relatively unrestricted. In some markets, scientific societies or patient advocacy groups may need to be involved.

In others, treatment options can be discussed in a non-promotional, fair and balanced way. For some companies this approach can be hard to accept, as it means giving the competition equal share of voice. If a company's brand has specific attributes, which more closely match patient needs, this may not be a barrier. Clearly, having market-leading share makes this less of an issue.

Do not forget that, when taking patient data for the purposes of ongoing communication, the provisions of the various data protection legislation come into play.

It is vital that, at the point of data collection, the broadest possible permissions allowable should be sought. This will prevent the potential risk that you will be left with a very expensive database containing thousands of patients' details that is unusable.

It is also necessary to define how the data are to be held, who has access to them and for what purpose.

When planning consumer campaigns it is imperative to involve legal/regulatory and data protection colleagues early on, so that they know what you are trying to achieve and can assist you.

Remember to consider the broader legislation too. Other sections of regulation come into play when advertising generally. For example, in the UK, there are the Advertising Standards Authority and Clearcast for broadcast media.

Gain support
Getting the support of other stakeholders is an effective way of ensuring that your campaign does not run into problems.

Be open with healthcare professionals about what you are trying to achieve, particularly when you are developing the strategy. Let them know what issues you are trying to address and explain the potential benefits to them, such as how your campaign could make their jobs easier or more rewarding.

If you cannot establish this common good or do not feel comfortable in communicating your objectives, it may be worth reconsidering whether you act at all.

If you go ahead with your campaign without the support of your stakeholders, you risk losing credibility. Consumer campaigns are often highly visible to physicians and other healthcare-related audiences. If the messages delivered by the consumer campaign are out of line with those delivered by the company and/or brand to other key audiences, the position of the brand itself can be severely damaged.

Further, there could be hostility to the programme. There are several examples of consumer campaigns that failed to take into account the interests of other audiences, particularly physicians, which subsequently received complaints and were withdrawn.

The worst crime of disease awareness campaigning is to be seen as scaremongering, which results in large numbers of the "worried well" rushing to visit their already overworked physicians. This is not a recipe for a successful campaign.

It is necessary to be clear about what you are trying to achieve from a commercial point of view, of course. However, you must also ensure that reaching these commercial objectives comes through the delivery of something that is beneficial to the health of the audience by addressing issues that they face.

Ask yourself:
• Do significant numbers of consumers fail to present with condition X?
• Is under-diagnosis or under-treatment an issue?
• Do patients have issues the impact of which are underestimated, like ongoing symptoms or side effects?
• Do patients fail to adhere to their treatment?

Once the answers to these questions are known, the next step is feasibility. Ask:
• Can this issue really be resolved by communicating with consumers?
• Will they understand the message/s?
• Will they care enough to change behaviour?
• Can this communication be done without alienating other stakeholders?
• Are there other groups that have a common interest in this area/issue, eg are there patient groups that can assist?

Answering these questions helps to establish the nature of the greater good that you are trying to deliver. Crystalising these answers in turn aids the communication of your objectives to other stakeholders, including internal legal and regulatory groups.

It is also necessary to establish what the patients will gain and relate this in a way that they can appreciate. While the possibility of avoiding a stroke in 20 years' time by sorting out your high blood pressure now might seem convincing to you, it may not be the most pressing offer they have seen today.

Which proposition is chosen for a particular condition depends on the consumer's perception of the problems it causes. In therapy areas with significant impact, the provision of the information itself and the possibility of a resolution may be sufficient.

The propositions for campaigns in asymptomatic conditions tend to need to have greater impact in order to get attention. These propositions tend to be more aggressive, pointing out risk in a way that consumers recognise then following on rapidly with the hope of a resolution.

Using this technique, of raising concern and immediately showing the benefits of positive action, helps quash the allegation that worry is being generated unnecessarily and reduces the risk of paralysing consumers through using a purely fear-inducing approach.

There are still huge opportunities for the pharmaceutical industry to help create the much vaunted informed healthcare consumer through responsible education programmes in disease awareness, treatment education and, of course, adherence. The likelihood that these opportunities will increase massively as a result of legislative changes at European level appears relatively low. It is more probable that much of what is currently allowed will be clarified into a single piece of legislation, which will help all concerned. Waiting for this outcome before acting, though, is to miss the opportunities that already exist to build expertise, the value of which will persist after any amendments are made in the legislation.

The Author
Michel Dubery is managing director, Europe, at Grey Healthcare Group

To comment on this article, email

29th June 2010


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