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Playing by the rules

In spite of tighter regulations, pharma and the medical community have the potential to build strong, positive partnerships that will help develop the future of healthcare
Playing chess

The long-favoured tabloid headlines regarding unsuspecting doctors being taken to glamorous, five-star locations and given luxury gifts to induce them to prescribe the latest drug are a far cry from today's realities. Attitudes within the industry have changed, and ever more stringent regulations relating to interactions between the medical community and pharmaceutical companies have altered the dynamics of relationships for good. With some bodies calling for a severing of all links, the following article explores the value of such relationships and provides some guidance as to how to ensure that future partnerships are a positive experience for all involved.

It has been argued that the goals of healthcare professionals (HCPs) are fundamentally different from those of pharmaceutical companies – the former wishing to provide the best care for patients, the latter seeking to maximise profits – and that ties between the two should be cut. But are such concerns justified and what can companies do to change these negative opinions?

Do companies and HCPs share a common goal?
Pharmaceutical companies obviously have to make profits in order to remain viable and continue to invest in research and development. However, without meeting the needs of HCPs, patients and payers by developing effective and well-tolerated treatments, companies would not succeed.

Relationships between pharmaceutical companies and HCPs are necessary. Medical professionals have extensive experience of the disease area, the day-to-day practicalities of disease management, patient needs, different treatment options and the most appropriate means of raising awareness of new data and best practice among other HCPs.

To ensure that the research and communication approaches  are suited to the needs of the wider audience, it is essential that companies seek guidance from such experts.

Sharing opinions or 'in the firm's pocket'?
Experts' involvement in manuscript writing, clinical trials and company-sponsored symposia or other educational events has also been criticised, with the true independence of those individuals being called into question.

Firstly, this clearly does a disservice to the well-respected professionals who give up their time for such activities and firmly believe in the ideas being communicated. Secondly, if industry representatives alone were involved in such activities, they would likely be dismissed as being too biased to be of scientific value.

The participation of these highly experienced individuals in helping to create and disseminate new data and ways of thinking is a fundamental part of improving the understanding of disease and its management.

How can positive relationships between companies and experts be developed?
By creating open, equal partnerships. The most effective partnerships come when both parties have an equal weighting, respect each other's expertise and opinions, and are able to share their views freely. Experts should not be seen as providing a 'service' to the industry, nor be put under pressure to alter their views to fit marketing strategies.

Any discussions with experts should be primarily centred on scientific issues and should not be seen as an opportunity to market a product covertly. It may seem obvious, but when you have asked an expert for his advice or opinion, you should follow up on it. Professionals are unlikely to be willing to work with you if they feel their input was ignored the first time.

Finally, companies need to avoid routinely using the same experts. This compromises the perception of independence of the individual, leading to criticism that he is 'in the pocket' of the industry.

Fabio Piva, head of men's healthcare at Bayer Schering Pharma, believes that stricter regulations are here to stay, but companies should use them to build value. He says: "We should be proud of following the rules and help key opinion leaders (KOLs) to see the benefit of working with companies that always play within them, even if those rules sometimes seem over the top. Ideally, KOLs should be as eager to work with the most compliant companies as they are to work with the best science.

"In a perfect world, the public should be made aware of the companies that play the game ethically and bear the cost of following the rules, because this is part of the quality that comes with our offer to the market. I believe the increasing challenges associated with more stringent regulations offer an opportunity to smart companies. Those that fail to take advantage of this will suffer only increased hurdles and costs."

Tips for building strong partnerships
The following suggestions provide a solid foundation upon which to develop relationships with medical experts:

•  Deal with experts professionally at all times
•  Do not compromise their integrity, independence or standing among their peers
•  Respect and acknowledge their guidance and expertise
•  Ensure a two-way flow of information
•  Brief experts appropriately and keep them informed
•  Avoid routinely working with the same individuals
•  Remunerate according to the task, internal policies and local regulations
•  Maintain transparency in communications.

But who should educate the HCPs?
Some authors have suggested that all education of professionals should be independent of pharmaceutical companies. While this may be an admirable goal, financial and logistical constraints make it largely unrealistic. Far from being concerned about bias or misinformation, a recent study has shown that the majority of physicians highly value the materials provided by companies and do not feel that their prescribing habits are unduly influenced by such activities.

In order to maintain this appreciation, all those involved in the production of materials need to be aware of the guidelines for developing items aimed at the medical community. Common sense is also a key part of the process.

Learning lessons in education
Overtly promotional pieces instantly lose credibility as educational tools. Any materials produced need to be of value to the HCP, which can be achieved by:

•  Ensuring the information is accurate and up to date
•  Raising awareness of current challenges or issues in clinical practice
•  Providing a new way of thinking about a condition or reinforcing best practice
•  Identifying the place in therapy and the long-term value of a new or established treatment
•  Providing efficacy and safety details for any relevant product
•  Encouraging HCPs to review their current approach practice and how they can improve this
•  Complying with internal and independent guidelines, eg, Association of the British Pharmaceutical Industry (ABPI) and European Federation of the Pharmaceutical Industries and Associations (EFPIA) codes.

And what of new media – should we be 'friending' doctors on Facebook?
Digital technology has already offered a wider audience access to the latest information via such initiatives as 'virtual meetings' and online interactive training modules. Many companies, however, seem reluctant to go further and dip their toes in the 'social media' water for fear of falling foul of the law or antagonising medical professionals.

While Facebook may not be an appropriate vehicle for communication, other digital media, networks and discussion forums could offer professionals fast and convenient access to the latest data, thinking and training opportunities. As for compliance, the rules stay the same – activities need to adhere to the guidelines, and the roles of pharmaceutical companies and experts need to be transparent.

It is apparent that, if the industry is to continue to work with the medical community, systems need to be put in place to reinforce the independence and credibility of the individuals involved. Any type of support offered should be declared so that participation in activities can be informed.

Finally, the industry must recognise and address the problems of the past, but be reassured that, when done  correctly, industry – HCP alliances can improve disease understanding and management, and ultimately patient care.

The Author
Rachel Hatfield is Head of Medical Education at DDB Seven
She can be contacted at

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18th April 2011


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