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On the right tracks

Navigate through 'grey' regulatory areas with informed and intelligent agency guidance

A toy trainRegulatory authorities, the pharmaceutical industry, professional societies and academic institutions continue to refine guidelines for interactions between the pharmaceutical industry and HCPs, including activities relating to promotional medical communications and scientific publications. Employees of pharmaceutical companies and medical communications agencies must understand and consistently comply with these laws, regulations and guidelines. One only has to read the lay press and journal editorials related to public perception of the industry and recent malpractice cases to realise that reputations can be easily damaged, and medical communications companies are exposed to the same reputational risks as their pharma clients if ethical practices are not followed.

The pharmaceutical industry has access to several resources that help define appropriate working relationships with HCPs, including international, European and national Codes of Practice for advertising and promotion of medicines, guidance for working with authors of peer-reviewed publications, and various other information sources. However, there are still many situations in medical communications activities where the laws, regulations and guidelines are not sufficiently specific, especially when working on international programmes involving HCPs from across Europe and the US, or with advanced web applications and other e-technologies. These 'shades of grey' are left open to interpretation. In order to mitigate risk, it is essential that medical communications agencies are not only aware of international laws, regulations and guidelines, but also act as partners and, in many instances, as advisors to the pharmaceutical industry.

Jason Gardner, medical communication and information, Merck Serono SA, Geneva notes: "Ultimately, it is the client who makes the decision on a given project, but I see it as the agency's responsibility to provide informed and intelligent guidance in all areas – 'black, white or grey' – based on the breadth of their experience in the subject. I value an agency that challenges decisions and actions to ensure that appropriate standards are met."

Compliance framework
To act as true partners or in an advisory capacity, compliance knowledge and application needs to be deeply ingrained within the agency. A useful framework to follow in establishing an internal compliance programme is that developed by the US Department of Health and Human Services Office of the Inspector General (see Figure 1).


Figure 1. Framework for compliance programme (based on US Office of Inspector General Guidance)

Framework for compliance programme (based on US Office of Inspector General Guidance)


Establishing a compliance officer (and committee, depending on the size of the agency), allows staff direct access to a well-informed group, that can provide counsel across a wide variety of HCP-focused programmes, ranging from simple copyright and permissions advice, to guidance on whether proposed activities would be permissible. By being exposed to a wide array of questions and real scenarios, the compliance committee itself develops a true understanding of the types of issues that fall into the 'grey zone'.

Common questions and experiences can then be proactively addressed by including these within regular updates to internal compliance guidelines, thus equipping other staff to deal with similar issues as they arise. The accumulated knowledge of the compliance committee may also be used to assist or advise pharmaceutical companies on development of their own guidelines and policies.

"Several agencies and external experts have provided assistance in the development of our policies. An agency's diverse experience across different therapy areas and project types is a great asset in gauging the relevance and implications when establishing best practice policies," said Jason Gardner.

Staff training
The risk associated with non-adherence to guidelines or ethical principles, for both the pharmaceutical client and the agency, is present from the first day that a new member of staff joins the company, and therefore early training is essential. A 'multi-step' training process may aid retention, dependent on whether the new employee has worked previously in medical communications and on his/her level of existing knowledge.

As a minimum, this process should include an 'induction' session with the compliance officer or member of the compliance committee, where the new employee is introduced to the company compliance programme, the implications of non-adherence, and is made aware of the internal guidelines and other available information resources; this should then be followed by in-depth training across all relevant areas. Some pharmaceutical companies also extend their own internal training courses to their agency teams.

Testing knowledge and understanding
Research indicates that people who receive training from their employer, regardless of the business in which they work, operate on average with only a 55 per cent level of competence; 15 per cent of the information employees act on is wrong, despite them being confident that they are right. So how do agencies ensure that their staff are sufficiently knowledgeable in compliance, and how can 'competent knowledge' be measured?

Annual staff testing of compliance knowledge is recommended, particularly given the evolving nature of guidelines in the pharmaceutical arena. Testing on an annual basis serves multiple purposes:
• It tests general knowledge and understanding
• It measures whether communication of recent changes in laws, regulations and guidelines (from the compliance team) have been taken on board
• It forces staff to revisit and re-read internal guidelines and SOPs
• It helps the compliance team identify areas for further training.

Compliance tests can also be very valuable training in themselves. Questions can be devised based on general guidelines and SOPs, but they can also be based on the many scenarios and questions raised by staff and addressed by the compliance team, thereby making the posed challenges and situations very relevant to the user's everyday activities. Some multiple choice systems also allow the user to select how confident he or she is in their chosen answer, thereby giving the compliance team a way to evaluate true competence vs guesswork.

Test programming also allows educational content to be inbuilt that appears to the user each time he or she selects a right or wrong answer, and analysis of the results helps identify areas where further training and coaching may be required.

A joint effort
Navigating the grey zone that falls between the black and white printed laws, regulations and guidelines can be problematic. Medical communications agencies and their pharmaceutical clients should work together to ensure that both parties are limiting any risk associated with lack of knowledge, lack of understanding, or interpretation. Robust compliance programmes on both sides helps ensure that risk is minimised and reputations are maintained.


What should be included in agency internal compliance guidelines 

• Company code of conduct
• Compliance team and objectives
• Scope of guidelines (including sources)
• Guideline enforcement procedures
• Implications of non-adherence
• Procedures for dealing with non-adherence
• Training and testing process
• Communication channels
• Auditing process.

Detailed guidelines on:
• Ethical conduct
• Interaction with HCPs (eg, appropriate services, payment for services)
• Use of consultants
• Specific groups (eg, purchasers/payers, patient groups)
• Educational grants
• Market research
• Documentation
• Promotional materials
• Transparency
• Internet and electronic media
• Exhibition stands
• Gifts, hospitality, payments, disclosure, travel
• Meetings (specific guidelines for different types)
• Ethical publication practices
• Clinical trial registries and results databases
• Useful sources/websites
• Templates.

Make guidelines relevant to services offered, and include examples and explanations so that guidelines can be put into appropriate context.


The Author
Angela Cairns is compliance officer and SVP, medical & scientific services KnowledgePoint360 Group
She can be contacted at or on +44 (0)1625 666062

To comment on this article, email

27th September 2010


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