Today the quality of compliance in pharmaceutical business operations has become an increasingly important issue reflecting significant changes in the regulatory environment almost worldwide. Pharmaceutical companies must conduct promotional activities accurately and within the scope of governmental approvals as well as corporate policies. Off-label and false or misleading promotion are strictly prohibited everywhere. Medical Affairs is normally involved in content approval of any promotional materials, and the appropriate employees must be trained to avoid improper promotional activities. The promotional review committee has to be familiar with the rules of promotion, including off-label promotion and false or misleading promotion. Such expertise in many cases is ensured by Medical Affairs, Compliance, Legal, Pharmacovigilance and Regulatory. Though some may be optional contributors, Medical Affairs and Compliance are mandatory. How to find a shortest path to compliant customer congruent services and avoid conflict of doing right things and doing things right? The solution might be in establishing a productive dialogue between Medical Affairs and Health Care Compliance. Below are some features that will help to ensure a win-win outcome.
1. Respect each other’s opinions.
It is necessary to openly discuss the opinion differences between the committee members in meetings. Medicals, Compliance, Regulatory, etc team members must learn to trust each other and rely on the expertise of the individual in whose discipline the controversy lies. No one should ever be attacked for his or her opinion. Try to fully understand why Marketing is producing this or that activity but at the same time be on the side of corporate policies. Preserving the constuctive balance of business orientation and compliance will help you to foster great achievements and reputation.
2. Have clear understanding of your roles and mutual expectations.
In most cases it is useful to formally review the responsibilities and expectations of committee members to prevent useless work and bogging down in future. Compliance specialists will be mostly focused on two risk areas such as inappropriate promotion (including off-label) or corrupted HCP interactions. So in collaboration with your Compliance Officer you’ll have to be ready to explain what, why and for whom are you doing. Besides be ready to explain to the compliance officer what is your mission and contribution to the outcome.
3. Conduct valuable committee meetings.
Make sure there is a clear purpose to meet together. If you can decide something just on the phone or e-mail, so its obviously no need to waste time. On the contrary, working excessively offline, between team meetings and on weekends, may as well signal a dysfunctional team. Responding to excessive e-mails and “copying all” is fatiguing and can disrupt the decision making process. Establish right balance between online and offline decisions.
4. Invest time in learning corporate policies and procedures.
This will let you save much more time and efforts in the future. Besides your dialogue with Compliance Officer will be well-founded and you will build trust based relationship.
5. Be transparent.
Take your time to explain to the compliance officer not only what is your activity or promo about, but primarily why you are investing efforts and budget to bring it up. Focus on the desired outcomes of your activities and make sure they are in line with the corporate code of conduct. Get ready for the questions and provide full and clear answers. All that will help you to earn trust of your Compliance Officer.
6. Be honest.
Making mistakes is OK, especially in environment of continuous change. Honesty requires us to overcome the fear of being judged by others, the fear of exposure and being seen as weak or incompetent and tell the truth. Honesty is the foundation of trust within your team and is probably most important quality for compliance related team work. In order to develop honesty in your team you have to refrain from judging each other or finger pointing.
7. Include additional personnel in team meetings if necessary.
Your meetings may slow down due to long discussions in the absence of important stakeholders who can bring light to the nature of the job. Such employees often from Marketing or Sales usually have the answers to questions – “How will this article reprint be distributed to the physicians?”, “Will this brochure be too complex for the prescribers to understand?”, etc.
Written by Dr. Alexander Tolmachev