The German sales company of an international pharmaceutical group was faced with the challenge of reorganizing its pharmaceutical compliance. Previously, the compliance officer had personally approved every collaboration with doctors and other medical staff. Due to the large number of activities, this regularly led to considerable delays in the approval process.
When the current interim manager took over the role of compliance officer, the task was to reorganize the pharmaceutical compliance system. The aim was to simplify and decentralize the processes as much as possible while complying with all rules. The new compliance system was also intended to prevent the following potential risks:
- Protection against the risk of criminal violations (taking advantage by public officials)
- Avoidance of violations of the industry code with associated fines
- Avoidance of reputational damage (negative press)
Efficient compliance system set up with rules of conduct and contracts
Transparent documentation of all activities and an efficient approval process are the keys to an efficient compliance system. The interim manager put together such a system with legal support from the following building blocks:
- Updating the rules of conduct, taking into account the decentralized decision-making options of the employees. This included transparent rules to minimize criminal law risks and compliance with the industry code.
- Drafting of standard contracts for all types of possible collaborations and a selection guide for employees to help them use the right contracts.
- Multi-stage approval process by line managers, the compliance officer and, in the case of public officials, by their employers. In the event of any discrepancies in the interpretation of the rules, the management ultimately decides.
- Regular training of employees.
As case law in the area of pharmaceutical compliance is fluid and this can have an impact on the industry code, the rules of conduct and the contracts used must be regularly reviewed and adapted. The interim manager developed new processes to avoid delays in approvals on the one hand and to meet the requirements of pharmaceutical compliance on the other.
Intensive employee training on the right choice of contract
In a first step, the pharmaceutical company's employees now decide on their own responsibility which collaborations with doctors they are planning and which contracts they use for this purpose. The interim manager therefore set up an intensive training program to teach them about the permissible activities and how to select the right contracts using a matrix. In case of doubt, employees receive support from their managers or the Compliance Officer.
Release of fee payments is reserved for the Compliance Officer
Fee payments (e.g. to contractual partners) can only be made upon submission of complete documentation. In the case of payments to public officials (e.g. doctors in state institutions), care must also be taken to ensure that planned collaborations are approved or acknowledged by their supervisors in advance and that they are informed transparently about the type of collaboration and the exact amount of the financial reimbursement. Approval for payment is given exclusively by the compliance officer.
In the pharmaceutical world, it is common for national experts to also be deployed for international collaborations. It should be noted that national rules continue to apply in these cases. The current interim manager has therefore instructed the Group and affiliated foreign subsidiaries on the rules to be observed when German doctors are deployed abroad at the invitation of the Group.
Bottlenecks in approvals eliminated with full compliance
The rules established and standard contracts used have proven their worth. The independent selection of contracts by employees on site has been successful and has prevented bottlenecks in approvals, as the compliance officer is only consulted in special cases.
Recurring training sessions have deepened the understanding of compliance rules among employees and their line managers. While face-to-face training courses were very helpful at the beginning, e-learning courses have proven their worth for follow-up training. These are always combined with a quiz to check their success and apply their knowledge to specific examples. Training courses can only be completed with a successfully completed quiz.
Keeping the compliance rules up to date at all times and reacting promptly to changes in case law and the interpretation of the industry code remains an ongoing challenge. It should also be noted that the interpretation of the compliance rules can vary from region to region.
