„There is no right way doing a wrong thing”.
Especially in the healthcare sector, the general public, competitors and prosecutors are expecting compliance with high standards to prevent the violation of applicable laws and regulations. Therefore, pharmaceutical and medical device companies are expected to have a professional set-up and organizational structures in place and to create transparency to the general public (e.g. FSA-Transparency Code). By this, the financial risks, the risk of reputational damage and the risk of a criminal investigation against the company’s management and staff will be averted or at least reduced.
The applicable rules no longer include only laws in the strict sense, but a variety of national and international industry codes of conduct (e.g. EFPIA, EUCOMED, BVMed Code of Conducts, FSA and AKG regulations, etc. ), which include additional binding rules for companies in the pharmaceutical and medical device industry.
The implementation of the provisions in the corporate structure and culture requires a profound knowledge of these rules and a long experience in the interpretation and application of legal requirements and codices in practice.
We accompany the development of the compliance requirements and the Code landscape in Germany and Europe for many years, support our clients in the development of precisely fitting compliance structures and provide practical support in the daily compliance advice.
Our services in the area of business compliance in the healthcare sector in particular include:
- Advising on cooperation with healthcare professionals (HCPs) as well as medical institutions and pharmacies
- Review of advertising presences from a compliance perspective (e.g. exhibition booths, patient information booths etc.)
- Elaboration, implementation and monitoring of compliance programs (identification of relevant risks, development of compliance policies, SOPs, organizational structures) under particular consideration of the size and the field of activity of the company
- Conducting compliance audits
- Elaboration and implementation of organizational compliance structures
- Elaboration and implementation of corporate governance policies and structures
- Advising regarding the set-up, the organization and the presentation of transparent structures related to the FSA Transparency Code
- Drafting standard agreements for collaboration with healthcare professionals and healthcare facilities (such consultancy, advisory, sponsoring agreements)
- Drafting standard forms, such as for invitations to internal and external training events
- Drafting standard procedural guidelines and processes for the daily handling of internal decision-making structures
- Training of personnel based on current training material, including training of Compliance Officer
- Set-up and running of a compliance-hotline