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According to Bundesverband Medizintechnologie e.V., every second innovation in medical technology originates from the everyday work of hospitals and doctors. That shows how important cooperation is between doctors or hospitals on the one hand and pharmaceutical companies or medical product businesses on the other.
Collaborations not only ensure important innovations, but also product safety. At the same time, doctors decide upon purchases and thus have power over revenue. Revenue which is paid for by the health system, not by the decision-maker.
This area of tension hopes to de-fuse healthcare compliance. Healthcare compliance – also referred to as the Public Funding Lawin some places – is an amalgam of laws, non-legislative rules and self-imposed barriers intended to avoid conflicts of interests and corruption.
In the case of collaborations with medical experts, it is particularly important to observe the four basic principles: separation, documentation, transparency and the equivalence of performance and counter-performance.
Apart from the anti-corruption provisions in the penal code and the regulations of the Therapeutic Product Advertising Act, there are a variety of domestic and international industry codes (EFPIA, EUCOMED, BVMed code, FSA and AKG rules etc.) that need to be observed.
I support you in developing tailormade compliance structures and provide practical help in daily compliance consulting.
My consultancy services include the following:
- Checking collaborations with medical experts as well as with medical facilities and apothecaries
- Reviewing advertising from a compliance law viewpoint (e.g. stands at trade fairs, patient information stands etc.)
- Preparing contracts for collaborations with members of medical circles and medical facilities (e.g. contracts concerning consulting, lecturing and sponsoring)
- Compiling standard documents, such as invitations to internal and external further-training events
Putting together standard procedural guidelines andprocessesfor the day-to-day handling of internal decision-making structures