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Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
In order to enforce such laws, the Medicinal Products Act itself (Sections 95 to 97) provides a legal regime of punishments for infringement of laws governing medicinal products. According to these regulations, fines and prison terms of up to 10 years can be imposed.
After granting the relevant authorisations, the competent authorities monitor manufacturers and marketing authorisation holders to ensure compliance with the respective provisions. Where any infringements or defects are detected, the relevant authorisation may be revoked or withdrawn and the authority may request further measures.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
There are self-regulating measures as well as measures issued by the authorities.
The Criminal Code imposes fines or imprisonment for bribery of healthcare professionals, on both the briber and the bribed healthcare professional.
The implementation of and adherence to industry codes is a self-regulating measure. For any infringement of an applicable industry code, the relevant decision-making body may impose fines and take further measures (eg, publication of the case). For example, potential penalties for non-compliance with the Association of Voluntary Self-regulation for the Pharmaceutical Industry Transparency Code include fines of up to €400,000.
For compliance reasons, it is recommended that pharmaceutical companies apply and adhere to the so-called ‘golden rules’:
- The principle of documentation – all documents and potentially important circumstances should be in writing and recorded accordingly (eg, contract management).
- The principle of transparency – all transfer of values to healthcare professionals should be disclosed to the competent institution or employer of the healthcare professional.
- The principle of separation – maintain a distinction between all activities by healthcare professionals and organisations and procurement decision-making activities in respect of medicinal products.
- The principle of equivalence – remuneration paid to healthcare professionals and organisations for services provided should reflect the fair market value of the service.
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