Medicines Approval Ordinance – (Arzneimittel-Zulassungsverordnung, AMZV)
The approval application must contain complete documentation that corresponds to the current state of science and technology and proves the quality, safety and efficacy of the drug. The complete documentation shall include:
a. General administrative data and documentation (including draft text and illustrations for container, packaging material, and drug information);
b. Summaries of documentation in accordance with Articles 3-6 or Articles 7-11 for veterinary medicinal products;
c. where required, a pediatric investigation plan in accordance with Article 5 of the Ordinance on Medicinal Products of September 21, 2018 (VAM).
Market Approval for Medicinal Products and Medical Devices:
The Swiss Federal Law on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA/HMG) regulates the handling of therapeutic products. The focus is on the protection of human and animal health.
Only high-quality, safe and effective therapeutic products should be placed on the Swiss market. Anyone placing medical devices on the market in Switzerland must provide the authorities responsible for market surveillance with the conformity certificate on request.
Medical liability law Switzerland
When a treatment error is discovered, patients often suffer from massive health restrictions and are unsettled because the treatment did not lead to the expected result. Medical facts and treatments are often difficult to understand, engendering a feeling of helplessness.
Medical liability law refers to the civil liability of physicians for errors in the treatment of patients in the entire medical and nursing field. In the assessment of medical diligence, it is assumed that the physician keeps abreast of the current state of science up to date. This applies in particular to specialists. If a physician lacks the necessary special knowledge, the due diligence requires that a specialist be consulted.
Based on the expert evaluation, it is possible to estimate your chances of success in the event of an out-of-court settlement or a court case.
Physician and Hospital Bills
You first have to check, before you pay. A procedure that can be particularly worthwhile when it comes to bills for expensive medical
treatments.
For each medical service, there is an equal number of tax points charged throughout Switzerland. For the first five minutes of a consultation, for example, there are 9.57 tax points. TARMED lists around 4,500 medical services, making it probably the most detailed inventory of the medical profession worldwide.
Due to the fact that hospitals and physicians in many cases overbill privately and semi-privately insured patients, the FMH Code of Conduct requires that patients know with whom they are entering into the treatment contract.
Are you an inpatient or polyclinic patient of the hospital? or do you sign a treatment contract with the physician within the framework of the chief physician consultation?
In 2020, FINMA conducted on-site inspections at a number of insurers. The results of the on-site inspections show that physician and hospital bills in supplementary health insurance appear to be unjustifiably high or without legitimacy.
In many invoices, it is not clear which additional services are billed to the supplementary insurance in addition to the defined flat rates for case costs from the mandatory health insurance (OKP). Further analyses by FINMA show that many contracts between supplementary insurers and service providers – doctors and hospitals – lack the necessary cost transparency.
