Federal Council tightens discount regulations for medical products

  • Monetary benefits of prescription drugs are prohibited if they affect treatment.
  • Price discounts and refunds must be reported.
  • According to MDR, procurement law judgement, this is the next regulatory hurdle for hospital purchasing.
  • Xatena helps hospitals prepare their purchasing for compliance and digitization.

On 10 April, the Federal Council adopted new provisions on the Therapeutic Products Act. The new regulations will come into force from 2020. This applies on the one hand to the advantages of prescribing doctors and pharmacists. The Heilmittelgesetz (HMG – Therapeutic Products Act) has a positive list of what is still permitted.

On the other hand, this concerns the purchase of pharmaceuticals and medical products. Discounts and reimbursements must not influence the treatment and must be passed on to the patients.

Granting and acceptance of price discounts and refunds must be able to be immediately disclosed to the Federal Office of Public Health (FOPH) upon request at any time from 2020 onwards. The FOPH will perform a supervisory function in this regard. This means that the FOPH will monitor and sanction (administrative action proceedings or, in the case of more serious infringements, administrative criminal proceedings). The only exceptions are retail medicinal products and medical devices in risk class I.

Agreements between insurers and service providers that parts of the rebates and reimbursements will be used to improve the quality of treatment are also possible.

Conclusion:

  • The subsequent settlement of discounts and refunds on the respective case is an enormously complex and IT-heavy project for hospitals.
  • It is more probable that discounts and rebates will be waived and prices will be renegotiated on a regular basis on the basis of forecast purchase volumes.
  • Some forward-looking hospitals have already adapted their purchasing strategies accordingly.
  • This becomes difficult for small hospitals and their purchasing associations. They have to change their strategies and processes and renegotiate all contracts.
  • Xatena can help hospitals to implement legally compliant and efficient purchasing via digital transformation.

Link to media release

https://www.admin.ch/gov/de/start/dokumentation/medienmitteilungen.msg-id-74631.html

Link to the basics

https://www.bag.admin.ch/bag/de/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/integr-transp-obligation.html

(Cover Photo: Piron Guillaume on Unsplash)

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