Integrity, Transparency and Obligation to pass on discounts for therapeutic products

Switzerland sets rules for integrity and transparency for therapeutic products. Financial incentives must not influence the prescription or supply of medicinal products. Discounts and bonuses are to be reported. The FOPH takes on the implementation.

By adopting the revised Therapeutic Products Act (TPA) on 18 March 2016 the Parliament has adopted two new Articles on integrity and transparency for dealings with therapeutic products, which replace the old Article 33 on the promise and acceptance of pecuniary benefits. A new Ordinance on the Integrity and Transparency in the context of Therapeutic Products (OITTP) is intended to govern the implementing provisions.

At the same time Parliament revised the obligation to pass on discounts as stipulated in the Federal Act on Health Insurance (HIA): A new aspect is that a part of the discounts (e.g. rebates on purchases) may be used to improve the quality of the treatment. The modalities for passing on or using these discounts will be set out in the Ordinance on Health Insurance (HIO).

Integrity (Art. 55 TPA)

The Integrity rule applies with respect to the prescription, supply and use of prescription medicinal products. “Undue advantages” must not influence the choice of the treatment. The TPA then cites situations that are not illustrative of undue advantages: Advantages of modest value (presents with a maximum value of CHF 300 per year); supporting contributions for research, education and training; compensation for equivalent services; as well as price discounts and refunds for purchasing therapeutic products, insofar as they do not influence the choice of the treatment. Article 55 offers the possibility to the Federal Council to extend the Integrity rule to further categories of therapeutic products. However, for the time being it is not foreseen to extend the jurisdiction of the Integrity rule.

Transparency (Art. 56 TPA)

Price discounts and rebates accorded for purchases of therapeutic products (not just for prescription medicinal products) are allowed, insofar as they do not, pursuant to Art. 55 TPA, influence the choice of the treatment. They have to be disclosed on receipts and invoices as well as in the accounting records. This applies both for purchases and sales. Documents are to be made available to the FOPH when requested. Exemptions to this obligation are therapeutic products with a low risk potential, i.e. medicinal products of distribution category E (available in retail trade) as well as medical products of class I (e.g. plasters, thermometers, walking aids).

Obligation to pass on discounts (Art. 56 HIA)

Up to now the obligation to pass on discounts as stipulated in the HIA (such as price discounts and rebates) has scarcely been practised. Parliament wants to end this lack of enforcement, and assigns the monitoring of enforcement and possibilities of sanctions to the Confederation. Health insurance companies and service providers may now agree that discounts do not have to be fully passed on. Such agreements have to ensure that discounts are mainly passed on and the part that has not been passed on is demonstrably used for improving the quality of the treatment. The agreements are to be made available to the FOPH when requested.

Implementation will be now by the FOPH

At present the Swiss Agency for Therapeutic Products Swissmedic is responsible for the implementation of the “Ban on Advantages” of Article 33 TPA. Swissmedic enforces the Ban on Advantages by means of proceedings for administrative measures or in the case of serious infringements with administrative-penal proceedings. It is the duty of the health insurance firms to implement the disclosure obligation of Article 56 HIA.

Implementation will fall within the ambit of the FOPH and is intended to be strengthened in its effectiveness and action. It is expected that the FOPH will take up its implementation tasks in 2020 and enforce the new law by means of proceedings for administrative measures and administrative-penal proceedings. The required Ordinances for this (the new OITTP and amendments to the HIO) will now be revised following the consultation that was carried out in 2017. These provisions are expected to be adopted by the Federal Council in spring 2019 and enter into force at the beginning of 2020.

Last modification 22.01.2019

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Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003 Berne
Tel. +41 58 463 51 54

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