ITD: What’s involved

Granted advantages must not influence the prescribing, use or supply of prescription-only medicines.

FOPH responsible for enforcement

Since 1 January 2020, the FOPH has been responsible enforcing the rules on integrity and transparency in the Therapeutic Products Act and the obligation to pass on discounts according to the Federal Act on Health Insurance.

This page tells you which advantages are inadmissible and which ones are permitted.

Report any suspected violation of these provisions to the FOPH.

News on integrity, transparency and discounts for therapeutic products

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Legislative changes

In March 2016, Parliament amended the provisions on material benefits and adopted the revised Therapeutic Products Act (TPA). Two new articles on integrity (Art. 55 TPA) and transparency (Art. 56 TPA) relating to therapeutic products have replaced the former Article 33 TPA on «Promises and acceptance of material benefits». The Ordinance on Integrity and Transparency in the context of Therapeutic Products (OITTP), adopted by the Federal Council on 10 April 2019, regulates the details.

At the same time, Parliament has revised the obligation to pass on discounts enshrined in the Federal Act on Health Insurance (HIA): Service providers (doctors, hospitals and pharmacists) may now use part of the discounts (for example a discount on the purchase of medicinal products) to improve the quality of treatment. The modalities for passing on or using these discounts are regulated in the Ordinance on Health Insurance (HIO).

The amendments to the TPA and HIA, including the corresponding ordinances (OITTP and HIO), entered into force on 1 January 2020.

Integrity in the choice of treatment

Treatment may be chosen only on the basis of scientific and objective criteria. Article 55 TPA on integrity states that the choice of treatment must not be influenced by advantages of any kind. This integrity rule applies to the prescription, supply and use of prescription-only medicines. Exceptions include gifts with a maximum value of CHF 300 per professional per year, provided they are relevant to medical or pharmaceutical practice or contribute towards research, education and training. Discounts and rebates are likewise permitted provided they do not influence the choice of treatment.

The rules on integrity are essentially a continuation of the longstanding practice of Swissmedic (and also of the Federal Administrative Court and Federal Supreme Court). In contrast with the previous rules, the focus is no longer on all medicinal products, but only on prescription-only medicines. However, as part of the revision of medical devices legislation, in March 2019 Parliament decided to extend the integrity provision to include «advantages relating to the prescription, supply and use of medical devices» (see AS 2020 2961). This requires a partial revision of the Ordinance on Integrity and Transparency in the context of Therapeutic Products (OITTP). The opening of the consultation for the partial revision of the OITTP is planned for 2025.

Transparency in relation to discounts

According to Article 56 TPA, all granted or received price discounts and rebates on therapeutic products must be reported and disclosed to the FOPH upon request. This requirement applies to both the sale and purchase of therapeutic products, except for those deemed to have low risk potential, such as over-the-counter medicines or Class I medical devices (for example, plasters, thermometers or walking aids).

Obligation to pass on discounts: Insured individuals and insurers should benefit from discounts

Service providers (e.g. doctors, hospitals and pharmacists) have a duty to pass on discounts granted to them either indirectly or directly (particularly price discounts and rebates) to patients and insurers (Art. 56 para. 3 HIA). This duty to pass on discounts has been a provision of health insurance legislation since 1996. It was modified by the partial revision of the Therapeutic Products Act and the Federal Act on Health Insurance. Oversight of compliance with the passing on of discounts granted to the service provider by individuals or establishments which supply medicinal products or aids and devices used for examination or treatment has now been assigned to the FOPH (Art. 82a HIA). This empowers the FOPH to obtain all the necessary information from insurers and service providers and their suppliers and to order discounts to be passed on if deviations are found.

Associations representing insurers and service providers may conclude an agreement to the effect that discounts are not passed on in full. However, agreements are intended only to cover discounts granted by individuals or establishments which supply medicinal products or aids and devices used for examination or treatment (Art. 56 para. 3 let. b HIA). The agreement ensures that service providers pass on most of the discount and that the part which is not passed on is demonstrably used to improve the quality of treatment. It contains at least the following information:

Type (e.g. discounts, rebates) and extent of the discount to ensure that most of the discount is passed on (Art. 56 para. 3bis sentence 3 HIA)
Modalities for transparent documentation in records and invoices (Art. 76b para. 2 let. a HIO)
The use to which the part of the discount that is not passed on is put, including the objective in terms of improving treatment quality (Art. 76b para. 2 let. b HIO)
Modalities for demonstrating the improvement in treatment quality (Art. 76b para. 2 let. c HIO).

Each agreement concluded and all subsequent modifications (including the addition of further parties to the agreement) must be reported to the FOPH without delay and disclosed upon request.

After the agreement has been terminated, the insurers submit a corresponding report to the FOPH (an annual interim report for projects lasting several years) on compliance with the agreement. The report must refer to a specific agreement and state the period covered (interim or final report). It should describe at least the treatment quality at the start of the agreement, the targeted improvement, the scientific methods used, which must be in line with recognised standards and guidelines, and the improvements in treatment quality that have been achieved (Art. 76c para. 2 and 3 HIO). It also contains an evaluation of the improvements in treatment quality achieved as a result of the agreement. The evaluation must be identified as such and must have been undertaken by an independent organisation identifiable as such using scientific methods in line with recognised standards or guidelines.

If a report is not able to demonstrate that the part of the discounts which has not been passed on has been used to improve treatment quality (Art. 76c para. 1 HIO), the FOPH may perform checks on the insurers and service providers and their suppliers and order discounts to be passed on (Art. 82a HIA) or even impose criminal sanctions (Art. 92 para. 2 HIA).