Therapeutic products: integrity, transparency and discounts

The prescription and supply of medicinal products must not be influenced by financial incentives of any sort. Discounts and bonuses are to be reported and in principle passed on to the insurer. The FOPH is responsible for enforcement.

By adopting the revised Therapeutic Products Act (revTPA) on 18 March 2016, parliament amended the provisions on material benefits. Article 33 on promises and acceptance of material benefits has been replaced with two new articles on integrity and transparency in the context of therapeutic products. The details are set down in a new ordinance on integrity and transparency in the context of therapeutic products (OITTP). The Federal Council adopted the ordinance on 10 April 2019, and it will enter into force on 1 January 2020.

At the same time Parliament revised the obligation to pass on discounts as stipulated in the Federal Act on Health Insurance (HIA): Care providers (doctors, hospitals and pharmacists) may now use part of these discounts (e.g. money off the purchase of medicinal products) to improve the quality of treatment. The modalities for passing on or using these discounts are set out in the Health Insurance Ordinance (HIO), and will also enter into force on 1 January 2020.

Integrity in the choice of treatment

Treatment may only be chosen on the basis of scientific and objective criteria. Under the new Art. 55 revTPA on integrity, the choice of treatment must not be influenced by financial incentives. The integrity rule applies to the prescription, supply and use of prescription medicinal products. For the sake of clarity, situations are cited that do not constitute “undue advantages”, for example gifts with a maximum value of CHF 300 per year, provided they are relevant to the medical or pharmaceutical practice (for example information screens in the waiting room), or supporting contributions for research, education and training. Article 55 revTPA also gives the Federal Council the option of extending the integrity rule to other categories of therapeutic products if required.

Transparency on discounts

Once the new Article 56 revTPA enters into force, all price discounts and refunds granted 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, with the exception of those deemed to have low risk potential, such as medicinal products available on a retail basis and Class I medical devices (e.g. plasters, thermometers and walking aids).

Patients and insurers should also benefit from discounts

Under the terms of Art. 56 HIA, service providers are obliged to pass on perks granted to them (such as price discounts and refunds) to the patient and/or insurer. So far this requirement has scarcely been enforced. Parliament now wants to put an end to this lack of enforcement and transfer the monitoring of enforcement and imposing of sanctions to the federal authorities.
Also new is that insurers and service providers may now agree that discounts do not have to be passed on in full. Such agreements have to ensure that the major share of discounts is passed on and that the portion not passed on is demonstrably used to improve the quality of treatment. Agreements must be disclosed to the FOPH on request.

Responsibility for enforcement now to lie with the FOPH

At present the Swiss Agency for Therapeutic Products Swissmedic is responsible for the implementation of the prohibition on advantages set down in Article 33 TPA. Swissmedic enforces this prohibition by means of proceedings for administrative measures or in the case of serious infringements with administrative penalty proceedings. It is the duty of the health insurers to enforce the disclosure requirement set down in Article 56 of the HIA.

Responsibility for enforcement will now be brought together under the FOPH in a move intended to allow more vigorous enforcement. The FOPH will assume its implementation role on 1 January 2020, enforcing the new law by means of administrative measures and administrative penalty proceedings.

Last modification 10.04.2019

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