Ordinance On Integrity And Transparency In The Therapeutic Products Sector Has Been Adopted

Author:Dr. Philippe Seiler, Markus Wang and Markus Schott
Profession:Baer & Karrer
 
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On 18 March 2016, the Swiss Parliament adopted the revised Therapeutic Products Act (revTPA). At the same time, the Swiss Parliament revised the provisions regarding discounts set out in the Federal Act on Health Insurance (KVG). The details of the revTPA and the revised provisions of the KVG are contained in a new Ordinance on Integrity and Transparency in the Context of Therapeutic Products (VITH) and a revision of the Ordinance on Health Insurance (revKVV) which the Federal Council adopted on 10 April 2019 based on the feedback received during the consultation process. The revised regulations will enter into force on 1 January 2020.

Overview

The key goals of the revised provisions of the TPA, the KVG and the KVV as well as of the VITH are to ensure that the prescription and supply of medical products is not influenced by financial benefits of any sort granted to health care providers (HCPs) while at the same time incentivising HCPs to negotiate discounts with suppliers or refunds since these may help to reduce health care costs and are, therefore, generally desired. The new legislation intends to achieve these goals with the following key principles:

integrity in the choice of treatment transparency on discounts benefits for patients and insurers stricter criminal sanctions and enforcement Key Principles in a Nutshell

Integrity in the Choice of Treatment

Article 55 para. 1 revTPA sets out the key principle that persons who prescribe, dispense, use or purchase prescription medicines and organizations who employ such persons may not claim, accept a promise or accept for themselves or in favour of a third party any undue benefit. At the same time, it is prohibited to offer, promise or grant any such person or organization any undue benefit.

The scope of article 55 para. 1 revTPA is limited to prescription drugs. The Federal Council did not make use in the VITH of its right to extend the scope to further therapeutic products, in particular medical devices.

Article 55 para. 2 revTPA defines in an exhaustive list those advantages which are not undue. It is particularly of note that rebates and refunds are explicitly not undue if they have no influence on the choice of treatment. The Federal Council did not specify the circumstances under which rebates and refunds do not influence the choice of treatment. However, according to the Federal Office of Public Health's (FOPH) FAQ on the subject, at least benefits which are entirely passed on...

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