Implementation Of Several Parts Of The Revised TPA And Pata As Well As Of The Therapeutic-Products-Ordinance-Package IV On 1 January 2019

Author:Dr. Markus Schott and Markus Wang
Profession:Baer & Karrer
 
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On 21 September 2019, the Federal Council decided to implement several parts of the amendments adopted in the spring session 2016 regarding the legislation on therapeutic products and the law on patents as well as the corresponding ordinances on 1 January 2019. In order to complete the second stage of the ordinary revision of the legislation on therapeutic products, only the implementation of the provisions on integrity and transparency as well as the passing on of benefits is missing, which is expected to take place in the beginning of 2020.

Overview

On 18 March 2016, the Federal Assembly adopted the second stage of the ordinary revision of the Federal Act on Medicinal Products and Medical Devices (TPA). As a consequence, the corresponding ordinances had to be amended comprehensively (Therapeutic-Products-Ordinance-Package IV). The amendments concern ordinances both of the Federal Council and of the Institutional Board of the Swiss Agency for Therapeutic Products Swissmedic, namely

the (fully revised) Ordinance on Medicinal Products (VAM), the Ordinance on Advertising of Medicinal Products (AWV), the (new) Ordinance on the Supervisory Fee for the Benefit of the Swiss Agency for Therapeutic Products, the Ordinance on Authorization of Medicinal Products (AMBV), the Ordinance on the Simplified Authorization of Medicinal Products and the Authorization of Medicinal Products in the Notification Procedure (VAZV), the (fully revised) Ordinance on Complementary and Herbal Medicinal Products (KPAV), the (fully revised) Ordinance of the Swiss Agency for Therapeutic Products on its Fees, as well as the (fully revised) Ordinance of the Swiss Agency for Therapeutic Products on its Personnel. Based on the feedback from the consultation process regarding the Therapeutic-Products-Ordinance- Package IV, the draft ordinances were amended selectively.

With the decision of the Federal Council of 5 April 2017, several provisions of the revised TPA as well as the corresponding ordinances' provisions had already been implemented at the beginning of 2018, namely article 9 section 2 lit. f revTPA regarding the continuation of cantonal authorizations of medicines, as well as article 67a revTPA regarding the powers of the Federal Council to collect, harmonize, evaluate and publish data on the prescription, supply and use of medicines in pediatrics.

Furthermore, the revision entails amendments of the Federal Act on Patents for Inventions (PatA) and the...

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