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Updated Integrity and Transparency Rules in Swiss Pharma Codes

13.01.2021

The revision of the Swiss Therapeutic Products Acts (TPA) and the enactment of the Ordinance on Integrity and Transparency in the Therapeutic Products Sector (VITH), together with the consolidated code of the European Federation of Pharmaceutical Industries and Associations, have entailed an update of the integrity and transparency rules in the Code of Conduct of the Pharmaceutical Industry in Switzerland (Pharma Code, PC) and in the Code of Conduct of the Pharmaceutical Industry in Switzerland on cooperation with Healthcare Professional Circles and Patient Organizations (Pharma Cooperation Code, PCC).

These codes play an important role in the Swiss healthcare environment by providing a framework of self-regulation for pharmaceutical companies. Around 130 Swiss pharmaceutical companies are signatories of the Pharma Code and around 60 of the Pharma Cooperation Code. Among them are pharmaceutical companies involved in the development, manufacture and distribution of original products (prescription and OTC), generics and biosimilars. The Code Secretariat of scienceindustries (Swiss Business Association Chemistry Pharma Life Sciences) is tasked with supervising compliance with the pharma codes.

In general terms, the revised Pharma Code and Pharma Cooperation Code were aligned with the new statutory legal framework on integrity and transparency (art. 55 and 56 TPA).

The Pharma Code's field of application has been extended to cooperations with healthcare professionals (HCPs), healthcare organizations (HCOs) and patient organizations (POs). Clause 4 PC is providing clear guidance on the permitted content of consultancy and service agreements with HCPs, and the HCOs respectively, and on the collaboration with and financial support of POs.

In respect of the principles of integrity, the revised Pharma Code maintains a fairly strict approach. For example, as opposed to the applicable legislation (art. 6(2)(d) VITH), any financing of accompanying activities (such as social events) during programs for continuing medical education and training of HCPs is prohibited (clause 32.5 PC). Also, the Pharma Code sets forth the importance of the principle of multi-sponsoring of educational events and support to HCOs and POs to prevent undue influence by a single pharmaceutical company (clause 15.7 PC).

With regard to transparency, the Pharma Code provides for disclosure obligations that go beyond the applicable legislation. Clause 31 PC clarifies the basic principles governing the support by pharmaceutical companies of continuing medical education and training and indicates that related financing must be made transparent to third parties. By contrast, art. 56 TPA only specifically addresses the transparency and disclosure of discounts and rebates granted on purchases of medicinal products.

Finally, clause 2 of the revised PC also provides for further guidance regarding advertising of medicinal products, in addition to the statutory legal framework (in particular the Swiss Ordinance on Pharmaceutical Advertising). As regards advertising to HCPs, this includes restrictions on the use of graphics, illustrations, photos and tables to avoid misleading advertising (clause 25.6 PC), on the permitted distribution of advertising (clause 29), and on the use of the term "new" in professional advertising (clause 24.3.2 PC).

Overall, the revised pharma codes provide helpful guidance and clarifications on various issues. It applies to all activities organized or performed in Switzerland. As regards support for continuing education of HCPs taking place abroad, the code applies if such HCPs practice in Switzerland (clause 11.1 PC).

The revised pharma codes came into force on 1 January 2021.

 

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