Overview
Following the revision of the Swiss Therapeutic Products Act (TPA), the enactment of the Ordinance on Integrity and Transparency in the Therapeutic Products Sector (VITH) and the entry into force of the Consolidated Code of the European Federation of Pharmaceutical Industries and Associations (EFPIA Code), the Swiss Pharma Codes have now also been revised. The revised Code of Conduct of the Pharmaceutical Industry in Switzerland (Pharma Code, PC) and the revised Code of Conduct of the Pharmaceutical Industry in Switzerland on Cooperation with Healthcare Professional Circles and Patient Organisations (Pharma Cooperation Code, PCC) were adopted on 14 May 2020 and entered into force on 1 January 2021.
Importance
These two codes play an important role in the Swiss healthcare system, as they provide a self-regulation framework for pharmaceutical companies. Currently, around 130 Swiss pharmaceutical companies are signatories of the PC and around 60 of the PCC. Compliance with these two pharma codes is supervised by the Code Secretariat of scienceindustries (Swiss Business Association Chemistry Pharma Life Sciences).
Pharma self-regulation consists of the voluntary commitment of actors to comply with certain standards of conduct. Only member companies of EFPIA are obliged to sign the respective country pharma codes. In contrast to the TPA and the VITH, which constitute mandatory public laws and primarily pursue a public health purpose, pharma self-regulation aims to ensure compliance with high ethical standards and fair market conduct by pharmaceutical companies.
Key changes to the Pharma Code
The changes to the PC can be divided into formal and material changes:
Next to adding several definitions (cf. clause 13 PC), the rules of the PCC on cooperation with healthcare professionals, healthcare organizations as well as patient organizations were again included in the PC – except for the disclosure provisions (cf. clause 4 PC). The scope of application of the PC was expanded which closed the gap that was created with the introduction of the PCC.
In substantive terms, the revised PC was adapted to the new legal framework on integrity and transparency according to art. 55 and 56 TPA. The main changes in this context are the following:
- The payment of meals is permitted up to a maximum amount of CHF 100 and only in the context of expert discussions and events (cf. clause 15.4 PC).
- Donations and grants may only be awarded to healthcare organizations and patient organizations, but never to healthcare professionals (cf. clause 15.5 PC). In addition, restrictions on the purpose for which they may be awarded are defined (cf. clause 15.6 PC).
- The principle of multi-sponsoring applies to events organized by healthcare professionals, healthcare organizations as well as patient organizations (cf. clause 15.7 PC). This shall prevent undue influence by a single pharmaceutical company.
- In contrast to state legislation (art. 6 para. 2 lit. d VITH), any funding of accompanying activities during programs for continuing medical education or training of healthcare professionals (such as social activities) is prohibited (cf. clause 32.5 PC).
- Clause 31 PC specifies the principles of support for continuing medical education or training by pharmaceutical companies and points out that the associated financing must be made transparent to third parties (cf. art. 16 EFPIA Code). In contrast, art. 56 TPA only explicitly refers to the transparency and disclosure of discounts and reimbursements granted when purchasing therapeutic products.
Furthermore, clause 2 PC provides for further requirements for pharmaceutical advertising, in addition to the statutory framework (in particular the Ordinance on Pharmaceutical Advertising, AWV). The distribution of specialized pharmaceutical advertising is now addressed in clause 29 PC, the requirements for the use of graphics, illustrations, photos and tables to avoid misleading advertising have been supplemented (cf. clause 25.6 PC) and the rules for the use of the term ""new"" have been adapted (cf. clause 24.3.2 PC and art. 5 para. 6 AWV). Moreover, clause 101.3 PC sets the obligation to observe the annexes and guidance of the international associations in the context of self-regulation.
Key changes to the Pharma Cooperation Code
In the context of the PCC, there were no substantive adjustments, but only amendments triggered by the PC revision. Next to adding several definitions (cf. clause 13 PCC), the integrity provisions also had to be formally adapted in accordance with the PC (cf. clause 15 PCC) so that they follow the same structure as art. 55 TPA resp. VITH. Furthermore, the exceptions to the disclosure obligation were reformulated, but their content was not changed (cf. clause 24.3 PCC).
The EFPIA Code aligned the disclosure rules for pecuniary benefits to patient organizations with the ones for professionals and health care organizations. This also had to be adopted in the PCC (cf. clause 36 PCC).
Conclusion
The revised Swiss Pharma Codes contain helpful regulations and clarifications on various topics. They maintain a strict approach with regard to the principle of integrity. With regard to the principle of transparency, the PC provides for disclosure obligations that go beyond the statutory requirements.
If you have any questions regarding the Swiss Pharma Codes as well as the imperatives of integrity and transparency, please do not hesitate to contact the team of MME Legal | Tax | Compliance.
