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Revised Pharma Code - in force as of 1 January 2021
Revised Pharma Code - comes into force on 1 January 2021
In the wake of the revision of the Therapeutic Products Act (TPA), the entry into force of the Ordinance on Integrity and Transparency in the Therapeutic Products Sector (VITH - only available in German) and the Code Consolidation of the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Swiss Pharma Code also had to undergo a comprehensive revision. On 14 May 2020, the Board of scienceindustries adopted the revised Pharma Code (revPC) and the revised Pharma Cooperation Code (revPCC) in the German language version. The Code Commission then decided to put the revised codes into force on January 1, 2021.
The changes can be divided into two categories: Firstly, a large number of formal changes, in particular a number of additional definitions (see Section 13 revPC and Section 13 revPCC), which are due to the EFPIA Code Consolidation. In addition, the rules of cooperation with health care professionals (HCP), health care organisations (HCO) and patient organisations (PO) of the PCC were reintroduced into the PC, with the exclusion of the disclosure provisions (see paragraph 4 revPC). This closed a gap that arose with the introduction of the PCC, whereby the cooperation provisions were formally restructured, but their content remained largely unchanged.
On the other hand, however, there were also certain substantive amendments, which are partly based on the HMG revision and entry into force of VITH, and partly on new requirements of the EFPIA Code of Practice 2019. These are:
- Formal alignment of the integrity provisions with Art. 55 of the TPA (see Section 15, in particular 15.3 revPC);
- Stipulation that allowances for meals are only permissible in the context of expert discussions and events and reduction of the maximum limit to CHF 100 (cf. 15.4 revPC);
- Clear stipulation that donations and grants may only be awarded to HCO and PO, but never to HCPs, and the restriction on the purpose for which they may be awarded (cf. clauses 15.5 and 15.6 revPC);
- Establishment of the bid on multisponsoring (cf. Clause 15.7 revPC);
- Harmonisation of the regulation on the use of the term "new" in professional advertising, whereby a compromise was reached between the requirements of the EFPIA Code Section 3.08. and the adaptation of Art. 5 para. 6 AWV (only available in German) (cf. 24.3.2 revPC);
- Additional requirements for the use of graphics, illustrations, photos and tables in advertising to health care professionals, which stem from the EFPIA Code Section 3.06 (see 25.6 revPC);
- Information on medicinal products that have not yet been authorised by Swissmedic was moved from the events (number 3) to advertising to health care professionals and information on medicinal products (number 2 - see number 26 revPC) for systematic reasons, formally adapted to the language of Swissmedic's requirements, but left unchanged in terms of content;
- With regard to the sample packs, the EFPIA guidelines (4by2 rule) were again not adopted: Swiss self-regulation continues to follow Swissmedic's guidelines;
- The establishment of already existing recommendations in the context of the distribution of advertising to health care professionals (cf. 29 revPC);
- Concretisation of the requirements in the context of continuing medical education and training, which stem from the EFPIA Code Art. 16 (cf. 31.1 revPC);
- Clarification of the requirements for the use of HCO logos (cf. 33.2 revPC);
- Certain clarifications in the context of non-interventional studies, which are based on the requirements of the EFPIA Code Art. 18, but have been adapted to Swiss specifics (cf. 57 revPC);
- Supplementary requirements on the topic of "Pharmaceutical company personnel", based on the EFPIA Code Art. 20 (cf. 61.2, 61.6 to 61.8 of the revPC);
- Obligation to comply with the annexes and guidelines of the international associations in the context of self-regulation (cf. 101.3 revPC);
- There were no independent adjustments of content in the context of the PCC, but only additions in the context of the TPA revision: in particular, the integrity provisions had to be adjusted here as well in analogy to the PCC (cf. 15 revPCC) and then the exceptions to the disclosure obligation were reformulated, although there were no changes in content (cf. 24.3 revPCC);
- With regard to the disclosure of monetary benefits to POs, the EFPIA Code was aligned with the requirements for HCP/HCO, which had to be adopted in the PCC; in the medium term, EFPIA aims to standardise the disclosure requirements for all three categories of HCP, HCO and PO (cf. para. 36 revPCC).
The practical recommendations as well as other explanatory documents on Swiss pharmaceutical self-regulation will all be reviewed by December 2020 and, where necessary, adapted so that they can enter into force.