SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang and Djamila Batache, Bär & Karrer Ltd
approved by the cantonal ethics committee and released for publication by the researchers. The data originates from the cross-cantonal application sub- mission platform BASEC (Business Administration System for Ethics Committees) and the international study database International Clinical Trials Regis- try Platform (ICTRP) (WHO database comprising 17 worldwide primary registers). The data listed in Annex 5 number 2.1 to 2.14 of the ClinO will be made automatically accessible to the public at the latest within six months from the grant date of the trial authorisation (Article 64 paragraph 5 of the ClinO). This will include a brief description of the clinical trial, the site(s) where the clinical trial is con- ducted, the criteria for the participation in the clinical trial, the disease category, and the health condition investigated, as well as an indication of whether the clinical trial includes rare diseases. The Registry of All Projects in Switzerland (RAPS) of the Swiss Association of Research Ethics Committees (“swissethics”), the umbrella organisation of cantonal ethics committees, also publishes clinical trials that have been approved by an ethics committee. Sponsors of clinical trials must, in principle, register a summary of the results of the clinical trial in the respective trial registry (Article 64 paragraph 1 of the ClinO and Article 65a paragraph 1 of the ClinO), as well as a lay summary in the cantonal database within a year from completion or discontinuation of the trial (Article 65a paragraph 2 of the ClinO). Sponsors of clinical trials of medical devices are sub- ject to analogous registration obligations (Article 41 of the ClinO-MD). Public access to the results of clinical trials of medical devices must be ensured by the sponsor by publica- tion in one of the registries listed in Article 64 para- graph 1 of the ClinO (Article 42 of the ClinO-MD). 2.4 Use of Online Tools to Support Clinical Trials Personal data held for research purposes must be protected by appropriate operational and organisa- tional measures (cf Article 5 paragraph 1 of the HRO).
The applicable ICH Guideline explicitly refers to the increasingly widespread use of electronic data han- dling and remote electronic trial data systems and outlines the additional requirements that must be met by the sponsor when using such tools (see in particu- lar Sections 3.16, 4. and 4.3 ICH Guideline for Good Clinical Practice E6 (R3), of 6 January 2025). In addi- tion, the use of online and electronic tools is subject to the limitations imposed by Swiss data protection law (in particular, the Federal Act on Data Protection (FADP) and the respective ordinance (Data Protection Ordinance, or DPO) – both of which have been com- Health data is considered personal data requiring spe- cial protection. The HRA regulates in detail the further use and disclosure of health data that falls within its scope of application. In principle, the disclosure of health data is permissible both within an organisation and to third parties depending on the type of health data, the intended further use, and the assignability to a specific person. The data protection provisions do not apply to anonymised and pseudonymised data, insofar as the data subjects are no longer identifiable. 2.6 Personal or Sensitive Data According to the HRA and its implementing provisions (Article 43 of the HRA and Article 5 of the HRO), any- one who stores biological material or health-related personal data for research purposes must take appro- priate technical and organisational measures to pre- vent the unauthorised use thereof, and must fulfil cer- tain operational and professional requirements. pletely revised as of 1 September 2023). 2.5 Use of Data From Clinical Trials Since 2016, the Declaration of Taipei on Ethical Con- siderations regarding Health Databases and Biobanks has complemented the Declaration of Helsinki.
3. Marketing Authorisations 3.1 Product Classification
The decisive criterion for the classification of a prod- uct as a therapeutic product (ie, as a medicinal prod- uct or as a medical device) is the intended purpose of the product, which – considering all objective (nature of a product) and subjective (designation and promo-
348 CHAMBERS.COM
Powered by FlippingBook