SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
in the respective trial registry (Article 64 para- graph 1 of the ClinO and Article 65a paragraph 1 of the revClinO), as well as a lay summary in the cantonal database within a year from com- pletion or discontinuation of the trial (Article 65a paragraph 2 of the revClinO). Sponsors of clinical trials of medical devices are subject 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 spon- sor by publication in one of the registries listed in Article 64 paragraph 1 of the ClinO (Article 42 of the ClinO-MD). 2.4 Restriction on Using Online Tools to Support Clinical Trials Personal data held for research purposes must be protected by appropriate operational and organisational measures (cf Article 5 paragraph 1 of the HRO). The applicable ICH Guideline explicitly refers to the increasingly widespread use of electronic data handling and remote electronic trial data systems and outlines the additional requirements that must be met by the sponsor when using such tools (see Sec- tion 5.5.3 of the ICH Guideline for Good Clini- cal Practice E6(R2) of 9 November 2016). In addition, 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 completely revised as of 1 September 2023). 2.5 Use of Data Resulting From Clinical Trials Health data is considered personal data requir- ing special 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 per- missible 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 pro- visions do not apply to anonymised and pseu- donymised data, insofar as the data subjects are no longer identifiable. 2.6 Databases Containing Personal or Sensitive Data According to the HRA and its implementing pro- visions (Article 43 of the HRA and Article 5 of the HRO), anyone who stores biological mate- rial or health-related personal data for research purposes must take appropriate technical and organisational measures to prevent the unau- thorised use thereof, and must fulfil certain operational and professional requirements. Since 2016, the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks has complemented the Declaration of Helsinki. 3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices The decisive criterion for the classification of a product as a therapeutic product (ie, as a medicinal product or as a medical device) is the intended purpose of the product, which – considering all objective (nature of a product) and subjective (designation and promotion of a product) circumstances of the individual case –
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