This collection examines clinical trial agreements, participant data and trial procedures in Switzerland, the EU and other jurisdictions. It includes a comparative series on pregnant participants.
These articles provide general information and are not legal advice.
A Swiss sponsor with trial sites in Switzerland, the EU and the UK deals with three authorization regimes, and nothing synchronizes their amendments or safety reporting. Agreements drafted for a Swiss-EU world may leave liability and data transfers unresolved.
A trial with EU and Swiss sites must satisfy both the GDPR and the Swiss data protection act (DSG). Consent to take part in a trial is not the same as consent to process the data, and whether Swiss trial consent meets the DSG for health data remained unsettled as of September 2025.
One informed-consent form under the Swiss human research act (HFG) does not automatically discharge the duties the data protection act (DSG) attaches to the same sensitive health data. For US sponsors, the open question surfaces in protocol design and site contracts, not during the trial.
Austria targets 35 days for approving a single-country trial and pays a refundable 14 percent research premium even to companies not yet profitable; the proposed EU Biotech Act would add a year of supplementary protection. Each benefit carries conditions the headline numbers do not show.
Denmark promises a phase I sponsor an approval or a request for information fourteen days after validation, Sweden and Finland run fast tracks of their own and Norway joins an EU pilot, but the four do not all count from the same moment.
Swiss law allows pregnant participants in clinical trials on additional conditions, yet most sponsors exclude them. Unpublished ethics-committee expectations, a debated burden of proof for trial injuries and insurers without data to price the risk explain why.
Art. 33 of the EU Clinical Trials Regulation allows pregnant participants in trials on additional conditions, yet fewer than 0.4 percent of EU trials include them. Ethics review in each Member State, national compensation rules and insurers without data to price the risk explain the gap.
US policy encourages trials with pregnant participants, but the rules have not moved. Subpart B binds only research HHS conducts or supports; for other FDA trials it is a draft-guidance recommendation. No general federal scheme compensates trial injury.
Swiss, EU and US rules on trials with pregnant participants read alike but differ on who reviews a trial, the father's consent, who pays if a child is harmed and fetal adverse event reporting. The ICH E21 guideline will leave those differences in place.
The Tavneos revocation puts the loss of clinical-evidence reliability between a US licensor and its European licensee. Different EU, US and Swiss procedures leave payment recovery, regulatory cooperation, supply and acquisition risks to separate contractual analysis.
The proposed Biotech Act SPC year would depend on product innovation, efficacy trials in at least three EU states and eligible EU manufacturing. US and Swiss sponsors face unsettled conditions, timing and certificate questions.
For advice on a particular matter, please get in touch.
Make an enquiry