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Clinical trials
Authorisation
What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Clinical trials in Sweden require authorisation from the Medical Products Agency (MPA). The application is made electronically. If the application is complete and no unclear points are identified, the authorisation is granted within 30 days.
Clinical practices
How robust are the standard good clinical practices followed in your jurisdiction?
According to the Provisions on Clinical Trials of Medicinal Products for Human Use issued by the MPA, the person in charge of clinical trials must have relevant knowledge and training in good clinical practice (GCP). The MPA has the authority to conduct inspections to ensure compliance with GCP.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
The sponsor must report to the MPA and the relevant ethics review board within 90 days after completion of a clinical trial at all trial sites, using EU common forms in electronic format.
If the sponsor concludes an ongoing trial in advance, they must inform the MPA and the relevant ethics review board as soon as possible and no later than within 15 days. The sponsor must state the reasons for termination of the trial and, where appropriate, the follow-up measures taken for safety reasons, using EU common forms in electronic format.
In addition, the sponsor must inform the MPA and the relevant ethics review board of any urgent safety measures that the investigator or sponsor has taken as soon as possible.
A comprehensive summary report must be submitted to the MPA no later than 12 months after the clinical trial has been finalised.
What are the informed consent obligations with respect to clinical trial subjects?
The Medicinal Products Act sets forth the rules regarding consent. Consent must always be obtained from the subjects and may be revoked. Further, the sponsor must comply with the rules on consent under the EU General Data Protection Regulation (GDPR).
Insurance
What are the insurance requirements for clinical trials?
The sponsor is responsible for ensuring that the subjects are guaranteed adequate financial protection, whether through insurance or otherwise.
Data protection
What data protection issues should be considered when conducting clinical trials?
Non-compliance with the GDPR, completed by the Swedish Act (2018:218), can lead to fines of up to 4% of a company’s sales in the previous year or €20 million. Under the GDPR, sponsors and investigators must consider how personal data can be processed under GDPR rules in clinical trials. The sponsor of a clinical trial is commonly considered to be the data controller under the GDPR and must therefore adopt appropriate measures concerning the processing of study subjects’ personal data and document these. The responsibility of the data controller or data processor of each actor involved in a clinical trial should be carefully considered and documented – in particular, in light of precedents such as the Roche AB decision adopted by the Swedish Data Protection Agency on 3 March 2015. The fundamental basis of the GDPR is for sponsors of clinical trials to obtain the study subjects’ consent to process their personal data. How the notice of information should be adapted for study subjects taking part in clinic trials after 25 May 2018 should be considered in order to obtain distinct legal consent under the GDPR. Alternatively, the processing of sensitive personal data can be permitted if it is necessary in specific circumstances for reasons of public interest in the area of public health (eg, ensuring high standards of quality and the safety of healthcare and medicinal products or medical devices). The large-scale processing of sensitive personal data is subject to conducting a data protection impact assessment and designating a data protection officer.
Sponsors of clinical trials should also be aware of specific rules under the GDPR for the transfer of personal data outside the European Union.
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