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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Clinical trials are governed by the Human Research Act, Articles 53 to 54 of the Therapeutic Products Act and the Ordinance on Clinical Trials. The general conditions for conducting clinical trials are:
the explicit and free prior written consent of the trial subjects (informed consent) (see Articles 16-18 of the Human Research Act and Articles 7-9 of the Ordinance on Clinical Trials);
the guarantee of full and complete compensation for injuries suffered in the course of the trial (see Articles 19-20 of the Human Research Act and Articles 10-14 of the Ordinance on Clinical Trials);
- the endorsement of the trial by the competent ethics committee (see Article 45 of the Human Research Act and Articles 24-29 of the Ordinance on Clinical Trials);
- approval of the trial by the Federal Agency for Therapeutic Products (Swissmedic) (see Article 54 of the Therapeutic Products Act and Articles 30-34 of the Ordinance on Clinical Trials); and
- registration of the trial by the sponsor in a public register (see Article 56 of the Human Research Act and Articles 64-67 of the Ordinance on Clinical Trials).
Clinical trials on minors, wards of the court, persons incapable of consent and pregnant women, and in emergency situations, are subject to additional conditions. The termination of the trial, as well as any change to the design of the trial, additional security measures and undesired incidents must be notified to the competent ethics committee and Swissmedic.
How robust are the standard good clinical practices followed in your jurisdiction?
All clinical trials of therapeutic products must be carried out in accordance with the recognised principles of good clinical trial practice. According to the Ordinance on Clinical Trials, trials with medicines must comply with the requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines on good clinical practice, and trials with medical devices must comply with the requirements of the applicable EU directives (Directives 93/42/EEC and 90/385/EEC), as well as International Organisation for Standardisation Standard EN ISO 14155: 2011 (see Articles 5(1) and Annex I of the Ordinance on Clinical Trials).
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
The person responsible for the conduct of the clinical trial (the ‘investigator’) must notify the ethics committee of the completion of the clinical trial in Switzerland within 90 days of completion (see Article 38(1) of the Ordinance on Clinical Trials). The investigator must submit a final report to the ethics committee within one year of completion (or discontinuation) of the clinical trial, unless a longer period is specified in the protocol (see Article 38(3) of the Ordinance on Clinical Trials). For clinical trials of certain categories, the sponsor must also report to Swissmedic (see Article 38(5) of the Ordinance on Clinical Trials).
Authorised clinical trials must be registered in a primary registry recognised by the World Health Organisation (WHO) or in the registry of the US National Library of Medicine. In addition, the sponsor must enter certain data in the supplementary federal database using a Swiss national language (see Article 64 of the Ordinance on Clinical Trials). Such information is publicly accessible (see Article 67(1) of the Ordinance on Clinical Trials).
What are the informed consent obligations with respect to clinical trial subjects?
Persons may be involved in a research project only after they have given their informed consent. Consent must be given in writing (see Article 16(1) of the Human Research Act). The persons concerned must receive comprehensible oral and written information on:
- the nature, purpose and duration of, and procedure for, the research project;
- the foreseeable risks and burdens;
- the expected benefits of the research project, for themselves or for other people;
- the measures taken to protect the personal data collected; and
- their rights (see Article 16(2) of the Human Research Act).
Before a decision on consent is made by the persons concerned, they must be allowed an appropriate period of reflection (see Article 16(3) of the Human Research Act).
The details are set out in Articles 7 to 9 of the Ordinance on Clinical Trials.
What are the insurance requirements for clinical trials?
For Category A clinical trials, where any measures for the collection of health-related personal data or the sampling of biological material entail more than only minimal risks and burdens, the policy value must be at least:
- Sfr250,000 a person;
- Sfr20,000 for damage to property; and
- Sfr3 million for the entire clinical trial (see Annex 2(1) of the Ordinance on Clinical Trials).
For other clinical trials, the policy value must be at least:
- Sfr1 million a person;
- Sfr50,000 for damage to property; and
- Sfr10 million for the entire clinical trial (see Annex 2(2) of the Ordinance on Clinical Trials).
The liability coverage must include damage occurring up to 10 years after completion of the clinical trial (see Article 13(3) of the Ordinance on Clinical Trials).
What data protection issues should be considered when conducting clinical trials?
As a rule, if a private person conducts a clinical trial, the Federal Data Protection Act applies (in particular, Article 4 of the Federal Data Protection Act). If trials are conducted by cantonal hospitals, data protection is subject to regulation of the respective canton.
Moreover, the Human Research Act contains data protection rules that apply irrespective of the person conducting the trial. Pursuant to Article 58 of the Human Research Act, ethics committees and the other enforcement bodies are entitled to process personal data. Sensitive personal data may be processed as far as necessary. Regarding the disclosure and cross-border transmission of personal data, Articles 59 and 60 of the Human Research Act provide for detailed regulation.
If the intention exists to make further use of research regarding the health-related personal data collected, the consent of the persons concerned must be obtained at the time of such sampling or collection, or they must be informed of their right to dissent (see Article 17 of the Human Research Act).
The health-related personal data collected during a clinical trial in an emergency situation may be evaluated only once consent has been obtained. In exceptional cases, the health-related personal data may be evaluated before consent has been obtained if this is necessary for the sake of the participants' safety and health. If consent to participate in a clinical trial in an emergency situation is withheld after the event, the health-related personal data must be destroyed. If the validity of the clinical trial or its results would be compromised in essential respects by the destruction of the health-related personal data, the use of the data in the clinical trial is permissible despite the withdrawal of consent. The health-related personal data must be anonymised without delay. The concerned person’s right to dissent is reserved. If it is foreseeable that data may be evaluated before consent has been obtained, or used in spite of the refusal of consent, this must be stated in the protocol (see Article 17 of the Ordinance on Clinical Trials).
There are also detailed rules regarding the further use and storage of health-related personal data (see Articles 32 and following and Articles 41 and following of the Human Research Act, and Article 18 of the Ordinance on Clinical Trials).
What is the marketing authorisation procedure for medicinal products in your jurisdiction?
The distribution of a medicine in Switzerland – irrespective of whether the medicine requires a prescription or may be sold over the counter – requires a marketing authorisation from the Federal Agency for Therapeutic Products (Swissmedic) (see Article 9 of the Therapeutic Products Act).
As well as the ordinary licence procedure, the statute provides for a simplified licence procedure that applies if this is compatible with the quality, safety and efficacy requirements provided for by Swiss law (see Article 14 of the Therapeutic Products Act). In particular, this is the case with regard to:
- medicines made with known active pharmaceutical ingredients;
- complementary medicines;
- medicines prepared by a public pharmacy, a drugstore or another establishment holding a manufacturing licence according to its own formula, conforming to a pharmacopoeia or a formula recognised by Swissmedic, and which are dispensed to the manufacturer’s own customers;
- medicines prepared by a hospital pharmacy or in the hospital’s own radiopharmaceutical unit for the needs of the hospital;
- medicines prepared by the army and used in the context of the coordinated army medical corps;
- important medicines for rare diseases; and
- veterinary medicines that are intended exclusively for animals not kept for the production of foodstuffs.
Following the submission of the required documents, the application is examined by Swissmedic, which decides whether the marketing authorisation is to be issued based on the quality of the manufacturing, the medicine’s efficacy and its safety (see Article 16 of the Therapeutic Products Act). The marketing authorisation may be withdrawn if the medicine has not been marketed within the last three years (see Article 16a(1)(a) of the Therapeutic Products Act).
The entire authorisation procedure (in case of an ordinary licence procedure) takes between 10 and 12 months, or between four and five months if the applicant chooses the expedited procedure.
What criteria are considered in granting marketing authorisation?
A marketing authorisation will be issued if the applicant can prove that:
- the medicine is high quality, safe and effective;
- the applicant is licensed for manufacture, import or wholesale trade; and
- its registered address, registered office or branch office is in Switzerland (see Article 10 of the Therapeutic Products Act).
What is the fee for obtaining marketing authorisation?
The fees for a marketing authorisation depend on the licensing procedure (see Article 4(1) and Appendices 1 and 2 of the Ordinance on the Fees of the Swiss Agency for Therapeutic Products):
- the fees for licensing a medicine with a new active substance are between Sfr70,000 and Sfr140,000;
- the fees for licensing a medicine with an existing registered active substance are between Sfr15,000 and Sfr42,000;
- the fees for renewing an existing authorisation are Sfr500; and
- there is no fee for market authorisations of products granted orphan drug status (see Article 14(1)(f) of the Therapeutic Products Act and Appendix 2 of the Ordinance on the Fees of the Swiss Agency for Therapeutic Products).
What is the validity period for marketing authorisation?
The marketing authorisation is valid for five years but can be renewed provided that the conditions for issuing the marketing authorisation are met (see Article 16 of the Therapeutic Products Act).
What are the consequences of failure to obtain marketing authorisation?
If a marketing authorisation has not been obtained or granted, the respective medicinal product may not be placed on the Swiss market (see Article 9(1) of the Therapeutic Products Act). However, small quantities of non-authorised medicines may be imported by patients or medical persons subject to certain conditions (see Article 20(2) of the Therapeutic Products Act and Article 36 of the Ordinance on Authorisations in the Medicinal Sector).
The punishment for wilfully endangering human health (if there is no danger to human health, the penalties are less severe; see Articles 87(1)(f), (2) and (3) of the Therapeutic Products Act) by placing on the market medicinal products without authorisation is a custodial sentence not exceeding three years or a monetary penalty, or a fine of up to Sfr200,000. If the person concerned acts in his or her professional capacity, the punishment is a custodial sentence not exceeding five years or a monetary penalty, and a fine of up to Sfr500,000. In case of negligence, the punishment is a monetary penalty or a fine of up to Sfr100,000 (see Articles 86(1)(b), (2) and (3) of the Therapeutic Products Act).
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