Preclinical and Clinical Trial Requirements
Important legal info on preclinical and clinical trial requirements in Latvia. Prepared in association with TGS Baltic, a leading law firm in Latvia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No, there is no requirement for clinical trials to be conducted in Latvia as a condition for marketing approval.
Following the national procedure, clinical trials may be conducted either in Latvia following the legal requirements of the Rules of the Cabinet of Ministers, or in any country of the European Economic Area (EEA) in accordance with the requirements of the respective legal acts of that country. Clinical trials conducted outside the EEA have to comply with ethical principles equivalent to those set out in the EEA, including adhering to the requirements of International Good Clinical Practice and ethical principles established in the Declaration of Helsinki, developed by the World Medical Association.
In Latvia, marketing approval may also be received following the mutual recognition procedure, which is based on the recognition of a pre-existing national marketing authorisation by one or more EU countries, or the decentralised procedure, where the application for marketing authorisation is submitted simultaneously in several EU countries, one being chosen as the “Reference Member State”. In such cases clinical trials may be conducted in any country of the EEA.
2. How are clinical trials funded?
Clinical trials are generally funded by the sponsor. The sponsor is a physical or legal entity, which takes responsibility for the initiation, management, or financing of a clinical trial.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
A trial protocol a document that describes the objective, design, methodology, statistical considerations, and organisation of a trial, states subject inclusion and exclusion criteria, procedure for trial monitoring and publication policy.
Trial protocols must be scientifically reasoned and prepared in accordance with the requirements of the guidelines for good clinical practice.
For clinical trial approval, the trial protocol, among other documents of the trial, must be submitted to and approved by the SAM. The Latvian Ethics Committee also reviews the protocol and expresses an opinion on the trial protocol. In order to receive an approval, the Ethics Committee must issue a favourable opinion.
4. What are the requirements for consent by participants in clinical trials?
All participants of clinical trials must sign an Informed Consent of the person to participate in a clinical trial (hereinafter the Informed Consent). The Informed Consent is documented in writing by filling out the consent form.
The Informed Consent must meet the criteria established by laws, i.e. the Informed Consent must:
- be given by a person capable of expressing his/her will or by his/her legal representative;
- be given only after being informed about the nature, significance, implications and risks of the clinical trial, objectives, risks and disadvantages, conditions under which it is to be conducted, insurance indemnity to cover the liability of the researcher and sponsor and the rights to revoke consent at any time as well as protection of personal data;
- be given freely by the participant or the participant’s legally acceptable representative. If a person cannot write, in exceptional circumstances, an informed consent may be given orally in the presence of one witness;
- meet the comprehensive requirements for content of the consent, including all information listed in point 2 above and the declarations of the participant, e.g. confirmation that the participant understood all the given information, had a possibility to ask questions and receive explanations, understood the right to withdraw from the clinical trial anytime, etc.
5. May participants in clinical trials be compensated?
Yes, the participants in clinical trials may be compensated. The participants are entitled to compensation only for the expenses incurred and the time spent for participation in the clinical trial (transportation, expenses, daily allowances). Compensation is paid by the sponsor or by the person authorised by the sponsor. Compensation is paid according to the agreement concluded between the participant and the sponsor of the clinical trial, i.e. when the payment of compensation is included in the Informed Consent form.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The participants in clinical trials have the right to compensation for any harm (both pecuniary and non-pecuniary) suffered as the result of participation in a clinical trial or arising in the context of the clinical trial.
Sponsors and principal investigators share the liability for any damage suffered by the participant as the result of participation in a clinical trial. The sponsor is not responsible for a deliberate or accidental injury caused to a participant by the investigator or other individuals involved in the clinical trial.
Sponsors and principal investigators have an obligation to insure their third party liability. There is no specific threshold.