Preclinical and Clinical Trial Requirements
All legal aspects surrounding preclinical and clinical trials in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, 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?
Clinical trials are not required to be conducted locally as a condition for marketing approval.
Following the national procedure, clinical trials may be conducted either in Estonia in accordance with the legal requirements of the Medicinal Products Act or in any country of the European Union in accordance with the local legal requirements.
If the clinical trial is conducted outside of the European Union, the State Agency of Medicines may, in the event of justified need, inspect at the expense of the applicant the sites located outside of the European Union required for the attestation of the compliance of clinical trials.
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.
2. How are clinical trials funded?
Clinical trials are usually funded by a sponsor. The sponsor is an individual, company, healthcare institution or organization which initiates, organizes and/or funds the clinical trial. The sponsor is liable for the compliance of all aspects of the clinical trial and the conduct thereof.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
The trial protocol of a clinical trial shall describe the scientific background and objective of the trial, the trial plan, selection of trial subjects, use of the investigational medicinal product and other treatment of trial subjects, evaluation of the efficacy and safety of the medicinal product, the methods of collecting, storing and processing of data, the statistical methods used, the system for ensuring the quality and for inspection of the trial, the ethical aspects of the trial, the financing and insurance cover of the trial and the principles of publishing of the results of the trial.
The protocol must be submitted to and approved by the State Agency of Medicines and by the ethics committee. Amendments to the trial protocol and conducting of the trial require prior approval of the State Agency of Medicines and of the ethics committee.
4. What are the requirements for consent by participants in clinical trials?
Consent must be given in writing after having been informed of all circumstances (for example, objectives, risks and inconveniences of the trial and the conditions under which it is conducted) relating to the clinical trial of a medicinal product.
The consent shall be documented in two original copies which shall be signed by the trial subject or his or her legal representative, indicating the date of signing, and by the person who notified the trial subject. One original copy shall be given to the trial subject, the other shall remain with the person who conducts the trial.
The trial subject has the right to terminate participation in the trial by withdrawal of the consent for trial at any time without any sanctions.
5. May participants in clinical trials be compensated?
Participants in clinical trials may not be compensated.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
A healthcare professional conducting a clinical trial and healthcare provider participating in a trial must provide necessary assistance to a trial subject within the limits of their competence. If necessary, the healthcare professional conducting a trial must ensure the availability of competent assistance of other health care providers to the trial subject. Also, it is required to inform the trial subject, among other things, of possible hazards and the manner and rate of compensation for any health damage sustained in connection with the trial.
The sponsor of the trial and persons conducting the trial shall ensure the rights of trial subjects to physical and mental integrity, inviolability of private life and the protection of information and data concerning him or her.
Medicinal Products Act enacts the liability of the sponsor of a clinical trial and of healthcare providers and health care professionals conducting the clinical trial. The sponsor of a clinical trial must ensure the trial subjects health insurance protection in the event of damage to health related to the trial.