Preclinical and Clinical Trials
All legal aspects surrounding preclinical and clinical trials in Lithuania answered in this structured guide. Prepared in association with TGS Baltic, a leading law firm in Lithuania, 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 Lithuania as a condition for marketing approval.
Following the national procedure, clinical trials may be conducted either in Lithuania following the legal requirements of the Law of the Republic of Lithuania on Pharmacy, or in any country of the European Economic Area (EEA) in accordance with the requirements of 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 Lithuania, 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 an individual, company, institution or organisation which takes responsibility for the initiation, management, and setting up the funding of a clinical trial.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
A trial protocol is a document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial.
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 State Medicine Control Agency of Lithuania (competent authority). The Lithuanian Bioethics Committee also reviews the protocol and expresses an opinion on the trial protocol. In order to receive an approval, the Bioethics 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;
- be given only after being duly and clearly informed of the objective, plan, applicable methods of the clinical trial, permissions issued by the competent authorities, benefits for the participant, rights of the participant, possible risks and hardships, insurance indemnity in case of damage, the right to revoke the consent and confidentiality guarantees regarding health information;
- be given freely by the participant or the participant’s legally acceptable representative;
- 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 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, subject to limitations. The participants are entitled to compensation only for the expenses incurred and the time spent for participation in the clinical trial. 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 a right to compensation for any harm (both pecuniary and non-pecuniary) suffered as a 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 a result of participation in a clinical trial, except for damage which occurred as a result of intentional actions of the participant.
Sponsors and principal investigators have an obligation to insure their civil liability. The sum of the compulsory civil liability insurance of the sponsor and the principal investigator must be not less than EUR 29,000 for the pecuniary and non-pecuniary damage incurred by a participant.