Civilinės atsakomybės už klinikinių vaistinių preparatų tyrimų metu tiriamajam asmeniui padarytą žalą probleminiai aspektai.
In Lithuania, as well as in other Eastern European countries, there is a relatively high number of people participating in clinicai triais of medicinai products. In foreign countries an increasing number of lawsuits against investigators, clinicai trial sponsors and heath care institutions are raised seeking compensation for the damage inflicted during clinicai triais, This indicates the risks involved. The protection of rights and interests of trial participants is thoroughly regulated by international, EU and the Lithuanian legal acts. From 2004, EU Member States have to implement the Clinicai Triais Directive. The Directive specifies that it is without prejudice to the civil and criminal liability of the sponsor or the investigator. The Directive does not require no-fault compensation. It requires insurance or indemnity covering liabilities of the sponsor and investigator. National health care institutions remain liable for clinicai negligence and other negligent harm to individuais covered by their duty of care. Nevertheless, civil liability for harm made to the trial participant has not yet been exarnined Lithuanian doctrine of law. This article analyzes Lithuanian legal acts, judicial practice, the doctrine of law and foreign scientific resources in order to assess the specifics of civil liability for harm to the participant of clinicai triais of medicinai preparations. First of all this article examines weather actions of investigators conducted during the clinicai trial can be regarded as health care services in Lithuanian legal system. It also intends to look at the peculiarities of civi! liability of health care institutions and medical practitioners involved in the trial as well as sponsor’s and investigator’s liabilities for harm which occurred during the investigation of medicinai product. Legal regulation of the compulsory clinicai trial insurance in Lithuania is also discussed. The problematic aspects of civil liability for harm to the clinicai trial participant are emphasized throughout the article. The author provides recommendations for further development of Lithuanian legal regulation, puts forward severai proposals on resolving questions arising in practical situations and suggests possible directions for further scientific research.
- Articles / Straipsniai