Lithuania

Regulatory

Lithuania is the largest of the three Baltic States. As many other European countries, after joining the European union in 2004, Lithuania has harmonized legislation on clinical trials with the EU standards.

Clinical trials in Lithuania are regulated by the State Agency for Drug Control. There are also 2 ethical bodies:

• Ethical reviews of clinical trials are carried out by Central Ethics Committees (CEC)
• Lithuanian Bioethics Committee (LBEC) is the main institution responsible for ethical evaluation of clinical trials in Lithuania.

These regional committees are authorized to consider applications for clinical trials that are planned only at research sites within the scope of the committees.

Official links

https://www.jforcs.com/wp-content/uploads/2019/08/An-insight-into-conducting-clinical-trials.pdf  

https://www.easthorn.com/geographical-reach/lithuania/

On average, it takes about 60 days to obtain all necessary approvals – the timelines are relatively short because all applications can be submitted in parallel.

Pharmaceutical Industry & Clinical Trials Market

Clinical trials for medicinal products have been conducted in Lithuania since the early 1990s. The number of trials is increasing every year. Currently, there are about 250 trials ongoing in Lithuania.

The market share is divided between generic and patented medicinal products, with generic medicinal products accounting for about 70% of the volume and 60% of the value in Lithuania.

Medical system

Lithuania has an excellent modern public health care system, financed by the government through the national health insurance system. All employers are obliged to register employees in the system and their family members automatically become participants. Low-income groups such as the elderly and people with long-term illnesses are not obliged to contribute but are still covered through the scheme.

Medical care, including emergency care, is free at the point of delivery. In non-urgent cases there is a standard referral system for general practitioners. European nationals with an EHIC card can access health care in Lithuania free of charge on presentation of the card and passport.

Country has a significant number of previously untreated patients. One of the main factors in recruiting subjects into a clinical trial successfully is encouraging the physician to participate. There is a high level of patient trust and confidence in the physician’s recommendation.