How does the ethical review process work in Estonia and which are the designated ethics committees?
The University of Tartu founded a multifunctional ethics commission in 1990 and a similar committee was established in 1993 at the Institute of Experimental & Clinical Medicine in Tallinn. These were renamed in 1999 as Human Research Ethics Committees in Tartu and Medical Research Ethics committee in Tallinn.
In 1998 the Ministry of Social Affairs set up the Estonian Council on Bioethics as a national co-ordinating centre. It acts in an advisory capacity to health authorities and government. This Ministry is also responsible for the requirements for membership, and the remit of, ethics committees.
The State Agency of Medicine, established in 1991, is the body responsible for final authorisation of clinical trials.
There is a separate committee, established in 2001, that deals solely with the Estonian Genome Project
The new Medicinal Products Act entered into force on 1 March 2005. The previous Act from 1996, amended on several times has been repealed together with several lower implementing Acts in full.
The new Act regulates RECs under Chapter 5, Articles 87 to 99. The new Act implements a number of European directives –including Directive 2001/20 and provides comprehensive regulation of the manufacture, handling, distribution, marketing, prescribing, advertising and authorising of medicinal products (both human and veterinary) and provides the rules for supervision and liability.
A decree by the Ministry of Social affairs is expected to fully implement these provisions.
Weblinks to Estonia Ethics Committees